Modern Pharmaceuticals - May 2012

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Editorial

5May 2012 I Modern Pharmaceuticals

TPartner‘ship’ sails

EditorialAdvisory Board

Ajit SinghChairman, ACG Worldwide

& Head, ISPE

Dr Abraham PataniPast President, IDMA & CMD, Inga Laboratories

Dr Gopakumar G NairIPR Consultant & Advisor

Dilip G ShahChairman, IGPA &

Secretary General, IPA

Daara PatelSecretary General, IDMA

he rules of the game in the pharmaceutical space have certainly changed and how! In the span of only a few years the inbound as well as outbound trade dynamics have witnessed significant strategic manoeuvres including a few course corrections in some cases. This has not only shaped the global forays (which are still evolving) of Indian pharma companies but also affected the India-specific strategy of pharma MNCs.

The latest case in point is the reported preference of pharma MNCs to enter into alliances rather than outright acquisitions of their Indian counterparts. Considering the numbers of partnerships that have seen the light of the day in recent months, it seems a distinctly new order of doing business in India is under way from the perspective of international Big Pharma.

So, what could be the trigger behind this shift in Indian strategy wherein most of the domestic companies have entered into an alliance to produce, sell or supply drugs within the country and abroad? Well, the primary reasons are both global and Indian. Let’s begin with the global factors. With a long pipeline of patent expiries as well as the humungous cost involved and high failure rates in developing new drugs, the partnership model of growth appears more attractive of late than the one based on acquisition.

On the other hand, with the Indian pharma market getting increasingly regulated, there is immense scope for the Big Pharma to leverage the emerging opportunities by joining hands with Indian companies based on a win-win value-added approach. Along with sharing responsibilities, costs and benefits, such partnerships appear more appealing to MNCs in the backdrop of recent amendments in the government’s foreign directinvestment policy.

That said, it is crucial to stay focussed on the priority action areas related to Indian healthcare needs in terms of accessible, affordable and adequate pharmaceuticals vis-à-vis the development of such collaborative models of growth. While it is good to bring down cost on a continuous basis (quality and safety being the given), ample prudence must be exercised by appropriate policy measures et al to ensure that the focus of R&D in such alliances stays in line with the primary disease areas rather than veering heavily towards

niche areas.

Manas R [email protected]

Contents


5 Editorial

10 News, Views & Analysis

16 Technology & Innovation

18 Technology Transfer

67 Projects

Special Focus

REGULAR SECTIONS

Details on page no.: 61

In Conversation With Harish Iyer Managing Director & CEO, Shantha Biotechnics Ltd

20

Nutraceuticals market ..................................................... 24Regulatory needs ............................................................ 26Pricing strategies of nutraceuticals ................................... 30Interface - V Bhasker Rao ................................................ 32Roundtable ..................................................................... 34Roundtable ..................................................................... 35

Nutraceuticals.................................23

Insight & Outlook

Contract manufacturing API market .............................40HP APIs for biogenerics .................................................42Interface - Amitabha Gangopadhyay ..............................44Roundtable ....................................................................46Clinical research industry ..............................................48Infl uenza vaccines market ...............................................50Access to healthcare .......................................................52Peristaltic pumps ...........................................................54Case Study - In-sight vision systems ...............................56

Facility Visit Jubilant Life Sciences Ltd Banking on integration

36

Automation Trends Robotics and lab automation for drug discovery

When future becomes the present! .............................58Bhanu Prakash, MD & CEO, Automed Systems Pvt Ltd

Energy Management Waste management

No haste while disposing waste ..................................60

Policies & Regulations Impact of NPPA Draft 2011

Win some, lose some ..................................................62Dr Ajit Dangi, President& CEO, Danssen Consulting

Strategy Proximity dilemma

To wish or not to wish? ..............................................64Dr Rajan T D, Pharma Consultant & Practising Dermatologist

Tips & Tricks Pre-grant oppositions

Knowing the nuances .................................................66Kamakhya Srivastava, Head-Group on Research Publication and Programme, LEX ORBIS IP Practice

Note: ` stands for Indian rupee, $ stands for US dollar and £ stands for UK pound, unless mentioned otherwise

Highlights of Next Edition

Special Focus: R&D in Pharma

Insight & Outlook : Pharma SEZ

Looking For A Specific Product?Searching and sourcing products were never so easy.

Just type MPH (space) Product Name

and send it to 51818eg, MPH Laboratory software and send it to 51818

69 Event List

71 Book Review

72 Products

84 List of Products

85 List of Advertisers

Active Pharmaceutical Ingredients (APIs) ............... 39


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News,Views & Analysis

10 Modern Pharmaceuticals I May 2012

Glenmark Generics Inc, USA the subsidiary of Glenmark Generics Ltd, has been granted fi nal Abbreviated New Drug Approval (ANDA) from the United States Food and Drug Administration (US FDA) for lamotrigine 25, 100, 150 and 200 mg tablets, the generic version of Lamictal® by GlaxoSmithKline. Lamotrigine is an anti-epileptic drug indicated for epilepsy and bipolar disorder. According to IMS Health, sales data for the 12 month period ending

December 2011, lamotrigine tablets garnered annual sales of $ 62 million.

Glenmark’s current portfolio consists of 80 products authorised for distribution in the US marketplace and 38 ANDA’s pending approval with the US FDA. In addition to these internal fi lings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of the existing pipeline and portfolio.

Novozymes Biopharma, part of Novozymes A/S, a world leader in bioinnovation, has recently announced that its recombinant human albumin (rAlbumin), Albucult®, is being used by Neomend in the company’s Progel® adhesion barrier sealant product that has recently received the European Union CE mark.

David Renzi, President and CEO, Neomend, commented, “Novozymes

has an extensive understanding of the regulatory pressures its customers are facing and its quality-assured, consistent b i o p h a r m a c e u t i c a l components make the company an ideal partner for Neomend. Th e Progel Adhesion Barrier Sealant CE mark is a vital milestone as it will enable us to help surgeons in Europe eff ectively prevent adhesions and its associated complications.”

Novozymes’ rAlbumin supports faster time to market for Neomend adhesion barrier sealant

Glenmark Generics receives USFDA approval for lamotrigine tablets

In keeping with its commitment to make medicines aff ordable and accessible particularly to cancer patients, Cipla Ltd recently announced a breakthrough price reduction in selected cancer drugs for the treatment of lung cancer; Hepatocellular Carcinoma (HCC), a form of liver cancer; Renal Cellular Carcinoma (RCC), a form of kidney cancer; and Glioma, a deadly form of brain cancer. Cipla’s brand ‘Soranib’ (Sorafenib) for the treatment of HCC & RCC will now be off ered to cancer patients at a price of ` 6,840 for a month’s therapy. Th is comes as a boon for patients with a 76 per cent reduction from the current cost of ` 28,000.

According to World Health Organization (WHO), there are about 2.5 million cases of cancers diagnosed in India every year. Most cases receive sub-optimal treatment due to the high cost of drugs. “Th is initiative of price reduction is a humanitarian approach by Cipla to support cancer patients” commented Dr Y K Hamied, Chairman and Managing Director, Cipla Ltd. He also added, “Drugs constitutes a signifi cant proportion of the overall cost of cancer treatment and reduction in costs can greatly relieve the burden.”

Cipla’ s Profi t After Tax (PAT) increased by 36.3 per cent to ` 292 crore during Q4 FY11-12 as compared to ` 214

crore during Q4,FY10-11. Th e company’s domestic revenues grew by 15.5 per cent to ` 754 crore during Q4 FY11-12, up from ` 652 crore during Q4 FY10-11. Th e growth in domestic revenues were largely on account of growth in anti-asthma, antibiotics, expectorants and anti-infl ammatory therapy segments.

Exports of formulations grew by 15.1 per cent to ` 855 crore during Q4 FY11-12, up from ` 743 crore during Q4 FY10-11. Exports of APIs degrew by 1.0 per cent to ` 230 crore during Q4 FY11-12, from` 232 crore during Q4 FY10-11.

Th e growth in export revenues were primarily due to growth in anti-asthma and anti-malarial segments.

Cipla announces a breakthrough price reduction on selected cancer drugs

Dr Guzzetti

Intertek India opens a new Extractable and Leachable (E&L) lab in Mumbai Intertek India recently announced the opening of its new analytical lab, specialised in conducting extractable and leachable studies in Mumbai. Dr Mara Guzzetti, Head, Operations - Chemical and Pharma Division, Asia Pacifi c, Intertek, inaugurated the lab with the vision to build a strong platform to provide extensive services to the pharma industry in India.

Investigation of materials that are coming into contact with pharmaceuticals and their possible interactions with these drugs are the basis of a better quality assurance for the packaging of the pharma products.

Dr Guzzetti said, “With the increase in generics and contract manufacturing activities in countries like India and China, it is imperative to

have strong local expertise to look into quality at all levels, including medical devices. Th e new high-end testing facilities established by Intertek will enable our team of experts to conduct all the sophisticated analyses that need to be carried out on the ground in order to better protect the patients from related potential health risk.”

- Chandreyee Bhaumik



Granules India Ltd has appointed V V S Murthy as Chief Financial Offi cer Pranesh Raj Mathur, who had the dual role of President – Active Pharmaceutical Ingredient (API) Division and CFO will continue his role as the President of the API Division. Murthy previously served as Group Chief Financial Offi cer at Dishman Pharmaceuticals and Chemicals Ltd and has over 32 years of experience in the fi nance industry including 17 years in the pharma industry.

“Th e addition of Murthy to the senior management team will ensure that we are able to move quickly and capitalise on new opportunities. His knowledge in optimising fi nancial systems, working with foreign subsidiaries and M&A experience will be benefi cial as our company continues to grow.

Mathur who recently completed his EMBA at the Indian School of Business, will focus his energy on taking P&L responsibilities for our API Division,” said C Krishna Prasad, Managing Director, Granules.

Dr Reddy’s Laboratories has launched quetiapine fumarate tablets (25 mg, 50 mg, 100 mg, 200 mg, 300 mg and 400 mg), a bioequivalent generic version of Seroquel® tablets in the US market following the approval by the US FDA of Dr Reddy’s ANDA for Quetiapine fumarate tablets.

Th e Seroquwl® brand had US sales of approximately $ 4.6 billion for the most recent 12 months ending December 2011 according to IMS Health.

Besides, it has also launched olanzapine tablets, a bioequivalent generic version of Zyprexa® tablets in the US market on April 23, 2012 following the approval by the US FDA of Dr Reddy’s ANDA for Olanzapine tablets. Dr Reddy’s Olanzapine Tablets in 20 mg had been awarded a 180-day period of marketing exclusivity in the US on October 26, 2011 that was commercialised through a commercial, manufacture and supply agreement with Teva Pharmaceutical Industries Ltd.

Dr Reddy’s announces the launch of olanzapine and quetiapine fumarate tablets

Granules India announces new Chief Financial Offi cer

Mylan Laboratories Ltd, the Indian subsidiary of Mylan Inc, recently announced that it has entered into a partnership with the UN’s Millennium Development Goals Health Alliance (MDGHA) and the Clinton Health Access Initiative (CHAI) to fi ght

childhood deaths caused by diarrhoea. At a recently conducted conference in Mumbai to discuss how public-private partnerships can be mobilised to advance the health of women and children in India, Mylan announced that

it would develop and expand access for needy children across the country.

Anirudh Deshpande, Senior Vice President, Business Development, Mylan Laboratories in India, said, “Th is is a tragic, heartbreaking and avoidable situation that largely can be addressed if these children simply get the treatments they need. At Mylan, we are committed to increasing access to these aff ordable treatments to the children of India and those in the rest of the world. We share the concerns of organisations such as MDGHA and CHAI about expanding access to these life-saving medicines, and we look forward to continuing to work with them to help meet these needs.”

Mylan to partner with UN and CHAI

Ranbaxy sales grow over 55 per cent with improvement in base business profi tability

Th e Board of Directors of Ranbaxy Laboratories Ltd at their recently held meeting took on record the unaudited results for the quarter ended March 31, 2012. Th e consolidated sales were ` 37,002 million and Earnings before Interest, Tax, Depreciation & Amortization (EBITDA) was 27 per cent of sales at ` 10,152 million. And, Profi t After Tax (PAT) of ` 12,468

million was registered. Commenting on the business results for the quarter, Arun Sawhney, CEO & Managing Director, Ranbaxy, said, “Th e focus on key products and markets, while maintaining emphasis on further strengthening quality and compliance standards has had a positive impact on the performance of Ranbaxy during the quarter. Th e company is working towards creating a sustainable, profi table,

growing business in the long run with diff erentiated, branded generics business at its base.” He added that an important development has been the resumption of exports to the US from the Indian facility. Sawhney highlighted, “Eff orts are on to improve the eff ectiveness and effi ciency of resource deployment continues, which is expected to result in further improving our base business in the coming quarters.”

Strides delivers robust Q1’12 performanceStrides Arcolab recently announced its fi nancial results for the quarter ended March 31, 2012. “Th e quarter’s strong operational performance in both specialties and pharma businesses refl ect the company’s strongly articulated niche IP led strategy. Th e performance is driven by signifi cant operating leverage and ramp up in capacity utilisation with continued regulatory approval momentum” said Arun Kumar, Vice Chairman & Group CEO, Strides Arcolab Ltd. Th e revenues excluding divested operations grew by 40 per cent to ` 495 crore (` 353 crore in Q1’11). And EBITDA excluding divested operations grew by 64 per cent to ` 137 crore (` 83 crore in Q1’11).



Ranbaxy has recently launched the drug Synriam, which it claims will prove a more effi cient and simpler treatment for malaria. It is the fi rst recently developed anti-malarial that is not based on artemisinin, one of the most eff ective treatments for malaria, which has begun to suff er from problems with resistance in recent years. Ranbaxy has hailed Synriam as India’s fi rst domestically developed drug - although none of its active ingredients were discovered in the country. Ranbaxy developed Synriam as a fi xed-dose combination of arterolane maleate and piperaquine phosphate, where arterolane is the New Chemical Entity (NCE) that was developed as an alternative to artemisinin. Synriam was produced as a combination therapy to follow

World Health Organization (WHO) guidelines on delaying the appearance of drug resistance. In clinical trials, Ranbaxy reported a cure rate of 95 per cent when three tablets were taken over the course of three days - a simpler drug regimen than other treatments. According to the WHO, 225 million new malaria cases are reported each year, resulting in more than 650,000 deaths. Most occur in developing countries. With that in mind, arterolane was developed with the goal of creating a drug whose synthesis can be scaled up simply to help keep costs down. By contrast, artemisinin is still produced from plant sources, making it expensive. Arterolane’s simple synthesis process means that it can be sold at less than $3 (£1.85) a course.

Ranbaxy launches anti-malarial drug Synriam

Abbott announces collaboration with Syngene Abbott has recently announced its plans to establish its fi rst nutrition R&D centre in the country in collaboration with Syngene. Th e Abbott Nutrition R&D Centre in India will focus on the development of science-based, aff ordable nutrition products for the country and enable the expansion of Abbott’s nutrition product portfolio there.

Abbott selected Syngene – a subsidiary of Biocon, the largest biotech company in India – to provide a science-based research and innovation team to work closely with Abbott researchers. More than 50 researchers and scientists will be based at the Abbott Nutrition R&D Centre in India at Biocon Park in Bengaluru, which is expected to open by June 2012.

Th e new R&D centre will focus on the development of nutrition products for maternal and child nutrition and diabetes care. Preventing undernutrition has emerged as one of the most critical health challenges in India. In addition, the centre will address local taste and texture preferences with new fl avours and formulations.

Quintiles names Tom Pike as the new CEO

Ella Foundation receives $ 100,000 grant to checkmate polio and block VDPV Ella Foundation recently announced that it has won $ 100,000 Grand Challenges Explorations (GCE) Grant. Th is project to ‘checkmate the polio virus’ during and after the eradication of poliomyelitis could result in a live polio vaccine that cannot perpetuate. Such a vaccine could carry the benefi cial eff ects of an oral polio vaccine namely safety, effi cacy, ease of manufacture, distribution

and administration along with the safety profi le of an injectable polio vaccine by eliminating Vaccine-Derived Polio Virus (VDPV). “GCE encourages individuals worldwide to expand the pipeline of ideas where creative, unorthodox thinking is most urgently needed,” said Chris Wilson, Director, Global Health Discovery and Translational Sciences, Bill & Melinda Gates Foundation.

Quintiles has recently announced the appointment of Tom Pike as CEO. Th is appointment is part of the company’s long-term succession planning. Dennis Gillings, CBE, who founded the company, continues as Executive Chairman of its Board of Directors. Pike joined Quintiles on April 30, 2012. “Pike has an impressive track record of helping customers navigate fast-changing environments and solving complex business issues,” Gillings said. “He has experience with organisations our size and much larger that will be extremely valuable to us. Pike has a disciplined and forthright approach that will enable him to earn the trust of customers and employees alike. I am confi dent he will soon make his mark on our company and the industry at large, continuing the Quintiles tradition of entrepreneurial leadership and pioneering growth.”

Tom Pike

Novozymes starts commercial supply of new and improved hyaluronic acid Novozymes Biopharma, part of Novozymes A/S, the world leader in bioinnovation, has announced the fi rst shipment of the company’s Bacillus-derived hyaluronic acid, Hyasis®, from its newly inaugurated manufacturing facility in China. Th e fi rst commercial products using Hyasis as a raw material are expected to reach the market in Q2 of this year. “Shipment of the fi rst commercial hyaluronic acid material from our new Q7 GMP facility marks an

important milestone on our journey to becoming a leading producer of high quality hyaluronic acid. With our new patented process, based on the safe bacteria Bacillus subtilis, the market will have access to a new improved source of HA, which is fully compliant with the highest pharmaceutical standards and developed with customers’ specifi c needs in mind”, said Th omas Videbæk, Executive Vice President, Novozymes A/S.



Dr Deven V Parmar, one of the most eminent personalities from the industry has joined Karmic Lifesciences Inc as CEO & Medical Director, Americas. He comes in with over 8 years academic experience and about 20 years of

rich professional experience in the pharma and clinical research industry. His illustrious career includes stints with Wockhardt Ltd, Veeda Clinical Research, GlaxoSmithKline, Ranbaxy and Serdia Pharmaceuticals. His areas of expertise include clinical research, data management, medical writing & statistics, pharmacovigilance, regulatory and due diligence, licensing, business development & co-development.

Karmic Lifesciences Inc is delighted to have Dr Parmar head activities in the US. Based out of New Jersey, his responsibilities would include handling all strategic, business and scientifi c activities for the US subsidiary.

Neurobiologix, has announced the launch of its presecription product Calming Cream, a new topical cream that is designed to naturally assist with nervousness, hyper-activity, mood, sleep disturbances and trouble falling asleep. By delivering fi ve active ingredients through the skin in a lotion base of lavender oil, Calming Cream increases the levels of calming and anxiety-

reducing neurotransmitters in the brain such as dopamine and serotonin. “Whenever the brain is not producing enough of the natural chemicals that inhibit stress and nervousness, the likelihood of experiencing diffi culty with relaxation, mood instability, sleep and stress is very high,” said Dr Kendal Stewart, MD, Neurobiologix.

Neurobiologix launches new calming cream to assist with relaxation and healthy rest

AstraZeneca and the Drugs for Neglected Diseases initiative (DNDi) have announced an agreement to collaborate on drug-compound screening for leishmaniasis, Chagas disease, and sleeping sickness, three Neglected Tropical Diseases (NTDs) that together aff ect nearly 10 million people worldwide. Novel drug candidates to emerge from this collaboration will bolster the drug development pipeline for new medicines urgently needed by millions of patients. In the

new partnership, AstraZeneca will provide to DNDi 15,000 compounds that have the potential for activity against leishmaniasis, Chagas disease, and sleeping sickness. Th e screening activities, coordinated by DNDi, will be performed at Institut Pasteur Korea (IPK). If active compounds against any of the three diseases are identifi ed as ‘hits’, DNDi and AstraZeneca will jointly assess their potential as starting points for future medicines. “As a global pharma company that

conducts a signifi cant amount of infectious disease research, AstraZeneca recognises the urgent need to deliver new medicines for people who suff er from neglected tropical diseases. Sharing science beyond our own labs with leading organisations like DNDi is a great way to tackle these complex diseases that have gone unchecked for far too long”, said Manos Perros, Head - Infection Innovative Medicines Unit, AstraZeneca.

AstraZeneca and DNDi to collaborate on drug screening for neglected tropical diseases

Dr Deven Parmar joins Karmic Lifesciences Inc as CEO & Medical Director, Americas

At Achema 2012 in Germany, Bosch Packaging Technology will exhibit its new packaging system that integrates a stick pack machine and a fl ow wrapping machine. A seamless interface between the primary and secondary packaging machines maintains output quality, helps to eliminate downtime and ensures the system provides optimal performance. Th e

system is suitable for handling of a wide range of granules, powders and pellets, particularly for the pharmaceutical industry and is designed to provide highly accurate dosing via sophisticated fi lling augers.

Frank Bühler, Product Manager, Bosch Packaging Technology, said, “We are seeing growing demand for Stick Packs due to the convenience, minimal material

requirements and easy and safe opening of this pack style. Th e combination of the Sigpack RA and HCM machines in this packaging system allows manufacturers to bring this pack style to market effi ciently and safely. It ensures precise dosing at high cycle speeds and we are pleased to have the opportunity to present it to pharmaceutical manufacturers at Achema in June.”

Bosch to demonstrate new turnkey packaging solution for powders

Dr Parmar

FDASmart concludes its second anti-counterfeiting conference FDASmart, held its ‘2nd Pharmaceutical Anti-Counterfeiting Conference in Emerging Regions.’

Th e theme for the forum was to acknowledge the serious threat of counterfeits and trace a multi-stake holder look at the progress made in winning the battle against

counterfeits. A world-class group of experts came together to drive home not only the problems but present innovative solutions to win the war against counterfeiters.

Panel discussion at the end of the session involved some provocative discussion that included the audience comments and feedback.



Th e Chennai-based global pharma major Orchid Chemicals & Pharmaceuticals Ltd has received approval from US FDA for its Abbreviated New Drug Application (ANDA) for naratriptan tablets in the 1 mg and 2.5 mg strengths. Naratriptan tablets are the generic equivalent of GSK’s Amerge tablets. Orchid Chemicals is a leading pharmaceutical company engaged in the development, manufacture and marketing of diverse bulk actives, formulations and nutraceuticals.

Abbott and GVMC partner to screen women in Vishakhapatnam for thyroid disordersAbbott and Greater Vishakhapatnam Municipal Corporation (GVMC) recently signed an agreement to provide diagnosis and expand access to care for thyroid disorders, to help improve the quality of life of women in Vishakhapatnam. Th is partnership is one of the fi rst-of-its-kind in the country that is initiated by a government body and will screen approximately eight lakh women from Vishakhapatnam over a period of three years. While GVMC provides the infrastructure, Abbott provides GVMC with subsidised diagnostics and educational materials. Abbott also will support the Indian Th yroid Society to provide advanced courses on the management of thyroid disorders for the medical offi cers of GVMC. Th e patients would be treated at the Department of Endocrinology, King George Hospital in Vishakhapatnam.

Orchid Pharma receives US FDA approval for naratriptan tablets

Waters brings award-winning UltraPerformance Convergence Chromatography to Analytics 2012Waters Corporation is exhibiting its award-winning ACQUITY UPC2 System for the fi rst time in Europe at the 23rd Analytical International Trade Fair for Laboratory Technology. Th e ACQUITY

UPC2 System is a new category of separations science instrumentation that gives laboratories previously unavailable options for tackling tough analytical

challenges. “Th e introductions we are bringing to Analytical refl ect strong customer demand for greater problem-solving capability, greater effi ciency and certifi able data quality. UPC2, NuGenesis

8 and our new line of analytical standards and reagents make this year’s Analytical one of the most exciting in years for us,” said Art Caputo, President, Waters

Division. Adding to this Harbaksh Sidhu, Program Director - ACQUITY UPC2 Program, Waters Division said, “With ACQUITY UPC2 we applied our expertise in ultraperformance chromatography to the traditional technique of SFC and emerged with a more universal laboratory tool with much broader applications.”

Quintile wins Best CRO in Vaccine Excellence Awards

GlaxoSmithKline Pharmaceuticals observes World Asthma Day On the occasion of World Asthma Day, GlaxoSmithKline Pharmaceuticals Ltd (GSK) organised asthma check-up camps. Th ese camps were held in around 20 cities across the country. Th e ‘Asthma check-up’ camps were conducted by respiratory specialty doctors as an endeavour toward creating asthma awareness and received tremendous response across the country.

Research shows that asthma runs in families. However, environmental factors also contribute. Many substances can aggravate allergies or increase the

severity of asthma symptoms in individuals who are sensitive to these allergens or irritants. Some of the most common seasonal and non-seasonal allergens and asthma irritants are - cigarette smoke, cockroaches, dust mites, mold, pets & animals, pollen. Asthma requires long-term care and monitoring. It cannot be cured, but it can be controlled. Asthma management requires recognition and monitoring of symptoms, lifestyle modifi cations, environmental changes, adherence to treatment and medication plans.

