Modern Pharmaceuticals - April 2011 by Infomedia18

Also available in Sri Lanka, Malaysia, Singapore, Thailand, Taiwan, China & Hong Kong

Editorial

Pharma on the tech track

ne of the ‘super profit’ industries is at the verge of losing over $150 billion with many branded drugs going off-patent in the next few years. Added to this is the pressure to maintain market share and profit margin amid increasing global competition. At this stage, the pharma world is seeing challenges as well as opportunities ahead. The abovementioned factors necessitate adoption of intelligent and practical solutions to drive business by raising efficiency & reducing time to market, and Information Technology (IT) is one of them. Besides, the shrinking new drug pipeline and slow production of new chemical entities have called for revisiting investments in ensuring right collaboration(s), standardisation and analytical tools. In this context, IT has the potential to not only help minimise errors and redundancy, but also expedite the drug development cycle for this sector. Clinical trials, in particular, demand the highest degree of efficiency in terms of global supply and forecasting, and IT can help here too! IT-based data management being centralised and integrated in nature can provide quick & accurate results and analysis for various stages of the drug development cycle. Some more advantages of IT include detecting an accurate match from hundreds of random candidates, analysing raw materials, keeping a record of the entire manufacturing process and maintaining electronic health records, among others. However,

one of the crucial challenges facing this sector in the country is getting experienced skilled resources. For further insights into this fast evolving space, turn to ‘Industry Update’. Now, let’s look at nanotechnology, the field that promises better and brighter prospects for pharmaceutical applications by virtue of providing intelligent systems, devices and materials. Nanobiotechnology, especially, can aid in direct delivery of drugs into the human body. Some other key application areas of this technology include cell structure and physiology, virus detection, radiation/ chemotherapy, neurological functions of the brain, biomedical engineering research and utilisation of imaging devices, to cite a few. At the same time, funding seems to be a significant challenge facing nanobiotechnology today. The solution to it can be explored in collaboration and licensing agreements between nanobiotech players, public sector institutions and pharma/ biotech companies. Besides, there is an urgent need to address several other issues before one sees practical realisation of nanotechnology in pharma. ‘Market Trends’ offers more details. Read on…

Special Interest Publications Division, ‘A’ Wing, Ruby House, J. K. Sawant Marg, Dadar (W), Mumbai 400 028 Tel: 91-22-3003 4669 / 4671 Fax: 91-22-3003 4499 Email: spedit@infomedia18.in

Editor: Manas R Bastia Features Editor: Arshia Khan Sr. Features Writer: Dr Asma Mohd. Yousuf Features Writer: Chandreyee Bhaumik Correspondent: Anwesh Koley (Delhi) Copy Desk: Parita Dholakia Products Desk: Abha Mishra Assistant Art Director: Varuna Naik Chief Photographer: Mexy Xavier Photographers: Neha Mithbawkar, Joshua Navalkar Sr. Designer: Sachin Bhogate Production: Vikas Bobhate, Pravin Koyande, Dnyaneshwar Goythale, Ravikumar Potdar, Ravi Salian, Sanjay Shelar, Lovey Fernandes, Pukha Dhawan, Varsha Nawathe, Akshata Rane, Abhay Borkar Branding & Marketing: Jagruti Shah, Ganesh Mahale CEO-Publishing: Sandeep Khosla Associate Vice President : Sudhanva Jategaonkar Circulation/Subscription: Sunil Nair, Distribution Head Email: sunil.nair@network18online.com, customercare@infomedia18.in

Ajit Singh Chairman, ACG Worldwide & Head, ISPE Dr Abraham Patani Past President, IDMA & CMD, Inga Laboratories Dr Gopakumar G Nair IPR Consultant & Advisor Dilip G Shah Chairman, IGPA & Secretary General, IPA Daara Patel Secretary General, IDMA

Manas R Bastia Editor manas@infomedia18.in

Editorial & Business Office: Infomedia 18 Ltd

Published in association with

Editorial Advisory Board

Other Business Offices Ahmedabad: (Shashin) Tel: 079-39826432 Fax: 079-39826464 Email: sipdahmedabad@infomedia18.in Bengaluru: (Mahadev B) Tel: 080-30010900 Fax: 080-30010999 Email: sipd.bang@infomedia18.in Chennai: (Hari) Tel: 044-39864200 Fax: 044-39864250 Email:sipd.chennai@infomedia18.in Cochin: (Robin) Tel: 0484-4054380/90 Fax: 0484-4054370 Email: kochi@infomedia18.in

New Delhi: (Surendra/Mukesh) Tel: 011-66303278 Fax: 011-23327884 Email: sipd.delhi@infomedia18.in Pune: (Rohit) Tel: 020-33223309 Fax: 020-33223322 Email: sipd.pune@infomedia18.in Surat: (Sunil) Tel: 0261-2630181 Fax: 0261-2630974 Email: surat@infomedia18.in Vadodara: (Samarth) Tel: 0265-3926500/01 Fax: 0265-2356013 Email: vadodara@infomedia18.in

Overseas Contacts:

Ringier Trade Media Ltd

China: (Craig Shibinsky): Tel: +86 21 6289 5533 Ext. 368; Fax: +86 21 6247 4855 Email: craig@ringier.com.hk

Coimbatore: (Prakash) Tel: 0422-3092600 Fax: 0422-3092666 Email: coimbatore@infomedia18.in

Hong Kong: (Octavia Au-Yeung): Tel: +852 2369 8788 Ext. 21; Fax: +852 2869 5919 Email: octavia@ringier.com.hk

Hyderabad: (Kalyan) Tel: 040-30647600 Fax: 040-30647676 Email: sipd.hyderabad@infomedia18.in

Taiwan: (Sydney Lai): Tel: +886 4 2329 7318 Ext. 16; Fax: +886 4 2310 7167 Email: sydneylai@ringier.com.hk

Indore: (Ameya) Tel: 0731-3074876 Fax: 0731-3074882 Email: sipd.indore@infomedia18.in Jaipur: (Durgesh) Tel: 0141-3007414; 3007411 Fax: 0141-2213728 Email: sipd.rajasthan@infomedia18.in Kolkata: (Deb Ranjan) Tel: 033-22658637/8638 Fax: 033-22652964 Email: sipd.kol@infomedia18.in Ludhiana: (Inder) Tel: 3026198, 3026199, 3026200, 3026201 Fax: 3026198 Email: ludhiana@infomedia18.in Mumbai: (Rahul) Tel: 022-30034640 Fax: 022-30034499 Email: spmktg@infomedia18.in

Singapore: (Annie Chin): Tel: +65 9625 7863; Fax: +65 6841 5273 Email: annie@janianmedia.com Germany, Austria, Switzerland: Tel: +41-44 734 0472, Fax: +41 44 734 0680 Email: info@islerannoncen.ch USA: Tel: (513) 527-8800, Fax: (513) 527-8801 Email: dhight@gardnerweb.com Issue Price: ` 100

Annual Subscription: ` 799

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

April 2011 I Modern Pharmaceuticals

Contents REGUL A R SEC TIONS Editorial .........................................................07 National News...............................................10 World News...................................................16 Tech Updates.................................................22 Events Calendar.............................................60 Book Shelf .....................................................65 Product Update ...................................66 Product Index ................................................71 Advertisers’ List.............................................72

FE AT URES 24

LEADERS SPEAK

'We want to be an MNC of the emerging market by 2020' ...says Dr Krishna M Ella, Chairman and Managing Director, Bharat Biotech

ROUNDTABLE Compulsory licencing for pharma: Should government tighten the norms?

INDUSTRY UPDATE IT in pharma: Have you taken the right dose?

MARKET TRENDS Nanotechnology in life sciences industry: A profitable venture?

RETAIL ZONE

Standalone chemists: Leveraging economies of scale

Rajendra Pratap Gupta, International Healthcare Policy & Retail Expert

LEGAL EDGE Patent linkage: Overlapping of two distinct legislations? Anuradha Salhotra, Managing Partner, Lall Lahiri & Salhotra

TECH BYTES 'We now have many examples of how the FT4 provides the information necessary to solve a complex problem' Tim Freeman, Director of Operations, Freeman Technology

INTERFACE 'As the focus shifts from drugs to biotech, delivery and management of content will become critical to brand success' Soumitra Sen, President and Head, DDB Health & Lifestyle

26 Highlights of Next Edition:

VIEWPOINT

Industry Update Pharma Machinery

Combating counterfeits: Fighting the flood with technology Meenaxee Padhy, Business Head, M&M Technologies Pvt Ltd

CURTAIN RAISER Bangalore INDIA BIO 2011: Connecting leaders of today with tomorrow

Details on page no.

Market Trends Nutraceuticals

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

Modern Pharmaceuticals I April 2011

National News Dr Reddy’s reengineers sales process in the cloud with Salesforce.com

Glenmark enters in an exclusive agreement with IDC

Salesforce.com, the enterprise cloud computing company has recently declared that India’s second largest pharma company, Dr Reddy’s Laboratories (DRL), has deployed Salesforce Client Relationship Management (CRM) across 200 users within 60 days. Dr Reddy’s has decided to move its Active Pharmaceutical Ingredients (API) marketing business to the cloud in order to improve visibility into its deals pipeline, track its end-to-end sales cycle also better analyse its sales funnel. Dr Reddy’s implemented Salesforce CRM with the help of IT consulting firm Bodhtree, who used its data integration engine MIDAS to integrate with existing mail, calendar, and SAP systems. Further, by streamlining its sales business on Salesforce.com, Dr Reddy’s expects to increase revenue by more than 30 per cent. Commenting in this regard, B V Srinivas, Deputy CIO, DRL, said “Salesforce.com’s ability to seamlessly integrate data captured offline with online systems is of immense help to our field sales team who need to track and update customer data on regular basis but do not have access to internet connectivity at all times.”

Glenmark Pharmaceuticals has entered into an exclusive agreement with ImmanenceIntégrale Dermo Correction (IDC), one of the leading Canadian companies for the distribution of a range of high-end dermatology products for India, Brazil, Mexico, South Africa, Egypt, Vietnam, Malaysia, and Thailand. Glenmark will be the sole licensee for the entire range of product portfolio across all these operating countries, thus marking the global entry of Glenmark into the high-end anti-aging cosmeceutical care segment. Commenting on this, Arvind Vasudeva, Chief Operating Officer, Glenmark Pharmaceuticals Ltd, said, “The association marks a new beginning for us in one of the fastest growing segments in dermatology.”

Avesthagen launches commercial WGS Avesthagen Ltd recently introduced its commercial Whole Genome Scanning (WGS) service in India. Avesthagen will use Affymetrix technology to decipher the association between single nucleotide polymorphisms (SNPs)/mutation and predisposition to the disease. The DNA chip used by Avesthagen for whole genome scanning features more than 1.8 million markers of genetic variation that include SNPs as well as probes for copy number variation (CNV). A whole genome scan of an individual would provide information to understand his/her own genetic make up that would lead to an increased awareness about the predisposition to a disease(s). The diseases, which are offered by Avesthagen, include major types of cancer, cardiovascular diseases, diabetes, schizophrenia, Alzheimer’s, asthma, anemia, arthritis and others. The facility can process 200 samples per month.

Ind Swi Labs gets USFDA nod for two more DMFs Pharma major Ind-Swift Laboratories Ltd, with a strong basket of over 40 products across 16 therapeutic segments, has received the US Food and Drug Administration (USFDA) nod for two more Drug Master Files (DMFs) temozolomide and telmisartan. Besides commercially supplying four molecules to the US, the company has also filed 20 DMFs with the US FDA, of which all have been approved. NR Munjal, Vice-Chairman and Managing Director, Ind-Swift Laboratories Ltd, said, “With this approval for temozolomide, an anti-neoplastic drug with market size of $ 700 million, and telmisartan, a drug for hypertension with market size worth $1.6 billion, the company is aiming at marketing these products once they go off patent.”

FDASmart’s forum on counterfei ng FDASmart Inc, a US and India based management used in Nigeria, Cognex, a leading state-of-the-art and pharmaceutical consulting/training company machine vision and track & trace vendor, Bilcare, recently held its first anti-counterfeiting forum in one of the leading nanotechnology serialisation Mumbai, India. The event was held in cooperation solution providers, Systech Inc, a New Jerseywith NLINKS Pvt Ltd, Mumbai, India. based serialisation company, ACG with is capsule This event witnessed discussions on how to combat encoded system, India’s leading Drug Manufacturer the counterfeiting of drugs with special emphasis Association (IDMA). Ram Banarse, FDA, Assistant on barcoding and serialisation requirements. Commissioner, Maharashtra and many more were Group of experts from the US, Europe and India also present at this event. It also saw Tata Teleservices Ram Balani came together, not only to discuss the problems Ltd (TTSL) making an announcement of the but also to present innovative solutions in order pre-launch of its mobile health solutions as part to fight against counterfeiters. The speakers included various of their nationwide launch in India. The stakeholders in the pharma industry including Glaxo Smith panel discussion was moderated by Ram Balani, Kline Ltd’s Supply Chain Manager, Sproxil’s consumer- CEO and Founder FDA Smart Inc who discussed the issues of based anti-counterfeiting solution that is in nationwide DGFT and DCGI barcoding and serialisation mandates. 10

Modern Pharmaceuticals I April 2011

National News Sun Pharma forms JV with Merck US-based Merck & Co Inc. and Mumbaibased Sun Pharmaceuticals have entered into a strategic collaboration to jointly develop, manufacture and commercialise new combinations of innovative branded generics (affordable versions sold under a brand name) in emerging markets. Further, the Joint Venture (JV), with equal representation from both companies, will be formed over the next few weeks, and will be based in the country. The JV will develop 8-10 molecules over a period of time. Dilip Shanghvi, CMD, Sun Pharmaceuticals, said that the JV reinforces its strategy

of partnering to launch products using its innovative delivery technologies around the world. “It will leverage Merck’s commercial footprint and clinical and registration expertise,” he added. Commenting on the deal, Adam Schechter, Executive VP, Merck, said that the JV will broaden Merck’s footprint in emerging markets, across Asia-Pacific, Latin America & Eastern Europe, Middle East and Africa. Further, it will attempt to address the huge unmet medical need, and therefore may turn out to be a win-win for both the companies.

Cipla launches ‘No Touch Breast Scan’ Cipla, one of the leading pharma companies from India, has recently introduced a breakthrough screening technology, ‘No Touch Breast Scan (NTBS)’, in India. This is a painless, non-invasive and radiation-free breast scanning technique for detecting breast cancer at an early stage. Commenting in this regard, Dr Shekhar Kulkarni, Consultant Breast Cancer Surgeon, Magnolia Breast Surgery Clinic, Pune said, “Breast cancer is rising rapidly among urban women and is now the most common cancer in cities such as Mumbai and Delhi. Unfortunately, most cancers are diagnosed when the disease is advanced leading to low chances of cure. Although mammography has been available for years it is not used that widely.” Again, welcoming the introduction of NTBS in India, Dr Rakesh Sinha, Consultant Gynaecologist Surgeon, BEAMS Hospital, Mumbai said, “The NTBS is a painless option for women who wish to get themselves regularly screened. It is of particular use in younger women who have dense breasts and mammography is inconclusive. If a woman shows changes on the NTBS then she is sent for further investigation, which includes mammography, sonography etc. At BEAMS Mumbai, of the 41 patients who have undergone the NTBS test, only 1 had to be referred for mammography.”

Glenmark’s NBE in IND studies Glenmark Pharmaceuticals SA (GPSA), a wholly owned subsidiary of Glenmark Pharmaceuticals Ltd India (GPL), has announced the discovery and initiation of Investigational New Drug (IND) enabling studies of a Novel Biological Entity (NBE) lead candidate, GBR 401, an anti-CD19 monoclonal antibody. GBR 401 is developed completely in-house by Glenmark’s Biologics Research Centre located in Switzerland. The disease areas primarily targeted by GBR 401 are lymphomas and leukemia of B-cell origin. GBR 401 has demonstrated strong anti-tumor potency and anti-proliferative apoptotic activity in several in-vitro and in-vivo studies. Commenting in this regard, Glenn Saldanha, CEO & MD, Glenmark Pharmaceuticals Ltd, said, “We are excited to announce GBR 401, which has been developed completely in-house leveraging our biologics antibody expertise. We are confident that the antibody expertise and product development capabilities of the Switzerland Biologics Research Centre will continue to enrich Glenmark discovery pipeline.” 12

Daiichi Sankyo to leverage Ranbaxy’s marke ng network Daiichi Sankyo Company Ltd (Daiichi Sankyo) and Ranbaxy Laboratories Ltd (Ranbaxy) recently declared the start of synergistic initiative to leverage Ranbaxy’s presence in Singapore to market innovative products originally discovered by Daiichi Sankyo. Effective March 1, 2011, Ranbaxy will market four products of Daiichi Sankyo origin, including Cravit® (levofloxacin) tab and Cravit® IV in Singapore. The products were previously commercialised by Kyowa Hakko Bio Singapore Pte Ltd (Kyowa Hakko Bio) in the country. Early this year, Daiichi Sankyo and Kyowa Hakko Bio agreed to transfer the marketing rights of the products from Kyowa Hakko Bio to Ranbaxy. “We are pleased to announce the first synergistic business development with Ranbaxy in ASEAN,” said Joji Nakayama, President & CEO, Daiichi Sankyo. “We are determined to work with Ranbaxy to further serve diversifying medical needs in this strongly emerging region.” Further, commenting on the development, Arun Sawhney, Managing Director, Ranbaxy, said, “Ranbaxy has a strong foot hold in the ASEAN region. We will use our marketing strengths to offer innovative medicines from Daiichi Sankyo in this fast growing region, beginning with Singapore.” Modern Pharmaceuticals I April 2011

National News Nichrome signs technology licensing agreement with TOTPACK Nichrome India Ltd, one of the leaders of VFFS machines in India, is all set to meet the requirements of packaging industry by providing special machinery that could extend re-closability and pourability for packaged products. The machinery typically known as Horizontal Form Fill Seal machines (HFFS) is highly automated and offers a variety of pouch formats. Nichrome India aims to use the advanced Spanish technology to manufacture and sell this HFFS machines L-R: Vaibhav Modak, Executive Director, & domestically and internationally. Under the Harish Joshi, MD, Nichrome India Ltd with Joaquim Miro arrangement, TOTPACK will support Nichrome with its experience and specialty of HFFS technology transfer and upgradation.These machines will be indigenously manufactured at Nichrome’s plant located at Shirval, Pune. The infrastructure at this plant currently accommodates a manufacturing capacity of 500 machines per year. The first machine will be launched at one of the biggest packaging expositions in Germany this year.“Nichrome has always been on the lookout for introducing latest packaging trends & technology whilst strongly promoting Indian make. With this collaboration, the company envisages a breakthrough in new market segments like cosmetics, personal care, food, neutraceuticals and Over-The-Counter pharma products. These industries not only need innovative packaging technology but also a pragmatic outlay,” informed Harish Joshi, Managing Director, Nichrome India Ltd. “We have ventured into this collaboration conscious of Nichrome’s brand strength & robust network, which would give our technology the right pedestal to serve both the domestic and internal markets,” said Joaquim Miro, CEO, TOTPACK.

Piramal Healthcare buys back ` 2,508 crore shares Piramal Healthcare has recently announced that it has completed buyback of 4.18 crore shares worth over ` 2,500 crore. “The buyback constitutes 20 per cent of the issued, subscribed and paidup equity share capital of the company as on September 30, 2010,” the company commented in a filing to the Bombay Stock Exchange (BSE). Again, Piramal had offered to buy 4.18 crore outstanding shares at a price of ` 600 each. The total purchase is valued at around ` 2,508.16 crore. Shares of the company closed at ` 416.90, down over 3 per cent on the BSE.

SAVA Medica signs agreement to be a part of JB SEZ Sava Medica Ltd has recently signed a deal with JB SEZ, the pharma specific SEZ from the J B Mody Group and HBS Realtors in order to establish a manufacturing plant. The plant that is a part of Sava’s expansion plans will cater to its exports to North America, Russia & CIS countries. Currently, the company exports to more than 20 countries in Asia, Africa, Latin America and CIS. Offered on a sub lease, the size of the land is roughly 10 acres. The plant will cater to about 60 per cent of the company’s turnover. Vinod Jadhav, Managing Director, Sava Medica Ltd, said, “We at Sava Medica want to derive the logistical advantage by setting up a facility in an area that is central to the pharma industry. This will give us the advantage of being closer to

customers. It will reduce cost of logistics for us as well as customers.” Commenting in this regard, Kayvanna Shah, CEO, JB SEZ Pvt Ltd, said, “ We at JB SEZ are looking forward to having Sava Medica set shop here, paving the way for other pharma companies looking to expand to establish themselves here too. The SEZ aims to generate employment to the tune of about 15,000 (indirect) and 5000 (direct) and target exports from the pharma units in the region of about ` 3000 crore per annum leading to further industrialisation of the state of Gujarat. Signing off Shah states, “Our basic plan is to popularise JB SEZ internationally as a paramount destination for the pharma industry and we are truly on course to achieve that milestone.”

