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Modern Pharmaceuticals - 16-31 July 2012

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Modern Pharmaceuticals is a leading monthly business magazine in India, catering to the pharmaceutical industry. Published by Network 18 Ltd., it covers the latest industry trends & technologies, business strategies & management issues, views & visions of industry leaders in the Indian and global context. In addition, this magazine acts as a useful platform for effective interaction between several producer and user fraternities.
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In Conversation With 14 Bhavesh Patel MD, Marck Biosciences Ltd Special Focus 15 Strategies of pharma HR Recruiting and retaining the right talent Interface 17 E Balaji MD & CEO, Randstad India Policies & Regulations 20 Central Drugs Standard Control Organization Needs an overhaul Agila enters Canadian market AGILA Specialties Pharma Corporation, Canada, a part of Strides Arcolab, has formed a Joint Venture (JV) with Jamp Pharma to introduce a variety of quality injectable generic drugs in Canada. This sales and marketing joint venture will operate under the name ‘Agila-Jamp Canada Inc’ in which Agila will hold 70 per cent stake and the remaining 30 per cent by Jamp Pharma. Agila-Jamp will be launching around 40 products in the next 2 years. Mylan sues Warner Chilcott, Mayne Pharma over Doryx MYLAN Pharmaceuticals Inc sued Warner Chilcott Plc and Australia- based Mayne Pharma Group Ltd alleging that they tried to restrict generic competition to their acne drug Doryx. Warner Chilcott and Mayne made minor changes with no therapeutic benefit to Doryx to delay approval of competing generic versions of the drug, Mylan said in the lawsuit. DRL launches ibandronate sodium tablets in US DR Reddy’s Laboratories launched ibandronate sodium tablets (150 mg), a bioequivalent generic version of Boniva tablets, in the US market. The company has launched ibandronate sodium tablets following an approval by the US FDAof Dr Reddy’s ANDA for Ibandronate sodium tablets. Chelsea to implement corporate reorganisation CHELSEA Therapeutics International, Ltd’s Board of Directors plans to implement a corporate reorganisation that includes a reduction in force, executive changes and changes to the company’s Board of Directors, and has authorised a plan to explore and evaluate strategic options for the company; with the goal of optimising long-term stockholder value. Ranbaxy to boost biosimilars business RANBAXY Laboratories Ltd will soon launch at least three copies of biotech medicines in India by 2015, mostly to treat cancer, and needs to develop such high-tech drugs to remain a serious player in the global generics business, stated Arun Sawhney, CEO, Ranbaxy. The company’s goal is to seek initial approval for all the drugs in India and then seek approval within four to five years in Europe and the United States. THE All India Organisation of Chemists and Druggists (AIOCD) has welcomed the Government’s draft proposal to move away from cost-based pricing to market-based drug pricing policy saying that it will best address patient needs and balance industry growth. It however said the proposal can be further strengthened if the Weighted Average Price (WAP) of all the brands formula is taken rather than taking WAP of top three selling brands as mentioned in the proposal. Commenting on this, J S Shinde, President, AIOCD, said, “At a time when the Indian pharma industry is facing challenges on multiple fronts, the WAP of all brands formula will result in greater impact on the industry in comparison to the WAP of top three brands formula proposed in the draft NPPP 2011 to best meet access, affordability, innovation and quality needs of patients.” Elaborating he added, “WAP of all brands formula takes in to account almost 90 per cent of the cumulative market share under price control by value in comparison to around 60 per cent taken into account by WAP of top three brands. WAP of all brands formula will result in more patient savings on National List of Essential Medicines (NLEM) formulations than the WAP of top three brands formula.” He further added that while WAP is being calculated on top three brands the price reduction is 8 per cent and if all the brands are considered then the reduction is 13 per cent. He suggested that the prices of the drugs must be arranged in descending order and median of the prices should be calculated. Shinde believes that pharma companies are also following market-based strategy. Over the last 2 decades, patients in India have suffered on account of the non-transparent and complicated cost-based pricing regime (DPCO, 1995), which has hampered patient access to essential medicines. Shinde stated that out of 74 drugs in DPCO 95, 26 are out of market and share of 48 have shrunk in sales. And thus, the patients are genuinely suffering. Discussing the Government of India’s reaction to this, Ameesh Masurekar, Director, AIOCD AWACS, said that the Government of India is deliberately delaying the whole process. Therefore, the association is of the opinion that market-based pricing would balance patient as well as industry interests, and prevent formulations going off the market on account of an unviable manufacturing environment as happened during cost- based pricing regime. It would also facilitate an environment that would attract more players to the market, further intensifying competition and provide more options to patients. Further, the association suggested that non-essential strengths, dosages and combinations not specifically listed in the NLEM 2011 be not included in the scope of the policy as such a move would burden the industry and stifle growth and adversely impact availability of essential medicines. - Chandreyee Bhaumik RECENTLY Anand Sharma, Union Minister of Commerce, Industry and Textile, chaired the first meeting of Consultative Group on pharmaceutical exports. Sharma highlighted that it was the entry of Indian generic medicines in the global supply chain that started an ethical debate worldwide between generics versus patented drugs, and ultimately the right of every citizen to access affordable quality medicines were upheld. The minister also apprised that substantial opportunities exist for Indian pharma industry in emerging economies like Russia, Africa and South America. He assured that the industry captains that the Government will take up the non-tariff barriers being mounted by US as also EU against Indian pharma industry in bilateral forums at appropriate levels. Dr Rajesh Jain, Joint MD, Panacea Biotec Ltd, who was also present at the forum, said, “The Government of India is serious and shows its commitment to develop exports in the next 5 years. The companies wanted the support of Government in order to realise this.” He added that the companies demanded faster regulatory system, adequate infrastructural support, and removal of unnecessary steps in the application process. He further highlighted that the outhouse clinical trial should be part of R&D tax deduction and the benefit of tax deduction should be after Minimum Alternate Tax (MAT). - Chandreyee Bhaumik CPHI Conferences is launching InnoPack India 2012, which will take place during 11-13 September at the Holiday Inn Hotel, Mumbai. It is a strategic initiative focusing on the critical issues pertaining to pharma packaging. This event will cover an array of issues like innovative packaging materials to effectively comply with international standards, anti-counterfeiting measures, 2D bar-coding implementation, quality and cost control measures under primary, secondary and tertiary packaging and will provide solutions to comply with the regulatory protocols, safeguard your drug and enhance patient care. With eminent speakers such as Edward Dunn, Senior Director, Packaging Technology; William Bosley, Senior Labelling Specialist, Watson Pharmaceuticals; Prabir Das, Vice President Packaging Development, Mylan, etc already on board, InnoPack India 2012 will bring together 80+ heads of packaging development and packaging R&D from pharma manufacturers, and will provide practical take-aways to develop innovative, intelligent, integrated and cost-effective packaging solutions. AIOCD to support market-based pricing formula Government keen to double exports in 5 years InnoPack India 2012, to be held in Mumbai Shinde Dr Jain 16-31 July 2012 I Vol 1 I No 2 I `1 00 Scan this code on your smart phone to visit www.mphonline.in
Transcript
Page 1: Modern Pharmaceuticals - 16-31 July 2012

In Conversation With 14Bhavesh Patel

MD, Marck Biosciences Ltd

Special Focus 15Strategies of pharma HR

Recruiting and retaining the right talent

Interface 17E Balaji

MD & CEO, Randstad India

Policies & Regulations 20Central Drugs Standard

Control OrganizationNeeds an overhaul

Agila enters Canadian marketAGILA Specialties Pharma Corporation, Canada, a part of Strides Arcolab, has formed a Joint Venture (JV) with Jamp Pharma to introduce a variety of quality injectable generic drugs in Canada. This sales and marketing joint venture will operate under the name ‘Agila-Jamp Canada Inc’ in which Agila will hold 70 per cent stake and the remaining 30 per cent by Jamp Pharma. Agila-Jamp will be launching around 40 products in the next 2 years.

Mylan sues Warner Chilcott, Mayne Pharma over DoryxMYLAN Pharmaceuticals Inc sued Warner Chilcott Plc and Australia-based Mayne Pharma Group Ltd alleging that they tried to restrict generic competition to their acne drug Doryx. Warner Chilcott and Mayne made minor changes with no therapeutic benefit to Doryx to delay approval of competing generic versions of the drug, Mylan said in the lawsuit.

DRL launches ibandronate sodium tablets in USDR Reddy’s Laboratories launched ibandronate sodium tablets (150 mg), a bioequivalent generic version of Boniva tablets, in the US market. The company has launched ibandronate sodium tablets following an approval by the US FDAof Dr Reddy’s ANDA for Ibandronate sodium tablets.

Chelsea to implement corporate reorganisationC H E L S E A T h e r a p e u t i c s International, Ltd’s Board of Directors plans to implement a corporate reorganisation that includes a reduction in force, executive changes and changes to the company’s Board of Directors, and has authorised a plan to explore and evaluate strategic options for the company; with the goal of optimising long-term stockholder value.

Ranbaxy to boost biosimilars businessRANBAXY Laboratories Ltd will soon launch at least three copies of biotech medicines in India by 2015, mostly to treat cancer, and needs to develop such high-tech drugs to remain a serious player in the global generics business, stated Arun Sawhney, CEO, Ranbaxy. The company’s goal is to seek initial approval for all the drugs in India and then seek approval within four to five years in Europe and the United States.

THE All India Organisation of Chemists and Druggists (AIOCD) has welcomed the Government’s draft proposal to move away from cost-based pricing to market-based drug pricing policy saying that it will best address patient needs and balance industry growth. It however said the proposal can be further strengthened if the Weighted Average Price (WAP) of all the brands formula is taken rather than taking WAP of top three selling brands as mentioned in the proposal.

Commenting on this, J S Shinde, President, AIOCD, said, “At a time when the Indian pharma industry is facing challenges on multiple fronts, the WAP of all brands formula will result in greater impact on the industry in comparison to the WAP of top three brands formula proposed in the draft NPPP 2011 to best meet access, affordability, innovation and quality needs of patients.” Elaborating he added, “WAP of all brands formula takes in to account almost 90 per cent of the cumulative market share under price control by value in comparison to around 60 per cent taken into account by WAP of top three brands. WAP of all brands formula will result in more patient savings on National List of Essential Medicines (NLEM)

formulations than the WAP of top three brands formula.” He further added that while WAP is being calculated on top three brands the price reduction is 8 per cent and if all the brands are considered then the reduction is 13 per cent. He suggested that the prices of the drugs must be arranged in descending order and median of the prices should be calculated. Shinde believes that pharma companies are also following market-based strategy.

Over the last 2 decades, patients in India have suffered on account of the non-transparent and complicated cost-based pricing regime (DPCO,

1995), which has hampered patient access to essential medicines. Shinde stated that out of 74 drugs in DPCO 95, 26 are out of market and share of 48 have shrunk in sales. And thus, the patients are genuinely suffering. Discussing the Government of India’s reaction to this, Ameesh Masurekar, Director, AIOCD AWACS, said that the Government of India is deliberately delaying the whole process.

Therefore, the association is of the opinion that market-based pricing would balance patient as well as industry interests, and prevent formulations going off the market on account of an unviable manufacturing environment as happened during cost-based pricing regime. It would also facilitate an environment that would attract more players to the market, further intensifying competition and provide more options to patients. Further, the association suggested that non-essential strengths, dosages and combinations not specifically listed in the NLEM 2011 be not included in the scope of the policy as such a move would burden the industry and stifle growth and adversely impact availability of essential medicines.

- Chandreyee Bhaumik

RECENTLY Anand Sharma, Union Minister of Commerce, Industry and Textile, chaired the first meeting of Consultative Group on pharmaceutical exports. Sharma highlighted that it was the entry of Indian generic medicines in the global supply chain that started an ethical debate worldwide between generics versus patented drugs, and ultimately the right of every citizen to access affordable quality medicines were upheld. The minister also apprised that substantial opportunities exist for Indian pharma industry in emerging economies like Russia, Africa and South America. He assured that the industry captains that the Government will take up the non-tariff barriers being mounted by US as also EU against Indian

pharma industry in bilateral forums at appropriate levels.

Dr Rajesh Jain, Joint MD, Panacea Biotec Ltd, who was also present at the forum, said, “The Government

of India is serious and shows its commitment to develop exports in the next 5 years. The companies wanted the support of Government in order to realise this.” He added that the companies demanded faster regulatory system, adequate infrastructural support, and removal of

unnecessary steps in the application process. He further highlighted that the outhouse clinical trial should be part of R&D tax deduction and the benefit of tax deduction should be after Minimum Alternate Tax (MAT).

- Chandreyee Bhaumik

CPHI Conferences is launching InnoPack India 2012, which will take place during 11-13 September at the Holiday Inn Hotel, Mumbai. It is a strategic initiative focusing on the critical issues pertaining to pharma packaging.

This event will cover an array of issues like innovative packaging materials to effectively comply with international standards, anti-counterfeiting measures, 2D bar-coding implementation, quality and cost control measures under primary, secondary and tertiary packaging and will provide solutions to comply with the regulatory protocols, safeguard your drug and enhance patient care.

With eminent speakers such as Edward Dunn, Senior Director, Packaging Technology; William Bosley, Senior Labelling Specialist, Watson Pharmaceuticals; Prabir Das, Vice President Packaging Development, Mylan, etc already on board, InnoPack India 2012 will bring together 80+ heads of packaging development and packaging R&D from pharma manufacturers, and will provide practical take-aways to develop innovative, intelligent, integrated and cost-effective packaging solutions.

AIOCD to support market-based pricing formula

Government keen to double exports in 5 years

InnoPack India 2012, to be held

in Mumbai

Shinde

Dr Jain

16 - 31 J u l y 2 01 2 I Vo l 1 I N o 2 I `10 0

Scan this code onyour smart phoneto visit www.mphonline.in

Page 2: Modern Pharmaceuticals - 16-31 July 2012
Page 3: Modern Pharmaceuticals - 16-31 July 2012
Page 4: Modern Pharmaceuticals - 16-31 July 2012

CONTENTSIn Conversation With 14 Bhavesh Patel MD, Marck Biosciences Ltd

Facility Visit 19 Karnavati Engineering Pvt Ltd Pharma manufacturing with a panache

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 Edition

Special Focus: Outsourcing/CRAMS

REGULAR SECTIONS05 Editorial / Guest Editorial

06 News, Views & Analysis

22 Technology Transfer

23 Tenders

23 Projects

24 Event List

25 Book Review

26 Products

28 Marketplace

30 List of Products & Advertisers

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

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M o d e r n P h a r m a • 16 - 31 J u l y 2 01 2

16

14

20

15

15Strategies of pharma HR Recruiting and retaining the right talent

16IT in transactional HR functions Providing a structured framework

Special Focus HR in Pharma

Interface E Balaji MD & CEO, Randstad India

Pradeep Vaishnav Senior Director- Human Resources,

India and South Asia, Sanofi

17

18

20Central Drugs Standard Control Organization Needs an overhaul

21Medical practioners Does your clinical meeting make a ‘point’?

Insight & Outlook Policies & Regulations

Strategy

Page 5: Modern Pharmaceuticals - 16-31 July 2012

5M o d e r n P h a r m a • 16 - 31 J u l y 2 01 2

Editorial

PPP: Perfect path to progress?

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

O f late, price control of pharmaceuticals in India has publicly been one of the most contentious issues. So much

so, it affects all the stakeholders of this crucial sector – right from producers to consumers and policy makers to distributors/retailers. While it is essential to have an ‘inclusive’ growth of this sector by ensuring affordability, availability and accessibility of medicines for the millions of citizens, the right formula to have ‘satisfactory’ price control over pharma products in the domestic market still remains elusive.

Perhaps the time is now ripe to solve this riddle by factoring in all possible variables required for this ‘formulation’ rather than having the conventional cost-based and/or market-based models. Some of the additional parameters can be investment in pharma R&D, logistics and distribution, among others.

Since pharmaceuticals and healthcare are part of the same value chain, it will be apt to closely analyse some of the recent figures in the latter and more importantly, contribution of its two key spending segments. The public sector in India accounts for a meagre 20 per cent of the total healthcare expenditure, ie, only 1 per cent of the GDP, which is among the lowest in the world. The share of private sector, at the same time, in healthcare expenditure of the country is as high as 80 per cent, which is among the highest in the world. To achieve the much needed

scale-up in Indian healthcare, a pragmatic approach calls for joining of hands by both the public and private sectors through Public Private Partnership (PPP) rather than trying individually to tackle this imminent challenge of enormous proportion.

With fast changing socio-economic mix in India as well as the predominant disease patterns, the role of the government is also seeing a radical shift from being a provider to a payer of healthcare services. Amid this, to have a sustainable, standardised and well-integrated PPP model in pharma & healthcare, the country needs to have a single, unified and futuristic accreditation/regulatory framework in place, with a clear mandate of 3 Ps (People, Processes and Performance). Easier said than done, the key to success in such PPP projects will lie in effectively managing the interests of all stakeholders across different well-defined roles.

Before signing off, our heartfelt thanks to all our readers who have promptly shared their valued feedback. During these early days of brand new Modern Pharma, such responses will further aid our endeavour to better serve the sector. Looking forward to more such interactions!

Consumer backed authentication: Protecting brands globally

In the 21st century, technology and computer systems play an integral part of everyday human life. Technology is being harnessed

not only to improve the wellbeing of people, but to protect and save lives. IT systems make information more accessible to patients and provide consumers ways to take greater control of their health and livelihood. In an effort to curb the multi-billion dollar global counterfeit trade market, there are solutions that empower consumers to ensure the genuineness of their products through a simple text message. Although such solutions work for any tangible good, including pharmaceutical products (medicine), automotive parts, agrochemicals, food and beverage, and even handbags, efforts are focussed on combating counterfeit medicines.

The pharmaceutical industry is particularly vulnerable to counterfeiting, and it can be quite dangerous and even fatal to consumers. In developing countries, the problem of counterfeiting important goods is exacerbated by weak regulatory oversight and high levels of illiteracy. In addition, counterfeit drugs cause further devastation in areas where diseases such as malaria, diabetes, AIDS and

tuberculosis are rampant, since people do not receive proper medications.

Globally, over 700,000 people per year are estimated to die from fake tuberculosis and malaria drugs alone.

We will not trick you into thinking that there’s one ‘silver bullet’ technology to stop counterfeit trade. It is a complicated problem that requires multiple layers of interventions; both socioeconomic remedies and technology-based solutions.

Consumer backed authentication caters for track and trace across the entire supply chain, there is still a need for chemical tests at ports and borders, frequent factory quality control inspections and post-market surveillance to detect sub-standard drugs due to mishandling.

These chemical tests are typically costly and it is hard to get such testing centers to all corners of large developing nations. However, consumers are everywhere, and they are a vigilant force that could be leveraged effectively (with the right tools) in the fight against counterfeits. With the explosive growth in mobile phone access in the developing world, it makes a lot of sense to use a participatory, ‘grass roots’ technology that is prevalent in such resource-challenged environments.