Quintiles announced that it has been named the Best Clinical Research Organization (CRO) in the Vaccine Industry Excellence (ViE) Awards 2012. Presented at the World Vaccine Congress now under way in Washington, DC, the awards recognise and celebrate the leaders, innovators and pioneers in the vaccines industry. “Th is is a great honour to be recognised as the Best CRO at the World Vaccine Congress,” said Dr Ellen Vigdorth, VP Allergy, Respiratory, Infectious Diseases and Vaccines.” Adding to this he said, “It is a huge achievement and underscores our commitment to the development of quality vaccines and anti-infective products.”

Th is award comes shortly after Quintiles was named for the second year running, the 2012 Asia Pacifi c CRO of the Year at the BioPharma Convention Awards.

Japan chooses Sanofi Pasteur for fi rst enhanced inactivated polio vaccine

Sanofi Pasteur, the vaccines division of Sanofi , recently announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved the company’s standalone Inactivated Poliovirus Vaccine (IPV) against acute fl accid poliomyelitis (Imovax® Polio).

Imovax® Polio will be added to the country’s public immunisation programme on September 1. Th e approval of Imovax® Polio by Japanese health authorities is a major milestone towards a polio-free world. Imovax® Polio is an inactivated poliovirus vaccine made from poliovirus types 1, 2 and 3. Since its launch in France in 1982, Imovax®Polio has been approved in 86 countries.

Technology & Innovation


Th e Mastersizer micro particle size analyser was developed to provide a simple-to-use compact particle analysis solution capable of being operated at or near the production line as well as in the laboratory. Sample handling and dispersion is simplifi ed by the use of standard 600 to 1000 ml laboratory beakers in place of a fi xed tank. Its robust construction and relatively small size have made the micro very popular for off shore and mineral exploration applications.

Dip-in pump and stir head with continuously variable single shaft pump and stirrer and continuously variable ultrasonic probe. Th e spring counterbalanced stir head is lowered into a standard 600 ml to 1000 ml laboratory beaker in which the sample is dispersed. It helps in measuring materials from 0.3 μm to 300 μm.

Malvern introduces mastersizer micro

Merck Millipore recently expanded the Mobius® CellReady bioreactor portfolio with the launch of a 50 L single-use stirred tank bioreactor for process development and pilot scale mammalian cell culture. Th is new bioreactor allows biopharma manufacturers to implement robust, single-use technologies that bring their drugs to market faster, with less risk.

“Th e Mobius® CellReady 50 L bioreactor is an important addition to the Mobius® family. We have integrated a number of innovative features that deliver ease of use, reliability and operational fl exibility compared to existing single-use systems,” said Paul Chapman, Vice President, Biopharm Process Solutions. Th e Mobius® CellReady 50 L bioreactor extends the company’s portfolio of single-use processing systems from cell culture through ultrafi ltration/diafi ltration.

Singapore scientists from Bioprocessing Technology Institute (BTI) under the Agency of Science, Technology and Research (A*STAR) have for the fi rst time, identifi ed the molecular ‘switch’ that directly triggers the body’s fi rst line of defence against pathogens, more accurately known as the body’s ‘innate immunity.’ Th e scientists found that this ‘switch’ called Bruton’s Tyrosine Kinase

(BTK) when turned on, activates the production of interferons - a potent class of virus killers that enables the body to fi ght harmful pathogens such as dengue and infl uenza viruses. Th is discovery of BTK’s role as a critical ‘switch’ that boosts the body’s anti-viral response, paves the way for developing anti-viral drugs that target the BTK ‘switch’ to fi ght infectious diseases.

Th e research team from BTI extracted a class of innate immune cells known as macrophages3 and challenged them with the dengue virus. Th ey found that the BTK-defi cient immune cells were unable to produce interferons, and hence had much higher viral counts compared to the healthy immune cells that had high-levels of interferons to fi ght the virus eff ectively.

Singapore scientists discover ‘switch’ to boost body’s immune response

Merck Millipore launches Mobius® CellReady 50 L single-use stirred tank bioreactor

Cognex Corporation has recently introduced OCRMax™, a new tool for Optical Character Recognition (OCR) and Verifi cation (OCV) applications that gives Cognex vision systems and vision software the power to achieve the highest read rates while keeping misreads to a minimum. OCRMax is fast, easy to set up and simple to use across all In-Sight® vision system

and VisionPro® vision software platforms. OCRMax overcomes the limitations of other OCR technologies.

It is an all-in-one tool that can handle character variations, text skew, proportional fonts and variable string lengths, making it the most robust character recognition tool in the industry. OCRMax is easy to set up and use, with minimal training being required. Th e key to achieving the highest read rates with OCRMax is its superior character segmentation capability. Th e segmenting functionality takes each character line and splits it into individual regions that each contains one character. Th is robust functionality ensures that OCRMax can handle distorted, touching and variably spaced characters.

Cognex sets a new standard for industrial OCR

OCRMax

Mastersizer

Technology & Innovation


Today, fast-paced pharma manufacturing and processing environments rely on high precision performance in order to ensure consistent product identifi cation, monitoring and tracking. Further, these products must be verifi ed to be of the highest quality—from manufacturing to delivery. In the past, barcode technology was commonly used to monitor and track these processes, providing users with reliable product information to ensure quality and

consistency. Due to recent technological advancements, manufacturers are moving towards the use of a more sophisticated solution, Radio Frequency Identifi cation (RFID), to track and trace products. By gathering more data through tags or transceivers, RFID allows users to read the authenticity onto the tag and write them to a data carrier. Further, RFID systems off er diverse I/O capabilities for superior communication and connectivity—allowing for maximum performance. Data carriers can also provide a high quantity of read or write operations with high speeds, ultimately increasing tracking capabilities to improve operations.

RFID technology improves product quality for diverse pharma applications

PerkinElmer, Inc has signed an agreement to provide Next Generation Sequencing (NGS) sample preparation solutions to Macrogen, Inc a Korean-based global sequencing company.

As part of the agreement, PerkinElmer will provide Macrogen with its Sciclone® NGS Workstation for high throughput automated next generation sequencing sample preparation, the LabChip® XT nucleic acid size selection and collection system, and the LabChip® GX nucleic acid separation system, to automate and increase the company’s sequencing analysis effi ciency and throughput.

“We are delighted to assist Macrogen in its global mission to help realise the promise of understanding the human genome through its services, to advance better therapeutics and diagnostics for clinicians and patients worldwide,” said Kevin Hrusovsky, President, Life Sciences & Technology, PerkinElmer. “Our next generation sequencing solutions are well suited for helping to ensure the quality and integrity of genomic information for use in making personalised medicine.

PerkinElmer’s Next Generation sequencing solutions

Waters Corporation has recently announced that Vicam® - a Waters® Business, has introduced the Fumo-V™ strip test, the newest member of its quantitative strip test family.

“Fumo-V strip tests make testing for mycotoxins more accessible to food and agriculture producers worldwide. Th ey rely on early detection to protect humans and animals from potentially lethal eff ects of contamination,” commented Marjorie Radlo, General Manager - Director of Operations, Vicam. “Our quantitative strip tests can easily be performed onsite or in the laboratory giving precise, numerical results.” “Th e Fumo-V test is well-suited to onsite locations. Users do not need to be chemists and can learn to use the test in less than 30 minutes, yet still obtain quantitative results,” said Dr Stephen Powers, Head - Research & Development, Vicam.

Vicam’s new Fumo-V Strip tests delivers accurate detection of fumonisin mycotoxins

Th ermo Fisher Scientifi c Inc has recently featured the new Th ermo Scientifi c myECL Imager. It revolutionises the capture and analysis of stained protein gels and nucleic acid gels by simplifying the entire imaging workfl ow. myECL

Imager incorporates advanced Charge-

Coupled Device (CCD) technology that results in greater sensitivity of X-ray fi lm, with a signifi cantly higher dynamic range. Th e intuitive touch screen controls with on-board computer simplify the image acquisition process while improved sensitivity and small instrument footprint make the myECL Imager an

eff ective substitute for the laboratory darkroom. Th e Th ermo Scientifi c myImage analysis software supplied with the instrument provides a suite of programmes to analyse nucleic acid or protein images, including automatic lane and band identifi cation and molecular weight overlay analysis programmes.

Th e myImage analysis software saves image fi les in a non-proprietary format for easy sharing with colleagues.

New imaging system from Thermo Fisher Scientifi c for life science applications

myECL

Technology Transfer


As part of our endeavour to spread the technology culture, this section provides a means to promote and facilitate exchange of select technologies. We strive to bring together suppliers of such technologies with suitable users for negotiations and industrial collaboration.

A novel process Foramides Synthesisamides synthesisThe present technology provides with an amidation reaction of unprotected a-amino acids in water under neutral conditions with various aliphatic, aromatic and heteroaromatic amines in the presence of coupling reagent l,l’-carbonyldiimidazole (CDI) at ambient temperature to obtain the corresponding a-amino acid amides. Areas of application

Medical and pharmaceutical industryForms of transfer

Technology licensing

Anti-ulceritic APIsAn Indian company offers anti-ulcer drugs like omeprazole, pantaprazole, omeprazole sodium, omeprazole magnesium and esomeprazole magnesium for operations in manufacturing processes.Areas of application

Formulation industriesForms of transfer

Consultancy

Clorsulon and its intermediatesAn Indian company offers clorsulon, a highly potent anthelmintic drug, which is administered to de-worm the intestines of sheep and cattle.Areas of application

Pharmaceutical industryForms of transfer

Consultancy

Detection and analysis of heavy metals in the industrial effluentsThe present technology relates to a device and method for detecting and also measuring the concentration of copper in an industrial effluent. This device comprises of an ion selective electrode (ISE) coupled to immobilise Bacillus sphaericus strain characterized in producing Urease on its one end and to a voltage measuring

device which is calibrated to indicate the concentration of the heavy metal in the solvent at its other end. Areas of application

Industrial effluents, accumulatesForms of transfer


Filter cleaning system An Indian company offers an automatic filter media cleaning equipment with drying system. It consists of air wash, water wash and drying facilities.Areas of application

Filter media cleaningForms of transfer

Joint venture, equipment supply

Formulation for leucodermaIt is well known that these diseases have property of recurrence and most of the medicines used for cure have various side effects and also the disease is not fully cured. The company offers the formulation that is quite effective in curing all the above three diseases in short period of time. In case of leucoderma after application of the formulation there starts formation of patches (natural colour of skin) within a week. Areas of application

Pharma and medical industryTransfer terms

Joint Venture, technology licensing, research partnerships

Herbal formulation for psoriasis and eczema An Indian company offers an innovative herbal formulation that has the ability to control & cure psoriasis and eczema within one month of application of the formulation.Areas of application

Herbal medicine

Forms of transfer Joint venture, technical services,

technology licensing

Natural preparation for anxiety relief A company offers food supplement in the form of tablets that effectively relieves mild to moderate anxiety problems. The ingredient is an herbal extract, which has been scientifically proved for its efficacy. Efficient decrease of anxiety symptoms, quick onset of action and no side-effects are reported to be the advantages of this product. Areas of application


Equipment supply

Process of preparation of nanoparticles for drug delivery systemThe present invention is related to a process for the preparation of the novel nanoparticles of apotransferrin or transferrin which are useful for the preparation of a pharmaceutical composition facilitating easy delivery of the drug. Areas of application

Medical and pharma industryForms of transfer


Pharmaceutical composition for the treat-ment of ophthalmic diseaseA company can offer technology for manufacturing a drug useful in the treatment of opthalmic disorders. A composition comprising Lithium chloride is the product which causes retinal cell regeneration. Lithium chloride alone helped in proliferation of retinal cells but is associated with other effects. Areas of application

Pharma and medical industryTransfer terms

Consultancy, technical services, technology licensing

Technology Offered

Technology Transfer


Technology Requested

Biotechnology for wastewater treatment systemA Thailand-based company, a wastewater service provider, is involved in the R&D of new technology for water, wastewater and waste treatment. It requires new ideas related to technology for developing its strength in the field of wastewater.Areas of application

Biotechnology, engineering Forms of transfer

Consultancy

Calcium GluconateA company needs technology for manufacturing of Calcium GluconateAreas of application


Technical services, project report, others

Extract of medicinal and aromatic plantsA company is interested in putting up a multi-purpose herbal extraction plant for the extraction of medicinal and aromatic plants and herbs like artemisinin/quinine sulphate and other alkaloids.Areas of application


Others

IV fluid manufacturing as SME An Indian company needs new and good technology to start manufacturing of IV fluids. Areas of application

Medical technologyForms of transfer

Technical services, others

Kite grading engineeringA company is looking for kite grading, which is a subservient of genetic therapy research particularly for the cardiovascular novice.Areas of application

Medical researchTransfer terms

Others

Manufacture of intravenous fluidsA company requires know how and technological requirements for the manufacture of intravenous fluids. Know how should include where to obtain appropriate grade raw materials.Areas of applicationPharma/medicalForms of transfer

Others

Manufacturing technology of hepatits B, tetanus, diphtheria and pertussis vaccinesAn Indian company is interested in a complete technology for start up of manufacturing of combination vaccines from bulk to formulations including supply of protocols for manufacturing and production strains.Areas of application

Human vaccinesTransfer terms

Others

Manufacturing of liquid bio fertilisersAn agro biotech company is looking for a proven technology for manufacturing of liquid bio fertilisers. They would like to know the kind of technology that could be offered (ie the product, efficacy, length of field trial) and a procedure of buying the technology along with the cost incurred.

Areas of applicationBiotechnology

Transfer termsOthers

Manufacturing technologies for mon-telucast, rosuvastatin, ursodeoxy cholic acid, D-biotinA company needs API/bulk drug manufacturing technologies for montelucast, rosuvastatin, ursodeoxy cholic acid and D-biotinAreas of application

API/bulk drugForms of transfer

Others

Pharma grade mannitol know-howA company is on the look out for a commercially proven latest technology & know how (turnkey) for manufacturing pharma grade mannitol in India. The estimated production capacity is 600 tonnes per annum.Areas of application

PharmaceuticalsForms of transfer

Others

Pharmaceutical Lyophilisation plantA Peru based company is looking for a Lyophilisation plant for pharmaceutical use. Capacity shall be around 175 to 200 square feet, for the lyophilisation of 20,000 vials of 10 mL per day. Areas of application

Pharma and food processing industryForms of transfer

Others

Share and Solicit TechnologyThe mission of Modern Pharmaceuticals is to spread the technology culture. Here is an opportunity to be a part of this endeavour by sending your technology on offer or technology

requirements. If you belong to any of these two categories, you are invited to furnish the techno-commercial details for publication. The write-up needs to be as per the format of

this section with information about the particular technology offered or requested, its areas of application and forms of transfer. Contact us: Modern Pharmaceuticals, Infomedia 18 Ltd,

‘A’ Wing, Ruby House, J K Sawant Marg, Dadar (W), Mumbai 400 028. Tel: 022-3024 5000, 3003 4695 Fax: 022-3003 4499 Email: [email protected]

Information courtesy: Dr Krishnan S Raghavan, In-Charge, Technology Transfer Services Group, United Nations - Asian and Pacific Centre for Transfer of Technology (APCTT), APCTT Building , C-2, Qutab Institutional Area, New Delhi 110 016, Tel: 011 - 2696 6509, Fax: 011 - 2685 6274, Email: [email protected], Website: www.apctt.org, For more information on technology offers and requests, please log on to www.technology4sme.net and register with your contact details. This is a free of cost platform provided by APCTT for facilitating interaction between buyers and seekers of technologies across the globe. After submitting technology offer or request to this website, you are requested to wait for at least two weeks for receiving a response from a prospective buyer / seeker through this website, before contacting APCTT for further assistance.

In Conversation With: Harish Iyer


Jasleen Kaur Batra

“At Shantha, our focus is to provide accessible and affordable healthcare”

…says Harish Iyer, Managing Director & CEO, Shantha Biotechnics Ltd. A graduate in Chemical Engineering from the Indian Institute of Technology, Chennai, he subsequently obtained his PhD in Chemical Engineering from Rensselaer Polytechnic, New York. He has over 15 years of experience in the fi eld of biotechnology and biopharmaceutical R&D and has worked with companies such as Genentech, IDEC Pharmaceuticals Corp and Biocon. Excerpts...

Harish Iyer


After joining Shantha what have been your areas of focus? Today, Shantha is at an interesting position. We have had several changes in the senior management team last year and so today we have a new team and a new identity. It is an exciting new phase in many ways. After coming to Shantha our focus as a company is to provide accessible and aff ordable healthcare. Th e most exciting news this year from the public health point of view was that India has no reported cases of polio and the end game of polio will be Inactivated Poliovirus Vaccine (IPV). So there are two things we are trying to do - one is look at IPV and how we can supply this to the market through Shantha, and also globally can we be a source of IPV. Our focus will also be on looking at IPV in terms of hexavalent packaging. Apart from this, we have an interesting R&D pipeline - we have rotavirus, which kills up to a 100 thousand infants in India alone and globally 5,00,000. Th is vaccine is in the clinical stage at the moment. We are also looking at long term R&D of Human Papilloma Virus (HPV) vaccine that will go under clinical trial towards the end of this year or early next year. Also, Shantha is primarily about supplying to the government - the public market of India. Th is year we are supplying considerable amount of vaccines to the government and we wish to do that in the future as well. We have WHO pre-qualifi ed vaccines, which we supply to the government. From our perspective, it is the responsibility of the government to deliver quality healthcare to the rural parts of India. It is hard for us to invest a huge amount of capital in the supply chain and we wish that the Indian government does this.

What are the critical areas while dealing with vaccines?Vaccines are complex models and so they need strict control on acid and raw materials coming in which can cause variability in the quality of the vaccine. We need to monitor all these components carefully and the manufacturing process has to be controlled as well. Another

important aspect is that of people. If people in the organisation are not trained to look at the right things there is a problem. Hence, it is important to have right checks and balance all across the company as the procedure of manufacturing vaccines and ensuring high quality is an extremely complex process. At Shantha, we give considerable importance to all these factors and are also looking at investing in training people, knowing what to look for and better production of vaccine to ensure that even before we go into production we are assured that the product would not fail.

What is your take on the vaccine policy of India?We do not have a strong vaccine policy in India. For instance, the tender system in India is not like that of the UNICEF. Th ere is no understanding of the

fi ve-year time frame or three-year time frame. Even today, we use the same vaccines that were being used before and have not really expanded like other countries. Th ere are new vaccines that can be brought in India such as the rotavirus and IPV. Also, the procurement mechanism and supply mechanism needs to be changed. Today, we need to have a more robust dialogue with the government on how to have more predictability.

How does Shantha’s vaccines pipeline look like?Presently, we have hexavalent and a typhoid conjugate vaccine that are

in early stages of research. Another novel vaccine that is in the pipeline is Human Papilloma Virus (HPV) vaccine associated with the prevention of cervical cancer. Hepatitis B and rotavirus are a few more vaccines in the clinical stage. It is also possible that we start manufacturing the vaccine for measles such that it can be made more aff ordable and accessible to the Indian market. We are expecting to launch rotavirus vaccine in India by 2015. We are in the early phase of clinical trials and have already fi nished one set of trials and would be entering phase II very soon.

What quality standards are maintained by Shantha?At Shantha our main goal is to get all our vaccines certifi ed by the World Health Organization (WHO). Today, the standards of WHO have also increased tremendously. WHO certainly expects higher standards from vaccines and other drug manufacturing companies. Hence, we ensure that all our products are WHO qualifi ed.

Please quantify the investments made by Shantha for healthcare every year for the Indian market.It is extremely important that one makes regular investments in the company to upgrade their machinery as well as acquire the latest technology available. Today, we are making investment in equipment as well as upgrading our facility. We are also looking at various ways in which we can supply our vaccines to the global market, so we are investing a lot in research as well. Hence, if we put together all these areas of investment, we invest approximately $ 300 million annually on India alone.

What are your expansion plans?We are in the process of setting up a facility 5 km away from our current facility, which would be used for manufacturing Shan 5, Shan 6, rotavirus and other vaccines, which should be ready by 2014. Th is new facility will also help us fulfi ll our dream of manufacturing a billion doses of antigen globally in 2015.

([email protected])

It is the responsibility

of the government to deliver quality

healthcare to the rural parts of India and we wish that the Indian

government does this.

Special Focus


Nutraceuticals market

Under the scanner ................................................................24

Regulatory needs

Why amendements are a must? .............................................26

Pricing strategies of nutraceuticals

Aiming towards extended aff ordability ..................................30

Interface

V Bhasker Rao

MD, Nandan Biomatrix Ltd ......................................................32

RoundtableWill an Act like the Drugs Prices Control Order (DPCO) help? ............................................................34

Are Indian pharma companies investing enough in nutraceuticals? .................................................................35

Nutraceuticals


The healthcare industry in India is showing great progress. With the passage of time there has been considerable

increase in spending on healthcare backed by an increase in the purchasing power of individuals. Moreover, a lot of signifi cance is being given to preventive medication,

and in this scenario the nutraceutical segment in India is all set to fl ourish. Today, the nutraceuticals market is one of the booming markets in India.

According to a research report from Freedonia, the global nutraceuticals ingredients market is forecasted to record yearly growth in excess of 7 per cent to reach almost $ 24 billion by 2015. Growth will come from ingredients

with clinically confi rmed health benefi ts that can be used in a wide range of dietary supplements, drinks, foods and nutritional preparations for children and adults. Additionally, market growth across developing nations is expected to be faster in terms of consumption and production compared with developed nations. Nutraceuticals are used in the prevention of potential diseases and the healing of already existing ones.

Nutraceuticals can be broadly defi ned as nutrients that include substances, which have their nutritional functions eg, vitamins, minerals, amino acids, fatty acids, and so on; herbs or botanical products; and the third category is dietary supplements such as probiotics, prebiotics, antioxidants and enzymes. However, most common nutrients supplemented as nutraceuticals are minerals and vitamins, or in combination and or with other antioxidants. And the Indian nutraceutical market is dominated primarily by the Fast Moving Consumer Goods (FMCG) and pharmaceutical industry.

Growth prospectAccording to Transparency Research, the nutraceuticals product industry is classifi ed broadly according to functional beverages, functional food and dietary supplements. And market growth is fuelled by dietary supplement segment expansion. Th e protein and peptides sector of the dietary supplement market is expected to record strong growth in the coming years. In addition to this, the non-herbal market segment of the dietary supplement sector is also forecast to record strong growth between 2012 and 2017. Further, the report also shows that the Asia Pacifi c nutraceutical product market is an emerging market in dietary supplements and functional food segment. Japan is stated to be the largest consumer of nutraceuticals. Also, the report shows that China is the second largest consumer of nutraceutical product as people are more conscious about their food habits and they have the largest population in the world. Th e functional food market in India is

Chandreyee Bhaumik

Special Focus: Nutraceuticals market

With time people are gradually comprehending that nutraceuticals help not only for well-being but also for therapeutic purposes, and with this realisation, the Indian nutraceuticals market is growing.

scannerthe

Nutraceuticals market


expected to have moderate growing rate as compared to dietary supplement in the region. Th e functional food and beverage market in India is expected to have a 70.74 per cent rise as compared to the dietary supplement in 2017.

Predominantly, vitamins and minerals derived from oral pills were used for curing certain diseases and ailments. However, as people are gradually becoming health conscious they are becoming prone to consume immunity-enhancing food supplements and wellness-related products. Th is is promoting the growth of the industry with players diversifying into production of various new varieties of products. Additionally, assistance from the government and the increasing demand from consumers will fuel growth in this market. Factors like increasing shift towards preventive therapies, increase in the disposable income, increase in healthcare spending, increasing shift towards self-medication, changing demographics along with the growth in pharmacy and wellness-related retail chains and favourable pricing environment have resulted in the growth of the nutraceutical market. Commenting on the market growth, Rajesh Kumar, CEO, SamiDirect, says, “Th e nutraceuticals market in India is growing at 25 per cent Compounded Annual Growth Rate (CAGR) every year.” Further, comparing the Indian market scenario with the US, Kumar avers, “Th e US market is more regulated since it evolved in the early 70s. Th e average growth is only 5 per cent per annum. Also, Dietary Supplement Health and Education Act (DSHEA) is undergoing many regulatory changes,

which also is aff ecting the slow growth in the US.”

Meeting the demandIndia is going to be a major market for nutraceuticals in the future. Discussing the growth strategies, Kumar reiterates, “Th ere is a huge unmet demand in the market in the area of preventive health care. We would be introducing need-based clinically researched nutraceuticals products in order to cater to this huge requirement. Additionally, we are planning to set up a call centre for products in diff erent languages. Th is will essentially help us to connect with people.” Again, he believes that in this way a company will be able to penetrate to remote regions within the country in a systematic way. Elaborating on the nutraceuticals market, Ritesh Chordia, Vice President - Sales and Marketing, Bioprex Labs, discusses, “With time we can easily discern the huge scope for nutraceutical market. Fortunately, today doctors are able to understand the benefi ts of nutraceuticals. Further, with time, people now realise that nutraceuticals are not only required for their well-being but also for therapeutic purposes. Th us, various companies are marketing vigorously in this regard.” In order to cater to the growing demands of the market the companies should study the demand pattern and then customise their products accordingly. For nutraceutical segment, proper validation process is required to be conducted.

