Modern Pharma - 1-15 April 2013

Utkarsh Palnitkar has joined KPMG India as Partner & National Head of Transactions & Restructuring and Life sciences practices. Palnitkar joins KPMG from Centrum Capital Ltd, a large financial services company, where he was an Executive Director. Prior to this, he was associated with Ernst & Young (E&Y) for 15 years. During this period, he was the leader of Advisory as well as the Life sciences practice, while also being the office managing partner of E&Y’s Hyderabad practice. He

was engaged in transaction advisory services, business advisory services and risk advisory services.

Speaking on the appointment, Richard Rekhy, CEO, KPMG India, said, “We are delighted to welcome Palnitkar into the KPMG family. An industry veteran, Palnitkar has a vast experience across life sciences,

business advisory, government, real estate and infrastructure advisory. I am confident that under his able leadership, the Transactions & Restructuring business will see exponential growth in the coming phase.”

Palnitkar is a Chartered Accountant from the Institute of Chartered Accountants of India. In addition, he has completed an Advanced Management Program - Harvard Business School and Leadership Programs from Indian School of Business.

Dr K Anji Reddy, Founder and Chairman of Dr. Reddy’s Laboratories Ltd, recently passed away of liver cancer at the Apollo Hospital in Hyderabad. He was considered as the drug discovery pioneer in pharmaceutical industry. His mission in life was to provide innovative new medicines at a price that the common man could afford.

Dr Reddy obtained graduation from University of Mumbai with specialisation in Pharmaceutical Science and Fine Chemicals and later PhD in Chemical Engineering from National Chemical Laboratory, Pune.

Soon after his studies, he served in the state-owned IDPL before he founded the company in 1984. He was honoured by the Government of India with the Padma Bhushan, one of the highest Civilian Awards in India, recognising his distinguished service of high order in the field of Trade and Industry. In 2012, CNBC TV18 conferred the Lifetime Achievement Award (IBLA) on him for being a visionary who had spent a lifetime building up his company into a colossus with a global reach putting Indian industry on the world map.

In Conversation With 12Nathan Sigworth

Co-Founder and CEO, Pharmasecure

Special Focus 14Contract manufacturing

Offering cost-effective solutions amid uncertain economic scenario

Facility Visit 20Venus Remedies, Baddi

Riding high on innovation

Event Report 258th Nutra INDIA SummitProviding impetus to the

surging nutraceutical market

Baxter closes deal for potential haemophilia drugBaxter International Inc has closed its acquisition of a potential haemophilia treatment from the French drug maker Ipsen and Inspiration Biopharmaceuticals Inc. in a deal that could be worth more than $ 180 million. Baxter, based in Deerfield, Ill, had said in January it agreed to buy the drug, labeled OBI-1, and related manufacturing operations.

Ipsen announced that Baxter agreed to pay $ 50 million upfront, up to $ 135 million in milestone payments and a percentage of global sales. OBI-1 is being studied as a possible treatment for people with acquired haemophilia A. OBI-1 has been designated an orphan drug in the United States and the European Union, meaning it will get years of marketing exclusivity if it is approved.

Avastin unit dose syringes recalled due to potential eye infection Clinical Specialties is voluntarily recalling Avastin unit dose syringes. The product has or potentially could result in an infection within the eye. Clinical Specialties has received reports of five intra-ocular infections from physician’s office and this is how the problem was identified.

The product was being used solely as an off-label use by ophthalmologists for macular degeneration and is packaged in sterile syringes.

Venus launches its first OTC product Ezenus Venus Remedies Ltd recently announced the launch of its first OTC product EZENUS, a stress reliever. While introducing this product, Dr (Mrs) Manu Chaudhary, Joint Managing Director, Venus Remedies Ltd, said, “EZENUS is a unique medical nutrition product which is absolutely safe, zero calorie, non–addictive, herbal candy, with clinically proven anti-stress activity. It is world’s first anti-stress product launched in easy to use candy form even suitable for diabetic patients. It is highly safe in acute stress management such as exam stress in children and in chronic stress like in alcoholic and smoking population, without change in life style by continuous detoxification and strong antioxidant activity.” EZENUS is a patent protected herbal, anti-stress formulation based on German Technology.

1 - 15 A p r i l 2 013 I Vo l 1 I N o 19 I `10 0

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Waters releases new products in the analytical standards and reagents portfolio

Waters Corporation has introduced Quality Control Reference Materials (QCRMs) and certified containers for the analytical standards and reagents product group. Designed for Waters instruments, QCRMs are the simplest and fastest way to understand a chromatography or MS system’s health while ensuring repeatable performances. Waters certified containers for solvents and mobile phases are uniquely processed and treated to prevent extraneous peaks and baseline noise. The new certified containers help ensure that our customers can produce dependable, consistent and high quality results as easily as possible. Manufactured to stringent standards, these unique

containers prevent extraneous peaks and baseline noise, glass chemistry interference and glass degradation

due to glass matrix hydrolytic attack. “We added analytical standards and reagents to Waters’ competency because they improve the accuracy of measurements. QCRMs and certified containers are another significant and innovative step in that direction. By integrating these products, customers can see improved data acceptance. Furthermore, by eliminating the need to mix and formulate standards and the unknown quality of mobile phase and solvent containers, our customers will have more time for scientific problem solving,” said Mike Yelle, Vice President, Consumable Business Unit, Waters.

Dr Reddy

Utkarsh Palnitkar joins KPMG as the National Head of Transactions & Restructuring and Life sciences practices

Dr Kallam Anji Reddy passes away

CONTENTS

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Facility Visit Venus Remedies Ltd, Baddi

Riding high on innovation

Event Report 8th Nutra India Summit

Providing impetus to the surging nutraceutical market

In Conversation With 12In Conversation With: Nathan SigworthCo-Founder and CEO, Pharmasecure

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

REGULAR SECTIONS5 Editorial / Guest Editorial

6 News, Views & Analysis

22 Projects

23 Tenders

24 Event List

26 Book Review

27 Products

29 Marketplace

30 List of Products & Advertisers

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12 14

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14Contract manufacturingOffering cost-effective solutions amid uncertain economic scenario

Green manufacturing practices Sustainable solutions to drive the future economy

Insight & Outlook

Interface Sunil AggarwalDirector, Airtech Systems India Pvt Ltd

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Interface Prof Ranjit Roy Chaudhury Chairman - Task Force for Research, Apollo Hospitals Educational and Research Foundations 21

Special Focus Pharma Manufacturing

5Editorial

Tapping the expanding exports pie

EditorialAdvisory Board

Ajit SinghChairman,

ACG Worldwide & Head, ISPE

Dr Abraham Patani Past President, IDMA & CMD, Inga Laboratories

Dr Gopakumar G Nair IPR Consultant & Advisor

Dilip G Shah Chairman, IGPA &

Secretary General, IPA Daara Patel

Secretary General, IDMA

T he global pharmaceutical market scenario seems set for a clear shift towards generics, albeit the causative factors may vary

depending on the present development status of a particular country. On one hand, while emerging opportunities due to patent expiries along with government efforts to expand healthcare insurance as well as cut down healthcare expenses are likely to boost the generics cause in the developed countries, on the other fundamental drivers such as affordability and availability will add traction to the growing footprint of generics in the branded generics developing markets.

From a numerical perspective, the global spending on generics is set to rise to $ 430 billion by 2016 from $ 242 billion in 2011, according to IMS Health. In this context, debatable questions remain how will this impact Indian pharma exports and, more importantly, what will be India’s share in this growing pie.

A recent report by India Ratings on the outlook for Indian pharmaceuticals for 2013 sheds light on this. As per this sectoral outlook report, top Indian pharma players will continue their good growth momentum at over 20 per cent in 2013, primarily led by exports to the US market, which offers huge near-future opportunities in generics, owing to the impending patent cliff and recently brought in changes in the US healthcare system.

According to a recent release of Pharmexcil, pharmaceutical exports of Indian companies in 2012-13 are likely to touch ` 75,000 crore – an increase of 25 per cent over the previous year. This growth is quite remarkable considering the competitive scenario and the current geo-economic climate. When one considers the country’s export figures in 2004, which stood at ` 17,000 crore, then the current year’s achievement (as well as over these years) is a tremendous feat! Also, one needs to recognise and appreciate here the contribution of the small and medium enterprises, which constitute a major part of the Indian pharma exports in this growth journey.

That said, it is now equally important to take adequate steps so as to reinforce and reinvigorate the new product pipelines for yielding commercial success sooner than later. In this direction, the latest Budget exemption of 15 per cent in investments of more than ` 100 crore to set up plant and machinery augurs well for further capital expansion of the Indian pharma sector. However, it remains to be seen how much of these will translate to green field pharma projects.

Nation taking a cue from Gujarat’s exemplary use of IT-based solutions

E-governance is the proven tool to generate administrative control, standardisation and efficiency in any system.

Nevertheless, customisation for technically intensive regulatory system such as Food and Drugs Control Administration (FDCA), Gujarat, which has 25 circle offices, testing laboratories and addresses the sensitive commodity of drugs and pharmaceuticals, was fairly a voluminous task. At the same time, due cognizance had to be taken for major reforms in the operations and working of international trade, national manufacturing and logistics sectors. FDCA - Gujarat in active association with National Informatics Centre (NIC) as well as encouragement and support from the Gujarat Government initiated the project ‘Xtended Licensing & Laboratory Node (XLN)’ with a view to reduce the delays in granting licences, sample analysis in the laboratory and corrective actions in the case of non-complying reports of various inspections. Generating effective control on the menace of spurious and misbranded formulations has been one of the benchmark expectations through e-governance.

Customisation of an approach of e-governance for the activities of

FDCA has been a great challenge and opportunity, given the legacy of administrative excellence of Gujarat FDCA.

After getting the web-based software and State Wide Area Network (GSWAN) in all FDCA circle offices, Food and Drugs Laboratory (FDL), Central Medical Store Organisation (CMSO) and Gujarat State Pharmacy Council were connected through a server for storage and retrieval of data. At the outset, compilation and retrieval of information and analysis of information appeared to be a huge task and extremely critical for the precision and credibility of this IT-based solution. Effective communication and training proved to be of great significance and vital to the execution of this process. The entire FDCA and NIC teams worked hard with great perseverance during this phase.

The system after customisation and hand over became operational very soon fulfilling the desired objective of speed and control. The concept of ‘SMS’ for communicating with the stakeholders and even public at large as far as information about substandard drugs was concerned has been endorsed as the most relevant, effective and economical solution for developing countries by Dr K Weerasuriya

of WHO at 71st International Pharmaceutical Federation (FIP) World Congress at Hyderabad.

The access to information about availability of blood at various blood banks and stock point and that too - blood group wise - is another benchmark service to healthcare sector and hence public at large.

The success of this e-governance exercise of FDCA - Gujarat has received nationwide attention and by the higher authorities such as DCG(I) and other departments interfacing with healthcare sector. Five states, (Maharashtra, Karnataka, Kerala, Himachal Pradesh and Andhra Pradesh), have replicated the ‘Gujarat Model’ of sales licensing software to cater to their functioning, while another six states (Madhya Pradesh, Goa, Tamil Nadu, West Bengal and Chhattisgarh) are planning to replicate Gujarat’s successful experience.

The Administrative Reforms and Public Grievances Department of the Government of India and Department of IT have conferred the national award for ‘e-governance for the year 2012-13 Gold Award’ upon Gujarat FDCA.

Dr H G Koshia Commissioner,

FDCA - Gujarat

Guest Editorial

Manas R Bastia [email protected]


Bureau of Indian Standards recognises SCHOTT’s expertise

in pharmaceutical glass manufacturing

DCGI suggests plan to ensure GMP-compliant drug plant exporters

Agila Biotech sets up a biotech plant in Malaysia

The international technology group SCHOTT has been appointed as a member to India’s national standards body. As a new Bureau of Indian Standards (BIS) member, the company will advise CHD-10, a subcommittee of the Chemicals Department, on specifications and guidelines for various kinds of glass manufacturing in India – mainly for pharmaceutical tubing and other applications such as fire-safe glass, household appliances and fibre optics. This allows BIS to tap into SCHOTT’s experience in the areas of specialty glasses, materials and advanced technologies.

“It is a tremendous privilege to support BIS in improving glass manufacturing standards in India,” said Sundeep Prabhu, Vice President - Marketing and Sales, Pharmaceutical Tubing, SCHOTT Glass India. “This milestone is another illustration of the outstanding standardisation of product quality and manufacturing processes SCHOTT has achieved in India. Together with BIS, our efforts will benefit Indian consumers as well as industry by ensuring that glass

products are safe, reliable and of highest quality.”

Working closely with India’s national standards body, SCHOTT will share its expertise with the aim of enhancing production and testing standards of India’s glass manufacturing industry. SCHOTT has constantly improved its quality standards to accommodate evolving market demands and deliver maximum benefits to its customers. A key global success factor for SCHOTT has been its strong focus on maintaining high quality standards. Company data released recently proves that SCHOTT managed to maintain stringent quality standards in the area of pharmaceutical tubing.

“At SCHOTT, we have been setting standards for manufacturing glass tubing with our technical terms of supply. This means we are committed to constantly improve our production process and offer our customers the highest possible transparency and quality assurance,” said Jürgen Achatz, Global Sales Director - Pharmaceutical Tubing, SCHOTT.

The Drug Controller General of India (DCGI) is drafting a plan that could ensure compliance of domestic bulk drug units exporting pharma products to the European Union. The compliance shall be weighed on the basis of World Health Organization (WHO) regulations. India exports pharma products worth more than $ 13.4 billion every year. API, worth more than $ 1 billion is exported annually to EU countries.

The plans draft suggests that zonal offices for drug regulation shall check API manufacturing processes in India. Once the check is conducted, the reports would have to be sent to EU drug regulatory authority that would certify the practice as WHO compliant.