The easy-to use, easy-to-understand consumer backed authentication works right at the consumer level, and takes only a few seconds to use.

Immediately after purchasing a product, consumers will find a label on the package that they can scratch-off to reveal a one-time use, item specific code. Then, they text the code to secure phone number and receive a message confirming that the product is authentic or warning that it may be counterfeit.

Along with protecting their consumers from harmful replicas of their products and increasing profits once lost to counterfeiters, brand owners can gain valuable market intelligence through the proprietary online client portal. In various countries, initial efforts to tackle counterfeiting have already begun. In India, the Directorate General Foreign Trade (DGFT) has initiated an action of mass serialisation to protect ‘Brand India.’ However, there is much confusion and apprehension in the industry on whether mass serialisation alone can provide a foolproof solution against counterfeiting.

Dr Ashifi GogoChief Executive Officer, Sproxil Inc

Guest Editorial

Manas R [email protected]

Page 6: Modern Pharmaceuticals - 16-31 July 2012

6M o d e r n P h a r m a • 16 - 31 J u l y 2 01 2

ASTRAZENECA and Cellworks announced a collaboration supported by the Wellcome Trust to speed the design of novel combination therapies for the treatment of drug-sensitive and resistant tuberculosis. Cellworks and AstraZeneca will pull from a pool of existing anti-infective drugs and attempt to find an effective combination with better efficacy and lower toxicity than the treatment regimens provided.

Under this collaboration, Cellworks will use its proprietary predictive platform to model drug for Multi Drug Resistant Tuberculosis (MDR-TB) and rationally identify ‘synergistic combinations’ with highest efficacy and lowest possible toxic burden and validate the best combination using invivo models.

Dr Anand Anandkumar, MD, Cellworks Group India, said, “Cellworks is honoured to take the lead on this unique drug development project which has the potential to save thousands of lives globally. We are proud to be working with scientists from AstraZeneca on such a socially valuable project, funded by one of the world’s leading science foundations.”

Dr Manos Perros, Head - Infection Innovative

Medic ines Uni t , AstraZeneca, said, “AstraZeneca is pleased to join this effort to speed the delivery of improved treatment combinations for TB patients worldwide. O u r c o n t i n u e d investment in infectious disease research has positioned us to

collaborate with organisations such as Cellworks and we would like to acknowledge and thank the Wellcome Trust for funding this important work.”

Dr Richard Seabrook, Head - Business Development, Wellcome Trust, said, “We are delighted to be supporting this collaboration, which has a strong mix of both innovation and drug development expertise.”

SERUM Institute of India, the flagship company of the over $ 1 billion Poonawalla Group has announced the acquisition of Bilthoven Biologicals, Netherlands. Through the acquisition, Serum will get access to technology and expertise for making the injectable polio vaccine (Salk). A unique capability and expertise that is currently possessed by a mere three other vaccine manufacturing plants globally. This first overseas acquisition by the Poonawalla Group will also provide the Group and Serum an important manufacturing base in Europe, along with access to the important European and the US markets. Serum Institute, the Group’s flagship company, has had business dealings with Bilthoven Biologicals for the last

35 years. Bilthoven Biologicals was owned by the Government of Netherlands. Serum Institute of India (Cyrus Poonawalla Group) has acquired 100 per cent shares of the company from the Government of Netherlands.

Elaborating on this, Adar Poonawalla, Executive Director, Poonawalla Group and Serum Institute, said, “The Poonawalla

Group is committed to investing over 70 - 80 million over the next 3 years to augment the infrastructure and enhance the manufacturing capacity of the Bilthoven’s facilities. Serum Institute has one of the world’s largest vaccine manufacturing facilities at Pune, India and with this second manufacturing facility based in Europe,

the company aims to access the developed markets of Europe and the US for its existing and future products in the pipeline.” He added, “It was for the technology and base in Europe for us to make our products there and use at as a base for Europe. Serum produces almost a billion doses every year of vaccines and we will expand both here and there by around 30 per cent.”

Poonawalla Group to invest over 70 - 80 million over the next 3 years

MERCK India classifies individuals who recommend products to the end consumer as ‘influencers’. They believe that is important for them to know about the ingredients of the product and bearing this in mind it has launched a Project EffexX, an online portal that enables experts to interact with influencers, about the products and technologies being used in the industry. They eventually plan to bring the end consumers and experts exchange and share ideas that will prove mutually beneficial to both. Siddhartha Sengupta, Head - Pigments, Merck India, said, “Through project EffexX we want to empower people and educate people about what goes into the making of

the products they use. The stake holders are primary consumers but the key part is played by ‘influencers’ like architects, designers, hair

stylists, spas, dermatologists, packaging designers who recommend people about

the kind of product that one should use. We want to get them on this website, discuss talk and educate them about the products that they recommend since this will give them a better understanding of key ingredients of the product.”Merck India also provides technical knowhow, guidance and facilities to its customers who are aiming to expand. Although they do not provide financial assistance, they provide them with a platform and expertise from the inception to launching if the product.

Sengupta added, “We believe in co-creation and that’s what we call the process of finding a partner and creating something together and making someones dream into a reality.”

- Shibani Shah

Merck India to educate and provide platform to ‘infl uencers’ through Project EffexX

News, Views & AnalysisPatent expiry of blockbuster drugs to benefi t generics manufacturers: Frost & Sullivan

GSK pleaded guilty

EMD Millipore wins prestigious R&D Magazine 100 Award

Astrazeneca and Cellworks collaborate

THE global generic pharma market is likely to witness strong growth in the next few years owing to the patent expiration of key blockbuster drugs and the judicious cost containment efforts of governments and healthcare service providers worldwide. “The patent expiry of several major blockbuster drugs between 2010 and 2017 will fuel the growth of the global generic pharma market,” according to Frost & Sullivan. “The trend is shifting towards less competitive, yet commercially attractive segments such as difficult-to-produce generics, speciality generics and biosimilars.”

Leading global generic pharma manufacturers have been proactive in forging strategic alliances with branded pharma companies for marketing rights and exclusivity in producing generic versions of blockbuster drugs such as Lipitor, Cozaar and Crestor, among others. market leaders such as Teva, Sandoz and Mylan are increasingly focussed on biosimilars, as this segment provides a competitive edge and presents huge profit margins.

While these are positive signs for market participants, a potential dampener is the progressively stringent regulations and price control measures being imposed by governments. As competition intensifies, generic drug manufacturers will have to make careful choices about the product segments that they wish to compete in and the appropriate time of entry into the market. “Large MNC generic firms need to adopt a differentiated approach by opting for products with technologically challenging formulations, products that require significant regulatory support, and products with limited availability of APIs,” said the research analyst. “Small and medium-sized firms should focus on products with relatively higher profit margins.”

GLAXOSMITHKLINE (GSK) has been pleaded guilty for promoting two drugs for unapproved use and also failing to report safety data about a diabetes drug to the US FDA. GSK will pay the sum of $ 3 billion, which includes a $ 1 billion criminal fine and forfeiture and $ 2 billion to resolve civil settlements and will be monitored by government officials for next 5 years. The charges against GSK included illegal promotion of Paxil, an antidepressant, for treating depression

in children from 1998 to 2003, even though it was not approved for anyone under age 18. The company also promoted Wellbutrin, typical antidepressant and smoking cessation aid, from 1999 through 2003 for weight loss, sexual dysfunction, substance addictions and attention deficit hyperactivity disorder. The company also conceded charges that it held back data and made unsupported safety claims over its diabetes drug Avandia.

EMD Millipore, the Life Science division of Merck, Darmstadt, Germany, has received the R&D Magazine 100 Award for its product, the Samplicity®Filtration system. The 50th annual R&D 100 Award recognises the 100 most technologically significant products introduced into the marketplace over the past

year. The Samplicity®Filtration system provides a higher throughput, ergonomic alternative to syringe-tip filters for the preparation of liquid chromatography samples. The system is utilised in R&D laboratories testing drug dissolution, food safety, cosmetics, biofuels and pharmacokinetic and pharmacodynamic properties of drugs. “This award is a testament to our commitment to offer our customers breakthrough technologies they can use to keep up with rapid advances in life science. With this system, we have met the demands of today’s ultra-fast, ultra-sensitive chromatographic analyses,” said John Sweeney, Head - Bioscience Business Unit, EMD Millipore.

L-R: Adar Poonawalla and Dr Cyrus Poonawalla with the Health Minister of Th e Netherlands, Her Excellency Edith Schippers

Sengupta

Sweeney

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ALBANY Molecular Research, Inc (AMRI) has recently relocated its compound-library capabilities to Hyderabad. Talking on the development Bruce J Sargent, Senior VP - Drug Discovery, AMRI, explained, “Compound libraries are a key starting-point in drug discovery; AMRI provides this service to pharma and biotechnology companies in many locations. Consolidation of the capability in India allows AMRI to leverage its existing cost-structure and to integrate the technology with our other drug discovery offerings. Pharma markets – including the India market – ultimately benefit through the effective discovery of novel drugs for commercialisation.”

AMRI Hyderabad will provide various chemistry services for its pharmaceutical, biotechnology and agrochemical customers. The medicinal chemistry team will support customer projects in therapeutic areas such as metabolic diseases, oncology and CNS. The centre will focus on the chemistry of

these programmes, which are directed at a whole range of targets from well established to novel. At its Hyderabad centre, AMRI also plans to establish new laboratories that are equipped to conduct parallel synthesis chemistry enabling the ability to design and synthesise custom libraries of molecules for pharmaceutical screening.

Mark Frost, Senior VP - Administration and CFO, AMRI, commented, “Hyderabad Research Center was a significant investment

in 2006 when we first created the operation. It was a modest investment to add the library capability.”

With the Indian pharma market graduating to become a global leader Subramanyam Maddala, President - India Operations, AMRI, said, “The pharma market in India is expected to touch $ 74 billion in sales by 2020 from the current $ 11 billion, according to a PricewaterhouseCooper (PwC) report. The growth rate for the domestic Indian pharma market is set to rise over

medium-term.” He highlighted, “The revenue CAGR over the past 3 years had been 12.4 per cent, but it is expected to be up at 15.3 per cent from FY12 to FY14, Barclays Capital Equity Research said here in its report – India Healthcare & Pharmaceuticals.”

Maddala added, “AMRI is planning to improve its positioning by investing in new capabilities in the coming years. The further investment in medicinal chemistry,

computational chemistry and custom library synthesis resources at HRC is a step in that direction. Apart from this we intend to further invest in niche generic APIs with global generic companies. We plan to invest in upgrades of our facilities to increase our reach to regulated markets like the US, Europe, etc, as well as invest in potential facility expansions for branded APIs to become a more important partner to major pharmaceutical companies.”

- Shibani Shah

News, Views & Analysis

AMRI to upgrade, invest and increase its reach in regulated markets

Sargent Frost Maddala

PharmaSecure launches psConnectTM: A mobile

health platform PHARMASECURE has launched psConnectTM - a mobile health (mhealth) platform that enables a variety of providers to offer mhealth services to patients. The task force for the Union Health Ministry has recommended SMS authentication as the ideal means of combating the counterfeit drug problem. Initially, three services will be provided: free health tips, refill reminders and health advice.

The psConnectTM establishes a two-way channel of communication between

the manufacturer and the consumer that can be used to disseminate important drug safety information, educate consumers about their particular ailments and inform patients about key public

health initiatives. The platform provides manufacturers numerous possibilities to increase their market advantage, distinguish their brand and create loyal consumers.

Speaking about the launch Kishore Kar, VP - Sales and Marketing, PharmaSecure PAS India, said, “PharmaSecure has established itself as a trusted name in the mobile authentication solution space and it’s the right time for us to take the next step. The consumer is empowered with information about his medicine, knowledge on a particular ailment, refill reminders to purchase medicine, health tips and ready accessibility to a doctor – everything with just one tap on his mobile phone. We are proud to be associated with HealthFore for these services.”

Commenting on the launch Nitin Goyal, Senior VP, HealthFore, added, “We are delighted to extend our Medi-Life service on the psConnectTM platform. The coming together of mobile telephony and the medical expertise is the only way to make affordable healthcare available pan India.”

Kar

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News, Views & Analysis

CIPLA announced Frank Pieters as the Head of European Region and the Global Respiratory Business. He comes on board with over 30 years of experience in the pharmaceutical industry in different senior management positions, with the unique background in respiratory medicine. Dr Yusuf K Hamied, CMD, Cipla Ltd, said, “Frank brings a wealth of expertise in the respiratory domain. With him at the helm, Cipla

would like to capture the huge commercial upside of 30 years experience in Cipla’s

respiratory medicine; both in emerging and regulated markets. Apart from global respiratory business, Frank will also spearhead the generics and value-added product portfolio across the European region through strategic alliances.”

Pieters said, “After spending many interesting years both at GSK and Teva, I am thrilled to join the Cipla, helping to expand both the respiratory business worldwide and the European business.”

PFIZER Ltd, the Indian arm of Pfizer Inc, has appointed Aijaz Tobaccowalla as the Managing Director to replace Kewal Handa, who had earlier this year announced his intention to retire in August 2012.

“With more than 20 years of experience in the pharmaceutical industry, Aijaz, is a seasoned leader who will continue to lead Pfizer India through this exciting period,” said Ahmet Goksun, Regional President, Emerging Markets Europe, Russia, India and Turkey (EURIT), Pfizer.

Tobaccowalla would be taking over as MD from August 16, it added.

He joined Wyeth in 1991 and since then has held a number of positions in business technology as a member of the leadership teams of Pfizer WBB, R&D, and PCBU, the company said.

In 2009 Tobaccowalla was appointed to his most recent role, leading business technology for Pfizer’s all biopharmaceutical business units.

Handa, who will retire from the company in August after two decades of association with the firm, is credited with Pfizer’s entry into branded generics segment in India.

Pfi zer appoints Aijaz Tobaccowalla as India Managing Director

Mylan aims to create $1 billion injectables franchiseMYLAN Inc (Mylan Institutional business) has received final approval from the USFDA for its ANDA for preservative-free Thiamine Hydrochloride Injection, 100 mg/mL, packaged in 200 mg/2 mL multiple-dose vials. This product is indicated for the treatment of thiamine deficiency.

Thiamine hydrochloride injection, 100 mg/mL, had US sales of approximately $ 18.6 million for the 12 months ending March 31, 2012, according to IMS Health. Mylan is shipping this product, presented in 25-vial packs, immediately. Currently, Mylan has 169 ANDAs pending FDA approval representing $ 83.9 billion in annual sales, according to IMS Health. Thirty-seven of these pending ANDAs are potential first-to-file opportunities, representing $ 25.6 billion in annual brand sales, for the 12 months ending December 31, 2011, according to IMS Health. According to the Mylan spokesperson, “We identified injectables as one our key growth drivers through 2018 and are aiming to create a $ 1 billion franchise in injectables.

- Chandreyee Bhaumik

Ferring, Albireo sign licensing agreement

FERRING Pharmaceuticals has entered into a licensing agreement with Albireo for elobixibat, a first-in-class compound for Chronic Idiopathic Constipation (CIC) and Irritable Bowel Syndrome With Constipation (IBS-C). Under the agreement, Ferring gained elobixibat global marketing rights, excluding Japan and a small number of Asian markets. Michel Pettigrew, Executive Board President and COO, Ferring,

said, “Elobixibat complements the company’s gastroenterology portfolio, which includes Pentasa for IBD and Picoprep for bowel cleansing. What is more, it fits well with our company philosophy of ‘People Come First’ - in particular the patient, as it addresses a problem that affects from 15 per cent up to almost a third of the population but that has seen little progress in treatment options over the years.”

WITH a budget deficit hovering around 6 percent and the economy poised to achieve a growth of only 6 percent this year, it will be interesting to see how the Government manages to accrue funds for making this policy a success. Even with the policy in place in Rajasthan and Tamil Nadu the stark reality is that medicines are out of stock in almost all clinics.

“The real challenge for the government will be to check leakages in the system. This policy might not be successful like the Mahatma Gandhi National Rural Employment

Guarantee Act (MGNREGA) scheme if proper checks are

not kept. Second challenge will be the procurement process. If the medicines are

not procured directly but via 3rd parties then there is a huge possibility of supply of inferior drugs,” said Dr Ajay Kumar Sharma, Practice Head - Pharma, Healthcare Practice, Frost & Sullivan, South Asia & Middle East.

“Another challenge is that medicines hardly constitute 25-30 percent of all healthcare expenditures. The real cost is the delivery of the services; the government has not been successful in building the necessary infrastructure and human resources in the last 3 decades,” he added.

WATERS Corporation marked it’s the 25th anniversary of the start of business operations in India, with the initiation of online ordering through a new order centre. Scientists and customers can now search and order Waters quality parts, sample preparation products, chemistries and consumables online at www.waters.com/order. With the new order center now open, Waters is introducing several new features designed to facilitate ordering and lower

transaction costs by including the posting of real-time product availability, local currency pricing, available discounts, order tracking and special offers. Scientists are now able to select products of interest and easily share their cart with procurement professionals.

India to give free generic drugs: A Frost & Sullivan perspective

Government likely to invest ` 2,000 crore for pharma R&D

Waters launches its new online centre

Dr Batra’s appoints new MD and a new CEODR Akshay Batra has been appointed the Managing Director and Hari Nair the Chief Executive Officer of Dr Batra’s Positive Health Clinic Pvt Ltd to help the organisation scale new heights of professional and patient-care glory. Dr Akshay Batra played an instrumental role in setting up Dr Batra’s B Perfect Pvt Ltd – a daycare aesthetic centre.

Hari Nair, an MBA from XLRI Jamshedpur, who had earlier worked with Tata

Steel, H & R Johnson, and Marico, joined Dr Batra’s as the Chief Operating Officer (COO) of the Products Division. In his new role as a

CEO, it will be his endeavour to scale up the business to new heights, through organic and inorganic growth measures.

THE Government is likely to form a venture capital fund of ` 2,000 crore to promote R&D in the pharmaceutical sector and is talking terms with Exim Bank for the same. “It

is important the Government of India focusses on R&D in India. Today, there are several tropical diseases that people in India suffer from, like malaria, typhoid and many more. The R&D in such areas is very poor and MNCs are not taking them up and the companies in India do not have the required capital. Hence, this investment would definitely help the pharma sector in India,” said Raj Vaidya, VP, Chairman - Communication Pharmacy Division, Indian Pharmaceutical Association.

