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EDITORIAL
On a firm footing he next year, for sure, seems quite promising for the Indian pharma! It is neither a mere hypothesis nor simple crystal ball gazing, rather the statistics say so. With blockbuster drugs worth nearly $ 30 billion going off patent in the US in 2011, India is estimated to gain approximately 30-40 per cent of the API component. Some of the enabling elements towards this feat include the country’s rising capabilities in biosimilars and high potency APIs such as oncology products, some hormones, etc. No wonder that some of the reputed multinational pharma firms have either initiated their operations here or are in final stages of collaboration. In hindsight, the big players in pharma have undergone a sort of transformation over the recent years. From the earlier business model of ‘one-does-all activities’, there is a clear emergence of ‘collaborative networking’ across business domains as well as geographic boundaries. In this context, India’s competitive advantage lies in offering a better cost-value proposition coupled with its strong capabilities in process chemistry, growing talent pool of right skills, availability of GLP & cGMP-compliant laboratories, strong process development and scale-up capabilities for API manufacturing, among others.
t
Also, it is important to observe here that the growth of segments such as biotechnology, bioinformatics, CRAMS, CROs, and pharma machinery manufacturing, etc is keeping pace with the larger pharma industry, going by the inflow of investment as well as expertise. This no doubt is a recognition of India’s achievements and evolution in the global pharma. Talking about the Indian pharma machinery sector, excise relief in certain zones, increasing international demand and globally competitive prices are some of the prominent growth drivers. At the same time, there is a strong need for this to create a robust R&D pool, deliver innovative products/services, and in the process rise to the next orbit of the value-chain. With some of the leading industrial events round the corner, the time is now ripe to make that crucial difference in business. This Special Edition of ‘Modern Pharmaceuticals’ showcases all these and more. Take a journey through the value-adding mix of features, news & views, and you will see the difference! Read on…
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Editor: Manas R Bastia
November 2010
Modern Pharmaceuticals
19
CONTENTS
F E AT URE S LEADERS SPEAK 'India has to shift its focus to innovation happening in biotech/device SMEs' ...says Dr Ajoy Kumar, Chief Executive Officer, Max Neeman International
ROUNDTABLE Prescribing habits of pharma companies: Shifting from doctors to chemists?
FACILITY VISIT Eisai Knowledge Centre, India: Capitalising on the India advantage
INDUSTRY UPDATE Pharma machinery manufacturers: Growing domestic with time
INTERFACE 'Purchasing pre-owned equipment can save the buyer up to 50 per cent or more on the cost of the same equipment purchased brand new' ...says Mahesh Karande, Head - Marketing, EQUIPNET (India) Pvt Ltd
MARKET TRENDS Pharma raw materials and excipients: India in sync with global regulations...
38 44 48 52 62 66
INTERFACE
52
44
48
'Waste management technology and effluent treatment are expensive propositions which require heavy maintenance' ...says Chandan Kumar, Executive Vice President, Manufacturing, Unimark Remedies
72
'The norms are mainly followed for compliance & obtaining licences than realising the importance and value of green chemistry' ...says Kiran Das, GM - Exports & Herbal, Anglo-French Drugs & Industries Ltd
74
MARKET INSIGHTS
76
CRAMS: India as a destination Dr Ravi Ratan Sobti Consultant - Pharmaceuticals (API), Rockdale Health, a division of Rockdale Infrastructre Pvt Ltd
MONEY MATTERS Investment patterns of MNCs in India: Impact and challenges Vikram Gupta CEO, IndiaVenture Advisors Pvt Ltd
MARKETING
66
76
Modern pharma manager: Not simply a man who ages Dr Rajan TD Pharma Consultant & Practising Dermatologist
CLINICAL RESEARCH
REGULAR SECTIONS
Clinical trials: An overview Rajendra Talele Vice President, Clinical Operations, Siro ClinPharm
Editorial ............................................................19
SMART SOLUTIONS
National News ..................................................22 World News ......................................................28 Tech Updates ....................................................34 Events Calendar..............................................100 Technology Transfer.......................................102 Book Shelf.......................................................104
Business intelligence in pharma: An aid in informed decision making Sanjay Mehta Chief Executive Officer, MAIA Intelligence Pvt Ltd
TECHNOFOCUS Advancements in clean-in-place technology: Critical in automating process cleaning Samuel F Lebowitz Technical Service Manager, Electrol Specialities Company
CURTAIN RAISER P-MEC & CPhI India 2010: Where South Asia meets
80 82 88 90 94
98
Product Update ..............................................106 Product Inquiry..............................................117 Advertisement Inquiry ...................................121 Product Index .................................................123 Advertisers’ List ..............................................125
20 Modern Pharmaceuticals
November 2010
Highlights of Next Issue Industry Update : Nutraceuticals Market Trends : Cosmeceuticals SEZ Focus : Baddi, Himachal Pradesh
Details on page no. 31, 32, 85, 86 Note: ` stands for Indian rupee, $ stands for US dollar and £ stands for UK pound, unless mentioned otherwise
NATIONAL NEWS
FDA APPROVAL
Biocon to invest in biomanufacturing and R&D facility in Bio-XCell Biocon recently announced its strategic foreign direct investment in Malaysia with the Malaysian Biotechnology Corporation SdnBhd(BiotechCorp). The investment will be made towards establishing a biomanufacturing and Research & Development (R&D) facility in Bio-XCell, which is a custom built biotechnology park and ecosystem at Iskandar Malaysia
EQUITY GAIN
Piramal Healthcare rewards shareholders with buyback of upto 20 per cent
Piramal Healthcare Ltd, (PHL), has announced that subsequent to completion of the sale of
TRIALS
Crofelermer, successfully completes Phase III trials Crofelemer, a first class anti-diarrhoeal drug successfully completed Phase III trials for HIV-related diarrhoeal drug completes its Phase III trials for HIV-related diarrhoea successfully, stated a Press Release by Glenmark. The completion of the top-line analysis of the primary efficacy
CRISIS MANAGEMENT
Ranbaxy Lab’s multiple triggers surge ahead, says Emkay report
After a prolonged crisis management phase, the worst seems to be behind Ranbaxy. Some of the positive triggers such as hiving off New Chemical Entity
22 Modern Pharmaceuticals
Johor. The business intent documents were exchanged between Biocon, which is India’s first billion dollar biotechnology company and BiotechCorp at Putrajaya in the presence of Indian Prime Minister Dr Manmohan Singh and his Malaysian counterpart, YAB Dato’ Sri Mohd Najib Tun Abdul Razak. Dato’ Iskandar Mizal Mahmood, Chairman, Bio-XCell SdnBhd and CEO, BiotechCorp, Malaysia, said, “Biocon’s strategic investment in Malaysia will propel our industry to the next
level. It will be a catalyst in our efforts of commercialisation as we enter Phase II of our National Biotechnology Policy, also known as Science to Business Phase”.
its domestic formulations business and its shareholding in Piramal Diagnostic Services Pvt. Ltd, the Board of directors considered & approved, subject to the approval of the members of the Company, and such other approvals/contents, to buyback the company’s equity shares. The buyback will be done for a maximum of 41.8 million shares which represents 20 per cent of the total number of shares at a price of ` 600 per equity share. The buyback price represents a
premium of 19 per cent over the average share price for the last three months. The buyback will be entailing a cash outflow upto ` 25.1 billion and will be completed by February 2011. This will be done on a proportionate basis through the Tender Office route as prescribed under the Securities and Exchange Board of India (Buy-Back of Securities) Regulations, 1998 in accordance with the provisions of the Companies Act, 1956 and the Buy Back Regulations.
endpoint from the Phase III ADVENT trial, a random, double blind, parallel-group, place controlled, two stage and adaptive design to evaluate the safety and the efficacy of Crofelemer in the treatment of chronic diarrhoea in people living with HIV/AIDS on Anti-Retroviral (ARV) therapy, was announced in the United States by Glenmark’s partners Napo Pharmaceuticals and Salix Pharmaceuticals. Further, Glenmark also
holds the exclusive marketing & distribution rights to this novel anti-diarrhoeal compound for multiple diarrhoea indications across 140 countries.
(NCE) R&D and monetisation of Aricept First To File (FTF) have already kicked in. Some further potential triggers waiting to pan out are the resolution of the FDA issue, monetisation of other Para IV opportunities such as Lipitor and Nexium, supply of Nexium Active Pharmaceutical Ingredient (API) and formulation to AstraZeneca, launch of Carbapenem in US & Europe and cost savings on account of manufacturing shift from Ohm
Laboratories to India and legal & consultancy costs with regard to FDA - Department of Justice (DOJ) issue. The recurring Earnings Per Share (EPS) for CY 11E has moved from ` 13.7 to ` 16.7. However, the estimates do not take into account the earnings upside from the aforementioned potential triggers, given the inability to ascertain a definite time frame for their occurrence.
November 2010
A glimpse of the event
NATIONAL NEWS
USFDA grants approval to new drug, announces Sun Pharma Sun Pharma has declared that USFDA has granted its subsidiary a tentative approval of its Abbreviated New Drug Application (ANDA) to market a generic version of IPR Pharmaceutical’s Crestor tablets 5 mg, 10 mg, 20 mg, and 40 mg.In another development, Sun Pharmaceutical Industries Ltd announced the expiration of the
CONVENTION
Pharmacopoeias of the world assemble at IDMA’s PAC 2010
Dignitaries on the dias
NEW VACCINE
Bharat Biotech announces the launch of HNVAC Bharat Biotech has declared the launch of H1N1 swine flu vaccine under the brand name HNVAC. This vaccine is the only developing world flu vaccine to be manufactured in cell culture that is highly sterile & controlled manufacturing process, instead of eggs. Dr Krishna Ella, Chairman & Managing
AGREEMENT
Biocon signs commercialisation agreement with Pfizer
Biocon SA, a 100 per cent subsidiary of Biocon Ltd, has recently signed a strategic global agreement with Pfizer for the worldwide commercialisation of Biocon’s biosimilar versions of
24 Modern Pharmaceuticals
subsequent offering period to the tender offer by Sun’s subsidiary Alkaloida Chemical Company Exclusive Group Ltd, for all outstanding ordinary shares of Taro Pharmaceutical Industries Ltd. Sun has been informed by Computershare, the Depository of the Offer, that as a total of 29,832 ordinary shares had been tendered pursuant to the tender offer representing approximately 0.07 per cent of the outstanding
ordinary shares. During the pendency of the subsequent offering period, no additional shares have been tendered. All tendered ordinary shares were accepted for payment.
The 13th IDMA-APA PAC 2010 was recently held in Mumbai. It marked the presence of pharma experts from the national and the international level. N R Munjal, President, Indian Drug Manufacturers Association, said, “The US Pharmacopoeia, British Pharmacopoeia, and the European Pharmacopoeia have already begun evincing keen interest in strategic collaborations
with the Indian Pharmacopoeia Commission (IPC) to source some monographs of certain drugs for inclusion in their respective editions”. Lauding the efforts of the Indian Pharmacopoeia Commission, Munjal said that the IPC should be commended for bringing out the latest edition, the 6th in the series, the IP 2010 within the next two years”.
Director, Bharat Biotech, said, “ Bharat Biotech is proud to develop and offer this vaccine with the best USFDA recommended cell culture technology for the Indian consumers. Our goal right now is to get the flu vaccine easily accessible and at affordable cost to high risk groups”. Bharat Biotech received the approval from the Drugs Controller General of India early in the month to launch this vaccine. This vaccine has also been developed
with approved strains from World Health Organization (WHO) and Centers for Disease Control (CDC) Atlanta.
Insulin and Insulin analog products like Recombinant Human Insulin, Glargine, Aspart and Lispro. The biopharma business posted a strong 27 per cent Y-O-Y increase in revenues in the first half of this fiscal with across-the-board growth in all core businesses like insulins, immunosuppressants, statins and branded formulations. Kiran Majumdar Shaw, CMD, Biocon Ltd, said, “This is indeed
a significant inflection point in our growth plan. Both, Pfizer and Biocon bring together a winning combination of marketing, manufacturing & research excellence, which will help build a formidable global footprint in diabetes care. Pfizer brings to us brand strength with a vast and unrivalled global marketing expertise that will enable Biocon to achieve global presence for its insulin portfolio”.
November 2010
Courtesy: www.wamfitandwell.com
DRUG APPROVAL
NATIONAL NEWS
OPPORTUNITIES
Trade and the rising consumer prosperity open up opportunities The Print–Packaging.com (P) Ltd (PPCL), in partnership with the All India Food Processors Association (AIFPA) will be organising PackPlus 2010 from December 3-6, 2010, at Pragati Maidan, New Delhi. The Ministry of Food Processing Industries (MoFPI) and Agricultural & Processed Food Products Export Development Authority (APEDA) are also supporting the show.
ANNOUNCEMENT
8th edition announced
of
BioAsia
(L-R) Dr B S Bajaj, Prof Raif G Vasilov, Kanna Lakshmi Narayana, K Rosaiah, Vyacheslav I Trubnikov, Peter T Hassan
LICENSING AGREEMENT
Anti-TrkA antibody from Lay Line Genomics in-licensed to Glenmark Pharma Glenmark Pharmaceuticals SA (GPSA), a wholly owned subsidiary of Glenmark Pharmaceuticals Ltd (GPL), has been granted by Lay Line Genomics (LLG) an exclusive worldwide licence to LLG’s entire intellectual property portfolio in the TrkA field. This licensed asset includes BXL1H5, which is a novel monoclonal antibody
NEW ACADEMY
FIOLAX® Academy doors in India
opens
Mohan Joshi
SCHOTT has set up FIOLAX Academy, which is a specialised training programme
26 Modern Pharmaceuticals
The event will showcase a spectrum of world class technologies and will also bring decision makers, entrepreneurs and technologists in the food processing and pharma industry on a common platform and help them build direct contact with suppliers of food processing and pharma industry and other ancillary equipment as well as integrated packaging lines. The event aims to be an apt platform for tapping the potential of the food &
pharma industry. The visitors will get to see new age machines and also meet the business authorities from the respective companies.
The 8th edition of BioAsia, a global bio-business forum, was officially announced by the Chief Minister of Andhra Pradesh, K Rosaiah. It will be held from February 21-24, 2011 at the first bio-city in Hyderabad. BioAsia 2011 will showcase three tracks MediAsia, HealthAsia, and AgriAsia. Rosaiah, said, “With an opportune theme of boosting bio-economy, BioAsia 2011 will feature multi-track conferences,
tradeshows and partnering, in addition to award ceremonies, networking receptions & other satellite events”. An agreement on Russia – India Biotech Network (RIBN) was also signed & exchanged in the presence of Rosaiah by Prof Raif Vasilov, President, Russian Biotechnology Society & CEO, Russian Bio-industry association and Dr B S Bajaj, convener, BioAsia 2011 and secretary, Federation of Asian Biotech Associations (FABA).
that binds to TrkA receptors. The deal is of immense importance as Glenmark has not only in-licensed a preclinical, unique monoclonal antibody, but also the exclusive licence to commercialise monoclonal antibodies against the TrkA receptor for pain. Commenting on this deal, Glenn Saldanha, Chief Executive Officer & Managing Director, Glenmark Pharmaceuticals, said, “We are excited to have been granted the sole licence to
commercialise monoclonal antibodies against the TrkA receptor for pain. We are also enthusiastic about the addition of BXL1H5 to the Glenmark discovery pipeline. Glenmark will leverage its expertise in monoclonal antibodies to progress BXL1H5 rapidly into clinical development”.
for converters of glass tubing as well as pharmaceutical companies. Employees from production departments, quality assurance & sales can now expand their knowledge on the use and benefits of glass for pharmaceutical packaging solutions. At FIOLAX Academy, experts from international technology group SCHOTT share their knowledge on the composition & production of pharmaceutical glass tubing to the converting and filling of the
containers, etc. Mohan Joshi, President, Tubing Division at SCHOTT Glass India in Vadodara, said, “Secure primary packaging solutions are crucial to support India’s pharmaceutical industry in growing business. With FIOLAX Academy we will support our partners along the pharmaceutical value chain in raising their quality and efficiency. This will help them improve their position on the domestic and international markets”.
November 2010
Visitors at the exhibition
WORLD NEWS
RECOGNITION
Exco InTouch receives ePRO accolade at the 2010 European Outsourcing Awards
Tim Davies with ePRO award
GENE THERAPY
GSK’s investment for gene therapy to treat rare genetic disorders GlaxoSmithKline’s announcement to develop and market gene therapy treatments for rare genetic disorders signals a ‘next step’ for the field of gene therapy, according to the American Society of Gene & Cell Therapy (ASGCT). The declaration represents a first-of-its-kind investment in gene therapy research by a major pharmaceutical company.