Roadblocks Several trends such as fortifi ed foods,

ayurvedic nutraceuticals, foreign tie-ups, players educating consumers, encapsulation are seen. However, in spite of the prosperity there are several challenges that the Indian nutraceutical market is facing. Th e key challenges to the market include lack of standardisation, marketing and distribution challenges, high pricing and lack of awareness. Elaborating on the challenges in this market, Kumar says, “Unfortunately, the approach in the market was more of curative one as of now. Initially, wellness was all about treating illness but we intend to bring a paradigm shift in the approach of wellness. We want to convey that we do not need nutraceuticals when someone is getting ill or delaying the onset of illness.” He further adds, “Th e biggest challenge is to reach out to people with the correct information. Th is context we are addressing with our direct client approach. Additionally, we are also working on the call centre concept.”

Elaborating on the level of awareness as far as nutraceutcials market is concerned, Chordia explains, “With time, people are getting aware about nutraceuticals. Fortunately, in today’s world the young generation has access to the Internet but the traditional people still have a diff erent mindset. Th ey prefer having the apple instead of the anti-oxidant Apple. We should also remember that the nutraceuticals do not have side-eff ects because the molecules are made of either plants or herbs.” Th us, the nutraceuticals market demonstrates an exciting market dynamics with huge growth potential.

([email protected])

Rajesh KumarCEO, SamiDirect

Ritesh Chordia Vice President - Sales and Marketing, Bioprex Labs

We should also remember that the nutraceuticals do not have side-effects because the molecules are made of either plants or herbs.

There is a huge unmet demand in the market in the area of preventive healthcare. We would be introducing need-based clinically researched nutraceuticals products in order to cater to this huge requirement.


Today, nutraceuticals is one of the booming markets in India. According to various reports, the total market for

nutraceuticals in India was valued at ` 44 billion in 2009 and is expected to reach ` 95 billion in 2013. Further, the US has been the major market for nutraceuticals with India and China becoming fastest growing markets. Today, nutraceuticals are gaining acceptance due to their ability to address several diseases. Vitamins, minerals and nutrients constitute about 85 per cent of the market, while antioxidants and anti-agents account for 10 per cent of other segments such as herbal extracts occupy 5 per cent of the market, globally.

Even today India does not have any strictly defi ned guidelines or regulations for the nutraceutical segment. In an

endeavour to receive global acceptance, Indian Government has taken several initiatives for laying down science-based standards for articles of food and to regulate their manufacture, distribution, sale and import, etc. Nutraceuticals are not a part of pharma and drugs formulation. Th us, rules and regulations also tend to be diff erent for this segment. Th erefore, in order to bring a sort of decorum in the scenario Indian government had introduced Food Safety and Standards Authority of India (FSSAI). However, this could not completely do away with the confusion that the players had. Further, the new entrants were not too sure about the minute details of the nitty gritty of the segment. One of the important considerations for regulation in the nutraceutical segment involves getting the licence and developing country specifi c health and label claims.

Primarily due to the growing health consciousness among consumers over preventive measures for diseases, this market is being fuelled with growth potential. Further, some nutraceutical companies have discovered India as an incredible R&D resource, stemming from the large and mature generic pharma industry that already exists there. Additionally, Indian research and technology in areas of fermentation processes, plant extraction and even chemical synthesis are generally much more developed compared to their Chinese counterparts and continue to have labour cost savings that make outsourcing attractive.

Present regulatory scenarioIn spite of the growth prospects of the segment there is ample confusion as far as the regulatory scenario is concerned. Discussing the present regulatory scenario, Kamal Anand, Senior General Manager - Consumer Products Division, Plethico Pharmaceuticals Ltd, says, “Th ere is no clear cut defi nition or strict guidelines to defi ne how a nutraceutical product in the market is created or sold. As a result, there are some grey areas. In some cases, a product is referred as a medicine and in some other instances it is referred as a food item. Th ere is a lot of ambiguity that needs to be addressed.” Elaborating on this further Anand adds that people take advantage of this ambiguity. He highlights, “Since this segment does not have any defi nite guidelines laid down, it does not fall either into food or pharmaceutical sector. It completely depends on which way the end receiver considers it. Even with the introduction of a new law, situation has not improved much due to the hindrances caused by infrastructural problems and other issues.”

Regulatory agencies in India do not encourage manufacturers to promote dietary supplements as natural products, but rather generally as drugs. Th us, it is diffi cult for manufacturers from the dietary supplement industry to compete with manufacturers within the (regulated) pharma market. Consequently, dietary supplement manufacturers must market their products within pharmaceutical

Special Focus: Regulatory needs

With too many nutraceutical players mushrooming regularly there is a need for a strict and clear & defi ned regulatory system. Lack of clarity in this regard will merely add to the woes.

Chandreyee Bhaumik

Why amendements are a must?

Illustration: Sachin Bhogate

Regulatory needs


industry regulations, under a drug or Ayurvedic manufacturing licence.

Th e two Acts governing the Indian nutraceutical industry are classifi ed under the following:

Foods are covered under the Prevention of Food Adulteration Act (PFA)

Drugs are covered under both the Drug and Cosmetic Act, 1940 and the Drugs and Magic Remedies Act, 1955

Classifi cation of a product as either food or a drug is based on manufacturers’ marketing claims.

When a product is marketed as a food, the advantage to the manufacturer is a less complicated process. However, some states still require product registration of these products as drugs. Under the PFA, functional foods are defi ned by Rule 32A as a ‘nutritional food,’ which is: “Food claimed to be enriched with nutrients such as minerals, proteins or vitamins.” To be compliant with the Act manufacturers, must include the quantities of such added nutrients on the label.

If, on the other hand, a product is to be marketed as a drug, the drug category includes allopathic drugs, traditional medicines (eg, Ayurveda, Siddha, Unani-ASU and homeopathy), and can include vitamins, minerals and herbs. Th e advantage to a manufacturer under drug regulations is that if it is approved as a drug, appropriate disease claims are permitted. Like other drug/pharma regulations, pre-market approval is a defi nite requirement. It is also important to note that no fortifi ed/functional foods are allowed under the drug regulations; these are covered under the Food Act.

Comparison noteTh e Indian regulatory scenario is very diff erent from that of the developed countries. Giving a comparative picture, Mohit M Jain, Executive Director & COO, Neiss Labs Ltd, avers, “Any user requires proper access to law and expect his/ her queries to be answered quickly and accurately. As compared to the US, the Indian regulatory system is very quick in responding to and resolving queries put forward by its users.”

Elaborating on how India is diff erent from the developed countries as far as the regulatory scenario is concerned, Anand avers, “In developed countries there is a clear cut demarcated way of functioning. For example, nutraceutical market in India is part of the Over-Th e-Counter (OTC) business. And I personally feel in India nothing is OTC and everything is OTC. But in developed countries the situation is diff erent. Th ere is a prominent line separating the prescribed and OTC products. In developed countries prescription products are never available without prescription and in case of OTC products though there is less medication, abundant information is available.” Talking about the diff erence, Jain adds, “Th e Indian Food and Drug Administration/Food Safety and Standard Authority of India (FDA/FSSAI) websites should be updated with more FAQs so as to render better precision to users.”

Amendments required Based on the above discussion, it is apparent that few amendments are required in the Indian regulatory scenario.

Elaborating on the required changes, Anand says, “Even today there are too many unorganised players in the market. Th ere are many nutraceutical products coming out of and inside the country. Everybody is competing on the delivering and pricing front. But in India, the end consumer is mostly not benefi tted because there is no proper way to give information. Th ese are the aspects that we need to look at. Th e end consumer must be informed about the positive and negative aspects.”

He continues, “Strict guidelines are required that would determine which product will qualify as a nutraceutical product. Also, sometimes people take undue advantage in passing a product as a nutraceutical product. Th is further indicates that there is a tendency to entice the customer with false claims. And, the most unfortunate part of the whole thing is that they still get away with this.” Anand continues that nutraceutical segment is still at its nascent stage and is not very organised. Discussing on how the situation can be improved, he shares that there needs to be a record to show if a product is not pertaining to a certain level of conduct. Th ere are several players in the market but not all of them are unorganised. Discussing the changes that are required, Jain remarks, “Amendments are required in terms of maintaining quality standards/protocols, maintaining claims on labels and enforcing & monitoring regulation. Th ese changes shall bring the Indian regulatory system closer to the US operating standards.”

([email protected])

Kamal AnandSenior General Manager - Consumer Products Division, Plethico Pharmaceuticals Ltd

Mohit M JainExecutive Director & COO, Neiss Labs Ltd

The Indian Food and Drug Administration/Food Safety and Standard Authority of India (FDA/ FSSAI) websites should be updated with more FAQs so as to render better precision to users.

In some cases, a product is referred as a medicine and in some other instances it is referred as a food item. There is a lot of ambiguity that needs to be addressed.


According to a recent report by Global Industry Analysts (GIA) the global nutraceutical market is

projected to exceed $ 243 billion by 2015 due to the consumer desire for leading a healthy life and increasing scientifi c evidence supporting healthy foods. Further, rising healthcare costs, an ageing population and growing beauty affi xation coupled with the introduction of supplements claiming to enhance beauty are expected to stimulate growth in the nutraceutical market. Elaborating in this regard, Hitesh Gajaria, Partner, KPMG India, avers, “While the US, Europe and Japan account for 85 per cent of the market share of the global nutraceutical market, India accounts for 1.5 per cent; thereby, indicating that the market is fairly underdeveloped in India.”

Pricing strategyFixing the price of a product is one of the vital decisions that is required to be made. Commenting in this regard, Gajaria points out, “To strategically price nutraceutical products it is important to consider the current need of the market, the products that are in maximum demand (depending on the awareness of health issues / disease profi le / lifestyle in the region).” According to him it is imperative that manufacturers competitively price their products and advertise them using the right medium / channels in order to create the required impact within the target customer audience. He highlights, “Th ere are numerous evolving trends that promote preventive medicine and self-treatment, which are likely to give an impetus to this segment.”

Th e nutraceutical market has tremendous potential globally owing to the high-income levels of people in developed economies, greater awareness

of healthcare and widespread preferences for specialty nutritional products. Discussing other considerations for fi xing the price of the nutraceutical product Gajaria continues, “In India it would be important to price the products keeping in mind the reluctance of the people to spend on health-related products apart from medicines or prescription drugs.”

Difference in pricesFurther, sometimes it is observed that a similar product is priced diff erently by diff erent companies. It must be remembered that it is the quality of the ingredients used by diff erent companies that marks the diff erence. Gajaria clarifi es, “It is extremely essential that the higher prices of similar products need to be justifi ed in terms of superior quality and better ingredients being used to manufacture it.”

Talking about the pricing strategy, Bhavesh Shah, CEO and Managing

Chandreyee Bhaumik

Special Focus: Pricing strategies of nutraceuticals

Aimingaffordability

towards extended

Different cost of ingredients results in making the price of similar nutraceutical products varied. A sneak peek into the signifi cant factors considered for the pricing of a nutraceutical product.

Pricing strategies of nutraceuticals


Director, Euphoria Healthcare Pvt Ltd, explains, “Availability of the ingredients is one of the important factors that need to be considered for fi xing the price of a nutraceutical product. Most of the time the ingredients required for producing the product is diffi cult to procure. Th us, the less availability of the nutraceutical ingredients along with a high level of consumption makes the nutraceutical product extremely expensive.” According to Shah, it is the demand-consumption pattern that determines the price of these nutraceutical products. He highlights, “Depending on the availability of the ingredients price of the nutraceutical products vary widely. It is only for a few products such as garlic capsules and some others that an optimum can be fi xed.”

Commenting on diff erent prices of similar products, Dinesh Chauhan, Director, C & C Organics Pvt Ltd, says, “It is the cost of the ingredients along with the expense of the extraction process that make the nutraceutical products expensive. Th erefore, products like lyco tine capsules, green tea extracts are expensive because of the high cost of the ingredients. Th e prices of the nutraceutical products fl uctuate depending on the increase and decrease of the cost of the ingredients.”

According to Gajaria following are the factors that need to be considered for fi xing the price of a nutraceutical product:

Evolving focus towards preventive therapiesTh e increase in disposable incomeIncreasing bend towards the concept of self-medication

Th e increase in number of wellness and pharmacy-related retail chainsFavourable and appropriate pricing environmentTh e ever-changing demographicsTh e growth in healthcare spendingTh e increasing focus on beauty and the positive endorsement of supplements that claim to enhance it

Gajaria says, “Th ese factors will create opportunity for non-core pharma companies and also provide a widening of off erings for pharma companies. For example, the nutraceutical segment gaining traction would refl ect upon the general public’s awareness towards healthcare. It endorses the idea of better lifestyle and health and the supplements are aimed to provide nutrients that are missing or are not consumed in suffi cient quantity in a person’s diet.”

Diffi culties facedDetermining the price of a product is not an easy aff air. Elaborating on this Shah says, “Th e biggest challenge that is faced is explaining the price to the consumers. Extraction is an extremely expensive process and it is very diffi cult to explain this to the end consumers. In majority of the situations it is the psychological barrier that prevents the end consumers from accepting the high price of the products.” Shah explains that it is almost a challenge to explain the nutritional and health benefi ts of the nutraceutical products to the consumers. He reiterates, “Various products such as pomegranate capsules for slimming, garlic capsules for cardiac, etc are expensive because of the high cost of the ingredients. Th e entire

process of extracting the ingredients to converting them into formulations is expensive. And it becomes very challenging to explain this to the consumers.” Talking about the challenges, Gajaria opines that the challenges faced by the nutraceutical market are lack of standardisation perception of high prices, lack of awareness about nutraceutical products in the market coupled with marketing and distribution challenges. He remarks, “Th e nutraceutical market is highly competitive and driven by several factors such as safety, price, effi cacy, brand loyalty and packaging. However, the major issue faced currently is maintaining consumer brand loyalty due to the growing similarity among products and formulations available in the market.”

An eff ective way to overcome these challenges would be by endorsing the products available in the market via the right advertising channels. Gajaria says, “Proper awareness is a prerequisite to increasing acceptability. Th e key players should ideally employ the various available mediums to advertise their products and also highlight the specialty of their product in comparison to competitor products. It would also be useful if a renowned dietician/nutritionist endorsed a particular company’s product as it would considerably improve brand recognition and increase product credibility.”

Th us, the pricing of a nutraceutical product is not a complex process but involves a great deal of thinking and planning as satisfying the end consumer is the prime target.

([email protected])

Hitesh GajariaPartner, KPMG India

Bhavesh Shah CEO and Managing Director, Euphoria Healthcare Pvt Ltd

Availability of the ingredients is one of the important factors that need to be considered for fi xing the price of a nutraceutical product.

To strategically price nutraceutical products it is important to consider the current need of the market, the products that are in maximum demand.


What fuels the growth for Nandan Biomatrix?India has a rich traditional heritage in the fi eld of Indian system of medicine, and ayurveda being one of the most traditional Indian medicine systems addresses individuals with its understanding about the holistic aspect of human beings functioning as a whole - this was the basic platform for Nandan. We have looked into the requirements of natural products industry connected to quality, quantity and consistency of products for India and abroad based on which we have created a roadmap for medicinal plants producing improved therapeutic content in cultivation, processing and extraction and its eff ective packaging resulting in state-of-the-art products in the global markets.

Has nutraceuticals developed as a defi ned market segment in India and how has Nandan Biomatrix worked towards achieving the same? Th e Indian nutra market is coming up with increasing emphasis on fortifi ed benefi ts as well as lifestyle product range concentrating on health and well being. It is a fast growing segment providing the greatest opportunity and Nandan has put in eff orts to achieve its market share in this segment. Our nutraceutical business has three segments: formulations, standardised herbal extracts and export.

How crucial is R&D for the development of nutraceuticals and does Nandan Biomatrix invest signifi cantly?R&D is the key component for progress of any industry and is more relevant for nutra segment throughout the entire process of farming to product manufacturing. Proper R&D results in improved varieties of herbs and medicinal plants producing a higher therapeutic content, improving method of cultivation and eff ective processing methodologies resulting in world class products. We have focussed on R&D in all the segments and hence we are confi dent of our market share in this segment.

What challenges are faced by this market in a country like India and are Indian pharma companies willing to enter this segment?Th e key challenges of this segment are maintaining the quality material as the feed stock, developing the products suitable for various applications, and of course, marketing of the products for profi tability. We have realised that to address these key challenges of maintaining the quality, quantity and consistency we need to develop a scientifi c and systematic approach for the segment. With growing popularity of this market segment we have seen several Indian pharma companies entering the same.

What has been the growth strategy of your company for the last fi ve years and how are you gearing up for the coming years?Growth strategy for the company has been mostly in developing scientifi cally validated innovative products targeting lifestyle disorders in healthcare and well being segment. We have developed highly effi cient aphrodisiacs products for men and women and value-added aloe vera products for general health. We at Nandan follow unique product development process, which set forth from scrutinising traditional leads till marketability. Our standardised extracts supplies are accompanied by analysis reports of microbial, heavy metal and pesticide residues. We carry out chemical-free processing at low temperatures to retain its purest form without altering the active ingredients nutritional and functional properties and its inherent therapeutic principles.

What are your plans with regard to expansion/product launches?In this era of greater awareness of health and preventive medication, grasping the eminence of nutraceuticals across the disease segments is essential and so we are expanding our phase 2 facility with high technology functional food processing unit.

([email protected])

Special Focus: Interface - V Bhasker Rao

“The key challenge of this segment is maintaining the quality material as feed stock”…says V Bhasker Rao, MD, Nandan Biomatrix Ltd, who has brought in scientifi c and systematic approach for the natural products industry in India. Here, he talks about the growth of the segment.

Titash Roy Choudhury

Special Focus: Roundtable


Will an Act like the Drugs Prices Control Order (DPCO) help?There are frequent claims that nutraceutical products are extremely high priced and varied. In this scenario, will an Act like DPCO help to better the situation?

Nutraceuticals do not come under the purview of essential drugs as they are mostly concerned with wellness. In this scenario, there is an urgent need to look beyond Acts such as DPCO that deal with pricing of essential drugs.

Editorial take

Dhiren P DalalDirector, Herbal Hills

Nutraceuticals are made out of natural ingredients and therefore the cost of these products is based on the price of raw materials. On the other hand, in case of generic drugs, the cost is based on chemical formulae. And thus naturally, the pricing strategies of these two segments of the products are completely diff erent. In this scenario, I feel that Acts like DPCO will not be of much help.

Additionally, depending on the quality of the raw materials (natural ingredient) the price of the same nutraceutical product may vary from company to company.

A perfect example in this situation is Chyawanprash. Th e price of the product is diff erent for diff erent companies. But in the case of allopathic medicines the cost of the product is the price of formulae. Th us, while for generic drugs DPCO can be implied I am unsure about the implication of DPCO for nutraceuticals.

Chandreyee Bhaumik

Dr H G KoshiaCommissioner, Food & Drugs

Control Administration, Government of Gujarat

It is important to note that nutraceuticals are not considered to be essential drugs. It still falls under the category of food supplements. Further, nutraceuticals do not have much of curative value as it is more of a special type of food supplement. In this regard, it can be said that DPCO primarily applies to medicines, in particular, essential and licensing medicines. Th erefore, I do not feel that DPCO would be of much use as far as the pricing of the nutraceuticals is concerned.

However, I agree that the high price of the nutraceutical products is a matter of concern. Th us, manufacturers should try to have a price control check on their own and regulate the price of these products. On the other hand, it is sometimes observed that the prices of the same nutraceutical product vary from one company to the other. Th is is primarily because of the diff erent quality of ingredients used in the same product by diff erent companies.

Vikram Gupta Founder & Managing Partner,

IvyCap Ventures Advisors Pvt Ltd

It is not easy to implement DPCO in the nutraceutical market right now. Th ough the market size is quite substantial the Indian nutraceutical market is still coming up.

However, the main issue is that the majority of the market is still treated as the Over-Th e-Counter (OTC) market and not the prescription market. Hence, most of the players are Fast Moving Consumer Goods (FMCG) kind of players, who operate on the typical FMCG margins. Further, most of the nutraceutical products are not treated as life-saving drugs or products. Th ey are mostly the preventive kind of products. I feel this is the basic issue. It is not going to be easy to bring the nutraceuticals under DPCO though it might be a good approach for some of the products under that category. If the nutraceuticals come under DPCO it will be of help to the end consumers as the prices of the high priced nutraceuticals will come down.

Roundtable


Are Indian pharma companies investing enough in nutraceuticals?Indian lifestyle has undergone a massive makeover. The demand for nutraceutical drugs such as multi-vitamins and protein supplements are increasing but are pharma companies investing enough in the segment?

Th e nutraceuticals segment is attracting many players from the pharma market. In India, there are still a few constraints that needs to be cleared before companies can look at this segment as a good investment destination.

Editorial take

Abhijit BhattacharyaChief Operating Officer, Omni

Active Health Technologies

Th e nutraceuticals segment has seen a steady growth since 15 years all over the world and has fi nally gained some foot in the Indian market. Not only pharma and food companies are eyeing this segment, exclusive nutraceuticals companies are emerging to particularly cater to this segment. A whole range of products in protein supplement, energy supplement is emerging along with variety of dietary supplements such as multi-vitamins or OTC products. Th en, there are also multi-vitamins that are targetted separately for men and women.

Th ere are many pharma companies investing in this segment to come up with their own dietary supplements and multi-vitamin tablets to meet the growing demands. Considering as an emerging segment, nutraceuticals has huge scope of expansion and growth for pharma and food companies. Pharma companies are willing to enter this segment to expand their product portfolio. But they are new to this and more awareness is required for creating better opportunities.


S V VeerramaniManaging Director, Fourrts (India)

Laboratories Pvt Ltd

Th e nutraceuticals market is encountering a booming growth worldwide and India is not lagging behind in this trend. Today, awareness regarding this segment has also increased considerably in India and among Indian companies. But one aspect that is still holding back the involvement of pharmaceutical companies in this segment is the lack of clarity with respect to nutraceuticals in India. When it comes to the regulatory status, it is not well defi ned in this country. Th ough nutraceuticals have been classifi ed into food and drugs separately there are some that are neither classifi ed as drugs or food. Although there has been some move earlier to create a separate group for nutraceuticals with proper regulatory status, it has not taken off so far. Under this unclear situation, Indian pharma companies are not able to invest enough in nutraceuticals. If the government provides a proper regulatory status to nutraceuticals, the companies will be able to invest with confi dence.

Sanjay Dhir CEO & MD, Zen Labs India

Nutraceuticals form a crucial part of the day-to-day life of any person considering the basic element of any nutraceutical is anti-oxidant that fi ghts with the free radicals being developed by the human body, which can cause harmful diseases including cancer. Nutraceuticals help in keeping the body active and considering the hectic lifestyle being led by Indians this segment is of immense importance. Although there is a huge demand for the same and there is an increasing population of India, pharma companies are not investing enough in this segment. And one of the main reasons de-motivating them is the intervention of Drug Price Control Order (DPCO). Th e basic component of any nutraceutical is vitamin and the price of most of these vitamins is controlled by DPCO. And looking at the price of the raw materials and cost of production vis-à-vis the retail price fi xed for most of these vitamins, the pharma companies do not see it as a viable opportunity since there are hardly any profi ts.


Jubilant Life Sciences Ltd is an innovation-driven pharmaceutical player catering to the demands of the global life sciences industry.

Established as a strong and leading Custom Research and Manufacturing Services (CRAMS) player and Drug Discovery and Development Solutions

(DDDS) provider outside India, the company is constantly endeavouring to move up the value chain. Jubilant Life Sciences leverages its focus on innovation and customer satisfaction and serves 150 customers from over 50 countries. It widely divides into two business segments: life sciences products and life sciences services. On April 13, 2012, a sector-specifi c SEZ for

chemicals was formally inaugurated by Narendra Modi, Chief Minister, Gujarat. Th is SEZ is spread over 300 acres at the Bharuch district in Gujarat, and is built with an investment of over ` 500 crore. With this SEZ, the company started the commercial production for niacinamide, which has a capacity of 10,000 Million Tonnes Per Annum (MTPA) niacinamide and 3-cyanopyridine.

Jubilant SEZWe visited the manufacturing facility for these nutritional ingredients and Proprietary Product & Exclusive Synthesis (PPES). Spread over 300 acre of land developed at the Vilayat Industrial Estate, it houses world scale plants for Vitamin B3 (niacinamide), 3-cyanopyridine, and fi ne chemicals like 2,3,5-collidine, 2,3-lutidine& 3-amino methyl pyridine. Th ese global scale plants of Vitamin B3 and 3-cyanopyridine at SEZ make Jubilant the largest producer of Vitamin B3 in India and second largest globally. Th e SEZ also has a manufacturing plant for Symtet, a crop science ingredient for one of the world’s largest and safest low cost insecticide through an environment friendly process. Th is will make Jubilant the world’s largest producer of the crop science ingredient for the insecticide through green route.

Jubilant SEZ houses state-of-the-art & world class general, specialised & specifi c industrial infrastructure facilities, appropriate & adequate social infrastructure facilities and the right atmosphere & environment for achieving new horizons for the Jubilant Bhartia Group. Th e group is hopeful of generating over ` 1000 crore revenue as and when the SEZ becomes completely operational. Th is SEZ currently provides direct and indirect employment to over 600 persons. It is well connected to road network through developed roads and national highway, to railway network through western railway line and waterways due to its proximity to Dahej Port. Th e facility has a constant supply of water and power and ample effl uent drainage facilities provided by state government. “Jubilant SEZ is fi rst of its kind in India - largest capacity, fully

In 2007, the ‘Vibrant Gujarat’ conference witnessed the signing of a Memorandum of Understanding (MoU) between Jubilant Life Sciences Ltd and the Government of Gujarat for the establishment of a sector-specifi c Special Economic Zone (SEZ). Inaugurated in April 2012, this SEZ is spread over 300 acre of the Vilayat Industrial Estate of Bharuch district, Gujarat.