- Jasleen Kaur Batra

Aijaz Tobaccowalla

Pieters

Cipla appoints a new head for global respiratory business

Dr Sharma

Dr Batra NairVaidya

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News, Views & Analysis

NPS Pharmaceuticals, Inc, a speciality pharmaceutical company developing orphan therapeutics for rare gastrointestinal and endocrine disorders, has amended its license agreement with Amgen for royalties from sales of cinacalcet HCl. Under the revised agreement, NPS will receive a one-time $ 25 million payment in July 2012 in exchange for its rights to receive royalties under the license agreement that are earned after December 31, 2018. The amendment also limits the royalty offset of the royalty advance that NPS received from Amgen in August 2011 to $ 8 million per quarter with royalties in excess of $ 8 million paid to NPS for the respective quarter, thereby extending the royalty advance repayment period. After the repayment of the royalty advance and a 9 per cent per annum discount factor on the outstanding balance, Amgen will resume paying NPS all royalties earned through December 31, 2018. As of June 30, 2012, NPS owed Amgen a balance of $ 92 million on the royalty advance. “This agreement significantly accelerates our cash flow with at least $ 75 million of incremental cash expected through 2013. These funds are expected to fully support the cash requirements to launch both Gattex and Natpara, and represent a critical step in our transition to a self-sustaining commercial-stage organisation. This innovative transaction underscores our commitment to accessing capital at the lowest possible cost and in a manner that is in the best interests of our shareholders,” said Luke M Beshar, EVP and CFO, NPS Pharmaceuticals.

RUSSIA should open its booming $ 19 billion pharmaceutical market and expedite the list of 500 drugs that it currently imports from India, said Anand Sharma, Commerce Minister, Industry and Textiles, during a recent visit to St Petersburg, urging Russian authorities to let Indian pharmaceutical companies form joint partnerships with Russian companies. India has asked Russia to establish a nodal agency to create a joint committee for implementation of Memorandum of Understanding (MoU) between Indian and Russian pharma companies, especially in the field of quality control

and standard requirements on conformity assessment of pharmaceuticals and bio-pharmaceuticals. India has already nominated its own nodal agency - The National

Institute of Pharmaceutical Education and Research (NIPER) - under the Department of Pharmaceuticals. Russia’s pharma market grew to $ 19 billion in 2011 from $ 6.6 billion in 2005, expanding at a compound

annual growth rate of 23 per cent. However, there are a number of non-tariff barriers Russia imposes, which makes it difficult for foreign companies to enter this market, in terms of drugs registration and R&D of new drugs.

ACEP commends congress for passing legislation that addresses drug shortages

Russia should open up its market to India: Sharma

THE American College of Emergency Physicians (ACEP) commends the United States Senate on passing legislation that will create a federal ban on certain synthetic drugs. The bill will be passed as a law once it receives the President’s signature.

Under this new law, the FDA will also require drug shortages to be reported to the FDA with at least six months notification. Specifically, the reporting requirement applies to drugs ‘intended for use in the prevention or treatment of a debilitating disease or condition, including any such drug used in emergency medical care during surgery.’

Dr David Seaberg, President, ACEP, said, “This law will give FDA the much-needed authority to require drug manufacturers to report any discontinuance, interruption or other adjustment that would likely result in a shortage,

especially those drugs needed to provide emergency care. Obtaining this information in a timely manner will allow the FDA to work with other manufacturers to produce the drug or reallocate resources to ensure the right drug is in the right community at the right time. Emergency physicians do not have the luxury of advanced planning to secure alternative drugs when severely injured patients arrive in the emergency department and the most effective medication is unavailable. The best course of action is to ensure that we do not find ourselves in that situation in the first place.”

The law will also ban two of the 17 ‘bath salts’ chemicals that are currently legally sold in the US. Seaberg adds that emergency physicians witness firsthand how these dangerous synthetic drugs are harming users. These products contain chemicals

that imitate the hallucinogenic or stimulant properties of marijuana, cocaine, ecstasy and methamphetamine, which can cause severe paranoia that may cause harm to the patient and others. The GAO will also conduct a study to examine the cause of drug shortages and provide recommendations to alleviate such shortages. Specifically the GAO must also consider what extent healthcare providers, including hospitals and physicians, are able to adjust care effectively to compensate for the drug shortages and what impediments exist that hinder these efforts.

Sharma

NPS signs amended agreement with Amgen

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News, Views & Analysis

IACC honours Baxter

Strides redeems FCCBs due 2012 net debt/equity at 0.75STRIDES Arcolab has redeemed the outstanding $ 80 million FCCBs on due date. The company had originally raised $ 100 million FCCBs in 2007 and had bought back $ 20 million during 2009. The total payout for redeeming the outstanding bonds was $ 116 million including the redemption premium of 45.06 per cent.

Post this redemption, there are no outstanding FCCBs. Dr T S Rangan, Group CFO, said, “The company diligently planned the redemption thereby achieving substantial de-leveraging of its balance sheet. We take this opportunity to thank the bond holders for their participation in our growth story.”

Mylan confirms first-to-file patent challenge relating to Pristique®MYLAN Inc has been sued by Pfizer Inc, Wyeth LLC, Wyeth Pharmaceuticals Inc, and PF Prism C V in connection with the filing of an Abbreviated New Drug Application (ANDA) with the US FDA for desvenlafaxine succinate extended-release tablets, 50 mg and 100 mg. This product is the generic version of Pfizer’s Pristiq® tablets, which are indicated for the treatment of Major Depressive Disorder (MDD) in adults.

Bristol-Myers to acquire diabetes drug maker AmylinBRISTOL-MYERS Squibb and Amylin Pharmaceuticals, Inc recently announced that Bristol-Myers Squibb will acquire Amylin for $ 31 per share in cash, pursuant to a cash tender offer and second step merger, or an aggregate purchase price of approximately $ 5.3 billion. The total value of the transaction, including Amylin’s net debt and a contractual payment obligation to Eli Lilly & Company, together totaling about $ 1.7 billion, is approximately $ 7 billion. The acquisition has been approved by the boards of directors of Bristol-Myers Squibb and Amylin.

BMS and Pfizer receive CRL from US FDA for Eliquis (apixaban)BRISTOL-MYERS Squibb and Pfizer recently said that the US FDA has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for ELIQUIS® (apixaban) for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation. “There is a significant unmet need to reduce the risk of stroke in patients with atrial fibrillation,” said Elliott Sigal, MD, PhD, Executive VP and Chief Scientific Officer, Bristol-Myers Squibb. “We believe that the two large trials called ARISTOTLE and AVERROES have established the therapeutic profile for ELIQUIS and demonstrated a meaningful advance over the standard of care.”

Teva announces progress of biologic investigational drugs TEVA Pharmaceutical Industries Ltd recently announced the presentation of clinical results for its biologic oncology candidates, lipegfilgrastim and balugrastim, at the Multinational Association of Supportive Care in Cancer (MASCC)/International Society of Oral Oncology (ISOO) 2012 International Symposium on Supportive Care in Cancer held in New York June 28-30. Lipegfilgrastim and balugrastim are long-acting Granulocyte Colony-Stimulating Factors (G-CSF) being evaluated for their ability to reduce the duration of severe neutropenia in breast cancer patients undergoing chemotherapy.

Ipsen’s Somatuline receives marketing approval in JapanIPSEN and its partner Teijin have received manufacturing and marketing approval from the Japan’s Ministry of Health, Labour and Welfare (MHLW) for Somatuline® 60/90/120 mg for sc injection (lanreotide acetate). In Japan, Somatuline® is indicated for the treatment of growth hormone and IGF-I (somatomedin-C) hypersecretion and related symptoms in acromegaly and pituitary gigantism (when response to surgical therapies is not satisfactory or surgical therapies are difficult to perform). Somatuline® will be available in a new enhanced presentation with a pre-filled syringe that does not need reconstitution and with a retractable needle that enhances safety for caregivers.

In Brief 1QFY13E is expected to be a strong and steady quarter: Kotak Institutional Equities

R EPORT by Kotak Institutional Equities states that 1QFY13E is expected to be a strong and steady quarter though not a spectacular one marred by hikes in tax rates and forex losses for certain companies. Priti Arora, Analyst, Kotak Institutional Equities, said, “While year-on-year (y-o-y) sales growth is expected to remain strong for all, we expect PAT growth to be mixed with a few companies reporting flat/PAT decline y-o-y due to hikes in tax rates and lower EBITDA margin y-o-y, forex losses and absence of licensing income. SUN and Divis remain our top picks; we advise using any weakness to add ahead of results.” She added, “Overall, we expect 1QFY13E to be one of the stronger quarters in FY2013E driven by low base of revenues in 1QFY12, ongoing exclusivities in US, pick-up in base business sales from the slew of launches in the US since FY2012 and benefits from rupee depreciation. We expect most of the frontline generic

companies to report strong sales growth of above 25 per cent boosted by higher realisation in rupee terms, exclusivity sales in US for DRL, Lupin, Ranbaxy, Glenmark and SUN on account of Ziprasidone, Lipitor, Cutivate and Stalevo and Lipodox respectively and pick-up in domestic sales growth due to pick-up in underlying growth, low base in 1QFY12; Ranbaxy, DRL, Cipla and Cadila reported single-digit growth rates in 1QFY12, additions of sales from Eli Lilly deal for Lupin.

Despite strong sales growth, we expect mixed EBITDA margin trends across companies and expect EBITDA margin to decline y-o-y for Glenmark, Cadila and Glaxo on account of high base last year and higher import content leading to higher import cost for Glaxo. Arora highlighted, “We expect DRL, SUN, Lupin and Ranbaxy to report highest EBITDA margin improvement y-o-y of over 100 bps due to ongoing sales from exclusivities in the US and operating leverage benefits due to pick-up in base business sales growth for SUN and Ranbaxy. However, we expect PAT to remain flat/decline y-o-y for Cadila, Glenmark, Dishman, Jubilant and Ranbaxy due to lower EBITDA margin y-o-y, forex losses in 1QFY13E versus forex gains in 1QFY12, absence of research/licensing income (Glenmark, Cadila) and hikes in tax rates (Cadila, Dishman).”

THE Indo-American Chamber of Commerce (IACC) has awarded Baxter ‘The Best US Company Operating in India’ under the ‘Other Services’ category. The award was presented at the 8th Indo-American Corporate Excellence Awards (I-ACE 2012) ceremony in Mumbai. The award was given to the organisation based on human capital management, corporate social responsibility and overall contribution to Indo-US business.

Anish Bafna, MD, Baxter India Pvt Ltd said, “This award is recognition of Baxter’s commitment to creating lasting social, environmental and economic value for our stakeholders in India’s healthcare

community. Baxter employees in India are motivated by a sense of responsibility and desire to make a difference. On behalf of the 1100 employees, we thank the IACC for this honour and recognition of our contributions to India’s needs for the past 15 years.” A distinguished independent jury comprising of business leaders from Indian and US based companies and the consular corps from the US Consulate evaluated the various participating companies. The ceremony was attended by over 300 guests including representatives from the Indo-US business community, government and business leaders, industrialists and members of the

US-India Business Community.

China amends patent law in fi ght for cheaper drugs

CHINA has overhauled parts of its intellectual property laws to allow its drug makers to make cheap copies of medicines still under patent protection in a move likely to unnerve foreign pharmaceutical companies. The Chinese move comes within months of a similar move by India to effectively end the monopoly on an expensive cancer drug made by Bayer AG by issuing its first so-called compulsory licence. Similar action by China will ring alarm bells in Big Pharma, since the country is a vital growth market at a time when sales in

Western countries are flagging. The amended Chinese patent law allows Beijing to issue compulsory licences to eligible companies to produce generic versions of patented drugs during state emergencies, or unusual circumstances, or in the interests of the public. For reasons of public health, eligible drug makers can also ask to export these medicines to other countries, including members of the World Trade Organisation

(WTO). Compulsory licences are available to nations to issue under WTO rules in certain cases where life-saving treatments are unaffordable.

Chinese move comes within months of

a similar move by India to end

monopoly of expensive cancer

drug

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News, Views & Analysis

The 5th Pharma Leadership Summit & Business Leadership Awards to be held in Mumbai

Ampio contracts with Syngene

Marken launches global regulatory

consultation services

Bayer declares data from the Phase III ALSYMPCA

In Brief

Biogen and Isis collaborate BIOGEN Idec and Isis Pharmaceuticals, Inc have entered into an exclusive, worldwide option and collaboration agreement under which the companies will develop and commercialise a novel antisense drug for the treatment of myotonic dystrophy type 1 (DM1), which is also known as Steinert disease.

Roche to cut 1000 jobsROCHE site in Nutley (New Jersey, USA) is to be closed and around 1000 jobs will be cut. The respective R&D activities are to be consolidated in Switzerland and Germany. The planned site consolidation and the streamlining of research activities within Roche’s pharma research and early development unit will support efficient allocation of resources for the group’s expanding product development pipeline. Roche Pharma will continue to have presence with Pharmaceuticals Translational Clinical Research Center of about 240 positions.

Sony DADC collaborates with Sony MedicalSONY DADC BioSciences has joined forces with its Sony Medical Business Unit (MBU) to develop and manufacture smart consumables for its new SH800 cell sorting instrumentation system. Christoph Mauracher, Head - BioSciencess, Sony DADC said, “The company was chosen based on its technical and commercial merits. The project presented significant technical challenges regarding redesign and precision including manufacturing to ISO 13485 standards.”

T H E 5 th Annual Pharmaceutical Leadership Summit & Business Leadership Awards 2012 will be held in Mumbai on Friday, 21st September at Hotel Hilton, Mumbai. It is being organised by Pharmaleaders in association

with various associations of the Pharmaceutical & Biotechnology Industry & supported by the Ministry of Commerce, Government of India & Maharashtra as the State Partner. Leaders will debate on ‘Brand India Pharma in line with the Indian

Government’s objective & vision to project Indian Pharma Industry in the global map.’ It will felicitate Business Leadership Awards to top performers in 30 categories. It is expected to see more than 200 CEOs participation from overseas.

AMPIO Pharmaceuticals, Inc (AMPE), a biopharma company conducting clinical trials on its three lead drugs (Ampion™, Optina™ & Zertane™), licensing distribution of these drugs and developing additional new drugs, is proceeding with the development plan for a combination product to treat both Premature Ejaculation (PE) and Erectile Dysfunction (ED).

Vaughan Clift, MD, Chief Regulatory Officer, Ampio,

noted, “Contrary to rumours that the FDA did not recognise PE as a treatable ailment, the FDA has expressly adopted the definition of PE as a disease condition, using the definition of PE provided by the International Society for Sexual Medicine (ISSM) Ad Hoc Committee

(ie, PE is characterised by ejaculation Ampio was recently awarded multiple patents worldwide for combinations of Zertane™ with any PDE5 inhibitors and for reduction of side effects of Tramadol. These patents will benefit from a full patent life and are important for negotiations with potential partners whose PDE5 inhibitors patent protection has expired or are about to expire which could be greatly extended by Ampio’s patents.”

MARKEN has launched ‘Marken Consultation Services’. This service provides global customs and agency regulation expertise for the pharma industry.

Import and export requirements are increasingly more complicated with ever-changing industry guidance and governmental regulations. Marken has been able to overcome these regulatory challenges for its customers. Marken keeps up to date with these changing regulations and provides solutions when necessary in order to keep shipments on time. Marken experts include licensed customs brokers, import specialists, and life science experts, aggregating more than 100 years of combined trade and regulatory compliance experience.

“Navigating US customs and government agencies for shipping drugs, biologics, specimens and APIs is a daunting and time-consuming task for the pharma industry, but this is what we do. We are offering this service to clients seeking advice before they start their planning. We engage clients early in their process so we can lead them through the maze of regulations, thus allowing them to focus their energies on R&D,” said Dan Bell, Director- Commercial Operations & Regulatory Compliance, Marken.

BAYER HealthCare recently announced updated data from the pivotal Phase III ALpharadin in SYMptomatic Prostate Cancer (ALSYMPCA) trial for its investigational drug radium-223 dichloride in men with Castration-Resistant Prostate Cancer (CRPC) and symptomatic bone metastases. “Bone metastases are one of the main causes of morbidity and death in patients with castration-resistant prostate cancer, yet until now there has been little progress made towards developing therapies that treat the cancer when it has spread to the bone,” said Dr Chris Parker, Principal Investigator, ALSYMPCA.

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News, Views & Analysis

Weight loss drug approved by US regulatorsUS regulators recently approved Arena Pharmaceuticals’ (ARNA) weight-loss drug Belviq - the first new prescription diet pill cleared for sale in the US in 13 years.

In approving Belviq (formerly known as lorcaserin), the US FDA followed the recommendation of an outside panel of experts who voted 18-4 with one abstention last month to support the weight-loss drug, while still voicing concerns about lackluster efficacy and lingering safety questions.

Natco Pharma loses Copaxone patent litigation against TevaTHE US District Court for the Southern District of New York has upheld the contention of Teva Pharmaceuticals (Teva) that NATCO Pharma`s (the company) Abbreviated New Drug Application (ANDA) for the generic version of Copaxone ® infringes all the asserted claims of Teva Pharmaceuticals.

NATCO has filed, with its partner Mylan Inc, in June 2008, an ANDA seeking approval for marketing of the generic version of the relapsing, remitting multiple sclerosis drug Copaxone ® and obtained a Para IV certification which essentially challenges the existing patents held by Teva Pharmaceuticals.

Astellas launches hyperphosphatemia medication in JapanASTELLAS Pharma launched Kiklin capsules 250mg (generic name: Bixalomar) in Japan for the treatment of hyperphosphatemia in patients on dialysis with chronic kidney disease.

The amine-functional polymers, Kiklin capsules, demonstrated the clinical efficacy in decreasing serum phosphorus concentration, in addition to a preferable long-term safety profile, in Phase III studies in patients on dialysis with chronic kidney disease in Japan.

Eisai to enter the Russia with the launch of epilepsy drug Zonegran ENTRY into the Russian marketplace is part of Eisai’s expansion plans, which include having a presence in the top 20 pharmaceutical markets and help treat more than 500 million patients by 2015.

Zonegran (zonisamide) is expected to be available across Russia as adjunctive therapy in the treatment of adult epilepsy patients with partial seizures, with or without secondary generalisation by the end of Eisai’s financial year 2012 (30 March 30, 2013).

HAL Allergy extends GMP contract manufacturing activitiesHAL Allergy BV has succeeded in extending its GMP contract manufacturing activities for clinical batch supply of both recombinant and viral products. The Dutch inspectorate had granted the permit extension after inspection of the operational activities in the BSL2 clean rooms and development laboratory in June 2012. Commenting in this regard, Harry Flore, CEO, HAL Allergy, explained, “This is a big step forward in our goal of becoming a key biotech service company. Modern production- and laboratory facilities and over 50 years experience in vaccine production will be key asset in partnerships with our customers.”

Optimer’s Dificid® (fidaxomicin) tablets approved by Health CanadaOPTIMER Pharmaceuticals, Inc recently declared that Dificid® (fidaxomicin) tablets were approved by Health Canada for the treatment of Clostridium Difficile infection (CDI), in adults 18 years of age and older and that Dificid is now available to treat patients in Canada.