GRANT APPROVAL
US grant for Xylos Corporation
Xylos Corporation, a leader in biocellulose technology for medical applications, has announced recently that the company was awarded a grant in the amount of $244,479
FUTURE VACCINE
Novartis to develop a complete meningococcal B vaccine Successful results from a Phase III study have raised hopes that Novartis’ meningococcal B vaccine candidate, 4CMenB, could be first to provide broad coverage against the deadly disease. The trial that involved more than 3,600 infants, met its primary end points showing a good response in the
28 Modern Pharmaceuticals
Exco InTouch, the leading provider of patient communication solutions for the pharmaceutical and healthcare sectors, has been recognised for its tremendous strides in the delivery of electronic Patient Reported Outcomes (ePRO) solutions at the 2010 European Outsourcing Awards (EOA). Exco InTouch was honoured with the award for ‘Most Innovative Relationship’, in recognition of their collaborative study with the University of Queensland. The study focussed on evaluating mobile
phone technology for the collection of patient self-report data, using a Java based version of the WOMAC (Western Ontario and McMaster Osteoarthritis) NRS 3.1 Index. Tim Davis, CEO, Exco InTouch, said, “It is an honour to receive an award that recognises the progress achieved by the relationship between Exco in Touch and the University of Queenland. Together we have delivered a mobile phone platform for osteoarthritis that improves business performance as well as confirms unique opportunities in clinical practice and research.”
Dr Barrie J Carter, President, ASGCT, commented, “This is a very significant step in recognising that gene therapy is now delivering on its promise to develop new therapies.” The GlaxoSmithKline PLC (GSK) partnership with Fondazione Telethon and Fondazione San Raffaele in Italy, will invest in developing and bringing to market retroviral gene therapy for the hereditary disorder Adenosine Deficiency Disorder-Severe Combined Immunodeficiency (ADA-SCID), also commonly known as bubble boy disease.
The alliance capitalises on research and clinical studies performed at the Milan-based San Raffaele Telethon Institute for Gene Therapy (TIGET). A TIGET clinical trial for ADA-SCID is the most successful demonstration to date that gene therapy can result in safe, long-term correction of disease.
under the US Qualifying Therapeutic Discovery Project (QTDP) programme. Among various eligibility guidelines, a QTDP applicant was required to demonstrate reasonable potential in developing new therapies to treat areas of unmet medical needs or to prevent, detect or treat chronic and acute disease & conditions. Xylos’ application was focussed on its innovative biomaterial solutions for the treatment, repair and replacement of human tissue.
Mark S McNulty, President and CEO, Xylos, said, “This award is another validation of the scientific importance of our technology and its potential to provide leading care for patients. Funding of this nature is critical to supporting young, innovative companies. In our case, it will facilitate ongoing investment in personnel and research, with the near-term goal of introducing leading-edge implantable devices based on our new class of biomaterial.”
majority of children vaccinated with this vaccine. 4CMenB showed an acceptable tolerability profile when co-administered with other routine infant vaccines. This supports the vaccine’s use in the first year of life, when the medical need is greatest. Andrin Oswald, Division Head, Novartis Vaccines and Diagnostic, said, “The challenge with MenB was that there were thousands of circulating strains. Therefore,
developing a broadly protective vaccine has been difficult until now.” He further continued, “This critical data highlights the promise of the 4CMenB vaccine addressing the unmet public health need of MenB, the most common cause of bacterial meningitis for which there is no readily available global vaccine.”
November 2010
WORLD NEWS
AWARDS
Thermo Fisher Scientific nominated for European Outsourcing Awards
Thermo Fisher Scientific, Inc, the world leader in serving science, is nominated for three prestigious European Outsourcing Awards (EOA). The EOA nominations
EXPANSION ACTIVITIES
Molecular profiles unveils new capabilities at AAPS 2010 Molecular Profiles has announced that it is to demonstrate its expansion of capabilities at the upcoming AAPS/FIP Pharmaceutical Sciences World Congress 2010. Following a sustained period of investment into facilities, equipment and personnel the company has broadened its services in the early development space. Designed
ACQUISITION
ATMI acquires Artelis, further widening its disposable technology
ATMI has acquired Artelis, a Belgian biotech firm, thus widening its disposable
PRECLINICAL STUDIES
Epistem deal with NIH-funded project on preclinical testing An NIH funded radiation countermeasure programme has extended its preclinical testing services contract with Epistem for up to five years. Since 2006, UK-based Epistem has received $3.5m (2.5m) to develop models and evaluate drugs for treating radiation damage to the gastrointestinal tract. Now, Epistem has sealed a five year subcontract, which it
30 Modern Pharmaceuticals
included two entries for Best Contract Analytical Project for the application of Thermo Scientific Watson Laboratory Information Management System (LIMS) in bioanalysis and one entry for Most Improved Process/Plant Facility and Best e-Business/IT Strategy for Thermo Scientific CONNECTS in pharmaceutical manufacturing. “Being recognised in three separate EOA award categories is a great honour and shows how Thermo Fisher Scientific is providing
breakthrough informatics solutions to the global life sciences industry. These three applications demonstrate how we work with and enable our customers to automate and integrate their laboratory operations, cost-effectively manage samples and resources, capture and analyse quality data, provide essential reports and ensure regulatory compliance,” said Dave Champagne, Vice President and General Manager, Informatics, Thermo Fisher Scientific.
to provide a de-risking approach to drug development, the services, performed in one location, include formulation development activities with preformulation, polymorph screening, salt selection, analytical services and Phase I clinical trial manufacturing, as well as existing state-of-the-ar t analytical & characterisation suites. Dr Nikin Patel, CEO, Molecular Profiles, said, “The FIP and AAPS Congress
will enable us to highlight our recent expansion activities. We are committed to bringing innovative scientific approaches to the rapid and pragmatic cost-effective development of formulations for Phase I and beyond.”
technology portfolio to the life sciences research and manufacturing sector. The acquisition will see ATMI add Artelis technologies to its offering of the broadest range of storage, mixing and stir tank disposable bioreactors. This will address the growing demand for disposables in the life sciences industry and help get drugs to market quickly & more efficiently. Mario Philips, Senior Vice President and General Manager, ATMI LifeSciences, said,
“ATMI’s key motivation for the acquisition was to create more value for its customers by going beyond the traditional value proposition of disposables.” He further added, “By bringing high-purity and ultra-clean products to a level of breadth & depth not seen before in the life sciences market. Both firms can help support the development of human and animal vaccines, monoclonal antibodies & cell therapy applications.”
expects will extend and grow the scope of the collaborative relationship. Catherine Booth, Managing Director and Co-Founder, Epistem, said, “This fresh contract covering five years will allow us to progress successful candidate drugs, in addition to developing models to assess treatments for the delayed effect of radiation damage.” Inking the deal makes Epistem a subcontractor to the US National Institutes of Health’s (NIH) Radiation/
Nuclear Medical Countermeasure Product Development Support Services Contract. The NIH contract has been awarded to the University of Maryland School of Medicine (UMSOM).
November 2010
MPh (November_2010) 1Tab-31
MPh (November_2010) 2Tab-32
WORLD NEWS
LAUNCH
Unique organic synthesis solvents by Clariant
Clariant recently launched unique organic synthesis solvents with favourable toxicological properties. Clariant also unveiled advances in no acute toxicity,
ALLIANCE
Dako and Quintiles alliance to speed the development of personalised medicine Dako, a Danish-based world leader in tissue-based cancer diagnostics, and Quintiles, the world’s leading bio pharmaceutical services companies, recently announced a strategic alliance to advance personalised medicine by collaborating on the co-development of targeted therapies and companion
COLLABORATION
Sanofi-Aventis establishes research collaboration with Harvard University
Sanofi-Aventis recently announced research collaboration with Harvard University. The goal of the collaboration is to advance
ISSUES AND CONCERNS
ANDA filing for Silenor® Somaxon Pharmaceuticals, Inc, has recently announced that the website of the US Food and Drug Administration (FDA) indicates an Abbreviated New Drug Application (ANDA) for a generic version of Silenor® (doxepin) 3 mg and 6 mg that was submitted on September 16, 2010. However, Somaxon has not received a Paragraph IV certification with respect
easy-handling solvents for use in pharmaceutical and other chemical applications with the launch at CPhl of Highsolv® P99 and Highsolv® E99 for organic synthesis (Hall 6 6L62). The two colourless, low viscous solvents with favourable toxicological properties offer yield-improving and performance-related properties, making them a viable replacement for commonly used toxic & flammable solvents for organic synthesis such
as dichloromethane, toluene, etc. Highsolv® P99 and Highsolv® E99 are highly versatile. They have high flash and boiling points that ensure useful operating temperatures for a wide range of chemical sequences. Readily miscible with diverse solvents, Highsolv® P99 is also miscible with water. Both solvents are stable to numerous strong bases and can be used in mildly acidic processing conditions, further extending their versatility.
diagnostics. Under the non-exclusive alliance, Dako and Quintiles will offer integrated drug-diagnostic development services and companion diagnostic products. The first such collaboration will support AstraZeneca in the development of one of its leading oncology compounds. As part of the alliance, Dako will develop cancer diagnostic tests and Quintiles will conduct the tests as part of the clinical validation. Both Dako and Quintiles will continue to work independently with bio
pharmaceutical companies and service providers in the industry. Thomas Wollman, Senior Vice President, Quintiles Global Central Laboratories, said, “Quintiles and Dako share the same goals for speed, quality and efficiency.”
knowledge in the area of human health through basic and applied research and to promote scientific exchange between Harvard University and SanofiAventis. The focus of this collaboration is translational biomedical research in multiple therapeutic areas such as cancer, diabetes and inflammation. Harvard University investigators will propose research projects across a wide range of areas. The funded projects will be selected by a Joint Scientific Steering Committee comprised
of representatives of Sanofi-Aventis and Harvard, respectively. Projects will be awarded funding based on their scientific merit & potential to generate translational insight and value to biomedical research. “We are hopeful that promoting open scientific exchange between Harvard’s leading biological researchers and SanofiAventis’ drug development environment will drive significant healthcare advances,” said Dr Marc Cluzel, Executive Vice-President, Research & Development, Sanofi-Aventis.
to this ANDA filing. Somaxon intends to vigorously enforce its intellectual property rights relating to Silenor®. Silenor® is protected by eight patents covering the method of use of the product and its formulation, all of which are listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book. Under the FDA’s rules and regulations, if Somaxon initiates a patent infringement
suit to defend the patents identified in any Paragraph IV notice that it has received within 45 days after the receipt of such notice, the FDA is prevented from approving the ANDA until the earlier of 30 months.
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TECH UPDATES
New Cognex DataMan® handheld ID reader offers industrial Ethernet and autofocus
GxPi’s x-docs CAPA module selected by Renovo as a hosted system
Cognex Corporation has launched its next-generation DataMan® handheld industrial ID scanner, the DataMan 8000 series. The rugged DataMan 8000 series is designed for the factory floor and offers the industry’s most advanced code reading technology using patented IDMax® technology for reading 1D and 2D codes regardless of size, quality, printing method or surface. “The DataMan 8000 series represents a true breakthrough for industrial handheld readers,” said Didier Lacroix, Senior Vice President, International Sales & Services, Cognex. The DataMan 8000 series is the first industrial handheld reader to offer integrated liquid lens technology. Also, the system’s unique modular communication design allows users to easily upgrade from RS-232/USB to industrial Ethernet with field exchangeable interface modules. This flexibility enables users to modify their initial reader installation to meet future communication requirements. The DataMan 8000 series is available in two models: DataMan 8500 and DataMan 8100. The DataMan 8500 readers incorporate patented UltraLight® technology from Cognex for superior image formation on any mark type and surface. The DataMan 8100 readers are ideal for applications that require superior code reading performance without specialty lighting. Cognex DataMan 8000 Series
Regulatory compliance service and product provider GxPi has recently announced that that its x-docs Corrective Action and Preventive Action (CAPA) Module has been selected by Renovo as a hosted system to manage vital documents for the company’s drug development process. Renovo uses the GxPi CAPA Module, which is part of the x-docs portfolio, to electronically track and manage its Corrective and Preventative management programme. Used in a hosted system environment, the CAPA Module minimises installation costs, thereby reducing the overall implementation and licensing costs of the product for the customer. Keith Williams, CEO, GxPi, commented, “We are extremely proud to have been selected by such a prestigious organisation, leading the way in biopharmaceutical innovations. The whole integration process has been smooth and the fact that Renovo is using the module as a hosted x-docs CAPA module selected system has reduced their GxPi’s by Renovo as a hosted system to overall implementation manage vital documents during the drug development process costs.”
Biomarkers for radiation cancer treatment In a recent study, researchers utilised a pharmacogenomics strategy to find biomarkers associated with radiation response that could help in customising individual cancer treatments more effectively. In this study, researchers led by Dr Liewei Wang, Mayo Clinic performed a genome-wide association study on 277 ethnically defined human Lymphoblastoid Cell Lines (LCLs) to identify biomarkers for radiation response. The group incorporated several lines of data from the LCLs, including 1.3 million Single Nucleotide Polymorphisms (SNPs), genome-wide gene expression data and ionising radiation cytotoxicity phenotypes. By looking for SNPs and gene expression patterns that associate with a radiation response phenotype, Dr Wang’s team narrowed down a list of candidate genes associated with radiation treatment response. To validate the biomarkers functionally, the team assessed the associations of a set of the candidate genes in three cancer cell lines. The validation experiments confirmed the expression of five genes as involved in radiation-induced response. “These studies will provide a foundation for future translational studies to individualise radiation therapy based on the expression of these candidate genes and may make it possible to design novel combination therapy for selected patients based on these biomarkers to overcome resistance,” observed Dr Wang. 34 Modern Pharmaceuticals
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Better marker for breast cancer may reduce need for second surgeries A team of chemists, radiologists and surgeons at the University of California created microscopic gas-filled spheres of silica, a porous glass, that have been developed to tag the location of early-stage tumours to show their position using ultrasound imaging in the operating room. This new compound can help surgeons more effectively locate breast cancers, reduce the need for second surgeries and lessen presurgical discomfort for patients. As an alternative, researchers created spheres of silica and filled them with perfluoropentane, a gas that has been used before in short-lived contrast materials for medical imaging. The rigid silica shells help the new material last longer. “These little gas-filled microbubbles stick to human breast tissue for days and can be seen with ultrasound. If doctors placed them in early stage breast cancer, which is difficult to see during surgery, they could help surgeons remove all of it in the first operation,” said Dr William Trogler, Professor – Chemistry, University of California. At just two micrometer in diameter, small silica microbubbles can be precisely injected into clusters of abnormal cells using a thin needle. Moreover, ultrasound scans reveal the position of the bubble in three dimensions on the operating table.
TECH UPDATES
iGPS offers the world’s first pallet rental service
Siemens to generate revenue of over with green technologies in 2014
Intelligent Global Pooling Systems (iGPS) is offering the world’s first pallet rental service to supply plastic pallets with embedded Radio Frequency Identification (RFID) tags to the pharmaceutical and life sciences industries. The company assuring its pallets will not absorb fluids that can lead to contamination and will not require treatment with toxic pesticides & fungicides. This is sure to appeal to drug manufacturers in light of recent product recalls following complaints of musty smelling bottles - a problem since attributed to the presence of trace amounts of the fungicide 2,4,6-tribromoanisole. Bob Moore, Chairman and CEO, iGPS, stated, “The new service, iGPS bios, follows a year of research into the unique needs of these critical industries, and provides a level of pallet hygiene & security that cannot be achieved with pallets made of wood or other organic materials.” The four embedded RFID tags serve to enable pharma and life sciences firms to trace the pallets throughout the supply chain. Along with the recently introduced Spider AT battery-powered GMS/GPRS/GPS wireless tags, the pallet’s exact location can be accurately identified, allowing drug firms to get shipments back quickly in the event of a recall that can reduce cost. Furthermore, the company’s plastic pallets weigh less than 50lb and unlike their 75lb wooden counterparts, can significantly lower fuel and transport costs.
In fiscal 2014, Siemens wants to exceed the 40 billion revenue mark with green technologies. In fiscal 2010, Siemens generated revenue of around 28 billion with products and solutions from its environmental portfolio, compared to slightly less than 27 billion in fiscal 2009. In 2010, the latest generation of high-efficiency transformers was also included in the technology company’s green portfolio for the first time. In fiscal 2010, products and solutions from the Environmental Portfolio enabled Siemens customers worldwide to reduce their carbon dioxide (CO2) emissions by a total of around 270 million tonne, an amount equal to the total annual CO2 emissions of the megacities Hong Kong, London, New York, Tokyo, Delhi and Singapore. Virtually every division in the three sectors industry, energy and healthcare is contributing to the company’s green portfolio. In 2010, the largest individual reductions in CO2 emissions were achieved by highly efficient combined-cycle power plants, wind farms, the retrofitting of existing power plants, energy-efficient lighting systems and ecofriendly trains. Other future growth drivers include, for example, smart grids and their key components, an area in which Siemens anticipates total orders of around 6 billion by the end of 2014.
iGPS plastic pallet
40 billion
Thermo Fisher Scientific unveils new checkweigher and metal detector
More durable HP / Agilent 1100 HPLC available now
Thermo Fisher Scientific, Inc, the world leader in serving science, has announced two new high-performance offerings for the pharma industry, the Thermo Scientific APEX 500 Rx metal detector and Thermo Scientific Versa Rx checkweigher. Equipped with an effective slack belt system, the Versa Rx can handle weighing, control and reject functions at line speeds up to 500 packages per minute. The APEX 500 Rx system is based on the trusted APEX metal detector platform, delivering excellent sensitivity, stability and automatic performance verification via the unique Thermo Scientific AuditCheck feature. “The APEX 500 Rx meets a major need in today’s market – a cost-effective metal detector that provides the highest level of product safety required for the pharmaceutical industry,” said Bob Ries, Product Manager, Thermo Fisher Scientific. With its single brushless motor drive, the Versa Rx involves low maintenance and is able to handle high speed lines with ease & unparallel accuracy. The system’s closed cabinet design and knife edge feature for handling unstable objects ensure greater accuracy. The Versa Rx can also be easily equipped with a number of optional, pharmaceuticalspecific features.