Banking on integration

Parita Dholakia

Facility Visit: Jubilant Life Sciences Ltd

Manufacturing plant for 3-cyanopyridine

Jubilant Life Sciences Ltd


backward integrated, in-house developed innovative technologies and world class quality products,” beams Hari S Bhartia, Co-Chairman & Managing Director, Jubilant Life Sciences Ltd.

PPES accounts for more than 27 per cent of overall sales of Jubilant Life Sciences. Proprietary Products (PP) and Exclusive Synthesis (ES), helps the company to monetise its expertise in pyridine chemistry. Th is new manufacturing facility is expected to further boost sales from the PP segment. Speaking about the USP of the SEZ, Shyam S Bhartia, Chairman & Managing Director, Jubilant Life Sciences, avers, “Th e starting raw material for the agrochemical & the nutrition product facilities are pyridine and beta picoline, respectively, which the Company produces in Gajraula, UP, using renewable resource such as alcohol produced from sugarcane molasses. All other plants throughout the world produce it through petrochemical route and hence have a much higher carbon foot print in comparison to our green process.”

Revenue generation from nutritional products has remain stagnant, but the management is hopeful for better traction, going ahead, with new launches via new capacity and newly derived applications in cholesterol lowering market for Vitamin B3.

‘Partner of choice’Jubilant Life Sciences is the fl agship company of Jubilant Group (13,000+ employees), having business interest in pharma life sciences & specialty chemicals, oil & gas (exploration & production), food & retail and consulting services in aerospace and oilfi eld services. Incorporated in 1978 as a mid-sized chemical player, it has gradually shifted

into pharmaceuticals. Th e group caters across the entire pharma value chain: drug discovery, R&D services and commercial manufacturing of Advance Intermediates (AIs), Active Pharmaceutical Ingredients (APIs) and other generic drugs. It has manufacturing facilities in India in UP, Maharashtra, Karnataka, Gujarat, and also in USA and Canada. It serves its customers across the globe and it is well recognised as the largest CRAMS

company out of India. Over the years, it has extended its footprint beyond India in the USA, Canada, Europe, and other countries across the globe. It expanded its business by building capabilities internally, through strategic build outs and acquisitions, resulting in a network of 7 world-class manufacturing facilities in India and 3 in North America and a team of around 6300 people across the globe with around 1500 in North America. Recently, it has been ranked number 6 amongst the Top 10 global contract manufacturing & services outsourcing players of the pharmaceutical industry. With the USP of

being vertically integrated, it is well placed to maintain margins and profi tability despite volatility in pricing.

Corporate Social Responsibility (CSR) is an integral part of how it conducts its business and all their eff orts are directed towards community development through focus on primary education, basic healthcare service, and livelihood generation programmes focussed on improving the employability of women and local youth.

Th e company and its managing directors have been recongnised with several awards, which bear testimony to its commitment towards operational excellence, innovation, corporate governance and social responsibility.

Prospective growthTh e company expects margin expansion in CMO and DDDS on account of a full year’s impact from signed contracts, traction in clinical trials and boarding of integrated programmes from key customers. Capacity expansion in proprietary products & exclusive synthesis, nutrition ingredients and APIs are also expected to boost revenues going forward. Th e launch of new products is expected to further strengthen Jubilant Life Sciences’ performance. With an aim to leverage innovation and scale of operations at every step of the pharma value chain to deliver value to stakeholders, the company has set its sight on the right track. Standing amid the vast acres of land, and seeing the production operation in full swing leaves one no doubt that the SEZ will achieve its set target sooner than later.It may be a new child to Jubilant Life Sciences, but in the near future it is accomplished to take somehuge strides.

([email protected])

37

Hari S BhartiaCo-Chairman & Managing Director

Jubilant SEZ is fi rst of its kind in India - largest capacity, fully backward integrated, in-house developed innovative technologies and world class quality products.

Shyam S BhartiaChairman & Managing Director

All other plants throughout the world produce the raw material through petrochemical route and hence have a much higher carbon foot print in comparison to our green process.

With the USP of

being vertically integrated, it is well placed to maintain

margins and profi tability despite volatility

in pricing.

Insight & Outlook

39May 2012 I Modern Pharmaceuticals 39

Contract manufacturing API market Focus on emerging regions ................................................. 40

HP APIs for biogenericsPotential unexplored .......................................................... 42

Interface Amitabha GangopadhyaySenior Director – Business Excellence and Strategy, Sanofi India ............................................................................44

RoundtableIs China a threat to India for APIs? ..................................... 46

Clinical research industry Why cynical about clinical? ................................................ 48

Infl uenza vaccines market Signifi cant unmet needs ..................................................... 50

Access to healthcare Need to focus on infrastructure and healthcare delivery ............................................................. 52

Peristaltic pumps Moving beyond the labs ...................................................... 54

Case Study - In-sight vision systems High-speed pharmaceutical glass vial inspection ................. 56

Insight & Outlook

Active Pharmaceutical Ingredients (APIs)

39


Insight & Outlook: Contract manufacturing API market

Globally the Indian pharmaceutical market holds third position in terms of volume while

for value it occupies the 14th place. Over the last decade we have seen a manifold increase in the potential of Indian pharma market especially in manufacturing where India has created its own niche. With high quality standards and compliance to regulatory standards, today India has more number of US FDA-approved manufacturing units

than its competitor market China. Gradually, India is becoming a hub of manufacturing and also attracting MNCs for outsourcing of manufacturing. Th e Indian contract manufacturing market for formulations is around $ 3 billion growing at over 40 per cent driven by high quality - low cost production models and manufacturing profi ciencies. In the recent years we have seen growth of Active Pharmaceutical Ingredient (API) market worldwide. “Global API market is $ 100 billion and growing at 8 per cent. While China is the world’s leading manufacturer by volume followed

by India and Italy, US is the largest consumer followed by Europe,” informs Dr Shrikant D Sawant, Director, Centaur Pharmaceuticals. He further adds, “API market is being fuelled by generic players as the demand for generics is growing at more than double that of prescription drugs due to the growing acceptance of generics by all stakeholders.” India is a key API player off ering good quality at reasonable price. Th e Indian API market was $ 12 billion in 2010 and has grwon over 9 per cent with 60 per cent exports.

Growth driversA report by Companies and Markets has shown how drug makers from developed countries like the US will be looking towards API makers like India and China. At present, US is currently the biggest market for APIs, but Asia and the Pacifi c region are forecast to grow 9.6 per cent annually over the next fi ve years, highlights the report. Th e trend indicates that gradually manufacturing of APIs will be shifting to emerging economies such as India and China. Contract manufacturing has been a strong segment for Indian markets as there are various factors propelling the growth in India over its western rivals.

Costs are very competitive in India. Th e cost involved in setting up and running a new manufacturing facility in India is only two-fi fth of that in West. Given the low development and labour cost the units can operate on lower margins. Th e expertise gained in manufacturing generics through reverse engineering has also helped in the process. “Th e demand for API will always be there as long as there is demand for formulations. Contract manufacturing for APIs will increase in the coming years, given the fact that MNCs will increasingly outsource the production process to India,” says Susheel Koul, Director, Enaltec Labs. But encompassing contract manufacturing

Focung regions emerg

The global API market has encountered signifi cant growth over the years. It is predicted to double in size in by 2021. With such prospects, emerging markets like India and China are becoming promising destinations for contract manufacturing of APIs.


on

Contract manufacturing API market


market for API is diffi cult since it is highly fragmented with many small players operating with diff erent models. “Some API manufacturers have capabilities to synthesise API from conceptualisation to commercialisation like Centaur Pharmaceuticals in psychotropic API. Other manufacturers specialise from N-1, N-2 stage to the actual API. Many generic players prefer to get the diff erent stages of manufacturing done from diff erent players to maintain confi dentiality,” says Dr Sawant.

But strong chemistry skills, developed API synthesis and manufacturing capabilities, adaptability and high quality at lower prices are the key drivers for API manufacturing in India. Th ese factors are attracting more and more companies from developed economies to outsource manufacturing to emerging markets like India. According to a report by Visiongain, the revenues from global contract manufacturing market are expected to hit $ 64 billlion by 2016, and more than double between now and 2021. India needs to gear up for this predicted rise in the contract manufacturing market worldwide and prepare itself aggressively to take advantage of the drugs that willbe are going off -patent in the coming years. Some Indian manufacturers are also now incorporating Lean Manufacturing and Six Sigma principles to help boost operational effi ciency and further improve quality, while facilitating compliance. Th ere is major

development taking place in the contract manufacturing of patented APIs in Indian market and India has the potential to become the global API hub in the coming years.

Future scope of this segmentTh ere is no defi ned contractmanufacturing market for APIs in India currently but looking at the growth of the global market the future; the same is profi table and worth investing. “As

India manufactures all APIs, the generic players purchase directly from the API manufacturers; almost no contract manufacturing involved. Th e latest technology and processes are available in India at lower costs hence even innovators purchase directly from the API manufacturers. However, technology

for biotech API or monoclonal antibodies and biologicals are not yet well developed in India, which may lead to API contract manufacturing in the future,” says Dr Sawant. One of the challenges that may hinder the growth will be tough competition from China. According to Visiongain, API manufacturers in both India and China will achieve increasing demand for their services and demand for generic and HP APIs will drive the growth of this market from 2011 to 2021. “Although India is self suffi cient in APIs we still purchase 50 per cent of APIs from China due to price economies. However, India is adept at manufacturing high-end API whereas China is fast catching up,” informs Dr Sawant. Fluctuating prices of raw materials may become a hindrance to the growth of the market for India. Koul points out, “Th ere is going to be a slow shift from contract manufacturing to contract research where the company will be asked to do some research on the product and then manufacture it too.” Some Indian pharma companies could probably benefi t signifi cantly by moving towards specialty APIs in the future.

With an unregulated market, contract manufacturing for API has not been tapped fully in India. With skilled labour, technical expertise and manufacturing units complying with regulatory standards, India can become one of the preferred market for contract manufacturing of APIs.

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According to Visiongain, API

manufacturers in both India and China will achieve increasing demand for their

services and demand for generic and HP APIs will drive the growth of this

market from 2011 to 2021.

Dr Shrikant D SawantDirector, Centaur Pharmaceuticals

Susheel KoulDirector, Enaltec Labs

While China is the world’s leading manufacturer by volume followed by India and Italy, USis the largest consumer followed by Europe.

Contract manufacturing for APIs will increase in the coming years, given the fact that MNCs will increasingly outsource the production process to India.


Biogeneric is gaining prominence with time and for generic manufacturing market such as India it holds

more possibilities. Th e generic version of biopharmaceutical is usually known as a biogeneric drug, diff erent from a biotech drug. When pharmaceutical products contain active ingredients that are biological in nature and are manufactured using live organisms then it is known as a biopharmaceutical. And the generic version of a biopharmaceutical can be termed as a biogeneric drug. Th ese drugs, which are usually the generic version of biotech drugs, hold huge potential for a generic pharmaceutical market like India. With expertise in generic manufacturing of several years along with high number of approved manufacturing units, India

is going to hold the helm of biogenerics in the coming years.

For any formulation, Active Pharmaceutical Ingredient (API) forms the basic component of any formulated end product, ie is the drug and in this case the biogeneric drug and when we talk about High Potency APIs (HP API) we refer to small molecules, having greater potency and are able to target and eliminate specifi c maladies, often taking patient-specifi c genetic information into account. “Th e expectation is that the share of HP APIs in the overall API market will continue to see increased growth with a Compounded Annual Growth Rate (CAGR) of 8.3 per cent from 2011 to 2016,” informs Dr Cyrus Karkaria, President- Biotechnology, Lupin Ltd. While KV Subramaniam, President and CEO, Reliance Life Sciences, says, “Th e HP API market is growing at a healthy rate with

several companies launching new products and biosimilars in oncology, hormone and steroids segments. Th e growth is primarily driven by generic products in emerging markets.” Among factors that are driving growth of HP API, it will be augmented by the oncology segment as they are predominantly used for the manufacture of cancer drugs. Considered especially eff ective for targeted therapy areas, HPAPIs are largely deployed for the manufacturing of drugs in niche therapy segments. “Moreover, HPAPIs are frequently being used on account of their eff ectiveness in relatively smaller dosages as compared to other APIs, which require higher volumes,” informs Dr Karkaria. Considering the eff ectiveness of HP APIs and the evolvement of biogenerics market worldwide, HP APIs will have a bigger role to play in this segment.

Biogenerics: Potential growth in IndiaTh e biogenerics market in India is about` 1,300 crore including recombinant proteins and monoclonal antibodies. Th e biosimilar market is growing at a fast pace in India too catching up with other growing segments. However, for being a truly global leader in this space, India would have to focus on the following aspects of addressing a defi ciency in the regulatory approval process, emphasising highest standards of quality of biosimilars, developing human competencies and accessing regulated markets. “Th e biogenerics segment can also off er signifi cant opportunity to Indian players, given the advantage that India has in its rich talent pool, technical expertise and comparatively low operational costs,” says Subramaniam. With the impending patent cliff , in 2016-17, drug companies, across the world are focussing on niche therapy areas where investments are high but margins are quite rewarding. “Biogenerics, in India, has tremendous growth potential and most leading Indian pharma companies are working towards tapping that potential. According to statistics from Datamonitor, the Indian biosimilars market is expected to grow to $ 580 million (` 2,580 crore) in 2012,” says Dr Karkaria.

Insight & Outlook: HP APIs for biogenerics

Potential unexploredWorldwide, the biogenerics market is growing exponentially and emerging markets such as India and China are leading the way. With APIs contributing highly to the development of any formulated end product, will High Potency APIs (HP APIs) fi nd a role to play for biogeneric drugs?


HP APIs for biogenerics


Offereing hopeful solutionsTh e advent of biopharmaceutical drugs has helped address unmet medical needs. However, only a fraction of the patient population has been able to aff ord these drugs due to the steep prices they command. Th e entry of biogenerics will pave the way for aff ordable therapy, consequently benefi ting a larger patient population. “Th e biopharmaceutical industry is expected to see strong growth in the coming years, driven by growing markets, several new biosimilar product launches in India, exports of biosimilars and product-based partnerships. Th is

may lead to an increased demand of HP APIs in the domestic market,” says Subramaniam. Biosimilar market is growing at a faster pace in India and a similar trend is seen in emerging markets. However, their growth in developed markets (especially EU) has not met the expectations of pharmaceutical companies. Th is is primarily due to the fact that these products are marketed as ‘branded generics’ and are not ‘interchangeable’. Further, there is still no clarity on the regulatory approval pathway in the US for development of biogenerics. So clarity in the regulatory front is something that is required. All the

biotech companies in India are gearing up for the removal of patent cliff from biotech drugs so that they can venture into generic versions of these biopharmaceuticals. With such a favourable condition the demand for not only APIs but also HPAPI will rise for manufacturing biogeneric drugs.

Th e effi cacy and performance of HP APIs is undoubtedly superior to APIs and they are required in small volumes considered to APIs. Th us, with the increase in production of biogenerics in the coming years we will also see an increase in the demand for HP APIs.

([email protected])

Dr Cyrus KarkariaPresident- Biotechnology, Lupin Ltd

K V SubramaniamPresident and CEO, Reliance Life Sciences

Biogenerics, in India, has tremendous growth potential and most leading Indian pharma companies are working towards tapping that potential.

The HP API market is growing at a healthy rate with several companies launching new products and biosimilars in oncology, hormone and steroids segments.


What motivated you to be part of this industry?My ambition was to become a doctor but somehow it did not happen and rather I studied Human Physiology, which is the basic of medical science. After doing Masters in Physiology from Presidency College, Kolkata, I was inspired by some of my relatives in this industry who with their touching anecdotes made me see this profession in a light where one could signifi cantly contribute to the health of people. Moreover, the profession dealt deeply with my subject, which further motivated me. I thus began my career as a Medical Representative with GlaxoSmithkline.

How has the Indian pharma industry evolved over the last two decades?Th e fundamentals of health-related industries have undergone a sea change, having not only impacted pharma but the overall healthcare industry. Th ese changes can be explained in various ways, such as increase in the overall ‘health awareness’ of Indians though still at a nascent stage (in comparison to the developed world). We need to realise a very simple fact of life that our body while through its wear and tear, is at risk. Th is must be recognised and dealt with (put to practice) proactively with a positive attitude. Having dealt with ‘awareness’ and the issue of ‘realisation’, comes the question of aff ordability.

Aff ordability does not only mean having more money (disposable income); rather, its adequate knowledge and education coupled with disposable income. Quite a part of the societal segment is becoming truly ‘aff ordable’, though the number is relatively small in comparison to the overall population. Th ere has been a great deal of changes in the disease pattern resulting in tremendous changes in therapeutic development. Earlier, communicable diseases used to be more than 60 per cent, which today is only 30 to 35 per cent. Th is shift is a major one. Today, the acute therapies are better understood and the awareness of chronic disease is increasing. A great deal of transition in the infrastructural design is seen throughout the country. Th e practice of empirical medicine is gradually shifting towards evidence-based medicine. All the above mentioned facts are driven by a quantitative and qualitative change in the medical fraternity resulting in the overall growth of the pharmaceutical industry in India.

Some time back, 80 per cent of the market used to be dominated by MNCs. Due to the spurt of growth by the Indian players, we today see a reversal of the picture - 80 per cent of the current market is now dominated by Indian companies, and some of which have gone global.

Th e awareness at the physician as well as the patient level has played a

pivotal role in the growth of the pharma market than the number of medicines being made available at an aff ordable price. Hence, emphasis on education and awareness is more critical than an introduction of a low-priced medicine.

Th erapeutic segments and areas have gained prominence over the years in India. In the earlier days, the industry used to be absolutely ruled by acute therapies. Today, we observe substantial growth of chronic therapies. However, this compositional shift is slower than the occurrence of disease. Th is is simply due to the fact that 60-70 per cent of the population has poor access to infrastructure/medicine in the semi-urban/rural India, which is still ruled by acute therapies. Among the chronic therapy areas, we see a great spurt in cardio and diabetes. Th ere are other emerging therapies such as central nervous system (for example, epilepsy etc) and oncology, which are gaining prominence.

Factors that are parallel to growthAs has been mentioned by many experts, the future growth can be explained through three diff erent scenarios based on the overall economy, government policies and of course the progress of health awareness and attitude. Scenario 1: At the current pace of

economy growth, governmental pricing policy and the attitude to

Insight & Outlook: Interface - Amitabha Gangopadhyay

“Diagnosis, doctors and drugs are three critical elements driving the growth of the pharma industry”…believes Amitabha Gangopadhyay, Senior Director – Business Excellence and Strategy, Sanofi India. He has been a part of some mega M&As in the industry. Here he talks about the mega transformation of the industry.


Amitabha Gangopadhyay


health, the pharma market will see a decent double digit growth

Scenario 2: An optimistic scenario whereby the government policies considerably boost the health economies, substantial investment pours in from various private/public quarters to build up the basic infrastructure required for diagnostics and other health care amenities. In such a scenario, the industry will see superlative growth.

Scenario 3: A conservative scenario where all the factors mentioned above do not support the infrastructure and other health amenities. In such a case, the industry will slow down to a large extent. However, at this juncture this is quite an unlikely scenario.

What role has the government played in this growth?We have to look at the growth from an overall perspective. Pharma industry is not a stand-alone entity. As the overall healthcare scenario progresses, pharma

industry gets an impetus. Government policies are more directed towards the correction of the fundamentals of healthcare. Th at is how the overall improvement in economy is supported by some of the policies, which drive infrastructural growth and the reach of medical facilities to remote areas. Th e government has worked across segments and is now coming up with partnership models that can further boost the reach of medical science.

What trends do you foresee in the Indian pharma market?Today, it is estimated that 25 per cent of the overall healthcare industry in India is pharma. Th is is likely to grow because of the rise in chronic therapies. More awareness, education and diagnostic facilities will pull in patients at a very early stage who will have better prognostic evaluation, insurance coverage etc. thus will remain in-therapy for an adequate period of time and maintain better health status.

On the other hand, the progress of medical science, medi-devices, specialised hospitals will bring in various procedural facilities which will be availed by Indian patients as well as patients of our neighboring countries and far off (medical tourism).

Within the pharma space, therapeutic segments like cardiovascular and diabetes will see a major spurt along with more life style oriented therapy areas, viz, dermatology, respiratory, CNS & gynaecology.

Th e incidences of cancer being on the rise and simultaneous discoveries in this fi eld will defi nitely provide better opportunities for treatment. Another growth area is vaccines which will be augmented by research along with many more incoming advanced therapeutic solutions through biotechnology. All this will change the pharma world substantially in its composition and quantum.

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While for certain processes China is taking the lead in API but when it comes to quality, Chinese API is still facing a tough time. India is slowly catching up and Indian API is preferred all over the world, which shows the continuing progress of Indian products.

Is China a threat to India for APIs?The tussle between two of the growing economies in the world is growing stronger day-by-day. Today, the Active Pharmaceutical Ingredient (API) market is encountering signifi cant growth and both India and China are trying to capture the global API demand.

Editorial take

Ravi R SobtiIndependent Pharmaceutical

Consultant

Th ere are certain processes in APIs where China has an edge over India. Like China can be called a threat for India when it involves fermentation processes. China today has advanced technologies when it comes to fermentation and all the processes involving fermentation. So when it comes to production of penicillin or steroids China stands ahead of India. India is currently importing steroid intermediates, steroid hormones to meet the country’s demand. But when it comes to processes based on synthetic chemistry India is way ahead of China.

On regulatory compliance too, India’s track record is better than China; there are signifi cantly higher numbers of USFDA-approved API production houses in India than in China. Whereas in few areas China has an upperhand there are certain aspects for API production where India is leading, so we can say that instead of being a threat to one another they are tough competitors when it comes to APIs.

Vinod KalaniChairman, MSME,

Sub-Committee, IDMA

When it comes to manufacturing facilities for API, China is ahead of India since the manufacturers receive aid and facilities from the government. Chinese companies receive support from the government for getting loans, clearances are made faster that gives Chinese manufacturers an edge over India when it comes to intermediates for APIs as well as APIs.

India exports intermediates for APIs from China. Earlier many Indian manufacturers were entering the API and new molecules market, but with the price control brought in action many units were closed down. So the momentum slowly diminished for the Indian API companies. Th e government should develop policies that are clear and consistent so that new players enter the market. Looking at the present scenario I consider China as a threat to India and Indian government should work towards providing a more level playing fi eld.

Rahul KirkindeAGM- Marketing & Technical,

Ideal Cures Pvt Ltd

When it comes to API market India has an edge over the Chinese APIs. API forms a very important part of the formulations and when it comes to getting an API for the formulations developed markets like Europe will always prefer an Indian API over a Chinese API. But when it comes to the formulators of the domestic market and rest of the world such as the African countries or Middle-eastern countries would opt for a Chinese API.

Chinese API gained prominence in the 90s but in the recent past there have been several cases where the quality of the Chinese API has come under the scanner. Th e problem is quality. Th e API may pass through primary tests but gets a red light for advanced stages such as impurities test or deviation tests. And due to these quality issues Chinese API has degraded in its value. Th us, at least China cannot be termed as a threat to the Indian API market.

Insight & Outlook: Roundtable



Some years ago, Indians encountered a particularly motivational slogan: ‘India Shining’. Although the slogan

had a political genesis, it contained the right cues that imbued common persons with positive energy. ‘India Shining’ defi nitely sounded realistic, making every Indian proud. It enabled many players to place India on the global map in the areas of innovation,

development and quality in the healthcare sector.

Why the myth?Over the past few months, however, the CR industry has been besieged by media reports and statements from various government quarters refl ecting abject ignorance about the CR industry, inaccurate reporting as well as political twists and turns. All of this has created

an extremely bad name for this vital industry, for healthcare and the nation. Th e stream of reports published was so strong, it seemed like a procession of electoral result bulletins. Most articles cited factors such as lax laws and regulations, illegal trials, sudden deaths, inadequate compensation, and Indians being used as guinea pigs. Over-reporting by the media has led to participating subjects reporting at sites and Clinical Research Organisations (CROs) with false adverse eff ects, attempting to extort money and blackmail trial organisers! Without doubt, blackmail and extortion are the last things anyone would have expected.

Society at large must realise that the drugs we consume have been tested not only in animals but humans too. If we claim to have become guinea pigs, let it be known that across the world millions of human subjects from diff erent nationalities were guinea pigs for the development of the medicines that people use today.

In a recently developed medical treatment for strokes, a medical device called ‘Solitaire’ has been tested in humans for clinical effi cacy. Solitaire is a self-expanding stent-like design and once inserted into a clot using a thin catheter tube, it compresses and traps the clot. Th e clot is then removed by withdrawing the device, thus reopening the blocked blood vessel. In the fi rst US-based clinical trials, Solitaire opened blocked vessels without causing symptomatic bleeding in or around the brain in 61 per cent of patients. It also led to better survival rates three months after a stroke. Th ere was a

Inaccurate reports have tarnished the Clinical Research (CR) industry’s once-glorious image, disregarding the fact that worldwide no drugs can be launched without human trials.