This approval was based on Health Canada’s evaluation of two large MNC Phase III clinical trials demonstrating that Dificid was as effective as oral vancomycin in providing an initial clinical response and was superior in providing a sustained clinical response for 28 days post treatment. Dificid is the first new treatment for CDI to be approved in Canada in over 20 years.

THE Himalaya Drug Company launched HiOwna-Jr for kids, a prescription-based nutritional supplement that promotes physical and mental growth and enhances immunity in children from age two to pre teens. It has been launched in two flavours - strawberry and chocolate.

“HiOwna-Jr is a unique health formulation that contains herbs widely known in Ayurveda for promoting child health,” said Philipe Haydon, CEO – Pharmaceuticals, The Himalaya Drug Company.

“We developed HiOwna-Jr keeping in mind the overall physical and mental growth in children and stronger immunity. That is why, in addition we have also included herbs known for their superior health benefits. HiOwna-Jr is fortified with 13 essential vitamins A, B1, B2, B6, B12, C, D,E, K, Niacin, Biotin, Folic acid, and Pantothenic acid and 9 minerals Iron, Iodine, Calcium,Phosphorus, Magnesium, Zinc, Chromium, Selenium and Molybdenum. It also has ragi (finger millet) that improves nutritive status; maricha (black pepper), a bio-availability enhancer;

Mandukaparni (centella), a cerebral activator, also known as ‘brain food’ in Ayurveda; and amalaki (Indian gooseberry), an immunity enhancer and the richest source of Vitamin C in nature,” added Haydon.

“HiOwna-Jr is the only health supplement in India to have pea protein along with the traditional whey protein,”

explained Dr Ajay Tumaney, Group Leader—Functional Food Development. He also highlighted, “Colostrum or ‘first milk’ is an excellent source of immunoglobulins, proteins that fortify the immune system and fight infections. It also contains proline-rich polypeptides that have a unique ability to modulate the immune system.” HiOwna-Jr. contains 30 times more colostrum per gram,

compared to other brands available in the category.

A recent Frost and Sullivan report pegged the nutraceuticals market in India at $ 1480 million in 2011, expected to reach $ 2,731 million in 2016 at a CAGR of 13.0 percent. Of this, the nutritional and health supplements are the largest sub-category accounting for 64 per cent of the market.

“Over the next two to three years, we intend to build the HiOwna into a 100 crore business. Eventually, we will have a separate business vertical exclusively focused on nutritional and health products for children and people of different age groups addressing different conditions,” said Philipe.

“We have high expectations from HiOwna and the 100 crore target seems well within reach. Firstly, we have a unique product. Additionally, we are clearly recognised as the face of contemporary Ayurveda. Finally, doctors trust Himalaya’s products. We enjoy their confidence of being an R&D driven company. As always, Himalaya will highlight the science behind HiOwna Jr,” he added.

Himalaya launches its fi rst prescription nutri-health product

In Brief

MOVIANTO, the logistics and transportation provider specialised in the pharma industry, has extended its existing agreement with LEO Pharma in order to encompass further European countries. Already providing logistics services to LEO Pharma in the UK, Denmark and the Czech Republic, the company has now awarded exclusive contracts to Movianto in Germany, Switzerland, Austria, the Netherlands and Belgium, now covering the majority

of Europe. Movianto around Europe will be undertaking full order to cash solutions on a country level for the client’s full portfolio of dermatology and thrombosis products. The range of services provided includes order entry, pick &pack and transportation, invoicing as well as cash collection and the handling of returns. The products will be delivered to wholesalers, pharmacies, hospitals and doctors.

Steen Winther, Director - Group Logistics, LEO

Pharma, commented,”We have been highly satisfied with the services provided by Movianto in the UK, Denmark and the Czech Republic and so it was a clear decision for us to extend the contract to include further countries. Movianto has shown great flexibility and excellence of service. The consolidation of service providers has also been of benefit to us and we are looking forward to continuing our successful relationship with the company.”

Movianto and LEO Pharma extend their business partnership throughout Europe

Intensifying treatment with NovoMix® 30 improves blood glucose controlNEW data from a subgroup analysis of the A1chieve® study show that intensifying treatment with NovoMix® 30 (Biphasic insulin aspart) can significantly improve blood glucose control in people with type 2 diabetes with a reduced incidence of hypoglycemia.

The results are from a subgroup analysis of 1033 patients, who were first treated with NovoMix® 30 twice-daily then intensified to three-times daily over the 24-week study period. The results show that patients had significant improvements in their blood glucose control without compromising safety.

Before initiation with NovoMix® 30, the average blood glucose control (HbA1c) among this subgroup of patients was (as high as) 9.8 per cent, despite the fact that 80.6 per cent

were receiving oral glucose-lowering drugs. This figure is well above the American Diabetes Association (ADA) recommended target of 7 per cent and such poor blood glucose control puts people at high risk of developing diabetes-related complications. The overall incidences of hypoglycaemia were reduced from 4.26 to 3.76 events / person-year.

Commenting on the data, Professor Philip Home said, “The study shows that premix insulin aspart when increased to three injections daily is an effective option for people with type 2 diabetes whether starting insulin or moving from other insulins. Improvements in blood glucose control of this magnitude would be of clinical importance to the people achieving it.”

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News, Views & Analysis

PharmaSuite to offer improved time to obtain results

VICAM’s immunoaffi nity column to enhance laboratory analysis

ROCKWELL Automation has released Rockwell Software PharmaSuite, version 4.0, the next generation of manufacturing execution system software specifically targeting regulated industries. Leveraging more than 20 years of experience in pharmaceutical manufacturing, PharmaSuite enhancements set a new standard for lower risk, lower cost and time to results while meeting the regulatory requirements found in the life sciences industry.

“The enhancements to Rockwell Software PharmaSuite reinforce our commitment to the life sciences industry,” said John Genovesi, VP - Information Software and Process Business, Rockwell Automation. “The new version offers significant performance, usability and deployment advantages enabling our customers to reduce cost of compliance and improve their manufacturing capabilities.”

PharmaSuite allows regulated manufacturers to meet their operational goals and productivity requirements in a consistent and predictable way. It tracks material, equipment and personnel involved in the manufacturing process and maintain a complete electronic batch record. PharmaSuite is based on S88 and S95 standards, which allows for better integration with other enterprise systems involved in manufacturing operations.

VICAM®, a Waters® Business, introduced the DON-NIV™ WB Immunoaffinity (IA) column, the only IA column in the market to simultaneously screen for Deoxynivalenol (DON) and Nivalenol (NIV). Coupled with liquid chromatography analysis, the DON-NIV WB column provides over 90 per cent recovery of both DON and NIV and doubles the productivity of commercial, government and food safety research laboratories.

“The new DON-NIV WB column provides rapid and simple sample

preparation using the superior strength of monoclonal antibody technology. DON and NIV are analysed simultaneously in the same sample, facilitating ef f ic ient research and more effective r i sk management for industry,” said Dr Stephen Powers, Head - Research & Development, VICAM.

“DON was the first trichothecene mycotoxin to be regulated by many countries. Increased interest in related toxins such as NIV drives the need for improved technologies,”

commented Marjorie R a d l o , G e n e r a l Manager - Director of Operations, VICAM.

DON and NIV are tr ichothecene mycotoxins produced by fusarium molds. Animal feeds which are contaminated with fusarium toxins cause feed refusal, weight loss, vomiting and diarrhoea – resulting in significant health, p r o d u c t i o n , a n d economic risks. NIV has also been linked to lung and brain haemorrhage and bone marrow i n j u r y t h r o u g h disruption of DNA and protein synthesis.

Cole-Parmer unveils fl uid handling and lab equipment at ACHEMA 2012

COLE-PARMER, a global leader in fluid handling, life science, general laboratory products, instrumentation, and equipment, presented a wide range of Fluid Handling and Lab Equipment at Achema 2012.

Attendees of ACHEMA had the opportunity to see a variety of Masterflex® pump systems live at the event. Lab equipment featured included

the Cole-Parmer® Rotational Viscometer, the StableTemp® Modular Block Heaters, the

Stir-Pak® high-speed, low-torque overhead stirrer system is a heavy-duty modular system that allows users to customise components to suit their mixing application. Several high-quality Oakton® thermometers were also available, including the Oakton® TempTestr® Infrared Thermometer with laser vision to pinpoint the center of the measurement area.

Bio-Rad’s QX100™ PCR awardedBIO-RAD Laboratories, Inc’s QX100 Droplet Digital PCR system won R&D Magazine’s R&D 100 award. These awards recognise the 100 most technologically significant products introduced into the marketplace over the past year.

“The QX100 Droplet Digital PCR system provides single copy PCR resolution to accelerate discoveries and new strategies for the research of inherited disorders, cancer, and infectious disease,” said Richard

Kurtz, Bio-Rad Division Marketing Manager, Gene Expression Division. Digital PCR, and more specifically droplet digital PCR (ddPCR™), is a refinement of real-time PCR that enables researchers to directly quantify and amplify nucleic acids, including DNA and RNA. With ddPCR the sample is separated into a large number of partitions and the amplification is carried out in each partition individually.

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In Conversation With

While driving his black-coloured Mercedez Benz (S-Series), the down-to-earth MD of Marck Biosciences, Bhavesh Patel explained how he tries to instill the values of simple living to his son. He does not consider his house or his car to be his priced possessions, and laughs off by saying, “All that belongs to the company.” He holds a Bachelor’s degree in Mechanical Engineering and a Master’s degree in Business Administration (Finance). After quitting a finance career, he held on to his dreams of doing something of his own. From mutely observing the operations of various companies in different verticals, he decided to be a part of the pharma industry. He says he wanted the industry to be capital intensive, should have scope for expansion and growth and be a generic product and not one which needed aggressive branding. Thus, Marck started its operations in 1997 near Kheda, Gujarat, with IV fluids and parenterals. In this free-spirited conversation, Patel takes us through the crescendo of his personal and professional life.

Start of the empireArmed with a Masters in Finance, Patel dabbled his hand as a merchant banker for a short while. But soon, he realised he had to fuel his dreams to open a company further, and quit. “At that time my parents were in the US and I wanted to migrate there. But somehow things took a different route,” he says. After quitting his job, he went back to Ahmedabad. He surveyed the options, travelled abroad extensively and studied different companies minutely, “I listed down a few segments that I was interested in, and that included auto ancillaries and medical instruments.” After thoroughly studying different sectors he came up with a specific criteria

for the industry he would enter. After arranging the necessary funds, he set up Marck at Kheda district in Ahmedabad, Gujarat. It is spread over 25 acre with a built-up area of around 19,000 square metre. It is capable of manufacturing Large Volume Parenterals (LVP) and Small Volume Parenterals (SVP). The facilities are ISO-certified and cGMP compliant. They meet the requirements of the regulatory authorities of countries such as the UK, Australia and groups like the EU. So why the name ‘Marck’ and he says, it was decided after some family member suggested it as per some astrological beliefs. Prod him further on whether things have come easily, he shurgs it off saying, not at all. The growth figures of the company tell a tale of steady perservernce and constant efforts. “If there was one thing that I could do differently since the start of the company, I believe it would be to be methodical since day one. I was not very methodical and systematic at the start, and learnt it the harder way,” he says, matter of factly.

Tough timesPatel had to face tremendous challenges in various forms to reach where he is today. At the time of establishing the company, getting the required finance was a task. He needed an investment at the tune of Rs 22 crore to set up the unit and the stock market was in bad shape. “I relied on personal finances at the start. I gathered money from friends and family, and even bank loans. It was tough to gather money through different sources and put things in perspective,” he recollects. The company had a turnover of over ` 6.5 crore in its very first year, and today Patel has plans to soon reach the ` 100 crore mark. After that hurdle was surmounted, a calamity at the plant became another. During the trial run of the plant in 1998, heavy rains affected the city. The manufacturing facility was partly submerged and there was considerable damage. He says, “Being in its infancy, the floods caused

a major blow. It took around three to four months to get the facilities back in action.” Thus, Patel proved that he is stronger than the problems, and moved on. The setback caused to the rains, pushed the company a bit further and created problems in obtaining the licence and the delayed production cost. But that too was conquered eventually.

How successful has ‘Marck’ been in leaving a mark in the industry since inception?Marck Biosciences was started in 1997 with one small line for making intravenous solutions; today we have more than seven Blow-Fill-Seal (BSF) lines. Over a period of time, Marck Biosciences has successfully moved from the image of a manufacturer to a preferred partner for many Indian as well as international pharma companies We also are the top three companies in the

country to make SVP. Marck Biosciences is among the few Indian pharma companies who have geared their production facility to become a versatile manufacturer of 0.5 ml injectibles to 1,000 ml irrigation solutions. We are also the first company in the world to launch Paracetamol IV in a plastic pack. I believe Marck Biosciences has successfully proved its versatility in the BFS space and is truly an emerging leader in the market.

How have you ensured that Marck has maintained the quality over a period of time?I believe that a good manufacturing facility is the one that has good hardware, evolved systems & trained manpower. We have extensive 48 hours induction programme, 45 days on-job training and evaluation of performance at various

stages. This programme has worked for us and we intend to continue the same, but lot more can be done. With the increasing developments in the Indian pharma industry, competition is only going to get tougher and quality standards stricter. I think that most pharma companies are adhering to quality standards, and will need to continue doing the same. It is a matter of losing the market and brand value for a company, once they lose out on quality.

If not Marck…I probably would have been involved with something that had to with ‘technology,’ and mostly something of my own. I definitely would not have continued in banking.

What next?Personally, I am happy the way things have panned out. I would have not continued my financial job streak for sure; I definitely would have gotten into doing something technical. At Marck, we are working across six therapeutic segments. Overall, the emerging market trends would continue to vary from segments to segments.

What started as a dream in 1997, for Marck to become the leaders in manufacturing IV fluids, has today become a reality. Under the leadership of Bhavesh Patel, MD, Marck Biosciences, the company has grown more than 10 times over the last decade. Excerpts from the interview with the versatile leader.

Quick bytesMessage to youngsters: Work hard; there is no substitute for hard work!One word that sums up all tips for success: ‘Execute’Tech savvy? Not much. E-mails are seen on a paper; writes down the next point of action

Staying true to one’s dreams

Parita [email protected]

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Special Focus

Being happy and satisfied at work is a rare combination. For the employee, it

not only gives the feeling of being worthy but also helps him/her give their best to the company. However, there are a few problems being faced by employees today in terms of compensation, a healthy work environment, a support team and many more that ultimately lead to attrition. Being a highly organised and knowledge-oriented industry, pharma sector requires employees who are highly skilled and talented; the loss of an employee may affect the company negatively.

Core of the problemAs globalisation has kicked in and a number of MNCs have entered the Indian pharmaceutical industry space, resulting in increased exposure for the employee. This in turn has increased the

expectation an employee has from an organisation. Due to these expectations, a number of issues have come to the surface. “Though there is ample skill available in the market, the sole problem of finding the right candidate for the right job still remains. Pharmaceutical companies today are not able to find the best candidate for their positions due to the same reason,” informs D G Rajarshi, Managing Consultant, Pharma Resource.

The production or R&D experience required for one company may not be the same everywhere, and hence, it is important that the candidate is extremely specialised in his/her field. Due to which it is also important that recruitment is done after a close look at the candidate’s profile.

Inspite of being aware of this a number of companies rush through the process of recruiting a fresher. “At the entry level, companies are in a hurry to recruit people as they believe they can train the employee as per their requirements, so whichever is the quickest recruitment they go ahead with that. But in my opinion the entry level recruitment is the most crucial of the lot. As the employee is a beginner it is important to ensure that the candidate is hired for a department he/she has an inclination towards; only then will they be in a position to produce the desired results. Today, manpower is available and India is churning up a lot of qualified graduates, but the required importance to technical skill is not given; the focus should be technical skills and not soft skills. It is only when the outlook towards this changes, will the entry level problems wash away,” explains Rajarshi.

One of the topmost problems being faced besides entry level recruitment is the increasing attrition rate. Several factors aid to this; right from the work environment, promotional avenues , compensation, etc. Another factor is redundancy; with

fast developing technology even the most experienced people in the industry are overpowered by the feeling of being redundant as they do not have access to the latest upgradation programs and lack training. “The work environment also plays a major role. The work environment of a company depends on the culture of the particular company, which varies from one company to the other. It is found that most of the new recruits tend to compare the work culture of the current company with that of their previous one. As no two companies can be the same; there is always a difference and this comparison forces people to get into a shell and not produce the desired results, or sometimes even think of a job change,” says Rajarshi.

Also, companies in the pharmaceutical sector do not involve the family as much as the other industries do. Motivation from within the home is very poor. “A few challenges are also being faced in terms of sourcing profiles for unique positions, ie, bio analytical, FDA auditing skills, lack of good communication skills, lack of domain knowledge, frequent job changes by candidates – low on employer stickiness and absorbent salary expectations at senior levels and more offer drops,” informs Suresh Anubolu, Chief Human Resources Officer, GVK BIO. Though these factors play a vital role in making an employee leave an organisation, there are various ways in which these can be worked upon and exits can be restricted.

Overcoming the challengesRecruitment on the whole is a tedious and a challenging job. However, besides this every industry witnesses certain industry-specific challenges, which they need to overcome to ensure that the employees are working in a stress free and relaxed environment, which makes them want to continue working in the same company.

For beginners, the work environment of a company is completely in the hands of the management. “A company must perform a kind of benchmarking exercise to observe what the employee desire. The kind of promotional avenues the employees would like to have should also be looked into

as there is a lot comparison between co-workers and the pharmaceutical industry in general is being competitive by the day,” expresses Rajarshi. He adds, “As for compensation, there needs to be some kind of clarity between companies of similar stature. For instance, companies below ` 100 crore should be in one stature and so on; once the stature is marked the compensation for the same stature should be more or less the same. There should not be a great amount of disparity in terms of compensation as it further increases the sense of incompetence and lack of confidence in the employee.”

Various retention strategiesTo retain the employee, the company first needs to identify the problem within the organisation. “They need to find out where the company is lacking. For instance, for one company the problem can be compensation, in the other it could be environment, etc. Depending on the stature of the company, the right compensation and environment can be provided,” says Rajarshi.

Creating an encouraging atmosphere with regards to awards, regular appraisals, public announcement of one’s achievements are a few steps being taken by various pharma companies today to ensure that the employee is happy at his/her workplace and wishes to continue.

“In addition to these, a few more strategies that are recently being adopted are faster career growth. This involves internal transfer. This is an extremely effective strategy, as employee might not be satisfied with his/her department. If one is given the option of internal transfer, the employee not just enjoys his/her work as they work in the department of their liking but their loyalty towards the company also increases,” explains Anubolu. Further explaining the other strategies, he adds, “Fairness in pay – as per market data, higher education policy, job rotation and rewards and recognition are crucial factors and must be followed by all companies to retain their employees. It is not just important to pay the employee well, but to ensure that he/she is working in a perfect environment with a blend of all these factors is equally important.”