The Agilent 1100 system is designed to be controlled with a hand-held controller or a computer running ChemStation. It is a modern series of stackable High Pressure Liquid Chromatography (HPLC) components. This system can be purchased with a computer running ChemStation or as a stand alone system. The Hewlett Packard HP/Agilent 1100 HPLC series is the current model and arguably the best design in the industry because of the optimised design of the quaternary pump ensuring virtually pulse-free & stable solvent flow, with dual floating pistons in series, precisely servocontrolled. This design with variable stroke volume allows pulse-free solvent delivery and efficient mixing. An inlet-valve electronically activated & synchronised to piston stroke - eliminates vapour formation with volatile solvents and is maintenance free. HP Agilent 1100 handheld control module lets the user enter operating parameters fast, store methods easily and display pressure profile, diagnostics & task-oriented information. It is highly durable. Further, the seal wash option for high salt mobile phases keeps maintenance to a HP Agilent 1100 minimum for lower operation costs.
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LEADERS SPEAK
‘India has to shift its focus to innovation happening in biotech/device SMEs’ …says Dr Ajoy Kumar, CEO, Max Neeman International. He points out the factors that Indian Contract Research Organisations (CROs) need to keep in mind for success in the long-term and other market opportunities, as the world pharma market faces drying pipelines, in a candid
g CEO of Cummins Diesel and ax Neeman International – the ost memorable and toughest uperintendent of Police, Bihar. I was colleague of mine who had arrested political pressure as well as demand hat if there is anyone responsible for should be taken against me. y fire. After this incident, all my ed their commitment to fight against afias who had a strangle grip on the edpur at that time.
ording to you is the biggest e clinical research industry? t crime in the clinical research he hype created about this industry netary perspective. The hype & focus e been on bringing new treatments nd expanding the innovation base nstead of taking India further on f research & development, all the taken up by the revenue and monetary t this industry promises. The primary cal research is knowledge expansion ing innovation. We have dumb sized s of monetary achievement, which
he factors that Indian CROs in mind to emerge successful? ges do they face? What are the points that Indian CROs need ors that Indian CROs need to keep ong-term perspective of success. We
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LEADERS SPEAK
Changing hats, from a COP to a CEO Important milestones over the last four decades of your life. Childhood I completed the earlier part of my education in Japan. A commendable fact about the Japanese people is their conscious and constant efforts to think for their country. This takes me back to a small incident of my childhood – my brother and I were having ice cream and since I could not find a bin anywhere around. I kept the ice cream cover on the roadside. I then saw a Japanese lady walking behind us pick up the paper from the road, and keep it in her bag without even uttering a work. After that day, I always made sure to throw the waste in the bin, but I still have been unable to pick up garbage of others. Teen As a teenager, my aim was to get into a top medical college, which I eventually did achieve. During my college days, I met some of the brightest children from different backgrounds, some of them overcoming difficult obstacles in their lives. The lesson that I learnt was what does not matter in life is how well off one’s family is or where one has been brought up, but what holds importance is how sincere & hardworking one is in achieving the goals. I also learnt that every child starts to run the marathon at the same point, but how far each one goes is purely based on one’s sincerity and dedication. Now, I see most of my classmates as extremely successful doctors practising across the world and I am proud of the time I spent with them. Adulthood The biggest transformation of my life happened after passing out from the medical college and when I joined the Indian Police Services. I was not sure of what I wanted to do in life but after I went to Bihar, I realised however difficult and corrupt the environment is, you can do lot of good if you sincerely want to. I remember of an incident where a dacoit gang had robbed a poor man whose daughter was to get married the next day. When I reached the poor man’s house, the man in spite of his loss said that he could not offer me a cup of tea but would get tea from his neighbour’s house. After 48 hours of continuous walking, we caught the gang along with the stolen items. I learnt a lesson for my lifetime that you can make a difference only if you want to. To ignore the poor and the weak is nothing but a sin. Entrepreneurship When I joined Max Neeman, it was a team of 20 people and now our strength has grown to about 300 people. As a leadership team, we were initially demoralised on our inability to convince customers, but now we have grown a lot through continued effort. This proves that persistence leads to victory. This has taught me to be frugal, persistent & patient and has also helped me learn a lot of other things.
should think of building business over a long time. One of the challenges that Indian CROs face is that they are geographically handicapped; however, this can be overcome by mergers, acquisitions, etc. India has to shift
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its focus towards innovations happening in small and mid-sized companies in the biotech/device & small molecule space. The growth target is to speed up not only the services that would help in patient enrolment but also to shift
November 2010
focus towards data management, medical writing and electronic data capture as well as tailored & customised solutions. We have to stop the perspective of ’one-size-fits-all’ and emphasise on customised solutions.
Please highlight the evolution of the Indian CROs in three sentences. The landscape of the CROs is identical to the human lifecycle. The child has just started crawling, and it will take time to first walk and then to run. We need to understand that before we start running we have to walk once. This lesson applies to everyone at Max Neeman as well.
What according to you are the inhibitions that companies may have when they outsource clinical research to India, and how well is Neeman placed to tackle the same? In the current scenario, most of the discoveries are happening in Europe and the US, and they are unaware of the capabilities of India. They have to be introduced to India first, and then to Max Neeman. The difficult part of the story is convincing them to come to India. My experience at Max Neeman with these clients is that once they have seen India and Max Neeman, we always get the contract. Max Neeman follows the hybrid model of a Knowledge Process Outsourcing (KPO) + CRO, wherein we believe in providing a comprehensive solution to our clients. We offer both quality thinking and surprise-free execution of projects. We believe in producing customised solutions and not just executing plain vanilla menu of services.
Who are the competitors to Indian CROs? The world is becoming flat and thus everyone is now a competition to each other. The competition is not just
LEADERS SPEAK
in India or Indian CROs but all good CROs irrespective of the geography. All CROs providing quality solutions at the right time would be a competition to anybody.
As the world pharma market is facing drying pipelines, what are the other market opportunities opening up for CROs?
currently working on a number of nutraceuticals and the business has grown significantly over the past two years.
How are Indian CROs expected to grow with regard to collaborations, focus on a particular therapeutic area and end-to-end service providers?
A good CRO need not worry about anything because good players perform well even in a bad environment. The challenge for any industry is not just proper execution of the projects and acquiring customers, it is much more than that, which includes keeping adequate innovation happening. There is a lot of related space one can venture, for example: v Hospital data analytics v Electronic Medical Records v Nutraceuticals
It would be pretentious of me to give any forecasts for the future, as it can
What potential does the food and beverage sector hold for CROs?
turn out to be one or more ways. If I could pretend to be a crystal gazer, I would say: v Indian CROs should go global and increase the geographical presence by mergers, acquisitions, partnerships, etc v Indian CROs must focus on specific service offerings like medical writing, where we have professionals with globally competitive skills. We also have an advantage of becoming thought leaders in certain therapeutic areas like cardiology, psychiatry, oncology and endocrinology. One space where we need to develop ourselves is product innovation. We are moving fast on the development part of the cycle, but we need to pull ourselves up in the area of research as well.
Quick bites
Food and Beverage regulations are becoming stringent day by day. All health claims being made will have to be substantiated by adequate scientific data and proper research. There is immense opportunity and potential in this industry. We are Areas that will bring growth for Indian CROs Indian CROs should go global and increase the geographical presence by mergers, acquisitions, partnerships, etc Indian CROs must focus on specific service offerings like medical writing, where we have professionals with globally competitive skills. Indian CROs need to develop on product innovation
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Aurigene is a path leader in choosing a ‘road less travelled’. Getting into co-discovery of innovative compounds is a brave initiative.
Could you chart the growth path for Neeman for the next five
November 2010
years with regard to focus areas and business development? Max Neeman aims to grow ten-fold in the next five years to become a strong company with 3,000-4,000 people. We are also working on widening our geographical access in order to increase our focus on small, mid-sized pharma & biotechnology companies across the globe. We endeavour to become the best CRO and create a niche in offering services to the small, mid-sized pharma & biotech companies. When they think of who is the best company to partner with, they should think of us.
What has been the business performance of Neeman since you have joined? Max Neeman has grown tremendously since I joined. It has grown ten-fold to the current strength of about 300. We have our regional offices in six cities, with active sites across the country. The team has strived hard to expand the client base, with some of the big as well as small & mid-sized pharma and biotech companies being our clients from across the globe.
If you had to choose the best CRO in India (besides Neeman), which one would it be and why? I would choose Aurigene. They are the path leaders in choosing a ‘road less travelled’. Getting into co-discovery of innovative compounds is a brave initiative. They have not only shown courage but also demonstrated great success in their work.
What is next for Dr Kumar? I am contemplating on setting up a low-cost healthcare service provider in Jharkhand for serving the poorest of the poor. This is my dream and I hope I am able to achieve it.
ROUNDTABL E
Prescribing habits of pharma companies
Shifting from doctors to chemists?
Courtesy: gillespiesdrugs.com
High consultation fees in hospitals & clinics, low economic status, easy accessibility to the pharmacist and the adoption of self-medication habit, may tempt a pharma company to approach a chemist rather than a doctor, for prescribing a drug manufactured by that company. Meghna Mukherjee presents the views of industry experts on the Indian scenario. The Indian Over-The-Counter (OTC) market is presently valued at $ 1,793 million and predicted to grow at an annual rate of 23 per cent. Various reports say that India currently ranks 11th in the global OTC market, and is expected to move up gradually to the 9th position in the next five years. Besides, there has been an immense change in the outlook of the masses. On one hand as the patient has become more aware and knows exactly what medication can be taken for cough, cold or headache, the availability of pharmacies or chemists makes these drugs more accessible to him/her at any time. Meanwhile, this may rule out the whole concept of an MR visiting a doctor. In order to maintain profit margins, pharma companies are now targeting the chemists instead of a doctors for prescribing drugs manufactured by them. Though the shift from the doctor to the chemist is not too alarming and found only in case of OTC drugs, it may sooner or later have its side-effects.
Dr Ashish Kumar Tiwari Medical Services, Umrao Hospital The shift in the prescribing habits of pharma companies has been observed in relatively few cases, like health-related problems that can be tackled without visiting the doctor. Consultation with a medical practitioner is recommended for patients to avoid unnecessary health problems. A doctor is the best person to prescribe a particular medicine, but for small issues, patients avoid visiting hospitals or clinics. This has happened because of the easy access to chemist stores, and also the knowledge gained from the Internet. This shift might benefit the pharma industry but not the patients. Moreover, the advantage need not be monetary only. The trust gained from the patients and easy accessibility to the chemist store are some of the factors by which the pharma industry can benefit.
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Apart from this, there are various pros and cons that can impact this shift. Further, self-medication may prove to be disastrous in certain cases if the patient is not aware of proper medication and the required dosage. Also, there are certain medicines that are not sold over the counter without proper prescription by a medical expert, as these are the ones that might be harmful. Though, the medicines which are sold over the counter are all OTC products, yet there might be some cases where a doctor’s prescription is a must. Packaging plays an important role in OTC products. This helps the patient to identify with a particular medicine. For example, ‘Disprin’ is known as a medicine for headache, and so if a person is suffering from severe headache, he would prefer going to the chemist rather than visiting a doctor. Again, sometimes, if the problem is not too severe, then the chemist can suggest some medicines. Like, if a person is suffering from toothache, then the chemist can assist him in giving the preferred medicine. Thus, this practice might be harmful, as the chemist does not hold any certified medical qualification.
ROUNDTABLE
Dr Dhairyasheel N Savant Consultant Cancer & Reconstructive Surgeon, S L Raheja - a Fortis Associate Prescribing habits of pharmacos are shifting from doctors to chemists for certain types of drugs. Judging the entire scenario, this change is not much alarming. The shift
D P Srivastava CEO, URL Formulations The pharma business, particularly in India, has seen a massive change in business practices over the last few years. Nowadays, prescription from a General Practitioner (GP) is always in danger of getting substituted by a chemist/pharmacist depending on the margin that the chemist/pharmacist makes on the said product. However, this is not true for many of the products for a disease where the patient has been taking medication for quite some duration. Further, the chemist/pharmacist gradually becomes more polarised towards pharmacy chains and the stand-alone chemist is getting marginalised over time. This shift towards the pharmacy chain will also affect the business practices, where the importance of doctor’s prescription will reduce. In the critical care segment, where the hospital pharmacy rules as far
Dr Luvkesh Bansal Director, Chief Dental Surgeon, Dental Care & Research Centre There are some instances that point towards the changing trend, and these can be attributed to various reasons, like innovative packaging being the core one. For example, Dr Reddy’s has created a unique packaging that bears a large picture of a tooth, for product ‘Anaida’, which is a combination of the Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) diclofenac and paracetamol. Medical
might be due to different reasons like cost, difficulty in dispensing medicines at the chemist store and others. Of course, the pharma industry has to deal with a group that is relatively concerned with pricing & quantity and not quality & indications. Again, there are no specific pros & cons. The only criterion is that of pricing & availability of the drug, which the chemist wishes to promote as per the feedback he receives. Even though this is being practised universally, it should be avoided for unnecessary medical complications in the future.
as selection of the product is concerned, the prescription again loses its importance. Further, the Indian market has always been a market for branded generics and in course of time, it will have more generic products. In the last few years, it has been observed that large pharma companies have moved into the organised generic – also known as generic space. This is not favourable as most of the doctor’s prescription may be substituted because the price and the margin will become the most important deciding factor for the chemist/pharmacist to dispense the product. Whether this will benefit the pharma industry is not certain, but the branded generics will lose its sheen over time, as observed in the past few years as pharma industry works on branding & creation of brand image, which is illustrated only to the management segment. However, with regard to acute therapy and critical care, there is less branding, which is more driven by price & margin. The trend has already set in and the companies having the advantage of integration that comes from Active Pharmaceutical Ingredients (API) to the finished product will stand a good chance to sustain these margindriven products.
representatives do not admit that this is a market strategy, but it is too obvious that after a few years, people will start perceiving Anaida as a painkiller for toothache and Saridon for headache. Such strategies work best for drugs that are OTC products or for companies, which perceive that the drug would be an OTC in the near future. The next factor could be poor control while dispensing medicines at the medical store, where one can buy any medicine without the doctor’s prescription. Few pharma companies try to encash on this loophole in our system. Further, cost advantage plays a major role. Most of the drugs that are dispensed without a doctor’s prescription are generic versions of the branded ones. The reason for this is the cost of the drug to the chemist and the consumer. Moreover, this cost advantage is more for the chemist than the consumer.
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ROUNDTABL E
Naini Setalvad Obesity, Health & Food Consultant, Health4you Prescribing habits of pharmacos are definitely shifting from doctors to chemists nowadays. There is a lot of information available on the Internet about different medications. Lack of time to visit
Partho Mukherjee VP - Sales, Anglo-French Drugs & Industries Ltd In ethical promotion, the market prescription privilege always remains with the medical practitioner. In metro cities and class A towns, there is an increasing dominance of consultants & super specialists, and obviously the consumers are also educated; hence, the prescriptions are not substituted. The reason is that both doctors & consumers have a brand orientation, and in the chronic therapy segment, no patient will be keen to change the brand under any circumstance. In these towns & metros, in the light of ‘Retain Chain’, some companies with or without a pharma background try to establish their own setup across a particular geographical area and squeeze in their profitability.
Shantala Manager- Quality Assurance & Regulatory Affairs PharmaLeaf The prescribing habits of pharmacos have definitely observed a shift from doctors to chemists. The reasons for this are the high consultation fees in hospitals & clinics, low economic status, easy accessibility to the pharmacist and the adoption of self-medication habit. Moreover, the easy accessibility to information of medicines on the Internet is also a major factor. This practice should not be encouraged in the Indian system. The pharmacists in India are not qualified enough
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the doctor and general practitioners is one of the main reasons for this shift. Often, if the problem or the disease is not grave, then the patient feels self-medication to be the best option. This trend might benefit the pharma industry since it is facilitated by the easy accessibility of the drugs at the counter. However, it can have various pros & cons attached to it, for example, it might lead to wrong medication or over-medication. On the other hand, simple cold, cough & flatulence can be cured by paracetamol and stomach disorders, by indigestion tablets. Though, this practice is common, yet it should not be encouraged since it might lead to further problems.
