Modern Pharmaceuticals - January 2011 by Infomedia18

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EDITORIAL

Promising prospects o begin with, here is wishing you a Great New Year! As we gear up to make the most out of 2011 with added optimism rallying around the robustness of Indian economy, it will not be complete without a quick glance at the year gone by. Amid this phase of recovery, there were a few exemplary trendsetters in the industry who not only believed in the maxim ‘Do not waste a crisis’, but were also able to fruitfully ride this storm as a window of opportunity. Not withstanding its share of challenges, the year 2010 was an inflection point for the Indian pharmaceutical fraternity and the economy, in general. A case in point is the global focus on India as a key growth market and a marked shift in the approach – not as a mere supplier but as a strategic partner. In other words, it signifies the country’s leverage not only on better cost proposition, but also lean and efficient business model as well as faster time-to-market capability. A careful consideration of the growing maturity of the domestic market, expanding ecosystem of start-ups, and rising demand from the core sectors, indicates the dawn of a new decade in which India can potentially become the fastest-growing economy in the world. This

in turn would create unparalleled opportunities to transform the lives of millions, and thereby attain the much sought-after inclusive growth. At the same time, there is an urgent need to ramp up infrastructure, especially power & land; access to capital & technology; manpower skills as well as provide conducive policy environment for the Indian industry. This year can mark the beginning of a phase, wherein opportunities would be new and would call for greater focus on innovation & novel models of growth. Hopefully, the surging economy, coupled with timely policy implementation, will go a long way in transforming global as well as Indian scenario. Believe, you will find enough value while referring to this special edition with an eclectic mix of the past, present and future of the pharmaceutical sector, as much as we valued in putting it together. Some of the content highlights include quality assurance in Indian pharma, and growing significance of pharma SMEs, among others. Of course, your opinions and feedback will only aid our endeavours.

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

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Printed by Mohan Gajria and published by Lakshmi Narasimhan on behalf of Infomedia 18 Ltd and printed at Infomedia 18 Ltd, Plot no.3, Sector 7, off Sion-Panvel Road, Nerul, Navi Mumbai 400 706, and published at Infomedia 18 Ltd, ‘A’ Wing, Ruby House, J.K.Sawant Marg, Dadar (W), Mumbai - 400 028. Modern Pharmaceuticals is registered with the Registrar of Newspapers of India under No. 14798/2005. Views and opinions expressed in this publication are not necessarily those of Infomedia 18 Limited. Infomedia 18 Limited reserves the right to use the information published herein in any manner whatsoever. While every effort has been made to ensure accuracy of the information published in this edition, neither Infomedia 18 Ltd nor any of its employees accept any responsibility for any errors or omission. Further, Infomedia 18 Ltd does not take any responsibility for loss or damage incurred or suffered by any subscriber of this magazine as a result of his/her accepting any invitation/offer published in this edition. No part of this publication may be reproduced in any form without the written permission of the publisher. All rights reserved.

Editor: Manas R Bastia

January 2011

Modern Pharmaceuticals

CONTENTS

F E AT URE S 14 20 31 37

HIGHLIGHTS OF 2010 - NATIONAL HIGHLIGHTS OF 2010 - INTERNATIONAL

NEWS ANALYSIS LEADERS SPEAK 'One of our major growth strategies is R&D' ...says Himanshu Dave, Director - Sales & Marketing, Astellas Pharma, India

ROUNDTABLE Medical laws in India: Faulty implementation or faulty laws?

FACILITY VISIT Cordlife Sciences Pvt Ltd, India: Striking the right ‘cords’

INDUSTRY UPDATE Quality issues in Indian pharma: Defaulters under purview

INTERFACE 'We aim to help Indian pharma and chemical manufacturers achieve safer operations' ...says Rajesh Saigal, Managing Director, Intertek, India

MARKET TRENDS Pharma SMEs: Playing the right cards?

MARKETING

Medical communication: At your finger ‘chip’ Dr Rajan TD Pharma Consultant & Practising Dermatologist

CLINICAL RESEARCH

Editorial ............................................................11

Clinical trial regulations in India: Inundation of global clinical trials Dr Shubhangi Desai Associate Director – Clinical Project Management, and Savitha Naik, Sr Executive – Regulatory Affairs, SIRO Clinpharm

National News ..................................................26

INDUSTRY INSIGHTS

World News ......................................................32

Cancer vaccines market: More to go in R&D…

Tech Updates ....................................................35

TECHNOFOCUS

REGULAR SECTIONS

Events Calendar................................................74 Technology Transfer.........................................76

Product Inquiry................................................87 Advertisement Inquiry .....................................89 Product Index ...................................................91 Advertisers’ List ................................................92

Parenteral delivery: Under control Jo Smewing Applications Manager, Stable Micro Systems Ltd

Highlights of Next Issue

Product Update ................................................78

iversary

Industry Update : Market Trends : R&D Anniversary Special : Supply Chain Management in Pharma

Details on page no. 29, 30

Note: ` stands for Indian rupee, $ stands for US dollar and £ stands for UK pound, unless mentioned otherwise Cover Photo Shoot: Joshua Navalkar

12 Modern Pharmaceuticals

January 2011

HIGHLIGHTS OF 2010 - NATIONAL

ACQUISITION

Hospira acquires Orchid’s injectable business

Abbott acquires Piramal’s formulations business

(January) Hospira, Inc, one of the leaders in generic injectable pharmaceuticals, signed an agreement to acquire Orchid’s generic injectable finished-dosage form pharma business. The deal, which is worth $ 400 million, includes acquisition of Orchid’s beta-lactam antibiotics manufacturing complex, comprising cephalosporin, penicillin & carbapenem facilities and pharmaceutical R&D facility at Irungattukottai, Chennai.

(June) Ajay Piramal’s flagship company, Piramal Healthcare, sold its domestic formulations business to US-based multinational drug major Abbott, in a $ 3.72 billion deal. This is the second largest in the Indian pharma space after Daiichi Sankyo’s $ 5.4 billion acquisition of Ranbaxy in 2008, and will make Abbott the largest player in the ` 60,000-crore domestic market, with a share of over 7 per cent.

Bilcare acquires INEOS’ Global Films business

Marck acquires injectible facility

(August) INEOS Group entered into an agreement for the sale of its Global Films business to Bilcare AG, one of the providers of research-led packaging, for approximately 100 million. Mohan Bhandari, Chairman, Bilcare Limited, said, “The acquisition is a paradigm shift in the pharma packaging space and a significant step towards creating a customer-centric company to offer path-breaking innovations & establish a global leadership.”

(December) Marck Biosciences Ltd acquired a large-volume injectible facility in Goa. The company will step up its manufacturing capacity for high-volume injectibles by over 33 per cent by March 2011. It has also taken over the assets of the Goa-based Ravish Infusion on a lock-stock barrel basis for ` 547 lakh in an auction process from Debt Recovery Tribunal 2, Mumbai. Marck also signed an MoU with Paragon Steels Pvt Ltd for purchase of its injectibles equipment worth ` 150 lakh.

ALLIANCE

Indoco inks drug supply pact with Aspen

Eli Lilly’s TB eradication efforts

(April) Indoco Remedies, Mumbai-based pharma company, secured a strategic lead by out-licensing its intellectual property to South Africa’s largest pharma company, Aspen Pharmacare. The deal includes several ophthalmic products and will extend to 30 countries from emerging markets. Indoco will offer these products for registration and supply them from its facilities approved by the USFDA and European Union. Aspen will market and distribute these products immediately after obtaining the regulatory approval.

(June) About 150 retail chemist outlets in the North-East zone of Mumbai have begun providing Directly Observed Treatment, Short-Course (DOTS) counselling and treatment services from May 10, 2010. The two-year project, with the support of Lilly Multi-Drug Resistant (MDR) TB partnership, is a unique public-private collaboration between the government, Chemists’ Association, International Pharmaceutical Federation (FIP), SEARPharm Forum and the Indian Pharmaceutical Association (IPA).

Indian & Victoria’s scientists to treat cancer

LLG in-licenses Anti-TrkA to Glenmark Pharma

(August) Victoria’s Deakin University and the prestigious Indian Institute of Science, Bengaluru, teamed up for a crossborder research project on drug delivery to treat cancer. The collaboration focusses on targeting the roots of cancer cells by developing a new generation of effective cancer medications to kill cancer-initiating cells, with fewer side effects. This is a $ 2.7 billion project funded by the AustraliaIndia Strategic Research Fund (AISRF), and supported by Indo-Australian Science and Technology Fund.

(November) Glenmark Pharmaceuticals SA has been granted by Lay Line Genomics (LLG) an exclusive worldwide licence to LLG’s entire intellectual property portfolio in the TrkA field. This licensed asset includes BXL1H5, which is a novel monoclonal antibody that binds to TrkA receptors. The deal is of immense importance as Glenmark has not only in-licensed a pre-clinical, unique monoclonal antibody, but also the exclusive licence to commercialise monoclonal antibodies against the TrkA receptor for pain.

Nichrome collaborates with Prodo-Pak

Bangalore institutes sign MoU with UM

(December) Nichrome India Ltd collaborated with Prodo-Pak Corporation, USA, to manufacture and sell high-speed multi-lane sachet machines. Under this technology licensing agreement, Prodo-Pak Corporation will support Nichrome in the transfer and upgradation of the technology. These machines will be for both domestic and international markets. With this technology, the company aims to offer machines with up to 15 lanes.

(December) The National Law School (NLS), Indian Statistical Institute & National Institute of Mental Health and Neuro Sciences (NIMHANS) signed an MoU with Maastricht Education and Research Centre (MERC), a subsidiary of University of Maastricht (UM). This will help NLS in research collaboration and PhD supervision with NIMHANS. It will facilitate educational cooperation for curriculum development, innovative methodological approaches, student assessment – academic & cultural exchange and joint research programmes.

14 Modern Pharmaceuticals

January 2011

HIGHLIGHTS OF 2010 - NATIONAL

ANNOUNCEMENT

ELLAB brings in centralised monitoring solutions

Elder develops its first nutraceutical drug

(January) ELLAB, a leading manufacturer of high-quality thermal validation systems, planned to introduce its latest product on total integration system for pharma companies. The system will integrate monitoring of different types of processing into a centralised monitoring room, eg, autoclaves, freeze dryers, storage areas, ETO sterilisation, etc. This unique system with highest level of accuracy & reliability, guarantees processing within safety limits.

(June) Elder Pharmaceuticals entered the nutraceutical business with the first-of-its-kind nutraceutical drug ‘Ecozyme’ - a chewable form of ‘coenzyme Q10’ to help build immunity against cardiovascular diseases, migraine, hypertension, diabetes and neurogenerative diseases like parkinson’s & alzheimer’s. While Elder will import the APIs for the drug from Italy’s Gnosis Labs, it has developed this drug form in-house and plans to file for global patent.

NPPA to conclude first pharm census of India

Strides Specialties rebranded

(July) The National Pharmaceutical Pricing Authority (NPPA) is to finalise the First Pharmaceuticals Census of India (FPCI). For this, the national drug price regulator launched a campaign in February 2008 to develop a comprehensive and reliable database. NPPA has collected data from 6,299 pharma units across the country through structured questionnaires under the FPCI. This pharma map of India will show all districts of the country where pharma manufacturing units exist.

(December) Strides Arcolab Ltd announced renaming of its specialities division. ‘Strides Specialties Private Ltd’ is now known as ‘Agila Specialties Private Ltd’. The name Agila reflects the brand ethos of Strides’ specialised product offering, which is smart, agile, determined and pragmatic. Strides also announced the appointment of Venkat Iyer as Chief Executive Officer of Agila Specialties.

APPOINTMENT

Avesthagen welcomes new member on board

Hilleman appoints Dr Akshay Goel as CSO

(August) Avesthagen Ltd appointed Jacques Vincent to the company’s Board of Directors. Vincent is currently on the board of Syngenta, a multinational seed & crop-protection company in Switzerland, Biophytis – a biotech start-up, and Mediaperformance – a media company in France. Dr Villoo Morawala-Patell, Founder & CMD, Avesthagen Ltd, said, “Vincent brings to table the experience and commercial knowledge of the MNCs. His advice would be critical for commercialising Avesthagen’s product pipeline”.

(September) MSD Wellcome Trust Hilleman Laboratories, Research and Development JV between Merck & Co, Inc, and the Wellcome Trust – a UK-based research charity, declared appointment of Dr Akshay Goel as Chief Scientific Officer. MSD Wellcome Trust Hilleman Laboratories will operate with a not-for-profit business model and is focussing on developing affordable vaccines in order to prevent diseases that commonly affect low-income countries.

CERTIFICATION

SAP certifies SpectraSoft for life sciences industry

Lifecell gains accreditation from CAP

(October) SpectraSoft Technologies, a business solutions specialist for process industries, declared that its SAP Business All-In-One partner solution ‘Spectra:Pharma’ addressing the life science business needs in India has cleared the qualification process and has been certified by SAP. This industry-ready solution has been developed by a team of experienced specialists from the life science industry and is built on the robust SAP ERP 6.0 platform.

(December) LifeCell International received accreditation from College of American Pathologists (CAP) under its Laboratory Accreditation Programme. CAP accreditation is awarded for excellence and compliance to international regulatory, quality & safety standards of the laboratory. This accreditation has placed LifeCell on the international quality compliance platform, as it joins 7,000 other laboratories worldwide.

DRUG LAUNCH

Marck Biosciences launches paracetamol IV

Bharat Biotech launches HNVAC

(August) Marck Biosciences Ltd, manufacturer and marketer of sterile dosages and Blow-Fill-Seal (BFS) specialist, launched paracetamol IV in plastic pack, manufactured using the BFS technology. It is a ready-to-infuse dosage form of paracetamol (in 10 mg/ml solution), indicated for shortterm treatment of moderate pain, especially after surgery, and short-term treatment of fever when other routes of administration are not possible.

(November) Bharat Biotech launched H1N1 swine flu vaccine under the brand name HNVAC. This is the only flu vaccine from the developing world that has been manufactured in highly sterile cell culture & under controlled manufacturing process, instead of using eggs. Bharat Biotech received the approval from the Drugs Controller General of India early in the month to launch this vaccine.

January 2011

Modern Pharmaceuticals

HIGHLIGHTS OF 2010 - NATIONAL

EXPANSION

Birla Vaidyashala expands into drug markets

Grundfos India expands production facility

(February) Kerala-based Ayurveda spa chain Birla Kerala Vaidyashala (BKV) announced its plans to collaborate with local pharma companies to sell its products across the country. It already has a tie-up with a company in South India to tap the market, and more tie-ups are in the offing. “We will sell our products, mainly for curing ailments. For this, we propose to tie-up with local pharma companies as well,” said Harsheet Kuroop, Managing Director, BKV.

(April) Grundfos Pumps India Pvt Ltd, a 100 per cent Danish subsidiary, inaugurated its new 7,000 sq m facility at Thoraipakkam, Chennai. Carlo Prola, Senior Vice President, Grundfos Group, said, “India is one of the important overseas markets for the company in the Asia Pacific region. The expansion of the Chennai-based facility further strengthens our capabilities to adapt to the local market and signifies our commitment to long-term business operations in India.”

GREEN FIELD PROJECT

Helvoet Pharma’s new facility at Khandala

India’s first pharma hub at Hyderabad airport

(October) Helvoet Pharma, part of the Daetwyler Group, set up its first greenfield production facility in Khandala Industrial Area, Phase I, on Pune-Bangalore Highway, with an investment of ` 120 crore. The new plant, spread across 36,000 sq m, will come up in the newly developed Maharashtra Industrial Development Corporation (MIDC) SEZ near Pune, and will serve as a strategic hub for exports to European countries.

(December) Lufthansa Cargo and GMR Group, the operator of Rajiv Gandhi International Airport, Hyderabad, announced their intention to develop the airport serving in South Asia for transport of temperature-sensitive pharmaceuticals. A modern state-of-the-art infrastructure will be set up to meet the complex standards of reliable, temperature-controlled transport. The customs procedure at the airport will be speeded up for faster transportation.

INDIA ENTRY

Grundfos launches ‘Incredible Indian Pump Yatra’

FIOLAX® Academy opens doors in India

(October) Starting from Ahmedabad on September 10, 2010, Grundfos India – a subsidiary of Grundfos, Denmark, initiated an innovative project, ‘The Incredible Indian Pump Yatra’. This is a fully equipped business lounge on wheels, which will have a series of interactive displays of a wide range of industrial pumps from Grundfos. The vehicle, with a floor space of 800 sq ft will enable visitors to gain hands-on experience of Grundfos products and solutions.

(November) SCHOTT set up FIOLAX Academy, a specialised training programme for converters of glass tubing and pharma companies. Production departments, quality assurance & sales can now gain more knowledge on benefits of glass for pharma packaging solutions. At FIOLAX Academy, experts from international technology group SCHOTT share their knowledge on composition and production of pharma glass tubing, converting & filling of containers, etc.

INVESTMENT

IOLCP to raise $ 5 million through FCC bonds

Biocon invests in biomanufacturing and R&D

(June) IOL Chemicals and Pharmaceuticals Ltd (IOLCP), one of the largest producers of APIs, ibuprofen & specialty chemicals in India, plans to set up a new manufacturing plant for producing Proton Pump Inhibitors (PPIs), with a capacity of 150 Tonne Per Annum (TPA). The company expects a turnover of ` 60 crore per annum from this initiative to diversify into new generic products line.

(November) Biocon recently announced its strategic foreign direct investment in Malaysia with the Malaysian Biotechnology Corporation SdnBhd (BiotechCorp). The investment will be made towards establishing a bio-manufacturing and R&D facility in Bio-XCell, a custom built biotechnology park and ecosystem at Iskandar Malaysia Johor. Business intent documents were exchanged between Biocon and BiotechCorp at Putrajaya, Malaysia.

MISCELLANEOUS

Panacea Biotec seeking new tie-ups

JNPC, Vishakapatnam allots 46 acres to Hospira

(June) Panacea Biotec, India’s third largest biotechnology company and one of the leading vaccine manufacturers by volume, is considering acquiring a pharma company with its own branded line of products or API unit in India. The Delhibased drug-maker is looking for USFDA or WHO-certified pharmaceutical formulation facilities, as its manufacturing facilities for vaccines and pharmaceutical formulations in India comply with international regulatory requirements.

(June) Dr K Rosaiah, Chief Minister, Government of Andhra Pradesh, handed over the allotment letter for 46 acres of land at Jawaharlal Nehru Pharma City (JNPC), Vishakapatnam, to Joe Cramer, Vice President-Global Operations, Hospira Inc, and Dr CB Rao, MD-Indian Operations, Hospira Inc, in Hyderabad. Hospira, Inc, plans to set up its facility at JNPC Special Economic Zone of Vishakapatnam, developed by Ramky Pharma city (India) Ltd.

16 Modern Pharmaceuticals

January 2011

HIGHLIGHTS OF 2010 - NATIONAL

MISCELLANEOUS

Wyeth launches pneumonia vaccine Prevenar 13

Ranbaxy moves new R&D unit to parent firm

(July) Wyeth, a subsidiary of Pfizer, Inc, in India, launched Prevenar 13, an advanced pneumococcal conjugate vaccine, to protect infants & young children from pneumococcus, a bacterium that causes pneumonia, meningitis and sepsis. Prevenar 13 covers serotypes 1 and 5, associated with complicated pneumonia, and serotype 19A, which has globally emerged as a leading cause of pneumococcal disease in children of age below five years.

(July) Ranbaxy Laboratories transferred its new drug discovery research unit to its Japanese parent company Daiichi Sankyo. Ranbaxy and Daiichi Sankyo India Pharma Pvt Ltd will merge their R&D systems into Daiichi Sankyo Life Science Research Centre. Daiichi Sankyo will now conduct new drug research operations, while Ranbaxy will retain the R&D functions related to generic drugs.

Quality seal assures product excellence

Gautavik, a multi industry distributor for India

(July) SCHOTT developed a quality seal to facilitate the use of superior quality glass tubing in India’s pharmaceutical and biotech industry. As primary pharmaceutical packaging is an integral part of the drug, the requirements for vials, cartridges, ampoules and syringes must meet the highest international standards. The quality seal assures that the pharmaceutical containers are made of high-quality SCHOTT glass tubing. The trademark ‘Manufactured out of SCHOTT Glass Tubing - Quality & Reliability’ can be used in all communications with pharma companies to create a clear advantage over the competition.

(August) Gelest, Inc, declared Gautavik International, a Mumbai-based company, an exclusive distributor in India for its line of silane, metal-organic and silicone products for advanced-technology applications in the life sciences, cosmetics and agricultural sectors. The targeted life science sectors include pharmaceuticals, biosciences, dental & medical devices. Gautavik International, headed by Dr Vasanti Yadav, successfully serves the high-technology sectors in India. The company has an established logistics & technically trained staff with the ability to service customer requirements.

AIPIAA educates indenting agents

Expansion of drugs storage space at airports

(August) The All India Pharma Indenting Agents Association (AIPIAA), a deemed association, hosted a workshop to educate the indenting agents. It was organised by the Central Drug Standard Control Organisation (CDSCO), to improve regulations & fast registrations of pharma ingredients. Dr Surinder Singh, Drug Controller General of India, said that any legitimate inputs falling under the Drugs & Cosmetics Act would be considered during registrations.

(September) Several demands by the pharma industry have made the government agencies to consider the possibility of having cold chain facilities at airports for drugs storage. The additional capacity at Delhi and Chennai airports is expected to be deployed over the next two or three years. Delhi International Airport Ltd (DIAL) is expected to create 3,000-4,000 sq m of additional cold room facilities for pharma products.

Abdul Monem Group to tap the pharma sector

Piramal Healthcare rewards shareholders

(September) Abdul Monem Group entered the pharma sector with the aim of providing high-quality products at affordable prices. Novus Pharmaceuticals Ltd is a Strategic Business Unit of Abdul Monem Group. Initially, the company plans to produce primary and chronic healthcare items, eg paracetamol and omeprazol, in order to reach out to common people. Novus is entering the sector at a time when most of the top 10 revenue earning pharma companies are increasing production capacities to meet the growing demand.

(November) Piramal Healthcare Ltd (PHL), announced that subsequent to completion of the sale of its domestic formulations business and its shareholding in Piramal Diagnostic Services Pvt Ltd, the board of directors considered & approved, subject to the approval of the members of the company, and other such approvals/contents, to buyback the company’s equity shares. The buyback will be done for a maximum of 41.8 million shares which represents 20 per cent of the total number of shares at a price of ` 600 per equity share.

Clinical trials to attract foreign investments

Cipla develops package to prevent HIV/AIDS

(December) Government of India is determined to help clinical trials industry attract foreign investments and projects. “The measures taken are regulations, speeding up procedural process in clinical trials and creating institutions to further develop the talent pool. India has taken giant leaps in many sectors, but the clinical trial sector has not grown substantially,” said Dr R Ramakrishna, Deputy Drugs Controller (I), Central Drug Standards Control Organization.

(December) Cipla developed a ‘Mother-Baby Pack’ in collaboration with UNICEF and other partners, in reducing mother-to-child transmission of HIV/AIDS. The pack contains a range of anti-retroviral drugs and antibiotics required by an HIV-infected mother, starting from the 14th week of pregnancy until sixth week after delivery. This pack will help HIV-positive mothers in the remotest corner of the least developed world to access PMTCT drugs.

18 Modern Pharmaceuticals

January 2011

HIGHLIGHTS OF 2010 - INTERNATIONAL

ACQUISITION

Orchid acquires US-based Karalex Pharma

Astellas acquires OSI Pharma for $ 4 billion

(July) Orchid Chemicals & Pharmaceuticals Ltd acquired Karalex Pharma, LLC, a US-based generic marketing and sales services company, New Jersey, USA. “This will provide a strong commercial US-based sales capability to Orchid, paving way for synergistic returns from our upcoming and long-term strategic generic pipeline comprising key first-tofile and paragraph-IV products,” said K Raghavendra Rao, MD, Orchid Chemicals & Pharmaceuticals Ltd.

(July) Astellas Pharma, Inc, acquired OSI Pharmaceuticals, Inc, a biotechnology company primarily focussing on discovery, development & commercialisation of molecular targeted therapies that address medical needs in oncology, diabetes and obesity. Masafumi Nogimori, President & CEO, Astellas, said, “This transaction is an important step forward for Astellas, which works towards developing a world-class oncology platform.”