The zonal office team investigating the practices would comprise two officers trained in the quality inspection process. There is a possibility of appointing only a single inspector. An expert in quality

control from regional or central drug testing organisations too could be part of the zonal team.

This inspection for checking compliance shall be of a different nature from the conventional checks. If the pharma processes are deemed as compliant with Good Manufacturing Practices (GMP) outlined by WHO, DCGI would give a written nod to the facility in question. The permission would remain valid as a quality assurance tag for three years.

Bio-XCell and Agila Biotech sealed a $ 34.4 million build-and-lease agreement for the establishment of a customised biotech facility located in the Bio-XCell ecosystem in Nusajaya, Johor, Malaysia. The agreement was signed between Rizatuddin Ramli, CEO, Bio-XCell and Dr Anand Iyer, CEO, Agila Biotech (Malaysia), a subsidiary of India-listed Strides Arcolab Ltd. “Agila Biotech is indeed poised to be a major anchor tenant for the Bio-XCell ecosystem and we are extremely

pleased to be able to offer our services and support for this promising project,” said Ramli. Bio-XCell will fund $ 22 million to cover the construction of the building

and part of the equipment. All other related state-of-the-art equipment, integration service and testing of this

turnkey project (estimated at $ 13-15 million) will be funded by Agila Biotech (Malaysia) from internal accruals and from external sources.

Work on the facility for the end-to-end manufacturing of biologics located on an 8.77 acre plot is expected to start as soon as all necessary clearances and permits have been obtained and all supplemental agreements

have been executed. Both parties are aiming for the R&D and manufacturing facilities to be operational by end 2014.

7News, Views & Analysis

Regulatory agencies to give their views on use of clinical data

Glenmark Generics recalls anti-asthma drug from the US market

High-profile representatives from regulatory agencies across East Asia will give their country’s perspective on clinical data evaluation for drug approval at Drug Information Association (DIA) Japan’s 7th Annual Conference for Asian New Drug Development in Tokyo, April 15-16, 2013. During a session entitled ‘Perspectives of Respective Regulatory Agencies in Clinical Data Evaluation for Drug Approval,’ Seong-ho

Kim, Director, Pharmaceutical Safety Policy, Pharmaceutical Safety Bureau, Korea Food and Drug Administration, will speak on Korea’s perspective

and Li-Li Su, Pharmacokinetic/ Pharmacodynamic Reviewer, Center for Drug Evaluation, will

speak for Taiwan. The Chinese perspective will be given by Dr Ling Su, Board President, DIA and Dr Yoshiaki Uyama, Director, Regulatory Science Research, Pharmaceuticals and Medical Devices Agency will speak on behalf of Japan. The event to be held at Nakano Sunplaza, Tokyo, aims to provide a forum for exchange of opinions among pharmaceutical industry professionals, academia and the regulatory agencies in East Asia.

Glenmark Generics is recalling from the US market multiple lots of Montelukast Sodium tablets (10 mg), used in treatment of chronic asthma and prophylaxis, on ‘off-odour’ complaints, according to US FDA. Montelukast Sodium tablets are Glenmark’s generic version of Singulair by Merck & Co Inc, indicated for prophylactic treatment of chronic asthma.

A notification issued by US FDA said that Glenmark was withdrawing from the market as many as 591,972 bottles of Montelukast Sodium tablets of both 30 and 90 count on complaints of off-odour. “The recall has been initiated on multiple complaints received from pharmacists and

consumers saying they detected an off-odour, described as moldy, musty or fishy in nature, which has been identified as trace levels of Tribromoanisole (TBA) and Trichloroanisole (TCA)”, said an alert issued by the US FDA.

“After initial investigation, the source for the moldy/musty odour has been identified as the presence of trace levels of Tribromoanisole (TBA) and Trichloroanisole (TCA). The presence of TBA and TCA has been observed in HDPE bottles supplied by one of our multiple HDPE bottle suppliers used in the packaging of our Montelukast Sodium Tablets. These compounds are often

used as a preservative in wood-derived packaging storage materials”, Glenmark had said last month.

“We have determined that all of Glenmark’s Montelukast Sodium Tablets continue to be safe and effective, and there is no reason to stop taking this medication”, the statement issued by Glenmark had said.

This recall is limited to material stored by wholesalers and in stock in pharmacies from the lot numbers and bottles identified above only and all other lots and bottles in use are unaffected and pharmacies may continue to dispense. Glenmark continues to ship unaffected product in alternative bottles, the release said.

In Brief

European patent office to grant patent for Macrocure’s CureXcell® Macrocure, a biotechnology company developing advanced cell therapy products, has announced that the European Patent Office (EPO) intends to grant a European patent covering companies’s flagship product, CureXcell®. The patent will be officially granted under an application titled ‘Activate Leukocyte Composition’ and will provide patent coverage for CureXcell® in Europe through March 2030. CureXcell is a novel approach to treat hard-to-heal wounds by replenishing the imbalanced inflammatory environment in non-healing wounds with a broad array of functionally active allogeneic immune cells. These cells are superficially injected into the wound bed, once a month, and release the necessary cytokines and growth factors for the wound to heal. “The granting of a European patent for CureXcell is a significant milestone for MacroCure, which fits with our strategy to become a leader in the hard to heal wound treatment market in Europe,” said Nissim Mashiach, President and CEO, Macrocure. Amid job cuts, AZ appoints Marc Dunoyer as Executive Vice President to head Global Portfolio & Product StrategyAstraZeneca (AZ) has announced the appointment of Marc Dunoyer in the newly created role of Executive Vice President, Global Portfolio & Product Strategy. He will join the company in the second quarter of 2013. He will be responsible for driving business strategy, including business development, M&As, portfolio and product strategies. Marc joins AZ from GlaxoSmithKline (GSK) where, as Global Head of Rare Diseases, he established an integrated global capability in treatments for rare disease R&D through to commercialisation. He is also Chairman of GSK Japan and a member of the Corporate Executive Team. “I am delighted Marc is joining us in this pivotal new role aimed at bringing greater integration across our R&D, commercial and business development activities,” said Pascal Soriot, CEO, AstraZeneca.

Dunoyer


Recent worries over antibiotics losing their effectiveness will only be exacerbated by the FDA’s latest drug safety update, released recently, which stated that the commonly prescribed antibiotic azithromycin can cause abnormal changes in the electrical activity of the heart.

Azithromycin, currently marketed as Zithromax by Pfizer, is indicated for a large range of bacterial infections, such as Chronic Obstructive Pulmonary Disorder (COPD), acute bacterial sinusitis, nosocomial pneumonia and certain skin structure infections. The drug’s wide ranging use, improved safety profile and short treatment duration of just five days, compared to the 10 days required by

many competing antibiotics, have made it a popular choice among physicians.

These detrimental effects were linked with potentially fatal heart arrhythmias in patients who already exhibited risk factors such as QT interval prolongation, low blood levels of potassium or magnesium and slower heart rates. They were also indicated in patients currently being treated for heart arrhythmias with certain drugs. A study first published in the New England Journal of Medicine in May 2012 showed that patients treated with azithromycin displayed a higher likelihood of developing complications of the heart in comparison to patients treated with amoxicillin, ciprofloxacin, or levofloxacin, or left untreated. The updated

safety information is likely to have been delayed by the manufacturers’ own studies to corroborate this evidence.

Dr Brad Tebbets, Analyst covering Infectious Diseases, GlobalData, did not expect the FDA’s announcement to dramatically affect the sales of Zithromax, but stated, “The news could decrease its uptake among patients at risk

of cardiac complications, and these adverse events could also make Zithromax more susceptible to competition from novel antibiotics.”

Some pharmaceutical and biotech companies are attempting to address the rising demand for novel antibiotics, in a p h a r m a c e u t i c a l f i e l d currently in a state of flux. “Most currently prescribed antibiotics are produced by generic manufacturers, and there is little incentive for pharmaceutical or biotech players to launch new products into the market,” said Dr Ramya Kartikeyan, Senior Analyst covering Infectious Diseases, GlobalData. “The GAIN Act in the US and the innovative medicines initiative in the EU both reflect acknowledgement by governmental, regulatory and research bodies alike of the need to increase research efforts to develop cures against drug-resistant

bacterial infections.” The UK’s chief medical officer, Sally Davies, recently stated that the antibiotics market has stagnated over the past 20 years.

“As regulators continue to provide incentives for the development of novel antibiotics, they must also address the issue of antibiot ic s tewardship both in companies and clinics,” said Dr Tebbets. If novel antibiotics are not used responsibly, resistant pathogens are bound to emerge, which would decrease the sales of the drug and limit treatment options. In addition, Dr Kartikeyan argued that public awareness of resistance is also required to enhance the effects of these initiatives.

Affymax, Inc and Takeda Pharmaceutical Company Ltd recently announced the decision to voluntarily recall all lots of OMONTYS® (peginesatide) injection to the user level as a result of new post-marketing reports regarding serious hypersensitivity reactions, including anaphylaxis, which can be life threatening or fatal. OMONTYS is indicated for the treatment of anaemia due to chronic kidney disease in adult patients on dialysis and is packaged in 10 mg and 20 mg multi-dose vials. The companies have been working actively with the US FDA, which has indicated its agreement with this decision. The companies have also issued a letter to healthcare professionals indicating that no new or existing patients should receive OMONTYS. To date, fatal reactions have been reported in approximately 0.02 per cent of patients following the first dose of intravenous administration.

The reported serious hypersensitivity reactions have occurred within 30 minute after such administration of OMONTYS. There have been no reports of such reactions following subsequent dosing, or in patients who have completed their dialysis session. Since launch more than 25,000 patients have received OMONTYS in the post-marketing setting. The rate of overall hypersensitivity reactions reported is approximately 0.2 per cent with approximately a third of these being serious in nature including anaphylaxis requiring prompt medical intervention and in some cases hospitalisation. The companies are actively investigating these cases.

In the meantime, dialysis organisations are instructed to discontinue use. The recall is being conducted with the knowledge of the US FDA.

Pfizer’s Zithromax side effects stress the need for novel antibiotics

Affymax and Takeda announced nationwide

voluntary recall of all lots of OMONTYS® injection


Swine flu virus now resistant to current medicine Tamiflu

America’s first macrocyclic and ionic gadolinium-based contrast agent gets US FDA approval

Swine flu virus may be now resistant to key medicine Tamiflu, raising fears a new outbreak may be difficult to fight, an Australian research has warned.

While just 2 per cent of swine flu (H1N1) strains around the world are resistant to Tamiflu, the Australian research found mutations in all strains of the swine flu that suggest they might be prone to develop resistance. Dr Aeron Hurt from the World Health

Organization collaborating centre for flu research in Melbourne, said the bug appears more prone than other types of flu to developing drug resistance, The Australian reported.

Tamiflu resistance develops when an individual under treatment receives the drug to control their symptoms. In most flu viruses, the changes that make the virus resistant to treatment also make it less likely to spread to others.

US-based medical imaging company, Guerbet, recently announced the US FDA approval of Dotarem® (gadoterate meglumine), a Gadolinium-Based Contrast Agent (GBCA) indicated for intravenous use with magnetic resonance imaging in brain, spine and associated tissues in adult and paediatric patients of 2 years and older, to detect and visualise areas with

disruption of the blood brain barrier and/or abnormal vascularity. Dotarem which is commercialised widely throughout the world since 1989 is the only macrocyclic and ionic GBCA. “This approval is a major milestone for Guerbet, which has a proud history of providing safe and effective contrast agents to patients worldwide,” said Yves L’Epine, CEO, Guerbet Group.

SPDS to conduct International Convention Disso India 2013 at Mumbai

US FDA approves Navidea’s radioactive diagnostic imaging agent

Society for Pharmaceutical Dissolution Science (SPDS) will be conducting its 1st Annual International Convention Disso India 2013 on May 3 - 4, 2013 in Mumbai. The event will promote introduction of new technology, innovation and would have deliberations on various issues faced related to dissolution. Disso India 2013 event shall witness eminent professionals from the pharmaceutical industry.

This event is being organised under the C h a i r m a n s h i p o f renowned Dr Vinay G Nayak, President-Technical , Alembic Pharmaceuticals Ltd and the Organising Secretary, Dr L Ramaswamy, Managing Director

- Sotax India Pvt Ltd. The scientific sessions are programmed and executed under the chairmanship of Dr Mangal Nagarsenker, HOD & Professor of Pharmaceutics, Bombay College of Pharmacy, Mumbai.

The event shall comprise plenary lecture, poster session, panel discussion and exhibits.

Disso India has been specifically designed for all the professionals from R&D,QA and QC as well as the academia. Around 250-300 delegates are expected to participate in this event, which would be first mega event focussing on dissolution. The event will take place at The Lalit, Mumbai. One can log

on to www.spds.in for registration.

The US FDA has approved Lymphoseek (Technetium Tc-99m tilmanocept injection), a radioactive diagnostic imaging agent that helps doctors locate lymph nodes in patients with breast cancer or melanoma who are undergoing surgery to remove tumour-draining lymph nodes. Lymph nodes filter lymphatic fluid that flows from the body’s tissues. This fluid may contain cancer cells, especially if the fluid drains a part of the body containing a tumour. By surgically removing and examining the lymph nodes that drain a tumour, doctors can determine spread of cancer.

Other US FDA-approved drugs used for lymph node mapping include sulfur colloid (1974) and isosulfan blue (1981). “Removal and pathological examination of lymph nodes draining a primary tumour is an important diagnostic evaluation for some patients with breast cancer or

melanoma,” said Shaw Chen, Deputy Director, Office of Drug Evaluation IV, Center for Drug Evaluation and Research, FDA. “To use Lymphoseek, doctors inject the drug into the tumor area and later, using a handheld radiation detector, find lymph nodes that have taken up Lymphoseek’s radioactivity.”