Again, in this mass marketing system, there is a definite role of retailers because prescribers are mostly MBBS and/or non-MBBS GPs. Also, mostly prescribed therapy groups include antibiotics, anti-ulcerants, analgesics, nutraceuticals, topical preparations, cough preparations, etc. Besides, the retail chain owners try to get direct purchases from depots to have more margins than usual. They may try and part with some of those margins with consumers, but companies will definitely have reduced profit margins. In future, if these retail chains start dominating the pharma retail business, then it will shift the business module in the pharma industry and, over time, the companies will have to part with some additional percentage and the distribution business may also be under threat. In mass marketing, there will obviously be an increase in the dominance of retailers who will try and dictate terms to the companies, the reason being that most prescribers are more molecule-oriented than having brand consciousness. Under these circumstances, there will either be a cut-throat competition or the health of the competition will be questionable.
to prescribe medicines to patients; hence, they should not be considered for prescribing medicines, but they can be considered for disseminating information about a particular medicine & treatment. The final authority for prescribing medicines & treatment plan should remain with the doctors. However, there are various pros and cons to this practice. This might benefit only if the chemist has the minimum essential qualification and knowledge of the medicine. Again, the medicine should be economical in case of minor health issues, and might help in treating only the symptoms of some disease but cannot completely cure the same. In this case, there are some high chances of complications involved. It results in adoption of a habit of self-medication, which might be risky at times since it might lead to not taking the complete dosage of antibiotics at a critical stage further complicating the health hazard.
FACILITY VISIT
Eisai Knowledge Centre, India
Capitalising on the India advantage From being a CRAMS associate for its parent company (Eisai Co Ltd) and supplying drugs to India and Africa at a low price, Eisai Knowledge Centre, India (EKCI) has chosen India to be the centre of activity. As the company awaits the FDA approval, which is due by next year, Arshia Khan takes a look at the business model and its plans for the future. ishakhapatnam, which is blessed with a natural harbour, has a coastline dotted with small hills that initially stunted its growth, but private and public entrepreneurship has meant that the city is now developing on these hills. The city has also become a pharma zone with more than 20 major pharma companies coming up here. The Jawaharlal Nehru Pharma City, developed by Ramky Group in collaboration with AP Industrial Infrastructure Corporation (APIIC), has 17 pharma companies. The adjacent Pharma SEZ has two global giants that houses Eisai Pharma of Japan and Pharmagel of Germany. According to various experts, the infrastructure and the facilities provided in this city are attracting investment. A visit to one of the pharma companies, Eisai Knowledge Centre (EKCI) truly showcases this.
v
Formation of EKCI Spread over a humungous stretch in the pharma city EKCI, established, in December 2009, has the aim of making India as the ‘Global Procurement Hub’, which is one of the strategies that Eisai Co Ltd, Japan has in mind for India. The total expenditure for setting up EKCI was around $ 50 million. Apart from that another $ 7 million
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dollar was spent on improvements, informs Sanjit Singh Lamba, Managing Director and Head, Global Procurement Strategy, EKCI. EKCI’s architecture reminds us of the big way an MNC can be present in India. And this is not just from the design point of view, but also from the quality standards and strategy adopted at the organisation. Every building, department, room has been given a name that further personifies it. For example, the building, Integrum, which has departments like the human resource, supply chain management, administration, global regulatory affairs, etc, signifies that everything is getting integrated in a very cohesive way. Complementing the design is the relaxed and rejuvenating environment, which is supported by green initiatives and plantations across the facility. There is a green house and a guest house for the employees at EKCI, and one for its Japanese counterpart is underway. “Besides, the administration also plans to make vegetable plantations around the facility, which can be used in the cafeteria. We also treat waste for horticulture,” says S R Saini, Director-HR & Administration, EKCI. Though the facility is GMP compliant, it will take 6-9 months before it goes commercial. As Lamba says, “By 2013 we look at manufacturing for Japan, and for global
FACILITY VISIT
markets as well. Speaking on the production capacity he informs that the demand is low for the Indian market. As of now EKCI manufactureS 1 billion tablets per year on a single shift basis. However, the same will be increased to two billion tablets per year, if the demand increases, on a two shift basis. The centre has high-end HPLC, GC, LC and NMR analytical instrument and machinery equipped from Waters, Agilent, Biomeriux, Thermo Fisher, Labnet, Newtronic, Fabtech, etc.
Differential pricing in India The idea behind setting up a manufacturing facility in India was to make healthcare affordable and accessible to a large number of people. As Lamba says, “This centre will serve as the global supplies hub for pharmaceutical products. Apart from this, it will also serve as a major research & formulation development centre, for innovative products and some of the new formulations for emerging markets.” He adds, “The drugs manufactured here would take care of the new emerging markets like Australia, Middle East, Russia, Turkey, Brazil, Africa and India.” Eisai not only has a manufacturing and R&D centre, but also its sales and marketing office in Mumbai. EKCI is Eisai’s second manufacturing centre, besides one in Japan. Furthermore Lamba informs that there will be only two sites for Eisai in future as well - India and Japan. Disclosing the long term plans Lamba highlights, “Our plan is to make this site as the manufacturing base for new drugs that will be approved in 2013-2014. These drugs will come from therapeutic areas that we have not ventured before, like oncology, life threatening situation like sepsis, etc.” He further informs that EKCI will later develop and manufacture these drugs in India. Lamba adds, “It is a good start and we have completed the process validation for one of the products in Japan. We are now working on donepezil viz, Aricept, for the Japanese market from where it will also be supplied to the EU and US.” Besides, on the combination side; EKCI has already completed stability studies for Epry and Aricept. It is now looking at manufacturing Parit and a couple of other projects for the Japanese market, by the end of this year. By making India as the global supplies hub, the company aims to follow a
Sanjit Singh Lamba Managing Director and Head, Global Procurement Strategy
Our products which loose patent in the US will be launched in India. And for this we are in talks with some Contract Research Organisations (CROs). In future EKCI in may work as a contract research and manufacturing services centre for the parent Japanese company. differential pricing model that MNCs like Merck, Roche, Novartis, etc, have adopted. He cites the example of Aricept for dementia and Alzheimer’s which is priced at ` 3,000 in the US, EU and Japan, and will be 1/10th the price in India and China (viz, $0.3/tablet). “This model will be replicated in Tanzania, Africa, etc, because these markets (population) cannot afford to buy these products,” says Lamba. Speaking in terms of the Asian market, Lamba elaborates, “I feel that the Asian market, which starts from Japan will slowly move to India. Also, there is a cluster of ten emerging markets/countries, which is growing rapidly that includes Middle East and Russia. Therefore, our plan is to make India a logistics hub and manufacturing base for such countries.”
Lamba highlights an interesting strategy, “We outsource work in areas where we do not have expertise, to CROs or tie-up/ acquire companies having niche specialities.” Sharing insights he says, “Indian market is diverse in nature, and requires combination products. Our products that will lose patent in the US will be launched in India. For this, we are in talks with some CROs. In future
EKCI may work as a CRAMS centre for the parent company. “ With an aim to become the global supplies hub, EKCI has scientists who work in a very aggressive time frame to meet the expectations of their global quality and products creation system. According to Lamba, the centre is slowly moving from an R&D centre to Eisai Products Creation Systems (EPCS). This means that they are not working on R&D as one entity, but the same is broken down into eight such units, one of them is known as Pharmaceutical Sciences and Technology (PST Group). Each such unit works like a venture company, which has the responsibility of managing the operations, investments, the Return On Investment (ROI), etc. Detailing the business model, Lamba says, “To support the PST group Eisai, Japan acquired a company called Morphotek in 2008, which specialises in mAbs, and has specialised treatment for oncology.” Moreover, from June 2010, the Global Procurement Strategy (GPS) of Eisai is engaged in supporting low cost buying for R&D like chemicals, intermediates and raw materials required by them. “So we looking globally, ie, India, China, Eastern part of EU and any part of the world, for companies that can supply us with quality standard at the right price.”
Testing lab
A view of EKCI
Business model
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FACILITY VISIT
Reaping from the benefits of this model, the first drug that will come from EKCI will be called as Eribilin for breast and lung cancer. Lamba shares the details, “This is a very potent product for anticancer and takes a year for manufacturing one kg. The estimated price of the API is ` 50 crore a kg. But with efforts in India, Japan and US, we are trying to bring it to 1/10th the price, which is a big task.”
point of view, large number of people live in villages, who cannot afford expensive products. Adding to this the market is very fragmented, with new products and very old products. All these factors made us thinking when we took the plunge. However, we could swiftly overcome all the challenges, thanks to our strategy, “ says Lamba. Speaking on the regulatory structure, Lamba says, “By now, most of the guidelines and regulations across the world are same.” He futhers elaborates, “Japan being a consensus oriented country takes more time for giving approval of the drugs. However, in India it is the DCGI and State FDA who give the approval but in Japan, it goes through a challenging process. He also says that though the guidelines look simple, there are companies in India that have got the PMDA approval to supply in Japan, but still could not supply because the population there is much more stringent than the regulations. “So the need of the hour is maintaining consistency in the quality of the product,” he adds.
When it comes to manufacturing drugs for Japan, quality is the biggest challenge. Lamba cites the reason, “Patients in Japan are adequately informed about the drugs they consume. Hence, the biggest challenge for us was to match the quality standards with the Japanese, as they attach equal importance to cosmetic and functional quality of the product. Therefore,
since inception we focussed purely on ‘quality’.” EKCI has kept this in mind from procurement, business as well as people point of view. Further according to Lamba, they knew some of the failures in India (some of the products were dispatched to Japan and they came back), which were taken as reference cases. However, today, he avers, “We have dispatched a few products to the US and Japan to evaluate if our quality is acceptable. As of now, they are very happy with the quality of the products, and that is the reason why we have also got some new projects like Epry and Aricept.” In order to control cost spending, EKCI started the Low Cost Operation Project (LCOP). This includes three areas of managing costs of which one is Global Procurement Strategy (India), which controls the cost of raw materials and products, thus maintaining a healthy bottom line. The other two being, Global Logistics Plan (US), Global Technology Function (Europe). Speaking in terms of the striking differences between the Indian and Japanese pharma markets, Lamba lists the hurdles, ”They are diverse in nature. Japanese market is dominated by innovative prescription products. Hence, the entry of generics in Japan is very low, less than 1 per cent. Whereas, most of the Indian market is dominated by branded generics.” He continues, “A major spending in Japan is financed by the government, therefore medical insurance rate is high. However, in India, less than three per cent of the people are insured. Drugs in India are priced lowest in the world, lesser than that in Pakistan and Bangladesh. Coming to economic
One of the departments — Integrum
Formulation plant
API pilot plant
CSR: For human care Without losing focus of its agenda, EKCI as a part of its CSR activity is working with WHO to supply drugs for diseases like malaria, filariasis, etc, required in African countries and India. When the inhabitants of the SEZ were displaced the company decided to employ them at EKCI as a part of CSR. These people have been assigned work based on their expertise and knowledge. Some of them work as gardeners, housekeeping, lab technicians, etc. The total number of villagers employed at EKCI stands at 60 of the 125 displaced. Besides, there are 126 employees on rolls, of which 30 are scientists (PhDs and MScs). For generating employment in the city, Eisai has also signed up with GITAM and AP University in June 2010 for placement of students. So far ten students from GITAM have been absorbed.
Overcoming hurdles
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Designing the road ahead The city is looking at a slingshot development in the next five years. The three growth engines are infrastructure, IT & ITES and travel & tourism. “We are also planning to launch Aricept-23 mg in India, which is already approved in the US. As of now we have Aricept 5-10 mg in India,” informs Lamba. “We are now moving from being a pharma company to a biopharmaceutical company. Though India is known for bio similars, we will however be working on innovative biotech products, ie, biopharma,” he signs off.
INDUSTRY UPDATE
Pharma machinery manufacturers
Growing domestic with time In the 70s heavy import duties along with restrictive import licensing policies were measures to balance the shortage of foreign exchange. With this change in the economic situation, Indian pharma machinery manufacturers decided to leverage on local manufacturing. Chandreyee Bhaumik traces their various phases of development till date and beyond. technology. The reports also indicate that the pharma machinery industry is growing at a rate of 15-20 per cent annually. Currently, the total number of pharma companies in the country is approximately 17,000 and there are more than 700 pharma machinery manufacturing units, informs Hitesh D Gajaria, Executive Director, KPMG. In the 70s, the Indian pharma machinery sector was practically non-existent. However, it has developed with time. Elaborating on the situation, Raj K Menon, Owner, Karishma International, avers, “In the 70s and 80s, as in all other industries, capital equipment were mostly imported and only big companies could import the highly sophisticated equipment from Europe. On the other hand, pharma companies were mainly Multinational Companies (MNCs) like Hoechst, Glaxo, etc. They brought their used equipment from their plants in Europe to their Indian units, to counter the high duty structure.” Courtesy: Brilliant Industries Ltd
he famous adage, “Advances in medicine and agriculture have saved vastly more lives than have been lost in all the wars in history,” by Dr Carl Sagan, American astronomer, writer and scientist, reaffirms the significance of a sound pharma industry. However, efficacy of this sector is almost dependent on the pharma machinery segment. The Indian pharma machinery industry is in a flourishing state. Several reports reveal that pharma machinery in India has a huge potential and many international manufacturers have collaborated with Indian companies. This has enabled the Indian pharma industry to procure machinery at a price almost one-third or sometimes even one-fourth of the import
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Undergoing the shift Citing the developments, Gajara says, “The imposition of high import duties led to a substantial rise in the prices of imported machinery, compelling domestic companies to manufacture machines locally.” Gradually, this marked a turning point for the industry and served as a major motivating factor for its growth. India enjoys a substantial cost advantage; machines manufactured in India are significantly less expensive than their counterparts in developed countries. Commenting on the reason for the difference in the cost, Gajaria avers, “Huge savings on capital investment of plant & machinery and low costs of technical manpower are the primary reasons that propelled the Indian manufacturers to introspect.”
INDUSTRY UPDATE
Tracing the market
Hitesh D Gajaria
With the boom in pharma exports, more and more machinery companies began to come up and grew rapidly with little protection from import duties and licences. That is when Cadmach for tablet, P+AM for capsules and Pharmalab for liquids established themselves as machine manufacturers. Piyush Tripathi, GM - Technical Sales, Chitra Pharma Machinery, explains, “The growth is slow and steady, as the market is slowly adapting to the changes. New machines are replacing older ones. Further, new mechanisms save running cost.” The market size of the Indian pharma machinery (FY 2009) is ` 1,500 crore, with 10 per cent growth rate. Further, the value of machines exported per year is ` 200 crore and the annual import is around five per cent of the requirement. Menon affirms, “The machinery industry is booming. Excise relief in certain zones, demand from the export markets, and competitive prices in the international market are helping the pharma machinery industry grow in leaps and bounds. Many foreign companies like Bosch, Fette, Glatt, etc have set up shop here, either on their own or through collaborations with Indian companies.” However, the Indian situation is different from that on the global front. Tripathi elaborates, “India is more interested in prices. They want advanced technology to be incorporated, but the cost is also a consideration for them.” He further continues, “In India, in the last three to four years, the growth has been slow, with not much innovation taking place. Moreover, here, in the pharma sector, we are more dependent on the standardisation. Again, on the global front, technology from China and Taiwan comes at a lower cost. India still needs to catch up in this arena. Programmable Logic Controllers (PLCs) are not manufactured in India. Still, we rely on the imports. In this situation, manufacturing in-house will cost less.” However, on the global front, innovations and changes are taking place. Tripathi says, “In the global market, initially it was all generic. But, now the
Executive Director, KPMG
The imposition of high import duties led to a substantial rise in prices of imported machinery, compelling domestic companies to manufacture machines locally.
system is becoming more specificationoriented.” Tracing the global situation in detail, Gajaria discusses, “Globally, German companies are known to manufacture machinery of the best quality, whereas India-made machinery has still not been able to reach the same quality pinnacle. Therefore, ensuring top quality and gaining international credibility are areas of improvement Indian pharma machinery manufacturers need to focus on.” Further, at the global level, computerised automation is rampantly used, whereas in India, manual operations are practised more frequently. Jignesh M Panchal, Partner, Karnavati Engineering Works, explains, “There is a definite scarcity of skilled manpower. Thus, in this situation, we will have to train the unskilled/semiskilled personnel.”
Visible trends With continuous improvement in drug administration, and research the need for novel pharma machinery has increased multifold. Further, the importance attached to US Food & Drug Administration (USFDA) accreditations and International Organization for
Standardization (ISO) certifications is also adding to the need. Also, India enjoys a considerable cost advantage, as the cost of manufacturing is much lower as compared to other countries, particularly North America and Europe. Discussing the oft-noticed trends in this sector, Gajaria points out, “Currently, more importance is attached to quality in order to compete on a global scale. Besides, increased number of facilities are cropping up in India with upgraded technology and infrastructure. Also, the number of certifications and accreditations to build ISO credibility is increasing.” Gajaria says that in recent times, there is an emphasis on export promotion and import of prototype machines. Further, to speed up several developments, collaboration and thus technology transfer is taking place. Tripathi believes that India is becoming more process-oriented. He avers, “We are still waiting to get in-house automation. Currently, we are targeting more on the process. In this scenario, manufacturers are finding alternatives to meet clients’ space management and output requirements. ‘Time’ is an important
Raj K Menon Owner, Karishma International
In the 70s and 80s, as in all other industries, capital equipment were mostly imported. The Licence Raj and high duties meant that only the big companies could import the highly sophisticated equipment from Europe.