With so much of talent available, getting the right person for the right job remains a challenge. “Every company has an HR department and they have their Key Performance Indicators (KPIs) at all levels and sometimes the focus is to catch someone from a bigger company. In the race to get someone bigger and better people, one tends to miss the calibre and skills of the person they hire,” concludes Rajarshi.

Strategies of pharma HRStrategies of pharma HR

Recruiting and retaining the right talentDue to increasing competition many employees succumb to the pressure job change at regular intervals. It is important for a company to spot the problem and find solutions to ensure that they can retain their employees. We discuss the various challenges faced by employees and also the retention strategies adopted by various pharma companies.

Jasleen Kaur [email protected]

Comparison (between present and previous companies) forces people to get into a shell and not produce the desired

results, or sometimes even think of a job

change.

D G RajarshiManaging Consultant,

Pharma Resource

If one is given the option of internal

transfer, the employee not just enjoys his/

her work as they work in the department of their liking but

their loyalty towards the company also

increases.

Suresh AnuboluChief Human Resources Offi cer,

GVK BIO

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Special Focus

I t is definitely more than often that we have faced attendance problems in the company and with a

click of the mouse the Human Resource (HR) department of the company has come forward with solutions. Indeed it is no rocket science or magic but definitely it takes a lot to be organised and ‘well managed’ as they call it. And extending a helping hand in this matter had been the inclusion of IT in the HR department of the company.

For any organisation, the HR department is one of the most vital departments. And HR cannot function without adequate IT solutions. IT makes the task easier and more efficient. The role that started with managing payroll system has broadened its horizon now.

Current scenarioToday, HR is an efficient tool for managing the talent pool of a company along with increasing their productivity and skills. Talking in this regard, Dr G P Naik, Director, International Institute of Human Resource Management (IIHRM), avers, “HR managers are traditionally known for carrying out routine functions like time office, security, canteen, payroll, statutory compliance and so on. But over the past 20 years the revolution of globalisation and

privatisation has brought world class organisations to open their offices in India. These organisations also brought with them the best practices in HR that can add value to business beyond the traditional routine activities.” Dr Naik adds that the HR professionals in India then realised that if they have to engage meaningfully to contribute for the success of business, they have to divest themselves of the mundane HR activities. Dr Naik highlights, “Two approaches that emerged to provide solace to HR managers at this juncture are outsourcing and automation. Functions such as employee services that cannot be handled by technology like employee relations was outsourced and the transactional activities like payroll, attendance, leave records, induction training were automated.” Seconding his thought, Suketu Shah, Director, Soham Computers, elaborates, “In a pharma company, never less than 100 employees are working at one time. Thus, IT helps in giving an order to the attendance system. With the help of IT direct data is obtained and through automated systems calculation of PF, loans, etc, becomes easier.”

Transactional HRIn a pharma company transactional HR functions are the routine activities carried out in the HR department like payroll, statutory returns, time management, attendance and so on. Dr Naik elaborates, “These activities are well defined, voluminous and repetitive in nature. Manually handling these traditional HR

activities is expensive, time consuming and capable of causing frequent errors. Hence, right answer to these problems was found through automation or computerisation. Initially, there was skepticism about automation in HR because of

the high investment and the resistance to technology due to lack of knowledge.” Dr Naik adds that HR managers were also worried about losing their jobs since it will be taken over by the computers. He emphasises, “But as we moved along with the changing times, cost of automation not only came down but quality of services improved; more and more HR managers became techno savvy and they reinvested their roles from being record keepers to business partners.” Transactional HR functions are structured, time bound and repetitive in nature; for example, calculation of provident fund or income tax deduction. Dr Naik says, “In case of smaller organisations having five or 10 employees it is possible even today to do them manually. But in larger organisations automating these functions will save the cost of manpower, improve the speed and accuracy, and

relieve the HR managers from unimportant activities to enable them focus on business.” Elaborating further in this note, Shah adds, “Nowadays, with IT in place, in a pharma company it is possible to know the detailed information about the employees, like his areas of work, his educational qualification, professional skills, experiences, etc.”

Cost factorIn most of the cases where technology is involved cost becomes a deterrent, bringing a hindrance to the progress path. Discussing the cost factor, Dr Naik elaborates, “The decision to automate transactional HR activities or carry out manually is basically a question more of mindset rather

than financial constraints. Today, there are hundreds of technology service providers in the market than ever before who are willing to come to one’s office, customise the software to one’s requirement and maintain it without interruption. Costs have come down substantially and even for as low as ` 10,000 a year so that smaller organisations can have their transactional HR activities automated.” Commenting on the cost factor, Shah says that this involves simple software and in most of the cases cost is not a hindrance. He adds, “The cost varies from ` 10,000-1,00,000 depending on the variety. The ones that perform simple calculations cost ` 10,000 and with increase in the performance capacity the cost also increases.”

Future ready Performing HR functions in a pharma company does not require any advanced knowledge in IT. Dr Naik says, “The challenges in automation of transactional HR are how one changes the mindset of service providing HR functionaries and service using employees. Service providers in manual system had lot of power and control on the service users. Similarly some service users like workers union leaders also had a ground to raise an issue about routine activities like attendance marking, salary payment, etc. When one automates, the people who were in control feel losing grip over the matter and brand automation as bad for the business. Hence, changing the mindset of people is the bigger challenge.” He continues, “The situation of automating transactional HR functions is well on time in pharma organisations and evolving in the traditional manufacturing sector but the situation is under control. Organisations are realising that the benefit of automation is much more than the cost involved for implementation.” He explains that organisations learn from each other’s experience as aptly described in the social learning theory of Albert Bandura. He reiterates, “HR associations such as National Institute of Personnel Management and National HRD Network shall organise more collaborative seminars and meetings with HR technology service providers to promote meaningful understanding. At the same time, HR technology companies should devise far more user friendly technology and pricing strategies, which are affordable to even the smallest HR department.” Therefore, IT has definitely brought decorum to the management of the employee strength of a company and thereby brought more productivity to the talent pool.

IT in transactional HR functionsIT in transactional HR functions

Providing a structured frameworkFrom maintaining time record to ensuring accurate payroll transactions, HR of a pharma company takes care of all. But manually the work becomes cumbersome. Hence, IT ensures error free and smooth work structure. Read on to find more about the difference that it brings.

The situation of automating

transactional HR functions is well on

time in pharma organisations and

evolving in the traditional manufacturing sector.

Th e decision to automate

transactional HR activities or carry out manually is basically a question more of

mindset rather than fi nancial constraints.

Dr G P NaikDirector, International Institute of Human Resource Management

(IIHRM)

In a pharma company, never less than 100 employees are working at one

time. Th us, IT helps in giving an order to the attendance

system.

Suketu ShahDirector, Soham Computers

Chandreyee [email protected]

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Special Focus: Interface

From an HR perspective, what are the trends in pharmaceutical marketing and sales functions today? Pharmaceutica l sa les professionals stay on top of the trends in the latest sales software applications; the newest prospective customers and their own networking base work for referrals. A pharmaceutical marketing consultant needs to know where to fit in the scheme of things relating to the clients’ best interest to make sales. While a pharmaceutical marketing consultancy remains a top choice for many clients, others prefer to use their own websites and in-house marketing plans to move their products. Others shop online for their inventory through the many global trading portals open now. Attrition at sales representative level remains a challenge for HR professionals. The attrition stands at around 30 per cent, which is a huge number if one considers that an average pharmaceutical

company would have at least 1,000 sales professionals. A huge chunk of the recruitment budget is spent every year on replacement of frontline sales professionals. Few steps that HR professionals have taken to curb this trend is to overview the compensation of sales professionals; however, this has had little impact on attrition itself.

How can a pharmaceutical company respond to cost control?The Indian pharma industry is witnessing attrition of 30 per cent at the field level and around 10 per cent at managerial levels. A few key HR-related measures that pharma companies can adopt in controlling cost are:

HR should become a strategic partner to the organisation: It is important that the HR teams in pharma organisations plan their management development, competency benchmarking, performance management and compensat ion strategies meticulously to ensure they retain and enhance productivity of employees and focus on conducive work culture

Flexible workforce to suit business requirements: Outsourcing and contract staffing are evolving trends that pharma companies have adopted for functions such as sales and IT. This provides them with tremendous flexibility to meet business demand at lower costs

Leverage technology and social media collaboration and marketing: There are various cloud-based applications that can be used to monitor the productivity and collaboration of employees. The overall investment in technology can be reduced through these tools. Also, social media has created a way to establish a direct link with employees and customers. These technology levers can serve effectively in employee engagement.

What are the challenges faced by the pharmaceutical companies today in terms of recruitment? How can the HR department help overcome that?A few measures can be taken, which are:

Creating a strong employer branding for the company:

The HR in collaboration with the marketing team should create employer brand awareness among the institutions where the employable community is being groomed. This could be play a major role in creating visibility and inviting talent to the organisation

Employability of the technically qualified community: The pharma selling happens through quick, smart and timely interaction with a member of the medical practicing community. The chunk of students or already employed members of the organisations somewhere seem to miss out on communication and the right attitude required to not just sell pharma but to win the space with the doctors. The HR department should play a vital role in assessment of employees and ensure training to members not just on the technical aspects of the products, but also extensively invest in improving personality, p r e s e n t a t i o n a n d communication skills.

Compensation and added benefits are the biggest driving force for an employee. How can a pharma company maintain a balance between the benefits to the employees and maintain profits within the company?While 80 per cent of metrics used by large pharmaceutical companies to determine incentives are financial, only 12 per cent are related to drug development and commercialisation. R&D is the backbone of any leading MNC pharma company and that is what gives them an edge over their nearest competitors. Pharmaceutical industry sales and R&D functions have operated on the premise that activity yields results, but that formula does not work. The pharmaceutical industry now has to turn itself inside out and focus on investments that produce results for customers.

What have been the strategic changes in the pharma recruitment market over the years?

Every organisation has the option of choosing candidates from two sources: external and internal. Sources within the organisation (transfer of employees, promotions, referrals) are internal. These minimise cost and also enable a ready talent pool for the company at any point in time. The external sources are largely different portals and outsourcing agencies. Companies have now opened upto RPO and VMS models, which are complete outsourcing of the recruitment process to manpower agencies. This is turn helps them to concentrate on core activities.

What kinds of retention strategies would you suggest for a pharma company to follow?The Indian pharma industry is growing exponentially, and companies are taking the big leap from survival to competitive strategy. Hence, there is a constant demand for the best talent, and the subsequent result is heavy attrition. Compensation also plays a vital role in the retention of quality talent and attrition is a serious issue in the pharma industry as it is knowledge-based and employees are its assets. An encouraging work atmosphere, good culture, need- and skill-based training and career growth with adequate salary are some provisions that control attrition.

What trends do you foresee for pharma in the future?Many MNCs have been eyeing to buy leading Indian pharmaceutical companies and grow inorganically as the latter have a greater understanding of the industry and have appreciative penetration into the Indian markets. Indian companies have responded to this challenge by expanding their field force and trying to spread their wings to reach out to maximum number of customers. The Indian government wary that prices of the drugs would increase if the trend continues, and this has delayed the process of takeover of Indian pharmaceutical companies.

Indian pharma companies are taking big leap from survival to competitive strategy,

…informs E Balaji, MD & CEO, Randstad India. He discusses the current trends as well as the challenges being faced by the pharmaceutical companies with respect to HR and also sheds some light on the trends that would soon dawn upon us.

Jasleen Kaur [email protected]

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Special Focus: Interface

What are the current oft-noticed trends in pharma HR?The often noticed trend in pharma is that we grow our own leadership team. If we look at Sanofi, we are in the business for the last 50 years in India. And here most of the people have started from the ground level and today most of them have reached the top leadership positions. The typical trend in pharma, unlike the BPOs or the telecom industry, is that leadership is developed from within the company. Thus, today’s most of the decision makers in the company, directors or marketing heads, or others have all grown from within. They had joined probably 20 years ago and today they have reached these leading positions. This is unique to most of the pharma companies.

Primarily, I would like to highlight the present young generation joining the organisation at the ground level and they have different expectations in terms of their career, compensation and other matters. And one of the challenges of the HR is how to integrate them. And 3-4 years ago we realised that in order to manage the younger generation we should have different ways. For this purpose, we have a programme called ‘Pratimbh’, where we intervene at the managerial level, helping them to comprehend their relationship with the young generation.

What is the primary qualification that you look for while recruiting?The presence of Sanofi is everywhere. Therefore, the primary qualification differs.

In manufacturing, we consider people with chemistry background more relevant. Electrical, mechanical and other engineers are also relevant for this. For, formulation development, which is more research driven activity, we look for scientists and regulatory people. Largely, they are required to be MPharm or PhDs for the

formulation development plant. For R&D, we consider medical doctors, those who are MDs in pharmacology, etc. Thus, largely, we prefer employees from science and pharmacy background since they are expected to constantly interact with the doctors and logic out the science behind the drugs. Next, the employees should be well acquainted with physiology also.

What kind of soft skills does Sanofi prefer?It is difficult to give a general opinion but overall the person should be patient centric. It should be remembered that the person, who is joining the pharma sector, is not joining the industry to sell/push the pills in the market. They need to know the efficacy of the drugs and how are the drugs helping the ultimate consumer. Even during the interviews conducted, we try to gauge the sensitivity of the applicant. Here, I must emphasise on the fact that we are moving from a typical pharma company to healthcare industry. When one is looking at pharma company one is selling drugs, but when one is looking at healthcare company then one is looking at the larger picture. Moreover, the person should be extremely transversal in nature.

He should always be aiming at results, by not only selling but also bringing awareness

to the doctors. Thus, it is important to know how he will be communicating with the doctors since we must remember that here the consumers are all high profile well educated doctors unlike the FMCG products where one sells it to the distributors.

Which are the retaining practices followed in your company?More than retaining practices I would like to refer them as

engagement practices since retention includes lot of external factors like the job outside, money, location. At Sanofi, a recent survey revealed that our engagement score to be around 85 per cent.

The most important element in engaging employees is being able to share with them in the company’s vision of where we want to reach in the next 5 years. Sanofi has developed various programmes for this purpose. Each of our programmes such as Disha, Pragati, Lakshya and many others are designed for employees to develop them so they can build their careers at Sanofi, and grow with the organisation.

What has also helped us is our strength-based philosophy that lays emphasis on developing strengths of employees rather than focussing on their weaknesses.Through our programmes, we help our employees to identify their key strengths and optimising these accordingly. Further, at Sanofi we are continuously evolving and are changing our business models and thus people

should be adaptable to various changes.

What are the ‘other than work’ HR initiated activities in your company?Here, we conduct various programmes for employees

and try to involve their families involved as well. We have one function called, ‘Kids at work.’ This year we had invited the children (below 12 years) of our employees and conducted several fun programmes. The response was huge as there were around two hundred people. Five years back the programme that started with 20-30 children, and today it has achieved so much.

Again, we have programmes on Dassera, Christmas Eves, etc. We also have picnic sort of programmes where the employees meet outside with their spouses. These are the programmes of the corporate office. We also have similar programmes for the manufacturing sites. As far as the field personnel are concerned, those who are super achievers, they are offered free trips with their spouse to either Paris or a place in Asia Pacific. Then, there are also small Sunday outings for these people. Additionally, there are also Corporate Social Responsib i l i ty (CSR) initiatives by the company. Our intention is that whatever CSR activity we do, we want our employees to be actively involved in them. We are happy to share that we have an Employee Vounteer Group for CSR. We also have Health, Safety, E n v i r o n m e n t ( H S E ) programmes under which we organise activities and awareness programmes focussing on employee health and safety.

We realised 3-4 years ago that in order to manage the younger generation we should have different ways

...says Pradeep Vaishnav, Senior Director- Human Resources, India and South Asia, Sanofi. He talks about the nitty-gritty of HR in pharma and how the work culture can be made more interesting.

The most important element in engaging employees is being able to share with

them in the company’s vision of where we

want to reach in the next 5 years.

Chandreyee [email protected]

What has also helped us is our strength-based philosophy

that lays emphasis on developing strengths of employees rather than focussing on their weaknesses.

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Facility Visit

K arnavati Engineering Ltd (KEL) was started in 1981, with a focus on transforming

machines to pharmaceutical excellence. A sister concern of Cadila Pharmaceuticals Ltd, the initiative to establish KEL was taken by Indravadan Modi, Chairman, Cadila Pharmaceuticals. Today, the organisation has come off age in carving out a huge name for itself in the market for its outstanding quality and customer service.

It is an ISO 9001:2008 company with state-of-the-art infrastructure and manufacturing capabilities for pharmaceutical machineries, toolings, line and allied accessories confirming to the highest standards of quality and reliability. It is accredited by the Government of India as ‘Export House’.

Infrastructural benefi tsBeing end-to-end solution providers in the tablet presses category and capsulation, it has a vast range of products for pharmaceutical machinery sector. It has a presence across the board in tablet compression, tablet press accessories, capsule filling equipment, capsule filling equipment accessories, laboratory equipment and granulation equipment. Several turn key projects in pharma plant design and erection, clean room panel, liquid line, tablet line, soft and hard gelatin capsule line and packaging line, are executed by the company.

The Gujarat-based plant is located at Kadi, which is some 40-odd kms away from the Ahmedabad Airport. Set in an industrial area, the entire plant is spread across more than

100 acre of land. The entire manufacturing operation is divided among the four major buildings across the vast area. Two of the major buildings deal with manufacturing of the various parts and pieces that are required for the instruments (Manufacturing lab and Manufacturing room). A separate section is dedicated to the Quality Control (QC) section and packing the goods before exporting them. One of the building deals with the entire assembling of the machines and the trial run is also undertaken here. This is where we witnessed live trials for its brand new ‘Mini II’ tablet manufacturing machine (which is a labscale production machine) that generates a record large number of tablets per hour.

Also, manufacturing machines for veterinary products (tablets and capsules) were running for trials. Most of these machines are completely automated and have as high as 5-level password protection.

Explaining the workforce and the working pattern, Mukund Modi, Sr VP, KEL, informs, “Major workforce in the manufacturing section comprises males; females are largely seen in the QC and R&D department. Since the manufacturing operation is on most days of the week, we have people working in different shifts of days/timings of the day.” This ensures that KEL can output maximum of the products in a continuous manner.

Brimming with actionWith an aim to be a significant global player in the chosen field of pharmaceutical machinery and allied equipment manufacturing, leveraging on human resource, technology, continual improvement of quality management system, experience and expertise, the company has come a long way since its inception.