Aurobindo receives USFDA approval for fosinopril sodium tablets Aurobindo Pharma Ltd has recently received a final approval from the US Food & Drug Administration (FDA) to manufacture and market fosinopril sodium tablets USP 10 mg, 20 mg and 40 mg. Fosinopril sodium tablets USP 10 mg, 20 mg and 40 mg is the generic 14

version of Bristol-Myers Squibb Company Pharmaceutical Research Institute’s Monopril® tablets 10 mg, 20 mg and 40 mg. The product falls under the cardiovascular (CVS) therapeutic category and is indicated for the treatment of hypertension. The product has a market size of approximately $ 20 million

for the 12 months ending September 2010 according to IMS and will be launched shortly. Thus, with this approval, Aurobindo now has a total of 134 Abbreviated New Drug Application (ANDA) approvals (102 final approvals and 32 tentative approvals) from US FDA. Modern Pharmaceuticals I April 2011

World News FSG launches Bioanalysis Zone community site at PITTCON

Table ng for containment and performance

Future Science Ltd, a part of the London-based Future Science Group (FSG), recently unveiled Bioanalysis Zone - an interactive online resource for the bioanalytical community. Users of Bioanalysis Zone will be able to view featured articles, interviews, industry news, product listings & reviews, webinars, white papers, job listings and much more. The site features selected content from the fortnightly, peer reviewed journal Bioanalysis together with specially commissioned content and interviews, plus key articles from related journals. Site content and functionality is entirely free to all site registrants. The website builds on the success of the journal Bioanalysis and seeks to meet workflow needs and bring the community together. “Our rationale is to provide a one-stop interactive site for the bioanalytical community. There is huge amount of know-how and enthusiasm within this community; by leveragingthe tools, technology and experience at FSG, we can channel this knowledge and insight through a broad-based community web site. We hope to provide our users with great service, functionality and a numberone work flow tool & forum. Bioanalysis Zone is still very much a work-in-progress and we look forward to working with the bioanalysis community to ensure its rapid evolution,” said Elisa Manzotti, Editorial Director, FSG.

GEA Pharma Systems - Courtoy™ will exhibit two tablet presses at Interpack in Düsseldorf from May 12–18, 2011. They represent the finest tabletting technology currently available and offer the ultimate in containment and high-performance production, and are perfect examples of inspiration meeting technology. The MODUL™ tablet presses from Courtoy™ have addressed this requirement for both fast product changeover and high containment with their Exchangeable Compression Modules (ECM). The MODUL™ P, currently supplied to leading companies throughout Europe, Japan, India and the USA, is perfect for formulation development, clinical trial production and small-batch/multiproduct production. By contrast, the PERFORMA™ S, renowned for its instant high-output capability of up to 405,000 tablets per hour, will be a stand-alone exhibit showing the automatic turret removal with upper and lower punches, the integrated arm for turret removal and the swivelling tablet chute.

Venus Remedies wins QC-100 Total Quality Management (TQM) award Venus Remedies Ltd, a research-based Dr Gilbert Wenzel, a member of the Venus pharmaceutical company, bagged the prestigious Board, received the Century International Quality international award QC-100 TQM in Gold Era (CQE) award on behalf of the company. Category in recognition of commitment to quality, Dr Wenzel said, “We are proud of receiving system efficiency, leadership, technology and such prestigious award, which Venus receives innovation. The awards were given by Business in recognition of its investments in world Initiative Directions (BID) International Quality L-R: Jose E Prieto, President & class manufacturing facilities in Panchkula, CEO, BID and Dr Gilbert Wenzel, Convention 2011 held in Geneva. 59 countries Member of Venus Board Baddi and Werne/Germany, its achievements in from around the globe participated in different R&D in the area on innovative injectables and categories in these awards and Venus is the only pharmaceutical its total quality orientation throughout the organisation, which company from India to have won this prestigious award. has also led to the certification from global health authorities.”

bo elpack® asep c machines and new products from rommelag® on show at Interpack At the Interpack trade fair, rommelag® shall exhibit in a demonstration every hour a bottelpack® 4010M aseptic machine for making unit dose eye drops and, as a new product on show at the fair, a high-voltage leak detector HVLD 926 for the non-destructive leak testing of large-volume containers. rommelag® is the inventor of the Blow-Fill-Seal (BFS) bottelpack® technology and the company offers its customers a complete range of packaging solutions and 16

services for filling liquids, gels and pastes. These are tailored to the individual needs of the customers in terms of container design, production capacity, unit volumes, product development and include a firstclass worldwide customer and spare part service along with the facility to carry out stability tests and also contract filling. The flagship of the rommelag® company are the BFS bottelpack® aseptic machines. The centrepiece is the sterile pyrogen-free container manufacture, aseptic filling of

sterile products and the hermetic sealing in one operation. Hourly outputs can reach 30,000 ampoules for container sizes from 0.1 ml to over 2000 ml. In-house laboratory and production facilities are available for project and customer-specific container and sealing developments as well as stability tests and contract filling. This unique portfolio allows customers to ideally package liquid and viscous pharmaceutical products with BFS bottelpack® aseptic machines. Modern Pharmaceuticals I April 2011

World News Wya Technology unveils new brochure for its newly launched Möbius mobility instrument Wyatt Technology Corporation has published a brochure in support of its new electrophophoretic mobility instrument, the Möbius. The 10-page brochure is a comprehensive document that outlines the unique capabilities of the Möbius, including an increased number of detectors at a variety of angles which produce a greater amount of data than any other ‘zeta-potential’

instrument. The surfeit of data results in the produc tion of more Möbius reproducible results than ever before. The brochure highlights that the instrument is up to ten times more sensitive than the other

Sanoﬁ Pasteur and IVI partner against dengue Sanofi Pasteur, the vaccines division of sanofi-aventis Group, recently announced that it is partnering with the International Vaccine Institute (IVI) to support the recently launched Dengue Vaccine Initiative (DVI). Sanofi Pasteur and the IVI will aim to raise awareness and to work to move dengue vaccination higher on the global health agenda. “Each year, an estimated two million people with dengue haemorrhagic fever require hospitalisation representing a significant burden on the fragile healthcare systems of developing and endemic nations,” said Dr Ragnar Norrby, Chairman of the Board of Trustees, IVI. “The fight against dengue requires a strong global commitment from all public health partners. The first dengue vaccine is now in the final stages of development. The IVI will be a key player in facilitating discussions among policy makers, with the objective of ensuring that once licensed the vaccine will be made available to those populations that need it most in a timely manner,” stated Olivier Charmeil, Senior Vice President, sanofi-aventis, Vaccines.

PRECOS and Argenta to oﬀer world class integrated oncology drug discovery services Preclinical Oncology Services Ltd (PRECOS) has extended its alliance with Argenta to continue providing comprehensive oncology focussed drug discovery services. Argenta, a service division of Galapagos NV, provides fully integrated drug discovery services to a range of leading pharmaceutical and biotechnology companies worldwide. The five-year extension of the alliance will allow both companies to offer unrivalled expertise in cancer research to their pharmaceutical clients. “We are looking forward to working with Argenta across a number of ongoing cancer-focussed contract research programmes, in addition to various major projects currently in the pipeline,” commented Professor Sue Watson, Chief Scientific Officer, PRECOS. Dr John Montana, Managing Director, Argenta, added, “PRECOS is a world leader in oncology preclinical research services. Through this alliance our pharmaceutical clients are able to benefit from seamless access to PRECOS’ models and scientists. We are excited to have PRECOS as a key extension of our team, working in partnership with our experienced oncology drug discovery scientists.” 18

instruments on the market and the first and only light scattering instrument that makes reliable, reproducible and nondestructive electrophoretic mobility measurements of macromolecules as small as 1nm while under dilute solution conditions. Furthermore, the Möbius can collect thirty times as much data as conventional technologies and produce the result in as few as thirty seconds.

Novozymes Biopharma supplies Neomend with albucult® for unique sealant technology Novozymes Biopharma,part of Novozymes A/S world leader in bioinnovation, has announced that its recombinant human albumin, albucult®, is being used by Neomend in its ProGEL® platinum surgical sealant. This product will be commercially available in Europe beginning in the second quarter of 2011. Neomend is an innovator in sealant and adhesion prevention products for the surgical marketplace. The company utilises albucult®, as a key component in ProGEL® platinum, the only sealant of its kind developed to treat pleural air leaks following lung resection surgery. Neomend’s ProGEL® is a hydrogel polymer consisting of Novozymes’ albucult® and a crosslinking component of Polyethylene Glycol (PEG). When they are combined, a rapid cross-linking reaction creates a hydrogel matrix that results in the formation of a strong, adherent and flexible seal. The technology, which has received a European CE Mark, enables surgeons to more effectively treat lung air leaks during surgery and has already been used in more than 8,000 procedures in the US since April of last year. David Renzi, Neomend’s President and CEO, commented, “Novozymes’ extensive experience in manufacturing, regulatory and global supply, combined with its commitment to innovation, makes the company the ideal partner for Neomend to work with on its unique sealant technology. We will launch ProGEL® platinum in Europe in the second quarter of this year, while also continuing the development of this platform technology into other clinical areas, such as spine, general surgery and gynaecology.”

Modern Pharmaceuticals I April 2011

World News Asia Paciﬁc drives growth of Bayer HealthCare Pharmaceu cals

Thermo Fisher Scien ﬁc launches Global Enterprise Services

Bayer HealthCare Pharmaceuticals, a subsidiary of Germany-based Bayer AG, raised its regional sales in Asia Pacific by currency-adjusted 5.8 percent (Foreign Exchange Adjustment - FX adj) to 604 million in 2010 compared with 2009. This surpasses the global growth of 0.9 per cent (FX adj), making the Asia Pacific region a driver of growth for the company. Among Bayer’s best-selling pharmaceutical products worldwide, the haemophilia medicine Kogenate® performed especially well, exceeding the 1 billion threshold for the first time after a 10.3 per cent (FX adj) increase in sales. Strong gains were also registered by the first and only oral therapy for advanced liver cancer drug Nexavar® (sorafenib), sales of which were up by 11.7 per cent (FX adj). Sales of the company’s novel oral anticoagulant Xarelto® (rivaroxaban), which has been introduced to markets across the region continued to grow very well. Nexavar® also registered strong growth of 41 per cent in the region, followed by YAZ® – the world’s first low-dose 24/4-day oral contraceptive pill approved for the treatment of both moderate acne and the physical and emotional symptoms of Premenstrual Dysphoric Disorder (PMDD) in women wanting oral contraception – with 23 per cent growth.

Thermo Fisher Scientific, Inc, has announced Global Enterprise Services, a suite of customisable service offerings that simplifies service delivery and increases laboratory productivity, providing laboratories with global resources to drive business efficiency and cost savings. Traditionally, laboratories rely on a variety of suppliers to provide a range of laboratory support services from planning, design, sourcing and logistics to asset management of instruments and equipment. Decisions regarding outsourcing of suppliers are typically made in a decentralised manner across multiple decision points, and this often results in service inefficiency, process overlap and higher costs. In addition, independent support solutions are rarely integrated, making it difficult to compare results, discover trends or track metrics to drive intelligent business decisions. The Global Enterprise Services portfolio delivers a customised solution at a laboratory or site level, using a consistent operational model and metrics set. The solution can scale systematically to an enterprise level, across multiple locations and countries, with minimal disruption. This integrated approach allows laboratories to consolidate tasks and integrate service delivery to drive streamlined operations, greater efficiencies and cost savings. It also leverages dedicated external resources to improve productivity with fewer internal resources, proactively manage service quality and delivery for accelerated service response times and first-time fix rates. It allows standardisation of consistent processes, resulting in consolidated laboratory service metrics to drive fact-based business decisions.

PharmaNet announces observa onal research survey results PharmaNet Development Group, Inc, a leading provider of drug development services to the pharmaceutical, biotechnology, generic drug and medical device industries, has announced the availability of the results from its fourth semi-annual industry survey on pharmaceutical observational research. The results reveal evolving trends in the design and implementation of post-approval research and identify best practices, and continuing challenges in observational studies and patient registries. The survey is designed to enhance the understanding of observational research among sponsors, regulators, policymakers, physicians and patients.

Almac and Exco InTouch form alliance to deliver pa ent compliance and ePRO services The Almac Group and Exco InTouch has announced that Almac’s Clinical Technologies business unit, the leading provider of IXRS® (Interactive Voice and Web Response) services relating to patient and drug supply management, has formed an exclusive integrated patient management alliance with Exco InTouch, an innovative firm specialising in patient recruitment, retention, compliance and ePRO services. The alliance will be focused on the integration of both technology and processes by both firms to deliver patient management, compliance, retention, and ePRO service offerings to sponsors of clinical trials. The Almac-Exco InTouch offering serves a pressing need in the drug development process; engaging, retaining and 20

enhancing compliance of patients from the earliest stages of recruitment and throughout the course of a trial. Exco InTouch will work with Almac to seamlessly integrate its market leading retention and compliance technology solutions with Almac’s IXRS® technology, an integrated phone and web platform. This unique industry offering will allow patients to receive messages for key elements of their required study conduct using Short Message Service (SMS) text messages, emails or phone calls. Examples of messages include reminders to attend clinic visits or to fill out patient diaries, medication prompts, notices to attend appointments in a fasted state, to return unused medication and even encouragement messages to keep all patients motivated to participate in the clinical trial. Modern Pharmaceuticals I April 2011

Tech Updates

Compact all-in-one chromatography equipment now available Bio-Rad Laboratories, Inc, has recently announced the launch of its new automated ch ro m a to g r a p hy station and its InPlace™ control console. The ch ro m a to g r a p hy station performs all process operations within a single unit, optimising valuable clean Bio-Rad’s Process Skid 00 room space and processing time. The chromatography station includes BioRad’s Process Skid 00, the industry’s first compact skid designed for small-scale GMP biopharmaceutical manufacturing. “Prior to the integrated design of chromatography station, users purchased chromatography systems, columns and packing accessories in separate units. Such standalone systems required the use of valuable clean room space, leaving biopharmaceutical manufacturers with limited options for small-scale production. The chromatography station addresses these issues, providing users with the same feature functionality as Bio-Rad’s Process Chromatography Skid 01 through 05 in a compact, affordable design,” said Emily Dale, Division Marketing Manager, Process Chromatography Division.

Whole transcriptome proﬁling solu on for 454 sequencing systems 454 Life Sciences, a Roche Company, and NuGEN Technologies, has recently announced the development of a unique sample preparation method and high-throughput sequencing solution for small and degraded Ribonucleic Acid (RNA) samples. 454 Life Sciences’ GS The collaboration leverages 454 Life Sciences’ junior system capabilities to construct sequencing-ready complementary Deoxyribonucleic Acid (cDNA) libraries from RNA samples and NuGEN’s experience and innovation with genomic sample preparation solutions. This collaborative effort provides researchers an end-to-end solution for transcriptome profiling using their most precious sample types. Under the collaborative relationship, the two companies have developed a solution using both NuGEN’s proprietary isothermal linear amplification products and the Genome Sequencer (GS) FLX titanium cDNA Rapid Library Preparation protocol for the GS junior and GS FLX systems.

FTIR instrumenta on by Thermo Fisher Scien ﬁc Thermo Fisher Scientific, Inc, highlights that its Fourier Tr a n s f o r m Infrared (FTIR) FTIR spectrometer instrumentation provides scientists with increased confidence in their results during Quality Assurance/Quality Control (QA/QC) testing. The Thermo Scientific FTIR instrument is designed to result in improved efficiency within the laboratory and simplify the process of complying with regulatory requirements.

The main function in QA/QC testing is to determine whether or not a product meets control specifications in relation to its identity, composition or purity. Each stage of QA/QC testing is defined by strict Standard Operating Procedures (SOPs) due to the importance of product quality. Performance verification routines provide regulatory and audit level detail on spectrometer performance, testing FTIR systems against manufacturer-published specifications. Not having to worry about the performance of their apparatus means the analyst can devote more of their time to more critical matters.

Novozymes Biopharma to present advances in cell culture technology at ESACT growth performance of cell culture media in the Novozymes Biopharma, part of Novozymes absence of serum for cell types important in viral A/S, has recently announced that the company vaccine production. will present two scientific posters at the 2011 The second poster, entitled ‘AnimalEuropean Society for Animal Cell Technology free cryopreservation and recovery media’ (ESACT) meeting, May 15–18, Vienna, Austria. examines recombinant human albumin The posters highlight the application of animal(rAlbumin) for its ability to replace serum in free recombinant supplements in cell-based the cryopreservation of CHO and hybridoma viral vaccine production as well as animal-free Novozymes Biopharma’s Recombumin® recombinant (Sp2/0) cells. Recombinant forms of other cryopreservation and recovery media. The first new poster, entitled ‘Application of human albumin protein components of serum are also assessed animal-free recombinant bioactive protein supplements to for their ability to support cell growth during the initial improve the performance of cell-based viral vaccine production’ recovery period following thawing. The findings of both demonstrates the potential of protein supplements to improve studies will be presented at ESACT 2011. 22

Modern Pharmaceuticals I April 2011

Tech Updates

Waters releases NuGenesis® SDMS 7.1 Waters Corporation has recently announced the release of NuGenesis® Scientific Data Management System (SDMS) 7.1 Service Release-7 (SR-7), structurally validated to support Microsoft’s Windows 7, both Professional and Enterprise 32bit versions, and Waters new Empower™ 3 Chromatography Data System (CDS). Additionally, the NuGenesis® SDMS 7.1 release features new functionality for enhanced SOP management, new instrument inventory capabilities and new technical foundation for interfaces

between Vision Publisher and SAP-QM or other LIMS systems. “Whether for desired efficiency gains or regulatory requirements, our customers are increasingly integrating Standard Operating Procedures (SOPs) using a range of instruments into their laboratory IT environments. Facilitating streamlined workflow procedures, SDMS 7.1 is the first release to support Windows 7 and Waters

New leukaemia cancer vaccine A new cancer treatment, which strengthens a patient’s immune system and enables them to fight the disease more effectively, is being trialled on patients for the first time in the UK. The treatment will use a new DNA vaccine, developed by scientists from the University of Southampton, which will treat a selected group of volunteers who have either chronic or acute myeloid leukaemia - two forms of bone marrow and blood cancer. Scientists believe they can control the disease by vaccinating patients against a cancer-associated gene (Wilm’s Tumour gene 1), found ‘expressed’ in almost all chronic and acute leukaemias. In the study, each participant will receive six doses of DNA vaccine over a six month period, with further booster vaccinations if successful. The vaccine will be administered in a groundbreaking new way, using electroporation, in which controlled, rapid electrical pulses create permeability in cell membranes and enable increased uptake of biological material after its injection into muscle or skin tissue. The electroporation system was developed by the US pharmaceutical company Inovio.

Mul -channel thermocouple data logger for high-accuracy measurement ITT Corporation has recently announced the introduction of the first of the ebro EBI 40 multi-channel data loggers from ITT Analytics. The 12-channel thermocouple data logger is ideal for thermal mapping in food, industrial, pharmaceutical and general lab applications, offering simple and high-accuracy measurement over wide temperature ranges. The easy-to-use ebro EBI 40 multi-channel thermocouple data logger from ITT Analytics, has been designed for a wide-range of applications including the measurement of EBI 40 core temperatures during baking processes, monitoring baking and freezing procedures and validation of dry heat sterilisers. In addition, the system enables simple qualification of coating lines and heat distribution studies in thermal chambers. The instrument also provides users with increased productivity and performance, resulting in significant cost savings and increased product output. April 2011 I Modern Pharmaceuticals

new Empower 3 CDS. Customers can move forward with SDMS and Vision Publisher using a state-of-the-art platform and benefit from streamlined QA/QC workflows, optimising productivity & efficiency and supporting Lean Six Sigma initiatives,” said Dr Maren Fiege, Informatics Senior Product Manager, Waters Division. The NuGenesis® SDMS is an automated electronic repository that stores and manages all types of scientific data to a centralised database, offering excellent integration with a multitude of research applications.