Eli Lilly acquires Alnara Pharmaceuticals

Pfizer to acquire FoldRx Pharmaceuticals

(August) Eli Lilly acquired Alnara Pharmaceuticals, Inc – a privately held company developing protein therapeutics for treatment of metabolic diseases. The transaction has been approved by Alnara stockholders and has received clearance under the Hart-Scott-Rodino Antitrust Improvements Act. As per the agreement, Lilly acquired all outstanding shares of Alnara for an upfront payment of $ 180 million, subject to adjustment based on existing cash at hand during closing.

(September) Pfizer, Inc, and FoldRx Pharmaceuticals, Inc, a privately held drug discovery and clinical development company, signed an agreement under which Pfizer will acquire FoldRx. Pfizer will make an upfront payment and contingent payments if certain milestones are achieved. The closing of the transaction is subject to regulatory approval in the US and may occur later this year. FoldRx conducts clinical and pre-clinical studies for investigational compounds to treat diseases caused by protein misfolding.

ALLIANCE

Waters collaborates with NC BioNetwork

Bristol-Myers Squibb, Allergan enter agreement

(January) Waters Corporation partnered with NC BioNetwork Pharmaceutical Center, and its new Analytical Training Lab, in Winston-Salem, North Carolina, to educate & train students and workers in life sciences, including those entering the state’s burgeoning biopharmaceutical industry. BioNetwork meets specialised needs of the state’s biotechnology-based industries by training workers and developing educational curriculum for the state’s community colleges.

(March) Bristol-Myers Squibb Company and Allergan, Inc, announced a global agreement for the development and commercialisation of AGN-209323, a phase II-ready, orally administered small molecule in clinical development for neuropathic pain. Under the agreement, Allergan will grant Bristol-Myers Squibb exclusive worldwide rights to develop, manufacture and commercialise AGN-209323 and back-up compounds.

Roche and Aileron develop stapled peptide drugs

Dako, Quintiles to develop personalised medicine

(September) Aileron Therapeutics and Roche collaborated to discover, develop and commercialise a new class of drugs called Stapled Peptide Therapeutics. These are a potential solution to drug as-yet intractable disease targets, including those originating from intracellular protein-protein interactions. Roche and Aileron will together develop drug candidates against about five undisclosed targets selected from Roche’s key therapeutic areas.

(November) Dako, a Denmark-based world leader in tissuebased cancer diagnostics, and Quintiles, world’s leading biopharmaceutical services companies, announced a strategic alliance to advance personalised medicine by collaborating for co-development of targeted therapies & companion diagnostics. Under the non-exclusive alliance, Dako and Quintiles will offer integrated drug-diagnostic development services & companion diagnostic products.

APPOINTMENT

PharmaNet gets new Director

New President for Pfizer

(December) PharmaNet Development Group, Inc, appointed Dr Chris Beaver as Director, Immunochemistry Services. He will lead the immunochemistry team in the company’s bioanalytical laboratories and work to expand its large molecule services. Dr Beaver brings in a combination of CRO leadership experience & technical expertise in large molecule bioanalysis, enhancing our ability to support the drug development strategies of our clients.

(December) Pfizer, Inc, has elected Ian C Read, currently Head of the company’s Global Biopharmaceutical Operations, as President, CEO and Director. Read succeeds Jeffrey B Kindler, who has retired from the company. On being elected, Read said, “I am honoured to lead an organisation with dedicated colleagues on the front line of medical innovation. We have a broad portfolio that spans the entire spectrum of human & animal health. “

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January 2011

HIGHLIGHTS OF 2010 - INTERNATIONAL

AWARD

Novartis 2010 Immunology Prizes presented

Lilly awarded for TB initiative

(September) Novartis 2010 Immunology Prizes were presented at the 16th International Congress of Immunology in Kobe, Japan. These awards recognise individual achievement and provide financial support to conduct further research by recipients. Professor Michael Bevan, Howard Hughes Medical Institute, University of Washington, Seattle, USA, received Basic Immunology Prize for research on T-cell selection & regulation and memory formation of CD8+ cytotoxic T cells in response to pathogens.

(October) An eminent international panel of judges selected Eli Lilly and Company to receive a World Business and Development Award for demonstrating what can be achieved through successful partnerships in the battle against Multidrug-Resistant Tuberculosis (MDR-TB). The World Business and Development Awards, given every two years, showcase the creative efforts of the private sector in applying their core business expertise to help achieve the goals.

Exco InTouch awarded for its ePRO solutions

Thermo Fisher nominated for EOA awards

(November) Exco InTouch, the leading provider of patient communication solutions for pharma and healthcare sectors, has been recognised for its significant strides in delivery of electronic Patient Reported Outcomes (ePRO) solutions at the 2010 European Outsourcing Awards. Exco was awarded for ‘Most Innovative Relationship’ for its collaborative study with University of Queensland, which evaluated mobile phone technology for collecting patient self-report data.

(November) Thermo Fisher Scientific, Inc, has been nominated for three prestigious European Outsourcing Awards (EOA). The EOA nominations included two entries for Best Contract Analytical Project for the application of Thermo Scientific Watson Laboratory Information Management System (LIMS) in bioanalysis and one entry for Most Improved Process/ Plant Facility and Best e-Business/IT Strategy for Thermo Scientific CONNECTS in pharmaceutical manufacturing.

DRUG

New standard of care for cervical cancer

Xifaxan® 550 mg introduced in US markets

(March) According to latest research, a new chemotherapy medicine ‘Triapine’ when used in combination with standard-of-care cisplatin chemotherapy and radiation treatment, provides reduction of cervical cancer in women. The first phase of the study conducted by Ireland Cancer Center of University Hospitals (UH) Case Medical Center, showed significant reduction in occurrence and control of the disease.

(June) Salix Pharmaceuticals has introduced in the US market, Xifaxan® (rifaximin) 550 mg tablets, indicated for reducing the risk of overt hepatic encephalopathy (HE) recurrence in patients aged 18 years or older. These HE patients in the US should consult their doctors about this important treatment option. HE is a serious disorder caused by chronic liver failure, which results in neurologic impairments in cognition, mental status and motor function.

FDA APPROVAL

Morphine sulphate oral solution for pain relief

High-dose, long-term PPI use may cause fracture

(March) The USFDA approved morphine sulphate oral solution for relieving moderate-to-severe, acute and chronic pain in opioid-tolerant patients. The medicine will be available in a strength of 100 mg/5 ml or 20 mg/1 ml. In this programme, the FDA will work with Roxane Laboratories to ensure availability of enough drug for patients. The FDA will work with patient organisations and prescribers to make them aware that an approved product is available.

(June) The USFDA has warned consumers and healthcare professionals about a possible increased risk of fractures of the hip, wrist & spine with high doses or long-term use of Proton Pump Inhibitors (PPIs). The product labeling will also be modified accordingly. Prescription PPIs contain esomeprazole (Nexium), dexlansoprazole (Dexilant), etc, and are used to treat conditions like GERD, stomach & small intestine ulcers & inflammation of the oesophagus.

FDA designation review for Amgen’s denosumab

Glenmark Generic’s theophylline tablet approved

(August) The USFDA has granted Amgen a priority review designation for denosumab, a subcutaneous RANK ligand inhibitor, for treating bone metastases to reduce skeletalrelated events in cancer patients. The Biologics License Application submission summarises clinical experience of nearly 6,900 patients in 18 clinical studies, including about 5,700 patients with advanced cancer in three pivotal Phase III head-to-head trials versus Zometa® (zoledronic acid).

(August) An ANDA by Glenmark Generics, Inc, has been approved by the USFDA for theophylline extended-release tablets, a generic version of LP Uniphyl® from Purdue Pharmaceutical Products. The tablets are available in strengths of 400 & 600 mg, and indicated for symptoms & reversible airflow obstruction associated with chronic asthma & other chronic lung diseases. The company will market & distribute the product in the US.

January 2011

Modern Pharmaceuticals

HIGHLIGHTS OF 2010 - INTERNATIONAL

GRANT

Japan gives $ 10 million for AIDS vaccine R&D

US grant for Xylos Corporation

(July) The Government of Japan has recently pledged a $ 10 million grant for AIDS vaccine R&D to the International AIDS Vaccine Initiative (IAVI) in the next five years. The grant will be channelled to the IAVI through a newly established World Bank trust fund. The IAVI, in collaboration with its Japanese partners, will continue to advance an AIDS vaccine candidate that is constructed using a paramyxovirus known as the Sendai virus.

(November) Xylos Corporation, a leader in biocellulose technology for medical applications, has recently announced that the company was granted $ 244,479 under the US Qualifying Therapeutic Discovery Project (QTDP) programme. A QTDP applicant was required to demonstrate reasonable potential in developing new therapies for fulfilling unmet medical needs or to prevent, detect or treat chronic and acute disease & conditions.

NEW PRODUCT

Water launches social media forum

Teva launches generic Valtrex®

(May) Waters Corporation has launched its latest online community featuring exclusive Waters® Empower™ Software and NuGenesis® Scientific Data Management System (SDMS) resources & access to Waters’ experts & shared user experiences. The development of Waters social networking communities is part of a growing trend in science industries that leverages peer-to-peer knowledge to resolve difficult challenges.

(June) Teva Pharmaceutical Industries Ltd commercially launched its generic version of GlaxoSmithKline antiviral product, Valtrex® (valacyclovir hydrochloride) tablets 500 mg and 1 g, approved by the FDA. Teva Pharmaceutical Industries Ltd, headquartered in Israel, is a leading generic pharma company. It develops, manufactures and markets generic & innovative pharmaceuticals & active pharmaceutical ingredients.

Unique organic synthesis solvents by Clariant

PharmaNet to launch a new brand identity

(November) Clariant has recently launched unique organic synthesis solvents with favourable toxicological properties. It unveiled advances in no acute toxicity, easy-handling solvents for use in pharma and other chemical applications with the launch of Highsolv® P99 and Highsolv® E99 for organic synthesis. The two colourless, low-viscosity solvents offer yield-improving and performance-related properties.

(December) PharmaNet Development Group, Inc, now has a new brand identity, and tagline, ‘PharmaNet Works For You’. The new brand and tagline reflects the company’s promise to its clients of providing intelligent solutions to enhance drug development programmes consistent with high standards of regulatory compliance, quality & reliability. The new identity unifies PharmaNet’s message across its subsidiaries & services.

ORPHAN DRUG

Clavis Pharma’s drug designated as orphan drug

Stromedix’s STX-100 receives orphan drug status

(January) Clavis Pharma, the Norwegian cancer drug development company, has recently announced that the USFDA has granted orphan drug designation to CP-4126 for treatment of pancreatic cancer. The designation follows the equivalent designation given by the European Commission in October last year. The US Orphan Drug Act provides incentives to encourage development of drugs for rare diseases affecting less than 2,00,000 people in the US.

(September) Stromedix, Inc, a biotech company focussed on innovative therapies for fibrosis and fibrotic organ failure, informed that USFDA granted orphan drug status to its lead clinical candidate STX-100 for treatment of idiopathic pulmonary fibrosis (IPF). Currently, there are no FDA-approved treatments for IPF, a debilitating and almost uniformly fatal disease in which patients experience progressive difficulty in breathing due to fibrosis of the lung.

PARTNERSHIP

Bayer partners with hospital in China

Sanofi collaborates with Harvard University

(August) Bayer Schering Pharma AG, Germany, entered into a long-term collaboration with The People’s Liberation Army General Hospital (301 Hospital) Beijing, China, for research programmes in women’s healthcare. 301 Hospital will receive research funding and its scientists can work at Bayer Schering Pharma’s research facilities in Berlin, Germany. Bayer Pharma’s scientists from the company’s new Global Drug Discovery-Innovation Center, Beijing, China, will participate and co-ordinate the research projects.

(November) Sanofi-Aventis collaborated with Harvard University, aiming to advance knowledge in the area of human health through basic & applied research and promote scientific exchange between Harvard University and Sanofi-Aventis. It will focus on translational biomedical research in multiple therapeutic areas. Harvard University investigators will propose research projects across a range of areas, and a Joint Scientific Steering Committee will select the funded projects.

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January 2011

HIGHLIGHTS OF 2010 - INTERNATIONAL

R&D

Phase I trial of genital herpes vaccine by BioVex

PLx’s PL 2200 Aspirin Phase II trial successful

(March) BioVex, Inc, has announced the initiation of the phase I study of its live attenuated genital herpes vaccine – ImmunoVEXHSV2. It is an open-label ascending dose trial for assessing safety and immune response in healthy volunteers. The study will be conducted at the Chelsea and Westminster Hospital, London, and will involve about 42 identified subjects.

(May) PLx Pharma announced positive results of the company’s Phase II endoscopic study of PL 2200 Aspirin. In its Phase II trial, the drug showed considerable decrease in the risk of ulcers and erosions compared with immediaterelease aspirin. The drug, when taken once a day for seven days, reduced the incidence of gastric & duodenal ulcers by 71 per cent and that of combined erosions & ulcers by 47.4 per cent, compared to immediate-release OTC aspirin.

Boehringer begins Phase III trial for Afatinib

Epistem recieves funds from NIH

(October) Boehringer Ingelheim initiated the phase III clinical trial to investigate one of its most advanced oncology pipeline compounds, Afatinib, for treatment of patients with advanced breast cancer. This trial, called the ‘LUX-Breast 1 Trial’ is the first to evaluate Afatinib in breast cancer, and the investigation widens the scope of potential cancer types for which Boehringer Ingelheim’s oncology portfolio may be suitable.

(November) An NIH-funded radiation counter-measure programme has extended its pre-clinical testing services contract with Epistem for up to five years. Since 2006, the UK-based Epistem has received $ 3.5 million to develop models and evaluate drugs for treating radiation damage to the gastrointestinal tract. Now, Epistem has sealed a five-year subcontract, which it expects will extend the scope of the collaborative relationship.

REGULATORY APPROVAL

Basilea’s CHE drug receives regulatory approval

Tarceva approved to treat advanced lung cancer

(January) Basilea Pharmaceutica Ltd has recently announced that Toctino (alitretinoin), a new once-daily oral treatment for adults suffering from severe Chronic Hand Eczema (CHE) unresponsive to potent topical corticosteroids, has obtained regulatory approval from Health Canada. “We are pleased that Health Canada has approved the use of Toctino for patients with severe CHE unresponsive to topical steroids. Our rigorous, well-designed clinical studies clearly show that Toctino can benefit a significant number of patients suffering from CHE,” said Dr Anthony Man, CEO, Basilea Pharmaceutica Ltd.

(May) As per a recent statement by Roche, an international partner of OSI Pharmaceuticals Inc, the European Committee for Medicinal Products for Human Use (CHMP) has given positive opinion for using Tarceva® (erlotinib) as a maintenance therapy for patients with advanced Non-SmallCell Lung Cancer (NSCLC) and stable disease (cancer remains largely unchanged) after initial chemotherapy. The positive opinion of CHMP clears the way for European Union (EU) approval and indicates that such patients may soon benefit from earlier treatment with Tarceva.

Japan approves Takeda’s NDA for Nesina

Applied biosystems forensic kits for use in NDIS

(May) Pharmaceutical Product Development (PPD) has announced that Takeda Pharmaceutical Company Ltd’s New Drug Application (NDA) for Nesina has been approved by the Japanese Ministry of Health, Labour and Welfare. This drug formulation was developed by Takeda and PPD’s compound partnering division. Nesina contains the active pharmaceutical ingredient alogliptin, and is a highly selective DPP-4 inhibitor indicated for treatment of type II diabetes.

(June) The US Federal Bureau of Investigation has approved Life Technologies Corporation’s applied biosystems Identifiler® Direct and Identifiler® Plus forensic kits for use by laboratories generating DNA profiles for inclusion in the National DNA Index System (NDIS) CODIS Database. The advanced capabilities of these new forensic kits, along with the company’s MiniFiler™ kit, recently approved by NDIS, has enabled a new era of efficiency and effectiveness for forensic DNA laboratories.

RESEARCH COLLABORATION

Lilly, Merck and Pfizer form ACRG

Sanofi, JDRF to develop type I diabetes drugs

(March) Eli Lilly & Company, Merck and Pfizer, Inc, have formed Asian Cancer Research Group, Inc (ACRG). This independent, not-for-profit company will improve treatment for patients with commonly diagnosed cancers in Asia. Initially, ACRG will focus on lung and gastric cancers. Lilly, Merck and Pfizer will create pharmacogenomic cancer databases having data of tissue samples from lung & gastric cancer patients, and will be publicly available to researchers.

(July) Sanofi-Aventis and Juvenile Diabetes Research Foundation (JDRF) have partnered to develop therapeutic treatments for patients with type I diabetes as well as to prevent diabetes in those at risk. Under the new partnership, Sanofi-Aventis and JDRF will jointly provide funds to academic investigators and non-profit medical research organisations to conduct research in regeneration and immune therapy.

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January 2011

NATIONAL NEWS

JOINT VENTURE

Ecron Acunova forms JV with Jamjuree Innovations Ecron Acunova (EA) has recently announced a Joint Venture (JV) with Chulalongkorn University’s arm, Jamjuree Innovations Co Ltd (JJI), Thailand, for clinical research (CR) in South-East Asia (SEA). JJI is a subsidiary of Chulalongkorn University’s intellectual property foundation and has strong ties with the University’s faculty of medicine, which

NEW FACILITY

Merck opens new application technology centre in India

Merck’s new application and technology centre at Nerul, Navi Mumbai

Merck Ltd has recently set up a new

ADVISORY SERVICES

Flamingo appoints Mott MacDonald as EPCM consultant Mott MacDonald has been appointed by Flamingo Pharmaceuticals Ltd to provide Engineering, Procurement and Construction Management (EPCM) services for the development of two pharmaceutical formulation plants in Nanded, Maharashtra. Mott MacDonald will be providing concept development, master planning,

EXPANSION

Thermolab’s new unit

Thermolab Group has recently launched its new group company, Thermolab Analyticals, along with its new corporate logo. This new unit will conduct stability storage and analytical

26 Modern Pharmaceuticals

includes Clinical Research Center (Chula CRC). The JV CRO is based in Bangkok, Thailand, and will be conducting clinical research in key SEA countries under the name of Ecron Acunova Company Ltd (EACL). Speaking on the JV, Dr Kiat Ruxrungtham, Professor of Medicine, Chulalongkorn University, said, “JJI has built expertise in regional quality clinical research by successfully conducting clinical trials for international sponsors in Thailand, Malaysia and Vietnam.

We are looking forward to expanding this model hands on local study and investigator relationship management in SEA for our clients.” Further, DA Prasanna, Founder and Chairman, EA, commented, “With this JV, our execution strategy will be enhanced when operating together, rivaling the capability of any competing leading CRO in South and SEA.”

application and technology centre at Nerul, Navi Mumbai. This state-of-theart facility will enable Merck to offer customised application and technology solutions to its customers in fields of drug discovery, automobile and decorative paints. Prantik Mukherjee, Head, Merck Millipore, said, “The facility is equipped with state-of-the-art application, demonstration and quality control laboratories that meet the stringent

international standards. We will also offer resources for sales force training, for Merck as well as for our customers.” This centre has eight laboratories where Merck will be creating and demonstrating its customised solutions. In addition to chromatography analysis, separation analysis is a critical method for identification and separation of new chemical entities and new biological entities. The centre will also open up new vistas in water and chemical analysis. capabilities in India.

detailed engineering, procurement support and construction supervision services. It will develop an oral solid dosage block and a beta-lactam block. The facilities will include tank farms, an effluent treatment plant, above-ground water storage and a provision for waste. Also, the project will comprise a storm water drain, an administrative building and a power sub-station as well as road & parking areas. The facility valued at $ 380,000

is expected to be completed by the end of 2011. D Saraiya, Project Director, commented, “We will be treating waste generated from the facility to provide zero discharge, without releasing any emissions into the atmosphere.”

testing of drugs & drug products. It will have a fully equipped laboratory with stability storage chambers functioning as per the International Conference on Harmonisation (ICH) guidelines and complying with the US and European regulations. Sandip Mhatre, Group Managing Director, Thermolab, commented, “Thermolab Analyticals is a new beginning towards becoming a 360

degree solution provider for Thermolab’s customers in the pharma industry. Through this company, we aim to become closer to the customers who have placed their faith in us and have supported us till date”. He further added, “With rapid expansion of the company across the globe, a new look for the brand was needed; thus, the new logo was opted for.”

January 2011

NATIONAL NEWS

AWARD

IOLCP wins National Energy Conservation Award IOL Chemicals & Pharmaceuticals Ltd (ILOCP) recently announced that the company has won the National Energy Conservation Award 2010. The company has won the first prize in the drugs and pharma sector for its continued efforts towards new technology implementation so as to conserve energy resources of

PRODUCT DISTRIBUTION

Lincoln gains marketshare with new products

Medifil

Lincoln Pharmaceuticals Ltd has strengthened its position in the Indian pharma industry with its technologically

PRIVATE EQUITY BOOST

Fermenta Biotech growth plans to get a boost Fermenta Biotech Ltd (FBL), a subsidiary of Duphar-Interfran Ltd (DIL) has recently announced that it has been authorised to enter into a definitive agreements with Evolvence India LifeSciences Fund (EILSF), a private equity fund exclusively focussed on the Indian life science industry.

NEW DEVICE

Eli Lilly launches insulin device

HumaPen® LUXURA™ HD

Eli Lilly and Company (Lilly) has recently launched HumaPen® LUXURA™ HD, an easy-to-use insulin delivery device for patients who may require the precision

the country. R K Thukral, Executive Director, ILOCP, said, “This year, we have achieved a considerable decline in energy consumption at our manufacturing units due to implementation of several energy conservation measures and ideas to increase the power efficiency of our equipment & processes. We are committed towards further improving our performance and achieving higher standards.”

This award is conferred every year by the Ministry of Power, Government of India.

advanced collagen bio-tech products, Medifil and Skin Temp. Lincoln had tied up with Human BioSciences Inc, Maryland, USA, last year for the exclusive marketing and distribution of its two innovative wound care management products in India. The products were 50 per cent faster in healing wounds, with a reduction in the frequency of dressing and no scar formation compared to the existing products. Moreover, Medifil and Skin Temp have acquired about 22 per cent marketshare in India. On the success of the products, Mahendra

G Patel, Managing Director, Lincoln Pharmaceuticals Ltd, commented, “Our mission at Lincoln Pharma is to provide customers with high-quality healthcare products at an affordable price. The introduction of Medifil and Skin Temp in India has enabled customers to benefit from an advanced wound care solution with better recovery and greater ease at a reduced cost. We are planning to set up a manufacturing unit in India to increase production and expand our reach so that more people can avail the benefits of these products.”

In this deal, EILSF will hold minority equity stake of FBL, which will be partly through issue of fresh equity from FBL and partly through sale of FBL shares by DIL to EILSF for a total investment of ` 40 crore. With this infusion of equity, FBL plans to broaden its product portfolio with increased R&D initiatives and augmenting its manufacturing facilities. Peter Bains, Chairman, FBL, said, “We are pleased to do this transaction

with Evolvence. Evolvence specialises in investing in life science-based growth platforms and we see this investment in FBL as a strong endorsement of our company’s ongoing strategy to build and deliver future growth and value to our shareholders.”

of half-unit dosing (HD). The new dosing feature enhances safety and accuracy in maintaining glycaemic control for patients, especially children with diabetes. LUXURA™ HD, a reusable pen, delivers 0.5-30 units of insulin in halfunit increments, and is for use with Lilly Insulin [Humalog (Insulin Lispro) or Huminsulin (Insulin Human)]. The device comes with a unique dosing dial that

can be moved forward and backward, without the loss of insulin. Sandeep Gupta, CMD, Eli Lilly, said, “For children with type 1 diabetes, their condition can often be overwhelming and difficult to manage. We are pleased to introduce LUXURA™ HD, which provides type 1 patients with the confidence and assurance of an accurate delivery of insulin.”