Insight & Outlook: Clinical research industry

Why cynicalabout clinical?

Clinical research industry


17.2 per cent mortality rate with the new device, compared to the 38.2 per cent mortality with an earlier device. If people want such treatments to be readily available, then Indian patients would also need to participate in such medical trials, despite the mortality rate. Ultimately, participation in these trials will lead to better treatments and better healthcare.

Quality affairIt is important to understand that without human trials one simply cannot have any medicines or modes of treatment that improve constantly. Any product that is introduced in any market goes through a battery of quality check points and complies with all the necessary regulations – right from development to manufacturing of the product. Regulations in India’s pharmaceutical sector and in the fi eld of CR are as stringent as in the aviation industry. India boasts of regulations that are on par with international gold standards and are in no way inferior to those in the west.

Despite the best regulations in place in any industry, however, irregularities can happen. Planes do crash, don’t they? Does this mean the entire industry is bad and should be banned or maligned? Despite rail accidents and air disasters, have we stopped travelling in trains or planes?

People have missed a critical point here. While irregularities should teach stakeholders how to tighten regulations and bring about better compliance, people have instead tarnished the industry’s image via negative propaganda. Th e entire industry advocates adherence to the highest standards and that those guilty of contraventions should be punished under appropriate laws. In the eyes of the world this has become a point of contention, with many contesting the idea that India should be considered a destination for drug development. Th ere are assertions and reports that investments will now move to China primarily because of regulatory delays, subjective interpretation of laws, bureaucratic issues and other hurdles.

Unfortunately, regulatory authorities have reacted to the recent alleged irregularities by making drastic changes to guidelines or by claiming that these trials were illegal. New draft guidelines on compensation are completely lopsided and do not leave any scope but for compensating towards anything that happens to the participating subject. Such guidelines will only suit bureaucrats and not the industry. Th e nation seems to be reverting to the British Raj, where rules were made purely to suit the rulers!

Did people ever consider the context in which the word ‘illegal’ has been bandied about? Th e very claim that the trials have

been conducted ‘illegally’ casts doubts over the functioning of regulatory authorities. Th e Drugs Controller General of India (DCGI) offi ce that has powers to approve or reject trials should be empowered with authority and resources to become more eff ective than it is at present.

Bringing in complianceVarious industry-based associations such as Association of Clinical Research Organizations (ACRO), Indian Society for Clinical Research (ISCR) and Association of Biotechnology-Led Enterprises (ABLE) have come forward and reached out to the offi ce of the DCGI and the Ministry of Health. Th e approach has been to collectively bring in compliance and regulations that will protect the interests of the participating subjects as well as promote the progress of science. Th is is the best and most prudent way to bring about improvements and ensure that CR is conducted in the appropriate manner.

At the same time, it would be a welcome change if other stakeholders – both government and the media – reiterate their trust in the CR industry, thereby creating a positive image for it, rather than merely sensationalising any news on it. Robust support and focussed eff orts from these stakeholders is all that is required presently to regain the lost glory and pride of the Indian healthcare industry. Th e entire industry is open minded and ready to collaborate with other stakeholders to make this happen.

An Indian perspective Analysts had projected that the total CR spending in India will increase by more than 30 per cent annually through 2010. India is now increasingly being recognised as a hub for global clinical trials as it has several prized attributes: Large and diverse patients’ pool for conducting clinical trials

Availability of medical, pharmacy and science graduates

Excellent infrastructure facilities Comparative cost advantage Changes in the patent laws

Th e CR industry in India has grown from ` 20 crore to ` 100 crore during the last few years. A McKinsey report fi nding had suggested that the CR industry was expected to touch ` 5,000 crore by 2010 and will employ 50,000 people during the next fi ve years.

Th ere will be a huge demand for qualifi ed and trained CR professionals.

Many pharmaceutical and CR organisations have already come forward to unlock the vast potential that India has, and are conducting clinical trials in India.

([email protected] )

Society at large must realise that the drugs we

consume have been tested not only in animals but humans too.

Ashish Dasgupta Vice Chairman, Association of Clinical Research Organizations (ACRO)


GlobalData estimates that the global infl uenza vaccines market was valued at $ 3,525 million in 2011, and is forecast

to grow at a Compounded Annual Growth Rate (CAGR) of 5.8 per cent over the next seven years, to reach $5,242 million in 2018. Th e moderate growth of the market is due to the increasing awareness among people about the importance of vaccination against infl uenza, and the approval of new infl uenza vaccines. Th e universal immunisation recommendation by the Advisory Committee on Immunization Practices (ACIP) and several government awareness vaccination programmes would help to increase the vaccination coverage for infl uenza.

Strong competition in the seasonal infl uenza vaccines market Th e current infl uenza vaccines market is primarily served by the trivalent seasonal infl uenza vaccines. Th ese available vaccines are either inactivated, such as Fluarix, FluLaval,

Fluvirin and Fluzone, or live attenuated such as Flumist. Th ese vaccines are effi cacious in providing immunisation against virus A subtypes, H1N1, H3N2 and type B strains. Th ey are rarely found to be associated with adverse events. Although these low priced seasonal trivalent infl uenza vaccines off er strong competition in the market, there is still scope for new entrants, which would off er immunisation against multiple infl uenza virus strains.

Signifi cant unmet needsTh e annual variability of virus strains and shorter shelf life of the vaccines lead to the requirement of yearly vaccination. Along with this, the egg-based vaccines may cause allergies in some people and take a long time for production, leading to shortages when the demand is high. A vaccine which off ers protection against multiple virus strains will help to address the unmet needs of the market. Also, technological advancement in the production of vaccines would reduce the

side eff ects caused by egg-based infl uenza vaccines, and would help to avoid situations of vaccine shortage.

Th e pipeline for infl uenza vaccines is strong in terms of the number of trials being conducted for the infection. Th e pipeline consists of 104 vaccines, with fi ve trials for regulatory fi ling and seven trials under phase III. Some of the vaccines that are launched either in the US or Europe are in the late stage development of the pipeline. Th e upcoming vaccines in the pipeline include universal vaccines, which would off er immunisation against multiple infl uenza virus strains. Also, there are ongoing trials for vaccines, which have an altered route of administration, such as oral vaccines, nasal vaccines and vaccine patches. Th ese vaccines may further increase the compliance level for vaccinations.

Infl uenza vaccines market size (2005-2010)GlobalData estimated that the major markets (the US, the UK, Italy, Spain, France, Germany and Japan) for infl uenza vaccines grew at a CAGR of 22 per cent from 2005, to be worth $ 6,055 million in 2010. Th e market includes seasonal as well as pandemic infl uenza vaccines. Due to the H1N1 pandemic in 2009, the market for infl uenza vaccines witnessed a signifi cant increase, particularly in 2009 which saw a CAGR of 112.6 per cent. Th e market now consists of seasonal infl uenza vaccines after the pandemic was declared to be over by the WHO in August 2010.

In the US, several pandemic or H1N1 monovalent vaccines produced by companies such as GlaxoSmithKline, Novartis, AstraZeneca and Sanofi were used. Th e H1N1 pandemic infl uenza vaccines centrally authorized in the EU for the year 2009 were Focetria, Pandemrix and Celvapan. Arepanrix and Cell-culture Derived Infl uenza A (H1N1) Emulsion HA vaccine are the approved vaccines for H1N1 infl uenza in Japan.

Th e market is also set to witness the launch of various seasonal as well as pandemic infl uenza vaccines during the forecast period. Th e launch of Phase III quadrivalent infl uenza vaccines in the coming years, such as Fluzone QIV and MEDI-3250, would off er immunisation against multiple infl uenza virus strains.

(Courtesy: GlobalData)

Insight & Outlook: Influenza vaccines market

Signifi cant unmet needsGlobalData expects the infl uenza vaccines market to grow at a rate of 5.8 per cent, from $ 3,525 million in 2011 to $ 5,242 million in 2018. The market is set to witness moderate growth after the end of the H1N1 pandemic.

6,000

5,000

4,000

3,000

2,000

1,000

02005 2011

CAGR (2005-2011) 7.8%

CAGR (2011-2018) 5.8%

Rev

enue

($

mill

ion

)

2018

Source: GlobalData


Unlike most nations, in India there’s a general tendency to pass the buck. Over generations, this has become

second nature, especially for people in positions of power or responsibility who fail to deliver. One way of passing the buck is by introducing a red herring – something that diverts attention away from the real issue.

A classic case is the government’s inability to ensure universal healthcare access even 64 years after India’s Independence. Th erefore, each time criticism swells about the sorry state of healthcare access, the authorities simply divert attention by introducing a red herring – high drug prices.

Th e truth is – pricing neither drives nor hinders healthcare access. Just as there is actually no fi sh species called ‘red herring’, pricing being liable for the lack of healthcare

access is an absolute myth. If pricing could propel access, India would never have had a high percentage of anaemic women – particularly since iron supplements are available for free in Primary Health Centres (PHCs) across India.

Getting to the root of the problemClearly, pricing is not the problem. Th e actual issue – India suff ers from lack of availability of medicines, an insuffi cient number of doctors or absence of healthcare personnel, and inadequate healthcare infrastructure.

Even though the offi cial policy of free supplements exists on paper, the ground reality of the other three conditions is rarely fulfi lled in tandem. Even if one of the three requirements is missing – availability of supplements, doctors on duty, PHC in the vicinity – the chain is broken

and delivery of free iron supplements never occurs.

India truly has lower prices compared to even other emerging countries or the developed nations. An analysis of prices of 53 drugs based on purchasing power parity revealed that India has cheaper drugs than other countries – such as Pakistan, Philippines, Malaysia, China, Th ailand and Indonesia.

It should be clear by now that since prices of medicines in India are amongst the lowest worldwide, pricing is not a barrier for healthcare access. In order to access medicines, India’s poor are largely reliant on the government healthcare systems represented by PHCs. But with the system plagued by inadequate infrastructure, poor availability of drugs in PHCs and shortage of doctors, nurses and pharmacists, it is these issues that need to be addressed.

To elaborate, it is estimated that across India there’s a cumulative shortfall of approximately 17,000 PHCs. Due to this, patients do not have easy access to medical help, since the nearest PHC could be too far away to be reached on foot. Across PHCs in India, there is an estimated shortfall of 8,500 doctors, while 41 per cent PHCs do not have health workers. So even if patients do commute to a far-off PHC, there may be no doctor to examine them and prescribe medicines.

As long as the authorities fl aunt the red herring of drug prices and keep bandying drug price control as an ostensible solution, healthcare access will always remain a mirage in India. Th e sooner they focus on the real issues by improving and augmenting healthcare infrastructure, increasing the number of medical personnel and ensuring year-round availability of drugs, the faster will India be able to fulfi l its mission of universal healthcare access.

Towards a cause Concerned about the inappropriate focus on pricing in the nation’s pharma policy, industry veterans – Daara Patel, Secretary General, Indian Drug Manufacturers Association (IDMA); Amit Bakliwal, MD, IMS Health; and Kewal Handa, MD, Pfi zer India – expressed reservations about

Insight & Outlook: Access to healthcare

Need to focus on infrastructure and healthcare deliveryVeterans claim that cost-based pricing in India for drugs will not work as the basic problem is access. They jointly demand that the government should stick to its draft policy to fi x maximum retail price of drugs based on market-based model.

Access to healthcare


its negative impact on the industry and on eff orts to boost universal healthcare access. Th ey believe that with drug prices in India already one of the lowest worldwide, it is more important to focus on the core issues that impede access. A cost-based pharma pricing policy would be counterproductive and further hinder eff orts to improve access.

“Attempts to advance healthcare access via cost-based pricing miss the point that lack of infrastructure and appropriate delivery systems are needed to boost access. Moreover, Indian pharma companies have always risen to the occasion and supplied medicines free of cost to needy patients or for deserving causes. To facilitate access, the government could abolish excise duties and taxes on the free medicines donated by pharma companies,” says Daara Patel, Secretary General, IDMA.

Patel highlights that the government should encourage public-private partnerships to provide universal access to healthcare, since it is not possible for public sector entities to address all the complex issues involved in improving access.

Bakliwal concurred that cost-based pricing was not the proper solution to

better access; “In spite of India having a high disease burden, delivery systems have not improved in the country, impeding access. Although aff ordability is part of access, individually attacking drug prices is not the solution. Given the importance of research and innovation in the pharma industry, it is necessary to strike a balance between access and innovation. We also need to understand that even having free drugs will not solve the issue of access, unless the basic problem of inadequate health infrastructure is not addressed squarely.”

Modelling an approachAccording to Handa, “It is not only a question of making medicines aff ordable, but also making them aff ordable in the right place for the right people. Cost-based pricing would simply not achieve this objective. Going by the state of healthcare infrastructure in India, effi cient healthcare delivery is far more critical than the pricing of drugs. Furthermore, the focus is more on treating the disease rather than preventing it. Before the issue of pricing comes to the fore, it is imperative to work for ensuring that adequate medical infrastructure is

developed at a fast pace. Th is includes augmenting the number of doctors, nurses, midwives and auxiliary healthcare providers.”It is best to leave pricing to market forces, according to Handa, rather than trying to impose a cost-based pricing model that may fi nally fail, as it did in many nations, including the Philippines. Th e pharma veteran is also averse to the idea of treating imported drugs on par with generics.

“Every nation has its unique inbuilt cost structure that takes into account aspects such as quality, research and delivery systems. Attempting to subsume diverse elements under a single price spectrum undermines competition, which underpins the spirit of competitive pricing and aff ordability.” He explains, “Any imported drug that’s overpriced will not survive, pricing itself out of the market. Cost-based pricing may only lead to unscrupulous manufacturers infl ating input costs, while those who go by the book may fi nd the margins unviable and thereby withdraw from certain categories. Th is could fi nally aff ect the quality of drugs and lead to the rise of substandard drugs that endanger the lives of patients. Such a scenario would only make the mission of universal healthcare access all the more distant,” concludes Handa.

In a separate move, three industry bodies Organization of Pharmaceutical Producers of India, Indian Pharmaceutical Alliance and IDMA — have jointly demanded that the government stick to its draft policy to fi x maximum retail price of drugs based on market-based model.

([email protected])

Kewal HandaMD, Pfi zer India

Cost-based pricing may only lead to unscrupulous manufacturers infl ating input costs, while those who go by the book may fi nd the margins unviable and thereby withdraw from certain categories.

Daara PatelSecretary General, IDMA

Amit BakliwalMD, IMS Health

In spite of India having a high disease burden, delivery systems have not improved in the country, impeding access.

To facilitate access, the government could abolish excise duties and taxes on the free medicines donated by pharma companies.


Insight & Outlook: Peristaltic pumps

The popularity of the peristaltic pump — aka tubing pump—can be attributed to its design. An electric motor

turns a set of rollers, which compress and release fl exible tubing as they rotate. Th is squeezing action creates a vacuum that draws fl uid through the tubing. Because the fl exible tubing is the only wetted part, maintenance and cleanup are simple and convenient.

Non-contaminationTh e peristaltic pump creates a contamination-free pumping system. Th e fl uid being pumped remains inside the tubing at all times and thus never comes in contact with any pump gears, seals, diaphragms or other moving parts. As a result, fi nding a pump compatible with a particular solution is as simple as choosing a chemically compatible tubing.

Th is makes peristaltic pumps ideal for transferring chemically aggressive or abrasive solutions as well as high-purity fl uids. Moreover, most types of pump tubing can be sterilised through autoclaving, gamma irradiation or ethylene oxide gas application, and most systems facilitate Steam-In-Place (SIP) and Clean-In-Place (CIP) techniques. Th is ensures complete sterility of the entire pump system with minimal cost.

Simple operationPeristaltic pumps are simple to operate and easy to customise. Th ey are self-priming, and many models have interchangeable pump heads that can be mounted in minutes using fi nger-tightened screws. Engineering advances have yielded designs that allow the tubing even in large process pumps to be loaded or replaced in

One of the fastest-growing types of positive displacement pumps on the market is the peristaltic pump. Once used exclusively in the lab, this pump has been transformed for use in process control, water treatment and plant production. Yet, many people remain unfamiliar with this evolving pump technology and its advantages.

positive eristaltic is pump control,

et, many g pump

Moving beyond the labs

IP66 and NEMA 4X rated. Stainless steel housing and sealed keypad – apt for washdown environment – simply hose down to clean

Self-priming pump - have interchangeable pump heads that can be mounted in minutes

Peristaltic pumps


seconds. In addition, most pumps feature simple controls with a dial or keypad for speed control, and straightforward menus for programming more complex tasks.

Low maintenancePeristaltic pumps require little maintenance beyond tubing replacement. Tubing must be replaced periodically to off set reduced fl ow performance. Th is procedure typically takes just seconds, which can be an advantage whenusing the same pump to transfer or dispense diff erent chemicals. When solutions are changed, only the tubing needs to be changed, and the pump can be up and running within minutes. In addition, many tubing pumps are designed with high an Ingress Protection (IP) rating, which meansthey can be hosed down for quick, thorough cleaning.

Tubing materialsPeristaltic pump systems are compatible with a wide range of tubing materials, including silicone, thermoplastics, Viton and even rigid PTFE. Th ere are also newly developed formulations of bi-layer, or co-extruded tubing—such as the new Masterfl ex® Chem-Durance™ tubing—in which a long-life tubing

material is laid over a thinner inner material that is compatible with aggressive chemicals, resulting in a tubing whose collective properties in a pump exceed those of either material alone.

Many tubing types also meet USP, FDA, USDA and/or NSF approvals. Th is makes peristaltic pumps suitable for handling a variety of fl uids from sensitive cell cultures to industrial solvents, and allows the same pump to be used in multiple applications simply by changing the tubing.

Multimedia pumping capabilitiesIn addition to generating enough suction to self-prime, peristaltic pumps create suffi cient vacuum to successfully pump most viscous fl uids—including those too heavy for other types of pumps. Yet, because these pumps employ a gentle pumping action that leaves solid components of the fl uid, including cell walls and particulates, intact, they are excellent for moving sensitive fl uids, slurries and suspended solids.

Peristaltic pumps are also used to move liquids, gases and mixed-phase fl uids.

Cost-effective operationPeristaltic pumps are relatively inexpensive to operate. Th ey are cost-

eff ective because they are easy to clean, they are eff ectively impervious to the most abusive, pump-damaging chemicals, and because the same pump can be used for multiple applications. Th is result in lower labour costs, lower m a i n t e n a n c e costs, less d o w n t i m e and increased production.

Pump application tipsBecause peristaltic pumps use fl exible tubing, as the pressure inside the tube increases, the tube has a tendency to swell, pressing against the rollers and causing premature wear. To reduce wear, make sure the tubing is properly loaded in the pump head, and purchase only quality tubing. For example, PerfectPosition™ tubing, developed specifi cally for the new Masterfl ex® B/T® process pump, is designed for high fl owrates and has markings printed on the surface to facilitate optimal tubing alignment.

If you are having problems with the pulsation inherent in peristaltic pumping, it can be reduced by using a pump head that has more rollers, and thus produces less pulsation. A pulse dampener also helps.

ConclusionsPeristaltic pumps have become a critical and reliable part of processes ranging from chemical transfer to pharmaceutical processing to wastewater treatment. Th eir versatility and ease of use has helped them meet a multitude of fl uid-handling challenges.

(Courtesy: Cole-Parmer)

A process tubing pump that can be easily loaded with two hands

High fl ow masterfl ex peristaltic pump


Insight & Outlook: Case Study - In-sight vision systems

For over 30 years, EISAI Machinery GmbH, located in Cologne, Germany, has been an expert in the fi eld of high speed

pharmaceutical product testing. Its latest device, the AIM 596, can inspect delicate glass vials in fractions of a second, thanks to two Cognex In-Sight vision systems.

Depending on the application and customer requirements, the machine can check approximately 6,000 packages and in its fastest version, the device, with its imposing inspection towers and star wheels, can even test up to 12,000 test units per hour.

A careful gazeIn the fi rst inspection step, the vision system, In-Sight 5600, determines the cake height of the freeze-dried contents and detects the presence of any foreign objects on their surface. At the same time, it looks for ‘splashings’ or splatters caused by unwanted boiling during the freeze-drying process.

A standard industrial camera then looks for foreign particles on the outside of the cake and cracks, scratches, or air pockets in the glass.

Th ese fi rst two camera systems are attached to a semicircular bracket that moves by an oscillating drive. It is here that the In-Sight 5600 demonstrates one of its key advantages: its robustness. Th e injection-molded aluminum and stainless-steel housing make the In-Sight impervious to vibration stresses. Another outstanding feature of the vision system is its speed. At a standard resolution of 640

x 480 pixels, it works at up to 60 frames per second, and in partial-scan mode, it can even reach up to 200 frames per second.

Zero tolerance for cracksWith an additional In-Sight

5600 the underside of the glass vials are inspected for cracks. For freeze-dried products, the vision system also checks the vials for unwanted particles and ‘meltbacks’ (condensate residue that can arise during the freeze drying process of protein-containing substances).

In the AIM 596, EISAI developers work with the In-Sight Explorer software to create a user interface customised to the customer’s requirements. In the event of product changes, machine operators can access preconfi gured fi les stored in an online database without problem. New test parameters are transmitted to the vision systems with just a few clicks.

A secure fi t on the glass edgeBefore proceeding to the fi nal test, an In-

Sight 5400C checks both the vial cap and the fl ip-off seal. Th e inspection criteria include the checking of the presence of the parts, the colour of the cover and, for aluminum caps, the correct processing of the crimp. While the glass containers rotate 360°, the In-Sight 5400C checks that the aluminum sleeves have been fi tted completely around the edge of the glass and the stoppers are tightly inserted.

Th e second inspection tower of the EISAI SD system checks liquid products for the presence of foreign particles. Th e rotating containers are stopped abruptly, leaving the liquid in rotation. In the middle of the glass vials, the liquid rotates rapidly and rises while, to the outside, its speed is slower and it sinks. Th is would cause a particle to pass through the inspection area several times. To check for particles, a focussed halogen light beam illuminates the glass vials and strikes a photo sensor.

Error-free sortingAfter exiting the test stations, the glass vials are conveyed by star wheel to the fi nal sorting station. Defective products are sorted into various trays, depending on the nature of the defect. Products that pass the testing process are forwarded to a labelling or packaging machine. Th en only the glass vials with 100 per cent product quality enter the pharmaceutical wholesale chain

High-speed pharmaceuticalglass vial inspection Few industrial sectors have such stringent quality requirements as the pharmaceutical industry. To meet these exacting specifi cations, companies are increasingly utilising intelligent vision systems. A look at one such solution provided by Cognex.

Case Study - In-sight vision systems


and are distributed to clinics, pharmacies and medical practices worldwide.Other conventional ways of testing the vials To identify any foreign particles, dust, glass particle, small creatures etc. in bottle/vial after washing process

To check body cracks or any physical damage

To check fi lling level of liquid or powder in bottle/vial

To check presence/absence of cap/seal on vial and also to check position of cap

To verify presence/absence of the label on bottle/bial

To verify label pattern matching and colour matching

To check and verify barcode. Th ese barcodes contain the detail of the product like batch no, MRP , manufacturing date, expiry date, etc

Other products in the same categoryPharma sector has stringent quality requirements. To meet these exacting specifi cations, companies are increasingly

utilising intelligent vision systems. Cognex off ers to provide solutions to these pharma sector companies with a range of products depending on requirements. Some are: Insight 5400 with track and trace software for traceability; Cognex In-Sight 5605® 5MP is a small, but critical component used extensively in the serialisation solution, not only to validate the presence, accuracy and readability of the various labels, but also to ensure product safety and package integrity etc.

Market for In-Sight 5600Market for all vision system is based on application and the product to be inspected. Before installation of products, the exact requirement is to be understood and thorough study of the application and production facility. In-Sight 5600 is based on high speed performance, and its robust application. Hence, it can be used in diff erent applications in diff erent verticals.

Services offeredCognex products are very easy to integrate and use. Th ough these products

are installed in production units, there is not much wear and tear involved of these products. Th erefore after sales service is not a major concern. If proper training is given to the staff , even shop fl oor engineering can set up the program. While in case of an emergency, application engineers are always there to provide support with immediate response.

Cognex is the only vision-based company in world, which has integrated more than 6,00,000 systems. Companies around world rely on Cognex vision system to enhance quality, optimise product quality and drive down production cost.

([email protected])

Didier Lacroix Global Senior VP (Sales & Marketing), Cognex Inc


What should automation be, friend, philosopher, guide or a slave? Of course most of us

would want it to be all of them and more, but the reality is that even with the most marvelous technologies of the 21st century, automation is still inching towards being a good slave. Th e next question is what should automation deliver? Time, precision, more sensitivity, productivity, speed, control, cost saving. Letting users decide would mean all of

the above and also serve coff ee, reality is that with every choice you make you have to give up something. Increase in speed mostly reduces sensitivity, with precision you sacrifi ce range. Before this article becomes philosophical and unworthy of attention, let us move on to the next question. What should scientists actually do, design experiments or conduct experiments? One thing is obvious is the lack of thinking power of machines, they are incapable of thinking like scientists. Letting scientist free to

think and let automation do the boring and mundane tasks is the way to do it, and that is the way it has been. One thing is clear that automation will never design experiments or think for us it’s easier to look at them as just tools and not like magic wands.