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INDUSTRY UPDATE
Piyush Tripathi GM - Technical Sales, Chitra Pharma Machinery
The growth is slow and steady, as the market is slowly adapting to the changes. New machines are replacing the older ones. Further new mechanisms save running cost.
factor; therefore, it should be noted that process time is reduced.”
Going green The push for sustainable environmental practices has executives worldwide discussing how to incorporate systems that do not harm the planet and at the same time maintain profit. The pharma industry is no exception. Duane Sword, VP - Portable Optical Analysis Group, Thermo Scientific, explains, “While many manufacturers are still using wet chemistry tests as part of their raw material identification process for liquids and solids, we have seen more and more companies invest in handheld instruments like Thermo Scientific TruScan analysers to improve efficiency & productivity, and protect the environment. Adding to the above thought, Pradeep V Joshi, VP – Technical, Anglo-French Drugs & Industries Ltd, says, “For tablet coating earlier we used methylene chloride, which is now replaced by water, hence, protecting environment from pollution. Dust generated from processes are collected through proper exhaust system
and passed through a scrubber to ensure a dust-free environment.” He also adds that the Small and Medium Enterprises (SMEs) can look up MNCs for guidance in case of green development.
Education platform Specialisation is the norm of the day, and pharma machinery industry is not an exception to this. Aasif Khan, Managing Director, Fabtech Technologies International Pvt Ltd, avers, “Today, we find many electrical or mechanical engineering graduates who cannot even identify a tablet compression machine. Therefore, there should be specialised courses for pharma engineering in our country.” To help improve the situation Khan says, after pursuing graduation from various universities in India, students can then undergo training for five to six months at an industry platform. He suggests, “Experienced and retired individuals should come together along with Indian Pharma Machinery Manufacturers Association (IPMMA) and build an institute where they can train and educate these students on the
Jignesh M Panchal Partner, Karnavati Engineering Works
There is a definite scarcity of skilled manpower. Thus, in this situation, we will have to train the unskilled/semi-skilled personnel.
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latest equipment. Machinery makers must sponsor to build sample facilities where the retired people can train students. Thus, we will have a trained manpower to work in the industry.” This will hopefully brighten the education scenario of this segment.
Assisting arms Every innovation is incomplete without the support of efficient technology and sound Research & Development (R&D). Analysing this situation, Menon comments, “There is hardly any R&D going on in the machinery industry. We still imitate the design from overseas.” On a sarcastic note he says, “One will be surprised to see the number of machinery manufacturers who visit the international expos, mainly to see or copy the latest technology. It is sad that for very high-speed & high-tech machines, we still have to look abroad!” However, everyone is not as pessimistic as Menon. They agree that there is a possibility for innovation in each step. Gajaria points out, “Most of the research, therefore, is invested in designing machines that enable multitasking and do not occupy much space. Further, the machines should be based on automated functions. Also, there should be application of more gadgets in the machine Variable-Frequency Drive (VFD), PLC, etc. Further, Panchal adds, “Continuous research is carried on mechanical, hydraulic, pneumatics and computerised automation. Siemens and Fanuc provide the computerised systems.
India as a destination In recent years, many foreign companies have come to India. There is no bar on any Foreign Direct Investment (FDI) in manufacturing pharma machinery in India. However, the increasing number of outsourcing assignments in the field along with collaborations indicates that the segment is witnessing growth. As Tripathi informs, “FDI has its own standards in pharma. There are laws in terms of schedule. In Indian pharma, there is schedule H and schedule M, that MNCs will have to follow along with the organisational features.”
INDUSTRY UPDATE
Pradeep V Joshi VP – Technical, Anglo-French Drugs & Industries Ltd
For coating of tablets earlier we used methylene chloride, which is replaced with water, and hence protecting environment from pollution.
Overcoming the impediments The road to become ‘sufficiently advanced’ is permeated with several obstacles. Menon elaborates, “Imports are the biggest challenge faced by the Indian pharma machinery industry. With zero per cent duty through many schemes, pharma companies are increasingly opting for good quality imported machines. On the other hand, with the mushrooming of machinery companies all over India, competition has become very stiff. As in any other industry, pharma manufacturing also has companies that compromise on
56 Modern Pharmaceuticals
quality and delivery schedules that are rarely adhered to.” With the presence of many companies, competition has become fairly healthy. The requirement for machines has been increasing and companies have to face competition from their peers. As Gajaria highlights, “In India, the capital investment on facilities & infrastructure is low and so is the cost of labour. As a result, companies do not have to compromise heavily on pricing in order to make profits. Also, with the diversity of equipment in the pharma domain, there is enough room for multiple players.” He
November 2010
adds, “However, the real concern lies in the competition that Indian companies face from China, where manufacturing costs are lesser and chances of losing out on outsourcing opportunities are greater.”
Predicting the future With evolution of new technologies like lasers, software, etc, the growth prognosis of this industry is optimistic. Gajaria explains, “Countries like the US, Japan and those of Europe led by Germany are likely to remain dominant pharma markets controlling over 80 per cent trade opportunities in the sector. Asian countries like South Korea, Taiwan and India are expected to have growth rates ranging from 12-15 per cent annually.” Menon concludes, “It is interesting to note that even during the economic slowdown, this industry remained unaffected to a large extent. This indicates its strength. Further the negative image of Indian machinery is slowly turning positive. This will help in increasing exports.”
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INTERFACE
‘Purchasing pre-owned equipment can save the buyer up to 50 per cent or more on the cost of the same equipment purchased brand new’ ...says Mahesh Karande, Head-Marketing, EQUIPNET (India) Pvt Ltd. And this is expected to gain further momentum, as it is now becoming a well-accepted practice by Small and Medium Enterprises (SMEs) as well as large organisations in India to buy pre-owned machines and equipment for various reasons. Karande shares insights on the regulations for these equipment with regard to the Indian market, with Arshia Khan.
What are the advantages and issues of buying secondhand biopharma R&D and manufacturing equipment? How big is the market for such products? Both small and large companies are realising the advantages of buying and selling pre-owned laboratory and manufacturing equipment. Whether it is a small, local lab or an enormous facility that is part of a multinational corporation, these companies understand that ‘pre-owned’ does not necessarily mean ‘used’ and broken down. Some equipment is delivered and then the owner does
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not need it anymore because of a project cancellation, an order error, or even a plant closure. Leading, global manufacturers often install and test equipment before it is identified as surplus and put up for sale. This testing process actually adds to the value of the items since the buyer has documented evidence of the equipment’s functionality. Select items can also be refurbished or retooled to fit a buyer’s needs. The obvious advantage is cost. Purchasing preowned equipment can save the buyer up to 50 per cent or more on the cost of the same equipment purchased brand new. With regard to the market, there are no validated statistics available as to the size of the Indian market. Nevertheless, it has been witnessed that SMEs and large organisations in India have been buying pre-owned machines and equipment for various reasons. In terms of the US scenario, the market was estimated at $ 30 billion ten years ago. On a ball park this could now be $ 75 billion.
Equipment for biopharma R&D is a high-ticket investment, and buying it new represents a huge capital outlay, especially for start-ups and SMEs. What is the scenario in the Indian market? In the lndian lab equipment market, there is good demand for pre-owned
November 2010
equipment as well as processing & packaging machines from SMEs and large companies, which seek to buy pre-owned equipment and machines either on ‘As where is condition’ or ‘refurbished’ without or with warranty. EquipNet helps its clients identify, appraise, track and relocate their surplus equipment within the same organisation. When the client no longer has a need for the equipment, EquipNet assists to dispose the assets by finding end-user buyers in 80 per cent cases and sometimes contacting used equipment dealers, through a variety of sales channels that include EquipNet MarketPlace www.equipnet.com, negotiated sales and auction events.
What are the kinds of equipment available for a second-hand sale? What is the approximate cost difference in buying a second-hand product? Laboratory equipment that is often found in the secondary market includes: HPLCs, GCs, mass spectrometers, NMRs, centrifuges and a wide range of other instrumentation. Manufacturing equipment spans a huge range of assets in the processing and packaging areas of a plant, eg, solid dosage section machines like fluid bed equipment, tablet compression machines, capsule filling machines, blister packing
INTERFACE
machines, etc. Any and all equipment in these areas can be found in the secondary market including tanks, mixers, blenders, granulators, dryers, bioreactors, labellers, wrappers, fillers, cartoners, etc. A buyer can expect to save up to 50 per cent on the cost of new equipment when purchasing preowned assets. In most of the cases, there are the OEM manufacturers’ sales and service team in India that support the buyer once the machine lands at their facility for installation, commissioning and after-sales service.
What are the challenges that companies face while selling their products? Biotech and pharma manufacturers are in the business of creating and manufacturing their end-products viz, formulations, APIs/bulk drugs, but not managing or selling-off their surplus and idle equipment. The biggest challenge is making the sale of their
idle assets a priority for the company. Fortunately, EquipNet has expertise in providing services to its clients by taking responsibility for the clients’ idle equipment initiatives, so that they can concentrate on becoming a more efficient and profitable organisation. Another challenge for clients with multiple locations is to ensure that each facility has fully bought into the program. Fortunately, EquipNet has comprehensive communications programs that easily explain the policies and procedures associated with relocating and selling surplus assets. One more challenge has to do with buyers inspecting equipment that they are interested in. Many sell equipment from facilities where production is still underway. EquipNet helps manage these sensitive issues, scheduling inspections at the seller’s convenience or even moving the idle and surplus assets to an EquipNet location where
the buyers can more freely inspect the equipment without impacting the sellers.
What according to you are the factors that will fuel the market for such products? In recent years, the unstable world economy has been a big driver for companies buying and selling their surplus and idle equipment. Many facilities are able to utilise the returns from selling their used assets to purchase new assets for their facility. Another driver is that it generates the need for pre-owned equipment with the introduction of new technology. For instance, as soon as Agilent came out with their HPLC 1200, there was an influx of 1100s in the secondary market. Other factors include market consolidation, the end of a government grant at a lab, project cancellation, etc. The older models are lapped up
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INTERFACE
by MSME companies, new start-up companies that are looking out to contain their capital investments.
What kind of after-sales service does EquipNet offer? EquipNet offers a variety of after-sales services including installation/commissioning of different categories of equipment. Some buyers purchase items and want them refurbished/retooled to fit their needs. EquipNet works with partners in a variety of equipment categories to make sure that the buyer is receiving what they need.
What are regulatory hurdles faced by companies buying such products? How can the same be tackled? As such, there are no known hurdles faced by companies buying pre-owned equipment/machines from companies within India. However, care has to be taken to ensure that the machines are in working condition or can be refurbished to bring to operational levels. Before buying, we also advise inspection of the machines/equipment to ensure that the buyer knows what they are buying. Also, importing a pre-owned equipment is governed by the Government of India’s Handbook of Procedures (Vol I), 27th Aug 2009 – 31st March 2014, Ministry of Commerce and Industry, Department of Commerce – http://dgft.gov.in – an extract of which says: 2.33 Import of second-hand capital goods Import of second-hand capital goods including refurbished/ reconditioned spares, except those of personal computers/laptops, shall be allowed freely, subject to conditions for following categories: 1. Import of second-hand computers including personal computers/laptops and refurbished/ reconditioned spares thereof is restricted.
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Import of refurbished/reconditioned spares of capital goods, other than those of personal computers/ laptops will be allowed on production of a Chartered Engineer certificate that such spares have at least 80 per cent residual life of original spare. 2.33.1 Notwithstanding provisions of Para 2.33 above, second-hand computers, laptops and computer peripherals including printer, plotter, scanner, monitor, keyboard and storage units can be imported freely as donations by the following category of donors: (i) Schools run by central or state government or a local body (ii) Educational institution run on non-commercial basis by any organisation
Re-using equipment that already exists in the market, one can save on energy, materials and waste by-product that would be required to produce a new asset. (iii) (iv) (v) (vi)
Registered charitable hospital Public library Public-funded R&D establishment Community information centre run by Central or State Government or local bodies (vii) Adult education centre run by central or state government or a local body, (viii) Organisation of Central or State Government or a Union Territory. Imports under this sub Para would be subject to the condition that goods shall not be used for any commercial purpose, is non-transferable and complies with all terms and conditions of relevant Customs Rules and Regulations.
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2.33A Customs or any other Central or State Government authority may avail of services of Inspection and Certification Agencies in Appendix 5 of the HBP v1, for certifying residual life as well as valuation/purchase price of capital good.
Which are the various ways used by companies to market such products? Over the last ten years, EquipNet has amassed a huge database of end users in the bio pharma market around the world. Unlike used equipment dealers who buy at a X price and then sell at 2X or 3X or sometimes 10X price, EquipNet is a ’facilitator’ between the seller and buyer of lab and manufacturing assets, thereby assuring highest returns directly to seller and same time ensuring a good bargain to the buyer. The company sends periodic emails promoting the featured inventory in a variety of categories to specific audiences who are interested in that specific equipment. Google is fast becoming the largest medium for finding pre-owned equipment resources.
How does one ensure that second hand equipment also takes care of green manufacturing? Sourcing second-hand equipment, by its very nature, is green. If you can re-use equipment that already exists in the market, you save on the energy, materials and waste by-product that would be required to produce a new asset. Relocating equipment within an organisation not only avoids costs but also prevents the disposal of a machine in perfectly good working order. The same is true with selling those assets to other manufacturers. Instead of contributing to landfills with large pieces of machinery just because one company changed its production requirements, the equipment can find new life in another company, even in a separate industry.
MARKET TRENDS
Pharma raw materials and excipients
India in sync with global regulations... Today, most of the countries have specific requirements for reviewing and approving pharma products to ensure product quality, safety & efficacy. Pharma regulations have witnessed significant changes due to an increase in the number and complexity of products. Geetha Jayaraman explores the importance of following rules & regulations in the pharma industry to improve product quality and gain customer satisfaction.
Courtesy: Dr. Joseph Marcola
he drive to reduce risks associated with pharmaceutical treatments has resulted in the implementation of stringent rules & regulations. Government authorities have introduced numerous standards and requirements that companies in pharma & healthcare industry must comply with. These regulations apply both to manufacturers’ own processes, particularly when seeking licences for new products, and their suppliers. As a result, manufacturers need to take a closer look at their suppliers, to see whether they are aware of the relevant standards. As an importer/trading company for various pharma raw materials, Sanjay Chanana, Director, Shah TC Overseas Pvt Ltd, says, “To keep an eye on the supplier, before the production process starts, the government and the manufacturers need to make teams for inspecting each facility. In this way they can
t
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know well in advance whether the end product will meet the standard. At the same time, they should regularly visit these plants to ensure quality and safety.” Compliance typically requires both rigorous quality management processes and state-of-the-art manufacturing technology. Dr Jochen A Dressler, Manager, Pharmaceutical Technology, Cognis GmbH, Illertissen, Germany says, “It also helps if pharma suppliers follow Good Manufacturing Practice (GMP) guidelines. In addition to quality, when choosing suppliers, manufacturers must consider their reliability in order to ensure long-term availability of the required materials and avoid interruptions in their operations. Again, if the drugs are to be produced and marketed globally, it makes sense to choose a supplier with an international presence.” As a global supplier of innovative specialty chemicals and ingredients, a manufacturer must offer solutions for pharma & healthcare industries, which should meet the necessary demands. Anant Thakore, Managing Director, AVIK Pharmaceutical Ltd, says, “The company’s strategy should closely align with wellness and sustainability megatrends. This would result in development of a significant number of naturally derived products, which can be used as building blocks, excipients and drug delivery agents. These include high-purity oleochemicals & derivatives, vitamin E TPGS, azelaic acid, chitosan and MCT oils.”
Selection procedure For ensuring that all raw materials and excipients meet the compendial requirements for the target countries directly from the raw material supplier in India, GMP is the
MARKET TRENDS
mandatory requirement as per the Food, Drugs and Cosmetics Act. Mala Miranda, Senior Manager - Technical Services, Signet Chemical Corporation Pvt Ltd, says, “The entire process of selection goes through the subtle channel of vendor identification, specification evaluation, physical sampling, vendor qualification – documentation & site audit, qualification as per compendium and incompatibility studies. After the product successfully passes through each of these stages, it qualifies for use in a prototype formulation. Then after proving its functionality in the prototype, it is finally earmarked for commercial use.” Adding to this, Subodh Priolkar, General Manager, Colorcon South Asia, says, “Proper audits of the suppliers should be conducted yearly to ensure that all rules and regulations are enforced. This helps to instill confidence in the customers.”