L-R: Sushil Kumar Shinde, Union Power Minister felicitating R K Thukral

January 2011

Modern Pharmaceuticals

NATIONAL NEWS

ANNOUNCEMENT

Aurobindo Pharma announces strategic divestment from Sinopharm Aurobindo Pharma Ltd (APL) has recently announced that it has entered into a definitive agreement with China National Pharmaceutical Group Corporation (Sinopharm) to divest in its subsidiary company, Aurobindo (Datong) Bio Pharma Co Ltd, China (ADBPL). Sinopharm will be acquiring the

PATENT REJECTION

US company’s anti-HIV drug patent rejected by India

India has recently rejected a patent application filed by the US-based

ACCREDITATION

Elder API plant gets accreditation from Japanese Ministry Elder Pharmaceuticals has recently received accreditation from the Ministry of Health, Japan for its Active Pharmaceutical Ingredients (API) plant at Patalganga, Maharashtra. This accreditation is considered to be difficult to get, as only companies with the best of infrastructure and quality are eligible

NEW DRUG

Biocon announces preliminary data on its novel oral insulin

Biocon, Asia’s leading biopharmaceutical enterprise, has released preliminary data of a recently concluded clinical study

28 Modern Pharmaceuticals

shares through its subsidiary company, Sinopharm Weiqida Pharmaceutical Co Ltd. ADBPL manufactures 6 Amino Penicillanic Acid (APA), a derivative of Penicillin-G, and most of its production is consumed by APL. After acquisition of 51 per cent equity in ADBPL, the investors will further infuse capital to enhance its shareholding to 80.50 per cent, reducing the APL share in the Joint Venture (JV) to 19.5 per cent. The Sinopharm Group will be infusing sufficient

funds to relocate the plant as required by local government in China and significantly enhance capacity & downstream products, leading to better economies of scale and reduced cost of production.

company, Abbott Laboratories, for its anti-HIV drugs Lopinavir and Ritonavir, stated a press release. The battle over the Intellectual Property Rights (IPR) of these drugs continued for four years. These are essential drugs, which are required for second-line treatment for patients who have developed resistance to first-line drugs. Initiative for Medicines Access and Knowledge (I-MAK) along with Indian companies like Cipla, Okasa and Matrix

challenged Abbott’s patent application. According to I-MAK, the drug was earlier priced at about $ 1,000 per patient per year, whereas Indian companies could produce these at a much lower cost of $ 400. Tahir M Amin, Director, I-MAK, said, “Abbott has a history of pricing this drug much higher in developed countries. A number of public health advocates have asked that Abbot should reduce the price or license it to other companies.”

for it. The company has developed two products that will be off-patent in the Japanese market in 2014. Elder has already filed a Patent Co-operation Treaty (PCT) patent (an international patent application) for one of the advanced intermediates for the Japanese market. Alok Saxena, Director, Elder Pharmaceuticals Ltd, said, “Elder is not positioning itself to be an API and advanced intermediate supplier to the

Japanese market. This accreditation for the API plant is a step towards strengthening Elder’s position as a supplier of APIs and intermediates in the Japanese market.” Further, Elder is in talks with Japanese generic companies for supply contracts.

conducted in India, on its novel oral insulin candidate for the treatment of diabetes – IN-105, stated a press release. A double-blind placebo-controlled trial with 264 patients was conducted at multiple centres across India. Patients poorly controlled on Metformin were randomised to receive either IN-105 or placebo. The IN-105 patient arm showed a statistically significant reduction in post-prandial glucose levels compared

to placebo during the study. Data shows that the drug is weight neutral and non-immunogenic, and demonstrated an excellent overall safety profile. Kiran Mazumdar-Shaw, MD & Chairman, Biocon, said, “Based on these encouraging results, Biocon is committed to continue its global development of IN-105 in partnership with a global pharmaceutical partner for which we plan to initiate partnering discussions.”

January 2011

MPH (January 2011) 1Tab-29

MPH (January 2011) 1Tab-30

NEWS ANALYSIS

Tinnitus injection

A breakthrough in drug discovery Tinnitus – as a temporary or permanent disturbance – affects an estimated 35-45 per cent of adults at some point in their lives. Considering this, Lincoln Pharmaceuticals has introduced a new injection– Tinnitin – for treatment of tinnitus in India. Meghna Mukherjee gives a perspective on the prevalence and treatment of tinnitus in the country. innitus is a medical condition in which a ringing noise or any other type of noise – in the absence of a corresponding external sound – seems to originate in the ear. It commonly affects people aged above 17 years. In India, approximately 45 million people currently suffer from this disorder, and this number is growing at the rate of 10 per cent. Medical researchers feel that either the static or the ringing that most of the patients hear can either be the nerve firing or the memory of a leftover sound. However, the treatments are mostly based on the fact that tinnitus is caused due to the damage to the microscopic hair endings of the auditory nerve in the inner ear. In view of this and huge number of people suffering from this disorder, Lincoln Pharmaceuticals, in agreement with Phafag AG, Switzerland, to use their Caroverine molecule, has come up with Tinnitin, in the form of injection. Phafag AG claims that according to certain physiological and morphological assessments in a study done by the company, a low-dose and longterm caroverine treatment might protect against ‘impulse noise-induced hearing loss’. In the study, caroverine was delivered subcutaneously using an osmotic pump. As per the company, this kind of delivery has the advantage of avoiding systemic side-effects. Many researchers, in their search for an effective treatment are also looking for a proper mode of drug delivery that will cause the least side effects. Caroverine is not available in the US or Canada for any purpose, as it has not been approved by the FDA. It is currently available only in Austria, Switzerland, Japan, and India.

Cost factor The market opportunity for Tinnitin Injection is nearly ` 25-30 crore. Since this product has been launched recently, about 40 per cent of the total market will be targeted. Later, this will be extended by creating awareness and educating people on the availability of this product in the country.

Investments and expansion Lincoln Pharmaceuticals has plans to conduct clinical trials for doctors & patients in India, and for this, investments amounting to ` 6-8 crore will be made in financial year 2011-12. Not only domestic patients but also medical tourism in India will be targetted through this. This will enable patients suffering from Cochlear Synaptic Tinnitus find adequate treatment in the country. The company is not looking for collaboration with any other pharma company in India. For 2010-11, the company aims for an R&D budget of ` 10 crore, which will be increased by 40 per cent in the coming year.

Future plans Lincoln Pharmaceuticals plans to manufacture and market Tinnitin with the technical know-how of Phafag AG. At present, manufacturing for six batches of the product is completed, which have been technically validated by a team at Phafag AG. The mission of Lincoln Pharmaceuticals is to set up at least 1,000 such Tinnitus clinics across India, in order to provide proper treatment to patients suffering with Cochlear Synaptic Tinnitus.

With inputs from Mahendra G Patel, Managing Director, Lincoln Pharmaceuticals Ltd

January 2011

Modern Pharmaceuticals

WORLD NEWS

NETWORKING FORUM

Informex and CMS Pharma to hold inaugural CEO Summit of Pharma Manufacturing

Informex and CMS Pharma have announced that the first annual CEO Summit of Pharma Manufacturing will be held in Charlotte,

NEW DIRECTOR

ERT appoints Klaus Besier to Board of Directors ERT has appointed Klaus Besier to the company’s Board of Directors. This strategic appointment will enable ERT to draw on Besier’s extensive experience and international perspective in helping companies develop, implement and execute global growth strategies to further penetrate healthcare &

EXPERT GUIDANCE

PharmaNet guides on regulatory pathway for biosimilars

PharmaNet Development Group, Inc, a leading provider of drug development services to the pharma, biotech, generic drug and medical device industries,

RESEARCH FUNDING

Bayer to make systematic investments for growth and innovations Bayer’s focus areas for investment will be R&D and marketing of new products, particularly in healthcare and cropscience. It will also spend on expanding activities in the emerging markets. This will require high level of investments in the coming years. But sales & earnings are under pressure from generic products, rising development

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North Carolina, on February 6, 2011, one day before the opening of the annual flagship InformexUSA event. Informex is the leading meeting place for buyers and sellers of high-value chemistry for a broad range of applications, and CMS Pharma is the trusted M&A and corporate strategy advisor for the custom manufacturing industry. The invitation-only summit will bring together the leading CEOs and Business Unit Executives in the contract manufacturing and contract research

sectors to discuss business strategies and industry trends, while providing a highlevel networking forum. “By holding the CEO Summit a day before the exhibition, we will be able to provide an additional, value adding resource to our VIP attendees at InformexUSA. We aim to make this a must-attend annual networking event for high-level executives from the pharma contract services sector,” said Jennifer Jessup, Global Brand Director, Informex.

clinical markets. Joel Morganroth, Chairman and Chief Scientific Officer, ERT, commented, “With his wealth of experience and capabilities in developing and implementing successful growth strategies, we are confident that Besier will greatly contribute to the strategic direction of the business and help ERTOn being appointed, Besier commented, “I am pleased to be part of a strong management team consisting of individuals who share a long industry track record. I look forward

to working with them to take ERT to an even higher level of leadership and technological innovation.”

has announced that its regulatory and pharmaceutical development experts are available to offer guidance on the regulatory pathway for biosimilars development in the US. This announcement came following a recent Food and Drug Administration (FDA) hearing. The two-day public hearing aimed to obtain inputs from interested stakeholders on specific issues and challenges associated with

implementation of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). Jeffrey Freitag, MD, Senior Vice President, said, “This hearing was an excellent forum for the FDA to receive valuable inputs from many interested stakeholders. While the regulatory pathway is still to be determined, the opinions expressed should help the FDA develop guidance for moving forward.”

costs and effects of healthcare reforms. Dr Marijn Dekkers, AG Management Board Chairman, Bayer, explained, “To finance the expansion of our growth activities, we need to redirect resources, improve efficiencies and cut costs.” Annual cost savings of 800 million are planned to raise investment in further growth, starting in 2013. About half of this amount will be reinvested. By the end of 2012, the company is likely to take one-time charges in the range of

Euro 1 billion, with part of this amount already being incurred in the fourth quarter of 2010. Also, it has planned to reduce the global headcount of 108,700 by an aggregate of about 2,000 by 2012.

January 2011

Klaus Besier

WORLD NEWS

TAKEOVER

ITT completes acquisition of OI Corporation ITT Corporation has announced the completion of its acquisition of OI Corporation (OI), for approximately $ 29 million. OI is a leading provider of innovative instrumentation for laboratory and environmental testing in the pharma, petrochemical, power and industrial markets. The

CUSTOMISED DRUGS

Personalised medicines occupy a growing role in clinical pipeline

According to a recent study by the Tufts Center for the Study of Drug Development, the role of personalised

EVENT

Novozymes Biopharma to present research findings on recombinant human albumin at 2011 PepTalk Conference Novozymes Biopharma, part of Novozymes A/S world leader in bioinnovation, will be presenting two scientific posters on manufacturing and use of recombinant albumin in formulation at PepTalk Conference, to be held during January 10-14, 2011,

DISCOVERY

New compounds block cancer cell growth and promote cell death

A recent study has found a new class of compounds that interfere with cell

company’s portfolio will enhance ITT’s Analytics business, which was formed earlier this year with the acquisition of Nova Analytics. “Addition of OI to our existing portfolio supports our strategy to acquire attractive companies to grow our presence in the $ 6 billion global analytical instrumentation market. “Combining OI with our own product offering allows us to expand our technical expertise to

serve our instrumentation customers, and will enable us to better serve our global customers,” said Chris McIntire, President, ITT Analytics.

medicine development is increasing in clinical pipelines of drug developers. This is encouraging companies to change their R&D paradigms. “Early indications show that development of personalised medicines is commanding more resources and fomenting more organisational change than is generally appreciated outside the industry,” said Christopher-Paul Milne, Associate Director, Tufts CSDD, and author of the study. He noted that the scientific,

regulatory, commercial and practical challenges confronting developers in creating personalised medicines are significant, and thus approaches taken by individual companies in the pursuit of these new medicines vary greatly. In particular, developers are working with academic medical centres to better understand disease mechanisms and identify the strata of target populations, and also with diagnostics developers to augment in-house capabilities.

San Diego, USA. The two posters cover the company’s latest research in the use of recombinant human albumin and its ability to address many of the formulation challenges faced by the industry. The posters offer protein scientists new insight into formulation & manufacturing and highlight how recombinant albumin can help optimise current processes. “As one of the industry leaders, we believe that our studies significantly

contribute to the development of the field, and we also welcome the opportunity to share our advances with industry experts who can benefit from the leading edge data,” said Dermot Pearson, Marketing Director, Novozymes Biopharma.

signalling pathways, providing a new approach to cancer treatment. The compounds, called non-Phosphoinositide PIP3 Inhibitors (PITs), checked tumour growth in mice by inducing cell death. “PITs cause cells to self-destruct by interfering with signalling pathways that regulate cell survival. As compounds promoting cell death, PITs show promise in halting the harmful, unwanted growth characteristic of cancer,” said Dr Alexei Degterev, Assistant Professor

- Biochemistry Department, Tufts University School of Medicine (TUSM). Dr Degterev, with colleagues at TUSM, Northeastern University (Boston, MA), Massachusetts General Hospital (Boston, MA), Harvard Medical School (Boston, MA) and the National Chemical Laboratory (Pune, India), identified compounds that could disrupt a cellsignalling molecule called PIP3. Of the 50,000 small molecules screened, the team identified two that inhibited PIP3.

January 2011

Modern Pharmaceuticals

WORLD NEWS

NEW SOFTWARE

ERT unveils ePRO solutions for clinical trial sponsors

ERT, a global provider of technology and services to the pharma, biotech

DRUG TRIAL

Landmark double-blind ROCKET AF study Bayer has announced the results of the pivotal, double-blind Phase III, ROCKET AF trial. In the study, rivaroxaban demonstrated superiority to warfarin in reducing the risk of stroke and nonCentral Nervous System (non-CNS) systemic embolism in patients with Atrial Fibrillation (AF). Importantly, rates of bleeding were similar to that with

FDA APPROVAL

USFDA approves second Bayer OC that raises folate levels

Bayer HealthCare Pharmaceuticals, Inc, has recently announced that the US Food and Drug Administration (FDA) has approved a new Oral Contraceptive (OC), SAFYRAL™ (drospirenone 3 mg/ethinyl estradiol 30

DRUG EVALUATION

FDA to review new treatments for obesity The Obesity Society (TOS) and the Obesity Action Coalition (OAC) had called the Food and Drug Administration (FDA) to consider the urgent need for more tools to address the obesity epidemic facing more than 93 million Americans, at an advisory panel for review of a new treatment for obesity. In October, the FDA rejected two other newly developed obesity treatments, Qnexa

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and medical device industries, has recently launched its comprehensive suite of electronic Patient-Reported Outcome (ePRO) solutions. This ePRO tool has increasingly become more sophisticated, to meet the diverse needs of sponsors and facilitate compliance by the patient. ERT offers a broad range of proven modalities of technology, providing the ability to choose the best ePRO solution to suit

the requirements of the trial, ensuring its accuracy and success. John Blakeley, Executive Vice President and Chief Commercial Officer, ERT, said, “We believe that to ensure an accurate and successful clinical trial, vendors must offer technologies that are as diverse and varied as the clinical trials. Therefore, ERT ensures that it gives a comprehensive, unbiased choice of sophisticated solutions.”

warfarin. And bleeding events most concerning to physicians & patients, including intracranial haemorrhage, critical organ bleed and bleeding-related death, were significantly lower in the rivaroxaban group. Professor Werner Hacke, Chair - Department Neurology, University of Heidelberg, Germany, and Member of the ROCKET AF Executive Steering Committee, said, “The ROCKET AF study has shown that once-daily rivaroxaban

promises patients an improved protection from stroke, with good safety and added convenience.”

µg/levomefolate calcium 451 µg tablets and levomefolate calcium 451 µg tablets). In women who choose an OC for birth control, SAFYRAL™ raises folate levels for reducing the risk of rare Neural Tube Defects (NTDs) in a pregnancy conceived while taking SAFYRAL™ or shortly after discontinuing it. SAFYRAL™ is the second Bayer OC, which contains folate. In September, the FDA had approved Beyaz™ (drospirenone 3 mg/ethinyl estradiol 20 µg/ levomefolate calcium 451 µg tablets and levomefolate

calcium 451 µg tablets), the first OC approved by the FDA to raise folate levels in women who choose an OC for birth control. “SAFYRAL™ and Beyaz™ are part of Bayer’s growing women’s health franchise, and these new products reinforce our commitment to providing women various contraceptive options,” said Leslie North, Vice President, Marketing, Women’s HealthCare, Bayer HealthCare Pharmaceuticals.

(phentermine/topirimate) and Lorquess (lorcaserin), citing safety concerns. Also in October, the FDA had asked to pull back the previously approved weight-loss drug Meridia (sibutramine) from the market due to safety concerns. The FDA Endocrine and Metabolic Advisory will now review a New Drug Application for Contrave for the treatment of obesity. “The time for action is now. The number of people affected by obesity is growing at rapid rate, and

millions of Americans affected by the disease are lacking the medically approved treatment and long-term options,” said Joe Nadglowski, President and CEO, OAC.

January 2011

Image showing the effect of embolic stroke

TECH UPDATES

Size-exclusion chromatography illuminates protein crystallisation Understanding membrane protein crystallisation is one of the main goals of molecular biology studies aimed at the structural characterisation of proteins. The work done by Malvern Instruments in conjunction with the Membrane Protein Laboratory at London’s Imperial College, has recently been published as an application note that outlines a method for providing insights into the likelihood of crystallisation of a sample and its protein content. ‘Analysis of membrane protein by multi-detector SEC’ describes how the Viscotek TDAmax Size-Exclusion Chromatography (SEC) system was used to characterise and optimise the proportion of protein and detergent in a purified membrane protein sample. Crystallsation of a membrane protein depends on several factors, eg, protein purity and detergent concentration or type. Removing too much of the detergent component of a membrane protein complex can lead to degradation of the protein and reduce the chances of crystallisation. SEC is the technique of choice for rapid & reliable characterisation of molecular weight and molecular structure for all types of macromolecules, The Viscotek TDAmax from Malvern Instruments including proteins.

K-Tron Process Group expands pharma feeder line K-Tron Process Group has expanded its pharmaceutical feeder line to include the K-PH-ML-D5-KV2, a vibratory loss-in-weight feeder designed for low-rate addition of difficult-flowing Active Pharmaceutical Ingredients (APIs). It offers an easy-to-clean design, suitable for quick and easy cleaning. The removable tray & end covers allow accessibility and ease of cleaning. The three-litre inlet funnel transition hopper is designed at a 65° slope for optimal flow ability into the vibratory tray. The unit offers a 20-ltr extension hopper with optional lid, along with inlet tri-clamp and sanitary flexible bellows for complete isolation of the feeder. A lid option is also available with a sanitary vent filter affixed by a tri-clamp. All tri-clamps are made of FDA plastic bio-clamp construction, to minimise the overall weight of the feeder, and maximise feeder accuracy. The discharge tray terminates to a triclover ferrule, with sanitary Pharma FDA silicone bellows for connection to the process below. The specialty vibratory feeding principle, coupled with K-Tron’s patented load cells and KCM controller, ensures high-accuracy feed for even the most difficult flowing products. This feeder is ideal for continuous pharmaceutical operations, such as continuous extrusion, granulation, mixing and coating.

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Modern Pharmaceuticals

TECH UPDATES

TSI’s new particle counter The TSI AEROTRAK™ 9550 portable particle counters offer best-in-class features and versatility. The Model 9550 provides a 1.77 CFM (50 L/min) flow with 0.5 µm sensitivity. It can sample 1 m of air in just 20 minutes. Compatible with TSI’s accurate ventilation probes that measure air velocity/ temperature, this product provides a complete solution for all certification requirements. Also, this particle counter can generate pass/fail reports for ISO 14644-1, EU GMP Annex 1 and FS209E. This product can be used as a standalone particle counter or can be integrated into a facility monitoring system like TSI’s FMS 5. The Model 9550 complies with all the stringent requirements set forth in ISO 21501-4. It is calibrated with NIST traceable PSL spheres using TSI’s world-class classifier and Condensation Particle Counters (CPC), the recognised standard for particle measurements. This lightweight equipment has stainless steel enclosure and allows storage of specific tests/ recipes and displays up to three environmental parameters. It is used for TSI AEROTRAK™ 9550 portable particle contamination monitoring. particle counter

Patient retention and compliance solutions for pharma sector Exco InTouch, the leading provider of regulatory compliant mobile patient communication solutions for the biopharmaceutical and healthcare sectors, advises that with heightened regulatory standards and the increasing trial complexity & duration of studies, patient non-compliance is becoming a growing issue that requires tailored, cost-effective solutions. To address these challenges, proactive employment of strategies that ensure patient compliance so as to avoid compromised data, trial failure or heavy financial losses is essential. Patient compliance can be improved by targeted patient recruitment and also by using reminders and motivational or educational messages throughout the study, which communicate the required activity and themes of appreciation/motivation directly to patients. Tim Davis, CEO, Exco InTouch, said, “Almost half of all trial delays are caused by patient recruitment problems, and we are all acutely aware of the massive impact of these delays in hundreds of thousands of dollars in lost revenue. By proactively factoring in retention solutions from the outset of a trial, 20 per cent of the typical 30 per cent of patients that drop out Mobile communication solutions can be avoided.” 36 Modern Pharmaceuticals

January 2011

Wyatt Technology’s MALS detectors used in virus research Wyatt Technology Corporation, the world leader in absolute macromolecular characterisation instrumentation and software, has announced that its instruments were used in a recent landmark study that transforms the previous scientific understanding of immunity to viral diseases, such as common cold, winter vomiting and gastroenteritis. The breakthrough research carried out by the United Kingdom’s Medical Research Council Laboratory of Molecular Biology (MRC LMB) demonstrates the ability of tripartite motif-containing 21 (TRIM21) to neutralise viral infection. Wyatt Technology’s Multi-Angle Light Scattering (MALS) detectors were used to monitor the interaction between TRIM21 and Immunoglobulin G (IgG). Also, the Heleos II instrument coupled with the Optilab rEX online refractive index detector were used to identify the positive interaction between a cytosolic IgG receptor, TRIM21 and IgG. Scientists discovered that TRIM 21 binds to antibodies with a higher affinity than any other IgG receptor in the human body and, once activated, begins to rapidly degrade virions in the cytosol, thus neutralising the infection. Dr Chris Johnson, co-author of the manuscript, said, “In protein chemistry, Wyatt Technology instrumentation coupled to size-exclusion chromatography is a powerful tool to determine particle mass, purity and even shape.”

Advanced roller compactor by Gerteis® The ULTRA-PACTOR® high containment roller compactor is the most technologically advanced roller compactor produced by Gerteis®. Building upon the proven MACRO-PACTOR® and with output capacities in the range 100 g to 400 kg per hour, the ULTRA-PACTOR® is designed within an ergonomic containment isolator to allow processing of potent products where high containment is required. The ULTRA-PACTOR® roller compactor is designed for full cleaning-in-place, to completely eliminate the operator’s contact with hazardous products. In addition to the unique Gerteis® roller compaction features of the MINI-PACTOR® and MACRO-PACTOR®, the features standard to the ULTRA-PACTOR® include containment performance of <0.1 µg/m³, ergonomically designed high containment isolator for the highest operator safety, RTP ports for optimised operator handling, push-push filter designs, permanent online pressure monitoring for all seals & pressure zones and fully automatic cleaning-in-place. The ULTRA-PACTOR® guarantees optimal protection for the operator against highly active and hazardous substances. With its ATEX compliance and the ability to purge N2 into the process area, this roller compactor truly pushes the boundaries in containment installations for dry granulation applications. ULTRA-PACTOR®

LE ADERS SPEAK

â&#x20AC;&#x2DC;One of our major growth strategies is R&Dâ&#x20AC;&#x2122; ...says Himanshu Dave, Director - Sales & Marketing, Astellas Pharma India. Having traversed the journey across varied functions like manufacturing, channel management, sales & marketing, his role in Astellas Pharma India involves charting and implementing the overall strategic growth for the company. Dave shares insights into his plans for Astellas Pharma India, with Meghna Mukherjee. ges hile ndia ame ndia ense while of neric new in lot inarch met bust offer e of the ons.

Each employee in our organisation is valued and is an important member regardless of culture, nationality or language. The diverse and multi-cultural workforce is our strongest asset and we will be continuously investing in them to strengthen our presence here.