The safety and efficacy of this new diagnostic drug were established in two clinical trials of 332 patients with melanoma or breast cancer. All patients were injected with Lymphoseek and blue dye, another drug used to help locate lymph nodes. Surgeons subsequently removed suspected lymph nodes for pathologic examination. Confirmed lymph nodes were examined for their content of blue dye and/or Lymphoseek. Results showed Lymphoseek and blue dye had localised most lymph nodes, although a notable number of nodes were localised only by Lymphoseek.


Pitavastatin 4 mg superior to pravastatin 40 mg in lowering LDL in HIV patients suggests phase IV study

AZ to focus on biologics, cut several jobs in research, sales and plans relocation of global headquarter by 2016

Mettler-Toledo launches AXR-P X-ray inspection systems

Eli Lilly and Company and Kowa Pharmaceuticals America, Inc recently announced results of a study evaluating the efficacy of LIVALO® (pitavastatin 4 mg) vs Pravachol (pravastatin 40 mg) in reducing Low-Density Lipoprotein Cholesterol (LDL-C) in HIV-infected adults with high cholesterol or dyslipidemia. Study was a phase IV, randomised (1:1), double-blind, double dummy, active controlled, parallel group of 12-weeks period.

Dyslipidemia is common in people with HIV infection. HIV-infected adults are at an increased risk for cardiovascular disease due to many factors, including lipid abnormalities. Results showed that after 12 weeks of therapy pitavastatin 4 mg had a significantly greater decrease in LDL-C compared with pravastatin 40 mg (P < 0.001). Those taking LIVALO saw an average drop in LDL cholesterol of 31

per cent, compared with a 21 per cent drop in the group taking Pravachol, a difference that was statistically significant, meaning it was too great to have occurred by chance. “We are pleased that the study objective was met, showing superiority of pitavastatin 4 mg to pravastatin 40 mg on LDL-C reduction in HIV-infected adults with dyslipidemia, and we look forward to further analysis of these data,” said Dr Craig Sponseller, Vice President - Medical Affairs, Kowa Pharmaceuticals America, Inc. “In HIV-infected patients with high cholesterol, data such as these represent an important step in understanding lipid management in this immunocompromised patient population,” observed study investigator, Dr Judith Aberg, Director - Virology, Bellevue Hospital Center and Director, Division of Infectious Diseases and Immunology, New York University School of Medicine.

In a major overhauling British drug giant, AstraZeneca (AZ), has announced loss of 1,600 jobs in R&D and 2,300 job cuts in sales and administration. The company recently denoted the closure of its R&D operation in Alderley Park, Cheshire, UK. The job cuts include reduction in the sales force in Europe, where the company has been hit hard on drug sales. AZ currently employs 51,700 people worldwide, with major operations in the United States, Britain and Sweden. Pascal Soriot, CEO, AZ, also revealed his intention of establishing a new global R&D centre and corporate headquarters in Cambridge in the UK by 2016. “I recognise that our plans will have

a significant impact on many of our people at our sites in Cheshire and London and the surrounding communities. We are fully committed to treating all our employees with respect and fairness as we navigate this period of change. “We remain strongly committed to the North West of England. We are keen to work with central and local government, as well as the business community in the region, to ensure that all practical solutions for the future of Alderley Park are considered in order to support the local economy over the long term,” said Soriot in a statement. The move signifies how US-based MedImmune is gaining power within the company and that AZ wants to focus on biologics.

After the success of company’s AXR X-ray inspection systems, Mettler-Toledo has introduced AXR-P, an improved version of its X-ray technology that is developed to help food and pharmaceutical manufacturers ensure the safety and integrity of a wide variety of packaged products. The device is capable of examining products for foreign body contamination and other quality defects, it offers manufacturers greater quality control to boost production and comply with stringent food safety standards, such as Europe’s International Featured Standards (IFS), to operate in lucrative international markets. The advanced X-ray machine allows brand owners to meet requirements of local legislation, such as the Framework Act on Food Safety introduced in South Korea in 2011, for the inclusion of more rigorous data monitoring on production lines, with storage of product inspection data for both conforming and non-conforming products.

The system’s easy-to-use Human Machine Interface (HMI) enables

operators to select and move images into a Graphical User Interface (GUI) for closer examination, as well as compare data from other products in the batch. The AXR-P, developed using standardised hardware is also straightforward to service and maintain with increased availability of spare parts and, to boost production line flexibility, additional plug-ins, which allow the inspection of up to 16 different lanes. Other customisation options are available to meet manufacturers’ needs.

Jun Zhang, Marketing Associate, Mettler-Toledo Product Inspection, said, “The dynamics of the food and pharmaceutical manufacturing industry are changing due to rising international and regional competition. Boosting production line efficiency, remaining cost-effective and staying ahead of the competition are paramount for manufacturers. Yet these needs must be balanced with ensuring adherence to ever-increasing and changing local and global regulations and standards.”


Lupin gets USFDA approval for new drugs

QbD organises ‘The next level in regulatory submissions’

Pharma major, Lupin Ltd, recently announced that its subsidiary Lupin Pharmaceuticals Inc. (collectively Lupin) has received final approval for its Valsartan and Hydrochlorothiazide tablets USP, 80 mg/12.5 mg, 160 mg/12.5 mg, 160 mg/25 mg, 320 mg/12.5 mg and 320 mg/25 mg from the US FDA to market a generic version of

Novartis Pharmaceuticals Corp’s (Novartis) Diovan HCT tablets, 80 mg/12.5 mg, 160 mg/12.5 mg, 160 mg/25 mg, 320 mg/12.5 mg and 320 mg/25 mg, respectively. Lupin has already commenced shipping the product.

Lupin’s Valsartan and Hydrochlorothiazide Tablets USP is indicated for the treatment of hypertension, to lower blood pressure in patients

not adequately controlled with monotherapy or as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals.

V a l s a r t a n a n d Hydrochlorothiazide tablets USP, 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg had annual US sales of approximately $ 1.7 billion.

The conference-cum-workshop on ‘QbD: The Next level in Regulatory Submissions’ organised by Indian Pharmaceutical Association (Delhi Branch) was held and successfully completed as planned at the India Habitat Centre on Saturday, March 23, 2013.

The event managed by Dr Gaurav Kumar Jain, Joint Secretary, IPA-Delhi Branch and Dr Naresh Sharma, Vice President, IPA-Delhi Branch, was attended by more than 60 participants from various pharmaceutical industries.

The conference started with the welcome speech by Dr Farhan Jalees Ahmad, President, IPA Delhi Branch. The welcome speech was followed by an introductory lecture on key components of QbD by Dr Saurabh Arora, Managing Director, Auriga

Research Labs and Executive Director, Arbro Pharmaceutical Ltd, which set up the base for the conference.

Dr Rajeev Mathur, Head-Regulatory of Ranbaxy laboratories Ltd, is a senior in field of regulatory affairs and gave the regulatory perspective of QbD from outlook of Industry.

Dr Sachin Gahoi, Assistant General Manager, Mylan Laboratories Ltd is a young

talented scientist who is working on QbD in Mylan Labs and no one better than a scientist working in lab can teach better about the nitty-gritty of QbD in actual practical aspect.

Prof Bhupinder Singh Bhoop, Professor, Faculty of Pharmaceutical Sciences at Panjab University is a well-known expert and was the most appropriate authority to impart knowledge about formulation by design.

Dr Sandip B Tiwari, Techinical Director, Colorcon Asia Pvt. Ltd, gave lecture on Excipients variability in application of QbD, as excipients variability plays a very important part in application of QbD.

Bimal K Kesh from Cubic Computing (P) Ltd discussed case studies where statistical software of QbD helps to manage data in effective and efficient manner thus improving process quality.

In between presentation a small description about vision of Society for Pharmaceutical Dissolution Science was laid down by Dr L Ramaswamy, Managing Director, Sotax India Pvt Ltd.

The presentations of the speakers were followed by the panel discussion session chaired by Dr Albinus M D’Sa, Deputy Director, USFDA, India Office.

Welcome speech by Dr Ahmad

T h e I n d i a n D r u g Manufacturers’ Association (IDMA) and Association of Pharmaceutical Analysts (APA) recently announced that the 16th Pharmaceutical Analysts’ Convention (PAC) 2013 will be held on September 27-28, 2013, at Hotel Hyatt Regency, Sahar Airport Road, Andheri, Mumbai.

The main theme for this year is ‘Generics the game changer.’ The event would provide an excellent opportunity for the professionals working in the pharmaceutical industry, R&D institutions, government laboratories and approved testing laboratories, academicians, machine manufacturers, API, excipients and intermediates manufacturers.

16th Pharmaceutical Analysts’ Convention

in Mumbai

Firms selling essential medicines at less than government-mandated price caps will have to freeze rates at existing levels, according to the upcoming drug pricing policy.

Reports stated that this would constitute a setback to

companies that sell essential drugs at rates below the government-set price.

There are reports that the Centre is in the process of expanding the number of drugs whose prices are regulated.

Firms selling medicines below government price will

have to freeze rates

12 In Conversation With

Nikunj [email protected]

I work with one of the best teams in the world on developing ways to help sick people get better

Tell us about the journey so far.It has been a lot of fun. I work with one of the best teams in the world on developing ways to help sick people get better. I love sitting in meetings with our customers, and listen to how they are working on delivering not just a better return for shareholders but also better products for their patients. I am proud to play a part in this industry.

The Indian pharma SME sector is considered a bit apprehensive in adopting security solutions. Is it true or the situation is changing now? When we started offering supply chain services in India in 2007, the Indian pharma sector was bit apprehensive in implementing verification-based supply chain security services due to the costs involved. But in recent years two things have happened: companies have recognised the value of consumer and stakeholder engagement far beyond supply chain security, and technology has advanced to allow economies of scale across the industry.

Companies are beginning to recognise that serialisation is not a commodity market; the hidden costs of manufacturing line shut downs due to poorly developed software are much more expensive than paying a little more in price for a quality software system to control your hardware. We spent millions of dollars on customising software for the Indian market and conducted extensive R&D with our early customers in India to develop excellent software optimised for this market, and this has made a difference in establishing a quality service that works well.

How important is drug security in today’s market scenario; and how far India has succeeded in this direction?Globally, there are several reported cases of spurious drugs exported from other nations to different global markets carrying a ‘Made in India’ label. In the domestic market too, consumer confidence needs to be assured through verification technologies. We are closely working with the Indian manufacturing industry to help differentiate their products both globally and here in India.

How do you find the Indian market in comparison with the EU and US markets?In a way, India is ahead. In the US and Europe, the ePedigree and ‘Falsified Medicines Directive’ projects are a long way from implementation. In India, even before the Directorate General of Foreign Trade (DGFT) serialisation mandate came into place, companies had already begun to work with us to implement serialisation-based supply chain solutions. I applaud the Indian government and the industry for starting with manageable solutions that were already in place through the private sector, and working to scale these across the industry in a manageable time frame. But there is something more than regulation that is driving this. For the Indian industry, which has a significant presence in the fast-growing emerging markets, there is an increasing awareness that getting inputs directly from consumers and other stakeholders in the supply chain for the use and movements of products is particularly important. Ser ia l i sat ion unlocks these possibilities.

Elaborate on the demand and growth gap in Asia and developed regions. The demand for medicine is growing at much faster rates in South Asia as compared to the US and EU markets, and the future of pharmaceuticals in India, Africa and other emerging economies is bright. Nevertheless, in coming years the industry will need to look beyond a saturated marketing strategy based on doctors. We are helping our customers take leadership by differentiating their products to consumers through opt in mobile health services that come with each product. We are also helping our customers understand discrete consumer behaviour over time.

How is PharmaSecure looking forward to tap the unearthed potential of Indian consumers?It is easy to use an example. Last week I went to a hospital in India for a routine check-up and was prescribed some medicines to treat a health condition. After filling my prescription, I verified one of my medicines using the

PharmaSecure’s SMS service and was offered a free initial call with a doctor. With some lingering questions I had forgotten to ask the hospital doctor, I opted in. The doctor answered my questions and warned me of a drug interaction. She worked with me to adjust my treatment plan accordingly. Serialisation is by large providing benefits to both the manufacturers and users. We get a lot of feedback from consumers on their use of certain products, and this helps our manufacturing c l ients better serve their patients.

Key strengths that keep PharmaSecure among the leading players?Two words: quality and innovation. We may not be the cheapest serialisation solution on the market, but we stand behind the quality and reliability of our services and are focussed on leveraging serialisation to create real value for our customers through innovative tools.

How do you address post-sales service?We understand that our manufacturers have complex lines and even a small issue can result in big losses. We have on-the-ground teams to respond immediately to sort out any problems, through offsite consultation or on-site visits. We have serialised hundreds of millions of products so far in the Indian market.

Where do you see PharmaSecure in the next five years?We would like to see that the pharmaceutical

industry helping their consumers access not just medicines but better health outcomes. We see ourselves helping the industry to accomplish this.

Any important/interesting learning you would like to share from life?My brother had a cycling accident in Mussoorie and ended up in a wheel chair. Later on, he made an award-winning film on what it is like to live an active life in India while being on a wheelchair. His message in the film is that if you trust God even bad things in life can be transformed to good. For me, this is a great source of inspiration.

How do you maintain a work-life balance?Whenever possible, I ride a cycle from my apartment in Delhi to my office in Gurgaon. I also like to spend time with my family whenever I get the chance.

We stand behind the quality and reliability

of our services and are focussed on leveraging serialisation to create

real value for our customers through innovative tools.