Talking about the investment in R&D and manufacturing ratio, Modi says, “A considerable part of our revenues are invested into R&D. We have in-house

experts in the field who dedicatedly work on the projects and are constantly available for technical support. Most of pharma manufacturing companies

hire freelancers for designing their equipement, and this keeps on changing from project to project. But here at Karnavati, we do not have freelancers. All the experts are on our payroll and work for us on all projects.” The team work of the employees has to be commendable since the assembling and entire nitty-gritty of fixing all the small pieces and parts of a machine together requires too much of concentration and dedication. A motivated work force and commitment from management has helped KEL maintain a steady pace at all times.

“At the end of the day, we are happy to achieve total customer satisfaction and achieve leadership in chosen markets, products and services across the globe through

excellence in technology, based on world-class research and development,” avers Modi. Explaining about the customer-centric services that KEL provides, he says that engineers are available for support all through the day. Mostly people send their technical problems via e-mail, and in rare cases they receive odd-hours phone queries.

The company’s Kalweka brand has carved its niche as an all purpose equipment for research and development in pharmaceuticals, chemicals, cosmetics and food industries. KEL has several products divided as per the kind of manufacturing required (R&D/Lab/Pilot/Production scale) and which industrial segments the machine caters to.

Providing manufacturing excellenceKEL boasts of bringing many firsts into the market. It was the first company to introduce small batch (R&D) tablet presses domestically. It led the industry for designing front controls for better ease of use in production machines. Table top fully automated capsule machine in early days when capsulation was considered to be a bulky affair, was introduced by KEL.

Been the believers of collective growth, the company has brought forward systems that facilitate and reinforce the same. Its management systems cover quality, health, safety and environment. These systems focus on managing operations effectively and are largely certified in accordance with international quality and environmental management standards. A large share

of its revenue is provided by exports. “Products are manufactured with the latest technology, and we always provide quality work. It is no wonder that several developed countries order our products,” avers Modi.

With an aim to provide products and services which contribute positively to society and improve the quality of life for our employees and the communities, most operations carried out KEL are a testimony to this aim. KEL has been at the helm of technology revolution in the field of pharma machinery for a decade and has become synonymous with tablet press series worldwide. Time shall tell how the growth of this technology and solutions-driven company goes further.

Karnavati Engineering LtdKarnavati Engineering Ltd

Pharma manufacturing with a panache

Tablet press machine

Striving for a happier and healthier tomorrow, Gujarat-based Karnavati Engineering Ltd is on its way to become a leading pharmaceutical machinery manufacturer in India and a significant global player. A technology-driven pharma manufacturing machinery- providing company, we trace the growth story since its inception.

Parita [email protected]

Strong presence of Karnavati Engineering Ltd More than 25 years of rich experience Over 1,700 successful installations across the globe Export to more than 50 countries across the globe Strong domestic presence with 5 branches across India Strong global presence with network of 30 business

associates More than 200 loyal customer base across the globe

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Insight & Outlook: Policies & Regulations

W hile the Indian pharma industry has grown to become the `Medicine Shop` to the world with

over $ 21 billion in sales (domestic + export ) in 2011, the Indian regulatory authority, however, has failed to keep pace with this phenomenal growth and is mired in controversies. Whether it is the appointment to the post of highest office, ie Drug Controller General of India (DCGI), or the recent indictment of the Parliamentary Committee on the new drug approval process where 30 odd new drugs were approved by the DCGI’s office without clinical trials.

According to this committee many drugs were approved based on `personal perception` rather than `scientific evidence` and were based on `managed` endorsement of the medical experts. This will not only result in public losing faith in the ability of Central Drugs Standard Control Organization (CDSCO) in guarding the public health but also country’s image in the eyes of global customer in the quality of drugs manufactured in India affecting our exports. India is increasingly becoming a `Destination of Choice` for outsourcing clinical trials because of abundance of patients of diverse gene pool, availability of well qualified scientists, proficiency in informatics and cost competitiveness. However, India

is slowly losing its edge due to its s low moving new drug approval process resulting in many international and even Indian majors moving to countries such as China, Singapore, Thailand, Brazil, etc, leading to loss of millions of dollars in revenue.

Intellectual Property RightsAnother important issue is the one related to protecting Intellectual Property Rights (IPR). For instance, USFDA follows the system of patent linkage. This is a practice of linking drug marketing approval to the patent status of the original product and not allowing the grant of marketing approval to any third party prior to the expiration of the patent term. Patent linkage system requires that the generic manufacturer gives proof to the FDA that the new drug for which an approval is sought is not covered by a valid patent in that

country. Indian FDA should follow the patent linkage system to protect the IPR of the originator. India also does not have Data Exclusivity (DE) in place. Most developed countries (including China, Korea, etc)honours DE. This means that generic company can launch their drug only after a lapse of certain period (eg, 5 years in USA) after the approval of the original drug, which means that the generic company cannot use the original data generated by the patent holder to get the marketing approval. Since clinical trials are quite expensive and take several years to complete, the data generated in such trials is an important intellectual property of the patent holder and must be protected. The DCGI claims that all the data submitted for approval is always held confidential. However, confidentiality is difficult to enforce in practice and therefore India needs to grant DE. Such changes will significantly attract more clinical trial outsourcing to India. India’s imports from China, particularly of APIs are on the increase. For instance, for penicillin-derived products, India is completely dependent on China. To ensure that the Chinese manufacturer conforms to the international GMP, Indian regulator should periodically inspect the manufacturing facilities of such exporters for GMP compliance by sending a team of well-trained FDA inspectors to overseas facilities. Although this process has begun, it needs to be strengthened.

Bringing a changeTo bring about the above changes, the most important reform we need is the organisation structure of the regulatory agency, ie, FDA. The inconsistency between the state and central drug control agencies

in enforcing various regulations of the Drugs Act, is making the approval process ad hoc and non-transparent, resulting in proliferation of irrational combinations, counterfeit drugs , non-compliance with GMP, rampant abuse of potent drugs like antibiotics, steroids, medicines for pregnancy termination, etc due to dispensing without prescription as well as misbranding (changing the active ingredient / swithout changing the brand name ). The parliamentary committee has also challenged the qualifications of the person required for the position of DCGI. In most developed countries (including China, Brazil, etc) FDA is headed by people with strong science background (eg, MD, PhD in medicine, pharmaceutical sciences, pharmacology, chemistry, molecular biology, etc). The pharmaceutical industry is slowly moving from Chemistry to Biology. It is expected that over 40 per cent drugs approved by US FDA in 2015 are likely to be biologics. Also, biosimilars offer a huge opportunity to Indian pharma.

Reforms requiredTo handle such complex products based on future technologies such as biotechnology including genomics, proteomics, stem cells as well as nanotechnology we need domain experts in the regulatory agencies. However, even a progressive state

like Maharashtra is content with an IAS officer heading the FDA for last several years. At one point of time, it even had a police commissioner as Commissioner of the FDA. Several representations in this regards to Maharashtra Government have fallen on deaf ears. Solution to above problems lies in having a Central Drug Authority, an autonomous body on the lines of US FDA headed by an outstanding technocrat (of the calibre of someone like Dr R A Mashelkar , former Director General of CSIR). The formation of CDA was proposed and approved by the cabinet way back in 2007, but like most government policies, it is still hibernating due to bureaucratic apathy and vested interests. CDSCO therefore needs comprehensive reforms recommended by various committees quite a while ago including formation of CDA. This will not only restore the confidence of general public in the quality of drugs it consumes but will go a long way in realising the aspirations of the Indian pharmaceutical industry in becoming a global leader.

Central Drugs Standard Control OrganizationCentral Drugs Standard Control Organization

Needs an overhaul The reputation of pharma industry in any country is based on its capability to develop, manufacture and market drugs, which are effective, safe and meet the laid down quality standards. Country’s drug regulatory authority therefore plays a key role in guarding the public health by ensuring that these criteria are fully met.

The inconsistency between the state and central drug control

agencies in enforcing various regulations of

the Drugs Act, is making the approval process ad hoc and

non-transparent

Dr Ajit DangiPresident & CEO, Danssen Consulting

[email protected]

Th e formation of CDA was proposed and approved by the cabinet way back in 2007, but like most

government policies, it is still hibernating due to bureaucratic apathy

and vested interests.

Major players and some of their biosimilar productsCompanies Biosimilar products launchedTeva TevTrophin (hGH), Interferon alpha 2b, Tevagrastim (G-CSF),

EpoSandoz Omnitrope (Somatropin), Binocrit (epo), Zanzio (G-CSF) Biocon Insulin, Epo, G-CSF, Streptokinase, and BioMAb EGFR Dr. Reddy’s Reditux (Rituximab), Grafeel (Filgrastim)

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Insight & Outlook: Strategy

Science is constantly evolving and newer things are being discovered every

day. Practitioners of medical science need constant up gradation of their knowledge and skills so as to deliver better results to their patients. Besides, physicians need to keep reading and attending seminars and conferences to know that certain drugs once considered useful are now being withdrawn due to recently understood adverse effects. Clinical procedures or surgical techniques undergo rapid transformation in their methods either because of newer addition of equipment or due to discovery of fresh data about pitfalls in the traditional technique.

Gadgets such as the endoscope, the CCTV, the 3-D digital camera and now robotic surgical assistants have transformed the way operations are done. Patients who have access to ‘Dr Google’ on their mobile phone are armed with questions about small surgical cuts, limited blood loss and shorter hospital stay and the physician he/she visits better be prepared to give convincing answers to his queries. Therefore, even physicians or surgeons who may not be directly involved in performing the newer procedures need to be aware of what is being done by his colleagues using the recent machinery.

Credit point compulsoryHitherto, not all practising physicians used to update their knowledge by reading journals or attending clinical meetings. Once he acquires the medical licence to practice his science, nobody questioned whether he was keeping abreast of newer developments in his field. Without having up-to-date knowledge, the medical advice provided or drugs prescribed may not be in the best interest of the patient. This issue was clearly realised by the fraternity and they could

see their western counterparts bringing in the credit system to compel their members to be on par with the best across the globe.

Consequently, the Medical Council of India (MCI) swung into action and now they have made it compulsory for doctors to upgrade their theory knowledge and clinical skills. According to their guidelines, for the renewal of their qualification-registration, doctors must earn 30 credit points every 5 years. These points are obtained either by carrying out research and publishing it in journals, delivering talks at specified specialty conferences/workshops, writing chapters in textbooks or authoring a textbook. Those who are unable to carry out any of these activities can earn points by attending conferences/seminars/workshops, which are approved by the local branches of the MCI.

Like in the west, the MCI has clearly outlined the way such meetings need to be conducted, the specific content of the programme, the venue at which it is to be held, etc, so as to standardise the Continuing Medical Education (CME) programme format, which was gradually being reduced to a farce.

According to their guidelines, if the guest speaker is invited from abroad, for a one-hour talk, the delegates earn one credit point. For local

experts, the regional branches of the council need to conduct a 3-hour session in order to earn the same point.

Under such a scenario, most of the routine ‘drug-promotion clinical meetings’ hosted by pharmaceutical companies either to launch newer drugs or the ‘thanksgiving’ party for an already established brand is out of the purview of the recommendation. Although such gatherings will continue, the impact of the same is gradually getting diluted.

Pharma losing groundAbout two decades ago there were just a handful of pharmaceutical players, dominated by MNCs. These companies had a limited range of drugs, which had a huge market, even as small pharmaceutical companies, which had a good hold on the local market, thrived alongside. At that time, physicians looked forward to pharmaceutical-sponsored events as it was an opportunity to bond with their colleagues over meals while picking up a few clinical tips from invited speakers.

Today, with the mushrooming of local and multinational pharmaceutical companies in the country, there is a ‘clinical meeting’ being conducted in some part of the country, every weekend! That is not all. In the middle of the week there would be a live webcast of a talk by an eminent international expert to which you can log in and participate.

The easy availability of medical updates through e-mail alerts from online journals and regular supply of books and journals from pharmaceutical companies keep physicians

who are interested in newer developments very well informed. There is no need for the doctor to attend all clinical meetings to learn about recent advances. Consequently, drug manufacturers find it difficult to attract doctors to attend their meetings.

Skip if no ‘point’When an Medical Representative (MR) comes with such an invitation, a junior physician who is yet to get busy in his practice may be able to make the most of such meetings, the senior practitioner who tries to get some free time, scurries for cover.

Physicians have to per force attend CMEs authorised by the MCI in order to earn credit points. Some of the Sundays get utilised in the process and they hardly get any time to spend with the family or go on personal outings. Therefore, when an MR invites the doctor for ‘a talk by an eminent guest speaker,’ the first thing the latter enquires is whether it will earn him points! ‘No point, no meeting,’ is the mantra for the present day physician.

Drug manufacturers spend huge sums to get

original research workers and clinicians from overseas in order to address local physicians about their work. All this time, money and effort is wasted if there is poor attendance. Pharmaceutical companies would do well to avoid such a fiasco by ensuring that speakers are invited for talks in such a way that they meet the criteria for the audience to earn credit points. This will ensure double incentive to the attending doctors who will not only get to carry some additional take home messages as well as achieve the CME target set by the medical council.

Put more thoughtP h a r m a c e u t i c a l d r u g companies will have to work out an annual calendar of events keeping all their product range in mind and invite specific doctor-groups, in line with the MCI recommendations. The speaker will now have to be chosen more carefully to ensure that the audience is rewarded with genuine new data on disease or drugs rather than listen to the same ‘standardised powerpoint presentation.’

One hopes that drug manufacturers, will divert their energies to organising genuine, academically enriching CMEs, which will be beneficial to physicians in more ways than one. Mr Marketing Manager, have you got the point?

Medical practitionersMedical practitioners

Does your clinical meeting make a ‘point’?In the need to keep pace with latest research and technology, older surgeons need to be aware of the improved operative methods so as to keep up with their junior colleagues. Consequently, hospitals, which employ a large number of medical specialists, will only enlist the services of those physicians who are experts in the most recent and financially rewarding techniques. And for keeping themselves abreast, pharmaceutical companies provide certain incentives to medical practitioners. A look.

Drug manufacturers spend huge sums to get original research

workers and clinicians from overseas in

order to address local physicians about their

work. All this time, money and effort is

wasted if there is poor attendance.

x

Dr Rajan T DPharma Consultant & Practising Dermatologist

[email protected]

Pharma companies will have to work out an annual calendar

of events keeping all their product range in mind and invite

specifi c doctor-groups, in line with the MCI

recommendations.

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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 transferConsultancy

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 transferConsultancy

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 transferJoint 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 transferTechnical 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]

Page 23: Modern Pharmaceuticals - 16-31 July 2012

23M o d e r n P h a r m a • 16 - 31 J u l y 2 01 2

Projects

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

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]

Drugs/MedicineOrg : State Pharmaceuticals Corporation of Sri LankaTRN : 11653493Desc : Supply of montelukast tablets 10 mgDSLD : NABOD : July 25, 2012Loc : Colombo, Sri LankaBT : Global (ICB)

Centrifugal lube oil cleanerOrg : Diesel Locomotive WorksTRN : 11657234Desc : Supply of centrifugal lube oil cleanerDSLD : NABOD : July 27, 2012Loc : Varanasi, Uttar PradeshBT : Domestic (NCB)

Laminar flow systemOrg : United Nations Office of Project Service (UNOPS)TRN : 11664601Desc : Supply of anaesthesia, spectrophotometer, laminar flow system and other itemsDSLD : NABOD : July 27, 2012Loc : New Delhi, IndiaBT : Domestic (NCB)

Centrifuging machineOrg : Uttar Pradesh Power Transmission Corporation LtdTRN : 11657388Desc : Repairing of 250 gph centrifuging machine of John Fowler makeDSLD : NA

BOD : July 28, 2012Loc : Aligarh, Uttar PradeshBT : Domestic (NCB)

Atomic absorption spectrophotometerOrg : Directorate General Factory Advice Service and Labour InstitutesTRN : 11584538Desc : Supply of atomic absorption spectrophotometerDSLD : NABOD : July 30, 2012Loc : Kanpur, Uttar PradeshBT : Domestic (NCB)

Drugs/MedicineOrg : State Pharmaceuticals Corporation of Sri LankaTRN : 11628128Desc : Supply of salmeterol xinafoate 50 mcg + fluticasone propionate 250 mcg, dry powder capsules for breath induced device -1,500,000 capsules for 2013DSLD : NABOD : July 30, 2012Loc : Colombo, Sri LankaBT : Global (ICB)

Drugs/MedicineOrg : State Pharmaceuticals Corporation of Sri LankaTRN : 11638716Desc : Supply of rabies immunoglobulin BP/USP.DSLD : NABOD : July 30, 2012Loc : Colombo, Sri LankaBT : Global (ICB)

Drugs/MedicineOrg : Ministry of Health and Family WelfareTRN : 11631118Desc : Supply cum rate contract of medicinesDSLD : NABOD : July 30, 2012Loc : Jaipur, RajasthanBT : Domestic (NCB)

Drugs/MedicineOrg : State Pharmaceuticals Corporation of Sri LankaTRN : 11628126Desc : Provision of miconazole cream BP/ micanazole nitrate cream USP 2% w/v - 800,000 tubes for 2013DSLD : NABOD : July 30, 2012Loc : Colombo, Sri LankaBT : Global (ICB)

FT-NMR spectrometer systemOrg : Indian Oil Corp Ltd (IOCL)TRN : 11250570Desc : Supply of 500 MHz FT-NMR DSLD : NABOD : July 30, 2012Loc : Faridabad, HaryanaBT : Domestic (NCB)

Horizontal laminar flowOrg : Agharkar Research Institute (ARI)TRN : 11664482Desc : Purchase of horizontal laminar flowDSLD : NABOD : July 30, 2012Loc : Pune, MaharashtraBT : Domestic (NCB)

Dishman Pharmaceuticals and Chemicals LtdProject type:New facilityProject news:Dishman is undertaking an investment program for construction of new facilities at its existing manufacturing site in India.

Project location:IndiaProject cost:NAImplementation stage:Ongoing

Contact details:Dishman Pharmaceuticals and Chemicals Ltd Deepak Pandya, Company Secretary and Head (Legal)Bhadr-Raj Chambers Swastik Cross Roads Ahmedabad - 380009 Tel: 079 2644 3053/079 2644 5807Fax: 079 2642 098 4384

Flamingo Nanded pharmaceutical plant projectProject type:New facilityProject news:Flamingo Pharmaceuticals Ltd with presence in acute therapies such as antibiotics and antipyretic is planning to set up a state-of-the-art plant at the SEZ in Nanded, Maharashtra, based on USFDA/UKMHRA specifi cations.

Project location:Nanded, MaharashtraProject cost:` 144.84 croreImplementation stage:Ongoing

Contact details:Flamingo Pharmaceuticals Ltd 7/1, Corporate Park, Sion Trombay RoadP O Box No. 27257Chembur, Mumbai – 400071Maharashtra

Tel: 91-22-30009300 Fax: 91-22-25233085Email: ashf@fl amingopharma.comWebsite: http://www.fl amingopharma.com/

Granules India Ltd second projectProject type:ExpansionProject news:Granules India Ltd is planning for an expansion of its existing facility. It will also be undertaking an investment programme at its Gagillapur facility comprising of expanding the capacity of its multi-product tableting and PFI plants and its warehousing capacity with automated storage systems.