Kindly share a SWOT analysis of Astellas India. What is the business model and strategy adopted by the company to strengthen its base in India? Strength: Astellas Pharma India is a global category leader in the field of transplantation. Astellas has a strong pipeline of research products, which will be catering to the unmet needs of the Indian population. Astellas Pharma India is known to be one of the companies that is dedicated to work tirelessly in order to earn the trust, and thereby meet expectations of patients and their families in particular â&#x20AC;&#x201C; not to mention a wide range of stakeholders that include medical professionals, employees and the local community. Weakness & Threat: One of the weaknesses and a threat to Astellas Pharma India is the strong generic market in the country. Opportunities: Globally, India has the second largest population with huge unmet needs. This provides Astellas Pharma India an opportunity to build a proprietary ethical pharma business. So we plan to tap only those areas where we can prove to be a prominent leader. This will help us meet the medical needs of the people. We will also focus on areas where growth is spurred by technological innovation.

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LEADERS SPEAK

What made Dave choose pharma...

Your educational background... I have completed General Management Programme at Indian Institute of Management – Bangalore (IIM-B), Masters in Marketing Management and Bachelors of Pharmaceutical Sciences from the University of Mumbai.

The greatest turnaround factor in your life... The greatest turnaround factor in my life was when I joined Astellas Pharma India.

With the success of global brands like Prograf, Vesicare, Harnal and Mycamine, which are the other products in the pipeline that Astellas Pharma India is working on? We have entered the transplantation market with our flagship brand – Prograf. We are currently evaluating the urology segment, which is our second global category leader after transplantation.

What influenced you to choose this career? My father had influenced me towards the pharma industry, but my inclination towards sales and marketing prompted me to specialise in this field.

How do you spend your leisure time? Spend time with friends and family. Also, sometimes I dedicate my time in helping the society and participating in some social work.

In addition, Astellas Pharma India is planning to invest in human capital. It is training its staff and upgrading the technological support for its employees. We hope this will provide us a platform for differentiating us from other companies in terms of our approach and quick response.

What is your opinion on the pharma education scenario in the country? The education system for pharma in India is more theoretical and not much in sync with the industry. The syllabus must be more in the context of the current pharma industry requirements. I strongly believe that students need more career guidance on opportunities available in the pharma industry. The Organisation of Pharmaceutical Producers of India (OPPI) has taken the initiative to reach out to students and assist them in planning their future in this industry.

Would Astellas Pharma, Inc (Japan), be looking at JVs or M&As in India? At present, we are settling for sales and marketing in India, and look forward to bringing in our research products

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after conducting an evaluation for the unmet needs in the market.

What is the company’s focus with respect to R&D in the country? Please quantify the investment plans of the company in this regard. One of our major growth strategies is R&D, which enables us to strengthen drug discovery research capabilities. We intend to take an active approach towards drug discovery for precision medicine by focussing on translational science and biomarker research. This can be done by utilising cuttingedge technologies in drug discovery research, prioritising strategic therapeutic areas and leveraging global development framework to bolster drug pipelines. Astellas will utilise multiple New Molecular Entity (NME) platforms like low-molecular-weight compound synthesis, fermentation, antibody/protein, etc, for drug discovery in focussed areas like oncology, immunology (transplantation) & infectious diseases, diabetes mellitus complications, metabolic diseases, neuroscience and urology.

January 2011

What do you think are the most essential features that a pharma company in India should adopt to grow globally? One of the most important features that a pharma company should be looking at for consistent growth in the global market is investment in R&D.

What are the future steps that Astellas Pharma India plans to take with regard to its motto ‘raison d’etre’? The business philosophy of Astellas Pharma India states that our raison d’être is to contribute towards improving the health of people around the world through provision of innovative and reliable ethical pharma products. I strongly believe that the sales & marketing department is the most vital link between association and doctors & patients, translating Astellas Pharma India’s philosophy into putting patient needs first. Our sales & marketing team will not simply gain scale through sales expansion but will maximise the value added to the lives of patients and everyone seeking a healthy life.

Other than new drugs, which areas is Astellas Pharma India planning to venture into? Highlight the growth areas for Astellas Pharma India. Currently, we have entered only into the transplant immunosuppressant market. We will be evaluating possible future opportunities as well.

ROUNDTABLE

Medical laws in India

Faulty implementation or faulty laws? India has all the reasons for conducting clinical trials in the country. But this benefit, while making the country a clinical trial outsourcing destination on one hand, has made Indian subjects guinea pigs on the other. Although Indian government has made certain rules to ensure safe clinical trials, adherence to these seems to be an issue. Meghna Mukherjee presents some experts views. The Associated Chambers of Commerce and Industry of India (ASSOCHAM) states that the clinical trial business was valued at approximately $ 1 billion in 2010 as over $ 200 million in 2009. This makes the country an ideal destination for conducting clinical trials. India participates in about 250 global trials every year, which is about 1.5 per cent of all global trials. The increase in clinical trials in the country is not only because the regulations are lax, but also because there is potential to recruit faster and at a lower cost than in the US or Europe. This cost- and time-saving is the primary goal for all foreign companies willing to conduct trials in India. The Indian regulations for clinical trial are in line with global regulatory norms and guidance. Also, there are ongoing efforts by the Central Drugs Standard Control Organization (CDSCO) to streamline regulatory processes and improve regulatory standards.

Dr A K Batham Executive Director, ACEAS Clinical Research The Indian pharma industry is regulated by the Indian drugs regulatory bodies and controlled by competitive domestic and international markets. Functioning in such a stringent environment, the industry has been able to register an exemplary growth. It has grown to become worldâ&#x20AC;&#x2122;s third largest in terms of volume and ranking. Exports of Indian pharma products have substantially increased and now contribute to more than half of the total turnover. Pharma products are exported to highly regulated international markets like Germany, Russia, China, the US and UK. Considering these achievements, the integrity of Indian drugs regulations and

medical laws, which are of international standards, cannot be questioned. Moreover, for exporting pharmaceuticals to regulated countries, Indian companies must fully comply with regulations in these countries. Indian pharma companies and Contract Research Organisations (CROs), such as Lambda Therapeutic Research Ltd, BA Research India Ltd and Quintiles, have done enough justice in conducting clinical trials by fully complying to regulations like International Conference on Harmonisation (ICH), Good Clinical Practice (GCP) and international regulatory requirements. They have also generated reports acceptable to international drugs regulatory bodies like US Food and Drug Administration (USFDA). Further, non-therapeutic clinical trials (bioequivalence studies) are required for registration of generic drugs. Laxity of medical laws and complacence in conducting clinical trials need to be addressed separately for therapeutic clinical trials on new chemical/molecular entities being developed as drugs, and clinical studies of public health interests.

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ROUNDTABL E

Dr Dhairyasheel N Savant Consultant Cancer & Reconstructive Surgeon, S L Raheja (a Fortis associate) Clinical trials market in India is booming, especially in the field of oncology, as there is a huge ill-informed patient pool that cannot afford costly chemotherapeutic regimens. This makes it easier for trial managers to conduct clinical trials on these patients. The positives are evident in that, patients who could not afford such costly drugs can now avail these. Since the numbers are huge, even a single institution or regional multi-centric groups can deliver similar treatment methodology, which is

Dr Dhananjay Bakhle Executive Vice-President, Medical Research, Lupin Ltd Clinical trials are a choice for a company that does not practise R&D and has opted out of drug discovery. Before any novel drug is introduced in the market, it has to undergo clinical trials. Most drugs in India have been introduced abroad and tested on patients there, and for many years, India did not have patents for these drugs. But now India has to conduct clinical trials before introducing any drug in the

Dr Khalid Saifuddin Group Head, Pharmacovigilance Operations, Novartis Healthcare Pvt Ltd Companies conduct clinical studies to increase profits and also provide benefits to patients. It takes approximately 8-10 years to launch a drug in the market, with an expenditure of $ 800 million to 1 billion. This time is too long and expensive. The faster a drug is launched in the market, the higher will be the marketshare of the company. Thus, companies are trying to accelerate the trial process by expanding out of the US and Europe and conducting trials in Asia & Africa. It takes

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January 2011

important in standardisation. The long-term benefit would be that these drugs will be available earlier for the population, as the trials will be completed early and ahead of schedule. On the flipside, this segment is poorly regulated, without approval from any ethics committee. Many physicians are initiating trials and are prescribing drugs that sometimes have little or no benefit and can also be harmful to patients. Patient selection is also biased, leading to skewed results of the trial drugs that have not undergone proper phase I or II trials and are administered, which can lead to side-effects. Further, as there is no effective regulatory body, the results may be fudged to favour the trials. There should be uniformity in the regulations and ethical committees to oversee clinical trials and proper collaboration with the groups abroad. Since India has a varied and mixed culture, ethnicities and languages, it has been opted as the ideal destination for conducting clinical trials.

market. For example, Ranbaxy had announced Phase III clinical trial in India for its anti-malarial combination, Arterolane maleate and Piperaquine phosphate. India can be an ideal destination for clinical trials. However, the system has some flaws. GCP was being followed before 2002. These guidelines were legislated and made mandatory for application in 2002. A recent report by Mint stated that the regulator will be making clinical trials mandatory and their inspection will become stringent. These inspections will be random but verified, and will bring out the anomalies in clinical trials. Also, there are training programmes and research institutes to train staff for conducting clinical trials. The rules & regulations that supervise clinical trials are quite strict in the country, and regulators are also working on the flaws in the system. Thus, India does not have lax medical laws.

lesser time to conduct trials in these regions. Also, a large patient pool, varied ethnicities, trained doctors & nurses, hospitals with good infrastructural facilities and high disease rates are the factors attracting most MNCs. Companies can thus save cost & time and deliver the drug faster to patients. The rules framed by the government are very relaxed. For example, when a drug is launched, the company that owns the drug has to submit a Periodic Safety Update Report (PSUR), which is a safety document giving updates on a drug being clinically tested. In other countries, if this document is not submitted periodically, then the companies are heavily penalised. But this is not the case in India. Here, some companies submit the PSUR late or not at all. Such instances have prompted the DCGI to revise these rules and regulations. MNCs conducting clinical trials is not only a boon for the Indian economy but also for patients, as this will enable the launch of a drug faster in the market.

ROUNDTABLE

Krishna Sarma Managing Partner, Corporate Law Group The number of clinical trials in India has grown at an astounding rate of 36 per cent annually from 2006-07 to 2010-11. In June 2010, the US Department of Health and Human Services (HHS) Office of the Inspector General (OIG) compiled a report to determine the extent to which clinical trials are taking place around the world. The report stated that though 80 per cent of the approved applications in 2008 came from foreign clinical trials (participants and sites), India accounted for only 0.4 per cent. In any case, India does not allow for first-in-human clinical trials for non-indigenous drugs. Thus, it would be factually incorrect to suggest that most of the human clinical trials by multinational corporations are conducted in India. There is an increasing concern

Dr Santhosh Kumar Medical Advisor, Anglo-French Drugs & Industries Ltd There are numerous reasons why India has become a hub for clinical trials in South Asia. The amendment of Patent Act 2005, ie, Trade-Related aspects of Intellectual Property Rights (TRIPS), which is stringent in protecting patients and clinical trial data has brought a massive change in the mindset of Western pharma companies about carrying out trials in India. Top Western pharma companies are looking towards

Dr Viral Shah Director, Cheeny Kum, Exemplar Care Pvt Ltd, Founder of portal cheenykum.com India has become a hub for clinical trials, as there is a diverse genetic pool and disease profile, high disease incidence in areas such as oncology, cardiovascular disease, diabetes as well as qualified doctors and medical staff, all of which are attracting

that the Indian laws/regulations governing clinical trials are lax and not well-implemented, following reports of death of infants and children during clinical trials conducted by pharma companies and at premier medical institutions in the country. However, blaming the medical laws of the country entirely for this would be presumptuous. The problem lies in the laxity of implementing the regulations on the ground. Part of the concern is the working of the ethics committee, which needs to be independent and imparted with institutional knowledge of conducting trials in India. The aspect of â&#x20AC;&#x2DC;informed consentâ&#x20AC;&#x2122; needs to be urgently tackled to suit the needs of the Indian scenario where a majority of patients are uneducated. Companies consider conducting clinical trials as a long-term investment to make a foothold in the domestic market because it makes sales of their products much easier. This happens particularly when Indian regulations insist on carrying out trials locally for the drug to be made available. It cannot be presumed that the regulation of trials is completely slack in the country. In fact, the DCGI recently announced a comprehensive clinical trial inspection programme that provides specific guidelines and checklists for standardising clinical trial regulations and making them more rigorous.

India as an ideal destination for carrying out phase-wise clinical trials. About five years back, the same companies were reluctant to carry out trials in India due to insufficient laws and unwillingness of the Indian medical fraternity to carry out the trials. The medical fraternity is now well versed with GMP-compliant medicines and is being trained to follow GCP/GLP guidelines. We have stringent regulations and laws like the western countries, but it may require strict adherence with proper watchdogs. This should happen in a couple of months as the DCG (I) and ICMR have taken the plunge in the right direction. Pharma companies are targeting the new drugs as well as attempting to generate data in India, with its wide population base and huge market potential. There are numerous clinical research institutes coming up in the country to train the staff for conducting ethical clinical trials.

clinical trials to be conducted in India. But, by no means are the Indian regulations easier than the international global standards. In fact, there are some very stringent patient safety aspects in India. The stringent Schedule Y is the law governing clinical trials. Also, ICH-GCP guidelines and Indian Council of Medical Research (ICMR) guidelines have to be complied with. No foreign sponsors are allowed to conduct first-in-man studies in India unless they prove with sufficient evidence that a particular drug is safe and can be studied in India. Although the laws and regulations are adequate, the system here is still lacking in some areas, such as inadequate manpower in the regulatory agency to guide and inspect the various stakeholders.

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FACILITY VISIT

Cordlife Sciences Pvt Ltd, India

Striking the right ‘cords’ With the USP of having three cell lines and multi country presence, Cordlife Sciences Pvt Ltd, India has taken up the mission of creating awareness and educating people as its next step. Arshia Khan gives a firsthand account of the action in place. Lymphoma and leukaemia, the top two cancers of the childhood, can also be treated with cord blood stem cells.

Cordlife: The parent company

arious statistics say that one child is born in India every two seconds, and this sums up to approximately 31 children being born per minute. Of this, even if 1 per cent of those umbilical cords are preserved, then in the future, India would probably have the cure to almost all diseases and illnesses. However, this would be possible only if people are aware of the use of umbilical cords, which is a grey area as of now. And the next concern to be resolved will be affordability to preserve the same. Not going by the nature of hurdles, Cordlife Sciences Pvt Ltd, India is engaged in banking these umbilical cords. A recent visit to the facility in Kolkata, which is not far from the main city, brought to fore the company’s dedication in researching the best possible treatments from stem cells and the preservation process of these cords,

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which is a sensitive and highly technical area. To fulfil this, the scientists and laboratory technicians also work in night shifts, to ensure that the umbilical cord is processed under desired conditions, without causing any delay. Cord blood is extracted from the umbilical cord after it is detached from the newborn. It is a rich source of stem cells and can be used to treat various diseases, including various forms of cancer and blood-related disorders. Before storage, the cord blood passes through three steps, processing, testing and cryopreservation. Cord blood, is the blood that remains in the umbilical cord and placenta. Cord blood is collected following the birth of the baby and after the umbilical cord is detached from the newborn. It is a rich source of Haematopoetic Stem Cells (HScs) responsible for replenishing blood and regenerating the immune system.

January 2011

Cordlife, the first private cord blood bank, was established in Singapore in May 2001, to collect, process and store cord blood stem cells. Cordlife adheres to the AABB (American Association of Blood Banks) standards, with ‘cleanrooms’, ultra-high security measures, 24x7power back-up and proper bio–medical waste management procedures. Cordlife has eight banks spread across AustraliaAsia, with its biggest unit in Kolkata. Globally, the bank has a capacity of six lakh specimens, and currently, has about 35,000 clients. Globally, Cordlife has 300 employees, of which 100 are employed in India. Cordlife’s network of stem cell banks is spread across Asia Pacific, with full processing & cryopreservation storage facilities in Singapore, Australia, Hong Kong, Indonesia, Philippines and India, with marketing office in Macau.

Cordlife India Cordlife Sciences Pvt Ltd, India had set up its base in Kolkata, in 2006, with an initial investment of $ 3 million (` 12 crore) through equity capital. “We plan to invest A$ 3-4 million for creating awareness and educating the people,” says Meghnath Roy Chowdhury, Managing Director, Cordlife Sciences Pvt Ltd, India. He further quips, “We registered a tremendous growth in 2010, of 300 per cent, with an increase in the number of samples as well.” Cordlife has a storage capacity of more than 5,00,000 specimens. It is the

FACILITY VISIT

Meghnath Roy Chowdhury Managing Director

Stem cell-based medicines and therapy will be the last resort in the management of disorders. However, biosimilars will soon ride the waves. And, considering a broad scheme of things, regenerative medicines will occupy a big portion.

only such facility that serves the Eastern part of India. The bank is licensed by the Drug Controller General of India (DCGI) to collect cord blood units from all Indian states and cities. As Dr Prosanto Chowdhury, Medical Officer, Cordlife, India informs, “We deal with almost all private hospitals in India. But, the collection from public hospitals is hardly 1 per cent.” Besides other part payment options, the one-time total cost of collecting, transporting, processing and cryogenic storing for 21 years is ` 75,000. While dealing with cord blood stem cells, which may later become a potential source material for life-saving treatments, there is frequent temperature and viability/pressure check to ensure stability of units and the samples stored. The Kolkata facility houses four storage units, each costing ` 5 – 7 lakh. The cryogenic storage vessels contain 800 samples in each of the four quadrants, the capacity of the whole tank being 3,200 units. The laboratory is equipped with High Efficiency Particulate Air (HEPA) filters to avoid contamination, and is fumigated every day to avoid contact with airborne infective particles. Besides, the laboratory is equipped with continuous double power back-up and up-to-date security & surveillance systems. In addition, the building is specially designed to withstand any natural calamity. Information Technology (IT) is an important factor in tracking the samples. Each sample is tracked through a unique identification number. The authorised

44 Modern Pharmaceuticals

personnel can gain access to the exact cryostorage location along with the patient’s medical history that includes the date of collection, any complications pre- and post-pregnancy, any form of illnesses, spouse details, related test reports and quality checks, which will assure that the doctor or scientist is looking at the right and useful sample. Since the bank collects sample from different cities in India, transporting them under the right condition is a must. To ensure the safety of these samples, the bank has a unique tie up with Jet Airways, such that the samples are transported without being X- rayed avoiding exposure to any form of radiation and thereby ensuring timely and priority transportation.

Moving ahead, Cordlife India also plans to set up more centres in the potential areas of the country. Roy Chowdhury explains the focus of the Mumbai centre, “The major purpose of this centre is to educate our clients and create awareness about the benefits of cord blood banking. We want our clients to make an informed decision on cord blood banking.” Other similar banks in India include Cord Care, a stem cells bank for storing umbilical cord blood of children as a potential resource for treating ailments, including cancer and immune disorders. Cord Care is a division of PathCare Labs, a Hyderabad-based diagnostic service

Ready for cryopreservation

Spreading wings The bank started its sales, marketing and operations forces in Mumbai last year in August for collection of samples. The centre in Mumbai houses 20 employees which is expected to grow over the coming months. “We plan to expand to Gujarat and whole of Maharashtra over the next few months as we feel western region is the single largest market and we propose to invest accordingly to attain maximum volume,” says Roy Chowdhury. He informs that they get the maximum volume of samples from Delhi and Mumbai, whereas the volumes from East and South India are more or less similar. While the laboratory houses 20 dedicated laboratory technicians, researchers, scientists, the corporate office houses approximately 135 people.

January 2011

Umbilical cord in Vial 2

Cryobag in cassette (which further will be used to store in the cryocylinders)

FACILITY VISIT

provider. It has a facility to store up to 1 lakh samples. The cost for collection, processing and preservation of cord blood is ` 75,000 and the samples are stored in cryogenic vaults for a period of 21 years.

Business strategy Cordlife India has tied up with both private and public hospitals across India to spread awareness on the importance of cord blood banking to the expectant parents. Besides, the bank has tie-ups with gynaecologists and conducts mother-child sessions at hospitals. According to an analysis and comparative awareness study in India regarding cord blood banking, West Bengal comes as

Differential Centrifugation (extraction of stem cells through three stage process of Differential Centrifugation)

Dr Prosanto Chowdhury Medical Officer

We have patents for T cell development and ex vivo expansion with research institutes. We share an understanding and have signed MoUs with companies doing R&D in this area.

the least aware state. “If 10 years ago, the awareness level was zero, today it has increased to 10. However, awareness is not a concern here but misconception is,” exclaims Roy Chowdhury. Currently, the bank is present in all the major metros and caters to the nearby tier II cities. Besides, there is an increasing number of geographical coverage and marketing promotion in Mumbai, Delhi, Chandigarh, Vishakhapatnam, etc. Cordlife is also looking at working with Non-Government Organisations (NGOs) as a part of its Corporate Social Responsibility (CSR) activity through which it will be able to relate to children and women.

Reinventing the ‘cords’ the right way

Viability test on sample

Placing the units in storage tank for cryo preservation

The bank has technologies in place that can differentiate Mesenchymal Stem Cells (MSCs), Epithelial Stem Cells (EpSCs) and Hematopoietic Stem Cells (HSCs), and this is one-of-its-kind, explains Dr Chowdhury. He elaborates, “We have patents for T cell development and ex vivo expansion with research institutes. We share an understanding and have signed MoUs with companies doing R&D in this area.” “Hence, Cordlife conducts research with universities and technical institutes in Singapore, Australia and the UK. When this research reaches commercial exploitation, it will be brought to India,” avers Roy Chowdhury. There are a few projects in the pipeline, which includes R&D activities with different institutes. The Cordlife Group, through its subsidiary, Cytomatrix® based in Australia,

researches, develops and commercialises powerful new therapeutics based on the use of cells to help treat diseases. It has developed stem cell expansion and T cell growth technology, which has the ability to grow stem cells outside the human body. Companies doing research in this area include Stempeutics Research, LifeCell, India, Reliance Life Sciences, Cryo-Save and Cryobanks International India (a joint venture between US-based Cryobanks International and RJ Corp). Stem cell-based medicines will be the next ‘in thing’ in the life sciences domain, airs Roy Chowdhury. He remarks, “The success of this industry depends on stem cell therapies and people are now more confident about stem cell-based therapies. Encouraging results have been found in R&D using stem cell and bloodrelated therapies for new lifestyle related diseases, such as stroke and spinal cordrelated disorders. Thus, there are enough reasons to believe the positive results that may come out.”

The next genre of medicines Although there is considerable research happening globally and in India on stem cell-based medicines and therapy, Roy Chowdhury believes, “Stem cell-based medicines and therapy will be the last resort in the management of disorders. However, biosimilars will soon ride the waves. And, considering a broad scheme of things, regenerative medicines will occupy a big portion. Keeping in mind India’s market size & potential, regenerative medicines, biosimilars and stem cell therapy, all will form a fair portion of the pie.”

January 2011

Modern Pharmaceuticals

INDUSTRY UPDATE

The booming Indian pharma industry is now being questioned for its product quality in international markets. Considering the sensitivity of life-saving drugs, any adverse event might hamper its image & business. Thus, a stringent quality control mechanism is needed to help the industry ensure global competence. Anwesh Koley presents a view of the evolving scenario.

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January 2011

INDUSTRY UPDATE

rugs and pharmaceuticals need responsible manufacturing. Not only does this reflect the medical excellence of a country at the international podium, but also the rapidly growing accountability towards millions who rely on these drugs. The Indian pharma industry, with a domestic turnover of over ` 20,000 crore has been growing at more than 10 per cent per year for the past one decade. This is enough a reason for domestic manufacturers to own responsibility towards pharma quality. As Sudhir Deshpande, Director General, All India Drugs Control Officers’ Confederation, (AIDCOC), avers, “The pharma industry in India is one of the most advanced and regulated industries in India. It has kept pace with technological advancements, and the quality of medicines manufactured by the Indian pharma industry is now well accepted globally.” Our exports valued at about ` 11,000 crore bring to light an even greater need to adhere to stringent quality norms, as the world is watching and using ‘Made in India’ pharma products, and also forming opinions about the same. “Apart from being Good Manufacturing Practices (GMP) compliant under Schedule M of the Drugs and Cosmetics Rules, 1945, the majority of pharma industry is compliant with GMP as per World Health Organization (WHO) guidelines,” adds Deshpande. India has various advantages with regard to pharma production. Chetan Pathak, Country Manager, Tectura India, believes, “Low R&D costs, skilled manpower, an efficient and cost-effective source for procuring generic drugs, especially with blockbuster drugs going off patent in the next few years, as well as an excellent centre for clinical trials in view of the diversity in population, all contribute to the steady growth of the Indian pharma industry.”