Automation and drug discoveryDrug discovery scientists have a problem that is symptomatic of the current century - the deluge of data. Th eir’s is a process of elimination and selection that takes up almost as long as their love aff air with the selected. Th e drug discovery process involves mainly identifying a target, Absorption, Distribution, Metabolism, and Excretion (ADME) studies, clinical trails leading to a commercial drug. Th e story of any drug from the lab to the store

The process of drug discovery has reached the next level where automation is playing an equally crucial role like the scientists. Robots, advanced processes and software for assay development, solutions for fi nding the target and selection, and automation today have an important role to play in drug discovery.

Automation Trends: Robotics and lab automation for drug discoveryAutomation Trends: Robotics and lab automation for drug discovery

When

future becomespresent!

the

Robotics and lab automation for drug discoveryRobotics and lab automation for drug discovery


would be fi lled with diffi cult choices made, high risk decisions, big leaps of faith, laced with personalities and technologies. Here is the continuing story of the role automation and technology played over the years in the drama of drug discovery.

Finding a target: Having successfully sequenced the genome of the mice, men and other organisms, has led to the science of understanding the sequences and making sense of the genetic data (genomics) and at the next level understanding the way the living cell functions (proteomics). All these processes lead to a large number of targets that need to be screened for its potential to become the next drug. Sheer size of targets lends itself to automation as traditional methods would take to long to take advantage of the data. So the solution is High throughput screening (HTS).

High throughput screening: Widely used in the pharmaceutical industry, HTS is a process of quickly understanding the activity of a large number of drugs like compounds, the objective is to identify ligands, ion channels or other pharmacological targets or fi nd pathways of interest. Usually done in microtiter plates, this process lends itself to a lot of automation, IT uses, robotics, liquid handling, data processing, control software and sensitive detectors. Th e automation available includes simple semi-automated liquid handling devices to pipetting stations, integrated with incubators plate washers and readers. Large corporations look at complete automated solutions where compound libraries are automated with robotics for pick and placing samples, with barcode readers ensuring traceability. Assay development is completely automated with nano litre dispensers stepping in to optimise on the small volumes of precious compounds that drug discovery scientists work with. With the level of automation currently available it is possible to have work stations that can pipette and deliver small volumes into plates or any vessels within 24 hours a day throughout the year. Th is enables scientists to focus on science and let the machine do the routine tasks.

ADME: Once the scientist is done with the screening and has found a target that he wants to spend time and energy on the next steps are to fi gure out how the target fares in the pharmacological and toxicity tests. Th ese series of studies known as ADME, try to fi gure out how the target candidate behaves within the organism, its absorption, distribution, metabolism and elimination characteristics. As scientists seek more complex answers on the targets, these studies include among others, toxicokinetics, pharmacokinetics/absolute bioavailability in toxicology species, protein binding, metabolite profi le, pharmacodynamics, etc, these could be both invitro and invivo studies; all these studies have large scale automation that assist scientists in seeking reliable answers in quick time. Some of the other automation available for ADME studies include, automated cell permeability workstation, in-silico screening, software for prediction of ADME properties based on chemical structure, etc, Nuclear Magnetic Resonance (NMR) is also used to identify functional groups in the target drug. Th e current trend is to move to systems that can do everything in molecular biology, DNA extraction, RNA extraction, and proteomics, all based on the same platform and software.

Multiplexing: Assaying is complicated when you study it at the cellular level; the way the compounds behave is dependent to a large extent on the cellular environment they fi nd themselves in. As in an assay an evoked response can trigger a reaction in a cell next to it, its effi cient for scientists to screen for several target molecules in the same reaction vessel. To do this researchers have developed what is called as multiplexed assays. Th ese involve using multiple tags and advanced image detection systems to spot eff ects simultaneously.

Emerging trendsTh e need to understand biology of interest as it functions in normal physiological context is becoming increasingly important and this need of scientists had led to the emergence of various instruments and reagents for live cell

imaging. Knowledge of biochemistry, cell biology, physiology leads to development of tools to study living cells using images acquired from imaging systems. Some of the techniques and technologies available are Fluorescence Tomography (FMT), live cell imaging, Fluorescence Resonance Energy Transfer (FRET) for studying interaction between molecules, Fluorescencein Situ Hybridisation (FISH) is a powerful technique for detecting RNA or DNA sequences in cells, tissues and tumours, etc.

Making automation payHow to effi ciently use automation and how to standardise it across the entire process is the question everyone has to ask when one decides to automate. Th ere are too many platforms competing in the marketplace, each off ering a specifi c solution, the challenge is to seamlessly integrate them all. It is critical to pick an architecture platform that is fl exible and is upgradeable and is modular, so that nothing you invest in becomes redundant too early. Diff erent equipment throwing up data in diff erent formats and the task of integrating them and making sense of it is a challenge.

It is never about what automation does to you, it is always about what you do with automation. As it is evident, automation is best utilised only after understanding ones needs, understanding the limitations of the solution, being aware of the skills one needs to develop to use it. And most importantly understanding how the process is impacted if one implements automation to a part of the process. After all a chain is as strong as its weakest link.

([email protected])

Bhanu PrakashMD & CEO, Automed Systems Pvt Ltd


Variety of chemicals are drained off from the waste discarded from hospitals and pharmaceutical companies.

Th e discovery of a variety of chemicals in surface, ground, and drinking water is not a rare sight anymore. It raises concerns around the country regarding the potentially adverse environmental consequences of these contaminants. Various reports show that minute concentrations of chemicals known as endocrine disruptors, some of which are pharmaceuticals, have detrimental eff ects on aquatic species and possibly on human health and development.

Talking about the concerns, Shruti Pande, Global Clinical Team Lead, Wockhardt Ltd, elaborates, “Th e pharma industry has been concerned about the environmental presence of hazardous pharma compounds and the potential risks including reproductive impairment, increased incidences of cancer, the development of antibiotic-resistant bacteria, and the potential increased toxicity of chemical mixtures.” She adds, “For many substances, the potential eff ects on humans and aquatic ecosystems are

not clearly understood. Th e increasing awareness of the harmful eff ects of these compounds has prompted development of numerous publications of the risks and consumer guidance from state agencies on proper disposal of unused medications, and guidance from the Environmental Protection Agency (EPA) on use and disposal of pharmaceuticals.”

Resource Conservation and Recovery ActTh e US EPA Resource Conservation and Recovery Act (RCRA) regulates the disposal of solid waste and includes numerous defi nitions of hazardous chemical waste. A number of common pharmaceuticals, such as epinephrine and warfarin, are listed as acutely hazardous wastes on the P-list published in 40 CFR 262.33 (e)

A number of chemotherapy items and other drugs such as lindane are listed on the U-list of chemicals found at 40 CFR 262.33 (f )If a P or U listed drug is the sole active ingredient when discarded, the item is designated as a hazardous chemical waste and must be managed in compliance with RCRA, similar to discarded Xylene or other

laboratory chemicals found in healthcare settings. Pande says, “Drug formulations that exhibit one of the characteristic of hazardous wastes including ignitability, corrosivity, toxicity or reactivity must also be managed as hazardous waste if discarded. Th ese management procedures include proper identifi cation, storage, manifesting, transport and disposal at a RCRA approved incineration facility.”

What needs to be done?Every pharma company should commit to certain goals for waste management. Pande lists them out as: Phase out Class I ozone depleting compounds (ODCs) in large Heating, Ventilation and Air Conditioning (HVAC), fi re suppression and industrial process equipment

Continue reducing the ozone depletion potential from releases of ODCs

Decrease the waste that is produced by improving recycling, reuse and recovery methods

Prevent soil and groundwater contamination at facilities and those owned by contractors hired to manage waste

She avers, “Pharma companies should apply green chemistry principles in R&D and manufacturing and explore means to recover or recycle solvents.” She adds that the pharma companies need to develop action plans in order to capitalise on waste minimisation opportunities. She highlights, “Supporting waste reduction eff orts by suppliers and contractors through the use of recycled, reusable and recovered materials is an important activity. Th e pharma companies should exclusively use approved special waste vendors. Conducting pre-selection and periodic follow-up audits of waste vendors to assure standards are mandatory steps.” Signing off Pande says, “Addressing contamination at sites and conducting onsite remediation activities with appropriate government disclosure and co-operation is very important for maintaining waste in a pharma facility.” Th us, waste management is not a cumbersome process but simply implies compliance to certain rules and regulations.

([email protected])

Energy Management: Waste management

With waste management gaining relevance it is the apt time for pharma companies to consider this as a priority. A look at the how’s and why’s of waste management procedure.

No haste

Shruti PandeGlobal Clinical Team Lead, Wockhardt Ltd

Pharma companies should apply green chemistry principles in R&D and manufacturing and explore means to recover or recycle solvents.

whiledisposing waste

Chandreyee Bhaumik


The Indian pharmaceutical industry has made a phenomenal progress in the past few years. It has crossed

$ 21 billion in sales, domestic and export

combined in 2011, both growing at double digits. With highest number of Abbreviated New Drug Applications (ANDAs), Drug Master File (DMF) and US Food and Drug Administration

(FDA) approved manufacturing facilities in the world outside the US it is recognised world over as a reliable source of quality medicines at aff ordable prices. Th is remarkable progress was achieved due to several factors.

Outstanding leadership of India’s entrepreneurs and scientists, reducing the span of price control from 370 to 74 drugs in a phased manner over the past three decades, lack of product patent, which enabled Indian companies to reverse engineer original research molecules of MNCs, are some of the primary drivers among many, for the growth of this dynamic industry.

Th e pharmaceutical scenario in the country has however undergone a sea change following the enactment of product patent law in 2005, and the industry is now moving from imitation to innovation. Ranbaxy, for instance has recently announced its anti-malarial drug discovered for the fi rst time in India. Many more new drugs are awaiting completion of clinical trials. How does then the National Pharmaceutical Pricing policy 2011 fi t in this new scenario. Like most half-baked government policies, NPP 2011 will hardly have any positive impact on access to medicines and healthcare of the nation. What we need is a comprehensive healthcare policy and not a piece-meal approach. No wonder the Department of Pharmaceuticals is having a second thought on implementing NPP 2011. Following are some of the factors we need to consider before embarking on drug price control.

Genesis of NPP It is often justifi ed that the drug policy is the outcome of the Supreme Court judgment which urged the government to consider appropriate criteria to ensure that essential and life saving drugs do not fall outside the preview of price control. Since when did government start honouring the Supreme Court judgments? With a prospect of losing ` 10,000 crore in taxes, not only it reversed the Supreme Court judgment and rejection of its review petition in Vodafone IT case but amended the IT rules that too retroactively from 1962 to suit its

Policies & Regulations: Impact of National Pharmaceutical Pricing Policy Draft 2011

With almost 80 per cent of healthcare cost falling outside the price control ambit, imposing a price control on drugs will not lead India to become a healthy economy. Focus on healhtcare infrastructure and delivery is a must, which means we need a comprehensive healthcare policy.

W n some, l se some

Impact of National Pharmaceutical Pricing Policy Draft 2011


objective. Th is is not to suggest that the government should not honour judgments by the Supreme Court, but it should come out with a policy that benefi ts the patients and also balances it with the viability of the industry. Th ere is a mistaken belief that currently only 74 drugs are under price control. Th e fact is the drugs which are not under price control have a cap of 10 per cent price increase per year. Is not this a hundred percent price control, particularly when infl ation is hovering around double digit?

Access to medicines Th e key challenge that we face today is access to medicines and not their prices. Not only drugs produced in India are priced lower than BRICS (Brazil, Russia, India, China and South Africa) countries but our prices are lower than even neighbouring countries such as Pakistan, Bangladesh and Sri Lanka. According to the World Health Organization (WHO) and many internal reports, access to medicines in India is less than 40 per cent, one of the lowest among the developing countries. Th is low access is not because of availability or high prices of medicines but because of poor health infrastructure where there are no or poor diagnostic facilities, doctors, hospitals, pharmacies, etc in the interior. Focusing on prices alone will not solve this issue. Over 80 per cent of healthcare cost falls outside the price control ambit. For instance, pathological and other diagnostic tests, doctors’ fees, hospital stay, etc are outside the purview of price control.

Reducing transaction costs One way of reducing the prices of medicines is to reduce the transaction costs which amounts to about 40 per cent, one of the highest in the world. Th is includes taxes such as VAT, customs and excise duties, local taxes such as octroi, distributors and retailers` margins, etc. Instead of having uniform margins for distributors and retailers across all products, it should have a slab-based structure, with reducing margins as the product price goes up. Suppose a product costing ` 10 per strip

under decontrolled category is given 20 per cent retailers margin, it amounts to ` 2/- margin in absolute terms. However a product costing say ` 1000/- per unit dose (Eg: erythropoetin injection) will yield ` 200 /- to the retailer at 20 per cent margin, which is much too high. Hence, there should be a slab-based structure with reduced percentage margin as the product price becomes high.

Prevention better than cure A developing country like India should deploy its limited resources to prevention rather than cure. Th is includes vaccination, immunisation, sanitation, hygiene, clean drinking water, cessation of bad habits such as tobacco chewing/smoking, safe sex habits, nutrition, exercise, environmental pollution and behavioural changes

through awareness building. India has successfully eradicated polio from its soil due to abundant availability of oral polio vaccine and building awareness through active promotion.

Health insuranceOver 80 per cent of our population pays from its own pocket for medicines and there lies the problem that needs immediate attention. We need to expand the health insurance sector by attracting foreign capital and expertise and promoting our own insurance schemes like Rashtriya Swasthya Beema

Yojana. Foreign capital in insurance will be diffi cult to attract unless equity participation is increased from present 26 per cent to at least 49 per cent, a proposal waiting for a long time.

Increased healthcare budget India’s defense budget for 2011-12 is ` 1,64,415 crore, which perhaps is justifi ed given our ‘friendly’ neighbourhood. However, this does not justify spending meager ` 26,780 crore per year on healthcare, which is less than 1 per cent of our Gross Domestic Product (GDP) (bailout package announced recently for Air India is ` 30,000 crore with almost zero prospect of getting this tax payer’s money back from the borrower). Most developed countries spend over 12 – 14 per cent of their GDP on healthcare. India needs to increase the budget to at least to 4-5 per cent of GDP to make any meaningful impact on healthcare. In spite of defi ciencies in execution of several government policies and delivery mechanism, several heath indicators, like child mortality, life expectancy, birth rate, etc are showing improvement, largely because of abundant availability of good quality drugs at aff ordable prices. Th e Indian pharmaceutical industry needs to be commended for this contribution and not penalised by infl icting illogical price controls on its produce.

Pharmaceutical business is increasingly becoming complex and knowledge & innovation intensive. It requires signifi cant investment for compliance with Good Manufacturing Practice (GMP), quality and safety, as well as R&D for discovering new drugs, technology up gradation, continuous medical education, Intellectual Property Rights (IPR), etc. By imposing such irrational price controls, the industry that cures sickness will itself head towards sickness. Price control for medicines is a remedy worse than the disease.

([email protected])

Focusing on prices alone will not

solve this issue. Over 80 per cent of healthcare cost falls

outside the price control ambit.

Dr Ajit Dangi President & CEO, Danssen Consulting


Situations wherein doctors are in an emergency room and are stopped by MRs or people calling on their cell phones for their birthdays/

anniversaries are being played out in numerous clinics across the country. Most pharmaceutical companies have procured all kinds of personal data from doctors. Th e company’s staff is well aware of the birthday, anniversary, names of spouse, children, everyone’s interests, hobbies, tastes, their choices for touring and holidays undertaken, etc.

While some doctors’ details were obtained by MRs themselves during their calls, data from other physicians were extracted surreptitiously under the guise of fi lling up forms for conference registration, CME society membership, doctors’ club membership, etc. Most busy physicians ‘outsource’ these form-fi lling exercises to the ever-obliging MRs by scribbling their personal information on their prescription pads. Th e MR later transcribes these details on the forms. In the process they get access to personal data. With the MR

having eased the physician burden, the latter would be in no position to complain about ‘date theft!’

Moreover how can one be rude when you wish them on an important day like a wedding anniversary? It surely is a catch-22 situation for the doctor! While young physicians may initially enjoy the attention, in private many senior physicians fi nd it objectionable to be interrupted while at work even it is to accept greetings on a personal event. However, not many are able to express it clearly for fear of appearing rude and insensitive.

Embarrassment awaitedImagine the physician’s predicament with a waiting room full of patients humorously notice a queue of MRs holding cakes, gifts and bouquets! Patients often enquire with the clinic staff about the exaggerated interest among MRs on that particular day. Most physicians who would like to treat their personal occasions as ‘private’ are forced to accept greetings from a dozen patients that day.

Physicians, who normally keep their conversation limited to the patient’s health status and see more patients in a limited time, may be compelled by the latter to disclose what he or she is celebrating that day! Th e consultation which is supposed to be a serious clinical discussion sometimes veers around to how Sagittarians are all alike!

This one takes the cake!In Mumbai, a young consultant had an uncomfortable situation to face on his 32nd birthday. Th at noon while he was busy in his consulting room seeing patients, an MR secretly landed at his residence holding a large black forest cake, in the presence of the doctor’s relatives who were invited for lunch. Th e guests

Making a sales pitch by gifting doctors on their personal achievements is not considered a great marketing tool. It can work contrary to expectation in case the doctor in question considers it an intrusion into his private domain. An assessment of the situation.

Strategy: Proximity dilemma

wishnot to wish?

orTo

Illus

trat

ion:

Sac

hin

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ate

Proximity dilemma


expressed their surprise to the doctor’s wife that “We did not know that pharmaceutical companies do this, as well,” while she tried to hide her embarrassed expression.

No sooner had the physician landed home the discussion switched to cut the ‘pharmaceutical cake.’ Promptly his teenaged niece enquired, “And what else do they provide, uncle?” Needless to say, the humiliated physician called up the Manager, the very next day, and asked him to desist from such practices in future.

Too close for comfortAll industries in the service sector have their own techniques to promote their sales. One of the oldest tactics is to pamper the people involved by celebrating their personal events. Wishing someone on their birthdays, anniversaries, success etc. is a common behaviour of human beings. Making telephone calls, sending messages or gifts is a common practice among all professions. Physicians and their families too celebrate these special occasions by enjoying a meal outside or having a feast with relatives.

In most cases, physicians who are hard-pressed for time reserve these moments to be spent with their families. As they grow senior in practice, gifts and mementoes do not provide any special sense of pleasure. Many of them are embarrassed to reveal their age or accept greetings. In such a scenario, a hall full of gift-bearing sales representatives is sure to get his goat! What is worse for the doctor is that the ‘celebratory’ MRs wait in the midst of suff ering patients who are eager to fi nish off their consultation and rush back home.

Excuse me, please!Fed up with this practice by pharmaceutical companies, despite his resentment on such activities, a senior consultant has notifi ed his receptionist to mark the day as a ‘No MRs day’ on his birthdays and anniversaries. Persistent MRs still manage to sneak in when a patient leaves the cabin and just push a rose or a pen to the doctor even before the receptionist can react.

A senior physician who celebrated his golden jubilee recently wanted to ensure that it was a purely private aff air. He provided a readymade placard to the receptionist with the words, ‘Th ank you for your good wishes. Please respect clinic rules and excuse meeting me today!’

Every method adopted by sales personnel is considered a winning idea till others copy and make it overkill. Th e pharmaceutical industry should try out more innovative plans to get the doctor’s undivided attention. Till then, it is wise not to get too close to the doctor with such old strategies; you may be unknowingly stepping on his toes!

([email protected])

Dr Rajan T DPharma Consultant & Practising Dermatologist

Tips & Tricks: Pre-grant oppositions


Patent invalidation, under the Patents Act, 1970, can be initiated whereby a person or a party referred to as

opponent may oppose a patent application before grant of patent or oppose a granted patent. The opposition proceedings before the

grant of a patent are referred to as pre-grant opposition. It is a peer-initiated challenge mechanism, which is administrative in nature (before the Patent Controller) and not judicial, giving an opportunity to a competitor/interest group to oppose unjustified protective rights.

Patent watch: A patent application having a bearing on any in-house patent/patent application or product

portfolio may be seen to determine if there is any prior art that would invalidate the patent that the patent offi ce had not previously considered. If said prior art is discovered, the company may bring an opposition proceeding to have the patent declared invalid.

88Tips&Tricks

Appeal: An appeal from the Controller’s decision, in a pre-grant opposition, does not lie under the

statute but there are now a chain of case laws under which it has been judicially determined that a pre-grant opposition is in ‘aid of examination’, hence the Controller’s decision is under section 15 of the Patents Act and can be appealed against before the Intellectual Property Appellate Board.

77Tips&Tricks

Business strategy: Th e current crop of pre-grant opposition cases is evidence enough that

generic companies are using it as a business strategy. Integrate the pre-grant opposition in a comprehensive IPR Management System to capture, evaluate and prioritise inventions in the process of IP creation, accelerating innovation, evaluating IP assets and accessing the business direction of competitors.

99Tips&Tricks

Kamakhya SrivastavaHead-Group on Research Publication and Programme, LEX ORBIS IP Practice

Obviousness: When dealing with obviousness, it is permissible to make a ‘mosaic’ out of the relevant

documents, but it must be a ‘mosaic’, which can be put together by a person ordinarily skilled in the art.

44Tips&Tricks

Who can fi le: ‘Any person’ by way of representation, in writing, can fi le a pre-grant opposition after publication

of the application (in the Patent Offi ce Journal) till the grant of the patent. Th e term ‘any person’, as judicially held, is to be construed in the context of wider rights given to the objector, s the concept of Lis is wide under pre-grant opposition.

22Tips&Tricks

Section 3(d): Th e test of patent eligibility under section 3(d), in context of pharmaceutical inventions,

requires comparative data to ascertain the diff erence in properties with regard to effi cacy between a derivative and its parent compound. It is known statutorily that the mere discovery of a new form of a known substance, which does not result in enhancement of known effi cacy, will not be treated as an invention. Th e application should show that the derivative of the known substance has a signifi cantly diff erent therapeutic eff ect.

55Tips&Tricks

Novelty - Absolute vs Relative: An examination of a patent application is based on the principal of

‘absolute’ novelty in terms of prior use; however, the ground of novelty on which third parties or persons interested can oppose a patent application limits the right of the opponent to oppose only on the ground of ‘prior public use’ in India and not elsewhere, ie ‘relative’ novelty.

33Tips&Tricks

Procedure: Th e opposition proceeding is time-bound and quick therefore before triggering any

pre-grant opposition, it is always advisable to prepare the statement and evidence in support of the representation very thoroughly.

66Tips&Tricks

Knowing the nuances

Filing a pre-grant opposition: Representation for opposition can be fi led within six months from the

date of publication of application as the Patent Rules prohibit grant of a patent before the expiry of a period of six months from the date of publication of the application. Th ere is no prescribed form or fee but consideration of a representation is possible only if the Request for Examination (RFE) has been fi led for the application to be opposed.

11Tips&Tricks

Projects


Alembic Pharmaceuticals LtdProject typeNew facilityProject newsAlembic Pharmaceuticals Ltd is planning to set up a new pharmaceuticals project. The project involves manufacturing of Diene.

Project locationPanchamahal, Gujarat Project costUnknownImplementation stageConstruction

Contact details:

Alembic Ltd

Alembic Road

Vadodara - 390 003

Gujarat

Tel: 0265-2280880

Fax: 0265-2281508


--------------------------------------

Blue Ocean Biotech Pvt Ltd Project typeNew facilityProject newsBlue Ocean Biotech Pvt Ltd is planning to set up a new pharmaceuticals project. The project involves manufacturing of liquid glucose.

Project locationEast Godavari, Andhra PradeshProject costUnknownImplementation stageConstruction

Contact details:

Blue Ocean Biotech Pvt Ltd

4-325, G Ragampet

Peddapuram Mandal

East Godavari

Andhra Pradesh – 533440

Tel: 0884-2329034


------------------------------------

Capsugel Healthcare LtdProject typeNew facilityProject newsCapsugel Healthcare Ltd is planning to set up a new pharmaceuticals project. The project involves manufacturing of Vcaps Hpmc (Hypromellosed) capsules. The company received industrial license from Secretariat of Industrial Assistance (SIA), Department of Industrial Policy and Promotion, Government of India for setting up the project.

Project locationRewari, HaryanaProject costUnknownImplementation stageConstruction

Contact details:

Capsugel Healthcare Ltd

21, Joniawas

Dharuhera

Rewari

Haryana – 122100

Tel: 012-7426 7092

Fax: 012-7426 7168

Email: CapsugelCommunications@

Capsugel.com

-------------------------------------

Claris Lifesciences LtdProject typeNew facilityProject newsClaris Lifesciences Ltd is planning to

set up a new pharmaceutical project. It involves manufacturing of large volume parenterals.

Project locationAhmedabad, GujaratProject costUnknownImplementation stageConstruction

Contact details:

Claris Corporate Headquarters

Nr. Parimal Crossing

Ellisbridge

Ahmedabad - 380 006

Tel: 079-26563331

Email: investorservices.corp@

clarislifesciences.com

-------------------------------------

Exemed Pharmaceuticals Project typeNew facilityProject newsExemed Pharmaceuticals is planning to set up a new pharmaceuticals project. The project involves manufacturing of tramadol hydrochloride.