Project location:Gagillapur, Andhra PradeshProject cost:NAImplementation stage:Ongoing

Contact details:Granules India LtdB V R K Srinivas – AVP FormulationsPlot No. 160/A & 161/E Gagillapur VillageQutubullapur Mandal RR District - 500 043 Andhra PradeshTel : +91 8418 255233, 257222 Email: [email protected]

Shasun Pharmaceuticals Ltd’s setting up pharmaceuticals manufacturing facility at VizagProject type:Manufacturing facilityProject news:Shasun Pharmaceuticals plans set up a manufacturing facility at Vishakhapatnam and increasing the capacity of existing plants by 2013.

Project location:Vishakhapatnam, Andhra PradeshProject cost:` 250 croreImplementation stage:Ongoing

Contact details:Shasun Pharmaceuticals Ltd 3rd & 4th fl oor, Batra Centre28, Sardar Patel Road Guindy, Chennai 600032 Tamil NaduWebsite: http://www.shasun.com/Tel: 91-44-43446700 Fax : 91-44-22350278

Vivimed Labs Ltd expansion projectProject type:ExpansionProject news :Vivimed Labs Ltd, plans to expand capacity for existing products, and develop and create capacity for new products.

Project location:Hyderabad, Andhra Pradesh

Project cost:$42 millionImplementation stage:Ongoing

Contact details:Vivimed Labs Ltd, K S Sastry Veernag Towers HabsigudaHyderabad - 500 006Andhra Pradesh Tel: 040 2717 6005/6Fax: 040 2715 0599Email: [email protected]

Zydus Pharmez expansion projectProject type: SEZProject news:Zydus Infrastructure Ltd, a part of Zydus Cadila Healthcare Ltd, plans to invest an additional `100 crore on the expansion of Pharmez, its SEZ for the pharma industry.

Project location:Ahemdabad, GujaratProject cost: ` 100 croreImplementation stage:Ongoing

Contact details:Zydus Infrastructure Ltd Zydus Tower, Satellite Road Ahmedabad - 380015GujaratTel: 91-79-26868100

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.

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24M o d e r n P h a r m a • 16 - 31 J u l y 2 01 2

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 SUS Georgia-India Life Sciences Opportunities SummitThe summit will feature a one-day “how-to-with India life sciences” series of speakers, a Business to Business matching (B2B) focus tailored for Atlanta companies in the vaccines and CROs, CMO areas, etc. The event aims to bring decision makers under one roof; August 23, 2012, ITC Maratha, Mumbai

For details contact:FDASmart Tel: +91 96196 61452Email: [email protected] Website: www.fdasmart.com/events/macoclife

Annual Pharmacovigilance 2012The event aims to discuss the latest technologies, methodologies and introducing pharmacy automations on work practices of pharmacovigilance, recent successful strategies and business models to bring out new medicines, keeping abreast of the changes impacting the drug safety industry, etc. Further, there will be discussion on global marketing strategies; August 31, 2012, Hyatt Regency Mumbai

For details contact:Virtue InsightTel: +91 44 64536444Fax: +91 44 64536443Email: [email protected]: www.virtueinsight.com

Automation 2012All leading companies in industry will

showcase their latest products and help one find the solutions at the show. The show brings latest technologies from an interesting array of fields such as: factory automation, process automation and control systems, robotics & drives, field instrumentation & smart sensors bus technologies, software solutions, wireless technology, building automation, and hydraulic & pneumatic automation in renewable energy. From technocrats to solution providers, vendors and tech-buffs, the fair is all set to draw every one alike; September 7-10, 2012, NSE Complex, Mumbai

For details contact:IED Communications Pvt Ltd Tel: +91 22 22079567Fax: +91 22 22074516 Email: [email protected]: www.iedcommunications.com

Pharmac IndiaIt is a-three-day event that aims towards highlighting several issues of the industry. This will be large hub of reputed professionals from pharma formulation, herbal products, veterinary drug, medical & disposal, pharma machinery and many other sectors. There will be visitors from pharma company marketing/purchase/export executive, marketing company & consultant, merchant exporters, contract manufacturers, pharma distributors, generic & OTC manufacturer & wholesalers, Government supplier, liaison agents,

sourcing companies, production & purchase professionals, and international business representatives; September 8-10, 2012, Gujarat University Exhibition Hall, Ahmedabad.

For details contact:Orbitz Exhibitions Pvt LtdTel: +91-22-24102801Fax: +91-22- 24102805Email: [email protected]: www.orbitzexhibitions.com

Indian Pharma Expo 2012Indian Pharma Expo 2012 is the perfect solution to meet the needs of the rapidly growing Indian pharma industry; to be able to network under one roof. There will be discussions on regulatory issues affecting the pharma market, commercial strategies and business models of key players, maximising revenue, overcoming challenges and achieving growth and revaluating possible development scenarios. Further, there will also be discussions on effective marketing strategies; September 22-23, 2012, Pragati Maidan, New Delhi

For details contact:UBM India Pvt LtdTel: +91 22 6612 2600Fax: +91 22 6612 2626-27Email: [email protected]: www.ubmindia.in

Indian Lab Automation conference and exhibitionILA 2012 will feature three technical conference tracks; Drug Discovery and Development, Advances in Bioanalysis and Advances in Genomics and Informatics. Each track will provide attendees with the opportunity to listen to presentations on cutting edge research in specific application areas, with an underlying theme of automating the technique, equipment or associated informatics; October 30-31, 2012, Renaissance Hotel & Convention Centre, Mumbai

For details contact:Select Biosciences LtdTel: +44 1787 315110Fax: +44 1787 315111Email: [email protected]: www.selectbiosciences.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.

AHMEDABADGujarat,

Oct 5-8, 2012

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, June 7-10, 2013

For details

Network18 Media & Investments LtdRuby 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 SJCBBB 2012 The 3rd Journal Conference on Bioscience, Biochemistry and Bioinformatics (JCBBB 2012) aims to provide a forum for researchers, practitioners, and professionals from the industry, academia and government to discourse on research and development, professional practice in bioscience, biochemistry and bioinformatics. This is one of the leading international conferences for presenting novel and fundamental advances in the fields of bioscience, biochemistry and bioinformatics. It also serves to foster communication among researchers and practitioners working in a wide variety of scientific areas with a common interest in improving bioscience, biochemistry and bioinformatics related techniques; September 1-2, 2012, Phuket, Thailand

For details contact:International Journal of Bioscience, Biochemistry and BioinformaticsTel: +91 422 2611146 Fax: +91 422 2611043Email: [email protected]: www.ijbbb.org

International Symposium on Pharmaceutical Reference StandardsThe event aims to discuss current topics and future approaches related to pharma reference standards. Pharmaceutical reference standards are essential for the quality control of

medicines. The symposium will bring together stakeholders involved in the production, characterisation and use of reference standards to exchange their views and opinions on the different issues related to the subject; September 3-4, 2012, EDQM Premises, Strasbourg, France

For details contact:EDQM Public Relations Division & DocumentationTel: +33 0 3 88 41 31 50Fax: +33 0 3 88 41 27 71Email: [email protected]: www.edqm.eu

NCCR 2012The 6th National Conference for Clinical Research 2012 (NCCR 2012) aims to serve as a platform that aims to bring together clinical investigators, industry professionals, regulatory agencies and policy makers in order to address the issues and challenges of the industry. By gathering people from various research disciplines, the event aims to foster constructive and forward looking discussions, sharing of experiences, and mutual commitment towards the betterment of humanity; September 23-25, 2012, Sunway Pyramid Convention Centre, Malaysia

For details contact:Association of Clinical Registries, Malaysia (ACRM)Tel: +603 4044 3060Fax: +603 4044 3080Email: [email protected]: www.nccrconference.com

CSBio 2012 CSBio 2012 will also cover the engineering sciences related to the pharmaceutical industry, in both material and manufacturing sciences. This conference would like to gather like minded researchers and industrial counterparts who are involved in designing, developing and improving industrial processes and equipment for large-scale chemical and pharma manufacturing; planning and testing methods of manufacturing; developing methods for the treatment of bi-products; devising production processes that are safe, efficient, profitable and environmentally sound; October 3-5, 2012, Bangkok, Thailand

For details contactSchool of Information TechnologyTel: +66 2470 9834Fax: +66 2872 7145Email: [email protected]: www.csbio.org

CPhI WorldwideThe event hosts over 1900 exhibitors and is the market leader for the global pharmaceutical ingredients industry. CPhI Worldwide has three co-located events: ICSE, P-MEC Europe and InnoPack. These events focus on specific sub-sectors of the pharma ingredients industry and provide visitors and exhibitors with additional capability to network and do business in dedicated areas; October 9-11, 2012, Feria de Madrid, Spain

For details contact:UBM India Pvt LtdTel: +91 22 6612 2600Fax: +91 22 6612 2626-27Email: [email protected]: www.ubmindia.in

2012 Nanotechnology ConferenceThe event aims to bring together a panel of highly-accomplished nanotechnologists and well recognised authorities in various aspects of nanomedicine. This unique international conference offers an opportunity for pharma scientists, clinical researchers, physicians, therapists and industrial leaders to discuss the important international breakthrough developments in drug discovery, drug development, drug delivery, drug therapy and commerce to share their thoughts. The four-day conference will focus on the basic studies through translational efforts and clinical trials and address topics of novel issues concentrating more on recent advances, difficulties, and breakthroughs. This is how the event aims to reach out to the experts and decision makers of industry; October 31- November 3, 2012, Riviera Maya, Mexico

For details contactZing ConferencesTel: +44 1223 750020Fax: +44 1223 280270Email: [email protected]: www.zingconferences.com

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25M o d e r n P h a r m a • 16 - 31 J u l y 2 01 2

Book Review

Reviewer: Dr Mandar Kubal, Consultant - Infectious Diseases and HIV AIDS, Infectious Diseases and Pulmonary Care (IDPC)

This is a fairly technical and voluminous book that deals with natural resources as sources of biologically active compounds in detail. The author has elucidated in the first chapter the potential biodiversity and chemodiversity available in the ecosystem as potential targets. Glances into the marine, fungal and plant ecosystems do give important leads into potential newer molecules. The follow-up chapters on metabolic engineering, computational approaches and application of electronic circular dichroism dwell in significant details into the application of newer technology for discovery and production of these compounds. The majority of the second half of the book deals with specific therapy areas. The application of newer biotechnology methods to natural resources has been clearly defined for specific areas like anti-virals, malaria, wound healing, anti-tumour agents, etc. Each section describes in brief the potential targets and newer methods of processing these active compounds.

The chapter dedicated to Chinese traditional medicine and Australian marine organisms gives a regional perspective to the topic. A good book for researchers, practitioners and pharma manufacturers actively involved in bioactive compounds derived from natural products.

Over the last few years, there has been an increasing interest and acceptance of traditional herbal medicine among Westerners. But often these therapies lack robust scientific data, which makes their widespread acceptance and commercial production difficult. This brilliant book attempts to shed light on every aspect of R&D of traditional medical products. The author in her opening chapter lays a good foundation of the types and diversity of traditional medical systems practiced across the world and the loop holes in studies planned regarding the same.

The chapter on collection and identification of raw herbs impresses the need for quality raw material in the initial start up process of herbal medicine. The next few chapters on extraction, isolation, identification, and bioassays of bioactive compounds from herbs give a conventional chemist’s perspective of traditional products. The section of chapters dealing with animal studies, safety studies and planning of clinical trials helps an investigator in the process of generating mainstream data regarding the herbal products efficacy and toxicity.

The book also gives a glimpse into the various regulations, GMP rules and quality control methods with respect to herbal preparations. The book ends with a brief overview of traditional Chinese medicine, its principles and various herbal formulations. A simple read even for the uninitiated in herbal medicine, for chemists and practitioners of herbal medicine.

Bioactive Compounds from Natural Resources

Traditional Herbal Medicine Research MethodsEditor: Willow J H Liu

Price: ` 8,400/-

Editor: Corrado Tringali

Price: ` 11,100/-

Publisher: Wiley PublicationsDistributor: 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]

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]

An

as well...thatinviterewards

Dear Reader,

‘Modern Pharma’ solicits original, well-written, application-oriented, unpublished articles that reflect your valuable experience and expertise in the pharmaceutical industry.

You can send us Technical Articles, Case Studies and Product Write-ups. The length of the article should not exceed 1,200 words, while that of a product write-up should not exceed 100 words.

The articles should preferably reach us in soft copy (either E-mail or a CD). The text should be in MS Word format and images in 300 DPI resolution & JPG format.

The final decision regarding the selection and publication of the articles shall rest solely with ‘Modern Pharma’. Authors whose articles are published will be sent a complimentary copy of that particular edition.

Published by Network18 Media & Investments Ltd, ‘Modern Pharma’ is one of the leading fortnightly magazines exclusively meant for producers and user fraternities of the pharmaceutical industry. Well supported by a national readership of over 80,000 and our strong network of 26 branch offices across India, this magazine reaches out to key decision makers among the Indian manufacturers of pharma products, machinery and allied sectors. Brought out in association with Hong Kong-based Ringier Trade Media Ltd (one of the world’s largest trade publishing houses with more than 200 special interest titles and offices in every major country), it ensures that advertisers are able to promote their products and services across the globe at no extra cost.

So get going and rush your articles, write-ups, etc…

Thanking you,

Yours sincerely,

In Conversation With 17Indravadan Modi Chairman, Cadila Pharmaceuticals Ltd

CEO Roundtable 15Future trends in the Indian pharma industry and the role of media to bridge the need gap Special Focus 18Recent advances in the pharma cold chain The need to get tech-savvy

Insight & Outlook 22Sales force automationSay ‘no’ to manual errorsVenus gets US patent for antibiotic drugVENUS Remedies has received patent from the US Patent Office for its new antibiotic product, which targets drug resistant infections. The product, CSE 1034, has been found to be effective against a wide range of drug resistant infections,

including the ‘superbugs’. Mufti Suhail Sayeed, Vice President, Venus Medical Research Centre, said, “The US patent of CSE 1034 is a landmark development for initiating the process of commercialisation of this novel drug.”

Alembic settles patent case with NovartisALEMBIC Pharmaceuticals along with Breckenridge Pharmaceutical (US), has settled a patent case with Novartis for rivastigmine tartrate capsules used for treating dementia. The companies have settled their Paragraph IV patent litigation with Novartis for rivastigmine tartrate capsules, a generic version of Exelon capsules of Novartis.Positive prospects for Japanese pharma industryTHE prospects for Japan’s pharma market over the medium term are very positive, said a report by Research and Markets. The country has one of the largest pensionable populations, healthcare is readily accessible, the government appreciates investment in biomedical research and the regulatory regime balances the requirements of the major stakeholders.

GSK to buy eczema drug Toctino for £ 146 millionGLAXOSMITHKLINE Plc (GSK) hasannounced that it is buying eczema drug Toctino from Basilea Pharmaceutica Ltd, for an initial £ 146 million ($ 227 million). Toctino is the only prescription medicine approved for the treatment of severe chronic hand eczema unresponsive to potent topical steroids in adults. It is commercially available in 14 countries, approved in 15 countries, and is in a phase III trial in the US.

WATERS India, one of the leading analytical companies is currently under the process of expanding its facility in Bengaluru. “The new facility is likely to have an improved set of laboratories, upgraded training facilities and more office space. When completed, the new facility will be approximately 16,000 square feet in floor space,” informed Art Caputo, President, Waters Division, Waters Inc. To expand the existing facility at Peenya, Bengaluru, the company has invested an approximate amount of ` 2 million. Besides this, the labs in Mumbai, Delhi and Hyderabad will also undergo an expansion in

the near future. The phase II of expansion woould be at Ahmedabad and Chandigarh. Besides expansion Waters is also

partnering with pharmaceutical companies, CROs and government agencies with the goal of expanding research capabilities, increasing laboratory efficiency, and navigating complex regulatory compliance requirements worldwide. Waters has recent partnered with Dr Reddy’s Laboratories, Lambda Therapeutic Research Ltd, the Marine/Agricultural Product Export Development

Agency and the India Environmental Protection Agency.

- Jasleen Kaur Batra

FOR pharmaceuticals, the EU market is going through an inflection point. MNCs such as MSD, Johnson & Johnson, Pfizer, Abbott, Lilly, Roche, Novartis, Teva, Takeda, Genzyme, Allergan, Gilead, Astellas, Bristol-Myers Squibb and GlaxoSmithKline have established their foothold in Ireland. Besides, Indian companies such as Reliance Life Sciences and Ranbaxy have a strong presence too. K V Subramaniam, President and CEO, Reliance Life Sciences, said, “Reliance Life Sciences Pvt Ltd, India, had acquired GeneMedix plc, a UK-based biotechnology company in 2007. This provided us with an opportunity to enter the European biopharma market.”Minakshi Batra, India Director, India Ireland, said, “Each country in

the EU region has typical characteristics of operating. Germany is a tender-driven, whereas France is an innovators drug-driven market. With such a background, it becomes absolutely essential for

Indian pharma companies to have an on-ground EU presence in order to expand into the EU territories. An on-ground presence either in terms of sales and marketing or a

small manufacturing base, could help in achieving radical benefits in terms of expediting go-to-market strategy by 40 per cent, reducing costs of inventory.”The Irish life sciences sector is about 45 billion

(mainly export oriented). While the EU pharma market is worth $ 48 billion, $ 16 billion is for the generics, presenting huge opportunities for India. Batra said, “The

Irish Government is highly proactive, business friendly and an astute visionary. Ireland has some of the best highly skilled talent. It has a standard, EU approved corporation tax rate of 12.5 per cent on all trading profits. Additionally, Ireland has an excellent network of double taxation avoidance treaty with 55 countries in the world including India. Recognising this, the Irish Government has put in place a national Strategy for Science, Technology and Innovation (SSTI) in the 1990s. In line with this, significant funding and support are available to fuel innovation across industry, research and education. Additionally, there is a 25 per cent tax credit provided to organisations for R&D & innovation.” - Chandreyee BhaumikQUINTILES recently announced agreements to establish a Quintiles regional headquarters for China in Shanghai and to significantly expand lab testing capabilities in China. “With its burgeoning economy and growing healthcare needs for its 1.3 billion citizens, China exemplifies the opportunities and challenges

of the New Health,” said Dennis Gillings, CBE, Executive Chairman, Quintiles, “By broadening our investment and infrastructure here, Quintiles is ready to partner with our biopharma customers as they look to realise China’s potential.” To provide the infrastructure essential for its growth strategy

in China, Quintiles is investing $ 14 million to establish a new 4000-square-metre (43,000 square feet) headquarters in Shanghai to serve China and nearby Asian countries. “This demonstrates our commitment to this district and to China,” said Ling Zhen, General Manager, Quintiles’ operations in China.