Importance of quality standards Consumers are increasingly becoming aware of the ingredients used in the products that they buy, and there has been a rise in the demand for safety, performance & convenience. “If manufacturers or suppliers wish to succeed commercially, they must put as much effort into meeting quality demands as per the norms set by the authorities,” says Dr Thomas Rosen, Global Product Line Manager Pharmaceuticals & Healthcare, Cognis Corporation, LaGrange, USA. He also adds, “Proper quality systems help them to manage the process of licensing new products with relevant authorities. Quality standards are important to ensure a reliable, uninterrupted supply of excipients.” Further, quality questionnaires are a good way for manufacturers to assess the standards implemented by their suppliers. Thakore says, “The quality standards broadly define the physical & chemical properties, the impurity profile, functionality and stability of each ingredient. Both product specifications and the pharmacopoeial monograph,
Sanjay Chanana Director, Shah TC Overseas Pvt Ltd
To keep an eye on the supplier, the government and the manufacturers both need to make teams for inspecting each facility before the production process starts. In this way they can know well in advance whether the end product will be up to the standard. help in drawing the limits on the material quality. The material at the manufacturers’ end is tested to conform to the compendial monograph as well as the in-house specifications. Often, the limits at the manufacturer’s end are more restrictive to accommodate the fluctuations that could occur during the shelf-life of a product.” The product on receipt at the customer’s end is similarly analysed to check for compliance. If a product fails to qualify in even one test at either end, it is termed as Out Of Specification (OOS) and is discarded or destroyed. Priolkar says, “US Food and Drug Administration (USFDA) has clearly set an expectation that quality should be built in the drugs produced from the beginning of development and manufacture rather than simply testing the quality of the finished product. This stance has brought in the concept of Quality by Design (QbD). This has forced industries to develop a thorough understanding of their formulation and process so that slight variations in the properties of ingredients do not affect the functionality of the final formulation. These efforts should enhance building quality in the manufacture of drug products.”
There must be proper validated systems like Standard Operating Procedures (SOPs) in place, which is enforced at each step of the pharma manufacturing process – raw materials to plant level to Quality Checking (QC) to shipping.
Selecting raw materials & excipients: India vs the world India has a strong quality control system in place, which is improving with the experiences gained by filing product registrations in various countries. Chanana says, “Indian Pharmacopoeia (IP) has, as recent as early 2010, added monographs of a few excipients that should help in harmonising global standards. IP is one of the most important additions that the government has taken. This is a positive step forward, and still much more can be done in this area to develop global quality excipients manufactured locally by Indian companies.” International Pharmaceutical Excipient Council (IPEC) has been actively involved in implementing and promoting global use of appropriate
Dr Jochen A Dressler Manager, Pharmaceutical Technology, Cognis GmbH, Illertissen,Germany
It also helps if pharma suppliers follow Good Manufacturing Practice (GMP) guidelines. If the drugs are to be produced and marketed globally, it makes sense to choose a supplier with an international presence.
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quality, safety & functionality standards of pharma excipients. However, these are just guidelines and not binding to anyone. Thakore informs, “The IP, published by the Indian Pharmacopoeial Commission (IPC) on behalf of Government of India, is the guide on quality standards that need to be met by a raw material – active or inactive, during its shelf-life.” Adding to this, Miranda says, “The IPC is playing an active role in taking under its umbrella, all the raw materials & excipients being produced and imported to our country. The IP is at par with other popular pharmacopoeia such as the United States Pharmacopoeia (USP), the PharmEuropa (Ph Eur) and the Japanese Pharmacopoeia (JP).”
quality systems, management responsibility, resource management, product realisation & measurement, analysis and improvement. As the objective is to ensure consistent production of material of desired quality characteristics, the manufacturer needs to maintain quality systems that meet the intent and help to deliver the GMP requirement.”
The authorities should be encouraged to accept the industry as competent partners, especially if a particular company
GMP and its importance GMP owes its inception to the aftermath of the horrific thalidomide tragedy. GMP is a legal requirement and should ideally cover each ingredient comprising a pharma dosage form. However, despite several moves by regulatory bodies, excipients are still not covered under this rule as only a fraction of the excipients manufactured make their way into a drug product. Most of the material manufactured are used in food and chemicals. Miranda points out, “IPEC and Pharmaceutical Quality Group (PQG) framed a GMP Guide for Pharmaceutical Excipients in 2006 to ensure the quality of excipients, which are critical to the safety, quality and efficacy of medicines. IPEC-PQG divides excipient GMP into five quality management systems – excipient
has established high quality standards and follows IPEC-PQG GMP guidelines. As of today, having an International Organization for Standardization (ISO) Certification and a Quality Policy in place best fits the bill, but tomorrow it could possibly be different. Thus, it is more important to use Current GMP (cGMP). Priolkar avers, “Pharma & biotech firms ensure that their manufactured products meet specific requirements for identity, strength, quality & purity. This is regulated for example by the USFDA through
Mala Miranda Sr Manager - Technical Services, Signet Chemical Corporation Pvt Ltd
Second-generation co-processed excipients are working their way into our formulation laboratories. There is a lot happening to drive progress into the growing Indian pharma industry and allied areas.
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21 CFR Part 210 and 21 CFR Part 211 for the pharma industries and the FDA guidelines documents on these regulations are available through Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation & Research (CBER). In essence, following cGMP practices ensures the finished product is pure and acceptable for human consumption.”
Overcoming the challenges One way of improving the current state is that the committees, which are in charge of establishing standards for quality control & quality assurance, such as the IP, should also include experts from the raw material & excipients industry. The main aim of these experts should be to provide better knowledge about new excipients, and thereby enable them to be brought to market more quickly. Dr Rosen clarifies, “The authorities should make it easier for the pharma industry to use compound excipients, provided that there is already comprehensive quality & safety data and a monograph in the Pharmacopoeia for individual components that constitute the compound product. For completely new excipients, regulatory issues should be minimised, and it should not take long for a new substance monograph to be published in the Pharmacopoeia. Further, communication between the authorities & excipients manufacturers should also be improved. The authorities should be encouraged to accept the industry as competent partners, especially if a particular company has established high quality standards and follows IPEC-PQG GMP guidelines. This requires an approach driven primarily by quality and not merely marketing concerns. New excipients are either compounds of two or more wellknown and monographed excipients, or completely new substances. There should be different approval processes in place for each type.”
MARKET TRENDS
Subodh Priolkar General Manager, Colorcon, South Asia
A law for monitoring the cGMP compliance by the excipient manufacturers is essential. In the past there have been instances where non-pharma grade excipients have been used in the formulations, which resulted in grave consequences to public health. Role of the government There are several glitches, especially for import of pharma excipients. The lack of information on excipients, chemistry, classification and application has led to several untold incidences of delays, mis-classification, fines & penalties. “The government needs to seriously view this situation and educate the concerned authorities on the nuances of this enthralling, excipient world. An example is the recent incidence of quarantining imported pharma lactose, classified under ‘milk & milk products’ and insisting on an Import Sanitation Permit from the Department of Animal Husbandry. Similarly, classifying sugar alcohols like Mannitol, Maltitol, etc under sugar is yet another example of this lack of information,” avers Miranda. Adding to this, Priolkar opines, “The Government should improve the present state of rules & regulation through education, development and enforcement of regulations. Development of a centralised FDA may help in enabling manufacture of finished products with the same standards across India.”
Government initiative The government is proactively taking a number of initiatives to encourage research. The fields of Contract Research and Manufacturing Services (CRAMS) and biosimilars are also opening up. Excipient manufacturers are becoming aware of QbD and other regulations concerning excipients. They in turn are tailoring their excipients to help the industry. Miranda elaborates, “Second-generation co-processed
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excipients are working their way into our formulation laboratories. There is a lot happening to drive progress into the growing Indian pharma industry and allied areas.” Besides these initiatives, the government can also work on introducing some stringent monitoring systems to keep a watch on the
Development of a centralised FDA may help in enabling manufacture of finished products with the same standards across India. manufacturers. Priolkar explains, “A law for monitoring the cGMP compliance by the excipient manufacturers is essential to ensure the safety of medicines. In the past there have been instances where non-pharma grade excipients have been used in the formulations, which resulted in grave consequences to public health.”
The need of the hour New pharma actives or dosage forms require innovative excipients, as they have a strong influence on the bioavailability & stability of pharma products. The quality & safety of such products and manufacturing costs involved are becoming increasingly important. Dr Rosen says, “The
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excipients industry needs to provide innovative products that will help the pharma industry to quickly bring their products to market. For this, excipients manufacturers also need to offer their customers a comprehensive array of additional services, such as providing formulation expertise, being involved in joint development projects and providing customer-friendly product handling processes.” In addition, for excipients manufacturers to be accepted as competent partners in the pharma industry, they need to provide consistent & reliable quality manufacturing processes, analytical testing and documentation. Priolkar informs, “New & potent molecules are coming to the market, which may need novel excipients. Currently, there is no mechanism in place for evaluating the safety & approval of the excipients. In India, we do not have differentiation between pharma & nutritional markets and have the same rules for both markets. In developed countries, different materials are approved for pharma and nutritional products.” Agreeing to this, Dr Rosen says, “A company’s sense of responsibility extends far beyond the factory gates. It starts at the beginning with the sourcing of raw materials, and goes right to the end of the product lifecycle. The manufacturer should work together with its customers in the pharma industry to develop customised products & solutions, and provide them with extensive technical expertise & formulation assistance.” The need of the hour is to stay attuned to global happenings; reported incidences of toxicity or casualties occurring due to contaminations like melamine, diethylene glycol & residual solvents and being ready to ensure quality vis-à-vis cost in the products sourced and supplied. Again, there is also a need for a law to check such incidences. After all, excipients are the ingredients used to formulate products – pharmaceuticals & foods, for betterment of human life.
INTERFACE
‘Waste management technology and effluent treatment are expensive propositions which require heavy maintenance’ ...says Chandan Kumar, Executive Vice President - Manufacturing, Unimark Remedies. Under his guidance, Unimark Remedies has undertaken massive plans for the implementation of green manufacturing technologies that reduce environmental hazards and are also cost-effective. In an interaction with Anwesh Koley, Kumar explains why investment in green technology is mandatory for all pharmaceutical companies.
What are the green manufacturing initiatives undertaken by your company? We have technology diversification. We select a technology, which leads to the production of less hazardous chemicals, less solvent discharge into the atmosphere and less consumption of water. Furthermore, we try to change the existing technologies from time to time – from solvent heavy techniques to mixed solvent techniques and finally, to least or no solvent state. There are two ways to recover the solvent generated during production. One is through evaporation or the emissions and the other is to recover it in the mother liquor. We try to reduce the mixture of solvent & liquor and also aim at decreasing evaporation losses. All these efforts are
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taken to ensure that the solvent does not get emitted into the atmosphere.
What is the total investment made by the company towards these initiatives?
How much recovery do you achieve from your plants?
The process of solvent recovery requires investments of around ` 10 crore. With regard to water treatment and condensation, our plant in Bavla entails around ` 18 to 20 crore, while our Wapi plant has witnessed investment worth around ` 10 crore.
As of now, we successfully achieve 97-98 per cent recovery in both our plants in Bavla, Ahmedabad, and Wapi. Condensation is a must for all waste emissions. Lack of proper condensation not only causes environmental damage, but also increases plant maintenance costs. Further, water management is also an important part of our environment-friendly operations. For this, we use zero discharge facilities, which help in cutting down our emissions. Here, we have ‘multiple evaporation system’ and the energy produced by this evaporation is used to evaporate more water, thereby saving energy. Again, ‘Efficient Treatment Plants’ (ETP) ensure effective treatment of water for plant usage. The third process, part of the zero discharge facility is Reverse Osmosis (RO) system. All these technologies are expensive and require high maintenance. Earlier, one kg of water required one kg of steam. Now, with the application of these techniques, one kg of water requires only 0.3 kg of steam to evaporate. This is all due to the multiple evaporation systems adopted. Moreover, we successfully recycle around 80 per cent of all the steam we generate. We also monitor the water that comes into the plant and the one that leaves either as steam or as waste. This is done through development of the right process for water treatment.
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Does quality of the final product differ with the usage of green and conventional technology? There is a remarkable difference in both quality and volume of the final product If we use more water & inferior solvent disposal methods, our time cycle for production increases and so does the cost of production, eventually resulting in lower output, which contains more impurities and is low on quality. Green manufacturing results in around 5-7 per cent savings for us.
Have you considered the use of renewable resources and biotransformations in perusal of your green initiatives? We are planning to shift towards biotransformations, though the process will take considerable time. Our transformation process is in the initial stages and we hope to shift within a few years. Biotransformation results in environment friendly output for the company as it generates higher volumes as well as increase in the economies of scale through increase in the output cycle.
INTERFACE
‘The norms are mainly followed for compliance & obtaining licences than realising the importance and value of green chemistry’ ...asserts Kiran Das, GM - Exports & Herbal, Anglo-French Drugs & Industries Ltd. While the need to incorporate environmentally sustainable technology occupies prime importance for pharmaceutical companies, profitability is the area that also needs to be taken care of. Das details the scenario in Indian pharma industry, to Anwesh Koley. produce environment-friendly products. Unlike in the last decades, these companies are not only concentrating on hazardous waste management and water treatment, but also on biomedical and municipal waste in order to become eco-friendly.
What are the applications of green manufacturing in the pharma industry? Green manufacturing refers to the adoption of eco-friendly approach in the manufacturing process. Lighting, HVAC systems and boilers operations account for a huge amount of energy consumption in pharma companies. Hence, energy conservation by using solar panels, access control lights and optimum utilisation of natural resources, green building concepts have been recommended to maintain the environmental balance. Recycling, reuse and renewable energy (biofuel) are advocated for reducing pollution. Pharma companies are adopting measures such as use of alternative fuels to fire boilers, which generate steam for manufacturing process, among others, to
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understanding and controlling pharma processes. For instance, using PAT for drying operations can reduce energy consumption by 80 per cent while eliminating a huge amount of chemical waste and its attendant solvent & waste. Another example of PAT is of changing process of film coating from organic solvent to aqueous coating.
Green chemistry is fast gaining acceptance among pharma manufacturers. What are its advantages?
Why is green manufacturing vital for pharma companies?
Green chemistry involves the utilisation of a set of principles that reduces or eliminates the use or generation of hazardous substances in the design, manufacture and application of chemical products. Thus, it deals with the use of chemistry for the prevention of air and water pollution. Further, green chemistry provides a number of benefits, which includes reducing waste, eliminating costly effluent treatment. Pharma companies have to take responsibility for two major issues: energy-efficiency and solvent reduction. In this regard, the Environmental (Protection) Act, 1986 and Rules, the Water (Prevention & Control of Pollution) Act, 1974 and Rules, the Air (Prevention & Control of Pollution) Act, 1982 and Rules, etc can be mentioned. These norms introduced by the Indian government have been mainly followed for compliance and obtaining licenses rather than realising the importance and value of green chemistry. For example, let us consider Process Analyticall Technologies (PAT). PAT is about timely measurement of process with the goal of
With significant growth in pharma manufacturing, there is a substantial increase in emissions coupled with the rising cost of manufacturing. Thus, adoption of green manufacturing can help in this scenario. The US Environmental Protection Agency’s principles of green chemistry include prevent waste, design safety products, implement less hazardous chemical process, use renewable feedstocks, employ catalysts instead of stoichiometric reagents, avoid chemical derivatives, reduce solvent use or use safer solvents and reaction conditions, improve energy-efficiency, design biodegradability, analyse in real-time to prevent pollution, minimise accidents, and recover all elements. Formerly, less sophisticated strategies for making organic chemical syntheses greener often carried a cost burden, which is no longer the case. The bigger challenge at present lies in overcoming human nature’s resistance to change. This may pose a challenge in organic chemistry, in which many of the classical chemical reactions have been in use for decades to produce small molecule drugs.
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MARKET INS IGHTS
CRAMS
India as a destination With manpower costs less than 15-20 per cent of that in the US, manufacturing costs at nearly 40 percent of the US, and the cost of setting up a manufacturing plant nearly 70 percent less than that in the US, India has established itself as a leading CRAMS player. However, IPR, infrastructure, and enabling early stage drug discovery are areas that need attention to stay in good stead.
Courtesy: Qwickstep.com
Dr Ravi Ratan Sobti ast two decades has seen a gradual transition in the business model of major pharmaceutical companies from a model where a global major pharma company performed all functions – discovery of the new chemical entities to distribution and sales – on its own to ‘emerging collaborative networking’ across the boundaries. The transition in the business model has been necessitated due to: v Economic downturn v Declining R&D productivity due to increasing failure rate of new molecular entities and high costs in developing new drugs v Increased penetration of generics v Fewer and smaller blockbusters (drugs with
l
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sales of over $ 1 billion) to replace existing ones going off-patent to decelerate market growth Sequel to above, the bottom line of the pharma companies came under pressure. To meet these challenges, the pharma majors are now looking at: v Investing in new technologies v Increasing presence in emerging markets by way of mergers and acquisitions, eg last few years have seen acquisitions of Indian major pharma companies such as Ranbaxy Pharmaceuticals by Dai-ichi Sankyo, Japan; Piramal Healthcare by Abbott, US, and Matrix Laboratories by Mylan, US, to name a few v Outsourcing from low-cost providers with world-class standards in line with international regulatory norms. Outsourcing, which started as a tactical option, has become strategic imperative by big pharma companies over a period of time to maintain their profitability. Outsourcing is taking place across the entire value chain with API manufacturing constituting larger portion (> 50 per cent) of total outsourcing followed by drug discovery. In this context, Contract Research and Manufacturing Services (CRAMS) plays a significant role. It involves outsourcing services/products from low-cost providers with world-class standards, in line with international regulatory norms. During the last few years, CRAMS has become a buzzword in the pharma sector. CRAMS offers excellent growth opportunities to India, besides China, and makes it a preferred destination because of its low cost R&D and manufacturing base, strength in the process chemistry, regulatory
Courtesy: RndBio
MARKET INSIGHTS REPORT
A research scientist in a laboratory
& manufacturing skills and availability of highly qualified scientific manpower at a considerably cheaper rate.