Project locationVadodaraProject costUnknownImplementation stageConstruction

Contact details:

Exemed Pharmaceuticals

628 A and B, ECP Canal Road

At. and Po. Luna

Taluka - Padra

Vadodara Gujarat

Tel: +91 9662536756, +91 9662536757


-------------------------------------

New projects and expansion activities are the barometers of industrial growth. These also present business opportunities to service providers like consultants, contractors, plant & equipment suppliers and others down the value chain. This feature will keep you updated with vital information regarding new projects and capacity expansions being planned by companies in the pharma/lifesceinces industry.

Projects


LupinProject typeNew facilityProject newsLupin is setting up a new manufacturing plant at the MIHAN Special Economic Zone (SEZ).

Project locationNagpurProject cost` 400 croreImplementation stageConstruction

Contact details:

Lupin Ltd

B/4 Laxmi Towers

Bandra Kurla Complex, Bandra (E)

Mumbai 400 051

Tel: 022- 6640 2222

Fax: 022- 6640 2130


-------------------------------------

SandozProject typeNew facilityProject news Sandoz, has set up a pharmaceutical formulation facility. This is Sandoz’s first large scale facility in Asia. The facility has been built as per US and European standards and is dedicated to these markets.

Project locationMumbaiProject cost$13 millionImplementation stageComplete

Contact details:

Sandoz

Plot Nos. D-31 & D-32, MIDC TTC

Industrial Area Turbhe

Navi Mumbai - 400 705

Tel: 022-5591 0485

Fax: 022-5591 0472


---------------------------------------

Unique Biotech LtdProject typeNew facilityProject newsUnique Biotech Ltd is planning to set up a new pharmaceuticals project.The project involves probiotics-microorganisms probiotic formulations.

Project locationRangareddy in Andhra Pradesh Project costUnknownImplementation stageConstruction

Contact details:

Unique Biotech Ltd

Plot–2,Phase -2

Alexandria Knowledge Park.

Genome Valley, Shameerpet

Hyderabad – 500078

Andhra Pradesh

Tel: 040-23480 346/47

Fax: 040-23751 345


--------------------------------------

WockhardtProject typeNew facilityProject newsWockhardt has set up a 28,000-sqm global-scale biopharmaceuticals manufacturing biotech complex. Project locationAurangabad Project costUnknownImplementation stageComplete

Contact details:

Wockhardt Towers,

Bandra-Kurla Complex, Bandra (East)

Mumbai - 400051

Maharashtra

Tel: 022-26534444

Fax: 022-26534242


--------------------------------------

Torrent Pharmaceutical LtdProject typeNew facilityProject newsTorrent Pharmaceut ica l i s going to expand its facility at Kadi and will be setting up a green field project at upcoming Dahej SEZ.

Project locationKadi, Mehsana districtProject cost` 300 crore Implementation stageConstruction

Contact details:

Torrent Pharmaceutical Ltd

Off Ashram Road

Ahmedabad- 380009

Gujarat

Tel: 079-26585090

Fax: 079-26582100


--------------------------------------Hyacinths Pharma Pvt LtdProject typeNew facilityProject news Hyacinths Pharma Pvt Ltd is planningto set up a new project that would involve manufacturing of ethambutal.

Project locationSrikakulam, Andhra PradeshProject costUnknownImplementation stageConstruction

Contact details:

Hyacinths Pharma Pvt Ltd

H. No 8-3-678/60

Yousufguda

Hyderabad: 500045

Andhra Pradesh

Fax: 040-23756566


--------------------------------------

Event List


Lab Expo & Conferences CoimbatoreThis event focusses on various aspects

related to lab equipment manufacturing

as well as promoting good lab practices

among the fellow professionals. The trade

show will be a two-day affair and will

witness attendance from a considerable

number of professionals who have been

involved with this profession for a long time.

This expo will also be supplemented

with informative sessions and

workshops. This is an excellent

platform for the lab equipment

manufacturers and distributors to

display their latest technological innovations

and creations in front of an international

audience. Moreover, this event also takes

care of a number of important issues related

to lab automation and labware equipment;

June 15-17, 2012, Codissia Intec Technology

Centre, Coimbatore

For details contact:

Paramount Exhibitors

Tel: +91 172 2274801

Fax: +91 172 2274803


Website: www.paramountexhibitors.com

Pharma Rural Marketing 2012This is one of the dedicated platforms that will

bring together senior level decision makers

from across marketing and strategic planning

functions within the Indian pharmaceutical

industry. During these action packed three

days, with high value networking and

business content, Indian and multinational

pharma companies, marketing consultants,

communication agencies, supply chain and

logistics management companies will identify

the key challenges within the industry

and discover business critical solutions to

overcome them; June 21-22, 2012, Holiday

Inn, Mumbai


UBM India Pvt Ltd

Tel: +91 22 6612 2600

Fax: +91 22 6612 2626-27


Website: www.ubmindia.in

Automation 2012All leading companies in industry will

showcase their latest products and

help one find the solutions at the show.

The show brings latest technologies

from an interesting array of fields

such as: factory automation, process

automation and control systems, robotics

& drives, field instrumentation & smart

sensors bus technologies, software

solutions, wireless technology,

building automation, and hydraulic &

pneumatic automation in renewable

energy. From technocrats to solution

providers, vendors and tech-buffs,

the fair is all set to draw every one

alike; September 7-10, 2012, NSE

Complex, Mumbai


IED Communications Pvt Ltd

Tel: + 91 22 22079567

Fax: + 91 22 22074516


Website: www.iedcommunications.com

Pharmac IndiaIt is a-three-day event that aims towards

highlighting several issues of the industry.

This will be large hub of reputed

professionals from pharma formulation,

herbal products, veterinary drug, medical

& disposal, pharma machinery and many

other sectors. There will be visitors from

pharma company marketing/purchase/

export executive, marketing company &

consultant, merchant exporters, contract

manufacturers, pharma distributors,

generic & OTC manufacturer &

wholesalers, Government supplier, liaison

agents, sourcing companies, production &

purchase professionals, and international

business representatives; September 8-10,

2012, Gujarat University Exhibition Hall,

Ahmedabad


Orbitz Exhibitions Pvt Ltd

Tel: +91-22-24102801

Fax:+91-22- 24102805


Wewww.orbitzexhibitions.com

Indian Lab Automation conference and exhibitionILA 2012 will feature three technical

conference tracks; Drug Discovery and

Development, Advances in Bioanalysis and

Advances in Genomics and Informatics.

Each track will provide attendees with

the opportunity to listen to presentations

on cutting edge research in specific

application areas, with an underlying

theme of automating the technique,

equipment or associated informatics;

October 30-31, 2012, Renaissance Hotel

& Convention Centre, Mumbai


Select Biosciences Ltd

Tel: +44 1787 315110

Fax: +44 1787 315111


Website: www.selectbiosciences.com

NATIONAL

India’s premier industrial trade fair on products and technologies related to Machine Tools, Hydraulics & Pneumatics, Process Machinery & Equipment, Automation Instrumentation,

Packaging & Auxiliaries, IT Products, Electrical & Electronics, Material Handling and Safety Equipment.

AHMEDABADGujarat,

Oct 5-8, 2012

For detailsInfomedia 18 Ltd

Ruby House, 1st Floor, J K Sawant Marg, Dadar (W), Mumbai 400 028. • Tel: 022 3003 4651 • Fax: 022 3003 4499 • Email: [email protected]

PUNEMaharashtra,

Nov 2-5, 2012

CHENNAITamil Nadu,

Nov 22-25, 2012

LUDHIANAPunjab,

Dec 21-24, 2012

INDOREMadhya Pradesh, Jan 11-14, 2013

AURANGABADMaharashtra, Feb 1-4, 2013

RUDRAPURUttarakhand,

Feb 23-26, 2013

Event List


INTERNATIONAL

The information published in this section is as per the details furnished by the respective organiser.

In any case, it does not represent the views of Modern Pharmaceuticals

Biomarkers World EuropeThis event aims to discuss how to

support target identification and

eliminate dead-end candidates,

to understand the range of

biomarker candidates, how to create

sophisticated animal models of

human disease to develop biomarkers

for proof-of pharmacology, how to

facilitate clinical trial stratification

and employ early surrogate end

points of efficacy, ways to define the

correlation between biomarker and

disease/therapeutic intervention;

May 22-24, 2012, Business Design Centre,

London, UK


Health Network Communications Ltd

Tel: +44 0 207 608 7055

Fax: +44 0 207 608 7050

Email: skhamissa@

healthnetworkcommunications.com

Website: www.healthnetworkcommunications.com

Conference on Social Media in the Pharmaceutical IndustryThis event aims to focus on keeping the

audience up-to-date with developments

in the ever-changing social media sphere.

With this industry moving at a rapid pace,

and with more patients and healthcare

professionals becoming more tech-savvy, the

pharmaceuticals industry need to embrace

social media; July 9-10, 2012, Copthorne

Tara Hotel, London, UK


SMi Group Ltd

Tel: +44 0 20 7827 6000

Fax: +44 0 20 7827 6001


Website: www.smi-online.co.uk

ICBLS 2012The aim of the International Conference

on Biological and Life Sciences (ICBLS)

conference is to provide a forum for laying

the foundations of a new principled approach

to Biological and Life Sciences. To this end,

the meeting aims to attract participants

with different backgrounds, to foster cross-

pollination between different research

fields, and to expose and discuss innovative

theories, frameworks, methodologies, tools,

and applications; July 23-24, 2012, River

View Hotel, Singapore


Asia-Pacific Chemical, Biological &

Environmental Engineering Society

(APCBEES)

Tel: +852 3069 7291

Fax: +852 2180 1366


Website: www.icbls.org

JCBBB 2012 The 3rd Journal Conference on Bioscience,

Biochemistry and Bioinformatics ( JCBBB

2012) aims to provide a forum for

researchers, practitioners, and professionals

from the industry, academia and government

to discourse on research and development,

professional practice in bioscience,

biochemistry and bioinformatics. This is one

of the leading international conferences for

presenting novel and fundamental advances

in the fields of bioscience, biochemistry

and bioinformatics. It also serves to foster

communication among researchers and

practitioners working in a wide variety of

scientific areas with a common interest

in improving bioscience, biochemistry

and bioinformatics related techniques;

September 1-2, 2012, Phuket, Thailand


International Journal of Bioscience,

Biochemistry and Bioinformatics

Tel: +91 422 2611146

Fax: +91 422 2611043


Website: www.ijbbb.org

NCCR 2012The 6th National Conference for

Clinical Research 2012 (NCCR 2012)

aims to serve as a platform that aims to

bring together clinical investigators,

industry professionals, regulatory

agencies and policy makers in order to

address the issues and challenges of the

industry. By gathering people from various

research disciplines, the event aims to

foster constructive and forward looking

discussions, sharing of experiences,

and mutual commitment towards the

betterment of humanity; September

23-25, 2012, Sunway Pyramid Convention

Centre, Malaysia


Association of Clinical Registries, Malaysia

(ACRM)

Tel: +603 4044 3060

Fax: +603 4044 3080


Website: www.nccrconference.com.my

CPhI WorldwideThe event hosts over 1900 exhibitors

and is the market leader for the

global pharmaceutical ingredients

industry. CPhI Worldwide has

three co-located events: ICSE,

P-MEC Europe and InnoPack.

These events focus on specific

sub-sectors of the pharma

ingred ien t s indus t r y and

provide visitors and exhibitors

with additional capability to network

and do business in dedicated

areas; October 9-11, 2012, Feria de

Madrid, Spain


UBM India Pvt Ltd

Tel: +91 22 6612 2600

Fax: +91 22 6612 2626-27


Website: www.ubmindia.in

Book Review


Reviewer: Sreya SenMSc Biotechnology, St Xavier’s College, Kolkata

Gene Cloning and DNA Analysis: An IntroductionEditor: TA Brown

Price: ` 3850/-

Molecular Cell BiologyEditors: Harvey Lodish, Arnold Berk, Chris Kaiser, Monty Kreiger,

Matther Scott, Anthony Bretscher, Hiddle Ploegh and Paul Matsudaira

Price: ` 5000/-

Known worldwide as the standard introductory text to the important and exciting area of recombinant DNA technology, ‘Gene Cloning and DNA Analysis – An Introduction’ addresses new and growing areas of research while retaining the philosophy of the previous editions. Assuming the reader has little prior knowledge of the subject its importance, the principles of the techniques used and their applications are carefully laid out, with over 250 clearly presented illustrations.

In addition to a number of informative changes to the text throughout the book, the fi nal four chapters have been signifi cantly updated and extended to refl ect the striking advances made in recent years in the applications of gene cloning and DNA analysis in biotechnology: Extended chapter on agriculture including new material on glyphosate-resistant plants

New section on the uses of gene cloning and PCR in archaeology Coverage of ethical concerns relating to pharma, gene therapy and genetically modifi ed crops

Th is book remains an essential introductory text to a wide range of biological sciences students; including genetics and genomics, molecular biology, biochemistry, immunology and applied biology. It is also a perfect introductory text for any professional needing to learn the basics of the subject.

‘Molecular Cell Biology’ stands out from its peers in this course in that it provides a clear introduction to the techniques and experiments of scientists past and present, not just an ‘encyclopaedia’ of information. Th is experimental emphasis, together with a solid paedagogical framework in the chapters, provides the clearest, most cutting-edge text available.

Th e value of this incredibly extensive reference book lies in the attention it gives to explaining methods and techniques as fully as is possible in a text that addresses so many aspects of this fast-expanding fi eld. Th is book is an essential tool for both students and professionals that need to broaden their knowledge in molecular cell biology. It provides the fundamental concepts and contains high quality illustrations/graphics. Th is is a very comprehensive book about molecular cell biology. It starts from the very basics of chemistry and protein, and ends with a clear molecular description of cell cycles and cancer.

Th is book serves as a systematic guide to the professionals involved in the industry. Further, this book can also be considered as an aid to the researchers and the pharma students, both for their professional and academic purposes.

72

Products



Just type MPH (space) Product Name and send it to 51818eg, MPH Laboratory software and send it to 51818

Steam boilerTh e fully automatic package steam boiler (IBR) has capacity ranging from 100 kg/hr to 2000 kg/hr with operating pressure of 10 kg/cm² g. Smoke tube & water tube version is also available. Coil is made from seamless tube of asthma 106 GR-B pipes. Th e unit is equipped with high effi ciency oil/gas burner with

air pre-heater arrangement which gives high thermal effi ciency.

Aero Th erm Systems Pvt LtdAhmedabad - GujaratTel: 079-25890158Email: [email protected]: www.aerothermsystem.com

Rapid mixer granulatorTh ese are designed to meet the requirements of GMP. Th e contact parts are made of SS-304/316. Th ese granulators come with specially designed control panel with display system and microprocessor. Th e bowl, lid mixing agitator and discharge housing are made of stainless steel. Al MS parts of the machine are cladded/covered

with stainless steel.

Avon Pharma Machines Pvt Ltd Th ane – MaharashtraTel: 0250-2450638


FreezerTh e MDF-C2156VAN freezers provide stable and highly uniform ultra-low temperatures for the long-term preservation of viable cells, tissues and biological materials. Off ering signifi cant advantages, these large capacity 150°C freezers combine exceptional performance and durability with reduced energy consumption and quiet operation. Th e freezers incorporate patented third-generation VIP PLUS insulation panels.

Sanyo E&E Europe BVEtten-Leur – NetherlandsTel: +31-76-5433833


Website: www.eu.sanyo.com

Bottle cappersRotary chuck style bottle cappers are designed to apply and rotate a pre-sorted cap on a container, based on a predetermined applied torque. Th e containers are fed onto the rotary chuck style capper and are separated and positioned on individual capping stations. Caps are pre-sorted and fed on the sliding table of the machine.

US Bottlers Machinery Company North Carolina – USATel: +1-704-5884750


Website: www.usbottlers.com

SievesTh ese are silicon moulded sifter sieves, fl uid bed dryer (FBD) sieves and FBE dryer sieves. Th e silicon moulded sifter sieves are available in various sizes from 12” to 48” diameter. Th ese are available in rivetted and special non-rivetted design. Th e mesh sizes vary from 4 mesh to 500 mesh with ASTM & BSS Standards.

Atlanto Enterprises Mumbai – MaharashtraTel: 022-23096098

Mob: 09819942853


Website: www.atlanto.net

Products


Starch paste kettleTh ese are specially designed for preparation of binder materials. Th e hemispherical kettles with jacket are mounted on trunion supports with the help of shaft. Th ese kettles have a small cylindrical top shell with a spout for pouring out binder mass. Th e starch paste kettles are made of SS-304/SS-316. Th ese come with

anchor type beater for paste mixing.

Bombay Pharma Equipments Pvt LtdMumbai – MaharashtraTel: 022-28594877

Mob: 09820124804


Website: www.bombaypharma.com

Linear vial washing machineTh ese high-speed linear vial washing machines are totally fabricated from SS materials, including the basic frame. Th e machines are suitable for handling wash of 5 ml to 30 ml vials without changing parts. Th ese are provided with high-pressure spray

nozzles that enter into the vials during washing time. Th e linear vial washing machines are equipped with safety devices to ensure smooth and silent operation.

Laxmi Industries Ahmedabad – GujaratTel: 079-22893810


Stoppering machineTh ese servo rotary stoppering machines are crafted for cleanroom productions. Th e compact size allows for a side-by-side confi guration, doubling the speed and matching the speed of the liquid fi lling machines for over 200 vials per minute side. Th ese systems perform full and partial insertion and can be easily changed over to diff erent stopper and bottle sizes.

Automated Machine Technologies, Inc North Carolina – USATel: +1-919-3610121

Email: offi ce@amtliquidfi lling.com

Website: www.amtliquidfi lling.com

Coating panTh ese are totally enclosed with stainless steel cladding and are available with standard gearbox, motor and hot-air blowing arrangements. Th e coating pans are provided with interlocked electrical circuit so that the heaters can be operated only after the blowers are switched ON to avoid burning of the heaters. Th ese coating pans are

manufactured from the SS-304 AISI 2B prime material quality with adequate mouth opening and depth.

Allegro Pharmachem Equipment Th ane – MaharashtraTel: 022-40146872


Website: www.allegroindia.com

74

Products


chopper blades. Th e impellers are specially designed to reduce product sticking to the blades, and can be easily removed for cleaning.

IMA - Industria Macchine Automatiche SpA Bologna - ItalyTel: +39-51-783111


Conductivity metersTh e mhoCounter CT-10 is a conductivity indicator & mhoCounter CT-11 is the meter with relay output option, which is programmable. Microprocessor-based electronics allow wide operating range and long term signal stability. Optional relays provide control for adjustment or

alarms. Also the meters come with saddle mounting option or standard fi ttings to adopt to any process fl ow solution. Technical specifi cations are: function: conductivity/TDS indication & relay output; accuracy: ±2 per cent of FSD; meter dimensions: 111 mm x 106 mm x 68 mm; display: 4-digit customised LCD; mounting; online type vertical or horizontal; installation: solventable T or clamp-on saddle; protection: weatherproof enclosure; and programming: through front panel keys.

Vatturkar IndustrialPune - MaharashtraTel: 020-2538 0568, Email: [email protected]

Website: www.vatsmeter.com

Capsule fi lling machinesKarishma Pharma Machines off ers manually-operated capsule fi lling machines for smaller batches and R&D purpose. Th ese capsule fi lling machines are simple to operate, having negligible rejections and weight variation. Th ey can be supplied with interchangeable parts for all

standard sizes. Th e capsule fi lling machines have recommended interchangeability for optimum output of 0/00-0/1/2—3/4/5. Output ranges from 55,000 to 60,000 capsules per 8-hour shift.

Karishma Pharma MachinesMumbai - MaharashtraTel: 022-2380 5979, Mob: 09821069064


Website: www.karishmapharma.com

In-line fi lling & stoppering machinesSterifi ll F200 inline fi lling and stoppering machines are provided for aseptic environments that can reach an output of up to 320 pieces per min. Th e machines are manufactured in AISI-304 or AISI-316 L and are fully compliant with cGMP standards. Also off ered are high shear mixers that are designed to perform wet granulation processes, combining active products by adding a binder solution. Th e granulation process is carried out very quickly due to the high energy transmitted to the product by the turbulence caused by the combined action of impeller and

Pharmaceutical medicinesSchwitz Biotech is engaged in off ering a wide assortment of pharmaceutical medicines that are known for their eff ective results. Made in proper hygienic conditions, these medicines are categorised into topical, oro-dental, gynaec & haemostats, intravenous fl uids, anti-allergic, cold & cough medicines, antibiotics & quinolones & cephalosporins, antacids, anti-ulcerants & laxatives and appetite stimulants enzymes. Th ese are formulated under the supervision of experts for ensuring optimum quality and durability of medicines.

Schwitz BiotechAhmedabad - GujaratTel: 079-2749 3057, Mob: 09825374233

Email: schwitz_rkb@rediff mail.com

Website: www.schwitzbiotech.com

FreezersSanyo MDF-C2156VAN freezers from provide stable and highly uniform ultra-low temperatures for the long-term preservation of viable cells, tissues and biological materials. Th ese incorporate patented third-generation VIP PLUS insulation panels, reducing the wall thickness from 175 mm to 135 mm. Th is achieves up to 25 per cent more storage capacity compared with a conventionally insulated freezer without increasing the footprint. Th e resulting capacity of 231 litres accommodates up to 14,000 2 ml cryo-tubes. In addition to the Sanyo-developed insulation, a double lid gasket helps maintain internal temperature stability by preventing cold-air loss. Th e freezers also provide uniform storage temperatures without the risks from sudden liquid nitrogen eruptions or splashing when samples are removed.

Sanyo E&E Europe BVEtten-Leur - NetherlandsTel: +31-76-5433833

Email: [email protected], Website: www.eu.sanyo.com

Products


Gravity feed metal detectorTh ese are designed to detect metal contamination in dry, powdery or granular free-fl owing products that can be gravity fed through a pipe. Th e detectors feature high sensitivity, high throughput and is compact in size. Both the reject chute and frame are of stainless steel. Th e metal detectors are designed to minimise system space.

Target InnovationNavi Mumbai - MaharashtraTel: 022-27790077

Mob: 09823309636


Website: www.targetinnovations.com

Cleanroom mouldsAdapplicator, Alu cap, Snap cap, PE bottle pack cap, PE twin port cap are only some of many cleanroom moulds from B r a u n f o r m .

Highly sensitive packaging and measuring components, caps for use in dental and insulin fi elds, dialysis components, hygiene products and the Adapplicator system developed by Braun, the spray alternative to needle injection, are few examples.

Neejtech IndiaAhmedabad - GujaratTel: 079-26561312Mob: 09825040231Email: [email protected]: www.neejtech.com

Precision melt supermixTh e new precision melt supermix delivers robust high resolution melt performance for sensitive and accurate detection of single nucleotide polymorphisms and CpG methylation for epigenetic studies. Th e PCR reagent is compatible with all HRM-capable thermal cyclers. Traditional genotyping

Disposable bioreactorTh ese are single use systems made of medical grade plastics, which are presterilised and ready for use, therefore not needing cumbersome SIP and CIP. Agitated by means of an external gyrational motion, which uses gravity naturally to make the contents fl ow in a uniform circumferential direction in a specially shaped round bag.

Lablinks Biotech Pvt Ltd Bengaluru - Karnataka Tel: 080-32440830

Mob: 09343748099


Website: www.lablinksbiotech.com

methods, such as denaturing high-pressure liquid chromatography and single-strand conformation polymorphism, involve lengthy protocols and require multiple days for completion.

Bio-Rad LaboratoriesCalifornia – USATel: +1-800-2246723


Website: www.bio-rad.com

76

Products


Rotary vane vacuum pumpTh e Minivac SVL series of low vacuum pump is a sliding vane-type direct/belt-driven vacuum pump mounted on common base frames. It is compact in size, vibration-free and hence can also be mounted inside the machine. Th e pump attains maximum

vacuum levels up to 29” of Hg with capacities ranging from 50-2000 lpm. Unique design of the lubrication system positively feeds minimum required oil to all rotating and frictional parts. Th e pump is useful in applications like capsule fi lling/capsule printing machines and other pharmaceutical machineries, packaging/labeling machines, screen printing/plate making, book binding/folding machines, vacuum chucking, etc.

Shree Siddhivinayak IndustriesDist Th ane - MaharashtraTel: 022-28458372

Email: minivac@rediff mail.com

Website: www.minivacpumps.com

Filtration and separation productsAdvantec’s wide range of fi ltration solutions are used for laboratory, research and process applications. Th ese products are used in a wide variety of scientifi c capacities and applications, such as microbiological analysis, air/gas fi ltration, and environmental

monitoring. Advantec’s range of fi ltration products fi ts comfortably within Cole-Parmer’s own product range. It off ers customers an additional and valuable range of unique quality products that will enhance their processes and research.

Cole-Parmer IndiaMumbai - MaharashtraTel: 022-67162222


Website: www.coleparmer.in

Diaphragm vacuum pumpTh e chemical-resistant diaphragm vacuum pump has oil-free vacuum option for laboratory and pilot scaled application. Typical applications include evacuating chemically aggressive gases and vapours from such equipment as rotary evaporators, vacuum drying

cabinets and centrifugal concentrators. Th e diaphragm vacuum pump is available in various options of materials, like EPDM, neoprene, Viton and Tefl on coated neoprene rubber. It is also available in the range of 15-33 lpm and generates a maximum vacuum of 30 Torr. Chemical resistant vacuum pump is supplied with three-phase fl ameproof motors.