Waters to expand in India

Ireland attracts Indian pharma

Caputo

SubramaniamBatra

Sayeed

1 - 15 J u l y 2 012 I Vo l 1 I N o 1 I `10 0

Scan this code onyour smart phoneto visit www.mphonline.in

Quintiles deepens investment in China

Manas BastiaSenior Editor

Network18 Media & Investments Ltd‘A’ Wing, Ruby House,J K Sawant Marg, Dadar (W)Mumbai 400 028 India

T +91 22 3024 5000D +91 22 3003 4669F +91 22 3003 4499E [email protected] www.infomedia18.in

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26M o d e r n P h a r m a • 16 - 31 J u l y 2 01 2

Products

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

Aerosol photometer The latest version, Model 2i, is used for leak testing of HEPA fi lters. The upstream aerosol mass concentrations

are displayed in actual mass concentration values of micrograms per litre (µg/l). Other features include user settable Aerosol Noise Suppression (ANS) which allows for more stable aerosol measurements when poor mixing is present, three unique data report functions – continuous, monitoring & summary modes, large 4.3 “ LCD display, thermal printer option to meet documentation requirements & USB output.

MeasureTest CorporationMumbai - MaharashtraTel: 022-2202 7982Email: [email protected]: www.measuretest.com

Orbital shaking incubators These orbital shaking incubators are designed for precise temperature control and simultaneous shaking applications required in fermentation studies, enzyme reactions, life

science, tissue culture and biotechnology research labs. The brushless induction motor with variable frequency drive is suitable for continuous operation. The powerful fan motor is available for forced air circulation to maintain uniform conditions inside the chamber and has hermetically sealed compressor with CFC free refrigerant.

Remi Elektrotechnik LtdMumbai - MaharashtraTel: +91-022-40589888Mob: 09820627422Email: [email protected]: www.remilabworld.com

Deep freezers These deep freezers are designed for storage of biological samples in biotech, life science, clinical research as well as medical & p h a r m a c e u t i c a l specimens, serums, vaccines, blood

components. These freezers are available with temperatures up to -20°C and – 40°C. It has features such as microprocessor controller with LED display, adjustable trays, electrical circuit breaker, overload cut off relay for compressor and sensor failure alarm.

Remi Elektrotechnik LtdMumbai - MaharashtraTel: +91-022-40589888Mob: 09820627422Email: [email protected]: www.remilabworld.com

Pharma refrigeratorThe pharma refrigerator has double walled chamber, with two different inner chambers. The two chambers are connected with common wall between the two chambers. Interior and exterior is made of stainless steel. Upper chamber

temperature is – 20° C, lower chamber temperature is 2 to 8°C and temperature uniformity is ± 1°C.

Newtronic Equipment Company Pvt LtdMumbai - MaharashtraTel: +91-022-28679326Mob: 9821089932Email: [email protected]: www.newtronic.in

Pharma print cartridgeThe pharma print cartridge and felt pad/roller are made for blister packaging machine, FFS machine and coding machine.

Absorbing material used is poly porous in various microns varying from 1 micron to 25 micron, depending upon the requirement of customer. The absorbing capacity of these cartridges is quite high and the cartridges are hard so the impression is good as there is cotton cloth knitted sleeves (covering) which is used to avoid direct contact of stereo with roller. The cartridges are made in various ID, OD and length depending on customer’s requirement. The maximum OD can be 85 mm, length up to 300 mm.

Process Instrumentation & ControlsVadodara - GujaratTel: 91-0265-235 7228, 232 0756Mob: 09228753005Email: [email protected]: www.piccode.com

Rotary bottle washing machines

The rotary bottle washing machines - NRWM – 96 are multifunctional machines that meet the GMP requirements of washing glass and plastic bottles. These operate on the rotary principle ‘GENEVA’ mechanism and require manual loading and unloading of bottles. The output consists of 4300 to 9000 numbers & direction of the machine is clock wise.

National Pharma MachineryAhmedabad - GujaratTel: +91-079-3090 3433, 3093 3433Email: [email protected]: www.nationalpharmamachinery.com

Linear bottle washing machines

The linear bottle washing machines facilitates inline washing operation and are built on rigid structure & are enclosed with elegant matt fi nished SS body cover. The cleaning is supported by tow inbuilt water tanks and pumping system. The output ranges from 3000 to 4200 bottles, & direction of movement is left to right.

National Pharma MachineryAhmedabad - GujaratTel: +91-079-3090 3433, 3093 3433Email: [email protected]: www.nationalpharmamachinery.com

Syringe pumps

The world’s fi rst single syringe pump has a touch screen interface and a new clamping mechanism which holds a single syringe (glass, plastic, or stainless steel) from 0.5 µL to 60 mL. The large color display allows the user to see all the operating parameters. Syringe sizes, fl ow rate, volume delivered & the elapsed

time are easily displayed. When used with check valves, the pump draws fl uid from a reservoir while opposite side dispenses fl uid. After dispensing the user-settable volume, the pump automatically switches direction and dispenses from the other side while the just-consumed side is being refi lled. Full-metal chassis provides noise isolation and anti-vibration features for increased reliability.

Cole-Parmer IndiaMumbai - MaharashtraTel: 022-6716 2222Email: [email protected]: www.coleparmer.in

Electrolyte analyser

The ST-100 electrolyte analyser is used for measurement of sodium, potassium and chloride in whole blood, serum, plasma and diluted urine. This also has a built-in lithium ion battery with power back-up of 10 hours. The ST-100 is completely automated, microprocessor-controlled electrolyte system that use current ISE technology to make electrolyte measurements. It is compact, economical and easy-to-use. The instrument has long life, provides high-performance and has maintenance-free electrodes.

Sensa Core Medical Instrumentation Pvt LtdHyderabad - Andhra PradeshTel: +91-8455-223400Mob: 09866861878Email: [email protected]: www.sensacore.com

Formaldehyde analyser

Formaldehyde analyser provides absolute concentrations for formaldehyde (HCHO) in aqueous media. It has RS232 serial port for computer interface The measurement ranges from 0 to 5 µ g/ml.The analyzer is widely demanded in the market for numerous applications.It can be available in varied specifi cations as per their requirements and needs.The equipment is available at pocket friendly price. Formaldehyde analyzer is suitable for the measurement of formaldehyde in aqueous solution.

Uniphos Envirotronic Pvt LtdMumbai - MaharashtraTel: +91-22-61233500Mob: 9909994063Email: [email protected]: www.uniphos-she.com

Microfl uidiser processor

The portable M-110P microfl uidiser processor is a bench-top lab machine that requires no compressed air or cooling water. Designed to operate at up to 30,000 psi process pressure, this portable microfl uidiser processor requires a standard 20 A, single-phase household electrical outlet and is easily incorporated into any laboratory setting. Utilising Microfl uidics’ fi xed geometry diamond interaction chamber technology and ceramic plunger, the processor easily enables the production of nano-suspensions and nano-emulsions, as

well as liposomal encapsulation and cell disruption with the fewest numberof passes.

TTL Technologies Pvt LtdBengaluru - KarnatakaTel: 080-2525 1859Email: [email protected]: www.ttlindia.com

Page 27: Modern Pharmaceuticals - 16-31 July 2012

27M o d e r n P h a r m a • 16 - 31 J u l y 2 01 2

Products

Moisture analyzer balance

The new MB series 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 & selection from four profi les 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 & 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

Tablet hardness tester

The portable Tablet hardness tester model iHT 100 is designed for simple, inexpensive & “in-situ” measurement tablet hardness testing. This 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 specifi ed hardness limits. The safety cover is to be 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 fulfi ls an automatic half-calibration (zero calibrated).

Erweka India Ahmedabad-GujaratTel: +91 92280 22065Email: [email protected]: www.erwakaindia.com

De-humidifi erThe AD 420 dehumidifier is incorporated with fully hermet ica l ly sealed rotary c o m p r e s s o r, p r o t e c t e d a g a i n s t 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 (with winding protection). Condenser and evaporator are made from copper piping covered with aluminium fi ns. Cooling circuit is made from copper piping with capillary tube and fi lter dryer. There is a service connector on the suction side. Automatic defrosting is controlled by Dry-Logic. The casing is aluminium, powder-coated & offers protection class IP X4.

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

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

Dual wavelength diffractometerIts Mova source is up to 2.5x more intense than a standard Mo sealed tube X-ray source. Its Nova source (Cu) up to 3x more intense then a 5kW rotating anode

with optic. It has simple and automatic switching between wavelengths. This is ideal for small molecule and protein crystallography and is fast, high resolution, automated data collection and processing. It has optional aircooler radiator for a self-contained system independent of any external water supply.

Agilent Technologies India Pvt LtdNew Delhi - DelhiTel: 91-011-46237100Email: [email protected]: www.agilent.co.in

Spectrophotometer

The Optizen 3220UV is used for analyzing components that require multiple wavelengths, time course operations and getting stable data sheets. It has USB ports for user-friendly programming updates and other accessory connections. It has universal sample cell holder that holds 8 cells. It has superb optics for maximized accuracy, exceptional precision and reliability. It has user-friendly software with scanning and time course capacities with versatile data processing.

Jay Instruments & Systems Pvt. Ltd.Navi Mumbai-MaharashtraTel: +91-22-2767 2955/0092Email: [email protected]: www.jayinst.com

TrayCellThe TrayCell is a fi bre-optic u l t r a - m i c ro cell designed for the UV/Vis micro volume analysis of D N A / R N A 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 fl uorescent dye labels (FOI), protein analysis (A280, BCA, Lowry etc.) & all UV/Vis analysis utilizing the wavelength range of 190 to 1100 nm.

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

PumpsE-Series Air-Operated Double-D i a p h r a g m (AODD) pumps are self-priming and provide gentle displacement of fl uids. They are equipped with the patented PERSWING P® air control system, which ensures

accurate reversal of the main piston and is characterized by low noise levels. They are created from a solid plastic block, offering advantages like increased pump security due to an innovative ring-tightening structure, increased capacity, decreased air consumption, reduced noise level, optimized fl ow pattern and a pulsation damper suitable for fl ange connection.

Dover India Pvt LtdChennai - Tamil NaduTel: +91-44-26271020Email: [email protected]: www.doversolutions.co.in

Capsule fi lling machine The automatic capsule fi lling machine is an encapsulation equipment. Its features include compact, sturdy, covered with stainless steel panels, hood covered with

acrylic guard. The fi ll weight adjustment takes place within seconds. It is provided with tamping mechanism for powder fi lling, which enables capsules to be fi lled with a weight variation with ±2 per cent. The variable AC frequency drive for main motor ensures speed adjustment. Faulty capsule and fi lled capsule ejection stations come with individual air controls. It is simple to operate and easy to maintain and has special purpose gauges for quick and easy change over.

Anchor Mark Pvt LtdMumbai - MaharashtraTel: 022-28682001, Mob: 09320036904Email: [email protected]: www.anchormark.com

FRP storage tankThe FRP storage tank is manufactured by hand lay-up and/or by fi lament winding process for the storage of highly corrosive

chemicals, acids and wastes. It is available in capacity up to 250 kl in various shapes, like square, round, rectangular vertical and horizontal with fl at bottom or conical bottom. The key feature of this tank is that it offers resistance to chemical and weather. It is lightweight, easy-to-maintain featuring good physical and mechanical strength. The reaction vessel is available with suitable lined agitator, gear box and electric motor.

EPP Composites Pvt LtdRajkot - GujaratTel: 02827-287059Email: [email protected]: www.atikagroup.com

Bottom discharge centrifugeThis centrifuge is fi tted with a cake scrapping a r r a n g e m e n t , which can be motorised or h y d r a u l i c a l l y operated to enable

to scrape the stickiest of cakes. The cake is discharged through the bottom chute provided. This results in reducing manual labour, less cake handling loss and uniform cake washing. The centrifuge is offered in vapour-tight construction with nitrogen blanketing for hazardous chemicals. CIP design with built-in cleaning nozzles ensures no product cross-contamination. The centrifuge is offered in three-point pendulum suspension and four-point inertia plate mounted designs to suit application considerations.

United Engineering EnterprisesMumbai - MaharashtraTel: 022-23083990, Mob: 09820761808Email: [email protected]: www.united-centrifuges.com

Ball valveThis ball valve comes with pneumatic rotary actuator. The valve is of on/off type with screwed, fl anged, socket weld, tri-clover end in three-

piece design. It is available in SS-304 and SS-316 investment castings and is fi tted with double-acting pneumatic rotary actuator that operators through 90-degrees angular movements of ball valve or butterfl y valves. Pneumatic actuator is mounted directly on the shaft of the valve. The actuator is supplied with solenoid valve mounted on it. It is available in different sizes up to 4” to control fl uids such as steam, chemicals, oil, air, and water.

Madho Controls Pvt LtdThane - MaharashtraTel: 022-25883252, Mob: 09820066046Email: [email protected]: www.madhocontrols.com

Air-cooled single-stage pumpThe oil-lubricated air-cooled single-stage pump comes with multi-vane built-in anti-suck

back system. It is provided with oil recirculation system having exhaust fi lters 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 fi lling, pick and place, leak detection, heat treatment, distillation, suction in hospitals, oil purifi cation, 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

Page 28: Modern Pharmaceuticals - 16-31 July 2012

28M o d e r n P h a r m a • 16 - 31 J u l y 2 01 2

Marketplace

Page 29: Modern Pharmaceuticals - 16-31 July 2012

29M o d e r n P h a r m a • 16 - 31 J u l y 2 01 2

Marketplace

Page 30: Modern Pharmaceuticals - 16-31 July 2012

30M o d e r n P h a r m a • 16 - 31 J u l y 2 01 2

List of Products & Advertisers

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

Aerosol Photometer ....................................... 26Activated carbon fi lter .....................................BCAir-cooled single-stage pump .........................27Atlantic green nitrile gloves ...............................3Autoclave gaskets ..............................................28Automatic carton over printing with embossing machine ........................................28Automatic label gumming machine ...............28Bacteriological chamber ..............................FICBall valve ............................................................27Barcode patient ID bands ................................29BOD incubator ...............................................FICBottom discharge centrifuge ...........................27Braided house....................................................28Cable................................................................. 28Capsule fi lling machine ...................................27Carton dispensing machine.............................28Chain pulley block ............................................28Cold chamber ..................................................FICColour masterbatches ......................................29Cords ..................................................................28Corona treater sleeves ......................................28Counter & power supplies .................................7Crabs ..................................................................28Crane ..................................................................28Deep freezer .................................................... 26Deep freezer .....................................................FICDe-humidifi er ...................................................27Demineralisation plant ...................................BCDiaphragm vacuum pump & compressor ....28Double sided rotary ..........................................11Dual wavelength diffractometer .....................27Dual zone chamber ........................................FICElectro-de-ionization ....................................BCElectrolyte analyser ...........................................26Encoder ................................................................7EOT/hot cranes .................................................28

FBD gasket ...................................................... 28Flame proof hoist .............................................28Formaldehyde analyser.....................................26FRP storage tank ...............................................27Gaskets ............................................................. 28Gear boxes .........................................................28Gloves ...................................................................3Goliath crane .....................................................28Goods lift ...........................................................28Hand / power operated label gumming machine ......................................................... 28High speed automatic big size label over printing machine ............................................28High speed automatic carton over printing machine ..............................................................28High speed automatic label counting machine ...........................................................28High speed automatic label over printing machine ..............................................................28High speed automatic lid dispensing machine ...........................................................28High speed automatic wallet dispensing machine ...........................................................28High speed tablet presses .................................11Hot air oven ....................................................FICHumidity chamber .........................................FICIncubator .......................................................FICIndustrial control & sensing device ..................7Infl atable gaskets ...............................................28Inverter/variable frequency drive ......................7Jib crane ........................................................... 28Labels ............................................................... 29Laboratory & medical equipments.............. BICLaboratory oven ..............................................FICLarge diameter welded pipes ...........................28Level controller ...................................................7Linear bottle washing machine .......................26

Measuring & monitoring relay for 1ph/3ph ............................................................ 7Medium speed tablet presses...........................11Microfl uidiser processor ..................................26Moisture analyser balance ...............................27Monorail trolley ................................................28Motion control ....................................................7Motorized chain pulley block .........................28O rings ............................................................. 28Oil seal ................................................................28Orbital shaking incubator ...............................26Other process equipment ................................11Pharma print cartridge ................................. 26Pharma refrigerator ..........................................26Photo electric sensor ..........................................7Photostability chamber ..................................FICPilot / lab scale tablet presses ..........................11Plastic masterbatches ........................................29Pressure sand fi lters .........................................BCPrinter ................................................................29Profi les ................................................................28Programmable logic controller .........................7Programmable terminal .....................................7Proximity sensor .................................................7Pump & valve ....................................................28Pumps ................................................................27Reverse osmosis unit .....................................BCRFID .....................................................................7Roller compaction systems ..............................11Rotary bottle washing machine ......................26Rotary tablet press ............................................11Safety light curtain ........................................... 7Seamless pipes ...................................................28Sections ..............................................................28Sheet ...................................................................28Side channel vacuum pump & compressor ..28Silicone FBD gaskets.........................................28

Silicone rubber braided hose ..........................28Silicone rubber compound ..............................28Silicone rubber cords/square/strips ................28Silicone rubber corona treater sleeve .............28Silicone rubber extruded gasket & profi le .....28Silicone rubber moulding ................................28Silicone rubber sheets.......................................28Silicone rubber sleeves (ITI approved) ..........28Silicone rubber sponge .....................................28Silicone rubber tubing .....................................28Silicone transparent platinum cured tubings .............................................................28Softening unit ...................................................BCSpectrophotometer ...........................................27Sponges ..............................................................28Squares ...............................................................28Stainless steel pipes ...........................................28Strips ...................................................................28Switching relay ....................................................7Syringe pumps ..................................................26Tablet hardness tester .................................... 27Tablet press machine ........................................11TC gaskets ..........................................................28Temperature controller ......................................7Timer ....................................................................7Tooling & spares ...............................................11TPU masterbatches...........................................29Transfer trolley ..................................................28Transparent tubings ..........................................28Traycell ...............................................................27Tubes ..................................................................28‘U’ tubes ........................................................... 28Ultra fi ltration systems ....................................BCVision sensor ..................................................... 7Welded pipes ................................................... 28Wire rope hoist .................................................28

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

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

Our consistent advertisers

Alok Masterbatches Ltd 29

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BC-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

Page 31: Modern Pharmaceuticals - 16-31 July 2012
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RNI No: MAHENG / 2008 / 27125, Postal Regd No: G / NMD / 122 / 2011 - 13, Posted at P.C Stg. Offi ce, GPO, Mumbai 400 001

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

32


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