…says Nathan Sigworth, Co-Founder and CEO, PharmaSecure. The dynamic entrepreneur visualised and realised the dream of secure drug delivery to the consumer’s door step and has been successful in developing a deep-rooted consensus among the Indian manufactures about the pharma security solutions.

14 Special Focus

Contract manufacturing is a strategic alternative for major pharma

industries as well as SMEs to address the cost constraints and cater to the needs of emerging biotech companies that lack adequate infrastructure.

In a recent pharma workshop, Cambridge Consul tants revea led that India’s domestic pharmaceutical sector is expected to grow to $ 55 billion by 2020, and is poised to double its total drug export to $ 25 billion through 2014. The sector will be driven by the technology- and innovation-based operation models. At present, the country houses over 20,000 pharmaceutical companies, which is expected to spur intense competition in the domestic and global markets. The projections clearly steer way for a bigger role of Indian pharma on the World map, with more projects in contract manufacturing being assigned to the Indian SME sector.

Current state of affairs Increasing cost of R&D and drug formulation are leading to higher constraints on pharma players to search for effective measures in order to maximise resources, for instance, outsourcing to Contract Research Organisations (CROs) and establishing new R&D facilities in Asia. The global market of contract manufacturing services is expected to grow at a rate of approximately 10 per cent per year in the near future.

The cost constraints on pharma manufacturers have led this sector to look out for low cost and effective resources to manage the expenses and retain the product portfolio. In the recent past Asia has emerged as a hub for cost-effective manufacturing services with continuous expansion of its manufacturing capability and up-gradation of the existing units. In the light of this trend, Asia could be the next most-sought destination for pharma contract

manufacturing with potential destinations including China, India, Vietnam, South Korea and Bangladesh.

In a PSM conference held recently at Delhi, Lalit Kumar Jain, Chairman Pharma SMEs, said, “SME manufactures produce 85 per cent drugs by volume and 40 per cent by value. Today, over 400 companies in Himachal and Uttrakhand are SME pharma and offer contract manufacturing services to major players. Any small unit need ` 1-1.5 crore to set up a five to six line unit, and the government needs to support the small units in order to maintain quality manufacturing.”

Pharma manufactures are increasingly opting for contract research, manufacturing and packaging services to comply with specific requirements, and in quest to reduce expenses and product development cycle while at the same time staying productive and efficient. The production and development strategies of pharma sector are guided by various factors such as delivering simple and efficient solutions as per consumer’s requirement.

Major trendsAccording to a recent report titled ‘Pharmaceutical Contract Manufacturing: World Market Outlook

2012-2022’; this decade, demand for manufacturing services will rise in all leading countries. Contract Manufacturing Organisations (CMOs) in India and China will experience rising demand for API and generic drug manufacturing. The trend will trigger a demand for manufacturing services of APIs, highly potent APIs, finished dosage, generic APIs, injectable dosage and solid dosage formulations.

Global market for contract manufacturing is expected to have the following major trends:

Globally, the pharma sector will witness significant trends, which in turn will lead to considerable growth of contract manufacturing segment

Major pharma companies will focus on collaboration for expanding in new

market and biotechnology through strategic alliances

With major drugs and biologics approaching original patent expiry that will further reduce the profit margins, eventually spurring to the outsourcing of drug manufacturing

Introduction of NDDS and new products, pharma SMEs will start developing the contract manufacturing facilities to assist in development of novel drugs

The emerging market will witness growth in outsourcing projects due to low-cost services and skilled manpower, for instance, China and India to address the contract manufacturing need of pharmaceutical f o r m u l a t i o n s a n d bulk drugs. With markets becoming

increasingly cost competitive, the low-cost Asian region is the most sought market, especially for manufacturing large-volume products. The trend is forecast to affect the contract manufacturing services sector across the globe.

Growth prospects In the near future, the pharma industry is expected to witness consolidation and expansion, which will offer significant opportunities to the contract manufacturers to form valuable partnerships

with major pharma businesses for delivering manufacturing and drug development services. In addition, expansion in newer market will also benefit contract manufacturing companies apart from enabling them to increase their footprints in regional geographies. Further, the small capacity contract manufacturers will be able to use their expertise in producing drugs for clinical trial projects and compete accordingly.

The contract manufacturing business is projected to register growth due to cost management factor, which will also include non-core services such as process and product optimisation in addition to drug manufacturing services. With growing complexities in manufacturing processes combined with the regulatory constraints, pharma players are devising better collaborative strategies. In the past few years, costing pressures have led manufacturing contractors to establish operations in emerging markets such as China, India, South Korea, Singapore and Malaysia. Asia is receiving considerable investment flow, as various western contract manufacturing companies are extending operations in these regions, particularly in China.

Offering cost-effective solutions amid uncertain economic scenarioFluctuation in regional economies and rising regulatory and pricing pressures on the pharma sector have driven the major players’ focus on low-cost regions to fulfil their manufacturing needs. Asia seems to be the preferred destination to address all the issues pertaining to pharmaceutical manufacturing.

Contract manufacturing


With growing complexities in manufacturing

processes combined with the regulatory

constraints, pharma players are devising better collaborative

strategies.

Special Focus

16 Special Focus

Globally, India is a well-known pharma manufacturing hub and ‘sustainability’ is the

latest buzzword in the pharma world. The manufacturing policy adopted last year by the Government of India aims to create 100 million jobs and account for 25 per cent of the GDP by 2022. At the same time, there remain several questions: how long a country can afford to neglect environmental issues in the manufacturing sector?; Why should businesses take the green practices critically?; What is in it for them?; What should they do?

Current Indian scenarioIndia’s rapid industrial growth has come at the high cost of increasing Greenhouse Gas (GHS) emissions, rising utilisation of resources such as water and increasing waste generation. “A green manufacturing economy is crucial for long-term sustainability,” suggests Prof Chithur Devaraj, Department of Operations, Somaiya Institute of Management Studies and Research. According to a recent report by the Confederation of Indian Industry and Boston Consulting Group, India generates close to 4 million tonne of hazardous waste from industrial and biomedical sources. Today, the country is the fifth largest GHS emitter in the world. During the past 10 years, India’s carbon dioxide emissions have increased more than 150 per cent. To overcome these challenges, the Indian pharma manufacturers need to adopt green approach in manufacturing.

The need to go greenBy definition, green manufacturing is a method of making a product with minimum waste and pollution. Implementing green manufacturing practices is aimed at substantially reducing air and water pollutants. These goals are met by designing appropriate products and processes. It is an important part of the business. The need is to satisfy legal obligations, saving ‘one earth that we have’ and address economic turmoil. “Globalisation has spurred the pharma industry in India to improve the environmental, health and safety operations,” says Dr R Smarta, MD, Interlink Marketing Consultancy.

How do we move ahead?Industrial India now recognises the importance of adopting eco-friendly manufacturing practices. MNCs have been going green for years to ensure reduced production cost and environmental sustainability. “Several manufacturers are adopting green chemistry and reducing water-energy consumption so as to lessen their carbon emissions and

economise operational costs,” affirms Prof Devaraj. Recent studies suggest that going green is a cheaper option and an environment-friendly approach. “Efforts in energy conservation, reduction of GHS and programmes in green chemistry involving solvent reduction and water-based methods in manufacturing are some examples of how companies seek to meet goals in

environmental sustainability,” he adds. Recent reports suggests that pharma manufacturing in India is catching up with the long-term benefits of green processes to improve corporate image, reduce costs and achieving compliance at the same time. “Companies are implementing plans to minimise waste and enhance energy efficiency,” says Prof Devaraj. However, there is still a long way to go in allied sectors. It is also important to address water consumption and waste generation as big levers of green. It is possible to reduce water consumption by better control of processes, recycling water and embracing new water-saving technologies.

Green chemistry is in!Researchers across the globe are finding more ecologically prudent ways for the production of pharmaceuticals. ‘Green chemistry’ refers to utilising a set of principles to reduce or eliminate the use/ generation of hazardous substances in the design, manufacture and application of chemical products. Principles of green chemistry involves the design processes to maximise the amount of raw material that ends up in the product; the use of safe, environment-benign substances, including solvents, whenever possible; the best form of waste disposal or not to create it in the first place. “A number of companies are now coming up with economical eco-friendly solvents in place of the hazardous chemicals,” hints Dr Smarta. “Companies are now finding innumerable

ways to cut down on harmful chemicals by using catalyst or cheaper, eco-friendly solvents,” says Prof Devaraj. “Solvents comprise an estimated 80 to 90 per cent of pharmaceutical waste and make them the major contributor of toxicity in Active Pharmaceutical Ingredient (API) production,” he adds.

Some aspects of green chemistry involve catalysis,

solvent replacement, use of renewable feedstocks, waste minimisation, process intensification, improving energy efficiency, better seperation processes, use of safer reactions and chemicals. “Numerous organic solvents are traditionally used in the production of API. This includes toxic and corrosive chemicals

such as toluene, methanol, benzene, carbon tetrachloride, chloroform etc. They are hazardous to the environment and life. Many are dangerous to human, demonstrating neurotoxic effects or suspected carcinogens. Residues from these compounds may remain in the finished drug product finding their way into a patient’s body and the environment,” avers Prof Devaraj.

Pharmaceuticals are manufactured by chemical synthesis in a step by step mode. “This is a process that requires several reactions, separations and purifications with many intermediate steps. As a rule, each step uses some or other solvent. Streamlining such process and reducing the number of steps and solvents can surely reduce cost thereby improving the economic factor. Moreover, companies are putting considerable effort to switch from conventional batch processing to continuous manufacturing processes. Continuous reactors reduce solvent use by allowing for more heat and enhanced mixing and homogeneity,” he says. “One of the ways companies are becoming cost effective is by adopting green chemistry. It is a highly sophisticated approach taken by the pharmaceutical industry to not just cut down costs but also function more responsibly towards t h e e n v i r o n m e n t , ” affirms Dr Smarta.

Rewards of going greenRewards are tremendous for the manufacturing companies. The government now recognises companies’ efforts of going green and rewards them in the form of tax benefits, incentives and financial help. Going green not only benefits the environment but also impacts the customers and a company’s perception in the market. Dr Smarta says, “One of the major rewards for a company adopting the ‘go green’ mantra could be enhancing the company’s image.” Insurance companies offer better rates to manufacturing companies that are taking steps to go green. In addition, such efforts result in cost saving. “The reality is that if a company can save money on energy, its product costs can go down and its customers will not need to pay as much. In addition, the company can always maintain the same costs and reap great profit on its products thereby helping the stakeholders,” advises Prof Devaraj.

Sustainable solutions to drive the future economyIn the current global economic turmoil, every industry is experiencing waves of intense pressure. Initially, industries were reluctant in adopting ‘green approach’ but considering the rewards that it offers, companies have recently started re-evaluating their ‘go-green’ strategies. Read on to learn more...

Green manufacturing practices

Hardik [email protected]

A green manufacturing economy is crucial

for long-term sustainability.

Prof Chithur Devaraj Department of Operations,

Somaiya Institute of Management Studies and Research

Globalisation has spurred the pharma

industry in India to improve the

environmental, health and safety operations.

Dr R Smarta MD, Interlink Marketing

Consultancy

ProcessDesign

Conceptof

GreenChemistry

WasteMinimisation

AccidentPrevention

Eco-friendly Materials

Figure 1: Concept of green chemistry

18 Special & Focus: Interface

What are the recent trends in the pharma manufacturing sector?The pharma sector is growing at 25-30 per cent every year. Exports from India have increased and this has lead to increased scope for not just core manufacturing but also pharma machine and equipment manufacturing. With new projects and expansions on the horizon, we see tremendous growth opportunities in this sector. Also, pharmaceutical expos that are being held in different parts of the world in the pharma manufacturing hubs are bringing together buyers and sellers. This in turn has helped the suppliers to reach international market.

What types of challenges are being faced by the Indian pharma machinery manufacturing sector?We are facing heavy competition from China as the Chinese pharma equipment and machinery industry is seeing a steady growth in sales volume over the years. Their competitive pricing is a major threat to Indian manufacturers. However, the after-sales services are not up to the mark. On the other hand, India is currently manufacturing good quality products and also provides good after sales services.

How do you envision the pharma export industry to grow over the next 5 years?Due to the current focus on export-driven sales, many pharma companies are in the process of setting up plants in export zones and African countries such as Nigera, Sudan and Uganda.

However, the growth in the Indian manufacturing sector has not been up to mark due to the recent wane in demand. Easy procedures for government regulations with better infrastructure and availability of skilled employees would take the manufacturing sector to the next level.

Which new technologies has Airtech introduced over a period of time?We are an air solutions provider for HVAC and cleanroom projects with tailor-made solutions for our clients. We have introduced the double skin air handling unit, reverse and horizontal Laminar Air Flows (LAF) static and dynamic pass boxes etc. Today, there is an increasing demand for precision and expertise. All pharma manufacturing units have to comply to USFDA and UKMHRA norms and standards. We are continuously making quality improvements to our products to comply with these standards. We are also involved in validation.

Over the last 10 years, how has the demands of the sector changed?Today, the pharma manufacturing sector wants to comply with different regulatory markets and is more aware of the norms guiding them. They look for energy conservative solutions and automated systems for the ease of compliance with regulatory norms. At Airtech, we have started offering complete turnkey solutions enabling superior execution and timely completion of projects.

Most clients are targetting the export market. They want to build facilities as per WHO and USFDA norms. There has been a sudden shift

on focus on quality as there is need to clear several audits.

The export trend witenessed recently...Off late, the government is inviting more companies to set up pharma manufacturing plants in Special Economic Zones (SEZs) and providing subsidies and income tax benefits. As demand for pharma units grow and new projects come up, the demand for pharma equipment and machinery also grows. Today, we manufacture 100 per cent export units. Currently, we export 20 per cent of our machinery and are looking to increase this to 35 percent by next year.