Sri Vishnu Pumps Manufacturing CoMumbai - MaharashtraTel: 022-28458373

Email: vishnupump@rediff mail.com

Website: www.minivacpumps.com

Walkable ceiling systemIclean ceiling system is designed to fi t every requirement and adhere to stringent quality standards that fi t in seamlessly with the rest of the room paneling. Th e ceiling panels are fastened to profi le that are placed on a particle-tight extruded aluminium grid matrix with caulked silicone sealant. Materials of construction include GI powder-coated & SS-304, 40 mm thick ceiling panels, 0.8 mm thick skin pass powder-coated GI sheets, factory-made cutouts, fi re-retardant PUF as in-fi ll, etc.

Integrated Cleanroom Technologies LtdHyderabad - Andhra PradeshTel: 040-3213478, Mob: 09989212162


Website: www.icleantech.com

Vial and bottle cap sealing machineTh is machine is compact, versatile and elegantly fi nished machine for sealing vials and bottles of various sizes and BT (transfusion) bottles or similar containers with aluminium/plastic caps. Some of the features include uniform sealing, no manual involvement, no repeated setting, while the sealing rollers rotate on bearings to give smooth motion for uniform sealing. Minimum time is required to change over from one size of vial to another. It also does not require any lubrication.

Anju Pharmaceuticals Indore - Madhya PradeshTel: 0731-2523968, Mob: 09893562415


Website: www.anjupharma.com

Products


Shaking incubatorTh e compact benchtop Stuart SI500 and SI505 shaking incubators have a unique retractable platform providing easy access to samples, a digital display showing the independently controlled

temperature and speed, and USB connectivity for long-term monitoring of the incubator temperature via a PC. Removable water reservoirs increase the humidity in the chamber of the Stuart SI505, dramatically reducing sample evaporation. Th e Stuart SI500 incorporates a versatile clamping system for securing fl asks of most sizes, while angle-adjustable stainless steel accessory tube racks with magnetic locking system providing quick coupling and de-coupling.

Bibby Scientifi c LtdStaff ordshire - UKTel: +44-1785-812121

Email: info@bibby-scientifi c.com

Website: www.bibby-scientifi c.com

Walk-in humidity chamberTh e unit has double-walled insulated PUF modular panels, which can be easily assembled at site. Interior is made of stainless steel and exterior is either made of mild steel fi nished with powder coating or stainless steel. Th e unit has full-length inner glass door and outside metal door with magnetic gasket and lock. It is provided with perforated stainless steel trays and has forced air circulation for uniform temperature. Th eintelligent controlling system has PLC base and PC communication. It has long lasting stainless steel tubular heaters with SS fi ns.

Newtronic Equipment Company Pvt LtdMumbai - MaharashtraTel: 022-28679326, Mob: 09821089932


Website: www.newtronic.in

Vial inspection machineIn the vial inspection machine (model SMPL-AIM-72) all contact parts are made of stainless steel and approved engineering plastics. Magnifi ed view with back lighting is available and rotation of spinners can be adjusted to give desired vortex in liquid. Th e vial inspection machine has separate counters for placing

good and rejected products.

Snowbell Machines Pvt LtdTh ane - MaharashtraTel: 0250-6456141, Mob: 09322777625


Website: www.snowbellmachines.com

Work benchTh e work bench features steel frames, panels and shutters made from prime quality CRCA steel. Th is steel is coated with epoxy paint and a special encapsulated powder that has a fi lm thickness of 40-60 microns. Th is imparts a

high scratch-resistance and the encapsulated powder ensures that no oil or chemical marks are formed on the surface. Every shelf on the cabinet is equipped with a load carrying capacity of 40 kg UDL to ensure maximum effi ciency in the cabinet drawer. High-precision double-extension ball slides are used.

Godrej & Boyce Mfg Co LtdMumbai - MaharashtraTel: 022-67964363, Mob: 09920113138


Website: www.godrej.com

80

Products


Metal analyserTh e 7700 series ICP-MS metal analyser is productive, simple-to-use, high sensitivity, low background, better interference removal, increased fl exibility, easier to maintain and service. Th is workhorse 7700x is used for most applications, and in

high-throughput commercial labs. It is designed specifi cally for semiconductor applications. Th e new 7700e off ers a simplifi ed and easy-to-use system for routine analysis. Featuring a new, confi gurable MassHunter software platform and a host of hardware developments, including a new frequency-matching RF generator and 3rd generation Octopole Reaction System (ORS3), all three 7700 series mainframes provide unrivalled levels of performance and ease-of-use.

Agilent Technologies India Pvt LtdNew DelhiTel: 011-51496664


Website: www.agilent.co.in

Screening machineTh e tumbler and vibration screening machines are available as per GMP and FDA-regulations for applications in pharmacy, food and fi ne chemicals. Th is machine is are used for treatment of valuable powders, pellets and granules. Th e hygienic design includes solutions for WIP-cleaning devices and ATEX certifi cation. Th e tumbler

screening machine is a high-performance screening machines for fractionating, protective screening and dedusting. Th e three-dimensional tumbling movement creates exceptional fi ne cuts for the bulk solids. Modular design allows the production of additional fractions through additional screening desks in one machine. For simple applications vibration screening machines, type VTS or Vibrall, are economic alternatives.

Allgaier Werke GmbHUhingen - GermanyTel: +49-7161-301353


Website: www.allgaier.de

Automatic capsule fi ller Th e model-A25 high-speed automatic capsule fi lling machine is compact, sturdy, covered with stainless steel panels, and the hood is covered with acrylic guard. It is provided with

tamping mechanism for powder fi lling, which enables capsules to

be fi lled with a weight variation within 2 per cent. Variable AC frequency drive for main motor ensures speed adjustment. Th e faulty capsule and fi lled capsule ejection stations are equipped with individual air controls. Th is machine is simple to operate and easy to maintain. Th e special purpose gauges ensures quick and easy changeover.

Karishma Pharma MachinesMumbai - Maharashtra Tel: 022-24181490, Mob: 09821069064

Email: capsulefi [email protected]

Website: www.capsulefi ller.net

Mini bilayer pressTh e mini bilayer press is designed to represent two-layer tablet productions at a small scale. With its larger turret diameter, variable speed allows for realistic scale up to larger rotary presses. It is provided with two force feeder system, which helps in maintaining uniform die fi ll and represents production equipment. It is provided with pressure compensation hydraulic system. Tablet thickness and weight adjustment settings are outside the machine. It is designed as per cGMP norms. All parts in the compression zone are of SS-304 or electroless nickel-plated.

Aayush Techno Pvt LtdAhmedabad - GujaratTel: 079-25898901


Website: www.aayushtechno.com

Liquid fi lling machineTh e four-head liquid fi lling machine is a highly versatile machine for fi lling foamy as well as other liquids into containers. It has a unique bottle separation method in which no turret or holding slides are used. Th is machine fi lls the liquid using the syringe principle and is very easy to use. Turntable is provided for bottle fi lling. Th is liquid fi lling machine is provided with variable speed conveyor and is suitable for fi lling all types of liquids with less density. It is equipped with 1.5 HP motor with gear boxand the diving nozzles is used for prevention of spillage and for foamy liquids.

Harshika IndustriesDist Th ane - MaharashtraTel: 0250-3246533, Mob: 09869457909

Email: harshad.g@rediff .com

Website: www.fi lling-machinemanufacturer.com

Products


Aluminum blister foilsTh e company manufactures diff erent kinds of aluminum blister foils that are widely used in various industries. Aluminum blister foils are suitable for high-speed packing applications. Th ese foils are one side coated with heat lacquer and the other side unprinted or

printed to facilitate pharmaceutical blister packaging. Th e range of aluminum blister foils are resistant to moisture, vapour and gases. Th ese are available in compact sizes and are economical as compared to strip packs. Th e foils help in the easy removal of the tablets as hard foils break easily when pressed hard. Also off ered is a range of foils as per specifi c requirements of customers.

Krish PharmapackDist Th ane - MaharashtraTel: 0250-3249666, Mob: 09594000600


Website: www.krishpharmapack.com

Digital fl ow metersVatturkar Industrial off ers digital fl ow meters and digital conductivity meters. Operators can easily install and recalibrate the meters online. Th e fl ow meters are proven in harsh industrial environment and are service free units based on the

state-of-the-art advance microprocessor technology. Both fi eld-mounted as well as panel-mounted meters are available. Th e digital fl ow meters come in diff erent forms, ie, standard panel-mounted and fi eld-mountable type (specially designed IP-65 enclosure to suit open atmosphere industrial conditions). Th ese are based on paddle wheel insertion type sensor. Th ese are applicable in water treatment industry, pharmaceutical industry, beverage/distillery industry, bottling industry, oil/refi ning industry, ready mix concrete plants, automatic liquid dispensers, chemical industry, etc.

MTS Engineers Pvt LtdAhmedabad - GujaratTel: 079-2640 0063, Mob: 09879407970

Email: [email protected], Website: www.mtsengrs.coj

Pharmaceutical label sealsTh ese seals are perfect for pharmaceutical labelling and security label seals type-D. Th ese are provided with covert security mark and a warning message to be applied on individual carton reaches retail outlets. Th ese are designed to break into small pieces during any attempt to remove

it from the applied surface and prevent subsequent re-application. Evidence of tamper is obvious. Th e pharmaceutical label seals are provided with invisible hidden mark for authentication. Th ese can be used for a multitude of identifi cation purpose and as tamper evident seals in pharmaceutical, bulk drugs, chemicals, agrochemicals, etc.

Safcon Security SealKolkata - West BengalTel: 033-2226 0513

Email: [email protected], Website: www.safconsecurityseal.com

Electric blanketsAristocrat electric blankets off ered are waterproof, shockproof, autocut, soft underlay to provide constant slow motherly warmth. It is a relief for the patients of asthma, gout-arthritis, backaches, bodyaches & pains, patients of diabetes, low blood pressure, and the aged alike. Th ese blankets supplement the much needed body energy and as such are really useful for senior citizens, some of whom pop out during sleep in extreme winters for need of energy. Th e electric blankets can be used in hotels to reduce high electricity bills; and can also be used in hospitals to provide comfort to patients.

Medico Pharmaceuticals ProcessorsAmritsar - PunjabTel: 0183-2258586, Mob: 09356000059


Website: www.medico.co.in

Hydrogen gas generatorSeries WM-H2 hydrogen gas generator use the latest polymer electrolyte membrane (PEM) technology to produce pure hydrogen. Th e exclusive double gas column dryer regeneration system eliminates all downtime for maintenance. Standard features are models available in 120, 180, 260, 400, 500, 650, 800, 900, 1000, 1200 cc/min, purity is > 99.99999 per cent, has automatic dryer regeneration, off ers pressure up to 12 bar (16 bar on request), etc. Th e instrument has patented gas/water separator electronically controlled. It provides LCD touchscreen, real-time outlet pressure, water quality, water level, auto-diagnostics with alarms. Remote PC monitoring is standard via RS232 or RS485 to interface the unit with customer’s PC software.

Lab Intelligence AppliancesAhmedabad - GujaratTel: 079-26561557, Mob: 09377729989


Website: www.lia.net.in

82

Products


no bottle friction and no particles are formed. Each pump consists of only two parts, for perfect sterilisation in an autoclave. Th ese machines have a capacity of 400 bottles/min, fi lling volumes of up to 30 ml and bottle diameter of up to 36 mm.

Marchesini GroupBologna - ItalyTel: +51-651-8711


Gas detector tubesUniPhos gas detector tubes off ered my United Phosphorous are easy, quick and accurate method for direct, onsite measurement of gases, vapours and aerosols. Th ese tubes are

simple to use, requiring minimum maintenance and no calibration. Th e gas detector tubes are available for NH3, H2S, SO2, CL2, PH3, HCI, HCN, CO, CO2, O2, C6H6 and many other gases and vapours. Th ese are also available with spot check of toxic gas concentration at work place at specifi ed intervals. Th e gas detector tubes are calibrated for a fi xed volume of air sample, which is drawn using a sample draw pump. Th e scale on the glass tube reacts to the stain length of PPM of contaminant concentration. Th is method of measurement is simple, accurate and highly specifi c.

United Phosphorous LtdDist Valsad - GujaratTel: 0260-2730156


Website: www.chemo-electronic.com

Temperature data loggersAmbetronics off ers temperature loggers that are suitable for pharmaceutical industries. Th ese data loggers have measuring range of -35ºC to 80ºC, accuracy ±0.5ºC and resolution of 0.1ºC with sensor Pt1000. Th e measuring rate can be selected from 1 minute to 8 hours. Th e data

loggers can store 4,000 values data in memory. Measuring mode has automatic with loop, start/stop or start with set measuring rate. Battery life is 3 to 5 years. Th e data logger housing is made up of stainless steel, PEEK. Th ey have IP68 protection class/housing for pharmaceutical industries.

AmbetronicsMumbai - MaharashtraTel: 022-2837 1086, Fax: 022-2822 6570


Website: www.ambetronics.com

Filling & capping machinesSteril 400 fi lling and capping machines are off ered for sterile applications in the pharmaceutical industry. Th ese can be installed under an isolator. Th ese consist of three modules and are suitable for diff erent layout requirements. Th e machines are completely accessible from the front and are protected by laminar fl ow recycling. Special care is taken to prevent obstacles to the linearity of the sterile air fl ow so that negative eddies would not form. Due to the bottle conveyor system, which uses a SS-316L belt, there is

Autoclavable stirred tanksAutoclavable stirred tanks and pressure vessels, are a novel concept of in biotech and pharma manufacturing. A fi nal formulation-cum-blending tank is usually employed during fi lling of sterile liquid formulations. Th e tanks are sterilised in an empty condition inside an autoclave large enough to hold the tank. Th ese can be autoclaved in vertical and horizontal orientation, without causing damage to the agitators. After autoclaving, the motor is fi t and the product is aseptically transferred into the tank under stirring. Th ese are available in a variety of sizes, vessels can be autoclaved in horizontal position; maximum operating temperatures up to 130°C & pressure up to 2.5 bar(g); all nozzles are provided with sanitary TC ends; and manufactured from good quality stainless steel.

Navin Process SystemsPune - MaharashtraTel: 020-2546 0214, Mob: 09273107155


Website: www.napro.co.in

Tablet compression machineTh e tablet compression machine (tablet press) is used to make tablets according to a pre-determined design. Punches and dies set into the tablet press to actually shape the tablets. Th e machine makes tablets for a variety of industries; but its largest application is in pharmaceuticals and vitamins. It is provided with turret made of special grade SG iron casting and interlock switches to all guard for safety of operator. Features include paint-free compression zone, variable speed step pulley, dust extraction nozzles, anti-vibration mounting, etc.

Shiv Pharma EngineersAhmedabad - GujaratTel: 079-29092380, Mob: 09377535927


Website: www.gmpmachines.com

Products


The information published in this section is as per the details furnished by the respective manufacturer/

distributor. In any case, it does not represent the views of Modern Pharmaceuticals

Fluid bed dryerTh is dryer is used for drying of wet material. It is equipped with air handling unit. Th e inlet air fi ltration is through pre, micro vee and hepa fi lter. It performs uniform and harmonious drying operation in a specifi ed time. It has applications in tablet-granulation section of pharma industries. Th is dryer is compliant with cGMP under WHO and USFDA. Also off ered is diversifi ed novel advanced techno-upgraded qualitative model of fl uid bed dryer like PLC operated, semi-

automated and manually operated dryer with multi faceted and user-friendly features.

Ratnakar Pharma MachineryAhmedabad - GujaratTel: 079-22892614, Mob: 094270 31284


Website: www.ratnakarpharmamachinery.com

FRP storage tankTh e FRP storage tank is manufactured by hand lay-up and/or by fi lament winding process for the storage of highly corrosive chemicals, acids and wastes. It is available in capacity up to 250 kl in various shapes, like square, round, rectangular vertical and horizontal with fl at bottom or conical bottom. Th e key feature

of this tank is that it off ers resistance to chemical and weather. It is lightweight, easy-to-maintain featuring good physical and mechanical strength. Th e reaction vessel is available with suitable lined agitator, gear box and electric motor.

EPP Composites Pvt LtdRajkot - GujaratTel: 02827-287059


Website: www.atikagroup.com

Bottom discharge centrifugeTh is centrifuge is fi tted with a cake scrapping arrangement, which can be motorised or hydraulically operated to enable to scrape the stickiest of cakes. Th e cake is discharged through the bottom chute provided. Th is results in reducing manual labour, less cake handling loss and uniform cake washing. Th e centrifuge is off ered in

vapour-tight construction with nitrogen blanketing for hazardous chemicals. CIP design with built-in cleaning nozzles ensures no product cross-contamination. Th e centrifuge is off ered in three-point pendulum suspension and four-point inertia plate mounted designs to suit application considerations.

United Engineering EnterprisesMumbai - MaharashtraTel: 022-23083990, Mob: 09820761808


Website: www.united-centrifuges.com

Sanitary tubes fi ttingsA wide range of stainless steel sanitary tube fi ttings for pharma, food, beverages, breweries, cosmetics and allied industries are off ered. Th e range includes bends, Tees, reducers, pipe, support and sight glass, etc. Th ese are available in tube OD sizes ranging from ½” to 6”. End connections available are tri-clamp, DIN and SMS. Th ese fi ttings are manufactures from SS-304, 316 and 316L, duly electro polished. All these products confi rms to cGMP and FDA standards. Elastomers off ered are of food grade and can be off ered in EPDM, neoprene, silicon and viton.

Cris Engineering WorksMumbai - MaharashtraTel: 022-2685 9440, Mob: 09892273314

Email: roque_ferns@rediff mail.com

Website: www.criseng.com

PalletsTh ese pallets are off ered as per GMP & USFDA norms and are used for multifarious applications in diff erent industries. Designed for optimal load bearing capacities, the pallets are manufactured on state-of-the-art plants. Th e pallets have many outstanding features and can also be tailor-made to meet customers’ special requirements.

Sintex Industries LtdKalol - GujaratTel: 02764-253500


Website: www.sintex-plastics.com

List of Products


Acoustic enclosure ...........................................28

Agitator .....................................................................3

Aluminum blister foils ...........................................81

Analytical instrumentation ....................................47

Analytical instruments ...........................................86

AODD pump ..................................................... BIC

Autoclavable stirred tanks ......................................82

Autoclaves .............................................................BC

Automatic capsule fi ller .........................................80

Batch disperser .................................................. 3

Blow/Fill/Seal machines .................................. 4, FC

Bottle cappers .........................................................73

Bottom discharge centrifuge ..................................83

Bulk bag fi ller .........................................................79

Calorimeters ..................................................... 3

Capsule fi lling machines ................................75, BC

Cartoners ..............................................................BC

Chromatography ....................................................86

Cleanroom moulds .................................................75

Coating pan ............................................................73

COD anaylser.........................................................65

Coloumns & chemistries .......................................47

Colour masterbatches .............................................43

Columns .................................................................86

Compact pneumatic cylinder .................................27

Conductivity meters ...............................................75

Corrugated tube heat exchanger .............................8

Diaphragm vacuum pump ................................76

Digital fl ow meters .................................................81

Disc pump .......................................................... BIC

Disperser ...................................................................3

Disposable bioreactor .............................................75

Dry van pump ........................................................28

Electric actuator & gripper ..............................27

Electric blankets .....................................................81

Elemental analysis ..................................................86

Empower ................................................................47

Filling & capping machines .............................82

Filtration and separation products.........................76

Fluid bed dryer .......................................................83

Freezer...............................................................73, 75

FRP storage tank ...................................................83

Gas detector .....................................................65

Gas detector tubes ..................................................82

Gravity feed metal detector ...................................75

Heat exchanger ................................................. 8

Heating baths ...........................................................3

High pressure homogeniser .....................................3

Hot plates .................................................................3

HPLC ...............................................................47, 86

Hydrogen gas generator .........................................81

Informatics ......................................................47

Inline disperser .........................................................3

In-line fi lling & stoppering machines ...................75

Inspection system ...................................................13

Kneading machine ............................................ 3

Laboratory reactor ............................................. 3

Laboratory software .................................................3

Linear vial washing machine .................................73

Liquid fi lling machine............................................80

Liquid sterile fi lling machine ...............................BC

Lonizer....................................................................27

Magnetic stirrer ................................................ 3

Mass spectroscopy ..................................................86

Metal analyser ........................................................80

Mills ..........................................................................3

Mini bilayer press ...................................................80

Molecular spectroscopy ..........................................86

Overhead stirrer ................................................ 3

Pallets ..............................................................83

Pharmaceutical label seals ......................................81

Pharmaceutical medicines ......................................75

Pilot plant .................................................................3

Plastic masterbatches .............................................45

Plate heat exchanger ................................................8

Pneumatic cylinder .................................................27

Precision melt supermix .........................................75

Pump............................................................. BIC, 28

Pure steam generator ...........................................BC

Rapid endotoxin detection system ....................75

Rapid mixer granulator ..........................................73

Refrigrated compressed air dryer ...........................27

Roots blower ...........................................................28

Rotary evaporator .....................................................3

Rotary pump ..........................................................38

Rotary tablet press ..................................................38

Rotary vane vacuum pump ....................................76

Sanitary tubes fi ttings.......................................83

Screening machine .................................................80

Seamless pipes ........................................................73

Shaker .......................................................................3

Shaking incubator ..................................................79

Sieves.......................................................................73

Solid-liquid mixer ....................................................3

Stainless steel pipe ..................................................73

Starch paste kettle ..................................................73

Steam boiler ............................................................73

Stoppering machine ...............................................73

Tablet compression machine ............................82

Tablet press machine ..............................................38

Tefzel HHS Isotactic PP material ..........................6

Temperature data loggers .......................................82

Th ermoplastic valves & piping system ...................6

Th ermostat & vaccum dryer / mixer .......................3

TPU masterbatches ................................................43

Tubes .......................................................................73

UHPLC ...........................................................86

UPLC .....................................................................47

U-tubes ...................................................................73

Vacuum booster pump ......................................28

Vacuum conveyor ...................................................79

Vacuum system .......................................................28

Vial and bottle cap sealing machine .....................76

Vial inspection machine .........................................79

Walkable ceiling system ...................................76

Walk-in humidity chamber ...................................79

Welded pipes ..........................................................73

Work bench ............................................................79

BC-Back cover, BIC-Back inside cover, FIC-Front inside cover

Product Pg No


Just type MPH (space) Product Name and send it to 51818eg, MPH Laboratory software and send it to 51818

P

Product Pg NoProduct Pg No

List of Advertisers

85

Advertiser’s Name & Contact Details Pg No Advertiser’s Name & Contact Details Pg No Advertiser’s Name & Contact Details Pg No

Our consistent advertisers

May 2012 I Modern Pharmaceuticals

Alok Masterbatches Ltd 43

T: +91-011-41612244

E: [email protected]

W: www.alokmasterbatches.com

Aqua Services 57

T: +91-265-2331748


W: www.aquaservicesindia.com

Bosch Limited BC

T: +91-9820421660


W: www.boschindia.com/pa

Cadmach Machinery Co Pvt Ltd 38

T: +91-79-25841491


W: www.cadmach.com

Charles River 75

T: +91-80-25588175


W: www.criver.com

Dover India (P) Limited BIC

T: +91-044-26271020


W: www.psgdover.com

Eng Expo 61

T: +91-09819552270


W: www.engg-expo.com

Everest Transmission 28

T: +91-11-45457777


W: www.everestblowers.com

Hapman India 79

T: +91-265-2517505


W: www.hapman.in

HRS Process Systems Ltd 8

T: +91-020-66047894


W: www.hrsasia.co.in

Ika India Private Limited 3

T: +91-80-26253900


W: www.ika.in

Nichrome 33

T: +91-020-66011001


W: www.nichrome.com

Reynders Label Printing India Pvt Ltd 27

T: +91 149 3305400


W: www.reynders.com

Salesworth India Pvt Ltd (Rommelag) FIC

T: +91-80-25274495


W: www.rommelag.com

Salesworth India Pvt Ltd (Seidenader) 13

T: +91-80-25274495


W: www.seidenader.de

SME Mentor 51

W: www.moneycontrol.com/smementor

Suraj Limited 73

T: +91-79-27540720


W: www.surajgroup.com

Thermo Fisher Scientific Sid Division 86

T: +91-22-67429494


W: www.thermofisher.com

Uniphos Envirotronic Pvt Ltd 65

T: +91-22-6123500


W: www.uniphos-she.com

UNP Polyvalves India Pvt Ltd 6

T: +91-265-2649248


W: www.polyvalve.com

Waters (India) Private Limited 47

T: +91-80-28371900


W: www.waters.com

Weiler Engineering Inc 4

T: +91-847-531-6733


W: www.weilerengineering.com

BC-Back cover, BIC-Back inside cover, FIC-Front inside cover

88

RNI No: MAHENG / 2008 / 27125Postal Regd No: G / NMD / 122 / 2011 - 13

Posted at P.C Stg. Offi ce, GPO, Mumbai 400 001 On 19th & 20th Of Every Month

Date Of Publication: 16th Of Every Month

Modern Pharm

aceuticals M

ay 2012

Date post:	29-Mar-2016
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Modern Pharmaceuticals - May 2012

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