Modern Pharma - 1-15 November 2012

LifeCell International announced the launch of ‘BabyShield,’ an advanced and non-invasive newborn screening programme. BabyShield can identify over 118 health conditions at birth, making it the most advanced newborn screening service in the world. Importantly, this test is performed in a non-invasive manner thereby making it safe for the baby and simple to implement in a healthcare setting.

Newborn screening is an early and preventive treatment that can be initiated in order to safeguard them from severe harm such as mental retardation, physical abnormalities, bone deformity, liver dysfunction or even death.

The BabyShield screening programme is performed using a few drops of blood collected from the baby’s umbilical cord at birth and urine sample retrieved after 48 hours of the baby’s birth. The test results are available within a few days of the arrival of samples. It aids early diagnosis and timely treatment, thereby improving a child’s chances of living a healthy and normal life.

Speaking at the occasion of the launch, Dr James Shoemaker, Associate Professor, Edward A. Doisy Research Center Department of Biochemistry and Molecular Biology, Saint Louis University School of Medicine, USA, said, “Giving birth to a baby is one of the most exciting and rewarding moment for parents. However, at times the child may be prone to life-threatening diseases which if undiagnosed at an early stage can

lead to a lifetime of regret. Newborn screening is recommended by medical councils across the world and is mandatory for all babies born in several countries including the UK, USA, Germany, Japan and Australia. I strongly recommend all parents to invest in a screening at birth, as prevention is always better than cure. BabyShield is a simple, safe and a non-invasive secure service that causes absolutely no harm to the baby.”

Dr Mayur Abhaya, President & Executive Director, LifeCell International, said, “BabyShield is a revolutionary development in field of newborn screening allowing for a completely pain-free and comprehensive way of safeguarding infants against any diseases. An one-time investment of ` 4,990, parents can relax peacefully knowing that their child will grow to be healthy and normal. We are extremely pleased to launch this facility across 100 cities in India.”

The recently released report expects 2QFY13 reported sales growth for the coverage universe to be upwards of 20 per cent y-o-y except for Cipla. Domestic market growth is expected to be 14-16 per cent except for Sun and Lupin, in whose case it expects growth to be higher (20-22 per cent). In US, it expects the sequential addition (in $ terms) to core sales (excluding FTF) to be strong for Sun Pharma (excluding Taro), Ranbaxy and Dr. Reddy’s. Further, Taro sales to remain stable on a sequential basis. For Sun and Dr Reddy’s, this addition is driven by recent launches while for Ranbaxy the core sales will benefit from post 180-days sales of Lipitor/Caduet. The impact of the warning letter resolution (in July 2012) for Cadila is not likely to be reflected during the current quarter. For Lupin/Glenmark, it expects market share gains to drive the incremental addition

in US. US sales in INR terms will also benefit from currency tailwind (20 per cent y-o-y).

Further, the report reveals that Sun Pharma will deliver strong earnings for the quarter—core sales and profit growth of 38 per cent and 28 per cent respectively on a y-o-y basis. It expects EBITDA margin (at 40.3 per cent) to remain stable sequentially. EBITDA margin is not comparable on a y-o-y basis due to change in inventory accounting policy (from 1QFY13). The key monitorable will

be Taro EBITDA margin—the price increase is expected in US dermatology portfolio to broadly sustain.

The report expects an improved performance for Dr Reddy’s and build a sequential recovery in margins by 280 bps (basis points). The recent US launches will be a key factor for the sequential improvement. In Lupin, EBITDA margin is expected to improve by 220 bps driven by a moderation in R&D costs (remains volatile on a quarterly basis—litigation expense is one-fourth of R&D). Given the presence of cash flow hedges, we build improved realisation for US sales for both Lupin and Dr Reddy’s on a sequential basis. Again, domestic drug price policy impact will be focus. The report shows that it expects the details on drug pricing policy to get announced before the start of the earnings season.

Lupin Ltd has announced that its subsidiary Lupin Pharmaceuticals Inc (collectively Lupin) has received final approval for its irbesartan tablets, 75 mg, 150 mg and 300 mg from the US FDA to market a generic version of Sanofi

Aventis US, LLC’s (Sanofi Aventis) Avapro tablets, 75 mg, 150 mg and 300 mg strengths. Lupin’s irbesartan tablets, 75 mg, 150 mg and 300 mg are the AB-rated generic equivalent of Sanofi Aventis’s Avapro® tablets . Irbesartan

is an angiotensin II receptor antagonist and is indicated for the treatment of hypertension and nephropathy in type 2 diabetic patients. Avapro® tablets had annual US sales of approximately $ 400.7 million.

In Conversation With 22Prof Ranjit Roy Chaudhury

Chairman, Task Force for Research, Apollo Hospitals Educational and Research Foundation

Special Focus 24Pharma manufacturing

in India Moving against several odds

Energy Management 31Energy brokers

The guiding ‘energy’ in companies

Automation Trends 30ARC sensor technology Revolutionary analytics

Eli Lilly announces late-stage clinical trial results of Alzheimer disease candidateEli Lilly and Co announced late-stage clinical trial results of its Alzheimer disease candidate, named solanezumab. The company claimed that the new study in combination with previous results presented in August, 2012 revealed 34 per cent less occurrence of mental loss in patients with mild symptoms of Alzheimer during a comparative study for a period of one and half year. The company may conduct further trials to gather sufficient data to file the drug approval application. The company is expected to take up the matter with FDA authorities to discuss the further necessary steps.

SMS Pharma sells Vizag unit to Mylan Lab for $ 33 millionSMS Pharmaceuticals has sold its manufacturing unit in Visakhapatnam to global major Mylan Laboratories for $ 33 million. The money raised through the sale will be used to clear some existing debts, cut overhead costs, in addition to strengthening existing production facilities and working capital. The agreement has been signed with Mylan and the legal process would take a couple of months.

Dr Reddy’s launches anti-asthma drug Dr Reddy’s Laboratories announced that it has launched montelukast sodium oral granules, a bioequivalent generic version of singulair oral granules, in the US market. The drug is used for treating asthma and seasonal allergies. The move follows the approval by the USFDA of Dr Reddy’s ANDA for montelukast sodium oral granules. The Singulair oral granules brand had US sales of approximately $ 61 million for the most recent twelve months ending July, according to IMS Health. Dr Reddy’s montelukast sodium oral granules in 4 mg are available in unit dosage package of 30.

Lupin receives FDA approval for its Kurvelo® tablets Lupin Ltd recently announced that its subsidiary Lupin Pharmaceuticals Inc (collectively Lupin) has received final approval for its oral contraceptive Kurvelo® tablets (levonorgestrel and ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg from the US FDA to market a generic version of Teva Branded Pharmaceuticals (Teva) Nordette® tablets (levonorgestrel and ethinyl estradiol tablets, USP), 0.15 mg/0.03 mg.

LifeCell launches ‘BabyShield’ newborn screening

1 - 15 N o v e m b e r 2 01 2 I Vo l 1 I N o 9 I `10 0

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Lupin receives FDA approval for generic Avapro® tablets

Unveiling the programme

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CONTENTSIn Conversation With 22 Prof Ranjit Roy Chaudhury Chairman, Task Force for Research, Apollo Hospitals

Educational and Research Foundation

Printed by Mohan Gajria and published by Lakshmi Narasimhan on behalf of Network18.Senior Editor: Manas R BastiaPrinted at Infomedia 18 Ltd, Plot no.3, Sector 7, off Sion-Panvel Road, Nerul, Navi Mumbai 400 706, and published at Network18, ‘A’ Wing, Ruby House, J K Sawant Marg, Dadar (W), Mumbai - 400 028. Modern Pharma is registered with the Registrar of Newspapers of India under No. MAHENG / 2008 / 27125. Network18 does not take any responsibility for loss or damage incurred or suffered by any subscriber of this magazine as a result of his/her accepting any invitation/offer published in this edition.

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Highlights of Next EditionSpecial Focus: Quality compliance - GMP, GLP, FDA

REGULAR SECTIONS5 Editorial / Guest Editorial

7 News, Views & Analysis

34 Technology Transfer

35 Projects

36 Tenders

37 Event List

38 Book Review

39 Products

42 Marketplace

44 List of Products & Advertisers

M o d e r n P h a r m a • 1 - 15 N o v e m b e r 2 01 2

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22 24

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24Pharma manufacturing in India Moving against several odds

Special Focus Pharma manufacturing

30

3132

33

Automation Trends ARC sensor technology: Revolutionary analytics Amol Malode, Product Manager, Forbes Marshall

Energy Management Energy brokers: The guiding ‘energy’ in companies

Drug delivery devices Simplifying the lives of patientsDr Jérôme Freissmuth, Director - Business Development, Product Management and Marketing - Packaging Technology division, Business Unit Pharma, Bosch Packaging Technology

Strategy The colour of medications: When shades matter…Barkha Dattani, Managing Director, Barkha’s Brand Clinic

Insight & Outlook

Roundtable Should the government disband the Foreign Investment Promotion Board?

Interface Dr Ajay SharmaAssociate Director - Pharma & Biotech, Healthcare Practice, Frost & Sullivan, South Asia & Middle East

26

27

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Facility Visit 29Glenmark Generics Ltd - Oraland semi-solid manufacturing Precision at every step

www.modernpharma.in

Manufacturing pharma machinery in India Acting local, going global

5M o d e r n P h a r m a • 1 - 15 N o v e m b e r 2 01 2

Editorial

The partnership privilege

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

Historically speaking, the strength of Indian pharma has been in process chemistry and reverse engineering. Also, given the rather limited

new product development experience and high cost involved in R&D, the progress in drug discovery has not been up to the mark. Nevertheless, a few Indian pharma companies are leading the way in new drug research, thanks to which there are some molecules in pipeline. As the generics pipeline grows and this segment opens up, it will bring along more opportunities for Indian pharma companies.

From a global perspective and amid intensifying competition, there is a continuously growing pressure on large pharma players (innovators) to keep pace with the desired R&D productivity level. With a long pipeline of patent expiries as well as the huge cost involved and high failure rates in developing new drugs, the next model of growth seems to be veering towards partnership based rather than on outright acquisition.

As the Indian pharma market gets increasingly regulated, there is tremendous scope for the Big Pharma to leverage the emerging opportunities by joining hands with Indian companies based on a win-win proposition. Along with sharing responsibilities, costs and benefits, such partnerships appear more appealing to MNCs in the backdrop of not-so-long amendments in the government’s foreign direct investment policy.

In this backdrop, the recent joint drug discovery deal of Tata Group’s Advinus

Pharma with Japanese pharma company Takeda Pharma, has reinforced this strategic shift of MNCs towards Indian drug research as well as promising prospects for startup companies engaged in pharma R&D. More importantly, such deals would take Indian pharma R&D to the next level of value-added ladder from mere contract research.

As part of this deal, Advinus will reportedly receive guaranteed funding of $ 36 million from Takeda to experiment on novel molecules in the areas of inflammatory disease, central nervous system and metabolic diseases. The research will be span over 3 years, and may even expand further. Further, the company will receive $ 9 million in milestone payment leading to candidate selection, besides milestone payments of up to $ 45 million per product, along with royalties on product sales worldwide.

This trend, on a long-term horizon, looks good for the Indian pharma sector. In order to sustain growth, they would have to adopt multi-pronged strategies including widening of product portfolio (especially into emerging niche segments), partnering with global pharma for joint R&D and expanding marketing & distribution networks. The outcome would depend on striking the right balance between risk and reward.

Analysing the industry’s strength and weakness

I ndian pharma industry has made a great headway in the global pharma map as cost-effective quality supplier to the diverse

needs of the globe in the last 2-3 decades. Having achieved this, industry has already acquired the Human Resource (HR), scientific pool and infrastructure, which is adequate to cope the ever increasing challenges of achieving excellence in GMP and compliance expectations of not only the importing countries, which are underrated for their regulatory controls, but also from the most regulated countries of the world. The unique feature of the Indian pharma fraternity is the intrinsic balancing ability of managerial reach to have control without giving away the economic efficiency of increased scale of operation and remaining compliant to the regulatory expectations.

Pharma industry has definitely acquired the soft skills from IT sector and managerial skills from the classic and renowned management institutes of India. The contribution of the Indian entrepreneurship and the innovative mindset however holds the key. Innovations in technology and techniques are the complimentary aspects for success of any economic operation. Although this holds true for any manufacturing or service sector, it holds greater significance in case of a knowledge-based sector

such as pharma where efficiency and safety are expected to be the prime considerations.

The regulations are constantly reviewed for these twin objectives with the risk-based approach. Thus, the regulatory compliance is now a function of rules and the spirit behind the rules. The ever-increasing industrial establishments, hospitals, retail outlets and clinical research organisations pose a significant challenge to the regulators such as the Food and Drug Control Administration. Thus, the self-vigilance and compliance culture of the pharma sector has been the primary support to regulators, who can therefore focus effectively on the black sheep of the profession. As a result, much needed and effective control is acquired on the menace of manufacture and distribution of spurious and substandard drugs.

Next, the control on spurious drugs is a great boost to the fair players of the pharma industry. One can visualise how the paradigm shift has been achieved in terms of the performance objectives. The resources, energy and skills, which were otherwise utilised in controlling or say regulating the functional and legitimate section of the industry, are now being preserved and properly allocated on those miscreants that were otherwise difficult to chase.

The global regulatory missionaries such as ICH, PICS etc are focussing on

the harmonisation of regulations and standardising the systems of operation and control.

The harmonisat ion and standardisation in the regulatory systems can be highly productive for the monitoring as well as compliance of the system. Harmonisation and standardisation is also working favourably to decrease the time frames for processing the regulatory registrations, and it increases the access to medicines as well as assists the overall inventory mobilisation of essential and life-saving medicines. The Indian pharma industry has thus realised the great advantage of looking at the world through one window rather than the multi-faceted compliance strategy. The significant rise in the EU-, US FDA-compliant facilities in India is a testimony to the integration of education, training and vision of the industry nominees as well as the regulating agencies.

Therefore, in the years to come, the pharma industry looks forward to prioritise on innovations in fundamental research with the manufacturing remaining focussed on efficient, techno-savvy operations with high degree of compliance approach.

Dr H G KoshiaCommissioner, Food & Drugs Control Administration, Gujarat

Guest Editorial

Manas R [email protected]


News, Views & Analysis

According to the State of the World’s Cities 2012-13 Prosperity of Cities report released by the UN, Hyderabad is a pharma capital and ahead in e-governance and seriously engaged in pursuit of sustainable prosperity.

However, “Economic growth is not perceived to have been matched by adequate infrastructure and services in Hyderabad and Bengaluru. Biotechnologies and computer/ communications also feature high in Hyderabad, with support from the centre, and with more than 40 research and education institutions,” said the report.

The water shortage pattern is more mixed in Asian cities, with Hyderabad and Bengaluru facing severe shortages. Vejella Satyanarayana from Hyderabad was an expert member involved in the report preparation.

Hyderabad hailed as

pharma capital in UN report

Governor Washington State (USA) visits Jubilant Life Sciences

headquarters in Noida

J&J seeking new process approval

for Droxil Jubilant Life Sciences Ltd, recently announced that Christine Gregoire, Governor, Washington State (USA), visited the company headquarters at Noida. The company has a key relationship with the state of Washington (USA), its US FDA-approved manufacturing facility for sterile injectables and allergy therapy products is based in Spokane (Washington). Commenting on the visit, the Governor Christine Gregoire, said “By investing in our community and technical colleges, as well as our research universities, we can provide the skilled workforce that Jubilant needs to prosper, resulting in more family-wage jobs in our community.”

Shyam S Bhartia, Chairman & Managing Director and Hari S Bhartia, Co-Chairman

& Managing Director, said, “Around 50 per cent of our assets are in North America with investments of close to $ 300 million in USA, providing job opportunities to about 1000 people. Currently, we have two US FDA-approved facilities, one for sterile injectables in Spokane, Washington and one for oral dosage formulations in Salisbury, Maryland, besides clinical research business in New Jersey.”

Merck inks licensing agreement with Vaxxas Merck & Co has inked a licensing agreement with Vaxxas Pty, based in Australia, for developing Nanopatch, which will be used for immunisation through skin. As per the agreement terms, Merck would provide upfront payment and research grants for evaluation of Nanopatch apart from development charges.

The Nanopatch-mediated vaccine delivery is targeted to the immune cells through the 1-centimeter-square, self-administered skin patch that is able to generate an instant immune response. In addition, Nanopatch may cost below $ 1 after commercial scale production, and could be a potential treatment alternative in case of flu epidemics. Vaxxas is also planning to conduct human clinical trials in next two years after successful animal-based trials. The low-cost skin patch may also prove a significant tool to deliver immediate treatment for vast population segment, in case of a pandemic. Watson gets Federal Trade Commission approval to acquire Actavis GroupWatson Pharmaceuticals, Inc has received the Federal Trade Commission (FTC) clearance for the acquisition of Actavis group of companies. Under the terms of the consent order with the FTC, Watson and Actavis have agreed to divest a number of marketed and pipeline products Par Pharmaceutical Companies, Inc and Sandoz.Subject to the consummation of the transaction between Watson and Actavis, Par Pharma will acquire the products of: Watson’s morphine sulfate extended release capsules; Actavis’ hydrochloride tablets; Actavis’ fentanyl transdermal film; Actavis’ diltiazem hydrochloride extended release capsules.

In Brief

Gregoire Bhartia

Johnson & Johnson has filed separate applications seeking clearance for its new production process from EU and the US regulatory agencies. The approval is being sought as an interim measure to resume the adequate supply of Droxil, which is used for various indications such as AIDS-related Kaposi’s sarcoma, multiple myeloma and ovarian cancer. The drug falls short of supply due to growing operational troubles in past one year and subsequent closing of J&J’s contract manufacturing partner, Ben Venue Laboratories. The discontinuation in the drug’s supply led to an overall loss of $ 37 million during Q1 and Q2 of the FY-2012, with a global sales dip of 87 per cent. Subsequent to the new arrangement, J&J would transfer the distribution and sales operation to another company, while Ben resuming the production activities of Droxil.



The newly launched Process Automation (PA) user community page (www.siemens.co.in/pa-user) is an initiative that aims to foster effective communication and knowledge-sharing between Siemens and end-users. The community provides a forum that enables PA users to network, share information and stay updated about the latest news and events related to PA.

The PA user community is an online forum that facilitates information sharing and provides updates related to the latest advancements in the field of PA. This first of its kind community in India helps users to stay in touch with upcoming events and trade fairs, new product launches, latest marketing information, new campaigns as well as other information related to industry specific solutions.

The PA user community has a host of clients spread across verticals such as pharmaceuticals, chemicals, food & beverages, glass, cement and solar. Speaking about this new initiative, Bhaskar Mandal – Head, Industry Automation, Siemens said, “The PA user community has opened up a new avenue

for communication that takes us even more closer to our customer needs. This initiative reflects the maturity of our organisation to open up our information channels for the benefit of the larger community. The feedback and inputs from the end user will help our quest to offer a better value proposition in the market.” Further,

users can also avail online service support that plays a crucial role during the production lifecycle.

In addition to product support, the community page also keeps users updated about the upcoming training events and knowledge enhancement workshops.

This latest initiative from Siemens reaffirms the company’s commitment towards its large user base. PA user community thus aims to enhance user knowledge through shared user experiences and learn new innovations in PA that would enable users to improve productivity and efficiency in today’s challenging times. Siemens is the world’s single-source leader of automation technology products engineered and manufactured for al l industrial sectors.

Siemens launches India’s first ever ‘process automation user community’

Dr Reddy’s Laboratories Ltd (Dr Reddy’s), together with its subsidiaries, have announced the intended public offer to acquire the issued and outstanding shares of OctoPlus NV (OctoPlus), a service based specialty pharmaceutical company, for an offer price of € 27.39 million (cum dividend) in cash, representing 100 per cent of the issued and outstanding ordinary shares. The offer price represents a premium of 30 per cent over the closing price of OctoPlus as of October 19, 2012.