Today, the pharma manufacturing sector wants to comply with different regulatory markets and is more aware of the norms guiding it

…says Sunil Aggarwal, Director, Airtech System India Pvt Ltd. Here, he talks about the Indian pharma machinery manufacturing sector and its growth opportunities.

Pallavi Mukhopadhyay pallavi.mukhopadhyay @network18publishing.com

20

Venus Remedies Ltd, based in Baddi, develops novel research products for critical unmet medical needs in compliance

with the global quality standards. The company’s core strength lies in its research products that cater to critical care and super speciality segment, including anti-infectives (Anti-Microbial Resistance (AMR)), anti-cancer, cardiovascular, neurology, pain management and wound care.

Pharmaceutical innovations need cognition of disease area and technical insight. While most businesses are limited to primarily focus on any one of these aspects, Venus adopted a business model that possess in-depth research activities, which delivers high impact drugs for patients. Talking about the business model Dr Manu Chaudhary, JMD & Director - Research, Venus Remedies, says, “We are focussed on our own research-based products in the fields of oncology, anti-infective and neurology. We have already made good in-roads into Anti-Microbial resistance (AMR) that we plan to cash-on in the near future. We could foresee the potential of antibiotics reduce due to resistance some 10 years ago and it is the result of our focussed approach that today we have the ‘Super bug’ tackling solutions under patent protection. We would like to enhance our penetration in global markets through strategic alliances on the strengths of product ownership and protection.”

Research-driven innovation Venus Remedies owns DSIR recognised research centre in Chandigarh that is continuously engaged in discovering innovative platform technologies to assist in targeted drug deliveries and diagnostics or new drug delivery systems. The company follows a sustainable investment model to support its R&D projects and boost existing capabilities. Emphasising upon the research focus, Dr Chaudhary explains, “The company invests around 16 per cent of total sales turnover in R&D and drug development to ensure updated and fully equipped modern infrastructure to meet the needs of the facilities. Venus Medical Research Centre aims at developing and formulating new and medically required fixed-dose combinations, novel drug delivery systems including target-based delivery of drugs especially for tumours and nanotechnology-based innovation.”

The company also offers expertise in analytical research, molecular biology research and toxicology studies and have marked breakthrough innovations through balancing basic biomedical and translational research for developing medicine in the area of critical illness. Venus has an impressive line of products and continues to thrive with newer launches at times.

Recalling the recent product launch by Venus Remedies, Dr Chaudhary informs, “We have launched CSE1034 under the brand name ‘ELORES’ recently. It is a novel Antibiotic Adjuvant Entity (AAE). Designed specifically to target growing bacterial resistance mechanisms, ELORES has a unique profile of action which gives it an edge over all the existing therapies. This unique antibiotic adjuvant entity creates a synergistic effect due to its activity on Acquired Multiple Resistance in Gram Negative Enterococci and Rods (AMRINGER), which stops development and spread of bacterial resistance. Our product is effective against Metallo Beta-Lactamases (MBL) producing pathogens, which are not susceptible to most of the existing antibiotics. It is also unique in its way that it not only kills resistant pathogens (bacteria) but also prevents the spread of resistance.”

Planning for the futre With a view to deliver effective solutions for life threatening diseases cost effectively, Venus is currently working on a robust pipeline of 25 products that are in different stages of development, comprising 12 novel products that have already been commercialised.

In addition to this, the company is looking forward to increase its footprint in domestic and global markets through collaborations with other leading players worldwide.

“We have engaged two world renowned consultants and are in talks with few well established companies of good repute for out-licensing deals. We are hopeful of materialising a good deal for out-licensing our research products soon in the near future,” she informs.

Equipped with a dedicated team of qualified professionals to conduct market surveys and researches to find out the needs and unmet areas in pharma and healthcare sectors, the company is aggressively reaching its goals through strategic future planning and attaining a leadership position in its areas of expertise.

Comparing the Indian pharma market with other global markets, Dr Chaudhary points out, “Indian market is different from global

demographies in terms of their regulatory framework. Throughout the world, regulatory systems are becoming more and more stringent to give holistic approach from experiment planning, performance, monitoring, recording, reporting and archiving. Efforts made by National Good Laboratory Practice (GLP) and Compliance Monitoring Authority (NGCMA) are credible but a lot more can be done to improve GLP awareness. Though it is not mandatory to get GLP accreditation in India, some manufacturers have already implemented the concept voluntarily.”

Making a difference to lives Venus Remedies is moving ahead on the basis of innovations, with a focus on developing novel solutions and establishing itself as an innovator company globally. The company has already commercialised a successful product line and is thriving to combat serious or life threatening medical ailments by putting its best resources available including funds, technical expertise, best practices and manpower.

Mentioning about the company’s vision and CSR activities, she states, “We firmly believe in our mission that says that we are in the business of preserving and improving human life through innovation and we manufacture medicines for patients, not for profits. Profits follow! Thus, we put in our 100 per cent efforts, dedication and commitment to deliver the best of our services and products to fulfil our objectives and serve the mankind.”

The company actively participates in public health programmes on a regular basis that include organising blood donation and eye check up camps at its campus in about every six months.

Facility Visit

We put in our 100 per cent efforts, dedication and commitment to deliver the best of our services

and products to fulfil our objectives and serve the

mankind.Dr Manu Chaudhary

JMD & Director - Research

Venus Remedies Ltd, Baddi

Riding high on innovationVenus Remedies Ltd is among the few research facilities focussing on Anti-Microbial Resistance (AMR) products globally. The company holds a significant position for developing various solutions in the critical care and super speciality segment, and is committed to explore the requirements of other serious unmet medical conditions.


With a view to deliver effective solutions for life threatening

diseases cost effectively, Venus is currently working on a

robust pipeline of 25 products that are in different stages of

development.

21Insight & Outlook: Interface

Suggest some measures for ensuring better clinical studies. First, the government must enforce accreditation for all centres performing clinical trials. Second, the doctors who are involved in clinical studies must be accredited, because a good doctor may not be necessarily having good ethics. So, accreditation will bring in accountability for both the research institute and the practitioners, thus in turn improving patient safety.

Third point is that all the research institutions must have ethics committees so that any trial being conducted within or through the organisation could be fair and authentic. Furthermore, each member of these committees must undergo adequate training about conducting fair clinical studies. Finally, these members must be accredited by the concerned regulatory authority.

The global regulatory agencies will not recognise our data until and unless we provide an ethics committee certification to the studies conducted in the country. Once we will have a proper accreditation system in place, we will have revenue, employment and our clinical trials’ growth will shoot up.

What are the major trends witnessed in clinical trials in India in the last decade?Major trend is that MNCs are bringing in more drugs for Cardio Vascular Diseases (CVD), cancer and diabetes mainly, but we are ignoring traditional Indian medicines and our herbal products. No serious studies are being conducted on these products, and also no toxicology study has been performed so far. Currently, they just conduct trial on four to five subjects and send the reports, which are not certified by the ethics committees. Independent investigator must monitor these trials to reap the benefits of these trends. We must have our own ethics committees to have a proper accreditation system in place for global recognition of trial data.

Considering that ‘ethics’ is considered a casual term in the India, how critical would you rate ethical practices while conducting clinical trials? The concept of ethics was highlighted in India about five years ago, and since then there has been some progress. Research papers are not accepted in journals unless the data is not certified by ethical committees. India has a significant number of medical and pharmacy colleges and research centers; and controlling unregistered trials is a difficult task. But definitely, we have made progress as now everyone is talking of and is aware about ethics committees and its importance. But given the magnitude of population and subsequent patients, it will take some time for things to fall in place. Apart from the human and animal safety, what steps are being taken for device trials? For device trials we have new stents, which needs to be certified through clinical trials, and most of them contain

drugs. But unfortunately, India lacks a separate medical device regulatory body, despite repetitive recommendation by various groups. Once this demand is met, we can introduce new stents, hip joints and various crucial medical aids.

How Clinical Trials Registry – India (CTRI) will help to achieve the goal? Clinical Trials Registry – India (CTRI) will help us because hereon we will know about the trials being conducted in the country as there will be a proper system in place to record the proceedings. Until now, we did not have the system for receiving information about the trials; and if there is no result even in six or eight months time, we can ask about the trials to the concerned departments and that will be the first step. Government of India has passed an order for registration of ethics committees. The second step in this direction will be the accreditation of all these committees by regulatory bodies. All the ethics committees will be accountable for authenticity of the trials data approved by them. The accreditation authority will also possess the right to cancel illegitimate data, if found.

We must have our own ethics committees to have a proper accreditation system in place for global recognition of trial data

…says Prof Ranjit Roy Chaudhury, Chairman - Task Force for Research, Apollo Hospitals Educational and Research Foundations. Here, he discusses some basic measures that can help in addressing the issues related to conducting clinical trials.


22 Projects

An

as well...thatinviterewards

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Ranking among the top five globally by production volume, the Indian pharmaceutical market today accounts for over 10 per cent of global drug production. It continues to be one of India’s biggest employers – with more than 340,000 Indian employees dedicated to an industry that is worth in excess of $ 22 billion. But senior delegates at the Cambridge Consultants Mumbai pharma workshop said Indian pharmaceutical companies must embrace innovation and adopt technology if they are to stay competitive at both a domestic and global level. The Cambridge Consultants workshop, attended by a cross–section of senior personnel from a variety of functions within leading Indian and MNCs, explored the question whether India would become one of the world’s leading pharmaceutical countries by 2030? Recent reports suggest India’s domestic pharmaceutical sector will grow to $ 55 billion by 2020. As a significant exporter of high-quality

generic drugs, India is expected to see the value of its drug exports double to $ 25 billion by the end of 2014, according to the country’s Minister of Health.Delegate feedback revealed that the Indian pharmaceutical industry still has significant growth opportunities, and major local companies could have the potential to compete with multinational pharmaceutical companies. Among them, the greatest impact in world markets will come from those Indian pharmaceutical companies which adopt technology innovations to differentiate their products and make them more competitive both domestically and globally. This trend for differentiation is particularly important as Indian pharmaceutical companies have fewer new generic opportunities. This is because the number of New Chemical Entity (NCE) filings to the US FDA has declined over recent years and the number of innovator drug patents

reaching their expiry date has peaked. Similarly, at a global level there are more generic pharmaceutical developers from other emerging nations, including China,which will offer low-cost competition for India, as well as the ongoing global threat of counterfeit drugs.Andrew Barrett, Director, Medical Technology in India, Cambridge Consultants, said, “In order to drive faster growth, and capitalise on their existing success, Indian pharmaceutical companies must now aim to create true added-value offerings with ‘super-generics’, which can deliver additional benefit to patients. Innovation and technology are key, and the required investments can be recouped because medical products have long lifecycles. Technology has a great role in drug delivery to extend these lifecycles, add value and, importantly, allow product differentiation in a crowded market space.”

In Conversation With 13Dr Ruchi DassFounder, Healthcursor Consulting Group

Special Focus 14EU-India Free Trade Agreement What is at stake for pharmaceuticals?

Policies & Regulations 17Indian pharmacy drug stores Need to have a strict regulatory system

Roundtable 19Is the race for generics stifling innovation in Indian pharma sector?

Dr Frank Heinricht appointed Chairman of the Board of Management of SCHOTT AGThe Supervisory Board of SCHOTT AG unanimously appointed Dr Frank Heinricht to the position of its new Chairman of the Board of Management in its meeting on February 27, 2013. Heinricht (50) is currently the Chairman of the Board of Management of Dr Heraeus Holding GmbH. He completed a degree in physics and a doctorate in engineering at the Technical University of Berlin and began his professional career at TEMIC Semiconductors. After holding positions as General Manager and Chairman of the Integrated Circuits Division, he was appointed Chief Executive Officer of TEMIC Semiconductor Group, in 1998. In 2003, Dr Heinricht joined Heraeus Holding GmbH as Member of the Board of Management. He was appointed Chairman of the Board and Labor Director in 2008. Dr Frank Heinricht will take office on June 1, 2013.

Venus signs exclusive marketing rights for Potentox with South Africa’s Adcock Venus Remedies Ltd, the r e s e a r c h - b a s e d g l o b a l pharmaceutical company has accord exclusive marketing rights for its novel antibiotic product, Potentox, to South Africa’s pharmaceutical giant Adcock in a deal the company announced.“We are pleased to join hands with Adcock and are confident that the deal shall take our research product to its meaningful stage in South Africa. Adcock will have exclusive marketing rights of the product in South Africa over the period of 15 year. The product will remain under patent protection till 2025 in African territory and is expected to be launched by mid of 2015 after getting due regulatory approvals.” said Pawan Chaudhary, CMD, Venus Remedies Ltd.

Dr. Reddy’s announces the launch of zoledronic acid injection Dr. Reddy’s Laboratories has launched zoledronic acid injection (4 mg/5 mL), a bioequivalent generic version of Zometa® (zoledronic acid) 4 mg/5 mL injection in the US market on March 4, 2013, following the approval by the USFDA. Dr. Reddy’s zoledronic acid injection 4 mg/5 mL is available in a single use vial of concentrate.