BioCision’s CoolSinkTM ensures <4°C cooling Used as an interface between a microplate and crushed ice, the BioCision CoolSinkTM thermo-conductive plate holder provides fast equilibration of all wells to below 4ºC and excellent well-to-well temperature uniformity. According to co-author Brian Schryver, Vice President, Research and Product Development, BioCision, “CoolSinkTM’s precision-engineered ‘direct contact’ stage design eliminates the insulating air gap typically found between plate wells and the resting surface. The module’s excellent thermoconductivity, due to its patented BioCision’s CoolSinkTM novel alloy construction, gives fast equilibration to below 4ºC, and using an ACM produces near identical well temperatures. This set-up provides a very simple way for researchers to ensure that all their samples are treated uniformly with no ‘plate edge effect’.” CoolSinkTM is an ideal tool for increasing the reproducibility of results in a variety of applications, such as cell-based assays, Enzyme-Linked Immunosorbent Assay (ELISA), Fluorescence Activated Cell Sorting (FACS) staining and analysis, migration or adhesion studies, temperature shift assays or any work with temperature-sensitive biomarkers. 23

Leaders Speak

‘We want to be truly an MNC of the emerging market by 2020’ Bharat Biotech Interna onal Ltd (BBIL) was established in the year 1996 by Dr Krishna M Ella, Chairman & Managing Director, BBIL, and his wife Suchitra K Ella, with a vision to generate innova ve technologies with a strong backbone of intellectual capital for manufacturing unique vaccines and biotherapeu cs. Today, BBIL is a mul dimensional biotechnology company specialising in product-oriented R&D leading to the produc on of vaccines and biotherapeu cs with global Intellectual Property Rights (IPRs) associated to its products. An insight into BBIL’s ac vi es and innova ons... Dr Asma Mohd Yousuf How has the journey been since the establishment of BBIL in 1996? In India, a scientist is expected to work in a job, where he/she gets respect. But a scientist as an entrepreneur is a thought not accepted in our country. So, yes, initially the journey for me was difficult. There were many challenges to overcome. The aim of an industrialist is to generate more revenue; however, in this process the passion for community should not be lost. Therefore, setting up of BBIL was not easy. The time when BBIL was established, the regulatory knowledge was limited. People handling the regulatory affairs had to be educated and evolved. Moreover, it was to be proved that biotechnology can be a successful industry. No one believed then that technology can change price values and can be very beneficial to the people as well as to the country’s economy.

How promising is the R&D in India and worldwide? What percentage of your revenues are reinfused into R&D? Unfortunately, so far no Indian company has launched a single molecule. India is still known for its generic market. Also, India is more known for impersonating innovations than coming up with new molecules. However, it is high time and we want to change this general notion. Also, to be sustainable and successful in today’s competitive market, it is very important to come up with innovations. This is only possible by conducting R&D. Investments should be made in R&D. However, when it comes to investing in R&D, people feel that it involves lot of money, but one should remember that you can be innovative and create successful molecule only with continuous R&D. Therefore, BBIL is not just engaged in manufacturing 24

Modern Pharmaceuticals I April 2011

Leaders Speak and marketing of vaccines and biotherapeutics, but is also engaged in conducting R&D. Investment at BBIL is a continuous plan. Twenty per cent of the company’s revenue goes in R&D, which also includes clinical research.

Kindly tell us something about the business model adopted by the company in terms of promising markets and disease areas. Our mission is to create technology for the people in compliance with global IPR. Our business philosophy is a simple fact that our competitors are not companies or countries, but infectious diseases that we are trying to combat. Currently, Indian pharma world is focussed on manufacturing and marketing of drugs for diseases like cardiovascular and diabetes. The Indian pharma companies want to compete with the global pharma giants like Merck, GSK, and Pfizer. By doing this, we are neglecting the diseases in our own countries. Instead of working on a diabetes molecule, we can also work on a malarial molecule. By thinking of diseases in India, we will come up with remedies for diseases that are drastically affecting our population as well as several other emerging economies in the world. By doing so, we will also focus on being innovative instead of impersonating. So the idea is very simple. We need to do something different than to impersonate or compete with a leading company. We at BBIL are strong believers of IPR, and we have talented young generation capable of coming up with innovations. Yes, an innovation through R&D is what we focus on. BBIL is working on manufacturing vaccines, which will be effective, will be of global standards and more importantly wil be affordable to common people.

Could you please highlight the innova ons at BBIL? By copying others, we are actually copying old technologies. Therefore, emphasis should be laid on R&D April 2011 I Modern Pharmaceuticals

Interes ng facts Besides out of respect to India, Dr Ella also wanted India to stand out for innovation. And thus, the company came to be known as Bharat Biotech, which is one of the first two biotech companies in India BBIL was the first company to set up in the very famous Genome Valley of Hyderabad. Genome valley (earlier known as Biotech Park) was barren land. It was chosen for setting up BBIL since incase of earthquakes, plants located closer to city are dangerous BBIL has the infrastructure and animal facility to test every potency from every batch before reaching market The animal facility at BBIL is 3000 sq m with European Union Good Laboratory Practices (EU cGLP) certification, and is one of the largest in India of technologies as well. At BBIL, we have Himax technology that increases production and reduces cost & capital investment. This technology was developed at BBIL for which we hold global patents as well. Revac-B+ was developed using Himax technology. It is the world’s first cesium chloride-free hepatitis B vaccine at a price of 20 cents a dose that has been dispensed to more than 350 million doses. Revac-B+ is currently exported to more than 65 countries. Besides, BBIL was the first company to launch preservative-free vaccine, which solves the issues of toxicity. BBIL also launched India’s first indigenously developed cell culture H1N1 swine flu vaccine. It is the only developing world flu vaccine to be manufactured in cell culture. The key benefit of our cell culture vaccine is its potential to scale up and produce large quantities quickly as required, it also has a much more sterile and faster production cycle, without the external dependence on eggs and thus enabling quicker response times in the event of a pandemic. BBIL currently has 47 global patents and five product patents. These patents range from formulation and protein stabilisation to viral adaptation and new vaccine development.

again stepping on the path leading towards generic market. Initially, Indian companies faced competition from foreign companies, but today it comes from Indian companies as well. Lack of vision, revenue and Food and Drug Administration (FDA) approval can kill a company. Without a focussed approach, there are chances of companies being sold out. This competition can kill the biotechnology and biosimilar market. This can lead to companies only concentrating on marketing or probably coming up of more Contract Manufacturing Organisations (CMOs), which is not good for India. Today, there are many CMOs that have come up in our country. However, it should be noted that CMOs are revenue model for companies, not country, as it will kill innovation. CMO is a labourious work with very less creativity. Anything on cost arbitration will not be effective. What is important is to stand out in the industry for the next 50 years, and for this, one has to get innovative. Moreover, the bandwagon of biosimilar by pharma companies is again injurious to Indian economy. It is high time we ask what we choose – to create a new molecule/technology or simply follow other developed countries.

In your view, what is the future of this segment?

With the vision to be a leader in regionspecific neglected diseases and to lead the emerging markets, we want to be truly an MNC of the emerging market by 2020. MPh

There are no focussed efforts on the development of biotechnology in our country. Presently, the main focus is on biosimilars. Developing biosimilars is once

Where do you see BBIL a decade from now?

(asma.yousuf@infomedia18.in)

Roundtable

Compulsory licencing for pharma

Should government ghten the norms? The Indian pharma industry aims to become a global pharma hub through high quality adherence, large produc on capacity and the benefits of economies of scale. However, this ambi ous target eyed by the industry faces a few bo lenecks and one of them is the prevailing licensing policy. Do we need to ghten the norms or keep them porous for sufficient growth of the industry? Experts in the field give a mixed bag of opinions. Anwesh Koley

ith high aims, the pharma industry sets forward its goal for the next decade. Alongwith facing hindrances like patent expirations, expanding generic market, the government is also facing dilemma with regards to licencing norms and in our country where access of medicines is an issue, would compulsory licencing work? Or are the current norms sufficient for the pharma industry?

All pharma companies carry the moral responsibility towards the health of the nation. Having said that, the practising doctors have equal responsibility to prescribe the right quality of medicine. In my opinion, the government needs to be extremely cautious and strict while issuing a licence to any pharma company. Licencing needs to be made compulsory in India. The government needs to be watchful and alert for the following reasons: Firstly, to prevent manufacturing of spurious drugs across the country. Secondly, there is a need to create awareness about mushrooming of small-time non-regulated drug

companies in order to try and bring them under regulatory purview. Also, there should be a governing body to monitor quality and keep standard guidelines with stringent quality check. There should be a standard marketing policy for all companies so that common people are not misguided. Finally, drug prices should be monitored closely in order to prevent buyers from being misled.

We live in an era wherein we depend on antibiotics and other antimicrobial medicines to treat conditions that decades ago, or even a few years ago, as in the case of HIV/AIDS, would have proved fatal. Hence, it becomes imperative for the government to adhere to pharmaceutical norms. The problem arises when people develop resistance to drugs on a regular basis. For instance, a WHO study asked the community that would they take antibiotics without a doctor’s prescription for their own use or that of your family members. To this, an alarming 53 per cent said ‘yes, they would’. Furthermore, when the survey asked whether they would save unused antibiotics for later use by you or by other family members, again, 63 per cent said ‘yes, they would’. This brings to light the urgency of implementing strict pharma norms because in a nation of 1.2 billion, it is very difficult to

spread information and awareness about the use of common drugs like antibiotics. When antimicrobial resistance - also known as drug resistance - occurs, it renders many medicines ineffective. For World Health Day 2011, WHO will be calling for intensified global commitment to safeguard these medicines for future generations. Not only India, but all member states in South-East Asia need to take up this challenge and establish monitoring mechanisms and remedial actions at all levels. Hence, the government should be aware of who is taking what for which medical requirement.

Dr Geeta Baruah Nath Senior Consultant Gynaecologist, Artemis Health Institute

Dr Nata Menabde World Health Organization (WHO) Representative to India

Modern Pharmaceuticals I April 2011

Roundtable As of today, the government should not tighten pharma norms further. The existing sets of norms are sufficient for the industry and it is all about implementing them properly. We have moved beyond licensing in India and only if the market requires more stringent norms, they should be implemented. If pharma products are being produced in sufficient quantity, there is no need to have licenses. Only if these are in short supply, should the government consider such a move. Currently, there is licensing going on even for patented products. The US Pharmacopeia prescribes guidelines and laws for standards for the quality, purity, strength and consistency

of pharma products, which are critical to the public health. These norms are widely followed around the world due to their high standards. However, every country has its own specific set of pharma laws, which need to be obeyed. In case of drug exporters, they will have to comply to the pharma norms prescribed in the importing country and not its domestic guidelines. This warrants high quality control measures by the government of the exporting country as a lot can be at stake.

The government should not tighten norms in the pharma industry as there is already enough control over the sector by the government. Compulsory licensing may not have a meaningful impact as patents are not the prime cause of poor accessibility of medicines in India. The sales of patented products account for much less than 1 per cent in the Indian pharma market. The existing laws are quite flexible and sufficiently clear and can be used effectively at the required times. Also, this issue of compulsory licensing will impact the M&A rules, which will in turn affect the profitability as there will not be enough margins to promote. The fear that these M&As between multinational companies and Indian pharma companies may lead to an oligopolistic market and jacking up of prices is unfounded and unsubstantial. It will be irrational for India to remove pharmaceutical sector from the automatic route and direct every such transaction through Foreign Investment Promotion Board (FIPB). Compulsory license should be issued only

in the event of a national emergency such as epidemics or non-availability of essential drugs at reasonable price, giving due consideration so as not to issue a compulsory license in an inappropriate situation. There are other ways to provide quality medicines at affordable prices to the masses. Collaboration between the pharmaceutical companies and the government is the best way to make high quality medicines accessible to all. Also, the government has already imposed a lot of measures for the pharma industry and all that is needed is proper implementation of the norms. The Central Drugs Standard Control Organization (CDSCO) – the apex body regulating pharma industry in India – has already issued a circular on January 1st 2010, announcing a set of new rules for exporters of pharma products.

Pharma industry in India has been highly successful not only in meeting the needs of the domestic market but it has also carved out a place for itself as a leading player in the generic market. While the global pharma industry has chosen the path of drug discovery, India’s pharma industry also has been innovative in meeting the need for cost-effective and quality drugs. It has established production facilities that conform to global standards. India’s pharmaceutical industry serves effectively the need especially of developing countries for affordable medicines. Formulations in various dosage forms are being produced in Good Manufacturing Practice (GMP) compliant facilities. Strong scientific and technical manpower and pioneering work done in process development have made this possible. The challenge that the global pharma industry faces in discovering new molecules that would keep their

new drug pipeline full, the industry is going through a transformation. Global companies are eyeing leading drug companies in India and in recent months the industry has witnessed mega M&As. Naturally, this trend is viewed with concern and eyebrows are raised. The pressure on the State to legislate is rising. Surely, the people of the country have a right to demand affordable medicine. Access to affordable healthcare is as important as food at affordable prices. Given the mood of the present government, the measure to keep global companies from predatory seems most unlikely. I would want the state level government to intervene but if India’s drug makers think otherwise, there is little that can be achieved by legislative measures.

April 2011 I Modern Pharmaceuticals

Omprakash Sadhwani Assistant Commissioner, Food and Drug Administration (FDA)

Prashant Saigal Vice President, Nestor Pharmaceuticals

Rajabahadur V Arcot Vice President and General Manager (South and South East Asian operations), ARC Advisory Group 27

Industry Update

Parita Dholakia

The pharmaceu cal industry was skep cal about the large-scale spending on Informa on Technology (IT). But today, this thought has totally changed. With emerging solu ons that increase opera onal eďŹ&#x192;ciency and reduce me, the health of this industry depends on a dose of IT.

Modern Pharmaceuticals I April 2011

Industry Update

silent trespasser has engulfed the pharma and healthcare industry and already seems indispensible at all stages of drug development cycle to the final delivery of healthcare and products! Yes, we are talking about IT. IT has been an integral part of the pharma and healthcare industries for a long time now, and the days of manual calculations and analysis are passé, at best. Pharma & healthcare companies are under immense pressure to maintain market share and profits and have realised the need to evolve & adapt in this age of cut-throat competition. Companies have adopted businessdriven intelligent and practical solutions that help them increase efficiency and reduce time and effort, and Statistical Analytical Software (SAS) is one of the leading solutions in this endeavour.

Pharma learns to love technology With a large number of patents set to expire in the coming years, it is predicted that over $150 billion worth of revenue from branded drugs will be affected! The reduction in newer drug production and dawdling production of New Chemical Entities (NCE) have necessitated that pharma companies invest in better collaborations, standardisation and analytical tools in order to improve R&D production as well as sales and marketing. Clinical trials are now becoming both more aggressive and efficient in terms of global supply and forecasting, and technology can help minimise errors and redundancy, expedite the drug development cycle and help improve the overall healthcare scenario in these changing times. IT solutions provide quick and accurate results and in today’s competitive environment all companies have realised the need to procure the same. The same thought is reiterated by Ilango Ramanujam, Vice President, Clinical & Regulatory Services, TAKE Solutions, “IT solutions’ essential aim is to bring about gains in operational efficiencies for integrating and analysing data from clinical trials, and to allow biostatisticians April 2011 I Modern Pharmaceuticals

Electronic data capture, assisted data explora on, centralised informa on management and processing and standards compliance are some of the solu ons that are associated with clinical data analysis. Use of IT solu ons is known to bring down the data analysis me by 50 per cent. Ilango Ramanujam Vice President, Clinical & Regulatory Services, TAKE Solu ons

and clinicians to focus exclusively on scientific innovation. Pharma and healthcare industries are highly regulated for patient safety and require compliance with guidelines. Electronic data capture, assisted data exploration, centralised information management & processing and standards compliance are some of the solutions that are associated with clinical data analysis. Use of IT solutions is known to bring down the data analysis time by 50 per cent.” In today’s scenario, the intriguing question is not what IT can do, but rather what IT cannot do! Data management has been an IT forte since a long time, but with the increasing demands for centralised, integrated, quick and accurate results and analysis, IT solutions for various stages in the drug development cycle are now being developed. Right from detecting an accurate match from a thousand random candidates, analysing raw materials, keeping a record of the entire manufacturing process, data management and analysis during clinical trials, to maintaining electronic health records - IT helps all along the way. In the pharma and health-related industries, SAS has emerged as a preferred data management tool for statistical analysis of research data, which includes but is not limited to data management from clinical trials of new drugs, clinical and health surveys, health insurance industries and patient information from healthcare providers. In the words of Ashit Panjwani, Executive Director, SAS India, “Healthcare is one of the most critical sectors for SAS. We are trying to build value opportunities, which can contribute to the pharma and life sciences sector. This is a wide

area and we are very excited to cater to the several needs of this industry.” SAS helps optimise the flow of valuable scientific and operational data within pharmaceuticals and biotechnology companies, thereby affording a fast and profitable introduction of drugs to the market.

Sassy SAS Introduced in 1997 in India, SAS provides support to several sectors including healthcare and pharma. Informs Panjwani, “We have several solutions that can help the healthcare and pharma industry, ie, right from Clinical Research Organisations (CROs), who use our data management solutions to big pharma companies, who uses our drug discovery/ development solutions.” Speaking on the benefits and universal appeal of SAS, Manoj Yasodharan, Head, Clinical Data Management & Biostatistics, Clinigene, informs, “SAS is a widely used solution in the arena of clinical research and provides the advantage of reproducibility and ease of exchange between CRO, regulator and sponsor. Today, almost all sponsors ask for data in the SAS data set to perform some ad-hoc or exploratory analysis, which is outside the scope of clinical trial registration.” SAS, owing to its extensive statistical functions and powerful reporting capabilities, has emerged as a key aid in the analysis of research data. Informing about the wide capabilites of SAS, Nimita Limaye, Vice President, Global Head, Strategic Data Services and Medical Writing, SIRO Clinpharm, says,“The clinical data needs to be analysed and presented appropriately and SAS is one of the software, which is widely used 29

Industry Update

are trying to build value opportuni es, which can tribute to the pharma and life sciences sector. This is a wide area and we are very excited to cater to the several needs of this industry. Ashit Panjwani Execu ve Director, SAS India

in the industry for this purpose. SAS is the industry leader for providing data integration and analysis tools to research organisations.” CROs may use different IT solutions for the various stages of the trial. For example, Yasodharan mentions that Clinigene uses NuGenesis SDMS for bioanalytical and bioequivalent studies, and Winnolin for pharmacokinectic studies. Informs Yasodharan, “Even though other software for data management like Oracle Clinical are available, SAS is preferred as it offers a single platform for data capture and analysis.”