Dr Reddy’s currently holds an irrevocable commitment from shareholders representing over 50 per cent of OctoPlus’s issued and outstanding shares.

This deal will help expand the expertise and scientific capabilities of Dr Reddy’s.

G V Prasad, Vice-Chairman and CEO, Dr Reddy’s said, “As we globalise our R&D efforts,

we are looking forward to build a research base in Leiden (Netherlands).”

Assuming that the requisite numbers of shares are tendered by the balance shareholders, the transaction is likely to be concluded by the end of the current fiscal year.

Elite Pharmaceuticals, Inc has received approval from the US FDA for generic phentermine capsules 15 mg and 30 mg. The company also announced that the sole supplier of the API approved for this phentermine capsule product has restricted the amount of API available to Elite and this will delay the launch of this product.

The supply restriction also prevents Elite, and its sales and marketing partner, from meeting growing demand for the phentermine 37.5 mg tablets and is also expected to restrict sales of this product.

Elite believes the supplier is wrongfully limiting supply. If Elite is unable to timely resolve this dispute in a reasonable manner then, unless and until Elite is able to obtain adequate amounts of API, it will not be able to sustain or grow the sales of the generic phentermine products. Elite has begun to qualify an alternative supplier, but qualification of an alternative supplier, due to FDA requirements, will entail a significant amount of time and could be expected to take 12 months or longer.

DRL intends to make a recommended public offer for OctoPlus N V

Elite Pharma receives approval

for generic phentermine

capsules

Prasad



SGS Pharmaceutical will set up new plant in Roorkee, Uttarakhand. SGS already posses a 60,000 square feet manufacturing facility in the tax free zone of Roorkee.

SGS will invest close to $ 1 million or ` 5 crore, the planned investment will be raised on Exhilway Private Capital Market (EPCM) by participating in the proposed private equity fund.

EPCM has marked an intrinsic valuation of $10.65 million or ` 59 crore for SGS Pharma. As per the valuations, SGS will undergo equity dilution of close to 9 per cent.

“We are committed to grow globally by launching our highly affordable pharmaceutical products. We are committed to achieve excellence in our area of expertise and we believe that with our efficient team in place we are bound to grow leaps and folds,” said Nnimish Gupta, Director, SGS Pharmaceutical.

SGS Pharma to set up new plant in Roorkee

US FDA in pact with Merck on SPA for phase III trial of TH-302 in combo with gemcitabine in pancreatic cancer

US FDA approves labelling update for BARACLUDE®

The US FDA has reached an agreement with the Germany based Merck KGaA, Threshold Pharmaceuticals’ partner for the development and commercialisation of TH-302, covering a Special Protocol Assessment (SPA) for a phase III randomised trial of TH-302 in patients with metastatic or locally advanced unresectable pancreatic cancer. The trial is designed to evaluate the efficacy and safety of TH-302 in combination with gemcitabine compared with gemcitabine therapy alone.

An SPA is a written agreement with the FDA that documents FDA’s

agreement that the design and planned analysis of a study can adequately address objectives in support of a regulatory submission.

“For the first-l ine treatment of patients with advanced pancreatic cancer, we are pleased with the FDA’s agreement that the design and planned analysis of this study adequately addresses the objectives necessary to support a regulatory submission,” said Barry Selick, CEO, Threshold.

Bristol-Myers Squibb Company recently announced that the US FDA has approved an update to the labelling for BARACLUDE® (entecavir) to include data on African Americans and liver transplant recipients with chronic hepatitis B infection. BARACLUDE, a nucleoside analogue discovered

at Bristol-Myers Squibb was first approved by the US FDA in March 2005 for use in adult chronic hepatitis B patients with compensated liver disease. It is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with evidence of active viral replication and either

evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. The current labelling update was accepted based on one study in African-American patients and one study in post-liver transplant recipients, each investigating BARACLUDE in these populations.

Micro Labs ventures into hypoglycaemic market Karnataka’s leading pharma major Micro Labs Ltd has now ventured into the untapped hypoglycaemic market with a novel dextrose drug ‘Hypotab’.

“Hypotab is an ethically promoted drug for the mild to moderate hypoglycaemia conditions. It is an immediately absorbable directly acting dextrose life saver,” said B R Srinath, Senior Vice President, Diabetes Task Force and Micro Nova, part of the Micro Labs Group.

The company has invested ` 5.5 crore for a dedicated production unit at Puducherry, with an installed capacity of one million tablets a month. The company uses the advanced AbMax technology, which helps pulverise the active ingredient dextrose to about 20 micron particle size for immediate absorption into the blood stream, said Srinath.

Inovio Pharmaceuticals’ synthetic vaccines delivered with minimally invasive skin electroporation technology Inovio Pharmaceuticals, Inc recently announced the publication of positive immunological effects in preclinical animal models of optimised Electroporation (EP) parameters for its minimally invasive skin (intradermal) EP delivery devices in the peer-reviewed journal, Human Gene Therapy. The newly published optimised conditions for Inovio’s skin EP delivery systems will dramatically enhance this delivery system as an attractive method for mass vaccination by decreasing dose levels, increasing tolerability of the vaccination and increasing the breadth of viable vaccine targets.

In Brief

Selick

Gupta



Researchers at the University of Michigan have determined how the hormone leptin, an important regulator of metabolism and body weight, interacts with a key receptor in the brain. Like insulin, leptin is part of a regulatory network that controls intake and expenditure of energy in the body, and a lack of leptin or resistance to it has been linked to obesity in people.

An understanding of how leptin and its receptor interact

could lead to new treatments for obesity and metabolic disorders, but the structure of this signaling complex has evaded researchers for years.

Georgios Skiniot is , a faculty member at the Life Sciences Institute and assistant professor in biological chemistry at the U-M Medical School, employed electron microscopy to obtain the first picture of the

interaction between leptin and its receptor. “It is exciting

not only because it might help with developing new drugs,” said

Skiniotis. “We now better

understand the design and

mechanisms of signalling through this class of receptors, which brings us

to a whole new set of intriguing questions.”

Par Pharmaceutical Companies Inc, a privately held, US-based speciality pharma company, has entered into agreements with generic drug maker Watson Pharmaceuticals Inc and Actavis Group in order to purchase for cash five generic products that are currently marketed in the US by Watson or Actavis, eight Abbreviated New Drug Applications (ANDA) currently

awaiting regulatory approval and a generic product in late-stage development.

The closing of the purchase agreements is contingent upon the closing of Watson’s acquisition of Actavis. The five currently marketed products include morphine sulfate extended release capsules, the generic version of Kadian, fentanyl transdermal system CII, the generic equivalent

of Duragesic, nifedipine extended release tablets, the generic version of Adalat CC, diltiazem hydrochloride extended release capsules, the generic equivalent of Cardizem CD, and metoclopramide hydrochloride tablets, the generic version of Reglan. According to Par, it expects to begin shipping these products to the trade immediately following the closing of the acquisition.

Target for obesity drugs comes into focus

Par Pharma to buy 14 generic products from Watson and Actavis Group

RCC Laboratories, a leading contract research organisation providing preclinical and safety toxicology & chemical testing globally and ViruSure GmbH have partnered to market the services of ViruSure in India. Through this partnership RCC will act as a sole agent for promoting ViruSure services in India.

ViruSure offers services in the areas of virus and prion safety testing for biopharmaceutical products, cell banking and cell bank characterization services and in vivo biosafety studies (adventitious agent testing, tumorigenicity testing, oncogenicity testing), which are highly valuable to pharma and biotech companies specializing on biological products (e.g. recombinant proteins, vaccines, human and animal derived biological products, cell based therapies).

“We are happy to partner with such a renowned company as RCC, who shares the same philosophy of quality and customer service that has made ViruSure successful,” stated Andy Bailey, CEO and Co-founder, ViruSure. “We look forward to offer our experience to assist Indian biopharmaceutical companies in reaching their goals for pathogen safety testing.” The partnership is a natural fit, since both RCC and ViruSure will help Indian companies elevate their quality standards through their combined service offerings.

RCC in marketing partnership

with ViruSure for India

Novartis drug shows significant early effect on reducing brain

volume loss at 6 monthsNew data will be presented at the 28th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) that reinforce the generally early and sustained efficacy benefit and long-term safety profile for Gilenya® (fingolimod).

“As the first once-daily oral M S t h e r a p y , growing rea l -world experience reinforces Gilenya’s high efficacy and long-term safety profile. With data showing an early treatment effect on relapses and brain volume loss, Gilenya continues to show positive outcomes for patients and Novartis remains committed to addressing

the significant remaining unmet medical need in the MS community,” said David Epstein, Head-Pharmaceuticals Division,

Novartis Pharma AG.A new post hoc analysis

of two large Phase III studies shows treatment with Gilenya 0.5 mg led to significant benefits on relapse-related outcomes within the first 3 months and on brain volume loss by 6 months compared to placebo.

Epstein



Safexpress wins special honours at 6th ELSC Awards

Safexpress, India’s largest Supply Chain & Logistics company, was bestowed with three very special awards for ‘Best Supply Chain Company of the Year’, ‘Best 3PL Company of the Year’ and ‘Best Logistics Provider of the Year – Road’ at 6th Express Logistics & Supply Chain Awards 2012. These highly coveted Awards were conferred upon Safexpress in a dazzling ceremony that took place on September 27 at Hotel Taj Lands End in Mumbai.

ELSC Awards are a part of the Express Logistics & Supply Chain Conclave, which is the flagship event of Supply Chain & Logistics industry in India. This conclave recognises and showcases companies that have set new standards in the delivery of supply chain & logistics solutions. Winners

of these awards are selected by ELSC Advisory Council, comprising luminaries from top Supply Chain & Logistics companies across Asia, which eventually selects winners from the nominated finalists on the basis of specific performance parameters. Thrilled on having won this ceremony’s biggest award for ‘Best Supply Chain Company of the Year’, Vineet Kanaujia, Vice President - Marketing, Safexpress, said, “We feel great pride in accepting this huge honour. It feels wonderful to be declared as the ‘Best Supply Chain Company’ in the country. What makes it even more special is the fact that we have created an undisputed market leadership position for Brand Safexpress over the last few years, which is why this coveted award has

been conferred on us again and again over the years. We would like to dedicate this award to all our customers, partners and employees who have contributed immensely in our success.”

Another top honour in this ceremony for the ‘Best 3PL Company of the Year’ was also conferred upon Safexpress. A

delighted Kanaujia said, “We have been driving a 3PL revolution in India over the last few years. We have set up 18 logistics parks across India at key industrial hubs, through which we provide world-class 3PL services to our clients. The ‘Best 3PL Company of the Year’ Award is a befitting recognition of all the efforts made by us in providing top-class services to our customers.” The other top honour in this ceremony for the ‘Best Logistics Provider of the Year – Road’ also went to Safexpress. Kanaujia opined, “Given the nature of India’s geography, majority of the logistics takes place through surface only. We have really devoted a lot of our time and energy in deeply understanding the terrain of the country. Today, our vehicles are covering every square inch

of the country. This is a domain where our knowledge levels and service levels are unsurpassable. So, I feel this award is a fitting tribute to the work Safexpress has put into the surface logistics domain.” Kanaujia concluded by saying, “These awards strongly reinforce our market leadership and matchless standing in the supply chain & logistics industry in the country. I would also like to praise the relentless efforts of each member of team Safexpress, who have always given their best even under tough circumstances. Team Safexpress can deliver positive results even in the face of adversities, and this is what sets us apart from others. Our employees’ efforts have helped us carve our own niche in the supply chain & logistics space.”

Kanaujia

Abbott recently announced the financial results for the third quarter ended Sept 30, 2012. Excluding foreign exchange, worldwide sales increased 4.1 per cent. Reported sales decreased 0.4 per cent, including an unfavourable 4.5 per cent effect of foreign exchange.

Abbott is announcing the initiation of a phase 3 clinical trial evaluating our interferon-free Hepatitis C (HCV) programme in genotype 1 (GT1) patients, following positive results from the phase 2b Aviator study, the largest and most comprehensive HCV trial to date. Initial results from Aviator showed sustained virological response at 12 weeks post treatment in 99 per cent of treatment-naive and 93 per cent of null responders for GT1 patients taking a combination

of ABT-450/r, ABT-267, ABT-333 and ribavirin.

“Abbott delivered another quarter of strong results with ongoing earnings per share up more than 10 per cent, despite a challenging global economy,” said Miles White, Chairman and CEO, Abbott. “There were several product launches across pharmaceuticals, vascular and diagnostics, which will contribute to future growth. In addition, we remain on track to separate into two leading health care companies on January 1, 2013.”

Abbott reports double digit earnings per

share growth in the third quarter

White



Rainin Instrument, a Mettler-Toledo subsidiary, has published a new white paper entitled ‘High Throughput FPLC with Packed Resin Tip Technology’. This addition to Mettler-Toledo’s thought-leadership library helps shed light on how novel PureSpeedTM resin tips promote easier, faster and more cost-effective protein and antibody purification than can be achieved using traditional

gravity/spin columns. Using conventional spin columns, protein purification requires a relatively large amount of resin for acceptable performance. However, experiments detailed in the white paper indicate that the higher resin volumes required in spin columns are not the key to optimising workflow.

PureSpeed’s bidirectional flow was shown to load PureSpeed’s relatively small

resin bed with the most protein possible, providing superior final concentrations and purity when compared to the spin column procedure. Protein capture was shown to be more repeatable as well, even at significantly reduced elution volumes. Further, the paper offers guidelines for using PureSpeed tip, body and bed sizes to gain maximum protein/ antibody processing.

StemCells, Inc recently announced the issuance of US patent titled ‘Liver engrafting cells, assays, and uses thereof.’ The patent broadly covers purified populations of human liver cells, including the company’s Human Liver Engrafting Cells (hLEC). hLEC cells were first isolated by company researchers in the late 1990s, and company scientists have repeatedly demonstrated the cells’ engraftment and robust bioactivity in vivo and that they are expandable. While the Company’s hLEC cells are purified from donated adult livers not suitable for transplant, the newly issued ‘164 patent importantly claims cells independent of tissue source. Therefore, the ‘164 patent has potential relevance to those deriving liver cells from iPS or ESC platforms. The term of the ‘164 patent extends into 2022.

“This new patent extends our IP protection around hLEC cells and should be of interest to those searching for an expandable human liver cell,” said Martin McGlynn, President & CEO, StemCells, Inc.

In October 2011, StemCells formed a wholly owned subsidiary to focus on both the therapeutic and research tool applications of its hLEC technologies and to serve as an investment vehicle for those interested in a ‘pure play’ liver cell company.

The Perrigo Company recently announced that it has received tentative approval from the US FDA for its Abbreviated New Drug Application (ANDA) to market OTC omeprazole and sodium bicarbonate

capsules 20mg/1100mg, the store brand equivalent to Merck & Co’s Zegerid OTC®. Perrigo expects to launch the product on the date when market formation occurs. Zegerid OTC® (omeprazole and sodium bicarbonate

capsules 20mg/1100mg), a proton pump inhibitor indicated to relieve frequent heartburn, had sales of approximately $ 42 million through food, drug and mass merchandisers for the last 12 months.

White paper explores effective protein purification

StemCells, Inc awarded broad US

patent covering expandable liver cells

Perrigo confirms tentative FDA approval for OTC version of omeprazole and sodium bicarbonate capsules

FDA approves ABRAXANE® for the first-line treatment of advanced

non-small cell lung cancerCelgene Corporat ion announced that the US FDA has approved ABRAXANE® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) for the first-line treatment of locally advanced or metastatic non-small cell lung cancer, in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy.

“Non-small cell is the most common type of lung cancer, the leading cause of cancer death in the United States,” said Dr Mark A Socinski, MD, Director, Lung Cancer Section, Division of Hematology/Oncology, University of Pittsburgh, and lead investigator of phase II and phase III lung cancer trials. “The FDA approval of ABRAXANE is exciting for healthcare professionals because it offers an important new treatment

option for all types of non-small cell lung cancer patients, in an area that has seen few treatment advancements in recent years.”

Regulatory submissions have been filed in Japan, Australia and New Zealand with anticipated decisions in 2013.

This approval marks the second indication for ABRAXANE in the US. There, ABRAXANE was first approved in 2005 for the treatment of metastatic breast cancer after failure of combination chemotherapy.

A B R A X A N E ® f o r injectable suspension is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline u n l e s s c l i n i c a l l y contraindicated.



AstraZeneca Pharma India Ltd (AZPIL) recently announced the launch of a new patented antiplatelet drug Brilinta® (Ticagrelor) in India. Brilinta® is an oral antiplatelet treatment for Acute Coronary Syndromes (ACS) in adult patients. Brilinta® is competitively priced to enable ACS patients benefit from having access to this medicine.

Brilinta® works by preventing the formation of new blood clots and maintaining blood flow in the body to help reduce patient’s risk of another cardiovascular event (called atherothrombotic events) such as a hear t a t tack or cardiovascular death.

Dr Paurus Irani, VP, Medical & Regulatory Affairs, AstraZeneca Pharma India Ltd, said, “With over 40 lakh people affected by ACS in India each year, Brilinta® gives cardiologists a new and effective treatment to help reduce the rate of heart attack and cardiovascular deaths in these patients. Such exciting medical breakthroughs do not happen very often.”

AstraZeneca launches its patented

life-saving drug Brilinta® in India

FDA advisory committee unanimously recommends approval of Gattex®

Mexican firm buys Pfizer plant in Puerto Rico

NPS Pharmaceuticals, Inc, a biopharma company developing innovat ive therapeutics for rare g a s t r o i n t e s t i n a l a n d endocrine disorders, recently announced that the US FDA’s gastrointestinal drugs advisory committee voted unanimously to recommend approval of Gattex® (teduglutide) for adults with Short Bowel Syndrome (SBS). The committee’s recommendation will be

considered by the FDA in its review of the company’s New Drug Application (NDA) for Gattex.

NPS also reported that five additional patients have successfully achieved i n d e p e n d e n c e f r o m Parenteral Nutrition (PN) and Intravenous (IV) fluids while on long-term Gattex (teduglutide) therapy in STEPS 2, a 24-month open-label study in adult SBS. “The results of today’s advisory

committee reinforced our belief in the favourable benefit-risk profile of Gattex,” said Francois Nader, MD, NPS Pharmaceuticals. “The unique mechanism of Gattex could make it the first and only long-term therapy that treats the underlying cause of this rare disorder by helping patients increase their ability to absorb nutrients and fluids to reduce or even eliminate their dependence on parenteral support.”

Bristol-Myers Squibb net sales decreases Bristol-Myers Squibb posted third quarter 2012 net sales of $ 3.7 billion, a decrease of 30 per cent compared to the same period a year ago, following the US patent expiration of Avapro®/Avalide® in March 2012 and Plavix® in May 2012. Excluding Plavix and Avapro/Avalide, net sales grew by 7 per cent compared to the third quarter of 2011.

US net sales decreased 43 per cent to $ 2 billion in the quarter compared to the same period a year ago. International net sales decreased 6 per cent to $ 1.8 billion. Gross margin as a percentage of net sales was 73.6 per cent in the quarter compared to 73.7 per cent in the same period a year ago. Marketing, selling and administrative expenses increased 5 per cent to $ 1.1 billion in the quarter. Advertising and product promotion spending decreased 19 per cent to $ 167 million in the quarter. Research and development expenses decreased 2 per cent to $ 951 million in the quarter. Roche Group boasts of strong sales growth in the third quarterRoche sales grew 4 per cent to 33.7 billion Swiss francs owing to major demand for its cancer medicines and its clinical lab business. Uptake of the Group’s recently launched cancer medicines Zelboraf, Erivedge and Perjeta has been positive.