Global concerns Recent activities in the pharma sector

Sudhir Deshpande Director General, All India Drugs Control Officers’ Confederation

There is continuous monitoring of the quality management system through self-inspection and external audits. This exercise enables the pharma industry to continuously review the system and take necessary remedial measures in case of a deviation in the system. related to quality compliance and non-adherence to the standards have caused concerns regarding the integrity of guidelines, quality control mechanisms and governing authorities of the industry. This is why the US Food and Drug Administration (USFDA) has raised questions on the quality of drugs supplied by few Indian pharma companies, and refused to grant them approval. Rajabahadur, Vice President & GM (South & South East Asian Operations), ARC Advisory Group, believes, “The Indian pharma industry has the distinction of having a large number of GMP-compliant facilities that are globally certified to manufacture drugs, with several of them having secured approvals from regulatory agencies such as USFDA, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and WHO. However, these have also run into difficulties regarding the quality of drugs produced.” The Patents Act of 1970, the Drug Price Control Order 1970 and Foreign Exchange Regulation Act 1973

have been instrumental in building indigenous capability with regard to manufacture of drugs. The New Drug Policy of 1978 provided additional momentum to domestic self-reliance and availability of quality drugs at affordable prices. DPCO 1987 heralded the increasing liberalisation in the industry. A primary feature of this Act was that it reduced the number of drugs under price control to 143. The Indian pharma industry does not lack overview and supervision by regulatory bodies. “The quality of drugs manufactured, sold and distributed is monitored by the Central Drugs Standard Control Organization (CDSCO) at the Central level and the Drugs Control Administration in each state. Quality monitoring is done by periodic inspection and random sampling at manufactures’, hospital, distributors’, doctors’ and retailers’ level,” says Deshpande. However, the sheer volume of manufacturing and distribution reduces the efficiency of such checks. “Domestic pharma companies lag behind their global peers in leveraging Electronic Batch Recording (EBR)

Chetan Pathak Country Manager, Tectura India

The recent backlash might have had some dent on our image as a ‘quality’ drug manufacturer, but with increasing compliance among Indian contract manufacturing community with internationally harmonised standards such as GLP, cGMP and GCP, things are on the way to become better.

January 2011

Modern Pharmaceuticals

INDUSTRY UPDATE

Rajabahadur Vice President & GM (South & South East Asian operations), ARC Advisory Group

Domestic pharma companies lag behind their global peers in leveraging Electronic Batch Recording (EBR) solutions and operations management systems built around standards, such as ISA 88 and S95.

solutions and operations management systems built around standards such as ISA 88 and S95,” adds Rajabahadur.

Quality glitches This brings to the fore manufacturing and distribution of counterfeit & spurious drugs in the domestic and international market. “Section 16 of the Drug and Cosmetics Act 1940 and rules 1945 prescribes standards for drugs manufactured in India. For drugs included in the Indian Pharmacopoeia (IP), the standards of identity purity and strength specified currently in the edition of IP are applicable. Further, for drugs not included in the IP, but included in the official pharmacopoeia of any other country, the standards of that country’s pharmacopoeia are applicable,” says Omprakash Sadhwani, Assistant Commissioner, Food and Drug Administration (FDA). He elaborates, “When the drug quality and authenticity of data are found dubious and questionable, it has an adverse impact on the company’s brand image and reputation, resulting in loss in revenues or even business. The biggest loss the company faces is the future business, as customers begin to distrust the brand. India’s pharma industry must be more proactive in ensuring quality of their products and be willing to walk its extra mile to emerge a stronger player,” airs Rajabahadur. It is not that the government does not have operational bodies in place to check the quality of pharma products. The Department of Chemicals and Petrochemicals is responsible

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for overseeing policy, planning, development and regulatory activities pertaining to chemicals, petrochemicals and pharma sector. These responsibilities as assumed by the body are broadbased. The Ministry of Health and Family Welfare examines pharmaceutical issues

Traceability reaches the full supply chain. This system must be able to trace back to a vendor and the client to which the medicine was sold. Effective traceability will ensure that FDA audits can be ordered any time, and companies must be able to execute a rapid product recall.

drugs are produced in India. Spurious drugs worth almost ` 4,000 crore are manufactured in the country. This is about 20 per cent of the total domestic pharma business. Despite constant monitoring undertaken for checking the spread of such manufacturing, the growth of fake drugs in the country is growing at the same rate as the growth of the entire industry. While quality problems do exist, there are other issues within companies as well, which need attention. “Although India’s pharma industry has secured approval from several regulatory agencies, companies are still operating their plants with minimal investments in manufacturing Information Technology (IT)/enabling technology. Production processes are largely manually operated with paper-based recording systems. India’s pharma industry lags behind in adopting the current automation technology at the production level, laboratory information management systems at the testing level and decision support enterprise solutions at the corporate level,” informs Rajabahadur. For this purpose, traceability is an important factor. Traceability goes beyond the manufacturing process, thus reaching the full supply chain. This system must be able to trace back to a vendor and the client to which the medicine was sold. Effective traceability will ensure that FDA audits can be ordered any time, and companies must be able to execute a rapid product recall.

Effective technology use in the larger context of public health, while the focus of the Ministry of Chemicals and Fertilisers is on industrial policy and implementation. According to the WHO, counterfeiting associated with medical products means ‘deliberate and fraudulent mislabeling with respect to identity, composition and/or source of a finished medicinal product or ingredient for the preparation of a medical product.’ As per WHO data 35 per cent of the world’s spurious

January 2011

Technology is the key driver for pharma manufacturing industry for ensuring quality standards and maintaining authentic records. “Quality cannot be tested in products; it should be built-in or be by design, and this calls for increased collaboration. Manufacturing processes in the pharma industry are intricate, involving millions of batch records. Also, the use of electronic records & e-signatures has become inevitable, as regulations mandating reporting requirements and manufacturing

INDUSTRY UPDATE

practices need well-documented systems and effective functioning. The ultimate goal should be to move towards electronic documentation, ensuring real-time traceability and statutory compliance,” explains Pathak. Rajabahadur agrees on the adoption of technology when he says, “Technology adoption should be the norm, not only to increase the productivity & efficiency, but also to ensure quality, traceability and compliance. Investments in enabling technology assets, such as automation systems, enterprise solutions and operation management solutions must be viewed from a strategic perspective.” While technology is of prime importance in manufacturing drugs, investments made in research and clinical trials are also important, as they represent the authenticity of the manufacturer. In recent years, India has established itself as one of the major players in the clinical trials arena. The country provides contract services to the international pharma industry in the form of clinical development services, and this has enabled India to emerge as a major centre for clinical trials.

Looking at the brighter side The current scenario, however, is not all that grim. “The recent backlash might have had some dent on our image as a ‘quality’ drug manufacturer, but with increasing compliance among Indian contract manufacturing community with internationally harmonised standards such as Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP) and Good Clinical Practices (GCP), things are on the way to become better,” voices Pathak. To this, Sadhwani adds, “While state drug control departments are the licensing authorities for manufacturing and selling units, manufacturers have to comply with regulatory provision and licensing conditions. The GMP-mandatory guidelines are enumerated under section M of D&C rules.” The high growth rate for the industry cannot be achieved at the

Omprakash Sadhwani Assistant Commissioner, Intelligence Bureau, FDA, Maharashtra

While state drug control departments are the licensing authorities for manufacturing and selling units, manufacturers have to comply with regulatory provision and licensing conditions.

expense of quality. “The negative publicity that surrounds some of the leading pharma companies in India could have been avoided, had they followed the industry best practices. It is time for the top domestic players to take the lead in addressing some

Continuous improvements in ensuring consistently the desired quality while complying with global standards will help the industry emerge as the best in class. of these issues. The companies, during greenfield or brownfield expansion, must evaluate their investment plans in enabling technologies and assess the adequacy of their existing technology assets,” believes Rajabahadur. On the positives of regulatory compliance, Deshpande asserts, “While India has the largest number of USFDA-approved units, outside the US, there is a need to comply with the requirements of various international regulatory bodies, which will keep the industry on its toes. There is continuous monitoring of the quality management system through self-inspection and external audits. This exercise enables the pharma industry to continuously review the system and take

necessary remedial measures in case of a deviation in the system.” A better harmony within the industry and its regulators can ensure timely adherence to product quality. “Collaboration driven by enterprise solutions allows for a more proactive and business-like approach for manufacturers to achieve regulatory compliance. This helps drive current and future regulatory requirements to be compatible with business operational excellence methodologies. In the pharma industry, the relationship between operations management and enterprise is now at the forefront,” feels Pathak. The Indian pharma industry must be conscious of quality and brand. Being in the business of generic drugs, the industry must focus on achieving operational excellence in the manufacturing process. Continuous improvements in ensuring consistently the desired quality while complying with global standards will help the industry emerge as the best in class. Quality niggles exist in every industry, but the pharma industry has more accountability attached to itself, thus warranting higher and stricter quality control norms. Also, there are various players who stick to conventional production and valuation techniques, as they are reluctant to adopt new technology, fearing that their return on investments would be adversely affected. Elimination of such notions, coupled with a more applicable quality control mechanism, would take the sector to great heights and also reinstill confidence in the minds of global customers.

January 2011

Modern Pharmaceuticals

INTERFACE

achieve safer operationsâ&#x20AC;&#x2122; a one-of-its-kind safety testing laboratory in Mumbai to offer enhanced testing services to customers across diverse industries. Rajesh Saigal, Managing Director, Intertek, India, speaks to Meghna Mukherjee on the importance of a safety testing laboratory and the whole process of setting up a laboratory.

What was the rationale behind setting up a new testing laboratory? This new laboratory is basically a part of process development and technology transfer in Ciba. The data generated helps the technology transfer group to assess the hazards that are likely to be encountered in the process and to take suitable measures to overcome those. This ensures that the process is transferred with measures undertaken and is intrinsically safe. With rapid globalisation, India plays a major role in Contract Research and Manufacturing Services (CRAMS) and companies are required to perform a thorough risk analysis for their products and processes. This laboratory is designed to meet these requirements.

What are the various features of a safety testing laboratory? Safety is crucial to any chemical process or unit operation. To help make these processes safer, the safety testing laboratory focusses on the safe handling of chemicals in powdered form and process safety testing to

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define the characteristics of chemicals and their safe processing parameters. The safety testing laboratory is for thermal hazard assessment. The manufacturing process has a reaction part and a work-up part, which may involve unit operations like drying, milling, distillation and power handling. The laboratory has the capability to obtain data required for risk analysis for reactions with instruments like Reaction Calorimeter (RC1) and differential scanning calorimetry. Unit operation and power handling assessment are done by data generated by instruments like dust explosion, minimum ignition energy (for explosion), minimum ignition temperature, powder resistivity, volume of gas evolved on decomposition and shock sensitivity.

Please quantify the investments made for this set up? We have invested over ` 45 million for instruments and setting up this laboratory. Another important area where we are also investing is providing training to the technical personnel.

January 2011

Please tell us about Interteksâ&#x20AC;&#x2122; clients and reach. Intertek is a leading provider of quality and safety solutions serving a wide range of industries around the world. From auditing and inspection, to testing, quality assurance and certification, Intertek is dedicated to adding value to customersâ&#x20AC;&#x2122; products and processes, supporting their success in the global marketplace. Intertek has the expertise, resources and global reach to support its customers through its network of more than 1,000 laboratories & offices and over 26,000 employees in more than 100 countries around the world.

What are the other expert services provided by the company? Our company provides a number of expert services like safety & environment, testing and regulatory. Safety & environment consists of thermal safety testing of powders in the laboratory (testing, inspection & certification), thermal study of chemical processes (testing, inspection & certification), off-site safety consulting

INTERFACE

services on risk management, consulting on air pollution and waste water treatment services (scientific & technical consultancy), on-site safety and environment audit services (scientific & technical consultancy), seminars as well as training programmes conducted on the above mentioned areas (commercial, training & coaching). Testing includes analysing impurities in chemical substances in the laboratory, testing and consulting into safety packages of medicinal products, etc. Regulatory services include preparing Material Safety Data Sheets (MSDS) for chemical substances and regulatory consulting.

Why does one set up a safety testing laboratory? A safety testing laboratory can be set up according to oneâ&#x20AC;&#x2122;s business needs. It could be for thermal safety data generation for reactions, powder handling hazard assessment, tox data for chemicals, eco-tox data, etc.

What kinds of certifications does this lab have? The laboratory was initially accredited by bodies like National Accreditation Board for Testing and Calibration Laboratories (NABL) International Organization for Standardisation (ISO) and International Electrotechnical Commission (IEC 17025). When the laboratory was relocated, a fresh certification was necessary and is currently under progress. The laboratory is not under the purview of Food and Drug Administration (FDA).

Which are the other areas that Intertek is concentrating on? The bulk of work is done for pharma companies and in safety area. However, we are looking at additional work that might arise from regulatory requirements in the near future. Our aim is to help the Indian pharma and chemical manufacturers achieve safer operations. This includes technical training since these concepts are new for most of the people in the industry. However, this is a completely different sector for us to make profits from.

What are your future plans? Currently, we have no plans to establish more safety testing laboratories in any other part of the country. We will focus on capitalising on this one.

Kindly specify the measures taken to ensure that the testing laboratories remain ecofriendly. Tests in our laboratory are carried out on samples. The tests do not require chemicals for testing. Moreover, the samples remaining after testing are sent for incineration.

January 2011

Modern Pharmaceuticals

MARKET TRENDS

Pharma SMEs

Playing the right cards? With the introduction of product patent laws in India, pharma multinationals have shown renewed interest in launching some blockbuster products here. This has opened new vistas for the pharma SMEs to leverage niche opportunities. But have they adopted the right approach? Chandreyee Bhaumik unveils the strategies to be adopted by the SMEs.

ndeed, the words of Mark Twain, American humourist, writer and lecturer, “Many a small thing has been made large by the right kind of advertising,” echo a deeper prediction in the pharma sector. Thus, it is the approach that indicates and marks a change in the outlook and true performance. The Indian pharma industry has witnessed considerable growth in recent years because of the rising requirement and a strong demand from export markets. In addition to Good Manufacturing Practice (GMP) compliance, several Indian companies have been trying to obtain plant approvals from international regulatory agencies like US Food and Drug Administration (USFDA), Therapeutic Goods Administration (TGA) and many others.

Making a mark According to the Organisation of Pharmaceutical Producers of India (OPPI), Indian pharma industry is estimated to have approximately 10,000 manufacturing units. While the organised sector forms 5 per cent of the industry with about 300 players, a maximum of 95 per cent is in the

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January 2011

unorganised sector. Further, a large number of players in the unorganised segment are Small and Medium Enterprises (SMEs) contributing to almost 35 per cent of the industry turnover. Dr Mandar Kubal, Consultant-Infectious Diseases and HIV Aids, Infectious Diseases and Pulmonary Care (IDPC), says, “Pharma SMEs are a unique segment catering to a wider domestic consumers and offering a basket of low-cost, quality controlled and wide range of products and Active Pharmaceutical Ingredients (APIs). While many of the bigger units have a pan India marketshare and presence, a majority of SMEs concentrate on a state or region.” With a large number of drug molecules expected to go off patent during the next few years and with the increasing emphasis on the use of generic medicines in developed countries, competition in the global pharma industry is set to become steeper. Taking the thought further, Vikram Gupta, Chief Operating Officer, India Venture Advisors Pvt Ltd, explains, “Small and medium players seem well poised to take on the global challenge, especially in the bulk drugs space. In order to capture this opportunity, there is a need for highly trained manpower, advanced technologies and cost optimisation through improved processes.” In general terms, the structure of pharma SMEs and other SMEs are in the same alignment. However, there are differences when it comes to industry expectations. Dipta Chaudhury, Program Manager, Pharma and Biotech Practice, (South Asia and Middle East), Frost & Sullivan, opines, “In the case of pharma industry, various regulatory standards need to be followed. However, the scenario is different in case of SMEs involved in the manufacturing of machinery. Therefore, for a pharma SME, the setup cost and time is comparatively higher.” Further, Dr Kubal explains that the following changes in the pharma atmosphere have had

MARKET TRENDS

a considerable impact on the SMEs in this industry. v A better organised Indian Drug Manufacturers’ Association (IDMA) and Confederation of Indian Pharmaceutical Industry (CIPI) – SME Task Forces have raised relevant and important issues at the government level v Establishment of SEZs for pharma, eg, in Gujarat – PHARMEZ v Low tax and excise-free states like Himachal Pradesh, Uttaranchal, Jharkhand and Jammu & Kashmir have aided the pharma trade in these regions v Clarity on domestic and international trade regulations along with other established agencies helped in facilitating the same v A greater foray into Contract Research and Manufacturing Services (CRAMS) and Contract Research Organisation (CRO) activities.

Game plan In order to capitalise on the opportunities, a strict & robust business plan is a must. SMEs have recently gained momentum in the Indian economy, commanding immense attention from banks, financial institutions, industry and academicians. Thus, enterprises are aiming to take full advantage of all the opportunities available to them in the current economy. Therefore, it will not be an exaggeration to say that SMEs are hoping to succeed and emerge as market leaders in the industry. Elaborating on the plan of action, Gupta avers, “It is critical for the SMEs to not lose sight of their core business, which should be built upon their major strengths, values & purpose.” Further, he shares an interesting take on the policy that the enterprise should adopt. He remarks, “SMEs should try to outsource off-the-shelf services available in the market such as legal, accounting, Human Resource (HR), administration, etc, for keeping their costs low.” Usually, there are two types of business models that the SMEs follow.

Dr Mandar Kubal Consultant-Infectious Diseases and HIV Aids, Infectious Diseases and Pulmonary Care (IDPC)

Pharma SMEs are a unique segment catering to a wider domestic consumers and offering a basket of low-cost, quality controlled and wide range of products and Active Pharmaceutical Ingredients (APIs). Chaudhury discusses, “Sometimes, the company manufactures and markets certain products on its own. On the other hand, there are companies that undertake third-party manufacturing on contract basis. In such a case, investment returns are obtained immediately. Following this mantra, the company can grow and expand further.” Elaborating on the business model that a pharma SME should adopt, Sanjiv Kaul, Managing Director, Chrys Capital, says, “Focus on niche competencies only. Rather than having a generalist approach, SMEs should concentrate on select geographies and scale up on these aspects only.”

Third-party manufacturing With time, several novel avenues are at the threshold of the SMEs. An emerging trend among these enterprises is seen in pursuing clinical trials. There are immense opportunities in the CRAMS segment for SME players having expertise and facilities approved by regulatory agencies. A majority of SME players in the pharma segment operate in the

local market, and primarily manufacture formulations. Further, the development of pharma Special Economic Zones (SEZs) is also offering support for the growth of SMEs. So far, about 20 SEZs have already been identified, which will focus only on the pharma industry. Commenting on SME participation in clinical trials, Gupta elaborates, “Clinical trials outsourcing industry offers immense opportunities to the SMEs in India. The global clinical trials outsourcing industry is highly fragmented, with several hundred participants ranging from small, limited service providers to full-service global drug development corporations. Although the industry is not capital intensive and obstructs entry of small, limited-service providers, there are significant barriers to becoming a full-service Clinical Research Outsourcing (CRO) company.” Continuing in this tone, Gupta reflects, “These barriers include the cost and experience necessary to develop expertise in a number of therapeutic areas, the ability to manage complex clinical trials, the experience to prepare

Vikram Gupta Chief Operating Officer, India Venture Advisors Pvt Ltd

Small and medium players seem well poised to take on the global challenge, especially in the bulk drugs space. In order to capture this opportunity, there is a need for highly trained manpower, advanced technologies and cost optimisation through improved processes.

January 2011

Modern Pharmaceuticals

MARKET TRENDS

Dipta Chaudhury

Investment pattern

Program Manager, Pharma and Biotech Practice, (South Asia and Middle East), Frost & Sullivan

Similar to any venture to prosper in its respective arena, investment and Return on Investment (ROI) is a crucial aspect, and pharma SME is not any exception. Chaudhury avers, “The investment is made either on the innovative or proven model. Companies have to give assurance to the investor. However, in certain cases, a completely new model is adopted, much like in the healthcare sector. In such a situation, with credibility comes the required assurance. Usually, the return is 25 per cent over a period of four years.” Further, Gupta shares an interesting take on the investment pattern. He says, “As the number of opportunities in the SME segment is growing, an increasing number of funds are targeting such opportunities. Typical investments are done with a view to expand the markets in terms of novel products or service lines or entry into new geographies.” Indian SMEs are going through a transformational phase and industry players are organising themselves to avail of the immense opportunities that have opened up globally. The SMEs in the pharma sector are set to report impressive growth in the years to come and the outlook for the industry remains strong. Echoing this trend, Gupta opines, “Given the long gestation period right from the discovery of molecules to the final approval for marketing, the current investments made towards R&D will lead to sustainable growth. Some important molecules developed by Indian players are already in different stages of clinical trials, some of which have reached the critical Phase II. However, SME players have been lagging in investments towards in-house R&D. To circumvent this fallback, several small players have started setting up separate clinical research units.”

In the case of pharma industry, various regulation standards need to be followed. However, the scenario is different in case of the SMEs involved in the manufacturing of machinery. Therefore, for a pharma SME, the setup cost and time is comparatively higher. regulatory submissions and integrated clinical data management capabilities.” Raj K Menon, Owner, Karishma International, elaborates, “New product launches, although mainly done by large players, help the SMEs acquire contracts for manufacturing and provides opportunities to supply APIs & related chemicals. Moreover, a marketing approval of generic products gives them the opportunity to increase their product portfolio.” The SME players in the CRO industry are using a number of strategies to improve their positions in this industry. Commenting on this, Gupta says, “The players are following the consolidation mantra. They participate in several M&As. Further, the enterprises are involved in services such as pharmacoeconomics and outcome studies.” Explaining the action plan, Gupta adds, “Companies expand geographic coverage, especially to serve large multinational clients. They invest in information technology and focus on spheres like medical specialty – eg, oncology, endocrinology, etc.”

Choosing the right partner Like the share of the profit, as the case may be, the partners should bear the risk factor as well. Thus, the choice of the partner in contract manufacturing depends on extensive prediction. Chaudhury reiterates in a similar tone. She says, “While selecting a partner in the venture, SMEs should have trust in the longevity of the partner for future activities. When one is initiating a partnership, then he/she should at least look at a partnership for a minimum of 3-4 years. The SME should not try to take advantage of its partner. And, there should not be any hurdles in profit or revenue sharing.” Categorising the typical criteria for partner selection, Gupta discusses, “Several aspects need to be considered while selecting the partner. There should be synergy in the business patterns of the companies. Also, companies with longer tenure in the business should have considerable financial muscle power. However, the most essential aspect to be considered is the cultural alignment between the companies.”

Sanjiv Kaul Managing Director, Chrys Capital

Focus on niche competencies only. Rather than having a generalist approach, SMEs should concentrate on select geographies and scale up on these aspects only.

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January 2011

Braving the odds SMEs face tremendous challenge due to inadequate infrastructural support in the country in terms of achieving operational efficiencies or reaching

MARKET TRENDS

their target customers. Menon opines, “Lack of proper infrastructure and funding opportunities are the major constraints. Banks are still hesitant to support these SMEs. However, with the advent of SEZs, this issue has been addressed to a large extent.” One of the biggest challenges for the SMEs is industry regulations along with price controls, taxes & duties imposed. The expanding span of control on drug prices in India remains one of the main concerns for the pharma industry. Gupta explains, “As the price is proposed to be fixed on the basis of manufacturing costs and fixed margins, the sales volume will determine the profits of the players. In this situation, SMEs may be hit due to the smaller economies of scale.” Further, inadequate marketing and distribution networks cause inefficiencies in delivery of products and services. However, partnerships with companies having a robust business plan can carve a niche in the pharma space.