Various modules A number of benefits are associated with the availability of demand-specific modules. Speaking about the various applications of SAS in CROs and the need to adopt SAS, Limaye says, “Experience in dealing with problem areas such as data transfer issues between the data management and biostatistics and programming team, or issues stemming out of an ambiguous Case Report Form (CRF) data element, which can lead to the inaccurate data capture of the data on a CRF form, have made it compulsory for software such as SAS to be used to ensure data standardisation and a seamless data interchange across the data lifecycle with Study Data Tabulation Model (SDTM) and Operational Data Model (ODM) standards guiding the entire workflow right from CRF design all the way until Case Report Tabulation Data Definition Standard (CRT DDS) generation. Thus, employing an SAS-powered clinical database, helps reduce the study set up time, time from database lock to analysis as well as ongoing maintenance costs.” 30

Drug development: SAS Drug Development provides a centralised, integrated system for managing, analysing, reporting and reviewing clinical research information. The solution enables organisations to make informed business decisions with confidence, to assess the safety and efficacy of research compounds more effectively and to collaborate across trials, phases and therapeutic areas successfully. This ultimately results in

SAS reduces the me lag between data capture and report genera on, roughly from 15 days to just 2 or 3 days. Thus, pa ent disqualiﬁca on can be iden ﬁed literally within a couple of days.

quicker release of better products to the market. Affirms Limaye, “SAS Drug Development gives research companies a single data repository for effective access, collaboration and analysis. Everyone has the same easy view into the ‘process’.” Data integration: Several pharma companies have realised the need for an optimal supply chain and financial management, following which data integration of the voluminous information obtained from clinical trials is getting the importance it deserves. Data integration without achieving end results for analysing the obtained data/results or without

any fancy charts and graphs is crude. SAS Clinical Data Integration organises, standardises and manages clinical research data and metadata. It provides the foundation one needs to ensure standard, trusted clinical data to support strategic analyses, such as cross-study and advanced safety analysis. This solution provides benefit not only to CROs but also to sponsors because of standardised data for internal analysis and lower cost and higher quality for submission standards. Speaking about the various benefits of SAS Clinical Data Integration, Limaye says, “Clinical Data Interchange Standards Consortium (CDISC) standards are increasingly used for submitting study metadata and data to regulatory agencies. In the US, the FDA has adopted CDISC standards for submission of tabulation data (SDTM) and the main study metadata XML file (CRT-DDS). SAS realises data standardisation involves more than just mapping to CDISC standards, so SAS Clinical Data Integration supports the implementation of an organisation’s internal data standards. In addition, SAS understands the importance of supporting healthcare data standards in the future.” PheedIT: PheedIT is a web-based solution built on SAS and web technology. It is a one-stop solution for the entire clinical research process. Other than data management at the time of trial, PheedIT can instruct when to start the launch of the trial after successful recruitment of patients. With plans to develop more such solutions that can cater to almost all sectors of the industry, SAS is proving to be one-stopshop solution. Says Panjwani, “SAS is trying to penetrate all sectors of the pharma space, right from inventories to managing the entire supply chain. We also are focusing on enterprise-wide analytical solution to cater to the healthcare and life science sector.” He informs, “One of the upcoming solutions is ‘Physician targeting,’ which will help in the healthcare industry and hospitals.” Modern Pharmaceuticals I April 2011

Industry Update

Today, almost all sponsors ask for data in the SAS data set to perform some ad-hoc or exploratory analysis, which is outside the scope of clinical trial registra on. Manoj Yasodharan Head, Clinical Data Management & Biosta s cs, Clinigene

Advantage SAS To enlist a few of the multi-fold user benefits, the following can be summarised: Compliance to regulatory standards: The proportion of rejected applications from the Food and Drug Administration (FDA) has remained constant over the years at about 10 to 15 per cent, affirming that regulatory standards are extremely important in the pharma field. With FDA announcing new electronic filing rules, maintaining standards gains more importance. Asserts Panjwani, “Compliance to regulatory standards is one of our biggest advantages.” As per Yasodharan, “Data in SAS formats are widely accepted by regulators/sponsors throughout the world. European Union (EU) and US regulators are recommending SAS formats to be submitted along with clinical study reports.” In addition, clinical data management (CDM) solutions provided by SAS are compliant with global, uniform standards of conduct and standard operating procedures that meet FDA and International Committee of Harmonisation (ICH) requirements. Agrees Limaye, “The reputation of SAS as a tools provider in this space is unmatched, and virtually all life sciences research companies use SAS for transforming, analysing and submitting clinical data to the FDA and other international regulatory agencies. With an established customer base and the availability of SAS Drug Development on the SAS 9 platform, there is increasing market confidence in SAS’ ability to provide advanced, integrated and scalable 32

life science solutions, which deliver unique capabilities and benefits.” Time factor: SAS reduces the time lag between data capture and report generation, roughly from 15 days to just 2 or 3 days. Thus, patient disqualification can be identified literally within a couple of days. Instead of focussing time on data collection, one can spend more time on analysis. As Yasodharan mentions, “Without IT solutions, it would be a very labourious work and many a times quality would be compromised. These softwares allow us to process huge chunks of data in a fraction of a second.” User friendliness: To analyse the reports of clinical trials or any other analytical studies in the pharma industry, statisticians are indispensible. Informs Ramunajan, “A study statistician and two programmers could comprise a

small team to complete the analysis of a trial. However, the team size can vary significantly depending on the trial scope and analysis timelines, and this eventually requires more programming staff.” While using different software one may require software-specific experts. However, SAS may give one a leeway considering its user-friendly interface. As informed by Yasodharan, Clinigene has four excellent SAS programmers, and they suffice. SAS programmers need not be statistical experts. The same is affirmed by Ramanujam, “With the use of SAS, experienced statistical programmers with minimum guidance from the study statistician can perform the statistical analysis.” Further, Panjwani agrees, “One might not necessarily require SAS experts to run the application, and a few months of training might be enough for anyone to handle the application.”

Hindrances The way the industry is progressing, it might be difficult to gauge the way in which such IT solutions would lead the path in India. It might face certain hindrances. Limaye agrees, “While this is a software that is used globally, the challenges lie in finding skilled resources

Examples of some companies using SAS solutions Company

Solution used

Purpose

AstraZeneca

SAS Enterprise BI Server

Minimising variations in the production process, expand contents of analyses performed

Solvay SAS Drug Development Expedite and globalise drug Pharmaceuticals development process resulting in shorter time to market Eli Lilly Several For drug discovery, toxicology studies, drug formulation development, clinical trials, sales and marketing, and manufacturing Clinigene

PheedIT (CDM)

Integrate data sources into a central repository for quick analysis of real-time data and online validation of patient eligibility Nicholas Piramal SAS Data Warehousing Streamlining the multifarious data lying in different systems and in various parts of the company Source: www.sas.com

Modern Pharmaceuticals I April 2011

Industry Update

SAS realises data standardisa on involves more than just mapping to CDISC standards, so SAS Clinical Data Integra on supports the implementa on of an organisa on’s internal data standards. In addi on, SAS understands the importance of suppor ng healthcare data standards in the future. Nimita Limaye Vice President, Global Head, Strategic Data Services and Medical Wri ng, SIRO Clinpharm

in India. Since the adoption of softwares such as SAS has been relatively new, experienced resources are difficult to find. Thus, resources with five to six years of experience, with a deep understanding of the clinical interpretation of the data are rare to find. This does result in a significant supply and demand gap, driving attrition, impacting wage structures as well as the long term growth of this business in this geography.” Says Yasodharan, “Because IT offers lot of benefits than its conventional alternatives, it has been used in almost all fields. These benefits help achieve increased quality output, less hours of work and better resource planning.”

April 2011 I Modern Pharmaceuticals

However, he continues, “Dependence on one particular solution or platform is a potential risk for any company.”

Are you IT’ed yet? According to the Pharmaceutical Research and Manufactureres of America (PhRMA), America’s biopharmaceutical sector spent a total of $67.4 billion on R&D in 2010, which is a $1.5 billion increase over the expenditure in 2009. These figures indicate the trend of pharma industry to invest in R&D, and to achieve their targets IT definitely acts as a catalyst in this quest. Squeezing profits, pressure of gaining market share, need to be keep pace with

the industry, efficient and timely results with minimum errors and providing an effective message to the masses, are some of the reasons several pharma and healthcare have turned to IT. Limaye’s take on the use of IT/SAS is interesting. She says, “IT provides tools such as SAS that allow for the efficient processing and analysis of data for regulatory submission. Thus, IT complements clinical drug development in this manner. Players in the IT industry leverage their expertise in this domain to establish an edge; however, it is always going to be about complementing clinical expertise with IT capability.” So incase one is still contemplating on whether to tread the old path of manual work and wait to get things on the move, we suggest that this is the right time to shed off these inhibitions and embrace IT-based solutions for all needs. SAS is just one of the myriad IT solutions, and the path of adopting IT is much easier than anticipated. Try it out! MPh (parita.dholakia@infomedia18.in)

Market Trends

Nanotechnology in life sciences industry

A proﬁtable venture? Nano Science and Technology Ini a ve (NSTI) contributed $15 million for the development of nanotechnology over ﬁve years. It enabled funding of about 100 research projects, set up six centres for nanotechnology and one for computa onal materials science across India. With this, does the pharma industry see a lucra ve prospect? nanoparticles. Again, it can be said that considering the strategic importance of R&D in this area, the Department of Science and Technology (DST) has been levying tremendous thrust on nanomaterials. The Indo-US joint forum on science and technology has identified this area of research for intense cooperation. Besides, Government of India’s Nanomaterials Science and Technology Initiative (NSTI) offers a forum for greater cooperation. As part of this scheme, Government of India has plans to spend ` 1,000 crore on R&D in nanotechnology over the next five years.

Coming to the forefront

Chandreyee Bhaumik

ttempts are being made by the Indian government to speeden new developments in nanotechnology, and several technologies from the laboratories are to be commercialised in this respect. Nanotechnology, an important aspect of biotechnology, is assuming interest, both in the industry as well as in academia. The concept of nanotechnology was proposed and popularised by the noted American physicist, Dr Richard Feynman. It encompasses the ability to arrange and rearrange molecular structures, which aims to bring a change

and thereby impact the way everything is manufactured. If we can pack 100 atoms into a cubic nanometre, and each atom can be any of the approximately 100 elements, then there is something like 100100 different ways in which we can arrange the atoms in just a single cubic nanometre. However, this is not an easy affair since there is no general consensus that will determine and direct how to achieve this. In 2007, India had initiated a programme with a budget of $255 million that would aim to promote nanoscience and nanotechnology. Further, several public and private research institutes are working on carbon nanotubes and

Nanotechnology is a multidisciplinary field bringing forth a convergence of basic sciences and applied disciplines like biophysics, molecular biology and bioengineering. Commenting on this, K V Subramaniam, President and CEO, Reliance Life Sciences, affirms, “It has impacted various fields of medicine including cardiology, ophthalmology, endocrinology, oncology, pulmology, immunology and highly specialised areas like gene delivery, brain targeting, tumour targeting and oral vaccine formulations. Nanotechnology also provides intelligent systems, devices and materials for better pharmaceutical applications.” In the same vein, Subramaniam avers, “Nanomaterials, particularly nanoparticles and nanocomposites, currently dominate the nanotechnology market. The largest end-user markets for nanotechnology are environmental remediation, electronics, energy and biomedical applications.” It is also seen that nanotechnology Modern Pharmaceuticals I April 2011

Market Trends is relevant to the pharma industry. Commenting on the use of nanotech in pharma sphere, Subramaniam continues, “In the pharma industry, application of nanotechnology to provide new drug delivery systems is an emerging area, requiring lesser investment and expected to be a high profit-making proposition. Cancer and central nervous system disorders are the fastest growing application areas. Hence, nanotechnology has generated significant interest in the pharmaceutical industry.” Discussing the scope of nanotechnology in biotechnology, Dr Santhosh Kumar, Medical Advisor, Anglo-French Drugs & Industries Ltd, explains, “Today’s highest resolution, the nanoworld, reveals structures inside cells, molecular components of structures and even ongoing processes in living organisms. Nanoscale devices and materials help scientists to interact with a variety of biological events down to the molecular level. These applications benefit life science research, clinical diagnostics, drug development and many other areas.” According to Nanotechnology in Healthcare, a novel study from The Freedonia Group, Inc, a Clevelandbased industry research firm, demand for nanotechnology medical products will increase by over 17 per cent per year to $53 billion in 2011. Again, the increasing flow of new nanomedicines, nanodiagnostics and nanotech-based medical supplies and devices into the US marketplace will boost demand to more than $110 billion in 2016. Elaborating on the current demand, Dr Kumar reiterates, “The critical need for new or improved therapies for many medical conditions will promote the adaptation of nanotechnology to an expanding number of biotechnologically driven pharmaceuticals. The total market for nanomedicines will command strong growth over the long term.” Further, he continues, “Treatments based on humanised monoclonal antibodies, nanopolymers and nanoproteins will drive gains, with compounds for April 2011 I Modern Pharmaceuticals

he pharma industry, applica on of nanotechnology to provide new drug delivery systems is an emerging area, requiring lesser investment and expected to be a high proﬁt-making proposi on. K V Subramaniam President and CEO, Reliance Life Sciences

cancer, heart diseases, neurological disorders and viral infections leading to new product introductions and growth opportunities. Advances in nanotechnology will also contribute significant improvements to the quality and performance of medical diagnostic products.

This industry is s ll at a nascent stage and would be driven primarily by the value proposi on speciﬁc to each end use - engineering, medicine and materials sciences, in par cular.

Time for a ‘nano’ approach Practical nanotechnology is essentially and significantly the increasing ability to manipulate (with precision) matter on previously impossible scales, thereby presenting possibilities which many could never have imagined - it therefore seems unsurprising that few areas of human technology are exempt from the benefits which nanotechnology could potentially bring. Hence, this science finds applications in almost every field/ business/science known. Dr Mandar Kubal, Consultant Infectious Diseases and HIV Aids, Infectious Diseases and Pulmonary Care (IDPC),says, “The major problems with the medications available today are the bioavailability, solubility, toxicity,

lack of targeted drug delivery system, to name a few. Also, for the industry at large, developing a New Chemical Entity (NCE) with the least of the above mentioned problems is time consuming and costly with the probability that it may never be approved for human use in the first place. If by applying the principles and components of nanotechnology, we can convert the negative points of the existing molecules, it would be much cheaper and more acceptable.” He further provides a few numbers to show the importance and the scope for this subject. Dr Kubal says, “As far as the international pharma innovators are concerned, many of their top brands are coming off patent by the year end. The losses estimated are around $ 70 – 80 billion due to patent expiry. It would rather be prudent to invest money in nanopharmacy rather than an NCE to cover up the losses. Major corporations are hence investing heavily in nano R&D, to find practical applications for old concerns.”

Taking a prac cal route This industry is still at a nascent stage and would be driven primarily by the value proposition specific to each end use – engineering, medicine and materials sciences, in particular. Further, nanobiotechnology is being increasingly looked at from the point of view of direct delivery of drugs into the human body. Applications of nanobiotechnology are widespread. Dr Kubal categorises the application of nanotech in pharma arena. He discusses, “The major applications of the technology in pharma industry lie in smarter drug delivery systems, smart material for tissue engineering and also 35

Market Trends

n the pharma industry, applica on of nanotechnology o provide new drug delivery systems is an emerging area, requiring lesser investment and expected to be a high proﬁt-making proposi on. Dr Santhosh Kumar Medical Advisor, Anglo-French Drugs & Industries Ltd

smarter diagnostic materials. Using this concept there is a possibility that many molecules that never progressed in clinical trials due to safety issue might see the light of the day and thus be available for clinical use. The dried up pipeline of drugs for many medical illnesses may suddenly find a lot of nano pharma gushing out of it.” This is one of the major areas of focus in the current environment. It involves using nano systems to deliver a particular dose of drug to the target. Dr Kubal clarifies this point and reiterates, “It may be a smarter drug delivery system of an older drug, e.g., Liposomal Amphotericin B, which is Amphotercin B delivered using a liposome as the vehicle and hence facilitating higher drug concentrations at relatively less nephrotoxicity than the conventional drug. Such preparations are now commercially available in India as generic versions too.” Smarter drug delivery may also involve targeted drug delivery to the intended target organ/cell only thereby preventing unintended damage to nearby tissue and hence definitely the side-effects. Dr Kubal says, “One of the major areas where this is utilised is delivery of chemotherapeutic

agents to the tumour cells only in case of cancers.” Aradhana Dixit, Senior Product Manager, Plethico Pharmaceuticals Ltd, believes that nanotechnology, biotechnology together with Information Technology(IT) can do wonders. Discussing the practical use of nanotechnology, she affirms that it can be extensively used for medicines. She opines, “Nanotechnology in medicine is currently being developed

Quick picks Nanotechnology is enabling new applications in the areas of molecular imaging and early detection, in vivo imaging, reporters of efficacy, multifunctional therapeutics and research tools. and involves employing nanoparticles to deliver drugs, heat, light or other substances to specific types of cells such as cancer cells.”

Pharma taking the front seat The key benefit of nanotechnology in

would rather be prudent to invest money in nopharmacy rather than an NCE to cover up the losses. Major corpora ons are hence inves ng heavily into nano R&D, to ﬁnd prac cal applica ons for old concerns. Dr Mandar Kubal Consultant Infec ous Diseases and HIV Aids, Infec ous Diseases and Pulmonary Care (IDPC)

the pharma industry would be in the area of novel drug discovery as well as developing novel devices for treatment of various diseases. Discussing the advantages in this context, Subramaniam asserts, “One example of current nanobiotechnological research involves nanospheres coated with fluorescent polymers. Researchers are seeking to design polymers whose fluorescence is quenched when they encounter specific molecules. Different polymers would detect different metabolites. The polymer-coated spheres could become part of new biological assays, and the technology might someday lead to particles, which could be introduced into the human body to track down metabolites associated with tumours and other health problems. Again, another example, from a different perspective, would be the evaluation and therapy at the nanoscopic level, the treatment of Nanobacteria as done by NanoBiotech Pharma.” Dr Kumar avers, “By 2016, nano implants will be widely employed in orthopaedic procedures and begin to gain experimental uses in tissue and neuron regeneration. By 2021, nanotechnology will serve applications that extend into most areas of critical and chronic care. Additionally, the development of monoclonal antibody and nanomaterial vaccines and, to a lesser extent, controlled-release nutritional preparations will create a large preventive medicine market.” While discussing the use of nanotech in the field of pharma, Dr Kumar opines, “The application of this patented nanotechnology enables the realisation of pharmaceutical forms that were up to now impossible. That means complex and cost-intensive manufacturing processes are needed to make these drugs available for the therapy.” In this context, he adds, “With the help of the patented nanotechnology, they are able to convert the drugs, which were previously available only in parenteral form, into, eg, oral administration Modern Pharmaceuticals I April 2011

Market Trends Helping hand from Government nces in technologies, such as DNA microarrays, micro lectromechanical systems and micro ﬂuids, will enable the realisa on of the poten al of nanotechnology for food applica ons. Aradhana Dixit Senior Product Manager, Plethico Pharmaceu cals Ltd

forms. This signifies a huge progress for the patient’s quality of life.” Therefore, it can be said, by utilising this new technology, customers can receive the benefits that were till date hardly possible. Nanotechnology is able to reduce manufacturing costs, and improve the specificity and the effectiveness of the drug, moreover, the ability to reduce the side-effects of therapy. Although still far from a cure, the area of healthcare where nanotechnology has made its greatest contributions is cancer. Nanotechnology is enabling new applications in the areas of molecular imaging and early detection, in vivo imaging, reporters of efficacy, multifunctional therapeutics and research tools. Significant achievements by Indian pharma industry so far by using nanodevices are: Development of one dose-a-day ciprofloxacin using nanotechnology Tumour-targeted taxol delivery using nanoparticles in Phase II clinical trial stage Improved ophthalmic delivery formulation using smart hydrogel nanoparticles Oral insulin formulation using nanoparticles carriers Liposomal-based Amphotericin B formulation

Delving deeper It can be said that one of the main goals of using nanotechnology for medical purposes is to create devices that can function inside the body and serve as drug delivery systems with specific targets and cancer detector. 38

In this regard, Dr Kumar establishes, “Current treatments for cancer using radiation and chemotherapy are invasive and produce debilitating side-effects. Nanotechnology has the potential to treat various forms of cancer by targeting only the cancer cells. Researchers at Rice University have developed a technique utilising heat and nanoparticles to kill cancer cells.”

Investment pa erns Several Indian companies have already made the required moves to compete with multinationals. Therefore, they have begun to invest intelligently into R&D. Dr Kumar opines, “Ranbaxy, Torrent, Wockhardt, Dr Reddy’s Laboratories, Sun Pharma and Piramal Healthcare etc together have made capital investments of over ` 200 crore. Cadila Healthcare, Cipla, Lupin and Aurobindo are making similar investments. By the end of the first decade of this millennium, the total investment into R&D will be to the tune of ` 500 crore.” While commenting on the investment pattern, Shruti Pande, Clinical Research Associate, International Clinical Research, Wockhardt Ltd, avers, “As with any new development, there are sceptics abounding on the fringes of nanotechnology. The science’s real potential will take many years to come to fruition, but in the meantime much of the research is being hyped up. The true extent to which many of those becoming involved are there for the long haul, and an investment in nanotechnology is for the long term.”

The Government has been at the forefront of promoting nanotechnology industry in India through its three major funding agencies, namely Department of Science and Technology (DST), Department of Scientific and Industrial Research and Department of Biotechnology. DST launched the Nano Science and Technology Initiative (NSTI) in 2001 under the leadership of Prof. C N R Rao. Dr Kubal says, “Its aim is to make India a major player in this sector, and provided a total of $15 million for nanotechnology over five years. The NSTI funded about 100 research projects, and provided funding for setting up 10 core groups in nano science, six centres of nanotechnology, and one of computational materials science at different institutions across India. DST remains by far the largest funding agency. Government spending in nanotechnology through all its funding agencies amounted to less than $20 million in 2003-04 out of total R&D expenditure of about $3.03 billion (0.8 per cent of GNP of India). According to government figures, the government has spent approximately $50 million over the past five years to promote R&D in the area of nanotechnology.