Roche was ranked the most sustainable healthcare company globally in the Dow Jones Sustainability Index (DJSI) for the fourth year in a row in September, underscoring the Group’s commitment to responsible business practices and the creation of long-term value.

In Brief

Mexican pharmaceutical maker Neolpharma has bought a Pfizer facility in Puerto Rico that was set to close at the end of this year. Neither party disclosed the value of the transaction.

Pfizer announced in May 2010 that it would be closing

two of its five factories in Puerto Rico, including the

130,000 sq metre facility in the San Juan suburb of Caguas.

Neolpharma plans to retain 130 of the plant’s existing staff and to hire another 60 people on a temporary basis.

Brilinta® works by preventing the formation of new blood

clots and maintaining blood flow in the body to

help reduce patient’s risk of another cardiovascular event

(called atherothrombotic events) such as a heart attack

or cardiovascular death.



The Pune-based Cipla Palliative Care and Training Centre recently concluded its World Palliative Care Day celebrations by organising a walk in the city. More than 500 people participated in the walk, comprising of doctors and nurses, members of different clubs & NGO’s, volunteers, patients and their families and students from schools, and college institutions practicing in the field of Palliative Care.

Observing the theme of World Palliative Care Day – “Living Life to the End, Palliative Care for the Ageing Population”; the Cipla Palliative Care Centre felicitated several non-profit organisations like Aasra Foundation, Samavedana, Centre for Special Education, Bhagini Nivedita Pratishthan and Aapla Ghar for their

tremendous contribution in building a better society and improving the quality of life for several underprivileged children and elderly people.

Dr Priyadarshini Kulkarni,

Medical Director, Cipla Palliative Care and Training Centre said, “It is heartening to see the increasing response to our walk every year. This year the theme of World Palliative

Care Day is caring for the elderly. The combination of chronic disease and advancing age calls for special skills which palliative care is ideally equipped to give. Cipla Centre conducts regular workshops for caregivers to help them take better care of patients at home. Recently we organised a workshop for people who are caring for those affected by Alzheimer’s disease.”

Speaking at the conclusion of the walk at Shaniwarwada, S V Iyer, Managing Trustee of Cipla Foundation informed that Cipla Centre was celebrating its 15th year and had cared for more than 8,000 patients. “I am happy to see the number of school children who are with us today and the society will benefit immensely, if we succeed in creating awareness about palliative care at a young age.”

Cipla Palliative Care Centre celebrates World Palliative Care Day

Bulgaria, a member of the European Union (EU), recently invited Indian companies to invest in its various sectors such as pharmaceuticals, tourism, agriculture and food processing.

“There is a lot of potential for Indian investors in sectors such as auto components, pharmaceuticals, agriculture and food processing, electronics tourism,” said Delian Dobrev, Minister of Economy Energy and Tourism. Adding to this he said, “We offer SOPs like lower taxes for investors and other fiscal incentives.” At present, few Indian companies including Suzlon Wind Energy, Elder Pharmaceuticals and Namdhari Seeds have presence in Bulgaria. Borislav Kostov, Ambassador to India, Bulgarian, said, “Trade and economic ties constitute an important component of the close and cordial relationship between India and Bulgaria. We are confident that with both countries competitive advantages, with India’s rapid developing economy and its role as an emerging global power and with Bulgaria being member of EU, its micro economic stability coupled with low tax rates, there is a great potential for expansion in bilateral trade and economic cooperation,” he said.

Bulagaria invites Indian cos to invest in pharma,

tourism

Sanofi and BMS announce restructuring of alliance

agreementSanofi and Bristol-Myers Squibb (BMS) Company have restructured their successful long-term alliance following the loss of exclusivity of Plavix and Avapro/Avalide in many major markets.

Under the terms of the revised agreement, which will go into effect January 1, 2013, Bristol-Myers Squibb will return to Sanofi its rights to Plavix and Avapro/Avalide in all markets worldwide with the exception of Plavix in the US and Puerto Rico, giving Sanofi sole control and freedom to operate commercially. In exchange, Bristol-Myers Squibb will receive royalty payments on Sanofi’s sales of branded and unbranded Plavix worldwide, excluding the US and Puerto Rico, and on sales of branded and unbranded Avapro/Avalide worldwide, in each case through 2018,

and will receive a terminal payment of $ 200 million from Sanofi in December 2018. Plavix rights in the US and Puerto Rico will continue unchanged under the terms of the existing agreement through December 2019.

“Our alliance with Bristol-Myers Squibb has been extremely successful and value-generating for both partners,” said Hanspeter Spek, President - Global Operations, Sanofi.

In addition, under the terms of the agreement ongoing disputes between the companies related to the alliance have been resolved. The resolution of these disputes includes various commitments by both companies, including a one-time payment of $ 80 million by Bristol-Myers Squibb to Sanofi in relation to the Avalide supply disruption in the US in 2011.

Dr Kulkarni



Alexandria Real Estate Equities, Inc recently announced that Roche Holding Ltd will establish its new Translational Clinical Research Center (TCRC) at the Alexandria Center for Life Science – New York City. The TCRC will be the mission-critical presence for Roche Pharma Research and Early Development

(pRED) in the US. “We are pleased with the selection of the Alexandria Center for Life Science as this will be a strategically important site for Roche,” said Mike Burgess, M.D, Acting Global Head, Roche Pharma Research and Early Development. “For Roche research, having the TCRC located in the Alexandria

Center for Life Science will be a critical element in helping us maintain the high caliber of scientific excellence within Roche pRED, carry out our long-term strategic research vision, tap into scientific expertise, and find new and innovative ways to move the drug development process forward.”

Roche selects the Alexandria Center™ for Life Science - New York City for its new TCRC

New Zealand aids drug delivery research at IIT BombayDrug delivery research in India is getting a boost with help from New Zealand’s nanotechnology company Izon Science. Izon Science gifted a highly advanced qNano system to Prof Rinti Banerjee from the Department of Biosciences & Bioengineering at the Indian Institute of Technology (IIT) in Mumbai.

The instrument was gifted to accelerate advancement of research in the area of nanoparticles for drug delivery. The gift recognises the path-breaking technology platform and drug delivery mechanism award winning Prof Rinti Banerjee has developed. qNano provides highly accurate information required to aid development of drug delivery systems that could deliver cancer drugs directly to the tumor.

Prof Banerjee is the winner of numerous awards for her work including most recently the prestigious National Award for Women Bio-scientists by the Department of Biotechnology, Government of India.

Restricted API supply affects phentermine tabletsElite Pharmaceuticals, Inc announced that Elite received approval from the US FDA for generic phentermine capsules 15 mg and 30 mg. Elite also announced that the sole supplier of the API approved for this phentermine capsule product has restricted the amount of API available to Elite and this will delay the launch of this product. The supply restriction also prevents Elite, and its sales and marketing partner, from meeting growing demand for the phentermine 37.5 mg tablets and is also expected to restrict sales of this product. If Elite is unable to timely resolve this dispute in a reasonable manner then, unless and until Elite is able to obtain adequate amounts of API, it will not be able to sustain or grow the sales of the generic phentermine products.

In Brief

Burgess

Cognex wins 2012 Control Design Readers’ Choice Award by 43 per cent margin

Cognex Corp recently announced that it has won the Control Design Readers’ Choice Award in the category of machine vision system by a margin of 43 per cent over the second place finisher. Control Design surveyed the machine builders and system integrators among its readership and of the approximately 1000 that responded 52 per cent answered that Cognex machine vision systems

delivered the best value compared to 9 per cent for the second place finisher.Cognex has won a Control

Design Readers’ Choice Award in the machine vision category every year since 2001 with seven first place wins and four second place finishes. “We are very proud to

win the Control Design Readers’ Choice Award for 2012,” said Ron Pulicari, Marketing Manager, Cognex.

“This award validates our strategy of continual investment into the R&D of our products. The overall result is continued best-

in-class products that help our customers improve the quality and traceability of their products while at the same time reducing manufacturing and distribution costs.”

Unichem Laboratories has received American health regulator’s tentative approval to market generic version of Sanofi Aventis’ Avapro tablets, a hypertension drug, in the US market. The company has received tentative approval from the USFDA for

irbesartan tablets in strengths of 75 mg, 150 mg and 300 mg, Unichem Laboratories. Final approval will be received after the patent expires on December 7, 2012. The product will be commercialised (after the final approval) from Unichem’s Ghaziabad plant.

Unichem Labs gets USFDA approval for hypertension drug



Hikal Ltd won the prestigious Award for the Best Responsible Care Committed Company for 2011 at the Annual Indian Chemical Council Awards function held at The Taj Mahal Hotel, Mumbai. The award was presented to Hikal by the ICC in the presence of the International Council of Chemical Association (ICCA), Responsible Care Leadership Group. Speaking on the occasion, Jai Hire math, CMD, Hikal, said, “The ICC Aditya Birla Award is a testament of Hikal’s commitment to continuous improvement in performance when it comes to environment protection, health and safety and commitment to sustainability through the development of innovative technologies. Our goal is to continuously improve the environmental, health and safety knowledge of people and those of the surroundings, using resources wisely and minimising waste and to foster the responsible management of chemicals in our development and manufacturing processes along the value chain. For us, being a responsible care company goes beyond the mandatory regulatory compliance and enables us to positively contribute to the sustainable development of local communities and society as a whole.”

Hikal wins the ICC Aditya Birla Award for

Best Responsible Care Committed Company 2011

Avery Dennison to add an emulsion coater in Pune, IndiaAvery Dennison, India’s

manufacturer and supplier of pressure-sensitive labeling material, will add an emulsion coater in early 2014 to its state-of-the-art facility in Pune to meet the needs of India’s growing label printing industry. This expansion of manufacturing capability reinforces the company’s commitment to the region and to the growth of the Indian packaging industry.

“Avery Dennison is committed to providing world-class products and services to the packaging industry in India, where we’ve operated for 15 years,” said Georges Gravanis, Vice President and General Manager, Avery Dennison’s Materials Group in Asia Pacific. “Our continued investments in the Pune plant reflect our commitment to help Indian manufacturers and their label suppliers grow and develop.”

The addition of emulsion coating marks the fourth

enhancement of Pune operations since the plant opened in 2008. In 2011, the plant introduced the widest and fastest adhesives coating line in India along with the latest pressure-sensitive roll materials handling and finishing equipment. They also inaugurated a first-of-its-kind Knowledge Center in Bengaluru in August 2012, to facilitate education, training and best practice among industry label converters.

The new, technologically-advanced emulsion coater at Pune will be used to manufacture a portfolio of pressure-sensitive materials to international standards for the South Asian market.

Opened in 2008, the Pune plant produces technically advanced pressure-sensitive materials

at a 28-acre site within the Ranjangaon Industrial Area in the Western Indian state of Maharashtra. Alongside operations in Gurgaon and Bengaluru, it is one of the company’s three major labeling

and packaging manufacturing facilities in India. Avery Dennison maintains a network of strategically located sales and distribution centres throughout India, including facilities in Delhi, Mumbai, Bengaluru, Hyderabad , Chennai and Kolkata. It also has operations in Bangladesh, Sri

Lanka and Pakistan.



Soon, a drug to boost blood circulationResearchers have launched worldwide trials of a drug that boosts the ability of red blood cells to carry oxygen around the body, and can aid faster recovery of patients with heavy blood loss. MP4OX is made from expired blood stocks and seeks to replicate the function of red blood cells in carrying oxygen around the body. The Royal London Hospital is leading the clinical trials and it is being given to patients with heavy blood loss in 56 centres around the world. MP4OX developed by US pharmaceutical company Sangart is a haemoglobin-based product processed from expired blood transfusion stocks. Haemoglobin molecules are the proteins in red blood cells which carry oxygen to muscles and tissue around the body. In trauma patients who have undergone heavy blood loss, these molecules are in short supply, and its makers claim MP4OX can deliver an oxygen boost to organs and tissue in

the body, reducing the risk of organ failure.

They say it carries no infection risk and can be given safely to all patients. “We are giving it to people who been severely injured in car crashes, have fallen out of a window, been stabbed etc.

Basically it is a drug which takes up oxygen and delivers it to cells which are starved of oxygen because there is not enough blood going around the body,” said Professor Karim Brohi, Barts and The Royal London Hospital. The drug has already been tested in a pilot trial of 50 patients, which appeared to show the drug was safe. That pilot has now been extended to a worldwide trial

encompassing some 360 patients, to further test its safety and efficacy. “In the initial trial, it seemed to show that people got out of hospital much quicker than patients who hadn’t had the drug. It was a small trial with lots of room for error, but there was a pretty strong signal that there were a lot more patients who were alive and out of hospital at 28 days compared to the ones who hadn’t had the drug,” said Brohi. However, he stressed that it was only after results from the extended phase 2b trial were in, that they would know how much promise the drug showed. MP4OX should not be regarded as artificial blood. “This is not a substitute for blood because we give less than a Coke can’s worth to each patient - while these patients may have lost up to five litres of blood - so in no way is it a substitute for giving red blood cells to patients. What it is doing is augmenting the ability of those red blood cells to do their job,” said Brohi.

As trade talks with Europe enter the final stretch, Canada’s patent-drug industry is making a final push to sell their brand of medicine to Canadians. One report from the KPMG consulting firm suggests spending by the industry in Canada has been underestimated and is about the 10 per cent level of sales it promised in the 1980s when Brian Mulroney’s government extended patent protection. Another study estimates there are 46,000 jobs connected to the brand-name drug industry and they are among the best-paying in the country. Canada has some of the world’s best researchers, a modern health system and first-rate facilities, yet gets only about one per cent of the $ 100 billion spent globally on pharmaceutical research and development. Russell Williams, the industry’s chief lobbyist, points to what happened after 1986, when investment dollars poured into Canada once the government extended patent protection for drug manufacturers.

Granules India Ltd, a fast growing pharmaceutical manufacturing company, announced financial results for its fiscal year 2013 second quarter ended September 30, 2012. Granules’ revenue increased by 9 per cent to ` 176 crore while net profit increased 228 per cent to ` 8 crore. Profitability margins expanded due to an increase in finished dosage sales and high production levels at all the facilities. The EBITDA margin expanded by more than 440 basis points compared to the corresponding quarter in fiscal year 2012 while the net profit margin grew by more than 300 basis points.

Big pharma wants stronger patent barrier

Granules India’s revenue increases by 228 per cent

Strides Arcolab Q3 net profit at ` 524.929 millionStrides Arcolab Ltd has posted a net profit of ̀ 524.929 million for the third quarter that ended on September 30, 2012 as compared to ̀ 464.681 million for the third quarter that ended on September 30, 2011.

Total income has decreased from ` 7801.509 million for the quarter that ended on September 30, 2011 to ` 6029.863 million for the quarter that ended on September 30, 2012.

New malaria drug requires just one dose and appears twice as effective as existing regimenScientists have reported the development of a new malaria drug that, in laboratory tests, has been twice as effective as the best current medicine against this global scourge and may fight off the disease with one dose, instead of the multiple doses that people often fail to take.

Even today, malaria continues to kill almost 1 million people annually. Gary Posner and colleagues explain that the best existing treatment is so-called Artemisinin Combination Therapy (ACT). It requires patients to take pills every day for several days, and many patients fail to complete the regimen leading to malaria parasites developing resistance to ACT. To curb drug resistance, the researchers have developed a new type of ACT that could stop malaria in a single dose.

It is described as a series of new compounds that given once is more effective than traditional artemisinin-derived substances. One of the new compounds, when combined with mefloquine, killed all of the parasites in some mice with just a single oral dose and allowed those mice to live almost twice as long as those treated with conventional ACT.

In Brief



Research shows that use of popular antidepressants is linked to an increased risk of some strokes caused by bleeding in the brain, but that the risk is low, according to a multi-study analysis published in the online issue of Neurology®, the medical journal of the American Academy of Neurology.

For the research, scientists analysed all the studies that looked at antidepressant use and stroke. This included 16 studies with more than 500,000 total participants. They found that people taking Selective Serotonin Reuptake Inhibitors (SSRIs), most commonly used antidepressants, were 50 per cent more likely to have an intracranial hemorrhage than those not taking the antidepressants and about 40 per cent more likely to have an intracerebral haemorrhage.

Antidepressants linked to increased risk of stroke, but

risk is low

Bosch launches cleaning system for pharma companies

The standardised compact sys tem f rom Bosch Packaging Technology for cleaning and sterilisation in place (CIP/SIP) is suited for pharmaceutical containers and vessels, as well as small production accessories, including filter units, mills, pumps and hoses. The modular system is manufactured in Dresden by Pharmatec, a subsidiary o f Bosch Packaging Technology.

CIP/SIP systems are used for reliable and reproducible cleaning and sterilisation of machinery and equipment. This cleaning and sterilisation process is especial ly important to ensure highest product quality for sterile pharmaceuticals. The basic configurat ion includes

a CIP tank to mix the necessary cleaning media, a flow pump, lines for Purified Water (PW), Water

For Injection (WFI), clean steam, compressed air, and the required measurement, control and valve systems.

The system can be quickly and easi ly configured with add-on modules to meet different customer specifications. In addition to a self-priming return pump, a pharmaceutical-compatible heat exchanger can be integrated into the existing CIP frame. The temperature of the cleaning media is controlled via steam or electric heat exchangers. Various dosing stat ions for detergent concentrates and sterile air filter units used for blowing out and drying the system can be integrated.

“The modular design and the use of proven standard components enable a fast

system configurat ion,” explained Volker Kempf, Project Manager a t Pharmatec. “This ensures efficient project execution in the shortest possible time – even when there are additional requirements.” The Dresden plant maintains a supply of all media required in the pharmaceutical industry, including WFI and pure steam, for system pre-testing. Along with Installation Qualification (IQ), the system also enables the implementation of the Operational Qualification (OQ), including spray pattern control, riboflavin testing and temperature mapping (cold spot analysis). This ensures that the CIP system goes into operation very shortly after being delivered to the customer’s site.

Roche recently announced the launch and immediate availability of multiple new SeqCap EZ Library target enrichment products. SeqCap EZ Library is a method that enables the enrichment of the whole exome or custom regions of interest prior to

next-generation sequencing. The new products are designed to enhance genetic variant discovery and detection in basic and clinical research studies, while minimising sequencing c o s t s w i t h excellent capture

efficiency. They are optimised for subsequent sequencing on a variety of next-generation technology platforms. “We are extremely excited to expand our targeted sequencing portfolio to meet the rapidly evolving needs of researchers in the field of next-generation sequencing,” said Thomas Schinecker, Head, Roche Sequencing Solutions. “Our proven industry leading performance in target enrichment technology gives us a strong foundation to offer these new solutions to researchers in basic research and translational research laboratories. In addition, we are looking forward into early next year when we will be launching new SeqCap EZ Reagents to provide customers with additional workflow convenience.”

Roche expands its targetted sequencing

portfolio with launch of

SeqCap EZ

CIP/SIP systems are used for reliable and

reproducible cleaning and sterilisation

of machinery and equipment.

This cleaning and sterilisation process

is especially important to ensure highest product

quality for sterile pharmaceuticals.

Schinecker



Sequella has licensed its B-SMART technology to Laboratory Corporation of America (LabCorp) to allow LabCorp to develop a new laboratory-based antibiotic susceptibility assay for Mycobacterium tuberculosis and to use the assay in the US commercially. Using B-SMART, LabCorp will develop assay that will combine nucleic acid testing with phage-based technology to recognise any resistance of M. tuberculosis clinical isolates to antitubercular antibiotics, irrespective of whether the resistance genotype is known. Sequella has retained all rights to commercialise B-SMART technology worldwide for indications other than tuberculosis and for territories outside

US for tuberculosis. The technology suits any nucleic acid detection system, which can be used to develop tests that detect resistance to any drug. Carol Nacy, CEO, Sequella said, “Sequella is happy to sign the first partnership for B-SMART technology with LabCorp. We look forward to a successful collaboration and a timely introduction by LabCorp of a new assay that can facilitate appropriate drug selection by physicians treating tuberculosis in this country.”