Market size Global CRAMS market, other than clinical, in 2008 was estimated at $ 51 billion with a CAGR of nearly 10 per cent. Contract research accounted for $ 16.58 billion and contract manufacturing accounted for $ 33 billion. APIs and intermediates account for nearly 67 per cent of global contract manufacturing constituting $ 33 billion with an estimated CAGR of 13 per cent. India’s custom manufacturing market in 2009 has been estimated at $ 0.89 billion with a CAGR of nearly 40 per cent. India’s share of custom manufacturing, which is less than 3 per cent of global contract manufacturing, is expected to increase to nearly 5 per cent in the next three to four years. Indian custom manufacturing organisations focus more on off-patent molecules and advanced intermediates. With changes in the IPR, pharma majors will gain confidence gradually for protection of their technologies and get their patented APIs outsourced from India. Several big pharma companies are entering into strategic alliances for long-term contract manufacturing services with Indian companies. India has been gradually increasing its share in clinical trial studies during the last five to six years in Phase II and Phase III clinical studies.
Growth drivers India has emerged as a preferred destination for CRAMS due to its ability to create a differentiating cost value proposition, which is powered by various factors. One of these is the low manufacturing cost. Indian manufacturing costs in USFDA approved plants have been nearly 40 per cent of the cost in the US or 50 per cent of the cost in Europe. This is supported by the cost for setting up of a manufacturing plant in India, which is nearly 70 per cent of the cost in the US. The manpower cost is 15-20 per cent as compared to the US. Moreover, availability of highly skilled manpower for manufacturing with degrees and diplomas from technical
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MARKET INS IGHTS
Critical success factors v v v v
Technical capabilities Project management Availability of scientists Availability of USFDA approved manufacturing units v GLP compliant analytical laboratories, equipped with modern instrumentation v Well-equipped process R&D laboratories institutes/colleges/universities, project management capabilities, IP protection due to changes in IPR in line with global requirements for product patents and life of patents stand the country in good stead. This is not all. The technical capabilities as reflected by the number of DMF and ANDA filings and approvals where India’s share is 34 per cent and 30 per cent of the total filings, cultural compatibility with qualified professional having fluency in English, regulatory environment, response time are some other advantages in India. The availability of nearly 120 USFDA approved manufacturing units are next only to USFDA approved manufacturing units in the US. Blockbuster drugs (sales of more than $ 1 billion) are coming off patent protection, eg drugs with a turnover of nearly $ 30 billion will loose patent protection in 2011 in the US. India stands to gain to the extent of 30 to 40 per cent of API component. Increasing capabilities in biosimilars and High Potency Active Pharmaceutical Ingredients (HPAPIs) such as oncology products, some hormones, prostaglandins are providing a leading edge to the country. These technical capabilities have attracted CMOs from abroad to work in India and some of them have already set up their units, for instance, Albany Molecular Research Institute, US, has already set up their unit for drug discovery near Hyderabad and acquired the manufacturing unit of Ariane Orgachem in Aurangabad. Drug discovery and development outsourcing, also referred to as
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contract research, encompasses target identification and lead optimisation to clinical trial Phase IIa. India is wellpositioned to provide services in the area of late stage discovery (research chemistry) and drug development services. India’s advantage of offering cost value proposition is powered by strong capabilities in process chemistry ranging across a wide range of reactions spanning old technology-based chemistry, complex and hazardous chemistry and high-end reactions involving asymmetric synthesis and other modern methodologies practised in organic chemistry synthesis; and strong analytical chemistry capabilities, eg, method development, method validation and transfer. The growing pool of scientists with Doctorate and Masters degree in chemistry, and chemical engineers; availability of cGMPcomplaint laboratories for the synthesis of low volume APIs, and GLP compliant laboratories for method development & validations; and strong process development and scale-up capabilities for manufacture of APIs required for preclinical & clinical studies are the other growth drivers.
Early stage drug discovery: There is a need to improve capabilities in the area of research biology, which is required for early stage drug discovery. Efforts are being expended to improve this area. Apart from the above mentioned issues, some other challenges are as follows: v Attracting and retaining highly skilled workforce v Ensuring pharmaceutical supply chain effectiveness v Governance, risk and compliance v Maximising revenue growth v Optimising commercial operations v Proximity to customers v Improvements in fermentation technology Last but not the least, India lags behind in terms of R&D and the innovation culture. Unlike Western countries where there is a constant interaction amongst universities, public institutions and industry for innovation, India lacks coordination in these three key centres of research and innovation. There is some co-ordination between the national laboratories and the industry, but a lot more is needed to create a culture of innovation, which requires co-ordination in all the three centres of research.
Issues and challenges Some of the issues pertaining to CRAMS are as follows: IPR: Although India has implemented the WHO-TRIPS patent regime, some pharma majors still perceive a risk on protection of their IP in the country. As a consequence, some companies are still reluctant to outsource certain parts of their value chain to India. One of the reasons of the risk perception for big pharma companies is due to the Para IV filing by Indian generic players. This concern is gradually waning as some companies have started launching their on-patent products in India. Infrastructure: This is an area of concern as India ranks as the lowest among the major players in CRAMS. The Government of India is trying to improve the infrastructure, but there is a long way to go.
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Regulations and future outlook Though India has emerged as a preferred hub for CRAMS, its main competitor is China, that is also investing continuously in improving its capabilities. Infrastructure, a quality of culture, EH&S and niche technology capabilities, eg, biology required for drug discovery, fermentation technology and HPAPIs are some of the areas that need immediate attention to stay ahead of the curve. Services such as bioinformatics software development and regulatory filings can be added to the list of offerings. Dr Ravi Ratan Sobti, is a Consultant - Pharmaceuticals (API), with Rockdale Health, a division of Rockdale Infrastructre Pvt Ltd. Email: rrsobti@yahoo.com
MONEY MATTERS
Investment patterns of MNCs in India
Impact and challenges Indian drugs and pharmaceutical sector has witnessed FDI Inflows of about $ 1.8 billion from April 2000 to August 2010, that came through the mix of strategic and financial investments. And leading the list is Mauritius, followed by Singapore, the US, the Netherlands and Japan. This article presents an analysis of the investment patterns of MNCs in India, along with the impact of the changing SEBI code.
Courtesy: Voiceofcroatia.net
Vikram Gupta hile the Indian pharmaceutical market is expected to reach a size of over $20 billion by 2015, and move into the world’s top 10 markets, MNCs will play an increasing role in the Indian market. They have been increasing their presence in India by acquiring stake in domestic pharma companies through automatic route as permitted in the FDI policy in this sector. As world’s third-largest producer of drugs by volume, and third-largest drug R&D workforce, India is already a major pharma player. MNC’ have spent reasonable amount of time in India and gathered first hand experience of the key advantages that the Indian market offers. Availability of infrastructure, systematic operations, ease of patient recruitment for clinical trials, trained and cheap labour, data management capabilities, etc, are making it increasingly attractive for MNC pharma companies to increase their presence in India.
w
FDI in Indian pharma MNCs had come directly to India with a strategic intent to capture the Indian consumer market. During
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the same time India witnessed a huge inflow of funds from financial investors. However, there is a clear difference in the approach of a Financial Investor versus the Strategic Investor. Financial investors have defined goals on their returns and the amount of risks they are willing to take. Indian drugs and pharmaceutical sector has witnessed FDI Inflows of about $ 1.8 billion from April 2000 to August 2010 that came from a mix of strategic and financial investments. Comparatively, the cumulative amount of the total FDI equity inflows from August 1991 to April 2010 stood at $ 134,642 million, according to the data released by the Department of Industrial Policy and Promotion (DIPP). For the production of drugs and pharmaceutical, Indian financial systems allow FDI of 100 per cent, subject to the fact that the venture does not attract compulsory licensing, and does not involve use of recombinant DNA technology. If one has to look at where the money is coming from, it will be difficult to track the source of investments. However, the primary route for investments into India has been Mauritius, mainly due to tax advantages that Mauritius offers to investors. During the financial year 2009-10, Mauritius has led investors into India with $ 10.4 billion worth of FDI comprising 43 per cent of the total FDI equity inflows into the country. This is followed by Singapore at $ 2.4 billion, and the US with $ 2 billion. The other countries from where a significant amount of FDI comes to India include the US (7.5 per cent), the UK (5.1 per cent), the Netherlands (4.1 per cent) and Japan (3.5 per cent). A lot of capital comes indirectly from countries such as the US and Japan through tax efficient zones such as Mauritius and Singapore. Mauritius may show as a source with higher percentage of funds coming to India mainly due to its tax efficiencies with India.
Impact of foreign investments on pricing There is a fear that the increasing presence of MNCs is impacting the pricing of drugs in india directly and/or indirectly. And this is possible due to the following reasons:
MONEY MATTERS
v Foreign companies have acquired stake in domestic companies at very high prices and they would want to recover their investment by increasing the prices of the drugs, wherever possible v Foreign companies typically have higher costs of R&D and marketing in their respective countries and they may want to recover these costs through increased prices in India v In certain cases, foreign companies may end up in a monopolistic situations and that may lead to increase in the prices of those drugs While the concern about the impact on price increase seems to be justified, it cannot be generalised across the entire range of drugs. There are two important aspects to consider: v The ultimate economics will work on the overall demand-supply situation, and unless the sellers are able to recover their costs they may not be incentivised to sell the drugs under price v With competition for generic drugs increasing, there is a need to bring in innovation driven therapies that can be brought primarily through globalisation of the pharma industry. Also as new disease areas are being discovered, innovative and target therapies will be the way to address serious illnesses
Challenges faced when investing While MNCs are increasingly finding investment opportunities in India, they are also challenged by various factors that impede their growth. Regulatory hurdles: Although the regulatory framework is improving in India, it still requires significant changes for improving the process of FDI in India Policies related to price control: This may impact investments in certain areas. For example targeted price control from DIPP may discourage entry of investors in those drugs especially if the controlled price does not provide appropriate returns on their investments Transparency, or lack of it, in many government systems: Many MNCs have policies with regard to their investment strategy in specific countries that prohibits
them from investings in areas where there is lack of transparency in government systems Valuations: Valuations of Indian companies are very high at the current levels. Deal valuations are increasing due to higher acquisition prices by foreign companies Potential cash transactions: Due to cash transactions in many businesses, it is difficult to gauge the true revenue or profitability numbers Competition: Competition is expected to increase from foreign companies. This would impact expected returns. A higher competition for limited assets will further escalate the price of such assets
investors, this upward revision of takeover threshold limit can give time and space to increase their holdings to 25 per cent without any need of an open offer. And, the increase in the open offer size to 100 per cent will give the opportunity to some international hedge funds, and ‘Buy-out’ funds to buy 100 per cent ownership of some of the Indian companies, which is not possible under the existing guidelines. The new 25 per cent threshold will bring Indian takeover rules close to the takeover rules in some developed markets such as the UK, where open offers are triggered once the shareholding crosses 30 per cent of a target company. The new code will increase market activity and benefit all parties involved.
Impact of ‘Takeover Code’ by SEBI SEBI has been working for making the markets more investor friendly and transparent. Under the new guidelines, open offers would require 25 per cent ownership (instead of 15 per cent as per the earlier guidelines) and also need to be issued for 100 per cent equity of the target company, instead of 20 per cent earlier. Any effort to acquire control of a company would now need an open offer, one that would be for the entire 100 per cent equity of the target company (including convertibles - no investor left behind). Moreover, to make that offer, a company would need to own 25 per cent of the target company (15 per cent earlier). Creeping acquisitions would now be limited to 5 per cent annually, but only after 25 per cent initial ownership. Open offer requirements may include indirect ownership of any kind that could provide de facto control of the target company. The key intention behind the new regulations is to improve corporate governance in M&As, and private investments. Besides they are expected to provide a transparent and investor-friendly regulatory structure for acquisitions. This is expected to have a positive effect on overall healthcare and life sciences industry. Pharma and biotech sector could witness better norms, pricing and timelines. However, this may lead to some funding constraints in the pharma and biotech sector. Also, there are quite a few companies in healthcare and life sciences space where at least a single public shareholder holds 10 per cent to 14.99 per cent of stake. For such
Future of foreign investments in India While all sectors of Indian economy are expected to grow in the coming years, Healthcare and Life Sciences is expected to boost the real growth in the economy. The key sectors that will attract investments in future include, domestic formulations, custom research and manufacturing services, hospitals, specialty clinics and diagnostic centers. India is also emerging as one of the fastest growing clinical research destinations with a growth rate that is two and a half times the overall market growth. Data indicates that India participated in 7 per cent of global Phase III and 3.2 per cent of Phase II trials with industrysponsored trials having grown at a spectacular 39 per cent CAGR, between 2004 and 2008. Various allied services for pharma and drug industry are also gaining momentum. Nearly eight of the top 10 pharma companies are carrying out one or more allied services in India, either by setting up captive centres or through tie-ups with CROs and IT/ITeS companies. Given the trend of investments by the MNCs in India over the last three years, it is expected that they will control almost 10 to 12 per cent of the total market with their patented products in the domestic pharma market, by 2015.
November 2010
Vikram Gupta is CEO, India Venture Advisors Pvt Ltd. Email:vikram.gupta@piramal.com
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Modern pharma manager
Not simply a man who ages Between the steady flow of patients, the only other person who regularly meets the physician is the MR. Sometimes he is accompanied by his manager, whose role is to leave an additional imprint on the physician’s mind while promoting the brands. Hence, the responsility of a pharma manager is an effective management of the brands, thus adding to the sales revenue. Generally speaking, the superior officer monitors the functioning of the subordinate manager who in turn supervises the work of the lower cadres. The entire exercise is designed to improve the company’s profit margin so as to pitch it higher than its competitors in the ORG rankings.
General trend
Courtesy: Orno Medical Solutions
Dr Rajan T D arketing departments of all pharmaceutical companies have a standard hierarchy to interact with physicians. The companies depute managers to supervise the work of Medical Representatives (MRs) once in a while. A couple of times in a year, the District or Regional Manager (DM or RM) makes rounds visiting the clinics of the important doctors to gain their feedback on the brands. They maintain a database of the topmost prescribers of their products and the National Sales Manager (NSM) makes it a point to call on these doctors in order to keep the sales figures ticking.
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The general trend followed by the pharma managers is to meet doctors at specified intervals, accompanied by their retinue, and observe how their deputies are performing. Besides checking out the rapport between physicians and Area Managers (AM)/ MRs, RM tries to build direct links with the doctor. The relationship sometimes matures to a mutually beneficial friendship, but quite often the interaction remains business-like with the RM trying to glean vital clinical clues relating to their drugs. However, from a doctor’s point of view, the visits by AM do not serve any major purpose other than checking on the working of the MR. Managers belonging to the national or zonal levels sometimes endeavour to stimulate the physician into disclosing unfulfilled needs in their pharmacological armamentarium that could help the company to look for newer products.
Skill and time management The AM is the one who always accompanies the MR, and is the first link between the field staff & his employer. He is in the best position to observe the intensity of
MARKETING
A manager at work By updating the MR with new medical developments, encouraging him to read newspapers or medical magazines, the manager can broaden the junior’s mind. Helping him to understand the value of his brand visà-vis the competitors’ or coaching him to make polite conversation with the doctor is an important task before the Manager. interaction between the physician and his subordinate. On his visits to various clinics he can observe the sequence of action of his MR. The order in which he chooses to visit doctors will determine the best utility of his time. The degree of comfort the MR has with the GP or consultant can be clearly understood by the Field Manager (FM). The manager can try to impart special skills to the young man so as to make work more rewarding for himself and the company. Updating the MR with new developments in the medical field by encouraging him to read newspapers or medical magazines, the manager can broaden the junior’s mind. Helping him to understand the value of his brand vis-à-vis the competitors’ or coaching him to make polite conversation with the doctor is an important task before the AM.
Lack of focus Sometimes people working as MRs are young men or women, who take up the job to financially support their higher education plans. Mostly, such candidate will lack the focus. There is a possibility wherein they would ignore a physician’s grievance like non-availability of some brand or a suggestion like introducing smaller pack of an expensive skin ointment. This is when the intelligence of the manager comes to test where he should be able to extract such complaints from the doctor even when the MR ignores it. Also, the manager should be able to deal with such staff whose productivity affects the company’s quarterly results.