Surviving the compe on Nanobiotechnology is a novel sector and among other challenges funding is an issue. As Subramaniam says, “Public sector funding is increasing in this area. Big pharma companies have so far been lukewarm to investing in these technologies. This may be overcome by industrial collaboration, consolidation and licensing agreements between nanobiotech players, government institutions and pharma/biotech companies.” Further, market development is taking time due to lack of regulatory guidelines and public concern over the potential health and environmental impacts of manufactured nanoparticles. Subramaniam explains, “There are some Modern Pharmaceuticals I April 2011

Market Trends Binocular vista true extent to which many of those becoming olved are there for the long haul, and an investment in nanotechnology is for the long term. Shru Pande Clinical Research Associate, Interna onal Clinical Research, Wockhardt Ltd

ethical, scientific, social and regulatory issues posing various challenges in practical realisation of pharmaceutical nanotechnology. Some major health risk associated with such devices includes cytotoxicity, translocation to undesired cells, acute and chronic toxicity; unknown unpredictable and undefined safety issues, environmental impact of nanomaterials and nonbiocompatibility.” Explaining the concerns in detail, he says, “Some ethical issues are altered gene expression, ultimate fate and altered or permanent anomaly in cell behaviour/ response on short/long term exposure. There are no specific Food and Drug Administration (FDA) directives to regulate pharmaceutical nanotechnology-based products and related issues.”

Rulebook details The notion that companies must innovate to survive has become more commonplace as competitive pressures and economic volatility define the business landscape. Dr Kumar shares his opinion in this regard. He says, “For challenges affecting the nanotechnology industry, three general categories are intellectual property issues, regulatory issues and pharmacovigilance. Combined, these have the potential to create a perfect storm for the industry if not properly addressed.” Intellectual property assets are the lifeblood of companies in all industries. Dr Kumar reiterates, “By 2011, the pharma industry faces the potential loss of approximately $70-$80 billion of drug revenues as various blockbuster drugs go off-patent.” He cites several critics’ opinions and says, “Critics argue 40

that Big Pharma either fell asleep at the wheel by not building nanotech capabilities early enough or that they were more focused on shareholder profits than on innovative therapies. As a result, some are even changing their business model to include outsourcing of various functions to stay competitive.” This is where leading biopharma or specialty pharma companies may have a slight advantage. In particular, those focused on nanotech-enabled discovery, development or platform technologies that increase benefits while reducing costs are now in a position of strength for licensing, outsourcing or other collaborative opportunities with Big Pharma. The challenge for Big Pharma will be to swiftly adapt to a new business model that has the right balance of inhouse and outsourced processes. They will also need to make efficient use of resources to identify and incorporate nanopharmaceuticals and processes into their pipeline. This will be virtually impossible for companies that have cut their tech-scouting staff and risked giving away cheap buying opportunities to competitors. The challenge for small/medium biopharma and specialty pharma will be to figure out the best way to get on Big Pharma’s radar. Discussing the regulatory issues, Dr Kumar cites a study and says, “With regard to regulatory issues and pharmacovigilance, safety and toxicity concerns continue to mount. An estimated $147-billion worth of nanoenabled commercial and consumer products were sold in 2007 and this amount it predicted to top $3.1 trillion by 2015, according to Lux Research, a market analyst firm.”

This segment holds an immense potential. Subramaniam says, “Nanotechnology industry is currently estimated to be around $ 12 billion globally. It is expected to grow multifold over the next ten years.” While discussing the future scope of this segment, Dr Kumar says, “Nanotechnology also has the ability to get us closer to personalised medicine. Targeted therapeutics with smart drug delivery devices and theranostics will drive this trend forward. On the surface, these two trends are not likely to have a favourable impact on pharma’s current business model, but they could if pharma adapts its business model to align more closely with scientific and market trends. The market will demand these technologies based on benefits and costs as compared to today’s alternatives. Areas of nanotechnology advances with a direct benefit to pharma and biopharma are those that will not only further improve efficacy and reduce side-effects of existing drugs, but that will enable a faster discovery process to eliminate non-efficacious drugs much earlier and with less investment.” Thus, in this regard it can be said that the companies that have decided to outsource these upstream processes will still need to understand what they are dealing with and incorporate the necessary processes and collaborative efforts with regulatory agencies to move the product along the development pathway. In short, it can be considered that recent development, market realisation of various pharmaceutical nanotools and global interest shown by scientists, governments and industries ensure that there is tremendous potential and scope of nano-based drug delivery system in the near future. In this strain, Dr Kumar categorises, “There is no doubt to presume that in next ten years market will be flooded with nano-enabled delivery devices and materials.” MPh (chandreyee.bhaumik@infomedia18.in)

Modern Pharmaceuticals I April 2011

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,

Retail Zone

Standalone chemists

Leveraging economies of scale It is diﬃcult for standalone chemist stores to thrive in these mes of chain drug stores. An associa on of chemists on a local scale can help several pharmacies together. Several beneﬁts and precau ons to form such associa ons are provided here. strategies to fight the competition from chain stores & thrive in business.

Economies of scale: Chemist cluster network

etail business is like cycling, either you are peddling and moving or you fall down. So it is important for the standalone retail pharmacy stores to increase its customer base and store sales to leverage the economies of scale and get higher profits. Normally, these things are restricted to drug store chains, but it is possible for the standalone drug stores to leverage the economies of scales with no change in their identity or without hiring a team of retail professionals.

Rajendra Pratap Gupta International Healthcare Policy & Retail Expert

For an individual pharmacy store to grow, it is imperative that the store focusses strongly on retaining and growing its chronic customer database (as 60-80 per cent of the sale is contributed by the chronic customers), increase the assortment of products (over the next three to five years, the share of pharmaceutical products will reduce and Over-The-Counter (OTC) and Fast Moving Consumer Goods (FMCG) products will increase), increase the margins from buying (retailers make money in buying) and enhance the income from merchandising (OTC & FMCG companies are paying for the premium – high visibility shelf space). Chain drug stores are on the growth path; the standalone pharmacy stores will either have to come together and leverage the economies of scale or face stiff competition from chain drug stores. So the top most priority for the standalone stores is to find

There could have been no better time than now to look at the chemist cluster network. All India Organisation of Chemists and Druggists (AIOCD) tried to start a chain but was marred by its reputation and lack of professional culture. Moreover, AIOCD has always been known for its arm-twisting tactics and could not garner support of the industry. Also, the organisational politics created an internal split within the AIOCD. The idea of an AIOCD chain was badly executed. Under the current scheme of things, it is clear that AIOCD cannot succeed in its goals. But the standalone pharmacy can try forming a network of stores (chemist cluster network) in an area or town, and order goods from the distributor together; or enter into a deal with a group of distributors to promise a certain quantum of orders and gain a higher percentage of discount & some schemes. Also, a lot of other benefits can come by forming such a chemist cluster network. It is very important for a standalone pharmacy stores to leverage the economies of scale through better efficiencies in the backend: supply chain – buying margins, as every single percentage extra margin from the distributer contributes to the profit. Also, if the chemists (cluster) are spread across an area or town, their representative can strike a good display or merchandising deals plus many other benefits. Modern Pharmaceuticals I April 2011

Retail Zone The way to go There is a chemist shop in India at a distance of every 50-500 metres, and everyone is doing business; serving its niche customers. Actually, there is little competition amongst stores, as customers keep going to their preferred store. In every area, one will find a top retailer who is doing a roaring business. Rest of the stores are more or less similar in sales when it comes to numbers. Other than the top chemist, chemists with like minded thoughts need to come together and form a chemist cluster network (without changing their identity) to take benefit of the changed scenario (competition from chain drug stores) by : Training the staff on the best practices: Individual stores cannot afford to get their staff trained in the best practices. But a group of 25 or 50 stores can pool in ` 500- 1,000 per month and get the staff trained on best customer service practices. Adopt common service standards – best pharmacy practices: Chemists can also distribute tasks to its members to find out the winning value propositions and best practices from the market and adopt it amongst its members. A standalone pharmacy store may not be able to do so. But the group of chemists can easily do it. Tie up with leading distributors to get higher discounts and schemes: The best part of forming a cluster network is to connect to a select list of distributors and route all the orders from the network to this group of selected distributors; without making any changes in the way the orders are given (the retailers could continue to give orders independently), so that it does not impact the supplies. Currently, the distributors are struggling for business due to merger of companies and increase in the number of distributors. If 25 or 50 chemists decide that for a company ‘X’ they will only give orders to distributor 123, they can bargain for an increase in margin between 2-7 per cent. This will drastically improve the profit margins for the business. Imagine a chemist doing a sale between ` 3-5 lac per month. S/he would increase April 2011 I Modern Pharmaceuticals

the earnings between ` 6,000 - 35,000 per month. Conduct camps sponsored by the pharmaceutical companies: Pharma companies conduct free diabetes, blood pressure, bone mineral density camps regularly. The chemist cluster network can speak with these companies and conduct camps regularly in their areas. This can be win-win for pharmaceutical companies, customers and the chemists of the network. It is a proven thing that by conducting a camp the customer loyalty and sales grows. Merchandising & display: Striking deals with OTC/FMCG companies for merchandising & display could also help. Today, the market is flooded with new launches and the mad rush between companies to increase visibility and market share. The representatives from the chemist cluster can speak with company representatives and strike group deals with FMCG/OTC companies for displays and road shows. Companies are paying between ` 150 to as high as ` 1,500 per store per month for premium display space. Cluster networks can make the best use of this opportunity. Adopt the latest technology: Due to the group power, it is possible to scout for a good Point Of Sale (POS) software, best hardware & other technical features by entering into a deal with providers. With 25-30 clients, any service provider will give a better deal. Improve prescription refills: With almost one new product being launched every day, it is not possible to service 100 per cent prescriptions. But a chemist cluster network can always fall back on each other in the network to ensure that the prescription fulfillment is nearly 100 per cent. Newsletter: With 25-100 chemists coming together, a monthly news letter on health facts or new schemes can become a reality. Gifts & promotions: The chemist cluster network can come out with lucky draws and promotions for increasing the sales in their network. It is easy to strike deals with the companies for procuring gift

hampers for lucky draws or also pooling a monthly contribution to come out with a lucky draw.

What not to do? It is more important to know the don’ts in this arrangement than do’s. The cluster network need not form a common brand (Great, if they agree for it! ) Do not sign a legal agreement. This arrangement should be based on mutual trust and shared goals of taking the organised chain competition heads on. Rotate the leadership (representatives) of the chemist cluster network every six months without repeating the representatives more than once. Thus, there would be no fight for positions, and everyone gets a fair chance to contribute to the growth of the cluster network. Never hold elections or take to voting. Best option is to have a draw amongst the members of the chemist cluster network to make it apolitical, thereby giving everybody a fair chance to lead the network. If 25 or 50 chemists are forming a network, it might be good to divide some responsibilities amongst its members to form separate teams to: attend to Good Pharmacy Practices (GPP), marketing and merchandising, newsletter, camps, training, innovations, lucky draws and promotions. With this approach, every member will be engaged and contribute his/her time and abilities to enhance the value of the chemist cluster network. Members of the cluster network must meet at least once every month informally to avoid any misunderstandings, build a strong bond, and explore every opportunity that comes their way. The underlying point is that if the cluster is able to leverage its group power, it can not only withstand competition from chain drug stores but also give a tough time to them due to their efficiencies and service. It is a rule of retail business; ‘United we stand, divided we fall.’ MPh (office@rajendragupta.in)

Legal Edge

Patent linkage

Overlapping of two dis nct legisla ons? Patent linkage is the prac ce of linking marke ng approval of a generic drug to exis ng patents for the parent drug. While many developed and developing economies of the world like the US, Australia, Canada, and Mexico have adopted this prac ce, other countries like India have not. This ar cle analyses the situa on prevailing in India. practice of linking marketing approval of a generic drug to existing patents for the parent drug. Thus, where such a regime exists, marketing approval for any generic drug is not provided until the patent on the parent drug has expired or the party seeking marketing approval has sought the permission of the patent owner of the parent drug.

Why patent linkage?

“P

atents remain by far the most controversial of the Intellectual Property (IP) rights harmonised under Trade Related Aspects of Intellectual Property Rights (TRIPS). Not only do patents confer significantly stronger rights of exclusivity than other IP regimes, the subject matter of patents

Anuradha Salhotra Managing Partner, Lall Lahiri & Salhotra

technology most directly impinges on economic prosperity.” These words by Sean A Page, Professor, Michigan State University, reflect the contradictory purposes served by patents and the dilemma of governments all round the world in developing an environment that supports the interest of the patent owners. Patents have a direct effect on economy of a country and it is with this view that various countries aim to create a balance between their patent legislation and other legislative provisions, which are directly or indirectly related to patented technology. Patent linkage is one such means of creating balance between different legislative provisions with a view to protect the interest of the patent owner. Patent linkage is the

Specifically, the concept of patent linkage is believed to be aligned with Article 28.1(a) of the TRIPS agreement, which confers on the patent owner, ‘the exclusive right, where the subject matter of a patent is a product, to prevent third parties not having the owner’s consent from the acts of: making, using, offering for sale, selling or importing for these purposes that product’. It will, thus, be evident that patent linkage regime basically endeavours to protect the interest of the patent owner, for which purpose patents are granted. However, certain countries consider this provision to be TRIPS plus provision, which as it requires the regulatory authorities to go beyond their normal mandate to seek information about conflicting patents before granting marketing approval for a drug. Patent linkage has been quite effectively incorporated in their legislation by a number of developed and developing countries, including US and China. On the contrary, there still exists a different set of countries, such as India, the European Union (EU) member countries and the like, which do not cater for patent linkages. In countries not subscribing to patent Modern Pharmaceuticals I April 2011

Legal Edge linkages, the patents are generally enforced through courts, whereas in countries with patent linkages, the regulatory authority additionally assists the owner in enforcing his patent by not allowing the generics to enter the market.

Patent linkage under TRIPS agreement Article 41 of the TRIPS agreement requires member states to provide sufficient enforcement procedures to enable effective action against any act of infringement of intellectual property. However, the TRIPS agreement does not explicitly prescribe patent linkages and it was left up to the member states to appropriately imbibe the provisions under Articles 28.1 and 41 in an effective manner within their legislation or regulations. The countries where the mechanism of patent linkages exists have justified its adoption to compliance with the said guidelines of the TRIPS agreement and with the sole aim of protecting the rightful owner of protected intellectual property. An important question that arises in this context is regarding the justification of countries that have not adopted patent linkage. A comparative study of situation in the various developed and developing economies of the world could help us to delve on this question.

is listed in the FDA list called Orange Book. Moreover, an applicant for a generic drug may seek approval upon showing to the FDA any of the following â&#x20AC;&#x201D; that the drug has not been patented, or the patent for the original drug has already expired or the generic drug is not infringing upon the patent or the original drugâ&#x20AC;&#x2122;s patent is invalid. Briefly, the Hatch-Waxman Act ensures that the FDA does not grant marketing approval to a generic drug until the patent has expired or is adjudged invalid. The said Act also provides generic manufacturers with a period of market exclusivity for providing the drug innovators with a minimum period of monopoly for enabling them to recover the cost involved in research and development of the drug.

In one of the marke ng approval cases in India, the Delhi High Court ruled that whether patent linkage is to be adopted or not is a policy issue, which is required to be taken care of by the government.

prevalent European patent system and their impact on market access of generic medicines, touched upon the views regarding avoiding patent linkage. In the said report, it was remarked that the regulatory authorities are not in an appropriate position to make a decision regarding the applicability of a patent to a particular generic product and that such decisions should be better left for the courts. It was further stated that originators of patented products often try to use pressure tactics against the regulatory authorities by sending warning letters accusing them of patent infringement when they accept or approve marketing authorisation applications. The report mentions that as many as 70 cases were started by originators in the year 2007 in Portugal and by inducting patent linkage in their legislation, such arm twisting of regulatory authorities could be encouraged. It was also stated in the report that the concept of patent linkage is inconsistent with the concept of application of patent rights, since granting of a market approval cannot be seen as actual commercialisation of product. Until recently, there have been no indications of any chances of implementation of patent linkage in EU legislation, and it is believed that the EU depends more on its stronger patents regime to protect the interests of patent holders.

European Union US: The pioneer in patent linkages? US is one of the few countries, which has given full effect to the concept of patent linkage. In 1984, a legislation called the Hatch-Waxman Act was enacted in the US, which had provisions for ensuring patent linkage within the country. Particularly, in the US, the Food and Drug Administration (FDA), which provides the marketing approvals for pharmaceutical products, maintains a list of all pharmaceutical products that are under patent coverage. The FDA does not provide marketing approval to a generic company of an already patented pharmaceutical product that April 2011 I Modern Pharmaceuticals

In EU, the legislation does not provide for patent linkage. However, EU member states are showing increasing interest in implementing patent linkage at the national level even though the EU states enjoy a data exclusivity period of ten or even eleven years. Many a times the data exclusivity period is co-terminus with patent term. As data exclusivity does not require the drug regulatory authority to ascertain patent status of the drug, it can be easily implemented by the authority itself. In its report of May 2008, the European Generic medicines Association (EGA), while deliberating on the issues of weaknesses in the

Canada Canada has a system in place similar to that of the US FDA. Canadian health regulatory authorities do not grant marketing approval for pharma products that are protected by patents listed in the Patent Register. Drug manufacturers are allowed to list patents relevant to their originator drugs in the Patent Register. The patents listed in the Patent Register form the basis to block marketing approval to generic drugs.

China China is one of the fastest growing economies of Asia. China established the State Food and Drug Administration 45

Legal Edge (SFDA), which ensures that no marketing approval for a drug is given unless it is satisfied of non-infringement of a patented product by the drug. In the event, there is an ongoing litigation on a patent; the SFDA would postpone its approval until the time limit for appeals has been exhausted. The SFDA works in close co-ordination with the State Intellectual Property Office (SIPO) and has established a database of new product registration files to guarantee an effective patent linkage mechanism. The SFDA also maintains a list of all approved registrations and these lists are available for inspection by patent holders. Upon determining any infringing product, the patent holder informs the SFDA, which in turn informs the applicant of the new product registration. In the event the applicant withdraws his application, the issue is resolved at the very instance; otherwise, the patent holder may utilise the civil remedies available to him under the Chinese laws. Besides, the SFDA imposes a duty on the applicant of the new product registration to certify that their products do not infringe upon any existing patents.

product is given when patent for the innovators product is still in force. The Ministry of Health that provides marketing approvals accepts an application for a new medicine only in case the new medicine is ‘similar but not the same as patented drug’.

Mexico In Mexico, the generic applicants seeking marketing approvals are required to inform the regulatory authorities regarding whether any valid patent exists for the product for which marketing approval is being sought. Upon receiving a new product marketing application, the health authorities closely work with the Mexican patent office to search for any existing patents in respect of the product covered under the application. In the event, search results in a valid patent being identified, the applicant is provided with an opportunity to put across his case, otherwise the application is rejected. To enable smooth functioning of this system, the Mexican patent office has established a practice of publishing patents through a special gazette that lists patents related to chemical substances and/or active ingredients.

Australia Australian Therapeutic Good Act, 1989 (amended) mandates that an applicant seeking registration for a therapeutic good must certify that the marketing thereof would not, in any way, infringe upon a patented product. Also, in the event there exists a valid patent and the applicant is desirous of marketing the medicine prior to expiry of the patent term, he is required to certify that sufficient notice has been given to the patent holder about the application for registration of the therapeutic good.

Jordan Jordan has instituted the system of patent linkage since 2000, before which period Jordan was considered to be a haven for copy products of patented drugs. In accordance with Jordan’s World Trade Organization (WTO) Accession Agreement in 2000, no marketing approval for a generic pharmaceutical 46

Singapore Singapore has a system similar to the US system. The generic applicants requesting marketing approval must make a declaration that the generic pharmaceutical product does not infringe any valid patent.