LabCorp to develop TB

antimicrobial susceptibility test using B-SMART

Goose launches proofreader

Goose, a specialist in providing pharma business re-engineering solutions recently announced the launch of Goose Proofreader, a 21 CFR part 11 compliant solution that enables excellent review of

printed materials. Goose also announced that two of the top pharma companies in India, Glenmark Pharmaceuticals and Aurobindo Pharma have already begun to use Goose Proofreader.

The major challenge that the pharma industry faces today is to make the artwork error free. Goose Proofreader is engineered to deal with

this challenge as it reduces the costly errors, increases accuracy and maximises productivity. Making the announcement Deb Pattnaik, Founder & CEO, Goose, said, “Our goal is to make Goose

Proofreader as an industrial standard. It is a completely new alternative to manage document proofreading task. Usage in our client

location has tackled even the most complex tasks such as evaluation of multilingual texts, comparison of images in different angles at the same time adhering to strict FDA regulations effortlessly. This is a key solution to current processes, which is human error prone leading to huge potential loss to the global pharmaceutical organisations.”

AB SCIEX has unveiled a new software application, LibraryView Software, which enables faster and reliable identification of contaminants in food, environmental, clinical research and forensic toxicology samples. The new software using customised compound libraries associated with different methods will enable scientists and lab technicians to screen

hundreds of samples for hundreds of potential contaminants and residues. The software also has QTRAP and TripleTOF technologies that help improve speed and reliability in screening workflows and also enable acquisition of full scan MS/MS spectra of compounds or contaminants present in a sample. The new LibraryView Software also enables high-

throughput labs to improve their workflows and processes by creating their own custom libraries with retention time information, LC conditions, and associated matrices. Dave Lavorato, Product Manager, AB SCIEX said, “LibraryView Software provides a quick way to screen samples and get answers without laborious data processing and data review.”

Abbott will expand the current CE-IVD product labelling for its Vysis ALK Break Apart FISH Probe Kit to allow the test to be marketed in the European Union as a companion diagnostic. The test uses Abbott’s proprietary Fluorescence in Situ Hybridization (FISH) technology to detect rearrangements of

the Anaplastic Lymphoma Kinase (ALK) gene in advanced Non-Small Cell Lung Cancer (NSCLC) patients e l igible for treatment with Xalkori, an oral f irst-in-class ALK inhibitor. Kristina Rodnikova, Head, Molecular D i a g n o s t i c B u s i n e s s Europe, Abbott, said, “Laboratories throughout Europe are familiar with

and experienced in using the Vysis ALK FISH test so they will be able to start testing lung cancer patients immediately to help doctors decide if XALKORI is the right treatment option for them.” FISH technology helps identify the role of particular gene or certain genes that play an active role in disease progression.

AB SCIEX releases new software application

Abbott launches ALK test in Europe

The technology suits any nucleic acid detection system, which can be

used to develop tests that detect resistance to

any drug.



WHO prequalifies a new artemisinin-based combination

treatment for malariaCipla along with Drugs for Neglected Diseases initiative (DNDi) recently announced the prequalification of the Fixed Dose Combination (FDC) of

Artesunate (AS) and Mefloquine (MQ) – ASMQ FDC – by the World Health Organization (WHO). This Cipla-manufactured ASMQ FDC is the first artesunate-mefloquine

FDC to be prequalified by WHO and is recommended for the treatment of malaria.

“The prequalification announcement is recognition that ASMQ FDC meets WHO’s high quality standards and we aim to make this treatment widely available throughout Asia,” commented Dr Jaideep Gogtay, Medical Director, Cipla.

“The availability of ASMQ FDC will have a direct impact on patients, especially in Asia. It addresses an important public health need in the region as it forms part of the malaria treatment arsenal necessary to control the disease,” said Bernard Pécoul, Executive Director, DNDi.

In addition to being easy to use (a single daily dose of one or two tablets over 3 days), ASMQ FDC will increase patient compliance and contribute to reducing the risk of resistance development, as it ensures both drugs are taken together and in correct proportions (four dosage forms based on age/weight dosing).

The ASMQ FDC is manufactured in Cipla’s world class manufacturing facility in Patalganga, India, which is approved by WHO-Geneva, US FDA, MHRA-UK and various other regulatory bodies.

Gogtay

SQI Diagnostic unveils automated SQiDlite multiplexing system

SQI Diagnost ics has i n t r o d u c e d S Q i D l i t e multiplexing system for p h a r m a c e u t i c a l d r u g development and contract research organisat ions performing bioanalytical a n d i m m u n o g e n i c i t y tes t ing. The SqiDl i te system, which can run on the company’s SqiDworks m i c r o a r r a y p l a t f o r m , integrates fluidics, washer, d r y e r , s c a n n e r a n d analysing functions in a user-friendly bench-top footprint. Claude Ricks, CEO, SQI Diagnostics said, “The company believes that the SQiDlite system’s automated, small footprint b e n c h - t o p p l a t f o r m with total load-and-go capabilities complements its custom assay business. With i ts user-friendly a s s a y d e v e l o p m e n t

s o f t w a r e a n d L I S interface combined with its ability to significantly reduce cost and labour, SQiDlite is posit ioned to become a platform of choice for bioanalytics and immunogenicity labs around the world.”

Quintiles releases new reporting and analytics solution

Quintiles has released Quintiles Infosario solution, an interactive, role-based navigation as part of its next generation of Quintiles Infosario Reporting & Analytics Platform. Quintiles Infosario solution integrates data, systems, processes and Quintiles’ therapeutic knowledge to have better-informed decisions from clinical trial planning and design, to trial execution services, through post-market outcome studies. The new navigation introduces templates, which allow users to create dashboards to view the relevant data and visualisations for specific day-to-day needs along with transparency into critical data at the study, programme and portfolio levels. The platform

with its new technology will enable customers to handle issues such as real-time oversight, risk mitigation, patient safety, productivity and time to market. Quintiles Infosario will assist clinical programme managers to

view the overall status of trials in a specific region and allow pharmacovigilance scientists to focus on safety-specific data. It will also help site start-up specialists to monitor patient enrollment at specific sites to forecast, benchmark and optimise the patient recruitment processes. Thomas Grundstrom, VP, Integrated Processes and Technologies, Quintiles, said, “Customers have experienced gaps in the availability of integrated, continuously updated data necessary to manage their studies. With the next generation of Quintiles Infosario, users can easily view data according to their specific needs and make better-informed decisions to run more efficient clinical trials and accelerate time to market.”

With the next generation of Quintiles Infosario,

users can easily view data according to their specific

needs and make better-informed

decisions to run more efficient clinical trials

and accelerate time to market.

Ricks


In Conversation With

We need to increase the scope and quality of clinical studies in our country and ethics committees have a vital role to play

Share some details about the meeting of ethics chairs and the agenda on cards. Currently, clinical trials are conducted in an effective, transparent and ethical manner in India. The only way patients can be protected from undue, unethical and excessive clinical trials is that these trials must be conducted under the surveillance of ethics committees. We have invited several representatives from accredited hospitals such as AIIMS, Fortis and Apollo, Public Foundation of India, Department of Biotechnology (DBT) and Government of India. These committees are discussing various points related to ethics in clinical studies such as ethical consideration for research in specific groups, incentives to patient and informed consent, ethics in bio-banking, ethics of global collaborative research projects, ethics of device clinical trials and national guidelines on stem cell research. We hope certain recommendations will be finalised, which will be forwarded to the government for consideration.

In addition, clinical trial is a big source of income and research, but unfortunately we conduct only 2 per cent of global trials against China’s average of 9 per cent and we are losing millions of dollars in the process. We see extensive news about Indians being used as guinea pigs by the drug companies in absence of proper monitoring. Despite having better technology, we are losing the revenue since ethics committees are not functioning in India.

India is a sought after destination in terms of cost-effectiveness and patients availability for conducting clinical trials in South Asia. How would you justify the trend? These are facts, but unless we conduct fair trials these companies will not come, in spite of this advantage. Because, if a drug company comes up with a result that is not accredited or validated by the ethics committees, no global regulatory agency will accept the data and we will continue to lose credibility. We need to increase the scope and quality of clinical studies in our country, and ethics committees have a vital role to play.

How medical fraternity, including doctors, hospitals, regulatory bodies, social groups and health clinics can play a significant role in ensuring fair trials and patient safety? These all are the prominent players to ensure ethical practices across the entire chain of clinical trial process right from the government nod to the final data accreditation. We are insisting on forming these ethics committees that comprise people such as lawyers, NGOs, civil society members excluding the doctors or any other direct beneficiary group of these studies.

Your reaction to a Supreme Court Judge’s indicative statement of stopping all the clinical trials in India. I feel the decision is not well considered by the Honourable Judge, because holding such a ban on clinical trials is going to affect the research and innovation potential of our scientists. No new drug can be invented in such a situation, and we will be dependent on other nations for conducting our trials despite having sufficient resources within our country. It is a sensitive issue, and any such mandate must be executed with thorough discussions with the responsible stakeholders.

What played a significant role in shaping your personal and professional life? At every stage of my life, people I worked with were very

good, whether be it school or college or Oxford University or various organisations that I associated with. The good qualities incorporated in me by my parents, teachers and guides kept me intact through all ups and downs of life. The most important lesson of my life is ‘The most eminent people are among those are most simple at heart.’

Kindly tell us about your struggling days during various stages of life.I hail from a small town in Patna district of Bihar. I did MBBS and went to Oxford for PhD where I was asked to pursue the BSc course to qualify for a doctorate degree. I did that course sincerely and got applauds after completion from one of my professor and subsequently pursued PhD. Although it was a tough test of my humanitarian instincts, I knew that it was a chance for me to build my future, so there was no room for taking it lightly. In addition, the weather condition and

an altogether unknown social circle, compared to Patna, also added to my woes but it paid later.

When we started the Postgraduate Institute of Medical Education & Research (PGI) in Chandigarh, initially we faced credit crunch in setting up the institute. Twenty years ago the situation was entirely different in terms of government funding. Unlike today, we had to raise our own funds; and I arranged it from WHO, ICMR, Central Council of Ayurveda to create a world-class pharmacology department. Later on, we started Doctorate of Medicine (DM) in clinical pharmacology, which is linked to WHO and UK.

In PGI, all department heads were outsider and we created our own tradition; besides, I was the first professor in the institute and put my best to build an institute of excellence. We adopted the model of Royal PG Medical School in UK, which only considers post graduate courses in medicines.

What is next on your cards? I still want to develop herbal medicines for common disorders, which can be used as better alternatives for allopathic medicines. There is an allopathic pill, named Polypill, which contains multiple active ingredients used for various indications

such as high BP, diabetes, coronary heart diseases, and acts as a preventive drug. In the similar line, I am working on a herbal Polypill that consist of our rich herbs such as tulsi, shatavri for curing high BP, increased lipid levels, diabetes and coronary heart diseases. Irrespective of my age, I still look to innovate something that may help humankind effectively.

Irrespective of my age, I still look to

innovate something that may help humankind

effectively.

…says Prof Ranjit Roy Chaudhury, Chairman, Task Force for Research, Apollo Hospitals Educational and Research Foundation. He provides some valuable insights on the need and importance of ethics in clinical trials in India at the meeting of chairs of ethics held at Indraprastha Apollo Hospital, New Delhi on November 3 and 4, 2012.

Nikunj [email protected]

Despite having better technology, we are

losing the revenue since ethics committees are

not functioning in India.


Special Focus

D riven by factors such as rising disposable income of the middle class, increased

government & private spending on healthcare infrastructure, increasing penetration of medical insurance penetration, etc the demand for pharma products in India has increased significantly. The pharma industry in India meets around 70 per cent of the country’s demand for bulk drugs, drug intermediates, pharma formulations, chemicals, tablets, capsules, orals and injectables. There are approximately 250 large units and about 8,000 small scale units, which form the core of the pharmaceutical industry in India (including 5 central public sector units). According to reports globally, India ranks third in terms of manufacturing pharma products by volume. According to McKinsey, the pharmaceutical market is ranked 14th in the world. By 2015 it is expected to reach top 10 in the world beating Brazil, Mexico, South Korea and Turkey. More importantly, the incremental market growth of $ 14 billion over the next decade is likely to be the third largest among all markets. Additionally, the US and China are expected to add $ 200 billion and $ 23 billion, respectively.

Market potentialMcKinsey & Company’s report, ‘India Pharma 2020: Propelling access and acceptance, realizing true potential,’ predicted that the Indian pharma market will grow to $ 55 billion in 2020; and if aggressive growth strategies are implemented, it has further potential to reach $ 70 billion by 2020. Further, Cygnus’ report forecasts that the Indian bulk drug industry will expand at an annual growth rate of 21 per cent to reach $16.91 billion by 2014. Discussing the market opportunities, Dr Ranjeet S Ajmani, CEO, Plasmagen Biosciences Pvt Ltd, avers, “With time increasing number of companies are getting into the market thus helping Indian patients get more access to medicines at cheaper rate. Further, quality control checks are stringent so that the safety profile is also maintained. And thanks to the Right to Information (RTI) act today, most of the manufacturing units are on their toes.” Elaborating on the market scope, Devinder Pal, Founder President & CEO, Catalyst Pharma Consulting, Former Joint MD, Elder Pharmaceuticals Ltd and Wholetime Director, Parke Davis (now Pfizer) India Ltd, says, “India is a potential gainer in the process. Indian cost of APIs is up to 50 per

cent lower than the developed countries (unfortunately our dependence on China for intermediates is increasing fast – a dangerous development). India leads in its share of Drug Master Files (DMF) (49.7 per cent) and Abbreviated New Drug Application (ANDA) (31 per cent) approvals. It is

claimed that ‘every second pill consumed in the world, comes from India.’” He continues that a demographic revolution is happening around the world due to higher life expectancy. India has a rapidly swelling number of senior citizens, even though it is a young country overall. Even by conservative estimates, the number of people in the 60-plus age group in India is expected to increase to 10 crore by 2013 and to 20 crore by 2030. At this rate, India will soon become home to the second largest population of elders in the world – needing more medicines.

According to Pal, the emerging markets are new exciting opportunities for MNCs and large Indian companies. These will account for 48 per cent of market growth in 2013. He affirms, “Given the considerable labour cost advantages and a large, well-qualified and English-speaking labour pool, India is emerging as the main beneficiary of global business process outsourcing industry. By signing strategic deals with several Indian companies, Pfizer, GSK, Merck (MSD), Bayer and the like have followed the dictum, ‘If you cannot beat them, join them’.” He adds that although, the Indian

companies are new (some say novice) at R&D game for NCEs, yet their output, despite limited budget and experience, is commendable.

Overcoming the hurdlesThe pharma manufacturing segment has always tried to overcome all the obstacles that

came on its way. According to Pal, unfortunately, Indian pharma companies lack both the marketing muscle and global reach - a vital necessity to recover the high cost of new drug development. They have tried to overcome this handicap by tying up with MNCs for worldwide launch. Continuing in this regard, he adds, “In 1962 the pricing policy was introduced for the first time. Right from then so many things have happened. India has faced so many controls and it has become ingenious with time. The biggest challenge is getting right people. There is a disconnect. People are needed to be adequately trained because no fresher coming out of college can work. Thus, having a proper training system is the need of the hour” He continues that there are higher regulatory challenges but India needs to overcome them. Pal emphasises, “We have to export to other countries. The manufacturing techniques, GMP standards need to be strictly followed.” Seconding the above thought, Dr Ajmani says, “Unfortunately, most of the regulatory people in our country are ill informed and therefore most of the procedures are delayed. And as a result, the company keeps on waiting unnecessarily. Adding to that most of the companies have not done their primary research.” Continuing in this regard, he says, “It must be remembered that the Human Resources (HR) department of a pharma manufacturing unit should be a strategic partner to the whole process. HR is not there for hiring and firing only. It is more than that. It is unfortunate but we have still remained very hierarchical in our work structure.”

According to Dr Ajmani, for the work culture to develop it is extremely important to corporate governance in place. He says, “Corporate governance needs to grow in our work culture. Till the time that the voice of the CEO is heard by the security guard, nothing will happen.”

Albeit greener grassIn spite of all the challenges, the Indian pharma manufacturing units have a prospective future. Dr Ajmani believes that in the next 5 years with RTI being more prominent there will be increasing public awareness. Further, he adds that media intervention will also contribute significantly in changing the pharma scenario and make it better. Overall, it seems to be the regulatory scenario that needs to be revamped to prevent the unnecessary delays that are currently taking place in this segment.

With time increasing number of companies are getting into the market thus

helping Indian patients get more access to

medicines at cheaper rate.

Given the considerable labour cost advantages and a large,

well-quali� ed and English-speaking labour pool, India is emerging

as the main bene� ciaryof global business process outsourcing industry.

Dr Ranjeet S AjmaniCEO, Plasmagen

Biosciences Pvt Ltd

Devinder PalFounder President & CEO,

Catalyst Pharma Consulting

Chandreyee [email protected]

Moving against several odds Despite few challenges, especially in terms of regulations, the pharma manufacturing segment seems to hold to its strong forte.Considering the present scenario, it is not far that India will be considered a pharma manufacturing hub. Read on to get an overview of the Indian pharma manufacturing segment.

Photograph: Neha Mithbawkar

Pharma manufacturing in India


Special Focus

The Indian pharma industry has come a long way. The machinery used in

pharma manufacturing have played an important role in the boom of the industry. With machinery being imported on a large scale during the 70s to the industry being completely independent; the Indian machinery manufacturers have risen and grown tremendously. The Indian machinery manufacturers are now not only supplying machinery within India but also exporting on a wide scale. With increase in demand for automated machinery, the manufactures are developing tailormade machinery for the drug manufacturing companies. The Indian pharma machinery manufacturers have come together and formed the the Indian Pharma Machinery Manufacturers Association (IPMMA); Rajesh Shah is the President and Mahendra Mehta is the Secretary. A spokesperson from IPMMA says, “The domestic market of pharmaceuticals is around ` 60,000 crore and is growing at 10-12 per cent. Export market revenue is around $ 12 billion, which is growing at 15-17 per cent. The overall Indian pharmaceutical business is likely to grow from $ 20 billion to $ 50 billion per annum by 2020 as per Mckinsey & PriceWater Cooper research reports of 2010 and India is the third largest supplier of medicines in the world in terms of volumes. Therefore, requirement of new pharmaceutical machines and replacement market for old machines will therefore grow significantly during the next 7-8 years.”

Current statistics of the Indian marketWith the huge growth of the pharma industry seen in the past couple of years and the huge growth expected in the future, the pharma machinery business is growing steadily every year. Neeraj Ahuja, MD, Harrison’s Pharma Machinery Pvt Ltd, said, “The pharma machinery industry is expected to grow at a parallel rate as the pharma industry.” The spokesperson at IPMMA says, “The estimate of the pharma machinery business in India depends on two parameters; one that are made in India and the other that are imported. There are Indian made machines that are about `1500 crore and imported machines are approximately ` 150 crore.”

The pharma machinery involves machines used during drug manufacturing,

packaging and processing. The spokesperson explains, “Almost all processing and packaging machinery are manufactured and supplied by domestic manufacturers for the past 40 years. However, during the last 10-15 years the Indian pharmaceutical industry has increased their export business substantially; the main market being US & Europe. Therefore, demand for high speed machines and some special type machines have increased significantly during the past 12-15 years; these machines are imported mainly from Europe, Japan, Korea, China and Taiwan. Many European machine manufacturers have set up

shop in India by having joint ventures with Indian companies. Few European companies have 100 per cent ownership in the local set up.”