Raj K Menon Owner, Karishma International

New product launches, although mainly done by large players, helps the SMEs acquire contracts for manufacturing and provides opportunities to supply APIs & related chemicals. Long way to go… Discerning the path of success of the SMEs, Kaul cites an instance. He says, “Mankind Pharma is a perfect example of a small organisation that has changed the contours of Indian pharma space in a short span of 10 years. The journey of the company from an SME in 1999 to figuring presently among the top 10 players in the domestic market shows that clarity of vision, along with passion and execution, marks the difference.”

Launches of new molecules by MNCs will accrue contract manufacturing and in-licensing opportunities for Indian players including the SMEs. With these thoughts, Gupta signs off, “SMEs have the opportunity to start leveraging niche opportunities and grow in their respective areas in a systematic manner. The companies focussing on their core businesses while utilising the support system available to them, will succeed in the long term and also have the potential to become MNCs of the future.”

January 2011

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MARKETING

Medical communication

At your finger ‘chip’ Internet and mobile phones are technologies that have revolutionised the way doctors practise medicine today. Not only these enable multitasking but also ease processes, like online appointments from physicians and medical advice through e-mail & SMS. All these developments hold numerous marketing opportunities for the pharma industry.

Dr Rajan T D ooing doctors to write more number of prescriptions is not an easy job, and any pharma manager is aware of this fact. Over the years, several techniques have been used to ensure that the physician prescribes the company’s brands. Traditional systems of drug promotion have been successful to a great extent.

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January 2011

However, with increasing competition and liberalisation of the industry, things are now becoming difficult for managers. Today, an average physician meets almost 50 Medical Representatives (MRs) a month, some of whom make multiple visits under various pretexts. In metropolitan cities, many busy physicians find it extremely difficult to give a patient hearing to MRs and pharma managers, even if they are inclined to do so, due to paucity of time. All these make pharma drug promotion a stupendous task. Drug marketing has moved out of doctors’ cabins and towards outdoor venues like seminars & conferences. Arranging home delivery of drugs directly to patients is another technique adopted to get the patient’s attention and also physician’s support. At major conferences, some sessions are given specific brand names by sponsors. Gradually, even conference halls are christened after specific brands, ensuring that physicians do not miss the name even while they are seated far away from their clinics. Earlier, all these systems relied on the doctor looking at a printed visual medium where the marketing staff explained the data to catch the clinician’s attention. However, the evolution in electronic engineering and information technology has opened innumerable avenues for medical marketing.

‘Chip’ tricks Today, technology has caught up with mankind in all the daily activities. PC has become an essential tool for secondary school students. An Internet connection, preferably a broadband connection, is now required for completing research projects

MARKETING

Electronic opportunities Online/SMS quiz contests ‘Teaser’ promotional SMS for new drugs Movie applications can be used to explain drug action and interactions to physicians Contests can be organised to select a brand name for a new drug SMS to intimate changes in drug packaging, price or availability in colleges. For professionals who are always on the move, a laptop is a ‘life-saving’ gadget. Mobile phones have transformed from being a simple verbal communication device to a multipurpose behemoth. Likewise, a doctor or a sales person without a cell phone is unimaginable today. The mobile phone enables patients to remain connected with their physician in an emergency, while the doctor can stay in touch with his family even from the operation theatre. How much ever one dislikes the invasion of privacy that it brings, one cannot deny the fact that the device is now an indispensable tool for all and sundry.

Digital drug detailing Pharma companies have started using laptops instead of conventional visual aids to promote their drugs. The technology enables the MR to quickly zoom in to the essential sections of his detailing and also display video clips of drug action inside the human cell. Electronic media has been used for conducting seminars. Without making scientists travel from across the seas, speakers who have piloted drug trials can directly interact with the prescribing doctors. Today, lectures are web-cast worldwide by experts from one corner of the globe and listeners get answers to their questions in real-time. The PC and mobile phone can be put to great many usages in the doctor’s clinic as well as at his home or place of relaxation. On an individual level, MRs have been using the mobile phone’s SMS to remind doctors for prescriptions.

Innovations unlimited There are a number of innovative ways in which marketing managers can put the electronic media to better use for boosting their sales targets. Electronic gadgets and their services can be smartly used to ensure that the physician is compelled to recall the desired brand. Companies can achieve this goal by various means using email and the mobile phone. A sneak peek into the possible techniques: A contest to select the brand name for a new drug can involve doctors who are using the new technology. Since the snail mail may not delay the process, instant messaging technology can be used to make physicians part of the decision-making process

January 2011

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MARKETING

‘Teaser’ promotional SMS for new drugs can be sent to physicians to stimulate his interest in a forthcoming launch. Instant feedback can be sought from the doctor to enable the marketing team to develop their eventual promotional strategy Mobile phone movie applications can be used to explain drug action and interactions within seconds, as against elaborate textual data Online/SMS quiz contests can be conducted. This being a nonintrusive exercise, the company can run a series of questions dealing with specific brands, with increasing level of difficulty. Correct answers sent via SMS/email can lead to the next round of questions A leading question can be sent where the doctor has to key-in the specific brand name. This can be an SMS/email game contest. Ensuring that the doctor recalls the brand name once more will help in the overall marketing exercise Using SMS to intimate changes in packaging, price and formulation can be of immense assistance to physicians individually. Prizes for these events can be in the form of useful clinical equipment or a year’s supply of essential disposable items like gloves, syringes or printed stationery.

Medical service on the web Many physicians and hospitals have their own websites, which also provide various online medical services. Pharma companies can place strip advertisements of their brands on websites that cater to medical doctors. Advertisements can also be displayed on selected websites providing medical updates, eg, specialty textbooks, journals, conference proceedings, online medical atlases, directories, etc. Pharma companies launch their research molecules with a lot of fanfare. They have huge expectations from these ‘block-buster’ brands. Websites named after these brands could provide services to physicians with

58 Modern Pharmaceuticals

regard to drugs, diseases, diagnosis, etc. Any advertisement or brand name carried on such sites provides instant brand recall. Currently, search engines like Google, Yahoo! and Wikipedia provide access to medical information and this data has to be sifted through to obtain answers to specific queries. Having a dedicated medical search engine related to drugs & diseases will be a boon to physicians and patients who then will not have to filter out non-medical material. Some pharma companies, in collaboration with specific specialty doctors’ associations, could take up the venture. Immense mileage could be achieved with such websites and their products.

Advertisements of pharma products can be uploaded on websites that are accessed very frequently. Helping hand for the doctor Busy practitioners are often invited as guest speakers by medical societies to address the members. These experts often have paucity of time to prepare the text and slides for their talk. Sometimes, the slide layout, its text size and colour schemes are not visually well standardised. To improve this, some senior doctors who are not well-versed with PowerPoint slide preparation need help from others. Further, pharma companies often have a team of people to prepare their in-house training material, the layout and appearance of which are visually superior. These companies could offer the services of these trained personnel to doctors in preparing material for their speech. The speaker in question could prepare the text material for the speech and the slide-making experts

January 2011

could prepare the slides and make these attractive by adding interesting graphics. The assistance of the company – and its brands – will not be easily forgotten by the gracious doctor. Physicians can also be assisted to put up their own websites and help them in running these. Advertisements of pharma products can be uploaded on websites that are accessed very frequently.

No looking back Change is permanent! There is no looking back at technological advancements. Critics of technology have always discussed the demerits of any marketing practice. There have been arguments about press and television advertisements influencing customer behaviour. Those who oppose gifting to physicians have for long been claiming that such acts interfere with medical ethics. Electronic drug promotion will also have its critics and pitfalls. Yet the astute manager will be compelled to use these gadgets, which today have become a part of the doctor’s life, to enter the hearts and minds of physicians. The foregoing is just an indicator of the immense possibilities that the industry can utilise to astound the physician. Will the early bird catch the worm? Only time can tell. Dr Rajan TD (MD, DVD, DNB) is an alumnus of Mumbai University and a Specialist in Skin & STD in Mumbai since 1991. He regularly writes in various periodicals on several social issues as well as those relating to the pharmaceutical industry. He has been the Associate Editor of ‘My Doctor’. He advises pharmaceutical industries on drug development, promotion and marketing strategies. Dr Rajan is an Honorary Consultant to ONGC, Indian Airlines, Air India and Larsen & Toubro Ltd. He also teaches at CMPH Medical College, Mumbai. Email: rajan.td@gmail.com

CLINICAL RESEARCH

Clinical trial regulations in India

Inundation of population are some of the positives the attention of foreign companies clinical trials in India. But all these sound regulatory environment in p to take advantage of this opport regulations governing trials must be and amended, where necessary.

Dr Shubhangi Desai & Savitha Naik ndia is one of most strate locations global phar companies to condu their drug Research a Development (R&D The country offers th advantages of low trial costs, large Engli speaking population, well-trained medical community, large population of qualified patients as well as a set of regulatory framework with guidelines. In order to conduct a clinical trial in India, permission is primarily needed from regulatory authority of India, ie, Drugs Controller General of India (DCGI), and also from institutes where the trial will be conducted. The DCGI is a body that falls under the Health Ministry and is responsible for regulatory approvals of clinical trials in India. Its functions include approval of trial, importing the drug for trial and sending biologicals overseas for testing. The DCGI follows Schedule Y of Drugs and Cosmetic Act, which was laid down in 1945, and was recently amended in January 2005. The change is promising and is supportive to the industry for clinical trials. Earlier, foreign drug trials could be conducted only in one phase below the

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January 2011

highest phase of testing abroad. Parallel global clinical trials are now being conducted in India as well, ie, permission is granted for concomitant phase II and III trials. As per the rules, the applicant has to submit details such as chemical and pharmaceutical data; generic & chemical name; dosage form; composition; animal pharmacology & toxicity data; animal toxicology and clinical data; as well as phase I, II, III & IV data to the DCGI. The protocol of the clinical trial with a consent form is also submitted. The authority also needs to know about the regulatory status of the drug in other countries, including names of countries where the drug is approved, and international package insert or the place where Investigational New Drug (IND) application is filed. Applicants have to report any Suspected or Unexpected Serious Adverse Reaction (SUSAR) from other

CLINICAL RESEARCH

participating countries, if any. Further, it is necessary to submit an affidavit from the sponsor stating that the study has not been discontinued in any country. In case of discontinuation, reasons for the same must be communicated to the DCGI. The process of approval can take up to 10-12 weeks as compared to an average of 30 days in the US Food and Drug Administration (USFDA) and 60-90 days in Europe. After the initial approval, it is mandatory to send safety reports in real-time and one annual report with all details of the study in India. After the study is complete, a detailed report must be submitted to the DCGI. The DCGI also undertakes inspections to ensure that trials are conducted as per protocol, ethics and the laid guidelines.

Institutional Ethics Committee (IEC)/Institutional Review Board (IRB) The IRB approval process can be

conducted in parallel with the DCGI review. The provisions facilitate the process of having study protocols in place and quickly initiating trials. In order to comply with all applicable regulatory requirements and guidelines, each IRB must have the following records: v Written Standard Operating Procedures (SOP) or charter v Constitution and composition of the IRB v Curriculum vitae of all IRB members v Copies of all trial documents received for review v All correspondence between IRB and investigator v Agenda and minutes of all IRB meetings v Final report of the study After granting the approval for conducting clinical trial(s), it is the responsibility of IRB to have a review of the trial in progress. This includes but is not limited to: v Review of safety reports (all

serious adverse events and adverse drug reactions happening at the trial sites) v Review and approval of amendment(s) in protocol or informed consent document v Review of significant deviations or violations (if any) The frequency of these reviews may vary from one institute to another, as specified in the respective IRB charters or SOPs, but is usually once in 4-8 weeks. The usual time for approval by the Ethics Commitee (EC) is 6-8 weeks.

Bright future... Despite several pitfalls, India is certainly gearing up to attract more and more researchers from around the world to conduct their clinical trial studies here. In this regard, the regulatory system is also being fine-tuned. Laws are being amended to facilitate entry of global clinical trials. Massive and concerted efforts are on to train research

January 2011

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CLINICAL RESEARCH

professionals and increase the base of investigators and supporting staff. These initiatives will certainly improve the current situation. In brief, India is already off the starting blocks and gearing up for an inundation of clinical research trials. This will ensure timely completion of clinical trials and, at the same time, generate high-quality data for international submission.

Recent regulatory reforms initiated by Central Drugs Standard Control Organization (CDSCO) Fast-tracking approval timelines: In September 2009, the CDSCO revised timelines for various regulatory processes. If the application is complete, first response from the DCGI office can now be expected within 30 days for T licence and 45 days for approval of clinical trial applications. Moreover, applicants can check the status of their application since the approval letters sent out by the DCGI office are displayed on the CDSCO website under ‘Daily Dispatch’ section. Single-window clearance for export No Objection Certificate (NOC): Indian regulators have recently introduced a single-window approval process through the DCGI for trial-related biological sample export NOC. Earlier, after obtaining permission from the DCGI for conducting a trial, an applicant had to apply separately to the Directorate General of Foreign Trade (DGFT) for an export NOC. This process has now been simplified and fasttracked, so that an applicant can apply simultaneously for trial permission as well as export NOC to DCGI, without the need for a separate application to DGFT. As per revised timelines, export NOC can now be expected within 10 working days, in contrast to the previous 2-4 weeks timeline for DGFT approval. Stringent pre-approval review process: Fast-tracking of the approval process does not imply that the DCGI has become lenient and will approve any or all applications. On the contrary, for global trials, the US IND number and US IRB approval letters need to be

62 Modern Pharmaceuticals

submitted along with trial application. The ethical and scientific aspects are closely scrutinised by the regulators, including protocol procedures, rationale for sample size, etc. Queries are being raised more frequently by the DCGI office and in the scenario of lack of appropriate justification by the applicant, a trial might even be rejected. Mandatory registration with Clinical Trials Registry-India (CTRI): The National Clinical Trial Registry (www.ctri.in) launched by National Institute of Medical Statistics (NIMS) under the Indian Council of Medical Research (ICMR) has been operative for the last two years (since July 2007). However, until recently, the registration was voluntary, or at the most, advisory. Since June 2009, prospective registration with the CTRI has been made mandatory for all trials to be conducted in India. By making available in public domain all the important trial-related information (eg, inclusion exclusion criteria, protocol summary, site details, name of contact persons, total sample size, etc), CTRI ensures accountability and transparency in conducting trials that are the two essential demands of globalisation. DCGI inspection of trial sites: Another welcome initiative by the DCGI is inspection of trial sites. Recently, the DCGI inspectors had visited an Indian site, which reported death of an infant participating in a vaccine trial by a foreign company and halted the trial, suspecting violation of regulatory norms. The process was expected to be in full swing starting December 2009, with trained teams of inspectors randomly visiting trial sites across India. The DCGI, in collaboration with the USFDA, has recently concluded an initial training session of 25 members to be designated as potential inspectors.

Initiatives for future governance DCGI is planning to initiate a system of registration and accreditations of Contract Research Organisations (CROs), to quality check their activities. A draft guideline on the CRO registration process has already been made and is proposed

January 2011

to be incorporated as new Schedule Y1 to Drugs and Cosmetics Rules, 1945. This draft includes the following: v Registration of clinical trial sites v Registration of EC/IRBs v Opening doors to allow early (Phase I) phase trials for foreign molecules in India v Creating environment for Phase 0 or microdosing studies in India v Ensuring penal provision for fraud and misconducts in clinical research The CDSCO also has a futuristic plan of implementing e-governance programme, which would enable companies to file, track and review trial applications online.

Conducting quality trials The Indian regulatory system has started adapting to the demands of quality, transparency and accountability of global trials. The recent initiatives underscore the fact that our national regulatory authority is in the process of becoming more pro-industry, more vigilant and more efficient, translating to a more USFDA-like regulatory system, which is the need of the hour. Dr Shubhangi Desai, PhD, Associate Director – Clinical Project Management, SIRO Clinpharm, is responsible for overseeing successful execution of SIRO’s clinical trial operations. She is associated with the field of clinical research for over a decade. Her career in clinical research began with Ranbaxy Laboratories, and her last assignment was as Head-Clinical Operations, Wellquest. Email: shubhangi.desai@siroclinpharm.com Savitha Naik, Sr Executive – Regulatory Affairs, SIRO Clinpharm, is responsible for planning, managing, executing and overseeing the submission of applications to the regulatory body – The DCGI and all regulatory activities in clinical operations. She has over seven years of experience serving pharma companies and CROs in India. Email: savitha.naik@siroclinpharm.com

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An innovator in the realm of steam power

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INDUSTRY INSIGHTS

Cancer vaccines market

More to go in R&Dâ&#x20AC;Ś The current global pharma market has a huge void regarding cancer treatment options. With the rising incidence of this disease, a huge patient population awaits a new approach in the management of cancer. There is a need for more therapeutic vaccines to treat the condition. Current competition Currently, the global cancer vaccines market is occupied by cervical and prostate cancer vaccines. The launch of these vaccines has renewed the interest in further development of vaccines for cancer. Although therapeutic vaccines were in the pipeline since long, not even one has been able to overcome the regulatory barrier, except Provenge from Dendreon. Provenge gained Food and Drug Administration (FDA) approval in April 2010. It is indicated for the treatment of metastatic castrationresistant (hormone-refractory) prostate cancer. Manufacturers have faced difficulty proving the efficacy and safety of these vaccines along with demanding manufacturing guidelines. The market is waiting for a paradigm shift in the treatment of cancer through introduction of new therapeutic vaccines that follow a more targeted approach.

Unmet need in global markets he global cervical cancer vaccine market in 2009 was estimated to be worth $ 1.41 billion. This market is expected to grow at a Compounded Annual Growth Rate (CAGR) of 5 per cent to reach $ 2.10 billion in 2017. The three complete dose courses of cervical cancer vaccines cost $ 380-$ 390. The global prostate cancer vaccine market is estimated to be $ 70 million in 2010. And in 2017, it is expected to reach $ 2.3 billion, growing at a CAGR of 66 per cent. The current pipeline for cancer vaccines seems promising, with numerous molecules present in phase II and III stages. From the market perspective, there will be multiple launches of vaccines between 2011 and 201315, which is expected to significantly increase the market size and also drive growth.

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January 2011

The current cancer vaccine market offers limited options for both prophylactic and therapeutic vaccines, creating a huge unmet need. The unmet need is high with regard to treating the existing condition. With the rising incidence of cancer, a huge patient population awaits a new approach in the management of cancer. There is a need for more therapeutic vaccines to treat the condition. Therapeutic cancer vaccines have a huge market potential, as they have the capability to address this unmet need. These have been developed following a targeted approach, and have fewer side-effects compared to other chemotherapy options. These will provide or increase the number of options available for cancer treatment.

Prevention and treatment options Most of the available options in the market

INDUSTRY INSIGHTS

Cervical cancer vaccines market: Global, revenue and market forecasts ($ bn), 2001–2017 2.5

2.0 CAGR (2009-2017): 5% Revenue ($ bn)

today are successful in prevention of a condition, but very few options are there for treatment of the same. The only approved cancer vaccine for treatment is Provenge, indicated for prostate cancer. Prophylactic vaccines are efficacious in offering protection against cervical cancer. However, for the patient population already suffering from the disease, limited options for effective drug treatment is available. There is moderate unmet need, especially for people who develop metastatic disease. In contrast, the market potential is immense for any new entrant having the capability to cater to these unmet needs. The market potential is huge for new therapeutic vaccines for cancers compared to that for prostate diseases. These vaccines, if successful, will be the first of their kind to enter the market and will surpass the sales of prophylactic vaccines. Although prophylactic vaccines are successful in

1.5

1.0

CAGR (2001-2009): 82%

0.5

0.0 2001

2009

2017 Source: GlobalData, GlobalData Sales-based Market Forecasting Model, Primary Research Interviews, KOL Interviews

preventing diseases and can reduce the number of people needing treatment, there is still a commercial opportunity in the area of drug treatment for people who develop the disease.

Therefore, these prophylactic vaccines will continue to be the primary form of market activity until an effective drug treatment option is arrived at. Courtesy: GlobalData

An invite that rewards as well... Dear Reader, ‘Modern Pharmaceuticals’ solicits original, well-written, application-oriented, unpublished articles that reflect your valuable experience and expertise in the pharmaceutical industry. You can send us Technical Articles, Case Studies and Product Write-ups. The length of the article should not exceed 3000 words, while that of a product write-up should not exceed 200 words. The articles should preferably reach us in soft copy (either E-mail or a CD). The text should be in MS Word format and images in 300 DPI resolution & JPG format. The final decision regarding the selection and publication of the articles shall rest solely with ‘Modern Pharmaceuticals’. Authors whose articles are published will receive a complimentary copy of that particular issue and an honorarium cheque. Published by Infomedia 18 Limited, ‘Modern Pharmaceuticals’ is the leading monthly magazine exclusively meant for producers and user fraternities of the pharmaceutical industry. Well supported by a national readership of over 80, 000 and our strong network of 26 branch offices across India, this magazine reaches out to key decision makers among the Indian manufacturers of pharma products, machinery and allied sectors. Brought out in association with Hong Kong-based Ringier Trade Media Ltd (one of the world’s largest trade publishing houses with more than 200 special interest titles and offices in every major country), it ensures that advertisers are able to promote their products and services across the globe at no extra cost. So get going and rush your articles, write-ups, etc… Thanking you, Yours sincerely,

January 2011

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TECHNOFOCUS

Parenteral delivery

Under control For a better effect, drugs are usually introduced into the body by parenteral route ie, through skin. This route of administration has undergone considerable developments to create new methods for analysing the performance of Controlled Release (CR) drugs. Here is a view of the utility of various controlled parenteral delivery systems. Jo Smewing evelopments in the field of transdermal drug delivery methods are paving the way for the future of systematic drug administration. The skin is the largest and most accessible organ in a human body; hence, pharma manufacturers are keen to take advantage of it as a drug delivery platform. The transdermal route helps reduce the risks and costs of intravenous therapy that can also be traumatic & intrusive. Transdermal CR systems usually combine a therapeutic component with an adhesive formulation that ensures a continuous delivery of the active ingredient through unbroken skin at a constant absorption rate. Skin adhesion and drug compatibility determine the efficacy of transdermal applications. Adhesive properties are critical because the amount of medication delivered is directly proportional to the skin contact area. Transdermal systems should cause minimum skin disruption and must be easy to handle & equally effective for the infinite variations that occur in human skin. In vitro tests are commonly used to determine and compare tack, peel adhesion and shear characteristics of transdermal samples. Automated texture analysis, facilitated through the use of a TA.XTplus texture analyser, for instance, allows carrying out such a testing in objectively controlled conditions that closely simulate real applications.

d Figure 1: Texture profile analysis

Figure 2: Back extrusion

Texture profile analysis Figure 3: Peltier plate

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Creams, lotions and topical gels are typical examples of dermal delivery drugs.

January 2011

Their retention on the affected area is challenged by various shearing forces such as breathing, swallowing and flexing of the skin. Their performance depends on viscosity, spreadability, bioadhesion and good drug release and absorption. Texture Profile Analysis (TPA) allows manufacturers to assess and fine-tune the mechanical characteristics of these products, optimising their acceptability & efficacy. TPA is a rapid and simple technique for measuring the hardness, adhesiveness and compressibility of semi-solid or selfsupporting substances (Figure 1). A large cylindrical probe compresses a sample, held in a container whose circumference slightly exceeds the circumference of the probe. Equally effective is a back extrusion test (Figure 2), where a disc is immersed in a viscous sample to measure the resistance to flow upon immersion and then resistance to withdrawal.