India In India, marketing approvals are given by the Drug Controller General of India (DCGI) under the provisions of Drugs and Cosmetics Act (DCA), 1940. Neither this Act nor any other legislation explicitly includes any reference to patent linkage. One of the earliest judgments with regard to applicability of patent linkages in Indian scenario was Bristol Meyer Squibb Company & others vs Dr B P S Reddy & others in which the Delhi Court passed an ex-parte order restraining the defendants from ‘manufacturing,

selling, distributing, advertising, exporting, offering for sale or in any manner dealing directly or indirectly in any product infringing the plaintiff ’s patent’. Also, the Court remarked that the DCGI, while performing his statutory duties, is expected not to allow any party to infringe any laws. It also remarked that in the event the drug for which approval is sought infringes upon a patent, the approval ought not to be given by the DCGI. This decision of the Hon’ble Court was believed to have mild connotation of introduction of patent linkages in India. The repercussions of the decisions were soon felt with widespread debate on the decision. Some legal scholars wondered whether the DCGI was technically equipped to appreciate patented technology prior to providing marketing approvals. On the other hand, the Organisation of Pharmaceutical Producers of India (OPPI), representing a lobby of foreign drug makers, argued that the government would be in effect promoting patent infringement by allowing marketing approval of generic drugs based on patented technology. This chaotic confusion was put to rest by the decision of the Delhi High Court dated February 9, 2010 in Bayer Corporation and another vs Cipla, Union of India and others. In 2008, Cipla, a generic manufacturer, announced introduction of their generic drug ‘Soranib,’ which was a substitute for Bayer’s ‘Nexavar’. In view of this development, Bayer, the rightful owner of patent number 215758 in respect of the drug wrote to the DCGI to deny marketing approval to Cipla in acknowledgment of their existing patent. Bayer, thereafter, filed the writ petition to seek injunction against grant of marketing approval to Cipla by the DCGI. Besides other issues, Bayer raised the plea that Section 2 of the DCA read with Section 48 of the Patents Act provides the concept of patent linkage. It was also contended that while making a drug approval application, the applicant was required to provide patent status of the drug, which indicates the intent of the legislature to enforce patent linkage. Modern Pharmaceuticals I April 2011

Legal Edge The respondents, on the other hand, contended that the mere grant of regulatory approval by the DCGI cannot amount to patent infringement. The DCGI contended that the ‘scheme of the Patents Act and the DCA were completely different and these legislations operate in different areas’. Cipla contended that there is no concept of patent linkage in India. Replying to Bayer’s contention regarding the intent of legislature to introduce patent linkages, it was said that merely by asking for patent status of the drug, the DCGI is not bound to ensure that a patented drug is not granted marketing approval. Thus, one of the issues framed before the Court and which is of prime importance to us in the present context is whether there is existence of patent linkage in India. Deliberating on this issue, the Court remarked that the right conferred under Section 48 of the Patents Act is essentially a private right and a negative right. Thus, the Court elucidated, that the said section does not confer any right even upon the patent holder to market the product. In effect, the patent holder is himself required to seek approval of the DCGI to seek permission to market his patented product. Further, the Court remarked that by granting approval on a patented drug, the DCGI does not itself infringe any patent or abets infringement. The Court highlighted that the Act does not require the DCGI itself to enforce a patent and deny marketing approval to a generic drug. Rejecting Bayer’s contention regarding existence of patent linkage scheme, the Court stated that accepting such an argument could mean that the DCGI has to operate with the presumption that every patent has been validly granted, which could mean that the DCGI would have to either refuse marketing approval out-rightly or put the application on hold until the patent expires or is held to be invalid. The Court said that this procedure would be beyond the scope of the powers of the DCGI since he is not equipped to deal with issues regarding validity of patents. Finally, the Court remarked that whether patent linkage is to be adopted or not is a policy issue, which is required to be taken care of by the government. The Court said that unless there are express provisions in the DCA, the Court cannot read such provisions in the Act by itself. Thus, the Court outrightly rejected the concept of patent linkage in India, thereby providing clarity to the confusion that existed before this decision.

Balancing act Indian drug industry, aptly named as the ‘Pharmacy of the World’ has been meeting the requirements of large number of countries. The innovator right owners have been successfully getting progressive implementation of these TRIPS plus provisions through lobbying and through provisions in Free Trade Agreements (FTA). It is matter of time when a proper balance between public interest and innovator’s rights will be struck in the ongoing tug-of-war. MPh (salhotra@lls.in)

April 2011 I Modern Pharmaceuticals

Tech Bytes

‘We have many examples of how the FT4 provides the informa on necessary to solve a complex problem’ …says Tim Freeman, Director of Opera ons, Freeman Technology, a powder characterisa on company, while talking about how FT4 can help in solving challenges in the formula on and product development. Chandreyee Bhaumik Please elaborate on the global market scenario of pharma and powder processing industries. Efficient powder processing is essential for the production of many different materials including foodstuffs, cosmetics, metal powders, minerals and, of course, pharma. However, when compared with handling liquids and gases the complexity

The pharma industry is now working hard to improve on their manufacturing efficiency, prompted by global competition and changing regulation. This includes the introduction of Quality by Design (ICHQ8, Q9, Q10) and the Food and Drug Administration (FDAs) Process Analytical Technology (PAT) initiative. As almost all pharma products are handled in powder form at some point during manufacture, efficient and effective powder handling is vital to success. It is recognised

Freeman Technology’s goal is to provide a quality powder tes ng instrument that meets, and thus caters to the needs of industry in order to acquire data, which reliably reﬂects how a powder will behave in use or during processing.

of powder behaviour complicates formulation, plant design and day-to-day operation alike. This makes the development and production of quality products challenging. In general, powder processors rely quite heavily on their own processing experience because there is less established science and engineering to guide them. 48

that new analytical technology is needed to improve the understanding during formulation & development, and to enhance process control during production.

Kindly share your experience with Freeman Technology. It has been more than a decade that Freeman Technology is working with

powders. Initially, when we started, we observed that the available powder testing tools were primitive, and thereby rarely fit the various modern purposes. Poor reproducibility was a common problem but just as important was that many techniques produced only a single number to describe the powder. They did not provide sufficient information for describing the different behaviours that the powder could exhibit in several processes. Freeman Technology’s goal is to provide a quality powder testing instrument that meets, and thus caters to the needs of industry in order to acquire data, which reliably reflects how a powder will behave in use or during processing. We work with powder processors from all areas of industry and academia in order to understand the difficulties that they face. Our development of the FT4 — the universal powder tester we design, manufacture and sell — reflects the knowledge that we have acquired over the last ten years. Therefore, our continued focus is to demonstrate how the FT4 can help in understanding, and thereby solving challenges in formulation and product development, powder processing, plant design and also Quality Control (QC). Again, we now have many examples of how the FT4 provides the information necessary to solve a complex problem, for which alternative powder characterisation techniques are inadequate. Further, for the pharma industry the FT4 has proven useful in many areas, with examples, such as improving the formulation of tabletting and dry Modern Pharmaceuticals I April 2011

Tech Bytes powder inhalation blends, scaling up activities, selecting equipment, and optimising and addressing batch-tobatch variability issues, to name a few.

Please discuss the technology for the measurement of powder ﬂow proper es. The FT4 powder rheometer applies dynamic testing. This indicates that it is capable of measuring the powder while in motion. By measuring the torque and force acting on a helical blade as it rotates down through a sample, the instrument determines flow energy, a measurement of how resistant the powder is to the flow. Again, measuring how the flow energy changes with, for example, consolidation, powder flow rate, humidity levels and/or composition is extremely useful for a process-related study, and therefore gives users the insight they require to properly optimise the powder behaviour. Most importantly, dynamic measurement permits the direct measurement of a powder’s response to air. With this additional methodology, it can be said that samples can be measured in a consolidated, conditioned, aerated or even fluidised state. Further, the FT4 also incorporates two other testing methods: shear testing and bulk property measurement (density, compressibility and permeability). Our experience has shown that it is this combination of diverse techniques that is most vital in tackling industrial powder processing issues.

Describe the R&D ac vi es that facilitate the func oning of the systems. One of the ways in which manufacturers can accelerate, and thereby improve the product and process development is to strengthen communications between those working in R&D and the people operating the plant. This is an area in which the pharma industry is trying to improve. It is true that during the manufacturing of a product April 2011 I Modern Pharmaceuticals

it is beneficial if there is time and opportunity to optimise its formulation. However, it also relies on being able to apply the knowledge in the R&D environment from the lessons learned by operating staff in manufacturing. By measuring those powder properties that accurately describe in-process performance, the team responsible for manufacturing can explain what properties they require in a formulation. The FT4 delivers the process relevant data that allows this. Again, it is also equally important as it allows formulators to pass on a specification that describes the powder in a way so that process designers can use it to develop an optimal processing solution. By providing a common relevant language for engineers and scientists, the FT4 facilitates better development.

What are the cost beneﬁts involved? The FT4 primarily delivers cost benefits by enhancing a user’s understanding of their powder. A typical purchase is driven by a need for knowledge or sensitivity that existing techniques are unable to supply. While the overall Return on Investment (ROI) from better product and process development and more efficient operation is often quite difficult to quantify, the FT4 often deliver specific gains that convert directly into a financial saving. These include: An improvement in operating practice that increases plant reliability Detection of batch-to-batch variability in the feed, prior to processing, improving plant utilisation Detection of batch-to-batch variability in a product leading to more consistent quality

What are issues faced by the Indian pharma industry and how do you plan to tackle the same? One of the challenges that Freeman Technology faces is our questioning of the understandable desire in the marketplace to work with a single number that summarises the properties

of a powder. While we still regularly meet people, who are looking for a single number technique, we are pleased to say that the need for more detailed multi-parameter characterisation has lately been accepted. Powders have many characteristics, and to assume that a single number can describe how they flow, compress, cake, respond to moisture, etc, is quite unrealistic. Thus, in this regard, it can be said that the major step forward, which has probably occurred in just the last few years, supports our approach.

Where do you plan to see the company in the next ﬁve years? Also, elaborate on the future trends in the industry. Freeman Technology will continue to address the challenges of powder characterisation with a focus on relating measureable powder properties to inprocess behaviour and final product attributes. Today, the FT4 approach offers what we have identified as the most direct way of measuring process relevant information, such as ‘how compressible is this powder?’ and ‘will this powder flow well from a hopper, mix well and charge electrostatically if blended in a high shear mixer,’ etc. However, we still rely on identifying a correlation between a measurement on the FT4 of say, cohesion and how the powder behaves in the process. Therefore, one of our key goals is to continue building the database of powder properties and inprocess behaviour so that formulators, process engineers and QC specialists have access to the kind of database that those working with liquids and gases have enjoyed for many decades. To some extent, this will require significant improvement in our understanding of the mathematics of powder behaviour, but as of today, with very few mathematical models available to predict behaviour, Freeman Technology will continue to focus on pragmatic, process relevant ways of directly measuring powder behavioural characteristics. MPh (chandreyee.bhaumik@infomedia18.in)

Interface

‘As the focus shi s from drugs to biotech, delivery and management of content will become cri cal to brand success’ …says Soumitra Sen, President & Head, DDB Health & Lifestyle (Part of the Mudra Group). He discusses the pharma market scenario and the interven on of these companies in the rural setup. He also provides interes ng snippets on brand success. Chandreyee Bhaumik What is your take on the Indian pharma industry? The market scenario is shifting towards Multinational Companies (MNCs) after an era of domination by Indian pharma companies. This shift is primarily the result of two factors, ie, the global downturn adversely affecting the export potential of Indian companies and

Thus, to work in this increasingly MNC-dominated market, we have consciously worked on strengthening our network knowledge capabilities. DDB Health Worldwide (headquartered out of New York) disseminates knowledge and expertise seamlessly across its offices in different countries. Network knowledge empowers us to manage clients expectations that today range from Rx pharmaceutical

We have evolved from being just an Rx brand consul ng ﬁrm to a total branding solu ons expert in the domain of health and lifetyle. This indicates that we have contributed strategically towards building brands in the Rx segment.

India becoming a signatory to General Agreement on Tariffs and Trade (GATT). This has resulted in Indian companies losing substantial financial ground in export as well as feeling restricted in the area of new product launches. MNCs on the other hand have renewed interest in generics and generic brands. This has become their next growth strategy because almost all of them have shrinking new product pipelines. 50

brand building to building salience for brands and disease/therapeutic areas among consumers to social health communication.

How has your journey been so far? Share your experience of handling several brands like Novar s, UNICEF, Royal Hygiene, Wrigley, HBI and Kokilaben Dhirubhai Ambani Hospital.

We have evolved from being just an Rx brand consulting firm to a total branding solutions expert in the domain of health and lifestyle. This indicates that we have contributed strategically towards building brands in the Rx segment like ‘Taxol’ and ‘Nuvaring’, as well as played stellar roles in strengthening OverThe-Counter (OTC) salience of brands like Nasivion, Kidbion-IQ, Calcium Sandoz, etc. We have also addressed the healthcare needs of the bottom of the pyramid by working with organisations like UNICEF and John Hopkins Bloomberg School of Social Medicine on mass awareness projects relating to polio, HIV AIDS, H1N1, new born care, etc. Moving ahead, we are concentrating on bringing in micro-specialisation in the area of Rx brand building.

Please highlight on the contribu on of adver sing majors in strengthening their healthcare wings to a ract pharma clients. Companies other than DDB Health & Lifestyle, which is making rapid strides in this area, include McCann Healthcare, FCB Healthcare and Ogilvy Common health. These agencies have the support of strong networks and learnings from global practices that are useful while addressing challenges posed by current market realities.

Please give a status update on the interven on of pharma companies in the rural areas. It is generally believed that India has one million medical practitioners, a majority of who work in urban and semi-urban Modern Pharmaceuticals I April 2011

Interface

areas. Quality healthcare till now was a distant dream for the 700 million people living in rural areas. Further, estimates suggest that an additional one million healthcare workers with basic training in healthcare services are performing the mammoth task of providing basic and minimal healthcare to this segment. Pharma companies belonging to the Indian as well as MNC forum have now realised the hidden potential & possibilities of this untapped market, and therefore started creating specialised divisions to cater to this demand. Prominent among such efforts is Arogya Parivar by Novartis, Prayas by Aventis and a yet to be named effort by Dr Reddyâ&#x20AC;&#x2122;s Laboratories. This trend will only assume more fervour in the future with medical insurance reaching the rural population, increasing buying power and investment in new healthcare infrastructure, which would be of better quality than the existing inadequate facilities.

What is the required investment for marke ng in this industry? Depending on the category, the brand, its heritage and salience along with opportunities that the brand offers, the advertisingto-sales ratio is generally approximately 30-35 per cent for new products. It can further go as low as one per cent for mature and big brands.

Tell us about your deals in the pipeline. We are concentrating on evolving into a total branding solutions company that believes in creating influence along with behavioural change among the various stakeholders. To achieve this, we are constantly trying to strengthen our offerings in areas like Customer Relationship Management (CRM) and other forms of management and various patient compliance programmes, etc.

Tell us about roadblocks in this area and your plans to tackle the same. As companies are gradually identifying the requirement of bringing healthcare closer to the end consumer, they need a massive change in their mindset from seeking a shortterm tactical solution to long-term strategic engagements. Additionally, to competently address the rural mindset, pharma companies would require specialised communication effort that is different from the usual doctorâ&#x20AC;&#x201C;medical representative relationship and concentrates on community development through village elders, gram panchayats, ASHA workers, etc. Lastly, as the focus of the industry shifts from drugs to biotechnology, delivery and management of content will become critical to brand success. Thus, pharma companies will have to substantially evolve their techno-marketing skills to address this need. MPh (chandreyee.bhaumik@infomedia18.in)

April 2011 I Modern Pharmaceuticals

Viewpoint

Comba ng counterfeits

Figh ng the ﬂood with technology It has been es mated that 10-15 per cent of the global pharmaceu cal commerce involves counterfeit or fake drugs, and in parts of Africa and Asia this ﬁgure exceeds 50 per cent. Besides, the situa on in India is grim as it is becoming a hub for counterfeits. Can technology solve this problem?

lthough counterfeiting of medicines is not a new phenomenon, it has attained greater importance in recent years because of its sensitising impact and rampant activities. Here an insight is provided to the underlying problem, and tools to eradicate the practice with the lowest inexpensive technology having multi-fold benefits. With least or no impact on drug price control, such action will protect the individual brand image of the pharmaceutical companies, rewrite efficient business rules, improve the efficiency of the supply chain management and inventory control. It will also help in meeting the global GS1 requirements with e-business approach. This traceability technology will empower the regulatory authority, which is the highest supervisory control and legally mandated to protect public interest. Finally, such technology can challenge the counterfeit and protect public healthcare.

Journey so far Our country has come a long way from the ancient Atharvaveda (the first ever Indian text dealing with medicines) to the cutting-edge technology of modern medicines. It is a journey accompanied

Meenaxee Padhy Business Head, M&M Technologies Pvt Ltd 52

with innovations and challenges. This journey has also seen a parallel rise of the dynasty of the unscrupulous merchants. Counterfeiting is no more a closed door practice. It has already spread its tentacles like an epidemic and has become a threat to public health, society, country and to the entire world at large.

What is a counterfeit medicine? As per World Health Organization (WHO)’s widely disseminated report, counterfeit medicines are deliberately and fraudulently mislabeled with respect to identity and/or source. Clandestine manufacturing setups (laboratories), filthy, unhygienic environmental conditions, fake packaging, look-alike labeling, all these are a part of the practice. Medicines with lapsed expiry dates are re-labeled and re-packaged with newer expiry dates, and smuggled and marketed. These are fake medicines. It is an important cause of unnecessary morbidity, mortality and loss of public confidence in medicines and health structures. As shown in (Figure 1), tablets sampled from pack on the left failed quality tests, while tablets from the pack on the right passed all quality tests. The pack on the left is a counterfeit of the genuine Indian generic. It had the batch number VM610. According to Dr Deshpande of VS International, “We have not produced Batch No. VM610 in 2008. Batch VM610 was manufactured by us in the year 2006 and exported to Nigeria in the same year.” In other words, the counterfeiters have taken a real batch number and showed that their

product belonged to that batch; they produced and sold expired products two years later of the real one.

The magnitude of the problem Empirical, reliable and transparent statistics about drug counterfeiting are virtually nonexistent. Although it is very difficult to gauge the magnitude, WHO and Food and Drug Administration (FDA) have certain statistics. It has been estimated that 10-15 per cent of the global pharmaceutical commerce involves counterfeit or fake drugs, and in parts of Africa and Asia this figure exceeds 50 per cent. As per the report of The Deputy Secretary General of the Council of Europe, WHO estimates that counterfeit medicines make up for 8-10 per cent of the European pharmaceutical market and in some countries even as much as 12 per cent. In India, the situation is grim. The Indian pharmaceutical industry has expressed displeasure over the repeated projection of the industry as the major producer of spurious drugs in the world. The Vienna-based International Narcotics Control Board (INCB) in its 2009 report has stated that India has become a hub of illicit narcotics trade. Drugs are sold through illegal Internet pharmacies where orders placed abroad are dispatched to buyers using courier and postal services. A recent report on The Washington Post reveals that India, the world’s largest manufacturer of generic drugs, has become a busy centre for counterfeit and substandard medicines. Stuffed in slick packaging and often labeled with the Modern Pharmaceuticals I April 2011

Viewpoint names of legitimate companies such as GlaxoSmithKline, Pfizer and Novartis, fake drugs are passed off to Indian consumers and sold in developing nations around the world.

The damages, the vic ms and the beneﬁciaries: Reality bites Experts state that the global fake drug industry, worth about $90 billion, causes the death of almost 1 million people a year and is contributing to a rise in drug resistance. As per an FDA report, they are the best placebos and the most dangerous medications. This illicit business practice, primarily attributed to easy money earning, paralyses the legal system, jeopardises regulatory systems, undermines the health care activities, betrays the vulnerability of the pharmaceutical supply chain system, and last but not the least, it attains gains wrongly by causing losses. A bigger cause of concern than public safety is the image that recent studies are portraying about India abroad. In June 2010, officials at Nigeria’s Abuja airport caught a shipment of fake antibiotics, containing no active ingredients, with a ‘Made in India’ label. In November 2009, the Sri Lankan government banned imports from four Indian companies following the discovery of dangerously substandard products, including vials containing broken glass or plastic. Fake medicines are being paddled to different countries with an Indian tag. In 2010, a huge fake drug racket was exposed in Chennai, where a league of miscreants has been selling expired medicines. The medicines have had their packaging tampered with to disguise their expiration with new expiry dates. Several such stories exist, reports are stacked up, but the underneath reality still remains gloomy and grim.