India is an ideal destination for outsourcing pharma manufacturing and machines play an important role in this. The low cost of manufacturing offered by the domestic contract manufacturers have attracted the international companies to oursource in India.

The spokesperson from IPMMA adds, “All pharmaceutical companies supply medicines for domestic consumption. This consists of around 60 per cent of the total production by volume and is growing at 10-12 per cent every year. This has given scope for all the Indian pharma machinery manufacturers to carry out business in the domestic market. India during the past has been maintaining the lowest cost of production for medicines compared to rest of the world. Looking at the growth during the past several years it does appear that the technology needs of the industry have been well balanced by the domestic pharma machinery suppliers along with some imported

machines supplied by foreign machine manufacturers.”

Hindering factorsIndian companies face challenges on the R&D side. The spokesperson from IPMMA suggests, “The biggest challenge is the ability of Indian manufacturers to carry out continuous R & D similar to the European machinery manufacturers. The machinery imported from China, Taiwan and South Korea is very competitive compared to European machines. To cope with the constant needs of the Indian pharmaceutical industry and to upgrade their processing and packaging machines as per various regulatory authorities always come up at a short notice is a big challenge.”

Technology transferThe pharma manufacturers have a wide global footprint and technology transfer is thus important for these companies. The machines being used need to be of the same quality and should be able to produce the same quality drugs across the country.

IPMMA elaborates , “Technology transfers, mostly from Europe, that started from 1996 have been quite slow. However, some of the major domestic pharma machinery manufacturers have been able to cope up with the technology needs of the Indian pharmaceutical industry without any assistance from the European manufacturers.”

Innovations in storeThe machinery used in pharma manufacturing is designed as per the needs of the drug manufacturer. Every drug manufacturing company has its own standards for manufacturing machinery and processes and the maintenance of the machinery, but in addition to all this, there are set standards from the US FDA and cGMP that they have to comply with. IPMMA adds,” Most of the innovations take place in Europe and US. New innovations either come via imported machines or by way of joint ventures. Some of the innovations are incorporated by the local manufacturers as per the needs of the Indian pharmaceutical industry.” Ahuja adds, “The pharma companies with changing trends are demanding more of automated machinery. Di f ferent companies have different criteria and hence automated and manual machinery is supplied accordingly.”

Indian pharma machinery manufacturers are expanding their base beyond India. Ahuja says that companies have started exporting their machines to the developing countries like India and it is good market. The Indian companies export to countries like Malaysia, Sri Lanka, Thailand, Indonesia etc.

Looking at the potential offered by Indian machinery m a n u f a c t u r e r s , t h e international machinery manufacturing companies have collaborated with many Indian companies. This has caused the price of the quality machinery in India to decrease.

The low cost machinery of prescribed standards in turn causes the cost of manufacturing the drugs to reduce on a large scale. This has thus made India an ideal choice for outsourcing drug manufacturing.

The pharma machinery industry is

expected to grow at a parallel rate as the pharma

industry.

Acting local, going globalThe Indian pharmaceutical industry and its allied industries are growing at the same rate. Pharma machinery industry being one among them is growing rapidly serving domestic as well as other developing markets. We take a look at the various dimensions of this industry…

Manufacturing pharma machinery in India

Shibani [email protected]

New innovations either come via imported

machines or by way of joint ventures. Some of the innovations are incorporated by the

local manufacturers as per the needs of the

Indian pharmaceutical industry


Special Focus: Interface

How will the introduction of generic drugs change the scenario? Generics will be cheaper drugs as compared to the branded ones. They have a low cost of marketing, production and distribution and are hence sold at a cheaper rate. The problem with generics is the counterfeit in medicines. The Indian government does not have an infrastructure to check the counterfeit of medicines.

How will the pharma pricing policy affect the industry? With the pharma industry going into a pricing policy it may be observed that almost 60 per cent of the products would come under the price control. The branded generics segment will continue to show the same growth but with the change in the government policy and introduction of universal healthcare schemes there will be an increase in demand for generics and this will lead to growth in the mid tier pharma companies. The top tier companies would continue

to grow internationally but it will be a challenge for the mid tier pharma companies engaged in the production of innovative drugs.

I believe there should be a pricing policy. We can extend the National list of essential medicines but when you include the combinational drugs the list goes up to 1300 drugs which constitutes almost 50per cent of the market. We can introduce a price control system but one also needs to understand that it will hamper the financial growth the of Indian companies that want to engage in developing innovative drugs.

The multinational pharma companies are buying Indian companies to manufacture drugs and sell it across the globe. They are following an innovative business model and looking at the bigger picture.

What is your take on the foreign investment in pharma? I suggest that the government should promote foreign investment. About 25-30 per cent of the revenue of the companies is being generated from their global counterparts. If MNC’s will not get an upper hand there will be backlashes and this will result in bigger companies having stakes in the smaller companies or have trade agreements.

How do you think the pharma industry would shape up?In spite of the changing policies, innovative drugs will be produced. The pharma companies are collaborating and the idea being ‘if we cannot fight alone then let’s join forces.’ Recently, we observed that the pharma companies formed an alliance to

globally address the drug development issues and such ideas will come up and cause the growth of the sector.

The pharma industry is very robust. The leaders of the industry are focussed to take the industry to the next level. What kind of business models will be seen in the pharma industry? It would be expensive if a high cost centre develops an innovative model for an emerging company. Hence the pharma companies have shifted their manufacturing in India. India has a vast talent pool; this will also attract the pharma companies to shift their manufacturing to India.

What is your take on the clinical trials industry?Predicting clinical trials is difficult because of its policy-dependent nature. There are no set rules for adverse event in clinical trials. In case of an adverse event, the whole industry is jolted and this paints a negative image about it.

The Indian companies have set up centres outside India especially in the Asian Pacific region.


The Indian government does not have an infrastructure to check the counterfeit of medicines

…says Dr Ajay Sharma, Associate Director - Pharma & Biotech, Healthcare Practice, Frost & Sullivan, South Asia & Middle East on the future of the pharma industry. Here he also talks about the various aspects of the pharma industry such as foreign investment, clinical trials and generic drugs.


Special Focus: Roundtable

Should the government disband the Foreign Investment Promotion Board?

Having an open FDI policy in pharma sector, without any control can be detrimental to our organisational setup, in turn threatening our rich resources. The agency has a justified reason to defend its establishment; however, its functionality and flexibility can be further exercised to seek improved and fair investment opportunities.

Editorial take

Somasekhar SundaresanPartner, JSA, Advocates & Solicitors

Prof Ranjit Roy ChaudhuryChairman, Task Force for Research, Apollo Hospitals Educational and Research Foundations

Pushpa VijayaraghavanVP, Sathguru Management Consultants

The reason why the Board exists cannot be changed. To leave the FDI in pharma open to market forces without any control may be detrimental to our organisational structure. We are not still in a position to protect our resources, so we need to continue with the Board, but it will need to the change course of action in the perspective of time. Dissolving a purpose-made institution will not serve the cause; the main issue lies with its conventional way of functioning and not the constitution. The M&A wave is catching up in pharma sector, so we need to be careful in sanctions, as our resources and innovations are on stake. Pharmaceutical industry is not like any other product manufacturing segment; it is related to health and cure and has a direct impact on our people and society. In India, we have good institutions, but our flexibility is limited. However, FIPB has the power of being flexible as per the country’s needs as the situation is not similar as it was 20 years ago, and will definitely going to change in the near future.

India is at a cross-road in the biopharma sector now pursuing the dual objective of fostering innovation to develop novel solutions as well

as ensuring continuous availability of affordable drugs for diseases faced by its population. While

several efforts such as BIRAC, SBIRI and BIPP foster on innovative product development, it is also

important that access to healthcare is not compromised and we do not end up straddling insurmountable costs - a bane that many developed countries are dealing with today. Given these considerations and criticality of the healthcare sector, it is understandable that the government would like to gatekeep brownfield investments that lead to controlling stakes of domestic enterprises. The sector has been open to foreign investments since 1991 and I think the government appreciates benefits of foreign investments and participation of globally successful multinational players. I believe that the sector should remain open to foreign investment but judicial gate keeping is acceptable. However, it is pertinent that these judicial regulations are implemented in a manner that they do not depress the overall investment climate. In addition to FIPB’s approval of all acquisitions of a majority stake, we now have several other entities such as the Competition Commission of India (CCI) and Department of Industrial Policy and Promotion (DIPP) being named as potential approving authorities. Given my view in favour of limited regulations, I do not believe that the FIPB needs to be dismantled but it is essential that the process be short, transparent and handled by a single entity so that it does not become a deterrent for potential investors.

The restrictions imposed on FDI in the pharma sector are a throwback to the pre-1991 era. The control empire is striking back. The arguments in favour of restricting FDI in pharma can be used for any sector that has a wide social impact. It is this philosophy that led to control over FDI in carbonated drinks, or in ice-cream and in soaps and detergents. If one takes pharma to be a sensitive sector, he/she could say hospitals are a sensitive sector. You could say software is a sensitive sector – IT controls all walks of life and foreign interest there can be made to seem fearful. You could say, the alcohol industry is dangerous – foreign interests can get our populace addicted and destabilise national interests. Market abuse requires a strong competition regulator to intervene. Placing hurdles in the way of capital flows will not be the solution. We are forgetting why we did what we did in 1991, and more importantly in 1999, when the system changed from prescribing what is permitted to listing out what is prohibited. We have the Competition Commission of India (CCI), which should be neutral to whether a competitor abusing the market is Indian-owned or foreign-owned. Assuming that control over FDI in the sector is necessitated because of pricing strategy is misplaced and will hurtle India back to the late 1980s era. An investment board, which has the ability to approve investments across ministries, is now being mooted. It is a good idea and should replace the FIPB, which was in any case meant to be a one-stop shop, but is failing in that duty.

The FIPB is the nodal authority for permitting FDI in all sectors where FDI is not allowed under the automatic route. The government has

recently taken two steps backwards by placing FDI in the pharma sector

under the FIPB route. While greenfield investments continue to be automatic, any

brownfield acquisitions require the prior nod of the FIPB. Is this not a hark back to the Licence Raj of yore? Should not forces of free competition and free spirit be allowed even in the pharma

sector? At a time when downstream FDI is freely permissible from a company owned

and controlled by Indians, what is the use of having a FIPB? The example of Sky of

UK breaching the sectoral cap in DTH operator, Tata Sky is a case in point. The DIPP’s concept paper suggests that sectoral caps have no relevance. Has not the time come to draw the curtains on FIPB?

Anup P ShahPartner, Pravin P Shah & Co, Chartered Accountants

The recent outcome

from a meeting mandates Foreign Investment Promotion

Board (FIPB) gateway and monitoring for FDI in pharma sector along with a 6

months maximum time limit for approval. FIPB was formed to provide a single window approval for FDI proposals in the country;

however, it seems not to offer any respite in terms of accelerating the clearance procedures. Should the

government dissolve the board?

Nikunj [email protected]


Incorporated in 1977, Glenmark Pharmaceuticals Ltd is one of the leading pharmaceutical companies in India today and among the top 100

pharmaceutical companies in the world in terms of revenue. The company is a leader in the discovery of new molecules and has six molecules in clinical development currently. The company has significant presence in key markets such as India, Brazil and Russia. Its subsidiary, Glenmark Generics Ltd (GGL), is among the top 25 generics organisations in the US with a growing presence in Western Europe. It is also a leading player in API in the regulated markets.

GGL was formed in 2004, as Glenmark Pharmaceuticals reorganised its business and separated its generics and API segment. The generics market is increasing tremendously and there are huge opportunities waiting for the companies to market their products both in the developed and developing nations.

Jalaj Sharma, President - Operations, Glenmark Generics, mentions “The generic markets of North America and Western Europe offer tremendous opportunities for high quality focussed companies such as Glenmark. As of now, collectively, Indian companies have just garnered a small portion of this huge market and hence the ability to grow consistently and continuously remains an opportunity.”

GGL is a 100 per cent owned subsidiary of Glenmark Pharmaceuticals Ltd and mainly serves the North American and the Western Europe, market. About 80 per cent of the production at this plant is marketed in the US, 15 per cent in Europe and the rest is marketed in Brazil, and South Africa.

Sharma adds, “While the US remains the largest market in North America and the world, the UK market is the largest in Western Europe. Glenmark views both the regions with equal interest.”

Overview of the plantThe Glenmark facility is spread across approximately 17 acre in which the solid dosage facility is across a handsome 20,000 sq m and the semi-solid facility is spread across approximately 2,000 sq m. The monthly capacities of the oral solids are about 400 million tablets and approx 50 million capsules. The semi-solid plant outputs more than 2.75 million tubes per month. It is one of

the largest US FDA-approved facilities in the country and is well planned. It is also approved by various regulatory bodies such as MHRA, UK; TPD (Canada), MCC (South Africa), WHO-GMP, ANVISA, Quintiles (a CRO; for EU-GMP), Ethiopia Health Authority, Brecon (a CRO) & Tunisia, UAE.

Both the oral solid dosages and semi-solid manufacturing plants have a similar design that enables an organised production pattern.

Glenmark has positioned itself as a leader in the semi-solids segment with close to 20 product approvals in the dermatology segment in the US. Most of the dermatology products are manufactured at the semi-solid plant in Goa.

Planning and precisionThe semi-solids manufacturing plant, the oral solid dosage plant, the quality analysis department, the hormone plant and a separate building for quality control and administration are spread over the entire site. Explaining the layout of the plant, Sharma says, “We have designed the layout to ensure minimum cross contamination during the transportation of materials. We also wanted the design such that there is minimum handling and transportation of raw materials, and the focus was primarily on keeping the processes automated and complying with the latest GMP norms.”

This precision is carried over from the manufacturing to the packaging process. It utilises the latest technology available for maintaining precision; monitoring is done using camera bar code at every level of the entire process to ensure that the right product and the right quantity is being packaged. The packaging is done based on the market requirement.

Sharma elaborates, “As we produce medicines intended for human consumption, precision is important and we achieve this by introducing several quality checks during the process. We use state-of-the-art equipment and focus on automating the process to avoid manual intervention at the end stages.”

The oral solid dosage plant is designed such that there are manufacturing units at both the sides with centrally located packaging systems.

Sharma explains, “We use automated packing lines with special cameras and modified design to have accuracy in the final packing. To ensure that the correct medicine is being packaged, and thus to guarantee patient safety, we use machines that

are specially designed for maximum accuracy.. To eliminate manual intervention as far as possible at the end stages of the packaging process, we are planning to install state-of-the-art machines.”

Evolving with passing timesSince being commissioned in 2004, the plant has evolved at different stages and with significant investment the plant has come a long way.

Sharma elaborates “We started off as a small solid-oral facility and now expanded to being one of the largest US FDA solid oral facilities in the country. The volume growth year on year has been approximately 18-20 per cent, which means the plant has nearly doubled capacity every four years. When we started, we manufactured around 80 million tablets per month and at present manufacture approximately 400 million per month. To ramp up the productions our manpower of 150 employees has now become approximately 700 employees in the semi-solid and oral-solid facilities.”

Environment, Health and SafetyAlthough ISO 14001 is not mandatory, the facility has voluntarily adopted ISO 14001 certification to ensure its commitment to the highest environment standards. Sharma elaborates, “Our efforts at the plant are always to exceed all applicable EHS standards and ensure that statutory EHS are complied at all times.”

In order to avoid any mishap and to be able to provide first hand care to its employees in case of an emergency they are coming up with a separate strategically located occupational healthcare centre within the facility. The centre is located such that it is accessible within minutes from the different buildings where the manufacturing processes take place.

There is a separate building that manages the power consumption of the entire facility to ensure that the energy is utilised efficiently.

While the facility follows the US FDA and cGMP practices, it also puts that extra effort to supply

the best to its customers and employees, along with ensuring good energy utilisation.

Facility Visit

As we produce medicines intended for human

consumption, precision is important and we achieve this by introducing several quality checks during the process. We use state-of-the-art equipment

and focus on automating the process to avoid manual

intervention at the end stages.

Jalaj Sharma President-Operations,

Glenmark Generics

Glenmark Generics Ltd – Oral and semi-solid manufacturing plant

Precision at every stepThe vision of Glenmark Generics Ltd, a subsidiary of Glenmark Pharmaceuticals Ltd, is to become one of the leading integrated global generics organisations. We visited their manufacturing facility at Colvale, Goa that focusses on oral solid manufacturing and semi-solid manufacturing.



Insight & Outlook: Automation Trends

ARC sensor technology

Biotechnology, being knowledge-intensive has tremendous economic potential, and has emerged as one of the rapidly growing economic sectors. Focussing on the practical use of biological systems to produce goods and services, biotechnology has made significant achievements in the growth of society. Varied applications in the fields of agriculture, healthcare, environment utilise latest technological advancement in measuring and maintaining biological processes.

Various biological processes do have a flip side too. These sophisticated processes are prone even to subtle variations in

external factors. A quick temperature or pressure variation, however small, could spoil the output. Similarly, unwanted changes in pH & DO values may harm the complete batch or product, resulting in a huge financial loss. That is why analytical measurement plays a crucial role in the manufacturing process of such hygienic products, and so the choice of a suitable and accurate measurement system is important.

Essential benefi tsTraditionally, sensor and transmitter combination type systems have been used for a long time for measurement of biological processes. However, these have their own limitation and are very susceptible to various error sources, namely,

Noise pickup Maintenance-free operations Transmission distance limitation Easy accessibility at uneven

installation Wireless communication in

hygienic areaAlmost 80 per cent of electronics

installation today suffers one of these issues, leading to erroneous data logging and analysis.

Hence, technologists have devised a measuring instrument with inbuilt electronics that can help not only eliminate the noise and errors but can also provide additional benefits and information from the sensor, in addition to the primary measurement.

The new ARC sensor technology revolutionises the integration of sensors by rethinking communication between sensors, end users and process control systems. The functionality of a

traditional transmitter has been replaced by a microprocessor within the sensor. ARC sensors eliminate the traditional transmitter and communicate directly with the control system. Sensors are available in all standard pH, dissolved oxygen and conductivity formats.

Established facilities ARC sensors can communicate without the use of a transmitter with 4-20 mA devices or digitally with a computer. In this area the advantage of the ARC system is in lab calibration with ARC View Handheld, retained records, and the proven quality and accuracy of the sensors. The 4-20 mA signal is more stable and reliable than the low currents or voltages in classical oxygen, conductivity or pH measurement.

New installationsIn digital mode, several ARC sensors can run and be maintained in parallel. Wired or wireless communication will make installation, handling and maintenance of the sensors and process control more reliable, simple and efficient. ARC View Handheld enables wireless, handheld, local monitoring of all sensors in process as well as in-lab calibration of sensors prior to installation into the process.

Feature to lookout before selecting an ARC solution

Digita l and/or analog communication by proven VP 8.0

connector head, complete with PG 13.5 process thread connection

Monitoring of all sensor functions, status of the sensor quality

On-line and off-line calibration, auto calibration function

Configurable using the RS 485 interface with PC, ARC View handheld or by using the ModBus RTU protocol from the process control system

Saves all relevant process information: Sensor identity and calibration data, operating hours, cleaning and sterilisation cycles, errors and warnings, etc.

This revolutionary technology has been adopted by many fermenter manufacturers and integrators across the globe. Due to its incredible features and ease of use, the technology is readily accepted by pharmaceutical and drug manufacturers too.

Intelligent ARC Sensor System

Advanced solution for the new installations that are running a digital network. The ARC sensor can be connected directly throught the Rs 485 MODBUS to the PLC/DCS.

Local reading can be enabled through a wireless connection to the ARC view handheld by additional wireless adaptor to the sensor.

Online sensor management solution for applications where the sensor is positioned far from the PLC/DCS.

Sensor can be connected directly via 4 to 20mA output from the sensor head.

Local reading can be enabled through a wireless connection to the ARC view handheld by additional wireless adaptor to the sensor.