Sticky situation: Transdermal patch adhesion Adhesive patches are widely used in highly targeted and custom-designed applications. A simple test to measure the adhesive properties of a transdermal patch involves a domical or spherical probe descending onto a sample, which has been attached to the platform with a double-sided adhesive tape. After allowing adhesive bonds to be created for a defined time, the probe is withdrawn. The strength of adhesion, indicated by the force required to detach the probe from the sample, is recorded by the texture analyser. Certain elements must be controlled to ensure maximum repeatability and consistency of results. These include the probeâ&#x20AC;&#x2122;s travelling

TECHNOFOCUS

speed, the amount as well as duration of applied force and withdrawal distance & speed. Ideally, a Peltier Plate (Figure 3) should be used as a controlled testing platform to prevent temperature fluctuations from affecting the results. The data obtained from adhesion tests are then transformed into a graph that helps analyse the results and optimise the characteristics responsible for the product’s performance (Graph 1). Moisture-activated polymers: The efficacy of topical films is dependent on correct application to the skin and retention of the product on the body for a sustained period. Incorrect application can result in inconsistent results from the same medication; thus, new moisture-activated patch applications have been developed to overcome these issues. In contrast to topical creams, the fixed dimensions of transdermal patches ensure better coverage of the affected area and control the release of active ingredients as well as their retention. In a simple test to measure bioadhesion of topical films, an adhesive sample is attached to a cylinder probe, which is then lowered onto a neonate porcine skin sample (which closely resembles the human epidermis). The texture analyser then measures the force required to remove the probe from the skin surface. For improving the test conditions to cater better to the requirements of hydrogel films, a flexible substrate clamp can be used to secure both the sample and the skin in place. The device consists of a

Graph 1: Results of adhesive tests

multi-slot plate and a clamp fixture and works in conjunction with an adhesive indexing system (Figure 4). The skin sample is held under the plate and the upper fixture lowers the sample down into each slot. The texture analyser then records the force required to withdraw after adhesive bonds are formed. Peel profiles: In order to assess the peel strength of a typical bi-laminar patch formulation, a cyanoacrylate adhesive is used to attach wetted neonate porcine skin to the sliding platform of a 90 Degree Peel Rig (Figure 5). A sample of the patch is secured vertically, held at the top with a clamp and, at the bottom, attached to the skin. As the clamp moves upwards, the sliding section of the rig moves horizontally, forming a 90° angle between the interface of the skin sample and the adhesive patch. A texture analyser records the force required to peel the patch off the skin sample. A 180° peel test (Figure 6) improves accuracy by maintaining a constant force before the clamp withdraws up with an automatic roller.

records the force needed to separate the surfaces, thereby measuring the mucoadhesion strength. The Gel Mucoadhesion probe was recently developed to enable successful attachment of a hydrogel sample to the underside of a probe, in order to perform a mucoadhesion test. The new probe incorporates an inverted cone shape, with machined concentric

Figure 4: Adhesive indexing system with flexible substrate clamp

Mucosal delivery Mucosal delivery requires a drug delivery system to be attached to a target area of mucous membrane, such as a part of the gut, for a predefined duration. Its success depends on the strength of the product’s mucoadhesive bonds, which can be measured using the TA.XTplus. Simple adhesive tests, similar to the ones described earlier, provide details of the mucoadhesive properties of films, powders, gastrospheres or polymers. But a more recent development, the Mucoadhesion Rig, closely replicates in vivo conditions with a porcine membrane sample positioned in a fixed volume of temperature-regulated gastric fluid. A cylinder probe, with a sample attached to it, descends into the vessel until the sample is in contact with the tissue (Figure 7). The texture analyser controls the force and time of contact between the two surfaces and

January 2011

Figure 5: 90 degree peel rig

Figure 6: 180 degree peel rig

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TECHNOFOCUS

grooves on its surface (Figure 8). These enable consistent volumes of hydrogel substances to set upon and remain attached to the probe surface for the duration of the adhesion test. Just right: Polymer syringeability Mucoadhesive polymers allow formulations to be attached to mucosal surfaces and deliver active ingredients to required sites, offering advantages such as good retention & easy application. Syringeability & viscosity are the governing characteristics of such formulations and can be assessed in a compression test, where a texture analyser expels equal amounts of samples from identical plastic syringes. The samples’ syringeability is calculated from the resistance to the expression force (Graph 2).

polymers are increasingly becoming prominent in mucosal & other delivery systems. An accurate definition of gel properties is pivotal for manufacturers of products as diverse as wound dressings, jelly lubricants and contact lenses. Aqueous gel is tested for its resistance to stress by using a cylindrical probe that is lowered onto the sample at a fixed speed and distance until the gel surface is fractured. The peak force required to fracture the sample indicates gel rupture strength. In case of self-supporting gels, manufacturers may wish to look into the product’s elastic moduli. Elastic moduli give an indication of a substance’s tendency to be deformed

Parenteral delivery In recent years, implants and injectable polymers have revolutionised parenteral delivery, but the ratio of inactive to active ingredients must be optimised to ensure both a therapeutic effect & ease of use. Gels: Gel substances and hydrogel Graph 2: Results of syringe tests

Figure 7: Mucoadhesion rig

elastically when a force is applied to it. This is done by lowering a cylindrical probe onto a gel sample, which is placed on a sandpaper to prevent slipping (Figure 9). This test allows manufacturers to evaluate gel strength, elasticity and gel rupture force. Injectable biopolymers and cements: Similar to the above mentioned mucoadhesive polymer syringeability test, the syringe test rig (Figure 10) measures the injectability of CR gels and polymers. The test determines the pressure force required to move 8 cm of cement through a 3mm diameter polyethylene catheter. The adhesive indexing system can also be used to measure the setting times of varying cement formulations.

Ocular delivery Figure 8: Mucoadhesion probe

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As with dermal tissues and oral cavities, the treatment of optic diseases also

January 2011

Figure 9: Testing gel elastic moduli

benefits from direct administration onto the affected area. Ocular drug delivery is significantly hindered by poor bioavailability of drugs, as the eye is protected by complex defence mechanisms. Contact lenses improve bioavailability by facilitating prolonged contact with the eye. A rigid lens’s mechanical strength can be measured by clamping a cross-section of a dumbbellshaped sample and measuring the maximum force required to stretch it to breaking point. The test gives an indication of the material’s suitability for pharma applications. However, soft contact lenses differ, as they have a high hydrogel content, which, in turn, has a very low modulus of elasticity. Their properties are therefore better tested in a way similar to the above mentioned gel elasticity and rupture force tests.

Pulmonary delivery An addition to the variety of controlled dosage forms, inhalation drug delivery via Metered-Dose Inhalers (MDIs) allows the administration of medication straight into the patient’s lungs. This route avoids delay in digestion and delivering medication to the affected area with speed & precision. As inhaler users may suffer from weakness when the drug dose is needed, it is important to monitor the ergonomic functionality of inhalers.

TECHNOFOCUS

Figure 10: Syringe test rig

Figure 11: Inhaler support rig

The efficacy of MDIs is determined by the performance of the metering valve, which releases the drug from container to the area of administration. For this, the Inhaler Support Rig (Figure 11) vertically secures an inhaler, while a hemispherical probe closely

imitates the finger action that releases the drug. The texture analyser measures the force required to press the inhaler and expel the medication.

Success of drug delivery modes In order to release active ingredients

gradually & predictably, CR drugs must adhere reliably to the target organ and withstand wear & tear without compromising their functionality. Testing in conditions that closely resemble reality enables manufacturers to optimise performance of their products. Stable Micro Systems offers a comprehensive portfolio of quality control systems to evaluate precisely the physical properties of diverse drug forms. Accurate quality control tests allow pharma manufacturers to develop formulations that combine optimal therapeutic efficacy with vital user-friendliness â&#x20AC;&#x201C; less frequent administration, improved convenience and greater patient compliance. And ultimately, these two qualities are the prerequisites for the long-term success of these methods. Jo Smewing is an Applications Manager at Stable Micro Systems Ltd. For further details, contact Kat Kalinina / ZoĂŤ Wilkins: kat@bdb.co.uk/ zoe@bdb.co.uk

January 2011

Modern Pharmaceuticals

EVENTS CALENDAR

National MUMBAI CHENNAI

PUNE

AHMEDABAD

Tamil Nadu Mar 11-13, 2011

Maharashtra Oct 14-17, 2011

Gujarat Nov 2011

Chennai Trade Centre

Auto Cluster Exhibition Centre

Gujarat University Exhibition Hall

India’s premier industrial trade fair on products and technologies related to Machine Tools, Hydraulics & Pneumactics, Process Machinery & Equipment, Automation Instrumentation, Packaging & Auxiliaries, IT Products, Electrical & Electronics, Material Handling and Safety Equipment.

For details Infomedia 18 Ltd Ruby House, 1st Floor, J K Sawant Marg, Dadar (W), Mumbai 400 028. • Tel: 022 3003 4651 • Fax: 022 3003 4499 • Email: engexpo@infomedia18.in

Concurrent Shows

Maharashtra September, 2011 Bombay Exhibition Centre

One of the largest advanced design and manufacturing events in India featuring Machine Tools, Material Handling and Safety Equipment, Automation & Instrumentation, Hydraulics & Pneumactics, Process Machinery & Equipment, Packaging & Auxiliaries, IT Products, Electrical & Electronics.

For details HiTech Manufacturing

Plastivision India 2011

3rd IPA Convention

An exhibition organised by AIPMA, Plastivision India 2011 is the 8th in series, and this event will highlight the key developments & growth of the plastics industry; January 20-24, 2011; NSE Complex, Mumbai

The 3rd Indian Pharmaceutical Association (IPA) Convention is a platform for manufacturers of laboratory equipment, machinery, pharmaceuticals along with personnel engaged in pharma software, books and career counselling to showcase their products and services. There will also be a satellite workshop and exclusive session on community pharmacy apart from addresses from eminent speakers; February 19-20, 2011; Indore

For details contact: AIPMA Tel: +91 22 6777 8899 Fax:+91 22 2825 2295 Email: marketing@plastivision.org Website: www.plastivision.org

PHARMAC INDIA 2011 This exhibition provides a unique platform and resources to the organisations in the pharma industry with a futuristic understanding of the Indian pharmaceutical industry and market potential for their products across the world; February 12-14, 2011; Ahmedabad Education Society Ground, Ahmedabad For details contact: Orbitz Exhibitions Pvt Ltd Tel: +91 22 2410 2801 Fax: +91 22 2410 2805 Email: amd.exb1@orbitzexhibitions.com Website: www.pharmacindia.com

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For details contact: Pharmexcil Tel: + 91 40 2373 5462 Fax: + 91 40 2373 5464 Email: info@pharmaexcil.com Website: www.ipapharma.org

25th Pharma Bio World Expo This is one of the foremost shows for the pharma and the biotech industry. One of the largest exhibition and conference for the chemical and the pharma industry, where industry professionals, decision-makers and senior managers from related industries will be displaying their varied products; February 23-26, 2011; Bombay Exhibition Centre, Mumbai

January 2011

Ruby House, 1st Floor, J K Sawant Marg, Dadar (W), Mumbai 400 028. • Tel: 022 3003 4650 • Fax: 022 3003 4499 • Email: hitech@infomedia18.in

For details contact: Chemtech Foundation Tel: + 91 22 2287 4758 Fax: + 91 22 2287 0502 Email: conferences@jasubhai.com Website: www.chemtech-online.com

CPhI India 2011 This will feature key decision makers in the pharmaceutical industry from 92 countries, including India, China, US, UK, France, Italy, etc. Major suppliers of pharmaceutical ingredients, outsourcing, equipment and bio-solutions are also expected to exhibit. The CPhI conference will include updates on latest innovations, technologies, trends and developments in the pharmaceutical industry in India; November 30 to December 2, 2011; Bombay Exhibition Centre, Mumbai For details contact: UBM India Pvt Ltd Tel: + 91 22 6612 2600 Fax: + 91 22 6612 2626-27 Email: info.india@ubm.com Website: www.ubmindia.in

EVENTS CALENDAR

International 3rd International Conference on Drug Discovery and Therapy The event provides a platform for all pharmaceutical scientists, interns and primary care physicians to discuss and learn about all important international breakthrough developments on drug discovery and new therapeutics. It focusses on the interdisciplinary fields of drug discovery, drug therapy and translational medicine; February, 7-10, 2011; Dubai For details contact: Eureka Science Ltd Tel: + 971 6 557 5783 Fax: + 971 6 557 5784 Email: info@icddt.com Website: www.icddt.com

ARABLAB 2011 ARABLAB is the global buying source for tomorrowâ&#x20AC;&#x2122;s technology makers & endusers, as well as a unique research source. Connecting people from over 75 countries, this expo will showcase the latest lab and instrumentation equipment from the worldâ&#x20AC;&#x2122;s leading manufacturers; March 7-10, 2011; Dubai International Convention & Exhibition Centre, UAE For details contact: The ARABLAB Group Tel: + 971 4 397 5418 Fax: + 971 4 397 5419 Email: info@arablab.com Website: www.arablab.com

BIOTECH WORLD 2011 The exhibition will show processes & devices for biotechnological productions and laboratory researches, biological preparations for pharmaceutical, food, agricultural sector and also biological agents, bioactive additives, test-systems, alternative energy sources, nano-molecular energy converters, laboratory safety, etc; March 21 - 24, 2011; The House of Moscow Government, Russia

manufacturers and suppliers of process plant & equipment. This exhibition will provide a platform for service providers to showcase their products and services to decision makers from leading pharmaceutical manufacturers; May 10-12, 2011; Charlotte Convention Centre, Charlotte, USA

For details contact: JSC Expo-Biochim-Technologies Tel: +7 495 933 9051 Fax: +7 495 933 9054 Email: atv@biomos.ru Website: www.mosbiotechworld.ru/eng

DUPHAT 2011 Dubai International Pharmaceuticals and Technologies Conference and Exhibition (DUPHAT) is an annual pharma event. It serves as a convergence point for pharmacists, scientists, researchers, manufacturers, distributors; March 22-24, 2011; Dubai International Exhibition Centre, UAE

For details contact: Arosa Exhibitions Limited Tel: + 1 980 219 8449 Email: gviniconis@arosa-group.com Website: www.charlotteconventionctr.com

CPhI China 2011 CPhl China is a platform where pharmaceutical manufacturers, biopharmaceutical companies, biotechnology companies & API manufacturers will display a variety of products & services. The event will enable business partnerships, launch new products and showcase innovations; June 21-23, 2011; Shanghai New International Expo Centre (SNIEC), Shanghai, China

For details contact: Index (Conferences and Exhibitions Organisation Est) Tel: +971 4 362 4717 Fax: +971 4 362 4718 Email: index@emirates.net.ae Website: www.duphat.ae

International China Pharmaceutical R&D Summit The 6th International China Research and Development (R&D) Summit 2011 will bring together over 80 speakers from international and domestic pharma & biotech companies to share expert opinions & experiences on transformation and innovation in clinical challenges, regulatory updates, NCE discovery efforts, pre-clinical partnerships, biosimilars development, etc; April 11-13, 2011; Grand Hyatt Hotel, Shanghai, China For details contact: IBC Life Sciences and BayHelix Group Tel: +65 6508 2401 Fax: +65 6508 2407 Email: register@ibcasia.com.sg Website: www.ibclifeSciences.com/china

International Pharmaceutical Exhibition The International Pharmaceutical Exhibition will bring together

For details contact: Cphl China 2011 UBM International Media Tel: +31 0 204 099 593 Email: haohao.chen@ubm.com Website: www.cphi-china.com

Bio-Europe Spring 2010 Bio Europe Spring 2011 is a forum to promote business development between pharmaceutical, financial and biotechnology companies in Italy; November 14-16, 2011; Milano Convention Centre, Milano, Italy For details contact: BIO (Biotechnology Industry Organization) Tel: +1 202 962 9200; Fax: +1 202 488 6301 Email: cbeckman@bio.org Website: www.bio.org/events

The information published in this section is as per the details furnished by the respective organiser. In any case, it does not represent the views of Modern Pharmaceuticals

January 2011

Modern Pharmaceuticals

TECHNOLOGY TRANSFER

Technology Offered this section provides a means to promote and facilitate exchange of select technologies. We strive to bring together suppliers of such technologies with suitable users for negotiations and industrial collaboration. Anti-ulceritic APIs An Indian company offers anti ulcer drugs like omeprazole, pantaprazole, omeprazole sodium, omeprazole magnesium and esomeprazole magnesium for operations in manufacturing processes. Areas of application Formulation industries Forms of transfer Consultancy

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

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

Forms of transfer Consultancy

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

Herbal formulation for psoriasis and eczema An Indian company offers an innovative herbal formulation that has the ability to control & cure psoriasis and eczema within one month of application of the formulation. Areas of application Herbal medicine Forms of transfer Joint venture, technical services, technology licensing

Intravenous fluids An Indian company offers the technology for the production of intravenous fluids (IV). The company has a large volume IV plant and can offer complete support for setting up a new IV plant. Investment required for the fully automatic plant is around ` 15 crore. The company can offer consultancy services/technical support to set up an IV plant on loan and license basis initially. Later, the collaborating party

can set up its own factory when it is ready for investments. Areas of application Pharmaceutical industry Forms of transfer Joint venture, technical services

Purified microfine red sanders wood powder An Indian company offers red sanders wood, which is a precious crude drug in the ayurvedic system of treatment. Pulverising by conventional technologies generates very high temperature, which in turn leads to high ash in the sanders wood powder. Red sanders powder so produced will be rich in drug and colour values. The powder will be microfine and free from ash and other impurities. Red sanders wood powder is used to apply on the face and skin to remove chicken pox marks, marks from burns, skin discolourations and pimples. It is also used to add in several drugs, processed foods, cosmetics and toiletries. The powder can be exported in large quantities as a value added item. The technology for microfine pulverising of red sanders wood was developed with the support of DSIR, under the Ministry of Science and Technology. Areas of application Ayurvedic pharmaceutical, food and cosmetics industries Forms of transfer Turnkey, others

Share Your Technology Propositions The mission of Modern Pharmaceuticals is to spread the technology culture. We offer you an opportunity to participate in this endeavour by publishing the best technology ideas. Technology developers/sellers are invited to furnish the techno-commercial details (with environmental benefits, if any) for publication in the Technology Transfer column of Modern Pharmaceuticals. R&D organisations, technical consultancy organisations and individuals assisting small and medium enterprises may send the relevant literature, indicating the scope & services and the areas of specification. Contact: Modern Pharmaceuticals Infomedia 18 Ltd, â&#x20AC;&#x2DC;Aâ&#x20AC;&#x2122; Wing, Ruby House, J K Sawant Marg, Dadar (W), Mumbai 400 028. Tel: 022-3003 4669/4671 Fax: 022-3003 4499 Email: spedit@infomedia18.in

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TECHNOLOGY TRANSFER

Technology Requested Biotechnology for wastewater treatment system A Thailand-based company, a wastewater service provider, is involved in the research and development of new technology for water, wastewater and waste treatment. It requires new ideas related to technology for developing its strength in the field of wastewater; which includes cleaning canals, removing sediments from waterways, biogas, microbiology detector and treated system quality. Areas of application Biotechnology, engineering, new technology Forms of transfer Consultancy

Areas of application Cell culturing - molecular biology Forms of transfer Material supply

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

Glove automation equipment Calcium gluconate An Indian company requires the technology to manufacture calcium gluconate. Areas of application Pharmaceutical industry Forms of transfer Technical services, project reports, others

An Indian company requires technology to produce glove by automation process. Areas of application Manufacturing industries, especially rubber industry and latex industry Forms of transfer Consultancy

Cell lines

Kite grading engineering technology

Thailand-based, ANH Scientific Marketing Co Ltd has been working in the field of life sciences in the country for more than 20 years. In order to complete the companyâ&#x20AC;&#x2122;s product lines and service customers/researchers/ scientists from the beginning to the end of the process, it would like a company to provide commercial cell lines of human and animals.

A Fiji-based company offers the technology of kite grading, which is a subservient of genetic therapy research particularly for the cardiovascular novice. It seeks assistance from a potential partner to provide equipment and technical support staff. Areas of application Medical research Forms of transfer Joint venture, partnership

Medical products An Indian company wants to manufacture intravenous fluids, saline, dextrose and related products used in the medical field. The company is involved in non-medical activities at present. The only medical involvement is its general practice in the UK. It plans to commence a nursing home project in Sri Lanka and would be interested in a joint venture with a suitable partner for its saline project. The project has been approved for tax concessions and its partner is expected to contribute in machinery production and know-how. Areas of application Medical and surgical Forms of transfer Others

Methyl cobalmine An Indian company requires technology for production of methyl cobalamine, which is an important basic drug. Areas of application To be used in pharmaceutical industries Forms of transfer Others

Pharma grade mannitol An Indian company requires the know-how for manufacturing pharma grade mannitol. The estimated production capacity is 600 tonne per annum Areas of application Pharmaceuticals Forms of transfer Others

Information courtesy: Dr Krishnan S Raghavan, In-Charge, Technology Transfer Services Group, United Nations - Asian and Pacific Centre for Transfer of Technology (APCTT), APCTT Building , C-2, Qutab Institutional Area, New Delhi 110 016 Tel: 011 - 2696 6509, Fax: 011 - 2685 6274, Email: krishnan@apctt.org, Website: www.apctt.org

For more information on technology offers and requests, please log on to www.technology4sme.net and register with your contact details. This is a free of cost platform provided by APCTT for facilitating interaction between buyers and seekers of technologies across the globe. After submitting technology offer or request to this website, you are requested to wait for at least two weeks for receiving a response from a prospective buyer / seeker through this website, before contacting APCTT for further assistance.