Figure 1: The genuine pack (R) and the fake pack (L)

favourable for drug counterfeiting. The report also discusses specific measures that can be taken at the local, national and global levels to combat counterfeit drugs. The measures taken by our government thus far are encouraging if not satisfactory. The clandestine industry has hurt the global image of the booming Indian pharma industry and its export worth $8.5 billion a year, mostly to African and Latin American countries. Various reports received from State Drug Controllers reveals that the per cent circulation of counterfeit drug in the Indian retail market is 0.3; however, independent estimation estimates a higher range up to 20-25 per cent, and even ranges high up to 35 per cent exist (WHO report). Efforts taken by Central Drugs Standards Control Organization (CDSCO) under Ministry of Health and Family Welfare, Government of India, along with the Drugs Controller General (India) [DCG(I)], non-government organisations (NGOs), consumer associations is quite encouraging, and

have revealed the real existence of spurious drugs even though in varied percentage. Mashelker Committee’s report also subscribes to the fact. To calm down the illicit trade, in 2008, the Drug and Cosmetics Act 1940 has been amended to Drugs & Cosmetics (Amendment) Act, 2008 by enforcing stringent penalties and punishment for those found guilty. The number of people arrested for manufacturing and selling fake drugs rose from 12 in 2006 to 147 last year, and drugs worth about $ 6.5 million were seized over this period.

Technology so far In addition to violating copyright provisions and constituting an economic crime, counterfeit medicines undermine national healthcare systems, resulting in loss of confidence of the systems of drug control and enforcement of drug laws because of failures in therapeutic efficacy and safety and pose serious health risks to their users. Their use can entail therapeutic failure and, in

Steps taken In its 1999 Guidelines for the Development of Measures to Combat Counterfeit Drugs, WHO provided an overview of the problem and identified key factors that make the climate more April 2011 I Modern Pharmaceuticals

Figure 2: The clandestine set-up for manufacturing counterfeit drugs. (L-R): The methods of storage and production, R: A cement mixer discovered during a raid on a counterfeit drugs manufactured in Haryana, 2008

Viewpoint

Figure 3: Even holograms are no more secured measures to protect the genuine

the worst scenario, death because the products are of doubtful quality, safety and efficacy and their sources are not guaranteed. Trafficking in counterfeit drugs should therefore be considered a potential life-threatening crime. This phenomenon has grown rampant in recent years due to counterfeiting methods becoming more sophisticated and increasing amount of merchandise crossing borders. WHO has responded to the challenge and is heading the movement by creating a global coalition of stakeholders called IMPACT (International Medical Products Anti-Counterfeiting Taskforce). The taskforce, created in 2006, has been active in forging international collaboration to seek global solutions to this global challenge and in raising awareness of the dangers of counterfeit medical products. “It is very difficult to dismantle the entire operation,” says Suresh Sati, Head of a New Delhi-based agency that helps police conduct raids against counterfeit drug syndicates across the country. Sati says, “When we bust one operation, two more spring up elsewhere. Convictions are rare.” The term ‘spurious’, ‘counterfeit’, ‘substandard’ are very distinct words in general but when used as an adjective for drug, the impact is only one, to deceive the consumers. An act against the consumer protection law, which is manned by syndicates, mushroomed all over the country. This is a wakeup call for the society and needs to be addressed with much promising solution and strategies. In a recent survey report, Barun Mitra, Director of the New Delhi-based Liberty Institute has quoted, “We are 56

behaving like ostriches with our heads in the sand and pretending that nothing is amiss even as the problem keeps growing and affecting Indian patients.” Mitra said that 12 per cent of sampled drugs from the capital’s pharmacies were substandard. “Companies are apprehensive of pursuing the cases for fear of bad publicity and possible loss of confidence among consumers,” Mitra quotes. Over years, some pharmaceutical companies have been using holograms as a measure to protect their products,

Arrests for manufacturing and selling fake drugs rose from 12 in 2006 to 147 last year, and drugs worth $ 6.5 million were seized over this period.

but no longer holograms are considered genuine or secure (Figure 3), even they are counterfeited and slowly have been labeled as outdated technology. The alternate solution to track down counterfeit medicine is by using the Radio Frequency Identification (RFID) technology. Together with retailing sector, even healthcare and pharmaceutical industries, RFID is considered as one of the promising solution to nail down counterfeits. However, the problem is that decades after RFID technology was invented, and years after the US FDA started touting it as the most promising way to authenticate drugs, RFID technology

as an anti-counterfeiting technology remains just that, promising yet far from proven. Even though many pharmaceutical companies are still opting for the use of RFID tags to track the drug’s progress throughout the supply chain regardless of its packaging arrangement, it is still unclear if the technology can ever live up to the promises not only in the pharmaceutical industry, which is at the leading edge of testing this muchhyped technology, but also in other industries. The usability questions go far beyond the technology, standards and privacy issues that are most often raised, and also into the very nature of what RFID simply is and is not, and what it will or will not ever be able to deliver to any anti-counterfeiting programme. There are certain firm reasons to focus on the limitations of the RFID technology. Firstly, it is a tracking device in the supply chain and not a security guarantor. Providing security is a tough challenge and RFID falls flat in that. Secondly, even though it has the potential to act as a security device for other applications, for the issue at hand, it is only a component in the supply chain that facilitates the journey of the drug along the supply chain more quickly rather than more securely. In other words, it facilities the documentation for creating the electronic pedigree, but fails to provide assurance of the authenticity of the drug to its user. Thirdly, they are reported to be flaky, and the read rate of the RF reader is poor in case of liquid medicine or foil wrapping. Most important is the cost factor of the RFID tag that predominantly controls the drug price, and can be one of the important variant.

Proposed technology at a glance M&M Technologies is striving hard since the past 20 years to bring forth the most innovative and appropriate technologies for addressing various issues like protecting the genuineness Modern Pharmaceuticals I April 2011

Viewpoint of a product, providing a complete track and trace solution (from the point of origin to the end user). With regards to combating counterfeit medicine, the technology in discussion with M&M Technologies, is unique in its features. It is a two-dimensional (2D) matrix code called secured QR code, with public (open) and private (closed) data encoded into it with 128 SSL encryption. The public data can be read by any 2D scanner including a camera mobile phone, which is password protected and the private data, can be read only by the specially designed scanners, which are also password protected. This process ensures highest security point of application as only the designated authorised custodian of the system can access and thereby hold control over the whole system. The code can be accommodated in minimum 25 mm Ă&#x2014; 25 mm square with all legitimate information required for traceability, can be printed with any printer including a thermal printer with the database accessibility from any ERP system including SAP and AS400. It complies with the clauses of global GS1 standard and provides full legal protection and also renews the e-business approach for the manufacturers.

Legal basis and subsidarity For our government and regulatory authorities, it is a boon. The regulatory authorities can enforce obligatory specific safety features like private data in every package of the medicine whether in strip form or any other packaging medium. This will facilitate the obligatory audit by the manufacturer to ensure reliability in supply chain. It can help them to restructure the healthcare industry and safeguard the public health. It can help to open newer avenues for challenging the counterfeiters, preventing the revenue leakage and provides 100 per cent accurate supervisory control with existing manpower inputs. Finally, it empowers both the regulatory authority and the consumers to distinguish between the genuine and fake. This is an end-to-end solution, which is free from limitations.

The path forward Technology should not act as a hindrance to implementation. Curbing counterfeiting is a mammoth task. It may involve a massive load for our government to comprehend, the Drug Control Authority to comply with, the manufacturers to adhere and finally the consumer to be alert. It also requires equal and voracious involvement of the law enforcement authority, our legal system, our consumer forums and all tangible authorities involved at every state, at every level, at every nook and corner of our provinces. Taking measures for this act requires respect for each institution, respect for our society, respect for our law of the land and above all respect for life. MPh (mp@mmtechnologiesindia.com)

April 2011 I Modern Pharmaceuticals

Curtain Raiser

Bangalore INDIA BIO 2011

Connec ng leaders of today with tomorrow Time has come when Bangalore INDIA BIO will make its appearance for the year 2011. With biotech sector as the core focus, the event aims to become a pla orm where the interna onal biotech companies can interact with India’s life science industry. Vision 2015 Leadership Series, BioPartnering IndiaTM, CEO Conclave, Bio IP Zone, Bio-Excellence Awards, BioQuiz, Industry trails and networking events.

Highlights

In retrospective

Chandreyee Bhaumik

angalore INDIA BIO (BIB), organised by the Department of Information Technology, Biotechnology and Science, Government of Karnataka and Vision Group on Biotechnology, has evolved after the last 10 successful editions. This year, Bangalore INDIA BIO (BIB) with the core theme ‘biotech for a better tomorrow’ is scheduled to be held during May 4-6, 2011 at Bangalore International Exhibition Centre, Bengaluru. The scale of the event has increased enormously with growing international participation and is considered as one of India’s leading biotech events. Pawan Kumar Bansal, Minister, Parliamentary Affairs, Science & Technology and Earth Science, Government of India, will be the Chief Guest for the inaugural function. Jerome Bonnafant, Ambassador of France to India, will also grace the inauguration function. This event will consist of multi-track conferences, international trade show, 58

The multi-track conference will focus on bio pharmaceuticals - regenerative medicine, drug discovery and development, vaccines, systems biology & discovery platforms, bio collaborations - clinical trials and contract research, bio informatics & next generation genomics, agri and industrial biotech - food security, enzymes and biofuels, business of biotech - entrepreneurship session, human resource development. Commenting in this regard, Mahinder Singh, Project Director, Bangalore INDIA BIO 2011, says, “The International Tradeshow at Bangalore INDIA BIO means business. It is the largest congregation of biotech fraternity to conduct interactions and business. We have carefully cultivated this platform as the meeting ground between exhibitors, over 800 delegates & 5000 business visitors from across India & overseas.” Bangalore INDIA BIO 2011 is expected to attract over 150 exhibitors from across the globe. Therefore, this exhibition aims to become a platform for connecting with the biotech world. Countries expected to participate in the 2011 event are US, Canada, UK, France, Chile, Cuba, Mexico, Germany, Spain,

Australia, New Zealand, South Africa, Japan, Singapore, Malaysia, China, Korea and UAE. Elaborating on this context, Singh comments, “This is almost 25 per cent more than the participation levels in 2010 on all counts.” Further, CEO Conclave will be addressed by eminent personalities and senior policy makers from the biotech fraternity. The theme for the discussion is ‘Is India’s leadership ready for establishing a biotech global foot print?’

Looking back Bangalore INDIA BIO is considered as one of the largest and most prestigious biotech events in Asia and has made a great impact on the industry, positioning India as one of the top destinations for biotech research & development, bioservices as well as a large market for end-products. Therefore, it can be said that the global biotech industry’s response over the years is a proof of its popularity. True, India is one of the very important destinations for the biotech industry worldwide. Thus, in this scenario, Bangalore INDIA BIO undoubtedly plays a major role in business development for India in the global biotech arena and has entrenched itself as a hub for innovations. This exhibition can also prove to be an arena of collaborations in this sphere. Thus, this event is a unique platform where international biotech companies can connect with leaders in India’s life sciences industry, scientific community, policy makers, and also, regulators and biotech states. MPh (chandreyee.bhaumik@infomedia18.in)

Modern Pharmaceuticals I April 2011

Events Calendar

National RUDRAPUR: Uttarakhand, Sept 23-26, 2011, Gandhi Park AHMEDABAD: Gujarat, Nov 14-17, 2011, Gujarat University Exhibition Hall PUNE: Maharastra, Nov 18-21, 2011, Auto Cluster Exhibition Centre CHENNAI : Tamil Nadu, Dec 16-19, 2011, Chennai Trade Centre INDORE: Madhya Pradesh, Jan 6-9, 2012, Poddar Plaza, Nr Gandhi Hall

together the international exhibitors and market leaders. This event will provide an excellent opportunity to showcase innovative products and solutions in the industry; October 12-14, 2011; Bombay Exhibition Centre, Mumbai

AURANGABAD: Maharashtra, Feb 17-20, 2012, Garware Stadium 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

PharmaTech Expo 2011 Jointly organised by PharmaTechnology Index.com and IDMA, this event aims to be the largest pharma expo in Indore. The objective of this event is to project the latest technological trends in the pharma industry, facilities & services available, quality control and government regulations. This event will showcase latest products, machinery, equipment developments in the industry for generating business and upgradation, and to show the brand value of organisations, joint venture with firms, project collaborations, etc; April 22-24, 2011, Lal Baugh Palace Grounds, Indore For details contact: IDMA Tel: + 91 22 2497 4308 Fax: + 91 22 2495 0723 Email: prach17@gmail.com Website: www.idma-assn.org

conference delegates, regulators and policy makers; May 4-6, 2011, TBA, Bengaluru For details contact: M M Activ Bangalore Tel: + 91 80 4113 1912 Fax: + 91 80 4113 1914 Email: redmanjunath@gmail.com Website: www.bangaloreindiabio.in

2nd Pharmac India The three-day event will cater to the pharma and healthcare industry in the country. It aims to attract reputed professionals from the fields of pharmaceutical formulation, herbal products, veterinary drugs, medical & disposal products and pharmaceutical machinery and equipment. The event will have exhibitors such as contract manufacturers, liaison agents, sourcing companies, generic and OTC manufacturers & wholesalers, government suppliers, etc; September 17-19, 2011; Gujarat University Exhibition Hall, Ahmedabad, Gujarat

11th Bangalore INDIA BIO Bangalore INDIA BIO will offer unrivalled opportunity in the Asia Pacific region to meet the leaders in the biotech world. The exhibitors profile includes bio-nations and states, R&D organisations, bio-pharma companies, bio-suppliers, bioinformatics, engineering & equipment, biotech parks, diagnostics & instrumentation, clinical research, consulting and allied services. The event will witness industry and corporates, trade commissions, international business representatives,

For details contact: Orbitz Exhibitions Pvt Ltd Tel: + 91 22 2410 2801 Fax: + 91 22 2410 2805 Email: info@pharmacindia.com Website: www.pharmacindia.com

Analytica Anacon 2011 Analytica Anacon 2011 is the 6th international trade fair and conference for analytical instrumentation, biotechnology, laboratory technology and services, which aims to bring

For details contact: Sonia Prashar Indo-German Chamber of Commerce Tel: +91 11 26878721 or 26111730 Email: soniaprashar@indo-german.com Website: www.analyticaindia.com

CPhI India 2011 The event will feature key decision makers in the pharma industry from 92 countries, including India, China, US, UK, France, Italy, etc. 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

Pharmapack Bombay The event aims to provide an innovative platform to showcase the latest information, technology and products to a focussed and target audience. The event promises to cater to the exporters, importers, biotechnology companies, medical device manufacturers, biopharmaceuticals etc. February 23-25 2012, Bombay Exhibition Centre, Mumbai For details contact: Intel Trade Fairs &Expositions Pvt Ltd Tel: + 91 22 2862 8126 Fax: + 91 22 2281 9008 Email: intelexpo@vsnl.net Website: www.intelexpo.com

Modern Pharmaceuticals I April 2011

Events Calendar

International International Pharmaceutical Exhibition The International Pharmaceutical Exhibition will bring together 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: Arosa Exhibitions Ltd Tel: + 1 980 219 8449 Email: gviniconis@arosa-group.com Website: www.charlotteconventionctr.com

experts and delegates from academia, industry and regulatory. Further, the event also hopes to ensure a consolidated movement towards common goals and targets and thus hopes to create synergy within the array of different disciplines, all having the objective to better serve the Health.; June 13 - 17, 2011; Prague Congress Centre, Prague, Czech Republic For details contact: Congrex Sweden AB Tel: +46 8 4596600 Fax: +46 8 6619125 Website: www.pharmscifair.org

CPhI China 2011 The Third Global Helsinki Chemicals Forum The event aims to discuss the current issues within chemical controls and chemistry. The forum will witness representatives from industry, authorities, NGOs, academia and also consumers. The event hopes to offer participants new opportunities and visions of the future operating environment for the chemical industry. It will also provide scope to the stakeholders to get involved in influencing future trends and decisions related to the industry; May 19-20, 2011; Helsinki Exhibition & Convention Centre, Helsinki, Finland

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

BioProcess International China For details contact: Chemicals Forum Association Tel: +358 50 530 5958 Email: henna.koppala@helsinkicf.eu Website: www.finnexpo.multiedition.fi

3rd PharmSciFair This event with around 1000 expected delegates, aims to help in understanding the different approaches and perspectives among the different players in pharmaceutical sciences represented by

BioProcess International China will be the 3rd annual event organised in China. The main topics of discussion will be on cell culture, cell line engineering, purification and recovery, process characterisation, process analytics, formulation and disposables technologies. The event will be attended by the biopharma companies, scientists, and executives from all over the world; August 22-24, 2011, Grand Hyatt Shanghai, China

For details contact: IBC Life Sciences Tel: + 65 6508 2401 Fax: + 65 6508 2407 Email: register@ibcasia.com.sg Website: www.ibclifesciences.com

CPhI South America This event aims to be a platform where several pharmaceutical manufacturers, biopharmaceutical, biotechnology companies & API manufacturers will display a variety of products & services. The event will enable business partnerships, new product launches and showcase innovations; August 2426, 2011; Transamerica Expo Center, Sau Paulo, Brazil For details contact: CPhl South America 2011 UBM International Media Tel: +31 0 204 099 561 Fax: +31 203 0632 616 Email: rob.sahi@ubm.com Website: www.cphi-sa.com

ICSE Europe The ICSE Europe aims at targeting the top leaders of the pharmaceutical industry. The event will organise an exhibition alongwith concurrent conferences. The exhibitors profile includes biotrails, pharmacology, pre-clinical, biotechnology, pharma equipments and machinery, production equipments, clinical research, patient safety monitoring, etc; October 25-27, 2011, Messe Frankfurt, Frankfurt, Germany For details contact: UBM Live Tel: + 31 20 409 9544 Fax: + 31 20 363 2616 Email: icse@ubm.com Website: www.icseexpo.com

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

April 2011 I Modern Pharmaceuticals

Book Shelf

Pharmaceu cal Process Chemistry Editors : Takayuki Shioiri, Kunisuke Izawa, and Toshiro Konoike Price : ` 10,000 Considering the relevance of process chemistry in the pharmaceutical industry, this book offers a thorough insight into the basic chemistry. ‘Pharmaceutical Process Chemistry’ provides information on the required industrial techniques along with morphology, engineering and regulatory compliances. Divided into several chapters and sub chapters, the book can be considered as an important guide for medicinal chemistry and the industrial & commercial production of medicines. It shows how the establishment of robust and speedy procedures helps in producing drug candidates and Active Pharmaceutical Ingredients (APIs) with high quantity. The various chapters discuss how dangerous procedures and hazardous reagents can be avoided. These chapters also advocate the selection of safer and environmentally friendly processes. Some of the chapters show the importance of synthesis and process research in the development of new drugs. Further, another chapter elaborates the design of dynamic salt catalysts based on aid-base combination chemistry. Again, one chapter of the book deals with the development of palladium catalysts for chemoselective hydrogenation and another illustrates industrial synthesis of perflurorinated building blocks by liquidphase direct fluorination. The book encompasses the entire span of pharmaceutical process chemistry and aids not just the process chemists but also academicians and students. It may also be beneficial to the researchers in their specified area of work.

Handbook on Injectable Drugs (16th edi on) Editor : Lawrence A Trissel Price : ` 14,900 The 16th edition of the ‘Handbook on Injectable Drugs’ brings together abundant information on 349 parenteral drugs that are commercially available. The information in the 16th edition is accumulated from 2788 references, including 65 new references to this edition. The book is designed for use in clinical situations. This book can be considered as a valuable companion and assist in receiving information regarding injectable drugs. The several chapters show tabulated results from primary research on the compatibility of the listed drug with infusion solutions and other drugs. Further, four compatibility tables demonstrating solution, additive, syringe and Y-site are provided for each drug. Besides, storage requirements and general stability information including pH, freezing, exposure to light, filtration characteristics and repackaging information are also provided. Some of the chapters also show key product data including common sizes, strengths, volumes and sizes in which the drug is supplied. The book encompasses a spectrum of injectable drugs and tries to answer the Frequently Asked Questions (FAQs) regarding the preparation, storing and administration of injectable drugs. This book will help the pharmacists in the formulation and clinical use of parenteral medications. Further, it can also assist students in their respective academics.

Available at: Wisdom Book Distributors, Hornby Building, 1st floor, 174, D N Road, Mumbai 400 001 • Tel: 022-2207 4484/6631 8958 • Telefax: 022-2203 4058 • Email: thadam@vsnl.com

April 2011 I Modern Pharmaceuticals

Product Update Vacuum suc on cups for blister packs

Octagonal blender

Schmalz India offers vacuum suction cups. The requirement for vacuum suction cups for handling blister packs are constantly growing. There is a trend to handle finer films at shorter cycles. With the suction cups designed and produced by the vacuum specialist Schmalz, one can play safe. Due to the large product line, the company offers the possibility to choose between different materials and geometries with specific benefits securing ones competitive advantage. Bellows suction cups made of PVC - are characterised by a highly flexible but also wear-resistant sealing lip and are suited for blisters, eg battery carton.