For DO, pH and conductivity measurements

Premium quality sensor solution for application where the controller or PLC is in close proximity to the sensor and no local display is required.

Sesnsor can be directly connected via the 4 to 20mA out from the sensor head.

Amol MalodeProduct Manager, Forbes Marshall

[email protected]

Revolutionary analytics


Insight & Outlook: Energy Management

Pharmaceutical manufacturing and R&D require continuous monitoring and the processes need to be carried out

at specific conditions including temperature. In order to maintain these temperature requirements, the manufacturing facilities need to be equipped with specialised equipment such as refrigerators and heaters. To cut down the cost of energy needed to run these state-of-the-art machinery, companies are now hiring energy experts that guide and provide strategies to utilise energy with proper efficiency and reduce the high cost associated with its consumption.

Impactful workThe energy cost can affect the facility’s competitiveness and viability. There can be risks associated with long-term contracts between energy suppliers, and the volatility in the market can cause the company to take wrong decisions that might not benefit them in the wrong run. Energy brokers bring in the expertise that pharma companies can take advantage of in order to gain the best prices and advise them with best energy procurement strategies. Rajendra B Chunodkar, Executive Vice President, Technical, Lupin Ltd explains, “Energy consultants have the knowledge, experience of dealing with vendors and professional expertise to negotiate with suppliers, so that their clients can focus on their core business. Pharma companies are largely benefitted by energy brokers by way of reduced energy costs and resolution of complex issues associated with supplier over-payments, in turn resulting in saving time, money and hassle.”

Suggesting strategiesAlthough the concept in not prevalent in Indian industry, with initiatives such as LAZORR the pharma companies are coming together to discuss issues of energy and gradually realising its importance. In the international market there are companies offering continuous monitoring of the market and continually provide energy

management with its specialised tools and experience.

Chunodkar elaborates the concept, “As the pharmaceutical industry strives to reduce environmental footprints, the energy brokers bring in their expertise of understanding the energy supply, therefore reducing unnecessary risks and administrative burdens for companies.”

LAZORR initiativeMost pharma companies are committed to protect the environment and make substantial efforts through conservations and efficiency projects to reduce carbon footprint. The companies are taking initiatives to educate and encourage their employees to use energy more efficiently. India’s six leading

pharma companies have formed an alliance ‘LAZORR’ to address the issue of energy management along with discussing other general problems faced by pharma industry. Chunodkar elaborates, “Lupin has been a part of the initiative known as LAZORR where six leading pharmaceutical companies including Lupin Pharmaceuticals, Aurobindo Pharma, Zydus Cadila, Orchid Chemicals and Pharmaceuticals, Ranbaxy Laboratories and Dr. Reddy’s Laboratories joined hands to share their best practices, in a bid to improve efficiency and bring down rising operating costs. In the quest for economy and efficiency, the companies are also looking beyond the pharmaceutical industry.”

Managing carbon emissionWith the rise in the environmental impact the pharma companies want to ensure their minimum contribution. The regulations also recommend an overall environmental compliant manufacturing facility and ensuring minimum carbon footprint adds to their kitty. Chunodkar states, “The pharma industry has a relatively lower number of large energy consumers, and therefore, a strategic approach towards energy supply management can be beneficial from a financial standpoint as well as a reduced carbon footprint. Multiple requirements for natural gas and electricity should be aggregated in a manner that gives each location a reduced price and better contract terms.”

Energy brokers

While pharma companies are engaged in delivering best quality drug, their energy consumption and carbon footprint are measured by energy brokers. These brokers bring in expertise to guide companies towards best energy procurement strategies that will enable them to invest at the right place at the right time.

The guiding ‘energy’ in companies

Energy consultants have the knowledge,

experience of dealing with vendors and professional

expertise to negotiate with suppliers, so that their

clients can focus on their core business.

Rajendra B ChunodkarExecutive Vice President,

Technical, Lupin Ltd



Insight & Outlook: Drug delivery devices

A precise definition of drug delivery devices is almost impossible to find. In general, they

support the transportation of active ingredients to the part of the body where they are needed and therefore can be considered as an application facility. Whether they are defined as pharmaceuticals or medical products depends on their purpose. For example, a powder inhaler qualifies as a pharmaceutical, while a catheter dissected with heparin qualifies as a medical product.

Pen systems: Close to perfectionDue to a significant refinement of most drug delivery devices in recent years, for some appliances, currently only little potential for improvement is left. The introduction of pen systems in 1985 considerably enhanced patients’ quality of life. Pens are loaded using cartridges and usually serve as multiple application systems. Several functionalities such as level indication and haptic of pen systems have already been optimised. Moreover, today’s pen systems feature electronic components such as memory control, which is mainly an application for children. In future, further refinement will focus on easier and safer handling, such as, improved needle protection to help avoid injuries and unintended application.

The optimisation of other parenteral systems also focusses on the patients’ compliance, ref lecting the awareness of fears such as needle phobia. Auto-injectors are usually loaded using pre-filled syringes and feature a needle cover keeping the needle hidden as long as possible. This often helps users

to overcome fears associated with self-injection. Diseases such as multiple sclerosis, osteoporosis , hepat it is , rheumatism and anaemia are typical fields for the application of auto-injectors. Treatment of these requires a singular dose or regular administration during longer intervals and is profitable from the industry’s point of view. Therefore, intensive development of auto-injectors is not only justified to improve patients’ quality of life but also from an economical perspective.

Further advancements mainly refer to production conditions. With optimised materials and designs, production costs wi l l decrease. As a result, devices are no longer too expensive to be applied as reusable items. Some experts believe ne e d le -f re e i nje c t ion technology will soon prove

to be successful. One of the reasons is the vaccine campaign launched by the World Health Organization (WHO). However, the pharmaceut ica l market remains cautious about these systems because they are believed to cause similar levels of pain as a puncture does.

Transdermal devices: More convenienceT r a n s d e r m a l d e l i v e r y devices are patch systems containing active agents, for ins tance wi th in matrices, which are diffused through the skin. Recent developments have led to optimised patch sizes and adherence features of the patches for better skin tolerance. A general trend in the western world goes towards the usage of and affinity for electronic devices, also influencing pharmaceutical applications. Exciting new developments comprise a combination of patch and pump, so-called ‘patch pumps.’ This can be illustrated with the example of the Pancreum BetaWedge insulin pump. The small device with a Bluetooth-enabled Personal Diabetes Analyzer (PDA) adheres to the skin and delivers insulin for as long as 3 days.

Electronic devices, such as

technologically suitable MP3 players and memory cards, enable easy and convenient measurement of the blood sugar level. With MyDose, Roche is currently developing a single-use infusion device for the subcutaneous delivery of a new drug formulation conta ining monoclona l antibodies such as Herceptin and MabThera . The subcutaneous delivery is based on the patients’ individual bodyweight or surface. It is easier to administer, and application times are significantly reduced. The main functional component of the device is the ‘Vartridge,’ a hybrid container which combines the features of glass vials and cartridges and is controlled via the electronics in the pump. As opposed to intravenous applications, patients no longer need to be treated in hospitals and are more independent in their everyday routine.

Pulmonary systems: Focus on asthma & COPDInhalable insulin seemed to hold a lot of promise. But the large size of the inhaler, increased treatment costs and the requirement for much higher insulin doses led to its withdrawal. The market for pulmonary systems has noticeably slowed down in developed countries, while it is still growing in the emerging markets. Yet pharmaceutical engineers continue with the advancement of these systems mainly with respect to asthma and Chronic Obstructive Pulmonary Disease (COPD). There are three different types of pulmonary systems. Metered Dose Inhaler (MDI) is the most common technology in the market at low cost level, especially for emergency products. The aerosol-based inhaler delivers the required amount of gaseous medicine to the lungs.

New products however are rarely developed in the form of MDIs for environmental and compliance reasons, such as patients’ co-ordination problems between breathing and actuation. The technology of the future – if no oral medication is available – is the Dry Powder Inhaler (DPI) with its simple application and small size. Medication is delivered to the lungs in form of dry powder which patients inhale without any solvent. The third pulmonary system is the nebuliser, which administers the inhalation liquid in the form of fine drops. Patients inhale the medication as a mist generated by different technologies such as ultrasound, piezo crystals or vibrating mesh.

Key to success of a new drugMany established medical devices, and especially applications for children, have been significantly optimised over the past years. From a current perspective, some of them are approaching their improvement limits, while others still have much potential for further refinement. In general, the equipment tends to be smaller, and handling is safer, easier and more convenient. At the same time, costs are decreasing for those devices that hardly require any further improvement.

ConclusionIn many fields, the market will not work without drug delivery devices. The compatibility of a device such as a pen, an auto-injector or a pump with a new drug is an important precondition for its success, especially in developed countries. The so-called ‘pharmerging markets’ currently require more basic and affordable technologies. Once the average unit cost decreases, the optimised drug delivery devices will also be successfully placed in these markets in large numbers. In the future, the trend towards more convenience with a clear focus on patients’ compliance is expected to continue at a smart pace.

‘Catching’ young doctors

Drug delivery devices currently range among the major pharmaceutical trends. Their optimisation is largely influenced by the pharmaceutical industry, physicians and patients. Present developments of new devices are increasingly focussed on patients’ needs. They give top priority to simplified handling, reduced pain, continuous documentation and facilitated adherence to medication intervals.

Simplifying the lives of patients

Dr Jérôme FreissmuthDirector - Business Development, Product Management and Marketing - Packaging Technology division, Business Unit Pharma

[email protected]

The YpsoMate autoinjector is an automated disposable injection device for pre-filled syringes. The device is triggered by push-on-skin activation which is convenient, ergonomic and preferred by patients.

The reusable Ypsomed ServoPen with intuitive handling is a pen system for insulin injection enabling easy everyday usage.

Pens are loaded using cartridges and usually serve for multiple application systems.

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The compatibility of a device such as a pen, an auto-injector or a pump with a new drug is an

important precondition for its success,

especially in developed countries.


Insight & Outlook: Strategy

T he earl iest pi l l emerged in ancient Egypt as a little round ball containing

medicinal ingredients mixed with clay or bread. For the next five thousand years - up until the middle of the 20th century - pills were round and white. Colour was almost n o n - e x i s t e n t . O T C medications were only available as tablets in ghostly white or pasty pastel hues; likewise prescription medications were colourless pills encased in clear or transparent orange vials. Liquids, with the exception of Pepto-Bismol’s pink, were drab as well. It is a different world today, thanks to advances in technology. The colour transformation started in the 60s’ and accelerated in 1975 when the new technology of ‘soft gel’ capsules made colourful medications possible for the first time. Shiny primary colours such as cherry red, lime green and tangy yellow arrived first. Today’s gel caps can be tinted to any of 80,000 colour combinations. As for tablets, continuous advancements in technology consistently bring new and colorful coating products to market. On the other hand, does colour really matter? Aside from the obvious fact that pills are more attractive to the eye, colour has indeed benefitted consumers as well as the pharmaceutical companies in several functional ways.

No ‘needle in hay’ situationColour helps the consumer distinguish the non-prescription or prescription medications from other tablets or capsules. This is especially relevant for the elderly who get confused when they take various medications, most of which are small white tablets. Researchers have also found that patients who took more drugs on a daily basis preferred bright pill colours. Consequently, colour and colour combinations are a powerful way to create emotional appeal and reduce medical errors. Consider another fact: Patients respond best when colour corresponds with the intended results of the medication. For example, calm blue for a good night’s sleep and dynamic red for speedy relief. A similar benefit is rooted in the synesthetic effects of colour - and specifically a colour’s

associations with smell and taste. Even early civilisations such as the Romans recognised that people ‘eat with their eyes’ as well as their palates. As proof, butter has been coloured yellow as far back as the 1300s.

Although technically we do not ‘eat’ pills, we do taste and swallow them. What would a grey pill taste and smell like? Smoky, fruity or moldy! How about a pink pill? Sour, bitter or sweet? Which one would be easier to swallow? Furthermore, synthetic effects of colours also include associations with temperature. For example, a blue pill is cool; an orange pill, hot.

Colour for healthcare and pharmacy productsCompetition in the pharmaceutical industry is robust. The shift in priorities toward marketing means that color is now a critical component of brand development and product identity. This requires that the colours be researched and tested, a little like the drugs

themselves. Nothing can be left to chance.

Aside from countless functional benefits for the consumer, colour is now playing an even more powerful

role in transforming the plain white pill into a unique, brand image. This has become even more significant due to recent events that have transformed marketing – and the role of colour - in the pharmaceutical industry. First, many medications – previously available only with a prescription - are now available as OTC products, without a prescription in the India. This means that customers are shopping for

medications and making decisions in stores. In fact, recent research by the Henley Centre reports that 73 per cent of purchasing decisions are now made in-store. Therefore, it is even more important for pharmaceutical products to catch shopper’s eye and to convey information effectively. As competition heats up, colour and design are critical to the brand. Consider the packaging and advertising for the new OTC, Celebrex: tranquil blue skies and the greener pastures of relief from suffering. Second, five years ago, the US FDA relaxed its restrictions on direct-to-consumer marketing of pharmaceuticals. As a result, broadcast and print advertising exploded. Just turn on your television and note which drugs are being marketed aggressively. ‘Ask your doctor about the purple pill…’ And it is not limited to television. Print advertisements are predominantly purple and the product’s web site is hosted. Consequently, drug companies are leaving nothing

to chance. The colour and shape of the pills, and the names and imagery used to sell products are heavily researched and tested, much like the drugs themselves. Colour has been elevated to a ‘powerhouse’ status because it is the most fundamental part of a drug’s personality. As is the case with all products – from computers to colas - purchasing decisions are not just based on what a product looks like (visual brand) but on the idea of the brand (its core brand value), how customers feel about it (emotional brand). In other words, colour has the unique ability to do all three simultaneously – to create emotional appeal, to communicate functional values and benefits (such as reliable pain relief), and to distinguish the brand from others.

Using logos for the right reasonsExtensive market research concluded that consumers did not ‘resonate with the imagery.’ They found that the colors like blue colour was too cool and was equated with being fresh and fine.

Along with colour what is becoming essential is the importance of logo in this industry. The style and the type of logo that is the face of the brand is catching attention to a major extend.

In conclusion, colour does indeed matter - 80 per cent of visual information is related to colour - and this is especially true for pharmaceutica l products. Colour is functional. Colour subliminally and overt ly communicates information and provides many other operational benef its. On the other hand, colour may not matter in the future of prescript ion medicat ions tablet s a nd capsu les . Scientists have created a coin-sized microchip drug dispenser that may be implanted under the skin. It would be programmed to release medications in concentrated formulas -- all on different schedules. Sensors may even be attached to the chip to detect the level of a drug in your body and then add more as needed.

‘Catching’ young doctors The colour of medications

According to recent research the colour, shape, taste and even name of a tablet or pill can have an effect on how patients feel about their medication. Recently, the researchers at the University of Bombay, New Mumbai, India, have surveyed users of Over-The-Counter (OTC) medication to find out just how much the colour of a tablet influences patient choice.

When shades matter...

Barkha DattaniManaging Director, Barkha’s Brand Clinic

[email protected]

Colour has been elevated to a

‘powerhouse’ status because it is the most fundamental part of a

drug’s personality.


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 applicationMedical and pharmaceutical industryForms of transferTechnology 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 applicationFormulation 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 applicationPharmaceutical 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 applicationIndustrial effluents, accumulatesForms of transferTechnology licensing

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 applicationFilter 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 applicationPharma and medical industryTransfer termsJoint 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 applicationHerbal medicineForms of transfer Joint venture, technical services,technology licensing

Natural preparation for anxiety reliefA 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 applicationPharmaceutical industryForms of transfer Equipment supply

Process of preparation of nanoparticles for drug delivery system The 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 applicationMedical and pharma industryForms of transferTechnology licensing

Pharmaceutical composition for the treatment 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.

Areas of applicationPharma and medical industryTransfer termsConsultancy, technical services,technology licensing

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 applicationBiotechnology, engineering Forms of transfer Consultancy

Calcium GluconateA company needs technology for manufacturing of Calcium Gluconate

Areas of applicationPharmaceutical industryForms of transferTechnical 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 applicationPharmaceutical industryForms of transferOthers

IV fluid manufacturing as SME An Indian company needs new and good technology to start which is a subservient of genetic manufacturing of IV fluids.

Areas of applicationMedical 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 applicationMedical researchTransfer termsOthers

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 transferOthers

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 applicationHuman vaccinesTransfer termsOthers

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 and a procedure of buying the technology along with the cost incurred.

Areas of applicationBiotechnologyTransfer termsOthers

Manufacturing technologies for montelucast, rosuvastatin, ursodeoxy cholic acid, D-biotinA company needs API/bulk drug manufacturing technologies for montelucast, rosuvastatin, ursodeoxy cholic acid and D-biotin

Areas of applicationAPI/bulk drugForms of transferOthers

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

Areas of applicationPharmaceuticalsForms 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 applicationPharma and food processingindustryForms of transferOthers

Technology Offered Technology Requested

Information courtesy: Dr Krishnan S Raghavan, In-Charge, Technology Transfer Services Group, Asian and Pacifi c Centre for Transfer of Technology (APCTT) of United Nations Economic and Social Commission for Asia and the Pacifi c (UNESCAP), APCTT Building, C-2, Qutab Institutional Area, New Delhi – 110 016, India.Tel: +91-11-3097 3758 (Direct), +91-11-3097 3710 (Board), Fax: +91-11-2685 6274 E-mail: [email protected], Web: 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.

Share and Solicit TechnologyThe mission of Modern Pharma 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 Pharma, Network18 Media & Investments 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]


ProjectsM o d e r n P h a r m a • 1 - 15 N o v e m b e r 2 01 2

Bulk drug and intermediate manufacturing plantProject type: New facilityProject news:Metrochem API Pvt Ltd have proposed bulk drug and intermediate manufacturing plant at District Medak, Andhra Pradesh. Project location:Medak, Andhra Pradesh Project cost: ` 480 million Implementation stage:Ongoing

Contact details:Metrochem Api Pvt LtdSunder Nagar, Erragada, Hyderabad-500038Andhra PradeshTel: +91-40-23813969/23812317Fax: +91-40-2370-5088 E-mail: [email protected]

Bulk drugs manufacturing unit & cogeneration power plant Project type:New facilityProject news: The project involves setting up of bulk drugs manufacturing unit & cogeneration power plant (8.25 MW). The plot area is 113.18 acre.

Project location:Mohali, Punjab Project cost:` 6000 million Implementation stage:Ongoing

Contact details:Nectar Lifescience LtdChandigarh-160017PunjabTel: 01172-3047777 E-mail: [email protected]

Manufacturing Of ayurvedic preparation vaporob Project type: New facilityProject news:Procter & Gamble Hygiene And Health Care Ltd is planning to set up a new pharmaceuticals project at Solan in Himachal Pradesh. The project involves manufacturing of ayurvedic preparation vaporob.

Project location:Solan, Himachal PradeshProject cost: NAImplementation stage:Planning

Contact details:Procter & Gamble Hygiene And Health Care LtdIndia P&G Plaza, Chakala, Andheri (E), Mumbai - 400099 MaharashtraTel : +91-22-2826 6000

Manufacturing of danazol Project type:New facilityProject news:Celon Laboratories Ltd is planning to set up a new pharmaceuticals project at Rangareddy in Andhra Pradesh. Project location:Rangareddy, Andhra Pradesh

Project cost:NAImplementation stage:Planning

Contact details:Celon Laboratories LtdPlot No 264,Patrika Nagar, Hyderabad-500 081Andhra Pradesh Tel : +91 40 4030 3838E-mail : [email protected]

Manufacturing of losartan potassium Project type: New facilityProject news:Aptuit Laurus Pvt Ltd is planning to set up a new pharmaceuticals project at Visakhapatnam in Andhra Pradesh. The project involves manufacturing of losartan potassium.