January 2011

Modern Pharmaceuticals

PRODUCT UPDATE

Digital colour mark sensor Lubi Electronics offers ‘Sunx’ LX-100 series digital colour mark sensor. It can detect any marking because the sensor is equipped with red, green and blue LED light emitting element. Furthermore, to expand the functionality the sensor comes with dual mode, ie, mark mode (ultra highspeed response) and colour mode (high-precision mark colour discrimination) to suit any application. This sensor comes with Mode Navi technology for enhancing features and is easy to use. It is provided with 4-digit digital display, 12-bit A/D converter, D-code, key lock, timer, NPN or PNP outputs, IP67 protection, etc. It is used in many applications/industries, especially in packaging, food, pharmaceuticals, textile, plastic and many more. Lubi Electronics - Ahmedabad - Gujarat Tel: 079-2220 5471, Fax: 079-2220 0660 Email: info@lubielectronics.com

PTFE lined valves Supremo line & Control manufactures fluoropolymer FEP, PFA, PTFE, lined SGI/WCB/SS/MS pipes, valves and fittings using Dupont’s technical know-how and raw materials for appropriate application of the resin for successful results with international quality for chemical industry. Salient features of these products include: low coefficient of friction, chemical inertness, non-toxicity approved by international food & drugs regulatory authorities, non-inflammable, self-sealant, excellent weather resistance, zero water absorption. Supremo Line & Control - Ahmedabad - Gujarat Tel: 079-2220 5282, Fax: 079-2220 5181 Email: supremoproduct@gmail.com

Digital wireless synchronised clock systems Ace Instruments offers Digital clocks, available in standalone and synchronisation versions. These synchronised clocks can have up to 120 number of slaves to one master and can be connected to the master clock via a 2 core communication cable on RS 485 Modbus multidrop network. All the clocks show the same time right up to the seconds. A built-in battery helps maintain accurate time even in the case of power cut. The master clock is a 2” high super bright seven-segment display panel with six displays, two each for hours, minutes and seconds. Optional GPS synchronisation for the master clock is also available wherein the master clock displays the global positioning system time, which is accurate to +/- 1 second. The slave clocks have a 4” high super

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bright seven-segment red LED display. The slave clocks can be at a maximum distance of up to 1,200 m (1.2 km) and yet show accurate synchronised time, same as the master clock. The clocks communicate over Modbus RS 485 communication network. Ace Instruments - Hyderabad - Andhra Pradesh Tel: 040-2307 8848, 3290 1226, Fax: 040-2307 8848 Email: sales@aceinstrumentshyd.com

PTFE rigid pipes and liners Hindustan Nylons manufactures PTFE rigid pipes and liners of diameter 25-100 mm and length 3.3 m, by using ram extrusion technology. These are used for making dipped pipes, lined pipes & replacement to glass/glass-lined pipes, in chemical process industries. These pipes are utilised for corrosion-resistant application in chemical, pharmaceutical, petroleum, petrochemical, atomic/nuclear and related industries. These are tested for spark test/dielectric strength test and certified for working/peak working pressures. Hindustan Nylons - Miraj - Maharshtra Tel: 0233-2644468, Fax: 0233-2644772, Mob: 09373054560 Email: contact@hindustan-nylons.com

Pass box interlock system Eltech Services offers Door interlock system. This is a microprocessor based controller with power supply of 220 VAC 50+/- 10 per cent. The system has an enclosure of MS power coat, is wall mounted and can be connected through D-sub connectors. This has digital input from reed switches and key switches and output is from digital to door locks and LED. It requires environmental condition of 0-50ºC. This system finds applications in pharmaceutical industries, food processing companies and clean room applications. Eltech Services Pvt Ltd - Secunderabad - Andhra Pradesh Tel: 040-2750 2803, Fax: 040-2750 4776 Email: sales@eltechservices.com

Push rivets Novoflex Marketing offers push rivets. These are designed to hold together two or more panels securely, attractively and economically. These are suitable for fastening most materials including metal, wood, hardboard, rubber, glass, plastic, etc. Due to special design wings they have excellent mechanical properties. The push rivets can withstand temperatures ranging from -25ºC to +85ºC and are available in standard black colour and in two different sizes. Novoflex Marketing Pvt Ltd - Kolkata - West Bengal Mob: 099031 63634, Fax: 033-2229 7814 Email: sales@novoflex.co.in

PRODUCT UPDATE

Analyser TTL Technologies offers â&#x20AC;&#x2DC;DIPA 2000â&#x20AC;&#x2122; particle size and shape analyser from Donner Technologies. It combines two complementary measurement techniques by integrating laser and video channels. It provides complete sample information on particle size distribution and numerous particle shape parameters with the help of high analytical resolution (analysing each sampled particle individually) and real-time sample visualisation. The analyser has a wide measurement range of 0.1-5,000 micron. It comes bundled with the software for comprehensive data analysis and report generation. The instruments can be fitted with a variety of modular measurement cells, which can be manually interchanged to allow for particle analysis in liquids, emulsions, creams, dry powders, fibres, heated liquids, aerosols and more, with minimal (or no) sample intervention and original state analysis. Analytical data can be displayed in a wide variety of tables and graphs. TTL Technologies Pvt Ltd - Bengaluru - Karnataka Tel: 080-2525 1859, Fax: 080-2529 1285 Email: analyticaldirect@ttlindia.com

January 2011

Modern Pharmaceuticals

PRODUCT UPDATE

Digital temperature & humidity data loggers BSK Technologies offers Temperature and humidity measuring meters of different types. Portable temperature/ humidity meters have the feature of data recording facility. The recording can be configured from 1 sec to 24 hours based on the needs. Humidity recording and transferring the data to PC is an added advantage of these types of meters. Hygrometers of economically priced models are useful for pharma companies, green houses, corporate offices, posh bungalows, etc. It has 2â&#x20AC;? & 4â&#x20AC;? big display temperature & humidity indicators for longer distance visibility for all pharma, process industries, textiles & polymer industries. The company has temperature/humidity transmitters of various models, on-line temperature infrared (IR) transmitters. With IR thermometer with data logging facility, the data stored can be transferred to a PC. Multi-channel thermometer with and without data logging facility are also available. The company offers Ph, tds, cond, ORP indicators, controllers at reasonable prices. Other products offered are indicators, controllers, transmitters, batcher, transmitters and digital battery-operated flow rate indicator cum totalisers, dosing pumps, process pump and safety valves. B S K Technologies - Secunderabad - Andhra Pradesh Tel: 040-3912 4339, Fax: 040-3912 6177 Email: info@bsktechnologies.com

Machinery for tablet/granulation Ratnakar Pharma Machinery offers Single and double rotary press and Mega Mark-II and IV. Available from 16-81 station press it suits large and small size batch and various shapes of the tablets. Also, there is a mini tab press for R&D model, fully automated and PLC-operated, semi-automated and manually operated tablet press. These ranges with the following details: single rotary tab pressâ&#x20AC;&#x201C; 16 to 23 station with output of 40,320-57,860 tablet/hr, available in D and B/D tooling; double rotary tab press- 25 to 45 station with output of 136,080-226,800 tablet/hr, available in B and BB/B tooling; Mega Mark-II available in 37 to 61 station with output of 222,000-366,000 tablet /hr; and Mega Mark-IV, available in 37 to 81 station with output of 325,000-583,200 tablet/hr. Ratnakar Pharma Machinery - Ahmedabad - Gujarat Tel: 079-2289 2614/094270 31284Email: ratnapd@yahoo.co.in, Website: www.ratnakarpharmamachinery.com

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PRODUCT UPDATE

Photoelectric sensors Omron Automation offers a wide range of Photoelectric sensors. These will solve all the sensing application needs such as diffusive reflective, throughbeam, retro-reflective and more. These come in a variety of shapes and sizes. The new E3FN series is extending the photoelectric sensors range to include cost-conscious clientele. It offers exceptional value without compromising on quality. These are M18 size cylindrical shape and pre-wired. The present product line-up includes diffuse reflective models (sensing distance up to 200 mm) and retro-reflective model (sensing distance 2 m). Available in both NPN and PNP, it has power source circuit reverse polarity protection, output reverse polarity protection and short-circuit protection. These meet IEC60529, IP67 degree of protection and EN60947-5-2 EMC and CE compliance. It is an ideal choice for machine makers and end users who are seeking value for money in this tough time. Omron Automation Pvt Ltd - Bengaluru - Karnataka Tel: 080-4072 6400, Fax: 080-4146 6403, Mob: 09980943045 Email: in_enquiry@ap.omron.com, Website: www.omron-ap.co.in

Bar code reader Banner Engineering India offers iVu Bar code reader (BCR), which reads 11 industry-standard bar codes to facilitate advanced traceability in packaging, material handling, automotive, pharmaceuticals and many industrial applications. The BCR with an integrated or remote touchscreen and intuitive interface allows users to configure, monitor, modify and inspect without a PC or external controller. It has following features: first-time users can also learn to use it without training; compact; rugged IP67rated housing available with or without an integrated ring light; and RS-232 serial communication port is provided for exporting bar code data. The sensor is available with a remote touchscreen for setup and inspection monitoring. The BCR is available with three different trigger modes to determine how the sensor captures and processes images. Banner Engineering India Pvt Ltd - Pune - Maharashtra Tel: 020-6640 5624, Fax: 020-6640 5623 Mob: 9322339208 Email: salesindia@bannerengineering.com

January 2011

Modern Pharmaceuticals

PRODUCT UPDATE

Vacuum pump inlet/exhaust trap Avni Enterprises offers compact vacuum pump inlet or exhaust trap manufactured by MV Products of North Billerica, Massachusetts. This vacuum pump inlet protects liquid ring-, oil sealed- and dry vacuum pumps from volatiles, organic solvents and acids in distillation, drying, degassing and similar processes. It combines several trapping methods into a single compact unit to condense, absorb and neutralise process byproducts from applications that generate volatiles, organic solvents and acids. It features three or four stages of effluent trapping, the first stage is a 200 sq inch baffle shield, which is surrounded by 3/8” ID cooling coils for condensing volatile solvents and chemicals on this large cooled surface. The third and fourth filtration stages are customised with activated alumina or charcoal, Sodasorb® and other types of filter elements to remove residual solvent vapour acids and particulates. Constructed from stainless steel, these inlet traps are equipped with an optional bottom cooling section with a ¼” NPT drain plug. Avni Enterprises - Mumbai - Maharashtra Tel: 022-3296 8812, 3260 9641, Fax: 022-2405 6329 Email: avnient@vsnl.com

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PRODUCT UPDATE

Ultrasonic processors Cole-Parmer India offers high-intensity ultrasonic processors. These ultrasonic processors can safely process a variety of organic and inorganic materials in a range of volumes. Typical applications include sample preparation, cell lysing, disaggregation, homogenisation, particle size reduction, soil testing and acceleration of chemical reactions. These are capable of delivering 500 or 750 watts at 20 kHz. The 500-watt models are recommended for smaller volumes, and for probes of 1/2-inch or less.The 750-watt models are recommended for larger volumes, 3/4-inch probes and the continuous flow cell & cup horn. These compact units fit on any laboratoryâ&#x20AC;&#x2122;s existing bench space. The timer controls processing from 1 second up to 10 hours and monitors the elapsed time as well as duration of processing. The sealed converter protects the unit from humidity, dust, dirt and fumes. These units monitor both power (watts) & energy (joules), and feature 100 per cent automatic tuning. The ultrasonic processors with temperature controller prevents overheating of harmful sample by terminating the ultrasonics when the sample temperature reaches a predetermined limit. Cole-Parmer India - Mumbai - Maharashtra Tel: 022-6716 2222, Fax: 022-6716 2211 Email: response@coleparmer.in

Chill roll flaker unit Steer Engineering offers chill roll flaker unit. It has a pair of adjustable roller, which cools and squeezes the molten material into a thin continuous band. The cooled extrudate is then passed through flaker, thereby reducing the material to small-sized chips suitable for feeding into the fine grinding machine. The squeeze roller in the unit is made of quality raw material and can be easily cleaned. It is made of heavy-duty robust mild steel sturdy structure, with stainless steel squeeze roller. Its features include easy cleaning process, consistent speed, etc. Steer Engineering Pvt Ltd - Bengaluru - Karnataka Tel: 080-2372 3310, Fax: 080-2372 3307 Email: info@steerworld.com

January 2011

Modern Pharmaceuticals

PRODUCT UPDATE

Strip seals Novoflex Marketing offers pilfer-proof strip seals, which prevent imitation of branded & quality products and help control adulteration & pilferage, thus protecting a companyâ&#x20AC;&#x2122;s reputation & brand image. These have a tamper evident locking action in a one-piece construction and are precision moulded from durable, tough, high-strength, weatherresistant engineering Nylon 66 material. These strip seals are light in weight, corrosion effective, economical and cost-effective. The companyâ&#x20AC;&#x2122;s name/logo can be permanently hot stamped on it. These seals can be used in pharmaceuticals industries, bulk drugs, airlines baggages, postal department, chemical industries, bank lockers, courier bags, containers, drums, etc. Novoflex Marketing Pvt Ltd - Kolkata - West Bengal Tel: 099031 63634, Fax: 033-2229 7814 Email: sales@novoflex.co.in

Centrifuges United Engineering Enterprises offers fulllid opening centrifuges, which conform to GMP standards for active pharmaceutical ingredients, herbal extracts, flavours, colours, chemicals and allied process industries. These centrifuges are of four-point suspension type in stainless steel construction. The entire body can be lifted & opened hydraulically. Thus, the basket and drain platform are exposed, facilitating easy & quick cleaning. The body is hydraulically lowered into the closed position and clamped to the lower portion of the casing by means of quick clamps. These centrifuges are suitable for manufacturing facilities that require frequent product changeover. These centrifuges are available in various designs, depending on cake characteristics and customer requirements, viz, standard top discharge, top discharge with bag lifting arrangement & bottom discharge with/without scrapper. The centrifuges can also be offered in vapour tight construction with nitrogen blanketing for hazardous chemicals. The CIP design with built-in cleaning nozzles ensures no product cross-contamination. These centrifuges are manufactured in batch capacities in the range of 5-600 kg. United Engineering Enterprises - Mumbai - Maharashtra Tel: 022-2308 3990 Email: uenggent@gmail.com

The information published in this section is as per the details furnished by the respective manufacturer/ distributor. In any case, it does not represent the views of

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86 Modern Pharmaceuticals

January 2011

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Accelerated ageing test Fuels Access control Fumigation Acoustic enclosures Gases Air chiller for IBC Gear oils Air filters Geared box Air shower controllers Geared motor Analyser GMP heat exchangers Analytical instrumentation GMP reactors Auto tube filling sealing machine Gold lab pH Bar code reader Heart valve frames Biodiesel HEPA filter terminal housing Biological safety cabinet HPLC Blister packaging machine Hydrogenator/autoclaves Blistrip Indicators Blow-fill seal machines Industrial control & sensing devices Calibration sources Industrial pumps for aggressive fluids Capping machines Capsule section machines Informatics Centrifuges Injectable manufacturing line Chill roll flaker unit Injectable powder filling machines First Fold Here Clean room doors Inspection systems Coloumns & chemistries Invertor/variable frequency drives Complete tablet bottle packing lines Lab conductivity Compositional & trace metal analysis Lab portable online Ph Conical screw dryers Laminar air flow workstation Controllers Level controllers Cooling tower Liquid filling machines Counters & power supplies Lubes-engine oils Digital colour mark sensor Machinery for tablet/granulation Digital temperature & humidity Marine air conditioning data loggers Material identificaton Digital wireless synchronised Measuring & monitoring relay for 1pH/3pH clock systems Dispensing booth Metallography Door interlock systems Motion controls Drives Ointment/cream/paste section machines Dry syrup powder filling lines Dry vane pumps Online TDS Dynomill ORP Empower Packaging machinery Encoders Pass box inter lock systems Ensule automatic capsule filling Pass box interlock system Evaporative cooling tower Pass boxes Second Fold Here Exhibition - Engineering Expo Petrol & fuel oils Exhibition - HiTech Manufacturing pH electrodes Show Photoelectric sensors Factory automation Plastic pallets Failure analysis Polymer characterisation Fan filter unit Potentiometer Filler compositional analysis Pre-engineered & pre-fabricated modular panel Filling tube Fire alarm Process heat exchangers Flame proof pH Process reactors Fogging machine Programmable logic controllers

Programmable terminals Proximity sensors PTFE lined valves PTFE rigid pipes and liners Pumps Push rivets Quality control equipments & apparatus Quick change terminal house Rapid endotoxin detection system Return air risers RFID Roots blowers Rotary vacuum dryers Rotocone dryers Safe change housing Safety light curtains Sampling booth SEZ developers Silicone carbide heat exchangers Spherical paddle chopper dryers Steam products Sterilising/depyrogenating tunnel Sticker (self-adhesive) labelling machines Strip seals Switching relays Tablet section machines Tableting machinery TDS conductivity Tempurature controllers Three-parameter display Timers Transmission ﬂuids Transmitters Turbula Turnkey projects Twin - screw elements Twin -screw co-rotating extruders Ultra deep temperature freezer Ultrasonic processors ULV fogging machine UPLC Vacuum booster pump Vacuum pump inlet/exhaust trap Vacuum systems Vision sensors Washing and air jet cleaning machines Water/brine/hydraulic oil/ chilling plant Wet glue labelling machine

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Bonﬁglioli Transmissions (Pvt) Ltd

Jicon Industries

Brothers Pharmamach (India) Pvt Ltd

LMT India Pvt Ltd

Charles River

Milltech Engineering Pvt Ltd

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Misumi India Pvt Ltd

Digital Instruments Corporation

Omron Automation Pvt Ltd

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Premium Transmission Ltd

Eltech Services Pvt Ltd

Radiant Enterprise

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Salesworth India Pvt Ltd (Rommelag)

Fabtech Technologies Intl Pvt Ltd

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PRODUCT INDEX

Product

Pg No

Accelerated ageing test....................................57 Access control ................................................... 79 Acoustic enclosures .......................................... 13 Air chiller for IBC............................................. 35 Air filters............................................................ 17 Air shower controllers...................................... 79 Analyser ............................................................. 79 Analytical instrumentation .............................. 67 Auto tube filling sealing machine ................... 51 Bar code reader................................................81 Biodiesel ............................................................ 57 Biological safety cabinet ................................... 17 Blister packaging machine ............................... 51 Blistrip ............................................................... 51 Blow-fill seal machines....................................... 9 Calibration sources .........................................25 Capping machines .............................................. 7 Capsule section machines ................................ 51 Centrifuges ........................................................ 86 Chill roll flaker unit.......................................... 85 Clean room doors............................................. 17 Coloumns & chemistries.................................. 67 Complete tablet bottle packing lines................. 7 Compositional & trace metal analysis ............ 57 Conical screw dryers........................................... 5 Controllers ........................................................ 25 Cooling tower ................................................... 37 Counters & power supplies........Front inside cover Digital colour mark sensor.............................78 Digital temperature & humidity data loggers .... 80 Digital wireless synchronised clock systems... 78 Dispensing booth.............................................. 17 Door interlock systems..................................... 79 Drives................................................................... 6 Dry syrup powder filling lines ........................... 7 Dry vane pumps ............................................... 13 Dynomill............................................................ 61 Empower ..........................................................67 Encoders ................................. Front inside cover Ensule automatic capsule filling...................... 51 Evaporative cooling tower ................................. 8 Exhibition - Engineering Expo ........................ 29 Exhibition - HiTech Manufacturing Show..... 63 Factory automation................... Front gate fold Failure analysis.................................................. 57 Fan filter unit .................................................... 17 Filler compositional analysis............................ 57 Filling tube ........................................................ 51 Fire alarm .......................................................... 79 Flame proof pH ................................................ 25 Fogging machine............................................... 81 Fuels................................................................... 57

Product

Pg No

Fumigation ........................................................ 81 Gases.................................................................57 Gear oils ............................................................ 57 Geared box ........................................................ 43 Geared motor.................................................... 43 GMP heat exchangers......................................... 5 GMP reactors ...................................................... 5 Gold lab pH ...................................................... 25 Heart valve frames ..........................................59 HEPA filter terminal housing.......................... 17 HPLC ................................................................. 67 Hydrogenator/autoclaves ................................... 5 Indicators .........................................................25 Industrial control & sensing devices .................................. Front inside cover Industrial pumps for aggressive fluids............ 55 Informatics ........................................................ 67 Injectable manufacturing line.......................... 17 Injectable powder filling machines ................... 7 Inspection systems............................................ 23 Invertor/variable frequency drives .................................... Front inside cover Lab conductivity..............................................25 Lab portable online Ph..................................... 25 Laminar air flow workstation .......................... 17 Level controllers..................... Front inside cover Liquid filling machines....................................... 7 Lubes-engine oils .............................................. 57 Machinery for tablet/granulation ..................80 Marine air conditioning................................... 35 Material identificaton....................................... 57 Measuring & monitoring relay for 1pH/3pH .............................. Front inside cover Metallography ................................................... 57 Motion controls ..................... Front inside cover Ointment/cream/paste section machines......51 Online TDS ....................................................... 25 ORP ................................................................... 25 Packaging machinery ..................................7, 51 Pass box inter lock systems....................... 78, 79 Pass boxes.......................................................... 17 Petrol & fuel oils............................................... 57 pH electrodes .................................................... 25 Photoelectric sensors ...... Front Inside Cover, 81 Plastic pallets............................................... 10, 79 Polymer characterisation.................................. 57 Potentiometer ................................................... 25 Pre-engineered & pre-fabricated modular panel ................................................ 17 Process heat exchangers ..................................... 5

Product

Pg No

Process reactors................................................... 5 Programmable logic controllers ............................ Front inside cover Programmable terminals....... Front inside cover Proximity sensors .................. Front inside cover PTFE lined valves.............................................. 78 PTFE rigid pipes and liners ............................. 78 Pumps.......................................................... 13, 55 Push rivets ......................................................... 78 Quality control equipments & apparatus .....51 Quick change terminal house.......................... 17 Rapid endotoxin detection system.................81 Return air risers ................................................ 17 RFID ....................................... Front inside cover Roots blowers.................................................... 13 Rotary vacuum dryers ........................................ 5 Rotocone dryers.................................................. 5 Safe change housing........................................17 Safety light curtains ............... Front inside cover Sampling booth................................................. 17 SEZ developers.............................. Back gate fold Silicone carbide heat exchangers ....................... 5 Spherical paddle chopper dryers ....................... 5 Steam products ........................Back inside cover Sterilising/depyrogenating tunnel ................... 17 Sticker (self-adhesive) labelling machines ........ 7 Strip seals........................................................... 86 Switching relays ..................... Front inside cover Tablet section machines .................................51 Tableting machinery........................... Back cover TDS conductivity.............................................. 25 Tempurature controllers ....... Front inside cover Three-parameter display .................................. 79 Timers..................................... Front inside cover Transmission fluids .......................................... 57 Transmitters ...................................................... 25 Turbula .............................................................. 61 Turnkey projects................................................. 5 Twin - screw elements...................................... 59 Twin -screw co-rotating extruders.................. 59 Ultra deep temperature freezer......................35 Ultrasonic processors ....................................... 85 ULV fogging machine ...................................... 81 UPLC ................................................................. 67 Vacuum booster pump ...................................13 Vacuum pump inlet/exhaust trap ................... 82 Vacuum systems ............................................... 13 Vision sensors ........................ Front inside cover Washing and air jet cleaning machines...........7 Water/brine/hydraulic oil/chilling plant......... 35 Wet glue labelling machine ............................... 7

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January 2011

Modern Pharmaceuticals

ADVERTISERS’ LIST

Advertiser’s Name & Contact Details

Pg No

Bonfiglioli Transmissions (Pvt) Ltd

Advertiser’s Name & Contact Details

Pg No

Fabtech Technologies Intl Pvt Ltd

17, 19

Advertiser’s Name & Contact Details Misumi India Pvt Ltd

T: +91-44-24781035

T: +91-22-61592900

T: +91-20-66470000

E: sales@bonfiglioliin.com

E: mails@fabtecheng.com

E: sales@misumi.co.in

W: www.bonfiglioliindia.com

W: www.fabtecheng.ae

Brothers Pharmamach (India) Pvt Ltd

Fluid Energy Controls Inc

T: +91-79-40213213

T: +91-44-42083536

E: brothers@usa.net

E: sales@fecindia.com

W: www.brothers.co.in

W: www.fecindia.com

Charles River

Forbes Marshall Pvt Ltd

Pg No FGF

W: www.misumi.co.in 55

Omron Automation Pvt Ltd

FIC

T: +91-80-40726400 E: srirams@ap.omron.com W: www.omron-ap.com Premium Transmission Ltd

BIC

T: +91-20-27488886

T: +91-80-25588175

T: +91-20-27442020

W: www.premiumtransmission.com

E: india.customercare@crl.com

E: seg@forbesmarshall.com

Radiant Enterprise

W: www.forbesmarshall.com

T: +91-79-66615344

W: www.criver.com Chilton Refrigeration

T: +91-422-3267800 Salesworth India Pvt Ltd (Rommelag)

E: chilton@sify.com

T: +91-80-25274495 W: www.gemindia.com 25

T: +91-79-22202762 E: dic@digitalinstruments.net

Hi Tech Manufacturing Show

E: mail@salesworth.com 63

Salesworth India Pvt Ltd (Seidenader)

E: hitech@infomedia18.in

T: +91-80-25274495

J B Sez Pvt Ltd

BGF

T: +91-22-26743719

E: mail@salesworth.com

Shiva Analyticals (India) Limited

E: aparadkar@jbsez.com E: sales@dipeshengg.net

T: +91-80-27971322

W: www.jbsez.com

E: gupta@shivatec-india.com 79

Jicon Industries

T: +91-22-28510398

T: +91 40 27759895 E: sales@eltechservices.com W: www.eltechservices.com Engineering Expo

W: www.seidenader.de

T: +91-22-66210000

W: www.dipeshengg.com

W: www.rommelag.com

T: +91-09820373804

W: www.digitalinstruments.net

Eltech Services Pvt Ltd

E: sales@gemindia.com

W: www.chiltonindia.com

Dipesh Engineering Works

E: radiant_enterp@rediffmail.com W: www.fogstarindia.com

T: +91-484-2544571

Digital Instruments Corporation

Gem Equipments

Sintex Industries Ltd T: +91-2764-253500

W: www.jicon.com

E: pallets@sintex.co.in

LMT India Pvt Ltd

W: www.engg-expo.com

W: www.fette-compacting.com

Everest Blowers

Milltech Engineering Pvt Ltd

W: www.sintex-plastics.com Steer Engineering Pvt Ltd

T: +91-80-23723309

E: srane@lmtfette.in

E: engexpo@infomedia18.in

10, 79

E: jicon.ind@vsnl.com

T: +91-9867168123

T: +91-09920401226

W: www.shivatec-india.com

E: info@steerworld.com W: www.steerworld.com

Waters (India) Pvt Ltd

T: +91-11-45457777

T: +91-22-22872295

E: info@everestblowers.com

E: info@milltechengg.com

E: waters_india@waters.com

W: www.everestblowers.com

W: www.milltechengg.com

W: www.waters.com

T: +91-80-28371900

Our consistent advertisers

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92 Modern Pharmaceuticals

January 2011

Modern Pharmaceuticals

January 2011

Modern Pharmaceuticals

January 2011