16 - 31 M a r c h 2 013 I Vo l 1 I N o 18 I `10 0


www.modernpharma.in

Agility India inaugurates its first temperature controlled facility for pharma near Nhava Sheva

With the Indian pharma sector bustling with activity and business growing at 14 per cent per year, the need for advanced logistics services has prompted Agility India to set up a temperature-controlled warehouse for its pharmaceutical customers near Nhava Sheva (near Mumbai). Agility, manages entire logistics systems that include warehousing, distribution, sorting and kitting. The consolidation centre was inaugurated by Chris Price, CEO - Asia Pacific region. This 3,000 sq feet, dedicated temperature controlled warehouse w i l l p r o v i d e customers in West India with optimal storage and

handling facilities.This custom bonded facility located at CWC Logistics Park CFS, Hind Terminal Facility, controlled at 18 oC, has all contingency measures in place in case of a power failure. Further, the facility provides continuous temperature tracking systems, daily data

loggers, and consolidation processes are set to be undertaken under the supervision of B Pharma graduates. The consolidation centre will witness a monthly maintenance and internal audit. The company will provide end-to-end services; starting from collection of temperature controlled

shipments in reefer vehicles to delivery of the same to respective customers. With Agility’s cost effective sea freight solutions for the pharma sector, Agility expects to see a healthy growth in the requirement of such services.Commenting on the new

development, Price, said, “We have our roots in emerging markets and we

make significant investments in such markets. We are looking to serve to our customer’s specific needs and provide value-added customer-driven solutions. India is seeing a lot of potential. With the current surge in generic drug market, we expect to see a lot more demand for such inclusive services as shipment sizes are going to get bigger. Against this backdrop, pharma supply chain consolidations will give pharma companies more value.”With its latest endeavour, Agility

is plugging gaps such as the transport problems associated with small shipments, troubles that arise due to extreme temperature and humidity conditions, unsuitable storage facilities and high costs associated with pharma freight operations. The next step for Agility is weekly departures to Rotterdam and Antwerp. Currently, Agility serves pharma biggies such as Dr Reddy’s, Mylan, Hetero Drugs, Aurobindo etc.With reliable port-to-port transit

times, good distribution practices and comprehensive knowledge about import and export regulations, Agility is well set to support its growing pharma customer base.

Price inaugurating the facility

Cambridge Consultants workshop reveals Indian pharma growth outpaces rivals

Dr Heinricht

Pallavi Mukhopadhyay

Manas R. BastiaSenior EditorModern Pharma

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Bulk drugs manufacturing unit Project type: New facilityProject news:Delta Finochem Pvt Ltd planning to manufacture bulk drugs manufacturing unit.

Project location:Nashik, Maharashtra Project cost: NA Implementation stage:Planning

Contact details:Delta Finochem Pvt Ltd, 121, MIDC, Satpur, Nasik 422 007, Maharashtra

Multi-speciality hospital Project type:New facilityProject news: B M Birla Heart Research Centre plans to construct a multi-speciality hospital. Project location:Darjeeling, West Bengal Project cost:NA

Implementation stage:Planning

Contact details:B M Birla Heart Research Centre 1/1 National Library AvenueKolkata-700027, West BengalTel: +91-(033)-24567890/30403040E-mail: [email protected]

Manufacturing of drugs Project type: New facilityProject news:Venus Remedies announced that it targets gaining returns close to $ 100 million over the next half decade, from the latest drug it launched — Elores. The drug has been designed to fight bacterial infection. India is the first country that has seen its launch.

Project location:India Project cost: $ 100 million Implementation stage:Planning

Contact details:Venus Remedies Ltd SCO 857, Cabin No. 10, 2nd Floor, NAC

Manimajra, Chandigarh (U.T.) Tel : +91-172-3933090, 3933094E-mail : [email protected], [email protected] : www.venusremedies.com

Modern vaccine facility Project type:New facilityProject news:Shantha Biotechnics Ltd focusses on R&D of generic biologicals, novel therapeutic antibodies, proteins and vaccines. Project location:Andhra Pradesh Project cost:NA Implementation stage:Planning

Contact details:Shantha Biotechnics Ltd 3rd Floor, Serene Chambers, Road No.7, Banjara Hills, Hyderabad, Andhra Pradesh, Tel: +91-(40)-23543010, 23548507 Fax: +91-(40)-23548476 New compression moulding facility Project type: New facility Project news:West Pharmaceutical India Packaging Pvt Ltd, an indirect subsidiary of West Pharmaceutical Services, Incorporated, has started construction of its new compression moulding facility located in Sri City, India.

Project location:India

Project cost: NA Implementation stage: Planning

Contact details:West Pharmaceutical India Packaging Pvt Ltd530 Herman O. West Drive, Exton, PA 19341Tel: +001-610-594-2900Fax: +001-800-345-9800

Rivastigmine transdermal patches manufacturing unit Project type: Facility expansion Project news:Sparsha Pharma International is planning for capacity expansion of rivastigmine transdermal patches manufacturing unit.

Project location:Medak, Andhra Pradesh Project cost: NA Implementation stage: Planning

Contact details:Sparsha Pharma International # 8-2-408, D-3, Sri Krishna AptsRoad No: 6, Banjara Hills, Hyderabad - 500 034Andhra Pradesh Tel: 040- 23352581/ 83Fax: 040-23352880Email: [email protected]

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

Information courtesy: www.tendersinfo.com1, Arch Gold, Next to MTNL Exchange, Poisar, S V Road, Kandivali (W), Mumbai - 400 067, Maharashtra, India

23Tenders

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: Fax: Email: [email protected]

UV-VIS spectrophotometer Org : University Of Agricultural Sciences

Desc : Supply of UV-Vis spectrophotometer

BOD : April 12, 2013

Loc : Bengaluru, Karnataka

BT : Domestic (NCB)

Nano spectrophotometer Org : University Of Agricultural Sciences

Desc : Supply of nano spectrophotometer with

accessories


Loc Bengaluru, Karnataka

BT : Domestic (NCB)

Ellipsometer Org : Gallium Arsenide Enabling Technology

Centre (GAETEC)

Desc : Supply of ellipsometer


Loc : Hyderabad, Andhra Pradesh

BT : Domestic (NCB)

FTIR spectrophotometer Org : Indian Oil Corporation Ltd (IOCL)

Desc : Supply of FTIR spectrophotometer with

drift accessories


Loc : Faridabad, Haryana

BT : Domestic (NCB)

NMR spectrometer Org : Department of Atomic Energy

Desc : Supply and warranty of compact 60 MHZ

proton NMR spectrometer reference

samples with accessories MNOVA

software etc


Loc : Mumbai, Maharashtra

BT : Domestic (NCB)

X-Ray fluorescence spectrometer Org : Mineral Exploration

Corporation Ltd (MECL)

Desc : Supply of wave length dispersive X-ray

fluorescence spectrometer


Loc : Nagpur, Maharashtra

BT : Global (ICB)

Refrigerated bench top centrifuge Org : All India Institute Of

Medical Sciences (AIIMS)

Desc : Supply of 18-high speed refrigerated bench

top centrifuge


Loc : New Delhi

BT : Domestic (NCB)

Mass Spectrometer (LC-MS/MS) Org : Centro De Neuroci ncias

E Biologia Celular

Desc : Supply of mass spectrometer (LC-MS/MS))


Loc : Portugal

BT : Global (ICB)

Tabletting machine Org : Ordnance Factory Board

Desc : Supply of tabletting machine


Loc : Pune, Maharashtra

BT : Domestic (NCB)

RF signal analyser Org : Defence Research & Development

Organisation (DRDO)

Desc : Supply of RF signal analyser


Loc : Bengaluru, Karnataka

BT : Domestic (NCB)

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

24Event List

N A T I O N A L E V E N T SPharma Pro&Pack 2013 PHARMA Pro&Pack Expo 2013 will offer an opportunity to expand business in the Indian and international pharma industry. Various industry majors from India and across the world will be present at the Technology Show. The event will help facilitate meetings with clients & prospective customers at one place on one platform thus expanding business to new customers locally & internationally; April 24-26, Bombay Exhibition Centre, Mumbai

For details contact:GPE Expo Pvt LtdTel: 91-79-40008253Email: [email protected]: www.pharmapropack.com

iPHEX 2013iPHEX plays a major role in introducing the Indian market to the advanced medicinal products. This show covers up the entire medical industry, starting from hospital services, medicines, pharmaceuticals and surgical sectors. 250 companies have already registered to participate in this event as they think that this podium is best way to reach out to the customers and publicize their brand name; April 24-26, 2013, Bombay Exhibition Center (BEC), Mumbai

For details contact:Pharmaceuticals Export Promotion CouncilTel: +91-40-23735462/23735466Fax: +91-40-23735454Email: [email protected]: www.iphex-india.com

ADME & Toxicology 2013 and ‘Nanomedicine’ conference and exhibition The conference will provide attendees with a learning and networking environment where they can share and discuss the latest developments in the field of life sciences. This conference will aim to provide a multidisciplinary approach to tackle the fundamental challenges in this specialty, innovative strategies for testing exposure, and techniques for improving the reliability and accuracy of results. The keynote speakers will give presentations on all areas of nanomedicine backed up by a panel of experts speaking on highly relevant and ‘hot’ topics such as green nanotechnology, nanomedicine in theranostics besides discussing topics such as novel synthetic approaches in nanomedicine, nano-delivery systems and regulatory and toxicology aspects in nanomedicine; May 30-31 2013, Raddison Blue Plaza, Delhi

For details contact:Select Bio LtdTel: +44 (0)1787 315110Fax: +44 (0)1787 315111Email: [email protected]: www.selectbiosciences.com/conferences/index.aspx?conf=ND2013

PHARMAbiotikaPharmabiotika 2013 is an exhibition with an in built buyer and seller meet which will help one in networking with 10000+ business visitors, 600 delegates and 400+ exhibitors, attending the global exhibition. There are around 30+ thought leaders from across the world sharing their valuable experiential learning in the 3 days

conference. The event will help in meeting the potential customer requirements mapping for developing new trade leads and analysing the exhibiting plan and execute trade objectives, September 16-18, 2013, Mahatma Mandir Convention & Exhibition Center, Gandhinagar

For details contact:Human Crayon Management Services Pvt LtdTel: +91- 120 – 6528801Email: [email protected] Website: www.pharmabiotika.com

Indian Pharma ExpoThe Indian Pharma Expo 2013 will be one of the a unique pharma events inIndia that will serve as a perfect platform for pharma entrepreneurs andinvestors, eager to be a part of the pharmaceutical business through franchisee and distributorship opportunities in the India pharma market. The two-day expo will bring together drug manufacturers, pharma companies and the largest suppliers and distributors of pharma products under one roof in order to facilitate the exchange of ideas for better growth of the industry; September 20-21, 2013, Pragati Maidan, New Delhi

For details contact:UBM Medica India Pvt LtdTel: +91-22-66122600 / 66122673Fax: +91-22-66122626Email: [email protected]: www.ubmindia.in

34th International Conference on Bioscience, Biochemical and Pharmaceutical EngineeringThe main focus of this conference is to bring scientists, researchers and scholars together to exchange and share experiences and research results about bioscience, biochemical and pharmaceutical engineering, and discuss the practical challenges encountered and the solutions adopted. The conference will deal with topics such as bioscience, biochemical and pharmaceutical engineering, affective neuroscience, astrobiology and more; December 5-6, 2013, Sheraton, Bengaluru

For details contact:World Academy of Science Engineering and TechnologyTel: +44-782-4879405Website: www.waset.org/conferences/2013/bangalore/icbbpe/

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.

HYDERABADAndhra Pradesh, May 31- June 3, 2013

For detailsNetwork18 Media & Investments Ltd

Ruby House, 1st Floor, J K Sawant Marg, Dadar (W), Mumbai 400 028.

I N T E R N A T I O N A L E V E N T S8th Annual Drug Discovery Chemistry Conference This is one of the few events specifically for medicinal chemists working in pharma & biotechnology sectors. It is focused on discovery & optimisation challenges of small molecules. Nobel Laureate will give the keynote address. The meeting will discuss Anti-Inflammatories, Fragments, Macrocyclics, Kinase Inhibitors, PPI & GPCRs. The event offers opportunities for scientists to create unique programs according to personal interests; April 16-18, 2013 Hilton San Diego Resort & Spa, San Diego, CA, USA

For details contact:Cambridge Healthtech InstituteTel: +1 781-972-5400Fax: +1 781-972-5425Email:[email protected]: www.drugdiscoverychemistry.com

Pharmaceutical Research Conference for Pharmacy Students & Young Graduates Themed ‘Meeting of the inquisitive minds: translating research into reality’, PRC 2013 is set to be the arena for pharmacy students & young graduates to showcase research & interact with other young researchers to ignite interest & exchange ideas. The conference will provide an environment for pharmacy students to present their research work and share their knowledge. Participants

can present and discuss the newest developments and breakthroughs in the field of pharmacy. It will set base for more interaction between pharmacy students and young graduates; May 11-12, 2013 Cyberjaya University College of Medical Sciences, Selangor, Malaysia

For details contact:Faculty of Pharmacy, Cyberjaya University College of Medical Sciences Email: [email protected]: http://prc2013.weebly.com/

18th Edition of FCE PharmaFCE Pharma will be held to promote pharmaceutical industry. At the event, exhibitors will get an opportunity to showcase their innovative products and services such as equipment, services, logistic, processes, quality control, outsourcing, analysis, laboratorial, process equipment, valves, automation and technology. The main aim of FCE Pharma will be to bring together world renowned companies related to raw material and packing. The event will provide the visitors with the latest developments and trends. The event attracts visitors and exhibitors from all over the world; May 14-16 2013, Transamerica Expo Center, Sao Paulo, Brazil

For details contact:NürnbergMesse BrasilTel: +55 (11)-3205-5000Fax: +55 (11)-3205-5070

Email: [email protected]: www.fcepharma.com.br/en/

International Congress of Toxicology 2013The theme for the conference is ‘From Basic Science to Clinical and Environmental Outcomes’. This conference encompasses novel approaches and technologies being used to properly assess the safety, toxicity, and risk for human health. The scientific programme will consist of keynote/distinguished lectures, symposia, workshops, round table discussions, debate and poster sessions. This meeting will provide attendees with ample opportunities to exchange the ideas and to launch collaborations; June 30-July 4, 2013, Coex, Seoul, Korea

For details contact:ICT XIII SecretariatTel: +82-2-557-8422Fax: +82-2-566-6084Email: [email protected]: www.ict2013seoul.org

Pharma Trials World Korea 2013Pharma Trials World Korea 2013 is where pharma companies, trial sponsors, regional and international CROs and clinical trial sites gather to strategise in accelerating clinical development, accessing emerging markets, enhancing clinical operations through effective offshoring and outsourcing in Korea; July 8-11, 2013, Korea

For details contact:Terrapinn Pvt LtdTel: +65 6222 8550Fax: +65 6226 3264Email:[email protected]: www.terrapinn.com

3rd International Conference on Environmental, Biomedical and Biotechnology 3rd International Conference on Environmental, Biomedical and Biotechnology is sponsored by the Asia-Pacific Chemical, Biological & Environmental Engineering Society. It is one of the leading international conferences for presenting novel and fundamental advances in the fields of environmental, biomedical and biotechnology. It also serves to foster communication among researchers and practitioners working in a wide variety of scientific areas with a common interest in improving environmental, biomedical and biotechnology-related techniques; August 24-25, 2013, Royal Hotel, Singapore

For details contact:Asia-Pacific Chemical, Biological & Environmental Engineering SocietyTel: +86-28-86528465 (China Branch)Email: [email protected]: www.icebb.org

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.