Febchem Engineering Works offers octagonal blender, which is a very useful machinery for pharmaceutical industry wherein gentle blending of dry granules or powder is to be done. It is provided with baffles for fast and efficient mixing, charging port and outlet with butterfly valve. The entire unit is mounted on a sturdy stand, complete with electric motor and gear box. It can be supplied with bin charging system and can be designed for vacuum for dust-free charging and discharging of product (optional).

Schmalz India Pvt Ltd - Pune - Maharashtra Tel: 020-4072 5500, Fax: 020-4072 5588 Email: schmalz@pn3.vsnl.net.in

Automa c capsule ﬁller Karishma Pharma Machines offers ‘Model-A25’ highspeed automatic capsule filling machine. All the powder contact parts are made in stainless steel 316. The main body of the machine is fabricated out of SS-304. It is compact, sturdy, covered with stainless steel panels, and the hood is covered with acrylic guard. It is provided with tamping mechanism for powder filling, which enables capsules to be filled with a weight variation within 2 per cent. The variable AC frequency drive for main motor ensures speed adjustment. The faulty capsule and filled capsule ejection stations are equipped with individual air controls. This machine is simple to operate and easy to maintain. The special purpose gauges ensure quick and easy changeover. The appropriate sensors ensure continuous flow of powder and empty capsules for uninterrupted operation of the machine. The control panel of the machine is equipped with PLC system, enabling visual display of the operating parameters besides ensuring accuracy, reliability and reduced operator fatigue. Karishma Pharma Machines - Mumbai - Maharashtra Tel: 022-2380 5979, Fax: 022-2381 1849, Mob: 9821069064 Email: zabinmenon@vsnl.com 66 66

Febchem Engineering Works - Indore - Madhya Pradesh Tel: 0731-2721951, Fax: 0731-272 3087, Mob: 09893256418 Email: response@febchem.com

Robot supported inspec on machine Seidenader Maschinenbau GmbH offers robot supported inspection machine (RIM). This has been developed with a new approach to inspect highly potent or cytotoxic products as used in cancer therapy. This is designed for small batches, such as for research and clinical trials, or where automatic inspection is preferred because of the nature of the product or the documentation required. The core of the inspection machine is a six-axis robot arm, which picks up container by container from a buffer table and places them into appropriate inspection stations. Upon completion of all inspections, it separates defect from good products. Three inspection positions can be equipped with different cameras providing more flexibility of inspection views and increased number of images. The inspection stations are similar to those used in conventional Seidenader inspection machines – for special requirements they can be designed to be suitable for isolator environments, and robust against product, cleaning agents and neutralising fluids. The base module inspects up to 15 liquid filled vials per minute for particles, fill level, cracks or defective closures, and checks lyophilised products for overall appearance, particles and other cosmetic defects. The robot can be equipped for handling vials, ampules, syringes and special containers from 1 ml to 100 ml. Seidenader Maschinenbau GmbH - Markt Schwaben Germany Tel: +49-8121-802-183/ +49 8121 - 802-486, Fax: +49-8121- 802-49183/ 100 Email: heidrun.sing@seidenader.de Modern Pharmaceuticals I April 2011

Product Update Near-infrared spectrometer Thermo Fisher Scientific Inc offers Thermo Scientific TruProcess analyser, the next-generation nearinfrared (NIR) spectrometer for real-time blend analysis, drying and other Process Analytical Technology (PAT) applications. The TruProcessâ&#x201E;˘ analyser demonstrates the proven precision of a benchtop system and is easily integrated into existing manufacturing processes. The analyser provides fast, reliable, real-time process analysis while optimising manufacturing throughput, ensuring product quality and lowering production costs. In addition, the analyser includes MicroElectro-Mechanical Systems (MEMS) technology that transforms traditional NIR spectroscopy into a process-line NIR sensor. The small and lightweight enclosure of TruProcess permits interface with the widest range of pharmaceutical process equipment. It features an integrated position sensor and wireless communications, can complete a scan within one second, and has the ability to monitor blending rates of up to 25 RPMs. The analyser is also compatible with Thermo Scientific Method Development software to allow for both qualitative and quantitative applications including drying, blending and moisture analysis. Thermo Fisher Scien ďŹ c - Pune - Maharashtra Tel: 020 6626 7000, Fax: 020 6626 7001 Email: Info.mc.in@thermofisher.com

On-line TOC analyser MeasureTest Corporation offers On-line TOC analyser from Anatel of USA. This can be measured both on and off-line. Off-line measurements (laboratory methods) are typically used for high concentrations (>1 ppm). On-line measurements are typically used for sub-ppm (<1000ppb) detection and quicker response than the lab methods. Most industries particularly pharmaceutical and semiconductor manufacturing now use on-line measurements due to the faster response, which is required for process control. Online TOC analysis comes with complete sample oxidation. Its complete regulatory compliance is USP <643>, <645>, and EP 2.2.44 and has wide dynamic range of 1 to 1,000 ppb. There is no requirement of reagents or chemicals. MeasureTest Corpora on - Mumbai - Maharashtra Tel: 022-2202 7982, Mob: 098690 12701 Email: measuretest@yahoo.com April 2011 I Modern Pharmaceuticals

Product Update Asep c machine Romellag offers bottelpack 4010M aseptic machine for making unit dose eye drops and, a high-voltage leak detector HVLD 926 for the non-destructive leak testing of large-volume containers. A complete range of packaging solutions and services for filling liquids, gels and pastes is offered. These are tailored to the individual needs of the customers in terms of container design, production capacity, unit volumes, product development and include a first-class worldwide customer and spare part service along with the facility to carry out stability tests and also contract filling. The centrepiece is the sterile pyrogen-free container manufacture, aseptic filling of sterile products and the hermetic sealing in one operation. Hourly outputs can reach 30,000 ampoules for container sizes from 0.1 ml to over 2000 ml. An integrated US class 100 (ISO 3) clean room in the filling area is also offered with the machine, as is automatic CIP/SIP cleaning. The bottelpack machines are simple to operate and particularly suited to 24/7 operation as a result of the automatic machine process. Rommelag Ag - Buchs - Switzerland Tel: +41-62-834 5555, Fax: +41-62-834 5500 Email: claus.munk@rommelag.ch

Stoppering machine Automated Machine Technologies offers servo rotary stoppering machine, which is crafted for clean room productions. Its compact size allows for a side-by-side configuration,doubling the speed and matching the speed of the liquid filling machines for over 200 vials per minute side. The system will perform full and partial insertion and can be easily changed over to different stopper and bottle sizes. The multi-axis servo system synchronises stoppers with bottles, thus eliminating the need for difficult mechanical adjustments over years of operations. Vibratory feeder bowl orients and supplies stoppers, and is servo driven for programmable changeover to a different bottle height. Automated Machine Technologies Inc - North Carolina - USA Tel: +1-919-361 0121, Fax: +1-919-481 2120 Email: Office@AMTLiquidFilling.com 68 68

Modern Pharmaceuticals I April 2011

Product Update Dryer Bombay Pharma Equipments offers fluid bed dryer and tray dryer. The fluid bed dryer is a process equipment used for uniform and efficient drying of products. It is available in the range of 5-500 kg, with or without PLC-based control. The fluid bed dryer is provided with stainless steel interconnecting duct lines with flanges for connecting remote mounted heating and fan motor modules. It is equipped with lifting and tilting device for easy handling, bag shakers, intrinsically safe earthing arrangement and bucket-type bottom chamber above ground level. The tray dryer is available with 6, 12, 24, 48, 96 and 192 trays with double wall construction. Made of SS frame work, with glasswool insulation, this unit comes with an air inlet, air filter and adjustable damper (outlet). It is also equipped with single insulated & self-locking door, and one fan for air circulation inside the area. The sophisticated control panel is with on/off push buttons and indicating lights. Bombay Pharma Equipments Pvt Ltd - Mumbai Maharashtra Tel: 022-2859 4877, 2852 1608, Fax: 022-2852 1608 Mob: 98201 24804, 98201 20086 Email: bombaypharma@vsnl.net

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 IP67-rated 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: 93223 39208 Email: salesindia@bannerengineering.com April 2011 I Modern Pharmaceuticals

Product Update S rring hot plate

Vial & bo le cap sealing machines

Cole-Parmer India offers ‘IKA® RCT Basic IKAMAG®’ digital stirring hot plate with a stronger motor of a higher speed range up to 1,500 rpm and temperature control mode for faster heating of the medium. The PT 1000 temperature sensor ensures precise temperature control. The maximum stirring capacity (H2O) is 20 L. It features a highly polished aluminium round top heating plate, which provides efficient heat transfer than standard top plates. Hot plate features an over-temperature safety circuit adjustable from 50-310°C to protect the samples from overheating, hence suitable for unsupervised operation. The exact temperature and speed setting can be done via digital display. The hot top indicator shows temperature reading, thus preventing burns. The bushing is according to DIN 12878 for connecting a contact thermometer enabling precise temperature control. The stirring hot plate finds applications in various industries such as process, pharmaceuticals, biotech, chemical, petrochemical, refinery and food & beverage. The company also provides accessories such as temperature sensors, electronic contact thermometers, reaction vessels and stirring bars.

Anju Pharmaceuticals offers vial and bottle cap sealing machines that are compact, versatile and elegantly finished devices for sealing vials & bottles of various sizes and BT (transfusion) bottles or similar containers with aluminium or plastic caps. The vials ready for sealing are placed one-by-one on the self-lifting stainless steel platform. This platform lifts upward automatically. As a result, the vials touch the sealing head, thereby lifting the head upwards. Sufficient time is provided to remove the vial platform after the completion of sealing operation. The features of the machine include: perfect & uniform sealing, therefore no manual involvement; no repeated setting required; sealing rollers rotate on bearings to give smooth motion for uniform sealing; minimum time require for changeover from one size of vial to another; and does not require lubrication.

Cole-Parmer India - Mumbai - Maharashtra Tel: 022-6716 2222, Fax: 022-6716 2211 Email: response@coleparmer.in

Fluid bed dryer

Anju Pharmaceu cals - Indore - Madhya Pradesh Tel: 0731-252 3968/7415, Fax: 0731-285 6142 Email: anjupharma@hotmail.com

Amulya Industries offers fluid bed dryer. This dryer is used for drying powders and granules in industries such as pharmaceuticals, chemical, food, cosmetic and dye. It is available in 2, 5, 10, 30, 60, 120, 300 and 500 kg capacity as per GMP standards with validation documentation. The structure is fabricated of rigid square pipes of SS-304/claded and polished to matt surface finish. All MS parts fabricated to smooth surface and painted. The contact parts are made of SS-304/316 with all joints fusion free argon arc welded. The internal surface is ground and polished to mirror finish. The control panel is fabricated of SS-304. It is mounted on machine stand for easy accessibility. The panel consists of switch gear fuses, relays, motor starter, indicating lamp, push buttons, etc. The drying time taken by this dryer for pharmaceutical granules and powders having 2025 per cent moisture is approximately 30-45 minutes at 80°C temperature, depending on physical properties of material, type of moisture contents, drying temperature, etc. Amulya Industries - Mumbai - Maharashtra Tel: 022-2852 0116, Fax: 022-2851 6488 Email: aamulya@vsnl.net

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

Modern Pharmaceuticals

70 70

Modern Pharmaceuticals I April 2011

Product Index Sl No Product

Pg No

Sl No Product

Pg No Sl No Product

Pg No

Accelerated ageing test......................................... 47

48 Force feed lubricator .............................................. 31

91 Process heat exchanger ............................................ 5

Access control system............................................. 33

49 Fuel........................................................................... 47

92 Process reactor .......................................................... 5

Air filter ............................................................. 37, 39

50 Gases ...................................................................... 47

93 Programmable logic

Air shower controller ............................................. 33

51 Gear oil .................................................................... 47

controller...................................Front Inside Cover

Analytical instrumentation ................................... 21

52 GMP heat exchanger................................................ 5

94 Programmable terminal ............Front Inside Cover

Aseptic machine ..................................................... 68

53 GMP reactor ............................................................. 5

95 Proximity sensor.........................Front Inside Cover

Automatic capsule filler......................................... 66

54 HEPA filter terminal housing....................... 37, 39

96 Q-series thermal analysis.................................... 19

Banking services................................................... 51

55 HPLC ....................................................................... 21

97 Quick-change terminal house......................... 37, 39

Bar code reader....................................................... 69

56 Hydraulic buffer ..................................................... 31

98 Rapid endotoxin detection system..................... 67

10 Bearings ..................................................................... 6

57 Hydraulic cylinder.................................................. 31

99 Return air riser.................................................. 37, 39

11 Biodiesel................................................................... 47

58 Hydraulic jack......................................................... 31

100 RFID.............................................Front Inside Cover

12 Biological safety cabinet .................................. 37, 39

59 Hydrogenator/autoclave........................................... 5

101 Rheology microcalorimetry .................................. 19

13 Broadband services................................................. 13

60 Industrial control & sensing

102 Robot supported inspection machine ................. 66

14 Cable carrier ........................................................... 6

device ...................................... Front Inside Cover

103 Rotary vacuum dryer............................................... 5

15 Cable connector........................................................ 6

61 Informatics .............................................................. 21

104 Rotocone dryer ......................................................... 5

16 Capping machine ..................................................... 9

62 Injectable manufacturing line......................... 37, 39

105 Safe change housing....................................... 37, 39

17 Chains ........................................................................ 6

63 Injectable powder filling machine.......................... 9

106 Safety light curtain .....................Front Inside Cover

18 Clean room door.............................................. 37, 39

64 Invertor/variable frequency

107 Sampling booth ................................................ 37, 39

19 Coloumns & chemistries....................................... 21

drive ...........................................Front Inside Cover

108 Screening machine ................................................. 11

20 Complete tablet bottle packing lines ..................... 9

65 Knife mill............................................................... 11

109 Separator.................................................................. 11

21 Compositional & trace metal analysis ................. 47

66 Laminar air flow workstation....................... 37, 39

22 Conical screw dryer.................................................. 5

67 Level controller ...........................Front Inside Cover

23 Connector.................................................................. 6

68 Liquid filling lines..................................................... 9

24 Control instrumentation ............Back Inside Cover

69 Liquid filling machine.............................................. 9

25 Counters & power supplies.......Front Inside Cover

70 Liquid food processing system ............................. 11

26 Crusher .................................................................... 11

71 Lubes- engine oil .................................................... 47

27 Diesel fuel.............................................................. 47

72 Material identificaton .......................................... 47

28 Dispensing booth ............................................. 37, 39

73 Measuring & monitoring

110 SEZ developer ..................................Front Gate Fold 111 Silicone carbide heat exchanger.............................. 5 112 Single-acting hydraulic cylinder ........................... 31 113 SME finance ............................................................ 51 114 Spherical paddle chopper dryer ............................. 5 115 Steam engineering products ......Back Inside Cover 116 Sterilising/depyrogenating tunnel .................. 37, 39 117 Sticker labelling machine......................................... 9

29 Door interlock system............................................ 33

relay ...........................................Front Inside Cover

30 Double-acting hydraulic cylinder......................... 31

74 Metallography ......................................................... 47

31 Dry syrup powder filling lines................................ 9

75 Motion control ...........................Front Inside Cover

32 Dryer ........................................................................ 69

76 Mullers ..................................................................... 11

33 Electrical turnkey project.................................... 33

77 Multi-function mill ................................................ 11

34 Empower ................................................................. 21

78 Near-infrared spectrometer................................ 67

35 Encoder........................................Front Inside Cover

79 Octagonal blender................................................ 66

36 Evaporative cooling tower..................................... 15

80 Online B2B marketplace.................................. 17, 71

37 Exhibition - Engineering Expo-2012................... 62

81 On-line TOC analyser............................................ 67

38 Failure analysis ..................................................... 47

82 Packaging machine ................................................ 9

39 Fan filter unit .................................................... 37, 39

83 Passbox............................................................... 37, 39

40 Filler compositional analysis................................. 47

84 Passbox interlock system ....................................... 33

128 UPLC...................................................................... 21

41 Filter ......................................................................... 11

85 Petrol & fuel oil ...................................................... 47

129 Vacuum suction cups for blister packs ............. 66

42 Filtration equipment.............................................. 11

86 Photoelectric sensor ...................Front Inside Cover

130 Ventilator ................................................................. 57

43 Filtration system ..................................................... 11

87 Pneumatic component .......................................... 11

131 Vial & bottle cap sealing machine........................ 70

44 Financial services.................................................... 51

88 Polymer characterisation....................................... 47

132 Vision sensor...............................Front Inside Cover

45 Fire alarm ................................................................ 33

89 Power pack unit...................................................... 31

133 Washing and airjet cleaning machine ................. 9

46 Fluid bed dryer ....................................................... 70

90 Pre-engineered & pre-fabricated

134 Wastewater treatment equipment ........................ 11

47 Food analysing & testing machine....................... 11

April 2011 I Modern Pharmaceuticals

modular panel ................................................ 37, 39

118 Stirring hot plate .................................................... 70 119 Stoppering machine ............................................... 68 120 Switching relay............................Front Inside Cover 121 Telescopic cylinder ............................................... 31 122 Temperature controller..............Front Inside Cover 123 Testing system ......................................................... 47 124 Three parameter display........................................ 33 125 Timer............................................Front Inside Cover 126 Transmission fluid.................................................. 47 127 Turnkey project......................................................... 5

135 Wet glue labelling machine..................................... 9

Advertisers’ List Advertiser’s Name & Contact Details Bharti Airtel Ltd

Pg No 13

Advertiser’s Name & Contact Details Gem Equipments

Pg No 15

T: +91-422-3267800

T: +1800 102 4005

Shiva Analyticals (India) Limited

Pg No 47

T: +91-80-27971322

E: sales@gemindia.com

W: www.airtel.in/mpls

Advertiser’s Name & Contact Details

E: gupta@shivatec-india.com

W: www.gemindia.com Brothers Pharmamach (India) Pvt Ltd

W: www.shivatec-india.com

9 Guan Yu Machinery Factory Co Ltd

T: +91-79-40213213

Siemens Ltd

T: +886-4-896-5198 E: brothers@usa.nets W: www.brothers.co.in Charles River

E: guanyeu@ms39.hinet.net

W: www.siemens.com/pharma

W: www.guan-yu.net

Spirax Marshall Pvt Ltd

Igus India Pvt Ltd

T: +91-80-25588175

T: +91-80-39127800

E: india.customercare@crl.com

E: info@igus.in

BIC

T: +91-20-27442020 E: seg@forbesmarshall.com W: www.forbesmarshall.com

W: www.igus.in

W: www.criver.com Dipesh Engineering Works

Indiamart Intermesh Limited

17,71

Sreelakshmi Traders

T: +1800-200-4444

T: +91-44-24343343

E: pr@indiamart.com

E: sreelakshmitraders@gmail.com

W: www.indiamart.com

W: www.sreelakshmitraders.com

T: +91-22-26743719 E: sales@dipeshengg.net W: www.dipeshengg.com J B Sez Pvt Ltd Eltech Services Pvt Ltd

FGF

Standard Chartered Bank

T: +91-22-66210000 T: +91-22-39401616

T: +91-40-27759895

E: aparadkar@jbsez.com

E: sales@eltechservices.com

W: www.jbsez.com

W: www.eltechservices.com

Livewire

Engineering Expo

W: www.standardchartered.co.in TA Instruments-Thermal Analysis

E: livewire18@infomedia18.in Omron Automation Pvt Ltd

T: +91-9920401226

E: sme.custoercare@sc.com

FIC

T: +91-80-40726400

T: +91-80-23194177 E: india@tainstruments.com

E: engexpo@infomedia18.in E: in_enquiry@ap.omron.com

W: www.tainstruments.com

W: www.engg-expo.com W: www.omron-ap.com Fabtech Technologies Intl Pvt Ltd

37, 39

Waters (India) Private Limited Shashwat Systems Pvt Ltd

31 T: +91-80-28371900

T: +91-22-61592900

T: +91-79-65214825

E: mails@fabtecheng.com

E: sales@shashwatsystems.com

E: waters_india@waters.com

W: www.fabtecheng.ae

W: www.shashwatsystems.com

W: www.waters.com Our consistent advertisers

COMPLETE ENGINEERING UNDER ONE ROOF @ www.engg-expo.com

Modern Pharmaceuticals I April 2011