Project location:Visakhapatnam, Andhra PradeshProject cost: NAImplementation stage: Planning

Contact details:Aptuit Laurus Pvt Ltd

Jawaharlal Nehru, Pharmacity, Visakhapatnam – 531021, Andhra Pradesh Tel: +91-0891-3061222Fax: +91-0891-3061271E-mail: [email protected]

Manufacturing of paracetamolProject type: New facilityProject news:Sri Krishna PharmaceuticaLs Ltd is planning to set up a new pharmaceuticals project at Rangareddy in Andhra Pradesh. The project involves manufacturing of paracetamol.

Project location:Rangareddy, Andhra PradeshProject cost: NAImplementation stage: Planning

Contact details:Sri Krishna Pharmaceuticals LtdC-4, Industrial Area, Uppal Hyderabad - 500 039Andhra Pradesh Tel: +91-40-27201101E-mail : [email protected]

ProjectsNew 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.

Information courtesy: www.tendersinfo.com1, Arch Gold, Next to MTNL Exchange,

Poisar, S V Road, Kandivali (W), Mumbai - 400 067, Maharashtra, India • Tel: 022

28666134 • Fax: 022 28013817 • Email: [email protected]


Tenders

Latest Popular Tenders Brought to you by www.tendersinfo.com

Org: Organisation’s name; TRN: Tendersinfo Ref No; Desc: Description; DSLD: Doc Sale Last Date; BOD: Bid Opening Date; Loc: Location; BT: Bidding Type

Drugs/MedicineOrg : Ministry Of Defence (MOD) TRN : 12775921Desc : Supply of doxycycline cap 100 mgBOD : November 20, 2012Loc : Delhi BT : Domestic (NCB)

Drugs/MedicineOrg : Ministry Of Defence (MOD)TRN : 12775909Desc : Supply of cefuroxime susp 125 mg/5 ml bott of 30 mlBOD : November 20, 2012Loc : DelhiBT : Domestic (NCB)

Drugs/MedicinesOrg : Ministry Of Defence (MOD) TRN : 12775793Desc : Supply of ceftazidime 1 gm injBOD : November 20, 2012Loc : DelhiBT : Domestic (NCB)

Drugs/MedicineOrg : Ministry Of Defence (MOD)TRN : 12775781Desc : Supply of cefuroxime 250 mg tabBOD : November 20, 2012Loc : DelhiBT : Domestic (NCB)

Drugs/MedicineOrg : Ministry Of Defence (MOD)TRN : 12775780Desc : Supply of amoxycillin 250 mg capBOD : November 20, 2012Loc : Delhi BT : Domestic (NCB)

Drugs/MedicineOrg : Ministry Of Defence (MOD)TRN : 12772647Desc : Supply of glucosamine 500 mg tabBOD : November 20, 2012Loc : DelhiBT : Domestic (NCB)

Drugs/MedicinesOrg : Indian Army TRN : 12762032Desc : Supply of alendronate sodium 70 mg tabBOD : November 20, 2012Loc : DelhiBT : Domestic (NCB)

Drugs/MedicineOrg : Indian Army TRN : 12762027Desc : Supply of doxycycline cap 100 mgBOD : November 20, 2012Loc : Delhi

BT : Domestic (NCB)

Drugs/Medicine Org : Indian ArmyTRN : 12762024Desc : Supply of cefuroxime susp 125 mg/5 ml bott of 30 mlBOD : November 20, 2012Loc : Delhi BT : Domestic (NCB)

Drugs/MedicineOrg : Indian Army TRN : 12762018Desc : Supply of hydrocortisone sodium succininate 100 mg injBOD : November 20, 2012Loc : DelhiBT : Domestic (NCB)

Drugs/MedicineOrg : Indian Army TRN : 12762017Desc : Supply of ascorbic acid 100 mg tabBOD : November 20, 2012Loc : DelhiBT : Domestic (NCB)

Drugs/MedicineOrg : Indian Army TRN : 12762015Desc : Supply of levofloxacin 500 mg tabBOD : November 20, 2012Loc : DelhiBT : Domestic (NCB)

Information courtesy: www.tendersinfo.com1, Arch Gold, Next to MTNL Exchange, Poisar, S.V. Road, Kandivali (W), Mumbai - 400067 Maharashtra, India

Tel: +91 22 28666134 • Fax: +91-22-28013817 • Email: [email protected]


Event List

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 Pharma.

N A T I O N A L E V E N T SAutomation 2012This is a prolific trade show that strives to present a wide range of scientific, laboratory, biotechnology equipment. The visitors will be highly benefittedfrom the event as there will be a conference too at the event. The event will also provide excellent networking opportunities. The event will be focussing on clinical research and will be attended by industry leaders; November 2-4, 2012, Hyderabad International Trade Exposition Centre, Hyderabad

For details contact:S D (India) CorporationTel: + 91 11 4703 4600Fax : +91 11 4705 6500Email: [email protected]: www.indialabexpo.com

P-MEC IndiaP-MEC India, the most well attended and talked about Pharmaceutical Machinery, Equipment and Technology event. In this event the leading Indian and international pharmaceutical machinery exhibitors showcase their latest technologies and announce product launches. P-MEC focuses on key challenges in pharmaceutical services to develop more efficient production routes and systems of increasingly complex healthcare products. Technology demonstrations and onsite seminars will complement your visit to the show floor; November 21 - 23, 2012, Bombay Exhibition Centre

For details contact:Chaitali DavangeriUBM India Pvt LtdTel: +91-22-6612 2642Email: [email protected]: http://www.pmec-india.com/

Pharma Biotech Expo & ConferencesPharma Biotech Expo & Conferneces is an exciting new networking platform & international exhibition for pharmaceutical machinery & equipment, biotechnology & applications industry. The event will be a preferred destination for the pharma and biotech and it will attract more than 10,000 visitors & exhibitors with 100 stalls; November 21-23, 2012, Hotel Le Mariet, Baddi

For details contact: Paramount ExhibitorsTel: + 91 172 2274801Fax: + 91 172 2274803Email: [email protected]: www.paramountexhibitors.com

Bangalore NanoBangalore Nano event has truly emerged as the premier event for research fraternity and industry to come together and explore emerging opportunities in this sector. The event comprising of exhibition & conference will encompass two full days of presentations and discussions and interactive networking activities; a meeting place for the global scientists, industry, academia & government with a focus on ‘Frontiers of Nanotechnology: Impact on India’; December 5-7, 2012, Hotel Lalit Ashok, Bengaluru

For details contact: MM Active BengaluruTel: +91 80 41131912Fax: +91-80-41131914Email: [email protected] Website: www.mmactive.in

Pharma Technology Show – DelhiThe event aims at bringing together world renowned companies as well as newly launched companies on one platform. It is an invitation to all those who want to seize this opportunity and to further galvanizing their position to take share of this lucrative market. The expected visitors will be the CEOs & top executives from pharma manufacturing industry, executives from production, quality control, R&D & purchase departments, professionals from R&D institutions, pharmacists from trade & profession, biotechnology specialists, top officials from regulatory agencies; December 7-10, 2012, India Expo Centre and Mart, Greater Noida

For details contact: Print Packaging.com Pvt LtdTel: +91 22 27812619

Fax: +91-11 41722130Email: [email protected]: www.print-packaging.com

Pharma World ExpoPharma Bio World Expo is one of the foremost shows for pharma and biotech industry in India. The show aims to be one of the largest exhibition and conference for chemical and pharma industry. There will be visitors and exhibitors from pharma processing, plants & equipments, pharma packaging machinery & materials, API, bulk drugs, additives, intermediates, analytical laboratory supplies (instruments, glassware, laboratory reagents / chemicals), environment control equipment & services, etc). This event aims to be a perfect meet for the entire industry; January 15-18, 2013, Bombay Exhibition Centre, Mumbai

For details contact:Chemtech FoundationTel: +91 22 22874758Fax: +91 22 22870502Email: [email protected]: www.chemtech-online.com

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.

INDOREMadhya Pradesh, Jan 11-14, 2013

PUNEMaharashtra,

Nov 2-5, 2012

AURANGABADMaharashtra, Feb 1-4, 2013

CHENNAITamil Nadu,

Nov 22-25, 2012

RUDRAPURUttarakhand,

Feb 23-26, 2013

LUDHIANAPunjab,

Dec 21-24, 2012

HYDERABADAndhra Pradesh,

May 31- June 3, 2013

For detailsNetwork18 Media & Investments 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]

I N T E R N A T I O N A L E V E N T SInternational Conference of National Strategies for TorchInternational Conference of National Strategies for Torch, Chlamydia trachomatis and human papilloma virus will address the latest clinical diagnostic, economic and scientific achievements in the practical and scientific medicine to meet the needs and interests of immunologists, allergists, laboratory specialists, gynaecologists, dermatovenereologists, infectology, microbiologists, health professionals. In addition, there will also be a large industrial exhibition in the new and interesting way; November 15-16, 2012, Kiev, UK

For details contact:NBScience LtdTel.: +38 044 233 27 70Email: [email protected] : www.nbscience.com

ICAR2012 The second International Conference on Antimicrobial Research (ICAR2012) will be a forum for the presentation, exchange and dissemination of information and experiences on anti-microbe strategies, in biotic or abiotic environments, in planktonic or adhered states, in biologically specific or unespecific ways, in vitro or in vivo, in a general context marked by the threat posed by the increasing antimicrobial resistance of pathogenic microorganisms; November 21-23, 2012, University of Lisbon, Portugal

For details contact:Formatex Research CentreTel: +34 924 258 615 Fax: +34 924 263 053 Email: [email protected]: www.formatex.org

ICBMS’12International Conference on Biological and Medical Sciences (ICBMS’12) aims at presenting the current research being carried out in that area. This conference is covered under International Multi-Conference on Chemical, Ecological and Biological Sciences (IMCEBS’12). The idea of the conference is for the scientists, scholars, engineers and students from the universities all around the world and the industry to present ongoing research activities, and hence to foster research relations between the universities and the industry. This conference provides opportunities for the delegates to exchange new ideas and application experiences face to face, to establish business or research relations and to find global partners for future collaboration; December 29-30, 2012, Grand Seasons Hotel, Kuala Lumpur, Malaysia For details contact:International Scientific Academy of Engineering & TechnologyEmail: at [email protected] Website: www.isaet.org

BIOSIGNALS 2013The purpose of the international conference on Bio-inspired Systems and Signal Processing is to bring together researchers and practitioners from multiple areas of knowledge, including biology, medicine, engineering and other physical sciences, interested in studying and using models and techniques inspired from or applied to biological systems. A diversity of signal types can be found in this area, including image, audio and other biological sources of information. The analysis and use of these signals is a multidisciplinary area including signal processing, pattern recognition and computational intelligence techniques, among others. With this vision in place the event aims to reach out to the industry professionals; February 11-14, 2013, Barcelo Sants Hotel, Barcelona, Spain

For details contact:Biosignals SecretariatTel.: +351 265 100 033Fax: +44 203 014 5436Email: [email protected]: www.biosignals.biostec.org

Bioinformatics 2013The purpose of the international conference on bioinformatics models, methods and algorithms is to bring together researchers and practitioners interested in the application of computational systems and information technologies to the field of molecular

biology, including for example the use of statistics and algorithms to understanding biological processes and systems, with a focus on new developments in genome bioinformatics and computational biology; February 13, 2013, Barcelona, Spain

For details contact:Bioinformatics SecretariatTel.: +351 265 100 033Fax: +44 203 014 5436Email: [email protected] :www.bioinformatics.biostec.org

International Conference on Life Science & Biological EngineeringThe aim objective of LS&BE 2013 is to provide a platform for researchers, engineers, academicians as well as industrial professionals from all over the world to present their research results and development activities in networking and digital society. This conference provides opportunities for the delegates to exchange new ideas and application experiences face to face, to establish business or research relations and to find global partners for future collaboration; March 15-17, 2013, Tokyo, Japan

For details contact:Kwansei Gakuin UniversityTel: 81 798 54 7394Fax: 81798 54 6082Email: [email protected] : www.lsbe.org


Reviewer: Dr Mandar Kubal, Director, Infectious Diseases & Pulmonary Care Pvt Ltd

The book is a good teaser into the world of naturally derived pharmaceutical products and drug development. Experts from around the world examine a multitude of topics, including evaluation of extracts from tropical plants for potential anticancer activity and cancer chemopreventive activity; use of Chinese lacquer tree sap products as pharmaceutical intermediates; and new approaches to drug discovery from the rainforest. Every chapter is brief and gives a gentle insight into the topic in consideration. The initial chapters detail the variety of plant and animal sources of pharmaceutical products available and under research.

The chapter on study into biodiversity and drug discovery potential is an interesting read for researchers and study planners. The latter half of the book devotes chapters to individual agents such as quinones, artemisinin, ginseng, lobeline, marine natural products and others. The book concludes with an optimistic view regarding the commercialisation of natural products. The book is a good motivator for generating interest in natural sources of drugs, but is definitely not an option as a textbook into the subject. The book lacks illustrations of natural sources, which would have increased its appeal to novice readers.

Multiparticulate Oral Drug Delivery

Biologically Active Natural Products: Pharmaceuticals

Editor: Issac Ghebre – Sellassie

Price: ` 4,495/-

Publisher: Informa HealthcareDistributor: Wisdom Book Distributors, Hornby Building, 1st Floor, 174, D N Road, Mumbai 400 001, Tel: 022 2207 4484/6631 8958, Telefax: 022-2203 4058 Email: [email protected]

Editors: Stephen J Cutler, Horace G Cutler

Price: ` 2,995/-

Publisher: CRC PressDistributor: Wisdom Book Distributors, Hornby Building, 1st Floor, 174, D N Road, Mumbai 400 001, Tel: 022 2207 4484/6631 8958, Telefax: 022-2203 4058 Email: [email protected]

There has been a great deal of information available regarding multiparticulate dosage forms since the 1950s. The editor has put together a compilation of chapters from various renowned authorities encompassing all the facets of multiparticulate drug systems.

The initial chapters detail the common as well as alternative techniques for creating micro pellets such as balling, spray congealing and cryopelletisation. The next chapters explain the various coating techniques that can be utilised to coat these pellets. Chapters on oral and liquid dosage forms discuss techniques and innovative variations in the formulation technique. The editor devotes a significant volume of data on modified release pellets and controlled release coated pellets. The concluding chapters explain the biopharmaceutical aspects of multiparticlutaes, their in vivo behaviour, and issues with their packaging. The chapters are highlighted with process diagrams and flow charts. Though numerous micrographs of pellets are provided by the editors, the book would have done better with illustrations of the equipment used in pelletisation techniques. Overall a great companion book to anyone and everyone in the formulation and research industry interested in multiparticluate or micro pellet drug delivery systems.

Book Review


Products

Shaking incubator

The compact benchtop shaking incubator has a unique retractable platform providing easy access to samples, a digital display showing 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 dramatically reducing sample evaporation. It incorporates a versatile clamping system for securing fl asks of most size, while angle-adjustable stainless steel accessory tube racks with magnetic locking system providing quick coupling and de-coupling.

Bibby Scientifi c LtdStaffordshire - UKTel: +44-1785-812121Email: info@bibby-scientifi c.comWebsite: www.bibby-scientifi c.com

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

coating or stainless steel. The unit has f u l l - l e n g t h inner glass door and outside metal door with m a g n e t i c gasket and lock. It is provided with p e r f o r a t e d s t a i n l e s s steel tray

and has forced air circulation for uniform temperature. The intelligent controlling system has PLC base and PC communication. It has long lasting stainless steel tubular heaters with SS fins.

Newtronic Equipment Company Pvt LtdMumbai - MaharashtraTel: 022-28679326, Mob: 09821089932Email: [email protected]: www.newtronic.in

Steam boilerFully automatic package steam boiler (IBR) has capacity ranging from 100 kg/hr to 2000 kg/hr with operating pressure of

10 kg cm². Smoke tube and water tube version is also available. Coil is made from seamless tube of asthma 106 GR-B pipes. The unit is equipped with high effi ciency oil/gas burner with air pre-heater arrangement which gives high thermal effi ciency.

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

Multi-purpose trolleyMulti-purpose trolley is used for ICU/hospital/surgery. It comes with multi-purpose aluminum extruded legs, heavy-

duty designed castor wheels, MDF monitor top with anti-skid rubber mat, lockable MDF, scratch-proof painted drawer box. Different box or tray are

Fluid bed dryerFluid bed dryer is used for drying of wet material. It is equipped with air handling unit. The 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. This dryer is compliant with cGMP under WHO and USFDA. Also offered 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: 09427031284Email: [email protected]: www.ratnakarpharmamachinery.com

Pharmaceutical medicinesA wide assortment of pharmaceutical medicines that are known for their effective results. They are made in proper hygienic conditions. These medicines are categorised into topical, oro-dental, gynaec and haemostats, intravenous fl uids, anti-allergic, cold and cough medicines, antibiotics and quinolones and cephalosporins, antacids, anti-ulcerants and laxatives and appetite stimulants enzymes.

Schwitz BiotechAhmedabad – GujaratTel: 079-27493057, Mob: 09825374233Email: [email protected]: www.schwitzbiotech.com

Walk-in humidity chamberThe 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 finished with powder

adjusted according to needs due to specially designed profi le of tapped strip. Because of aluminium metallic structure, earthing is affi rmative and provides safe working for electrical and electronic appliances.

Envair Electrodyne LtdPune - MaharashtraTel: 020-30688117Email: [email protected]: www.envairelectrodyne.com


Products

De-humidifierD e h u m i d i f i e r is incorporated with hermetically sealed rotary c o m p r e s s o r protected against o v e r l o a d i n g and vibration-i n s u l a t e d bearings. It has an axial fan with

plastic fan wheel and winding protection. Condenser and evaporator are made from copper piping covered with aluminium fins. Cooling circuit is made from copper piping with capillary tube and filter dryer. There is a service connector on the suction side. Automatic defrosting is controlled by Dry-Logic. The casing is aluminium, powder-coated and offers protection class IP X4.

Origin DehumidifiersMumbai-MaharashtraTel.: 022 – 22044156, Fax: 022 – 22875114Email: [email protected]: www.origincorp.com

Moisture analyser balance

Moisture analyser comes with halogen heating which removes moisture from entire area of the sample. It has user friendly visualization display for process of drying and selection from four profiles for drying. It gives detailed print out of the analysis in compliance with GLP/GMP standards. It has a built-in RS 232C interface for PC or printer and large LCD display with AEP (Advanced Eye Protection).

Citizen Scale (I) Pvt. Ltd.Mumbai-MaharashtraTel: 022-4243 770; Fax: 022-4243 7800Email: [email protected]: www.citizenscales.com

TrayCellThe TrayCell is a fibre-optic u l t r a - m i c ro cell designed for the UV/Vis micro volume a n a l y s i s of DNA/

RNA and proteins. It is designed for measurements of DNA/RNA or protein samples and enables highly accurate analysis of extremely small samples with remarkable reproducibility. Its dimensions are equivalent to a standard cuvette in order to work in most spectrophotometers. It is used for nucleic acid analysis, determination of the incorporation frequency of fluorescent dye labels (FOI), protein analysis (A280, BCA, Lowry etc.) and all UV/Vis analysis utilising the wavelength range of 190 to 1100 nm.

Hellma GmbH & Co. KGMüllheim-GermanyTel: +49(0) 7631/182-0 Fax: +49(0) 7631/135 46Email: [email protected]

Tablet hardness tester

The portable tablet hardness tester is designed for simple, inexpensive and “in-situ” measurement tablet hardness testing. It enables the user to react quickly to adjust the compression force of a tablet press and reduce the costs created by tablets produced out of specified hardness limits. The safety cover is opened; the sample placed in the measuring station and is pressed against a metal plate connected to an electronic load-cell moved by a hand wheel, until the sample brakes. The result of the measurement is shown on the built-in-LCD in N, Kg or lb. Every time the unit is switched ON, it fulfils an automatic half-calibration (zero calibrated).