25Event Report

8th Nutra India SummitProviding impetus to the surging nutraceutical market

The 8th Nutra India Summit was held amid a thriving intellectual gathering of individuals from the global nutraceutical,

pharma, functional foods and dietary supplement industry. The Summit was held in Mumbai across a span of 4 days during March 13-16, 2013 and was inaugurated by Satej Dnyandeo Patil, Minister of State for Home, Rural and Food & Drug Administration (FDA), Maharashtra.

The event witnessed several sessions addressed by 65 acclaimed speakers and attended by 500 plus delegates. Participants from 20 countries including China, Japan, Singapore, Brazil, Canada, USA, New Zealand, Germany, Switzerland, France, Poland, and the Netherlands from 300 organisations were seen at the event.

Focussing on further growth With today’s mantra being ‘invest in healthy living’, this market has visions of growing to one of India’s key markets in the future. The growing evolution of both the pharmaceutical and nutraceutical sector was discussed during the event. According to reports, the nutraceutical industry is poised to be a $ 4 billion industry by 2015. While the nutraceutical industry is deemed to be a promising sector, its need for convergence with the booming pharma sector was highlighted. Sandeep Gupta, Group VP - BD & Strategic Initiatives/Innovation, Geltec Pvt Ltd, said, “Today, the pharmaceutical industry is still the frontrunner. However, with the recent spate of acquisitions, companies such as Reckitt and Pfizer will soon enter the Indian supplement market alongside Amway, which is already adding value and creating awareness about this segment. Today, emerging lifestyle diseases need to be addressed by nutraceuticals as prevention is more important than cure. Self-regulation will be the key to success for the nutaceutical industry.” Adding to this, Dr R K Sanghvi, Chairman, Nutraceutical & Medical Subcommittees - IDMA, said, “Pharma can help impart critical knowledge about nutraceuticals to the doctors as many are still unaware of it. With proper understanding and education, this sector will witness a steady growth over the next few years.” Going forward, the nutraceutical and pharmaceutical industry should enter a strategic relationship in order to cater to the changing customer needs.

Allied activitiesIn addition to the seminars and conferences, various other activities were arranged on the sidelines by the organisers. The Morning Mantra session at the 8th Nutra India Summit included talks by several keynote speakers. Further, the CEO Summit focusing on the theme ‘Regulation, Innovation and Validation of Claims’ also brought together various important industry leaders. Nutra Excellence Awards recognised the contribution

of important personalities and organisations. Nutraceutical bigwigs such as Amway, Sami Labs, British Biologicals and more were awarded under various categories

The InterlinX Partnering Tool helped organise nearly 140 B2B meetings. An ‘Expression of Interest’ was signed between Brazilian Society of Food Science & Technology, International Society for Nutraceuticals, Nutritionals and Naturals (ISNNaN) & Nutra India Summit.

NuFFooDS, The Health & Food Expo, saw around 50 exhibitors from India and overseas including corporate, scientific labs, wellness organisations and attracted around 3,000 visitors. The Expo also witnessed the launch of Metagenics in India by Heal Wellness. Free sampling of products took place in the Expo, making it a suitable platform for product launches and sample distributions. The NuFFooDS Expo also organised seminars conducted by the Indian Dietetic Association, Mumbai Chapter on better health for better living.

With the nutraceutical industry seeing a steady rise in growth figures and consumer demand, the 8th Nutra India Summit set a good platform for knowledge sharing and business meetings alike. This report takes a closer look at the happenings at the event this year.

Pallavi Mukhopadhyay pallavi.mukhopadhyay @network18publishing.com

Representatives of British Biologicals receiving award from Dr V Prakash, Chairman, 8th Nutra India Summit

26 Book Review

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

One of the ‘legendary’ books in the pharmaceutical industry, this 17th edition on injectable drugs adds in new monographs to make this an up-to-date reference guide. A must have for everyone in the pharmacy space or the industry as a whole, the book comprises 332 monographs of injectable formulations arranged alphabetically. Each monograph is organised into multiple subheadings. The first ‘products’ details the various dosage sizes, strengths, volumes and packing in which it is supplied. It also stresses the point that formulation information must play a significant role in deciding selection of drug by healthcare providers. ‘Administration’ deals with the various routes by which the drug can be administered. Another major heading is ‘stability’ of the formulation. ‘Compatibility’ with other injectable drugs and infusions is of paramount importance especially when administering through Y – sites or three ways. This is described in a tabular format for major infusions used commonly. The book concludes with an appendix devoted to parenteral nutrition formulae and their constituents. The book is a plethora of information, which is impossible to recollect at a moment’s notice, but can easily be retrieved from this book. A must have text for all healthcare personnel, pharmacists, pharmaceutical scientists among others.

Essential Microbiology for Pharmacy and Pharmaceutical Science

Handbook of Injectable Drugs 17th Edition

Editors: Geoffrey Hanlon & Norman Hodges

Price: ` 2,250

Publisher: Wiley – BlackwellDistributor: 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]

Editor: Lawrence A Trissel

Price: ` 19,000

Publisher: American Society of Health – System PharmacistsDistributor: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]

Understanding microbiology is an integral part of pharmaceutical sciences, both for developing molecules against microbes and also in ensuring sterile drug formulations. This book gives an excellent overview into the concepts of microbiology relevant to a pharmacist or a pharmaceutical scientist. The book comprises three major parts, the first of which deals with the very basics of microbiology. The first part devotes chapters to bacteria, fungi, protozoa and viruses in brief. Each chapter elaborates on the structure, clinically relevant functions and medical targets for therapy. The second part goes on to describe the various infections caused by bacteria, fungi, protozoan and viruses. The initial chapter in part 2 about infection basics and immunity aims at a revision of old and new concepts, followed by a chapter dedicated to the various types of antibiotics available today. Part 3 is of more direct interest to the industry, as it deals with bioburdens, sterility testing, identification of organisms, antiseptics and disinfectants, design of sterile processes and facilities, and the use in medicine production. The book has a good flow and uses simple language but is no way a complete text. However, what it lacks in text, it makes up in colourful flow charts, diagrams and actual photographs. This is a good book for pharmacy students to revisit their basic concepts about microbiology.

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Ranking among the top five globally by production volume, the Indian pharmaceutical market today accounts for over 10 per cent of global drug production. It continues to be one of India’s biggest employers – with more than 340,000 Indian employees dedicated to an industry that is worth in excess of $ 22 billion. But senior delegates at the Cambridge Consultants Mumbai pharma workshop said Indian pharmaceutical companies must embrace innovation and adopt technology if they are to stay competitive at both a domestic and global level. The Cambridge Consultants workshop, attended by a cross–section of senior personnel from a variety of functions within leading Indian and MNCs, explored the question whether India would become one of the world’s leading pharmaceutical countries by 2030? Recent reports suggest India’s domestic pharmaceutical sector will grow to $ 55 billion by 2020. As a significant exporter of high-quality

generic drugs, India is expected to see the value of its drug exports double to $ 25 billion by the end of 2014, according to the country’s Minister of Health.Delegate feedback revealed that the

Indian pharmaceutical industry still has significant growth opportunities, and major local companies could have the potential to compete with multinational pharmaceutical companies. Among them, the greatest impact in world markets will come from those Indian pharmaceutical companies which adopt technology innovations to differentiate their products and make them more competitive both domestically and globally. This trend for differentiation is particularly important as Indian pharmaceutical companies have fewer new generic opportunities. This is because the number of New Chemical Entity (NCE) filings to the US FDA has declined over recent years and the number of innovator drug patents

reaching their expiry date has peaked. Similarly, at a global level there are more generic pharmaceutical developers from other emerging nations, including China,which will offer low-cost competition for India, as well as the ongoing global threat of counterfeit drugs.Andrew Barrett, Director, Medical

Technology in India, Cambridge Consultants, said, “In order to drive faster growth, and capitalise on their existing success, Indian pharmaceutical companies must now aim to create true added-value offerings with ‘super-generics’, which can deliver additional benefit to patients. Innovation and technology are key, and the required investments can be recouped because medical products have long lifecycles. Technology has a great role in drug delivery to extend these lifecycles, add value and, importantly, allow product differentiation in a crowded market space.”

In Conversation With 13Dr Ruchi DassFounder, Healthcursor Consulting Group

Special Focus 14EU-India Free Trade Agreement What is at stake for pharmaceuticals?

Policies & Regulations 17Indian pharmacy drug stores Need to have a strict regulatory system

Roundtable 19Is the race for generics stifling innovation in Indian pharma sector?

Dr Frank Heinricht appointed Chairman of the Board of Management of SCHOTT AGThe Supervisory Board of SCHOTT AG unanimously appointed Dr Frank Heinricht to the position of its new Chairman of the Board

of Management in its meeting on February 27, 2013. Heinricht (50) is currently the Chairman of the Board of Management of Dr Heraeus Holding GmbH. He completed a degree in physics and a doctorate in engineering at the Technical University of Berlin and began his professional career at TEMIC Semiconductors. After holding positions as General Manager and Chairman of the Integrated Circuits Division, he was appointed Chief Executive Officer of TEMIC Semiconductor Group, in 1998. In 2003, Dr Heinricht joined Heraeus Holding GmbH as Member of the Board of Management. He was appointed Chairman of the Board and Labor Director in 2008. Dr Frank Heinricht will take office on June 1, 2013.Venus signs exclusive

marketing rights for Potentox with South Africa’s Adcock Venus Remedies Ltd, the r e s e a r c h - b a s e d g l o b a l pharmaceutical company has accord exclusive marketing rights for its novel antibiotic product, Potentox, to South Africa’s pharmaceutical giant Adcock in a deal the company announced.“We are pleased to join hands

with Adcock and are confident that the deal shall take our research product to its meaningful stage in South Africa. Adcock will have exclusive marketing rights of the product in South Africa over the period of 15 year. The product will remain under patent protection till 2025 in African territory and is expected to be launched by mid of 2015 after getting due regulatory approvals.” said Pawan Chaudhary, CMD, Venus Remedies Ltd. Dr. Reddy’s announces the launch

of zoledronic acid injection Dr. Reddy’s Laboratories has launched zoledronic acid injection (4 mg/5 mL), a bioequivalent generic version of Zometa® (zoledronic acid) 4 mg/5 mL injection in the US market on March 4, 2013, following the approval by the USFDA. Dr. Reddy’s zoledronic acid injection 4 mg/5 mL is available in a single use vial of concentrate.

16 - 31 M a r c h 2 013 I Vo l 1 I N o 18 I `10 0


www.modernpharma.in

Agility India inaugurates its first temperature

controlled facility for pharma near Nhava Sheva

With the Indian pharma sector bustling with activity and business growing at 14 per cent per year, the need for advanced logistics services has prompted Agility India to set up a temperature-controlled warehouse for its pharmaceutical customers near Nhava Sheva (near Mumbai). Agility, manages entire logistics systems that include warehousing, distribution, sorting and kitting. The consolidation centre was inaugurated by Chris Price, CEO - Asia Pacific region. This 3,000 sq feet, dedicated temperature controlled warehouse w i l l p r o v i d e customers in West India with optimal storage and

handling facilities.This custom bonded facility located at CWC Logistics Park CFS, Hind Terminal Facility, controlled at 18 oC, has all contingency measures in place in case of a power failure. Further, the facility provides continuous temperature tracking systems, daily data

loggers, and consolidation processes are set to be undertaken under the supervision of B Pharma graduates. The consolidation centre will witness a monthly maintenance and internal audit. The company will provide end-to-end services; starting from collection of temperature controlled

shipments in reefer vehicles to delivery of the same to respective customers. With Agility’s cost effective sea freight solutions for the pharma sector, Agility expects to see a healthy growth in the requirement of such services.

Commenting on the new development, Price, said, “We have our roots in emerging markets and we

make significant investments in such markets. We are looking to serve to our customer’s specific needs and provide value-added customer-driven solutions. India is seeing a lot of potential. With the current surge in generic drug market, we expect to see a lot more demand for such inclusive services as shipment sizes are going to get bigger. Against this backdrop, pharma supply chain consolidations will give pharma companies more value.”With its latest endeavour, Agility

is plugging gaps such as the transport problems associated with small shipments, troubles that arise due to extreme temperature and humidity conditions, unsuitable storage facilities and high costs associated with pharma freight operations. The next step for Agility is weekly departures to Rotterdam and Antwerp. Currently, Agility serves pharma biggies such as Dr Reddy’s, Mylan, Hetero Drugs, Aurobindo etc.