Erweka India Ahmedabad-GujaratTel: 9228022065Email: [email protected]: www.erwakaindia.com

Powder characteristics testerP o w d e r characteristics tester employs methods to determine the f l o w a b i l i t y a n d

floodability of dry powders. This model is the latest design of the powder characteristics tester, which utilises state-of-the-art features to identify the specific characteristics of powdered samples for a wide range of application fields. Features are automated vibration with electronically controlled vib-sensor for repeatable results, optional integrated HEPA filter dust protection, test sieve identification measure by recording test sieve serial number, complete powder characterisation in one instrument, reduced operator intervention insuring analysis accuracy and repeatability, user-friendly software, reduce analysis time, complies with FDA tapped bulk density (USP) ASTM, Kawakita’s equation for Compressibility etc.

Hosokawa Micron India Pvt LtdChennai - Tamil NaduTel: 044-26211257Email: [email protected]: www.hosokawamicron.co.jp

Online washing/ cleaning/drying system

Online system has the following sections: Washing section which is equipped with large-opening plastic modular belt conveyor with side-walls where high washing efficiency is achieved, ultrasonic online cleaning section where ultrasonic waves generating transducers are built into the chamber of this section just under the side-wall conveyor belt, Hot air drying section where continuous drying of wet components is done and inspection conveyors which is equipped with belt suitable conveyors driven with a variable frequency drive for online inspection of components.

NTB International Pvt LtdPune - MaharashtraPh: 02135 309 201 / 235, Fax: 02135 309 200 Email: [email protected]: www.ntbindia.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 Pharma

Air-cooled single-stage pumpThe oil-l u b r i c a t e d a i r - c o o l e d single-stage pump comes with multi-vane built-in anti-suck

back system. It is provided with oil recirculation system having exhaust filters to produce mist-free exhaust. The pump is available with capacities ranging from 15 m³/hr to 150 m³/hr. The pump is used in various applications like packaging, bottle filling, pick and place, leak detection, heat treatment, distillation, suction in hospitals, oil purification, degassing and drying, etc. Advantages of the pump are less oil, less power, noise less and pollution free compared to normal oil seal vacuum pumps.

Toshniwal Instruments (Madras) Pvt Ltd Chennai - Tamil NaduTel: 044-26252716Email: [email protected]: www.toshniwal.net

Conductivity meterThe mhoCounter CT-10 is a c o n d u c t i v i t y indicator and 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. These meters come with saddle mounting option or standard fittings to adopt to any process flow solution.

Vatturkar IndustrialPune – MaharashtraTel: 020-25380568, Mob: 09422320551Email: [email protected]: www.vatsmeter.com

Electronic panel timerThe electronic panel timer is housed in small industrial grade plastic box. It gives 5 per cent setting accuracy and 1 per cent repeat accuracy. It is

Magnetic drive centrifugal pump

Lutz magnetic drive centrifugal pump is available in two series range AM and TMR. The materials are in glass-filled PP or carbon-filled ETFE. Unique feature of the TMR series is that the pump can run dry for up to 15 mins without damage. The inlet/outlet for the pump is offered in threaded (BSP/NPT) or flanged (ISO/ANSI) connections. The TMR series is disassembled without disturbing the motor. Maximum flow rate that achieved is up to 30 m³/hr and heads up to 25 mWc. The strong magnetic coupling made up of rare earth materials and three versions of each model allow pumping of liquids of special gravities from 1.00 to 1.85.

Shanbhag & AssociatesMumbai - MaharashtraTel: 022-28346604Email: [email protected]: www.shanbhags.com

Rotary evaporatorR o t a r y e v a p o r a t o r is used for efficient and gentle removal of solvents from samples by evaporation.

The evaporator has a safe, innovative design with unique reversing feature for better evaporation. Motorised lift has a “safety stop” function. If the power cuts out, the evaporator piston is automatically lifted out of the heating bath. Rotation speed ranges from 20-270 rpm. The bath heats from 20 to 180°C adding versatility by allowing use of water or oil. Digital rotation speed display is on all models. In digital models, temperature control of the heating bath is done by a micro-controller eliminating sudden uncontrolled boiling or “bumping”. They have an infrared interface for data transfer from the heating bath to the drive unit and RS 232 interface for PC remote operation with Labworldsoft software. Control models offers additional functions like integrated vacuum controller, integrated solvent library, automatic boiling point recognition, color graphic display, display of distillation curves, USB interface etc.

Cole-Parmer India Pvt Ltd Mumbai - MaharashtraTel: 022-67162224 / 2222Fax: 022-67162211Email: [email protected] Website: www.coleparmer.in

available in 415 V or 230 V with one changeover contact. Timing range is 30 sec, 60 sec, and 120 sec. Power and delay indications are provided on the front side of the timer. Potentiometer is provided to set the required time. It measures 102 mm x 65 mm x 43 mm and weighs 250 gm approximately.

Gelco Electronics Pvt LtdAhmedabad - GujaratTel: 079-22200902Email: [email protected]: www.gelco-world.com


Marketplace


Marketplace


List of Products & Advertisers



10 Stn. Pilot Press ................................................... 7

8th Nutra India Summit ........................................ 40

A Range Of Safety Sensors For Multiple

Applications .......................................................... 16

Agitator .................................................................... 12

Air-cooled single-stage pump ............................... 41

Allen Cap ................................................................. 34

Allen CSK ................................................................ 34

Alpha Press ................................................................ 7

Ambient Air Monitor-Envirotrack & Sampler ... 43

Amino Acid Analyser ............................................. 46

Analytical Instrumentation .................................BIC

Aseptic Liquid Packaging System ........................... 6

Atomic Absorption Spectrophotometer .............. 46

Autoclaves ................................................................ 13

Ball Check Valve .............................................. 20,39

Ball Valve ........................................................20,38,39

Barcode Patient ID Bands ..................................... 43

Batch Disperser ....................................................... 12

Bend ......................................................................... 38

Blower ...................................................................... 41

Blow-Fill Seal Machines ......................................... 31

Bush .......................................................................... 39

Butterfl y Valve ...............................................20,38,39

Calorimeter ........................................................... 12

Capsule Filling Machine ........................................ 13

Car Washin Hose .................................................... 21

Cartoner ................................................................... 13

Chemical Gas Detector .......................................... 43

Clamp ....................................................................... 42

Coating Machine ...................................................... 7

COD Analyzer & Digester ..................................... 43

Colloid Mill Std./GMP Model ................................ 7

Coloumns & Chemistry ......................................BIC

Communiting Mill ................................................... 7

Compact Pneumatic Cylinder ............................FIC

Complete Range Of Filling And Crimping

Machines For Aerosol ............................................ 27

Conductivity meter ................................................ 41

De-Dusting & De-Burring .................................... 7

De-humidifi er ......................................................... 40

Diaphragm Valve ..........................................20,38,39

Digital Panel Meter ................................................. 35

Dip-Pipe................................................................... 20

Disinfectant ............................................................. 42

Disperser .................................................................. 12

Double Rotary Tableting Machine ......................... 7

Drging Oven .............................................................. 7

Dry Vacuum Pump ................................................ 43

Dust Extractor ........................................................... 7

Ecofl ux Corrugated Tube Heat Exchanger ......... 8

Elbows ...................................................................... 20

Electric Actuator & Gripper ................................FIC

Electronic Gas Monitor ......................................... 43

Electronic panel timer ............................................ 41

Empower................................................................BIC

End Cap ................................................................... 38

Evaporation ........................................................ 14,19

Exhauster ................................................................. 41

Expansion Bellow ................................................... 20

Fasteners ................................................................ 34

FEP/PFA/PVDF Material ....................................... 39

Filter Cock ............................................................... 38

Fittings ..................................................................... 39

Fixtures..................................................................... 42

Flow Indicator ......................................................... 38

Fluid bed dryer ....................................................... 39

Fluid Bed Processor .................................................. 7

Fluid Bed System ...................................................... 7

Flush Bottom Valve ................................................ 20

Foot Valve ................................................................ 38

Fully Threaded Bar ................................................. 34

Garden Hose / Power Spray ................................ 21

Gas Chromatograph ............................................... 46

Gasket ....................................................................... 39

Gear Pump .............................................................. 10

Giga Press .................................................................. 7

Grip Plier ................................................................. 42

Guided Compact Pneumatic Cylinder ..............FIC

Heart Valve Frame ................................................ 11

Heating Bath ........................................................... 12

Hex Bolt ................................................................... 34

High Pressure Homogenizer ................................. 12

Horizontal Handel Clamp ..................................... 42

Hospital Equipment ............................................... 42

Hot Plate .................................................................. 12

HPLC......................................................................BIC

Hydraculic Accessories ........................................... 21

Impeller ................................................................. 38

Industrial Pump ...................................................... 36

Informatics ............................................................BIC

Inline Disperser ....................................................... 12

Inspection System ..................................................... 9

Jigs .......................................................................... 42

Kamlok & Drylok Coupling ............................... 36

Kneading Machine ................................................. 12

Labels ..................................................................... 43

Laboratory Reactor ................................................. 12

Laboratory Software ............................................... 12

Laser Particle Size Analyser ................................... 46

Liquid Sterile Filling Machines In Vials

/ Cartridges / Syringes & Ampoules .................... 13

Loading Arm ........................................................... 36

Long Neck Pipe End .............................................. 38

Lonizer ...................................................................FIC

Machines And Plants For Dry And Wet

Preparation ............................................................. 3

Magnetic drive centrifugal pump ......................... 41

Magnetic Stirrer ...................................................... 12

Mass Mixer Granulator ............................................ 7

Mechanical Vacuum Booster................................. 41

Mega Press ................................................................. 7

Mill ........................................................................... 12

Mini Roll Compactor ............................................... 7

Minin CM Mill ......................................................... 7

Mixing & Drying ............................................... 14,19

Modular Ot & Clean Room Sysytem .................. 42

Moisture analyser balance ..................................... 40

Monoblock High Vacuum Pump ......................... 43

Mosquito Fogging Machine .................................. 42

Mrfrs Of Thermoplastic Valves &Piping System

From Polypropline ................................................. 17

Multi-purpose trolley ............................................. 39

Non Return Valve ................................................. 38

Nozzles ..................................................................... 36

Nuts .......................................................................... 34

Oil Seal High Vacuum Pump .............................. 43

Online washing/cleaning/drying system .............. 40

Overhead Stirrer ..................................................... 12

Packaging Solution .............................................. 18

Pallets ....................................................................... 42

Paperless Recorder .................................................. 35

Peristaltic Pumps .................................................... 42

Pharmaceutical medicines ..................................... 39

Pilot Plant ................................................................ 12

Pipe ........................................................................... 39

Plastic Masterbatch ................................................. 43

Plate Heat Exchanger ............................................... 8

Plug Valve ........................................................... 20,39

Pneumatic Tools & Accessories ............................. 21

Pole Ring .................................................................. 38

Powder characteristics tester ................................. 40

Precision Fabrication Work ................................... 42

Printer ...................................................................... 43

Process Controller .................................................. 35

Production HPCL................................................... 46

PTFE ......................................................................... 39

PTFE Lined Piping ................................................. 20

PTFE Lined Systems ............................................... 20

Puches & Dies ........................................................... 7

Pull Action ............................................................... 42

Pump ..............................................................10,42,43

Pure Steam Generator ............................................ 13

Rapid Endotoxin Detection System ................... 43

Receptacle ................................................................ 36

Reducer ............................................................... 20,38

Reducing Flange...................................................... 20

Refrigrated Compressed Air Dryer ....................FIC

Regular Hse / Pesticide Spray Hose ..................... 21

Rod ........................................................................... 39

Roll Compactor ........................................................ 7

Roots Blower ........................................................... 42

Roots Vacuum Pump ............................................. 43

Rotary Evaporator .................................................. 12

Rotary evaporator ................................................... 41

Rotary Gear Pump ................................................. 10

Rotary Pump ........................................................... 43

Rubber Below .......................................................... 42

Rupid Mixer Std ....................................................... 7

Sampling Valve...................................................... 20

Scoop ........................................................................ 38

Seal 42

Self Tapping & Machine Screw ............................. 34

Shaker ....................................................................... 12

Shaking incubator .................................................. 39

Sheet ......................................................................... 39

Showel ...................................................................... 38

Sight Flow Meter .................................................... 36

Silicone Fbd Gasket ................................................ 42

Silicone Rubber Braided Hose .............................. 42

Silicone Rubber Compound ................................. 42

Silicone Rubber Cords/Square/Strip .................... 42

Silicone Rubber Corona Teater Sleeve ................. 42

Silicone Rubber Extruded Gasket & Profi le ........ 42

Silicone Rubber Moulding .................................... 42

Silicone Rubber Sheet ............................................ 42

Silicone Rubber Sponge ......................................... 42

Silicone Rubber Tubing ......................................... 42

Single Rotary Tableting Machine ........................... 7

Single Stage Monoblock Vacuum Pump ............. 43

Single Stage Vacuum Pump .................................. 43

Single Use Sachet” Solution. .................................. 18

Slipon Flange ........................................................... 38

Solid-Liquid Mixer ................................................. 12

Spade ........................................................................ 38

Special Tpu Gas Hose ............................................ 21

Spray Systems-From The Single Machine To The

Complete Filling Line ............................................ 27

Stainless Steel 304 (A2) & 316 (A4) Fastener ..... 30

Steam boiler............................................................. 39

Stirrers ...................................................................... 20

Straight Line Action ............................................... 42

Swing Check Valve ............................................. 20,39

Swivel........................................................................ 36

Tablet Hardness Tester......................................... 40

Tee ...................................................................... 20,38

Tefl on Coating ........................................................ 20

Tefzel Caoting .......................................................... 20

Tefzel Hhs Isotactic P.P Material .......................... 17

Temperature Controller ......................................... 35

Thermostat & Vaccum Dryer / Mixer ................. 12

Tissue Culture Consumable .................................. 23

Toggle Action Clamp ............................................. 42

Toggle Press ............................................................. 42

TrayCell .................................................................... 40

TRI Lobe Roots Blower ......................................... 41

Tube .......................................................................... 39

Twin - Screw Co-Rotating Extruder .................... 11

Twin - Screw Element ............................................ 11

Twin - Screw Extruder ........................................... 11

Twin Lobe Roots Blower .................................. 41,42

Two Stage Vacuum Pump ................................ 42,43

Ultra Sonic Flow Meter ....................................... 35

UPLC ......................................................................BIC

Vacuum Pump ...................................................... 43

Valve ...............................................................20,38,39

Vertical Handle Clamp .......................................... 42

Walk-in humidity chamber ................................ 39

Washer...................................................................... 38

Water For Injection Generation Still.................... 13

Water Ring Vacuum Pump ................................... 42

We Know Water ...................................................... 25

‘Y’ Type Strainer .............................................. 20,38

Zero Liquid Discharge Effl uent Treatment ..... BC

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

Product Pg No Product Pg No Product Pg No Product Pg No


List of Products & Advertisers



Our consistent advertisersBC-Back cover, BIC-Back inside cover, FIC-Front inside cover

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

8Th Nutra India Summit 2013 40

T: +91 22 2438 5007/9

E: [email protected]

Acme Air Equipment Co Pvt Ltd 41

T: +91-79-25831985


W: www.acmeairequipments.com

Analytical Technologies Limited 46

T: +91-265-2253620


W: www.ais-india.com

Ani Engineers 10

T: +91-2752-241479


W: www.anivaryapumps.com

Bhavya Polymers 42

T: +91-2762-224114


W: www.bhavyapolymers.com

Bosch Limited 13

T: +91-80-41768218


W: www.boschindia.com/pa

Chamunda Equipments 42

T: +91-79-27522437


W: www.chamundaequip.com

Chamunda Pharma Machinery Pvt.Ltd. 7

T: +91-79-25842712


W: www.cm1981.com

Charles River 43

T: +91-80 - 25588175


W: www.criver.com

Eppendorf India Ltd 23

T: +91-044-42111314


W: www.eppendorf.co.in/tcc

Essae Teoka Limited 15

T: +91-80-30213000


W: www.essae.com

Fluid Energy Controls Inc 36

T: +91-044-42083536


W: www.fecindia.com

Food & Pharma Specialities 14,19

T: +91-0120-4236204


W: www.foodpharma.in

Food & Pharma Specialities 19

T: +91-0120-4236204


W: www.foodpharma.in

Great Eastern Impex Pvt Ltd 43

T: +91-011-2347431/32


W: www.geipl.com

Hi-Tech Applicator 20

T: +91-79-25833040


W: www.ptfeindia.com

HRS Process Systems Ltd 8

T: +91-20-6604-7894/95


W: www.hrsasia.co.in

Ika India Private Limited 12

T: +91-80-26253900


W: www.ika.in

Joyam Engineers & Consultants Pvt Ltd 43

T: +91-79-26569533


W: www.joyamvactech.com

Netzsch Technologies India Pvt Ltd 3

T: +91-044-42965121


W: www.netzsch-grinding.com

Nichrome India Ltd 18

T: +91-20-6601-1001


W: www.nocrome.com

P P I Pumps Pvt Ltd 42

T: +91-79-25832273


W: www.ppipumps.com

Pamasol Will Mader Ag 27

T: 41-55-417-4040


W: www.pamasol.com

Parth Poly Valves Pvt. Ltd 38

T: +91-79-22200198


W: www.parthvalves.com

Pilz India Pvt Ltd 16

T: +91-20-2421-3994/95


W: www.pilz.in

Prayag Polytech Pvt Ltd 43

T: +91-011-47262000


W: www.prayagmb.com

Procon Technologies Pvt Ltd 35

T: +91-79-27492566


W: www.procon.co.in

Raajratna Ventures Ltd 30

T: +91-79-27561915


W: www.raajfasteners.com

Ravel Hiteks Pvt Ltd 42

T: +91-044-24961004


W: www.ravelhiteks.com

Reynders Label Printing India Pvt Ltd FIC

T: +91 149 3305400


W: www.reynders.com

Salesworth Synergies Pvt Ltd(Rommelag) 31

T: 91-80-25274495


W: www.rommelag.com

Salesworth Synergies Pvt Ltd(Seidenader) 9

T: +91-80-25274495


W: www.seidenader.de

Samson Extrusion Ind Pvt Ltd 21

T: +91-022-23422238


W: www.samson-grp.com

Sanosil Biotech Pvt Ltd 25

T: +91 22 22872295


W: www.sanosilbiotech.com

Shende Sales Corporation 42

T: +91-020-24488005


W: www.shendesales.com

Sintex Industries Ltd 42

T: +91-2764-253500


W: www.sintex-plastics.com

Skan INC 42

T: +91 22 24382000


W: www.skaninc.com

SSP Pvt Limited BC

T: +91-129-4183700


W: www.sspindia.com

Steer Engineering Pvt Ltd 11

T: +91-80-23723309


W: www.steerworld.com

Supremo Line & Control 39

T: +91-79-22205282


W: www.supremoproduct.com

Uniphos Envirotronic Pvt Ltd 43

T: +91-22-61233500


W: www.uniphos-she.com

UNP Polyvalves India Pvt Ltd 17

T: +91-265-2649248


W: www.polyvalve.com

Waters (India) Private Limited BIC

T: +91-80-28371900


W: www.waters.com

Weiler Engineering INC 6

T: +91-847-531-6733


W: www.weilerengineering.com

RNI No: MAHENG / 2008 / 27125, Postal Regd No: G / NMD / 122 / 2011 - 13, Posted at P.C Stg. Office, GPO, Mumbai 400 001

On 19th & 20th Of Every Month, Date Of Publication: 16th Of Every Month

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