With reliable port-to-port transit times, good distribution practices and comprehensive knowledge about import and export regulations, Agility is well set to support its growing pharma customer base.

Price inaugurating the facility

Cambridge Consultants workshop reveals

Indian pharma growth outpaces rivals

Dr Heinricht

Pallavi Mukhopadhyay

27Products

Powder coating boothThe primary purpose of the powder coating booth is recollection of oversprayed powder for reuse. The booth also acts towards containment of the oversprayed powder within its confines, thereby preventing powder spillage in the work area. The powder coating booth is designed to accommodate manual or automatic applicators on either one side or in a back to back fashion. The booth is engineered to be stationary or mounted on wheels or trolleys to reduce the cleaning time in case of high volume production plants.

Intech Surface Coating Pvt LtdPune – MaharashtraTel: 020-2292 2350, Mob: 09822000625Email: [email protected]: www.intechfinishing.com

Compact cooling centrifuge These compact cooling centrifuge model CM-8 Plus is suitable for routine sample analysis in medical, hospital, pathology and

institutional laboratories. With a wide choice of rotor heads and adaptors, this unit is truly versatile. The brushless induction motor with frequency drive ensures gentle start and has CFC–free refrigeration system. It has motor overload protection, gas hinge to prevent falling of door and emergency lid lock release.

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

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

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

Water bathThis equipment offers superior temperature accuracy, rugged construction with minimum heat loss. Pump circulation flow gives maximum uniformity of temperature. Water bath are used for incubation in water media, immersion requirements, external circulation to spectrophotometer, jacketed glassware, etc. They are also used for heating of solution / liquids in a jar flask and many other applications in the field of research, development, production and quality control.

SarbiMumbai – MaharashtraTel: 022-26049538Email: [email protected]: www.sarbi.com

Aerosol photometer The la tes t version, Model 2i, is used for leak testing of HEPA filters. 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 and summary modes, large 4.3 " LCD display, thermal printer option to meet documentation requirements and USB output.

Universal supermixesUniversal supermixes, iTaq universal SYBR green supermix and the iTaq universal probes supermix, are compatible with any real-time PCR instrument. These products deliver robust performance and enable users to obtain high-quality data across all real-time quantitative PCR (qPCR)

applications. Both are 2x concentrated, ready-to-use reaction master mixes and are made with a proprietary optimised buffer formulation for maximum sensitivity and reproducibility. The SYBR green supermix is optimised for dye-based qPCR and contains SYBR green I dye, whereas the probes supermix is formulated for probe-based qPCR (simplex or duplex). Their key benefits include broad dynamic range and sensitivity, optimised buffer formulation, ability to overcomes challenging duplex qPCR and antibody-mediated hot-start DNA.

Bio Rad India Pvt LtdGurgaon – HaryanaTel: 0124-2398112/13/14, Mob: 09350047686Email: [email protected]: www.bio-rad.com

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

28 Products

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

the respective manufacturer/distributor. In any case, it does not represent the views of

Modern Pharma

Cold cabinets The REMI cold c a b i n e t s a r e designed for bio sample storage. The intell igent controller helps maintain temperature in case of sensor failure. The data stored in PC server with Lan connectivity can be monitored on any PC with password authentication. The machine is filled with PUF insulation to eliminate void pockets and the powerful fan motor is for forced air circulation to maintain uniform conditions inside the chamber.

Stability chamberStability chamber is designed as per international standards to meet requirement of all registration authorities. This equipment offers superior temperature accuracy, humidity accuracy, minimum heat loss, better air flow for maximum uniformity of temperature and humidity. Stability testing is an integral part of formulation development. It helps to generate information, which permits well-considered proposals to be made for the shelf life of drug substances products and recommended storage condition. Stability data is required to be submitted as part of the dossier submitted to the regulatory agencies for licensing approval.

SarbiMumbai – MaharashtraTel: 022-26049538Email: [email protected]: www.sarbi.com

Lyophiliser The lyophiliser is used for pharmaceuticals, biotechnology and allied industries. Lyophilisation is the preferred drying process, for heat labile substances or where any

physical, chemical or enzymic changes are detrimental to the products and its applications. Sublimation of frozen ice directly in the form of vapour under high vacuum is the basis of lyophilisation process. The system offers optimal flexibility in programming the recipe to suit a wide variety of products. The drying chamber is designed for full vacuum and overpressure of 2.5 bar.

MachinfabrikMumbai - MaharashtraTel: 022-25555596Email: [email protected]: machinfabrik.com

Molecular weight detector

Zetasizer μV is a versatile size and molecular weight detector that can be added to any system to boost experimental productivity by maximising information flow from a single experiment. It is a dual integrated light scattering system with particular value for protein characterisation. It uses dynamic light scattering to secure precise molecular size measurement while at the same time offering static light scattering for absolute molecular weight measurement. It allows the characterisation of discrete samples with only 2 μL of material. The instrument can be added to any protein SEC system to bring absolute molecular size and molecular weight capability to the chromatography experiment, and avoid the need to calibrate the column.

Malvern Aimil Instruments Pvt LtdMumbai - MaharashtraTel: 022 - 39183596, Mob: 09867368075Fax: 022 - 39183562Email: [email protected]: www.malvernaimil.com

Sysmac automation platformIt is a new automation c o n t r o l l e r N J - S e r i e s t h a t i n t e g r a t e s m o t i o n ,

sequencing, networking, RFID tracking and vision inspection. It comes with new software - sysmac studio - that includes configuration, programming, simulation and monitoring and a fast machine network - Ether CAT - to control motion, vision, sensors and actuators. The NJ-Series incorporates an Intel processor with fan-free operation. It delivers a true integrated development environment (IDE). Sysmac studio also offers an advanced 3D simulation environment to develop and test off-line motion profiles such as cams & complex kinematics. Intellectual property (IP) can be safely secured using 32-character passwords.

Omron Automation Pvt LtdMumbai - MaharashtraTel: 022-42288400 Email: [email protected] Website: www.omron-ap.co.in

Pneumatic conveyorThe MiniVac p n e u m a t i c conveyor comes with a complete integral blower, which eliminates the need for an expensive plant air

or a separate compressor. The regenerative blower increases operating efficiency. It lengthens filter life and maximises performance with a standard reverse pulse jet filter cleaning system that keeps the filter clean and at optimum operating efficiency. The standard size access doors allows for easy filter replacement in less than five minutes without the use of any tool. The compact and integral blower eliminates the need for air piping and makes installation easier.

Hapman Systems Pvt LtdVadodara – GujaratTel: 0265-2517505Email: [email protected]: www.hapman.in

SIP and CIP systemThis SIP and CIP system has a CIP module which is activated by a PLC and complies with 21 CFR part-11 of USFDA. This system is equipped with a positive valve and an open/close indicating sensor and is provided with a supply pump and a return pump with auto draining system. It comes with complete automatic operation and has user definable parameters. The system displays on-line view of process and fault messages. Its features include: restart of cycle from the same stage where stopped due to power failure or fault, printing of process parameters, storage of parameters, etc. The manufacturing vessel is available in portable-or stationary-type according to CGMP and ASME standards.

Vyanktesh Fabricraft Pvt LtdNashik – MaharashtraTel: 0253-6602691/2383603Email: [email protected] Website: www.vyankteshfabricraft.com

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

Cole-Parmer IndiaMumbai – MaharashtraTel: 022-67162222Email: [email protected]: www.coleparmer.in

Strip sealThe pilfer-proof strip seal prevents imitat ion of branded and quality products and helps control adulteration and pilferage. It has a tamper-evident locking action in a one-piece construction and is precision moulded from durable, tough, high strength, weather resistant engineering Nylon 66 material. The strip seal is lightweight, corrosion-effective, economical and cost-effective. The company’s name/logo can be permanently hot-stamped on it. This seal is used in pharmaceuticals industry, bulk drugs, airlines baggage, postal department, chemical industry, bank lockers, courier bags, containers, drums, etc.

Novoflex Marketing Pvt Ltd Kolkata – West BengalTel: 033-22260513, Mob: 09903163634Email: [email protected]: www.novoflexgroup.com

Flexible screw conveyorThe helix flexible screw conveyor has only one moving part. The conveyor can be disassembled in less than 20 minutes for cleaning and maintenance. It can achieve lengths of up to 80 ft long. A wide range of auger styles and sizes ranging from 2 to 8 inches in diameter is offered. The product meets stringent standards and has USDA certifications. It is one of the most economical conveyors and can be used in many applications.

Hapman Systems Pvt LtdVadodara – GujaratTel: 0265-2517505Email: [email protected] Website: www.hapman.in

PTFE-lined valvesFluoropolymer FEP, PFA, PTFE-lined

SGI/WCB/SS pipes, valves and fittings are manufactured using technical know-how and raw material for appropriate application of the resin. They have low co-efficient of friction, chemical inertness, excellent weathering resistance, zero water absorption, are non-toxic, non-inflammable, self-sealant and approved by international food and drugs regulatory authorities.

Supremo Line & ControlAhmedabad – GujaratTel: 079-22205282, 22205181Email: [email protected]: www.supremoproduct.com

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

Before taking delivery of any machine, one must

take trials of the product for a short time. This

will help determine the product’s efficiency and

effectiveness.

Sharayu Sawant (Director-Shruti Flexipack Pvt Ltd)

29Marketplace

Heartbeat of theHealthcare Industry

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30 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

Access control ....................................................... 29

Acoustic enclosure ............................................11, 23

Aerosol photometer ................................................ 27

Air circuit breaker .................................................BIC

Air shower controller ............................................. 29

Air sterilisation .......................................................BC

Ambient air monitor - Envirotrack and Sampler .....6

Barcode patient ID band ..................................... 29

Capsule filling ....................................................... 17

Chemical gas detector .............................................. 6

CIP/SIP system and effluent treatment plant ....... 8

Clean room door ..................................................FIC

Cleanroom equipment and accessories ............... 19

COD analyser and digester ..................................... 6

Cold cabinet ............................................................ 28

Colloid mill ............................................................. 17

Comminuting mill ................................................. 17

Compact cooling centrifuge .................................. 27

Compact pneumatic cylinder ............................... 13

Contactor and motor starter ...............................BIC

Container sterilisation ...........................................BC

Content uniformity testing ..................................... 7

Deep freezer ....................................................... 9,10

Dissolution testing .................................................... 7

Door interlock system ............................................ 29

Drives/Invertor ......................................................BIC

Dry van pump ..................................................11, 23

Dynamic pass box ................................................FIC

Electric actuator and gripper.............................. 13

Electronic gas monitor ............................................. 6

Exhibition - Plastivision 2013 ............................... 27

Fire alarm .............................................................. 29

Fire resistant door .................................................FIC

Flexible screw conveyor ......................................... 28

Fltration ................................................................... 15

Guided compact pneumatic cylinder ................ 13

High-purity water treatment systems for injectibles .8

Human-Machine Interface (HMI) .....................BIC

Humidity chamber .............................................. 9,10

HVAC and MEP ....................................................BC

International exhibition for pharma and healthcare ..25

Ionizer ...................................................................... 13

Label ....................................................................... 29

Laminar air flow unit ...........................................FIC

LVS .........................................................................BIC

Lyophiliser ............................................................... 28

Metal doorset ......................................................FIC

Modular clean room ............................................FIC

Molecular weight detector ..................................... 28

Oven .................................................................... 9,10

Pass box inter-lock system .................................. 29

Photostability chamber ....................................... 9,10

Physical testing .......................................................... 7

PLC .........................................................................BIC

Pneumatic coveyor ................................................. 28

Powder coating booth ............................................ 27

Printer ...................................................................... 29

Profile nano filters for CMP applications ........... 15

PTFE-lined valve ..................................................... 28

Pump ..................................................................11, 23

Punch and dies ....................................................... 17

Pure water and steam process ................................. 8

Rapid endotoxin detection system ..................... 29

Refrigrated compressed air dryer ......................... 13

Reinforced silicone hose ........................................ 17

Reverse laminar air flow ......................................FIC

Roll compactor ....................................................... 17

Roots blower .....................................................11, 23

Separation and purifying solutions ................... 15

Servo .......................................................................BIC

SIP and CIP system ................................................ 28

Stability chamber .................................................... 28

Strip seal .................................................................. 28

Syringe pump .......................................................... 28

Sysmac automation platform ................................ 28

Tablet press ............................................................ 17

Tablet press accessory ............................................. 17

Three parameter display ........................................ 29

Tubing product ....................................................... 17

Turnkey solutions for Biotech and Pharma industry ... BC

Universal supermixes ........................................... 27

Vacuum booster pump .................................. 11, 23

Vacuum system .................................................11, 23

Virosil pharma .......................................................... 3

Walk-in humidity chamber ............................. 9,10

Walk-in incubator ............................................... 9,10

Water bath ............................................................... 27

XRX 20 bioreactor system .................................. 15

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T: +91-2551-230877


W: www.mackpharmatech.com

MITSUBISHI ELECTRICAL INDIA PRIVATE LIMITED BIC

T: + 91-020-27102000


W: www.MitsubishiElectric.in

Pall India Pvt. Ltd 15

T: +91-80-40164131


W: www.pall.com

PRAJ INDUSTRIES LTD 8

T: +91-020-22905000


W: www.praj.net

REYNDERS LABEL PRINTING INDIA PVT LTD 13

T: +91-149-3305400


W: www.reynders.com

SANOSIL BIOTECH PVT LTD 3

T: +91-22-22872295


W: www.sanosilbiotech.com

SOTAX INDIA PVT LTD 7

T: +91-022-42950191


W: www.sotax.com

UNIPHOS ENVIROTRONIC PVT LTD 6

T: +91-22-61233500


W: www.uniphos-she.com

RNI No: MAHENG / 2008 / 27125,

32

Modern Pharma - 1-15 April 2013

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