Zonal & national level managers Usually senior rank managers make quarterly or half-yearly trips to different regions of the country. In any industry, it is human tendency to take one’s superiors to clients who will speak well about them. Consequently, ZMs are chaperoned by the AMs to those physicians, who are good supporters of the company. Being hard-pressed for time, the RM/ZMs too leave the ground logistics to the local team and they are content with making small talk with doctors who are showering them with prescriptions. During these interactions only pleasantries are exchanged and thanksgiving motions are passed. Meanwhile, the doctor gets a welcome break from his tiring practice. It would be worthwhile if the ZMs or NMs identify senior
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A physician at work Physicians make minute observations about some hitherto unknown adverse effects of a new brand. Some of them provide valid reasons against an inappropriate drug combination launched by the company. They would be well aware that this type of information can only be understood by a senior manager and not by MRs. general practitioners or consultants, who have something to explain about the pros and cons of their products or related issues. They could meet the doctor independently without making it a group activity. Astute senior physicians make fine observations about some hitherto unknown adverse effects of a new brand. Some are able to provide valid scientific reasoning against an inappropriate drug combination launched by the company or incorrect detail on a visual aid. Physicians are well aware that this type of information can only be imbibed by a senior manager and will refrain from voicing these concerns to the lower personnel. Besides, they can give valid inputs even on the packaging, pricing and promotion of the brand. Obviously, such interactions with senior physicians may be virtually impossible as they will not appreciate any interruption in their clinical practice. In such cases, the senior manager may have to arrange luncheon meets or
other informal interactions with the doctor inorder to get his/her views on the brand.
Solving special issues The marketing team is often troubled by concerns other than the pharmacological aspects of their brands. Finding the utility of leave-behind literature (LBL), choosing an appropriate professional journal as a gift subscription or selecting a festival gift for senior consultants are issues where the National Sales Manager (NSM) may be riddled with choices. Instances of choosing an appropriate speaker for a proposed CME or sponsoring a research study are decisions which only senior level managers can take. Therefore senior managers should be in touch with eminent consultants so that they can select legitimate people for such high-skilled work. In order to know who the respected names in different specialties or key-opinion leaders are, the ZM or NSM must interact with junior physicians as well.
Clinicians v/s medical advisors
The marketing team usually works in tandem with the medical advisor, who heads the clinical research team of the company. Medical advisors of pharma companies are usually highly accomplished individuals, who have all the essential details on drug molecules, its chemistry, actions & interactions. However, being a medical person is not necessarily being ‘clinical’ as well. A general practitioner or the specialist is the person who knows the Table 1: Clinical Information network pulse of the patient. His vast clinical experience cannot Medical advisor match the knowledge of National Marketing/ + Sales Manager the medical advisor, who Clinical research is usually confined to his team office room equipped with Internet connection. Zonal/Regional Managers Undoubtedly, there are certain questions that are best answered by the clinician. Field/Area Manager Unless these questions are put up to him or her by the Doctor: Practising general physician/consultant marketing managers, the
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pharma company’s outlook will be based on the sole opinion & decisions of the medical advisor. Thus, in order to tap the practising physician adequately, the medical advisor of the company should train the marketing team to pose the right questions. Therefore, the RM-ZMNSM group should be well knit (Table 1) so as to funnel out accurate conclusions on their proposed launches. Globally, there are numerous instances of ‘innovative’ drugs being launched with much fanfare and promoted using novel techniques only to be withdrawn without a whimper after drowning several millions of dollars. In India, drug companies have imported successful international brands without understanding our ground realities and failed miserably. Therefore, an ambitious pharma manufacturer should develop a system of taking advice from the clinician to authenticate what its in-house medical advisor has determined. Filtering and assimilating accurate information from the physician to be delivered to the medical department of the company is a vital job of the managerial cadre. In conclusion, the company, which will lead the rankings will be the one that has a right mechanism of extracting vital clinical information about its brands from the clinician and which utilises this information in order to top the marketing ladder. Dr Rajan TD (MD, DVD, DNB) is an alumnus of Mumbai University and practises as a Specialist in Skin & STD in Mumbai since 1991. He regularly writes in various periodicals on several social issues as well as those relating to the pharmaceutical industry. He has been the Associate Editor of ‘My Doctor’. He advises pharmaceutical industries on drug development, promotion and marketing strategies. Dr Rajan is an Honorary Consultant to ONGC, Indian Airlines, Air India and Larsen & Toubro Ltd. He also teaches at CMPH Medical College, Mumbai. Email: rajan.td@gmail.com
MPh (November_2010) 2Tab-85
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CLINICAL RESEARCH
Clinical trials
An overview The growing awareness on safety and quality of pharmaceutical products has magnified the significance of clinical trials. These trials are conducted meticulously in different phases, with the aim of determining the safety and efficacy of products before being marketed. Read on for more insights… with their nature & intensity; and pharmacokinetic behaviour of the drug as far as possible. These studies are often carried out on healthy adult volunteers (tests are conducted on at least two subjects at each dose level) using clinical, physiological and biochemical observations. These trials are usually carried out by doctors/investigators in clinical pharmacology, with necessary facilities to closely observe and monitor the subjects for safety. Usually Phase I trials are carried out in one or two investigational centres.
Phase II: Exploratory trials
Courtesy: Srispharma.com
Rajendra Talele s per the Good Clinical Practice for Clinical Research in India (Indian GCP), clinical trials are defined as ‘a systematic study of pharmaceutical products on human subjects – (with patients or non-patients as volunteers), in order to discover or verify the clinical, pharmacological (including pharmacodynamics/pharmacokinetics), and/or adverse effects, with the objective of determining their safety and/or efficacy.’ Different phases of clinical trials namely Phase I; Phase II; Phase III and Phase IV are well-defined in the Indian GCP. These phases are elaborated below.
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Phase I: Human/clinical pharmacology trials The objective behind Phase I trials is to determine the maximum tolerated dose in humans, pharmacodynamic effect, adverse reactions, if any,
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In Phase II trials, limited patients are studied carefully to determine possible therapeutic uses, effective dose range and further evaluation of safety and pharmacokinetics. Normally 10-12 patients should be studied at each dose level. These studies are usually limited to three-four investigational centres and carried out by clinicians specialised in the concerned therapeutic areas, having adequate facilities to perform the necessary investigations for efficacy & safety.
Phase III: Confirmatory trials The purpose of these trials is to obtain sufficient evidence about the efficacy & safety of the drug in a larger number of patients, generally in comparison with a standard drug and/or a placebo as appropriate. These trials may be carried out by clinicians in the concerned therapeutic areas, having facilities appropriate to the protocol. If the drug is already approved/ marketed in other countries, Phase III data should generally be obtained on at least 100 patients distributed over three to four centres primarily to confirm the efficacy of the drug in Indian patients when used as recommended in the product monograph for the claims made.
CLINICAL RESEARCH
Phase IV: Studies performed after marketing of a product Trials in Phase IV are carried out on the basis of the product characteristics on which the marketing authorisation was granted and are normally in the form of post-marketing surveillance, assessment of therapeutic value, treatment strategies used and safety profile. Phase IV studies use the same scientific & ethical standards as applied in pre-marketing studies. After a product has been placed in the market, clinical trials designed to explore new indications, new methods of administration or new combinations, etc, are normally considered as trials for new pharmaceutical products.
Various stakeholders clinical trials
of
Every stakeholder of clinical trial is responsible for producing essential documents of proposed study. There are five major stakeholders for any clinical trial. They include: Sponsor: A sponsor is an individual or a company or an institution taking the responsibility for the initiation, management and/or financing of a clinical study. The sponsor is responsible for preparing protocol, investigator’s brochure, Case Report Forms (CRF), investigational drug, original submission to regulatory authority, assuming responsibility of the study, etc. A sponsor can delegate partial or complete activities to the experts from Clinical Research Organisations (CRO) that can complete the work as per timelines and requirements of the sponsor. However, final responsibility of conduct of any trial always lies with the sponsor. Clinical investigator: Clinical investigator is a person responsible for the conduct of the study at the trial site. He is responsible for the rights, health & welfare of the subjects. Further he is also responsible for enrolling eligible patients, prescribing investigational product, collecting data and any adverse event pertaining to enrolled subjects as per the protocol in the predefined fields of CRF.
Important documentations required The sponsor is responsible for preparation of following documents, which serve as the backbone for any clinical trial, apart from being responsible for preparing an informed consent form and patient information sheet for patients. Protocol: Every clinical trial requires a detailed protocol defining rationale & objective of the trial, ethical consideration and study design giving primary and secondary end-points, if any. It also calls for description of the type of study – random, single blind or double blind, medications & treatment, dosage, route of administration, packaging and labelling of medications, – patient selection criteria as well as withdrawal criteria, handling of investigational product, assessment of efficacy and assessment of safety. Finally, protocol needs to have details on statistics, data handling and management, quality control & assurance. Investigators’ brochure: An investigator’s brochure is ‘a collection of data (including justification for the proposed study) for the investigator consisting of all the clinical as well as non-clinical information available on the investigational product(s) known prior to the onset of the trial’. There should be adequate data to justify the nature, scale & duration of the proposed trial and to evaluate the potential safety and need for special precautions. If new substantially relevant data is generated during the trial, the information in the investigator’s brochure must be updated. Investigator’s brochure usually contains physical, chemical & pharmaceutical properties and formulation, non-clinical or animal studies, clinical studies – previous studies carried on human beings, toxicological studies and summary for data and guidance to the investigators. Case report form: A case report form is a printed, optical or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject. Investigational drugs: An Investigational product is a pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorisation when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use. Regulatory authority: The Drugs Controller General of India (DCGI) or an office nominated by him is the regulatory authority for the purpose of carrying out clinical trials in India. The regulatory authority approves the study protocol, reviews the submitted data and conducts inspections Ethics committee: An independent review board or committee comprising medical/ scientific and non-medical/ non-scientific members, whose responsibility is to verify the protection of the rights, safety and well-being of human subjects involved in a study, forms the ethics committee. Trial subjects / patients: An individual participating in a
clinical trial as a recipient of the investigational product.
Why India? Among Asian countries, India has been attracting a lot of clinical trials due to a large pool of treatment naïve patients and English speaking population, ICH GCP trained investigators, rapidly improving medical technology and hospitals network. Various market research reports indicate a continued healthy trend for clinical trials industry in India.
November 2010
Rajendra Talele, is Vice President, Clinical Operations at Siro ClinPharm. Email: Rajendra.Talele@siroclinpharm.com
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Business intelligence in pharma
An aid in informed decision making Currently, the demand for BI solutions is largely driven by MNCs & large enterprises. BI solutions seem to have gained more acceptance and significance in pharma industry where time plays a pivotal role in the future of the company. The article reviews the importance of BI solutions to the Indian pharma industry.
Courtesy: bytesizedsolutions.com
Sanjay Mehta s market pressures demand increased innovation and shorter time-to-market product lifecycles, pharmaceutical companies need to re-think and evaluate alternative business models, focussing on technologies like Business Intelligence (BI) tools. With the heightened competitive environment among the new entrants in the pharma industry, pharma companies need to use all the tools at their disposal to operate more efficiently, increase revenue and re-balance the decision-making power. In order to build a significant marketshare in an expanding and competitive drug market, pharma companies need information management solutions that allow them to make better business decisions, thereby maintain revenue growth.
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An allocation of assets & resources relating to new product development, the mix and priority of sales & marketing initiatives are important. The vertical structure of organisation around product or therapeutic-specific silos has fostered the creation of multiple, disparate data sources and formats – islands of data. Real-time business activity monitoring across brands and functional departments require that these data be integrated into a single repository, which represents a significant challenge to the pharma industry. Further, the need for transparency has also impacted the way pharma CXO’s think about their particular business processes and continued heightened regulatory environment. BI for pharma companies has now become what Enterprise Resource Planning (ERP) is for manufacturers. Thus, it is difficult to keep track of important information. For the pharma industry, BI offers Management Information Systems (MIS) reports, data analysis and allows them to monitor the vast amounts of data. The availability of these patient-centric data, combined with the need to address the decreased effectiveness of traditional promotions, has made pharma companies aware of the need to integrate information coming from both internal and external sources. BI solutions are being embraced as a means to translate and interpret this information in support of strategic & tactical business decisions. In an increasingly competitive market, pharma companies can utilise BI for growth by improving product development, enhancing go-to-market strategies, increasing operational performance, optimising their supply chains, regulatory compliance and driving revenue & marketshare.
SMART SOLUTIONS
Customer analysis BI can help to identify & target individuals and demographics that could be considered ‘undiagnosed’, with educational campaigns whose goal is to encourage these individuals to get screened and tested for possible issues. It can also combine product sales information with customer groups and customer channel information to analyse what makes customers fill prescriptions at a more consistent rate or what makes physicians prescribe certain drugs at a higher rate.
Sales & marketing analysis BI allows companies to identify products that are most profitable, monitor consumer behaviour in terms of prescription renewal & product purchases, track the success of marketing campaigns, and analyse profitability by product, customer, geographical area or other factors. As part of their ongoing analysis of the market and competitive landscape of the industry, pharma companies can regularly track the marketshare of individual drugs & drug groups. Companies can do this by considering the following: v Analyse the prescription activity in a geographic region v Dissect buying trends of the largest customers v Provide web-based analytics to a sales force v Target physicians having high prescription rates of a certain drug or treatment with new drug information Some of the companies who have implemented BI software solutions are Wanbury Ltd and Glenmark Pharmaceuticals Ltd. MAIA Intelligence has entered into a partnership and strategic alliance with ERP vendors like Soham for its Pharma Suite and other consulting partners like Religare Technova to jointly offer this BI solution specifically for the pharma industry. There are many other small - to medium-scale pharma organisations that use 1KEY BI, which has been bundled with their ERP. Most Small and Medium Businesses (SMBs) again look for a value proposition around three aspects – whether the solution is easy-to-buy, easy-to-use and easy-toinstall & nurture. Further, BI helps them build reports that compare trade in particular months with that in previous years, and all this analysis is available to the top management. In today’s competitive market – whether SMB or enterprise – customers are demanding better quality of service at lower prices.
Penetration, adoption & importance of BI in Indian markets BI represents significant market opportunity in terms of market size, mainly because they comprise large organisations. These companies accumulate vast amount of data through global discovery projects, numerous clinical trials and cost-marketing activities. These factors create a more pronounced and immediate need for BI tools across the product lifecycle in the pharma sector. As a result, a growing number of companies are turning towards enterprise-class BI solutions that provide a common underlying architecture & end-user interface and integrate data from different laboratories, both research & clinical. The maturity of BI adoption can best be seen with the new economy companies, including those in the pharma sector. Currently, many pharma companies have deployed & stabilised ERP/CRM/SCM/HRM or core business (transactional) applications and are thus looking for a tool that can leverage the IT investment in these packaged applications. We are seeing great interest from verticals, such as pharma companies, to adopt BI for increasing their competitiveness & transparency. In India, there is a general awareness on the theory and concept of BI. They are spearheading BI adoption by going in for separate BI units within the organisation to provide the ‘right’ product to the ‘right’ customer and at the ‘right’ time & price. This industry is one of the early adopters of BI in India. Currently, the demand for BI solutions is largely driven by MNCs &
November 2010
Courtesy: businessintelligencebi.com
Again, BI can provide critical data analysis to pharma companies in order to support informed, strategic action. Data across functional departments can be integrated, providing context for critical business decisions. Thus, BI gives a true enterprise view across our value chain. Enterprise-wide BI can integrate and co-ordinate data from R&D, sales & marketing, with critical external data vital to real-time adjustments to resources & priorities. Internal data, including information from product development, territory management systems, sales force automation tools and consumer direct marketing can be examined across brands rather than within specific product areas. Thus, BI helps decision makers make more informed decisions and supplies users with critical business information on their customers or partners, including information on behaviours & trends. Furthermore, BI allows the comparison and review of past performances, in addition to looking forward with different ‘what if’ models, where the user can manipulate the data. Again, BI enables a clear understanding of business, which is crucial. There is a need for an instant view of current sales against budget or break-even, and a view of administrative tasks that negatively affect cash flow, including improper tracking of running items, drug returns for expired ones & timely replacement orders, tracking timely utilisation of materials to avoid expiry, etc.
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large enterprises. BI solutions seem to have gained more acceptance and significance in pharma industry where time plays a pivotal role in the future of the company. Return on Investment (ROI): ROI on BI is high and fast. An example of Human Resources (HR) analytics can be considered here. HR department, equipped with the facts & analysis, can plan and take the necessary action. This is just one area within an HR domain. Likewise, BI can help any pharma organisation for ad-hoc reporting, dynamic MIS thus enabling costsavings, and increasing revenue. Hence, a high rate of ROI happens quickly on BI. Total Cost of Ownership (TCO): Contrary to the traditional BI (MNC), operational BI leaders like MAIA Intelligence’s 1KEY have low TCO, considering the Enterprise License Cost, IT-user involvement during deployment, IT-user involvement for support, implementation, training and overall business value delivered. Implementation of 1KEY happens as fast as within two days and business users are trained in just few hours. Hence, the TCO is low in case of BI tools like 1KEY. Based on Gartner research, only 30 per cent of companies that have deployed BI consider their deployments ‘very successful’ – the vast majority is labelled ‘somewhat successful’. Moreover, most existing BI players (traditional BI) are primarily focussed on Strategic BI alone. These tools are expensive and used by only top management and the remaining 85 per cent of business user pyramid is deprived of a BI for MIS, analysis and monitoring or gauging performances, which, if provided, can help them gain visibility into the business. BI Market: There is still scope for growth in the BI market. It has penetrated only 10-15 per cent of the known user base, but there is opportunity for BI well beyond today’s known markets. Gartner Report ‘Hype Cycle for ICT in India 2008’, expects BI market in India to reach $46.8 million by 2012. India is a huge market for BI and is fast growing with double-digit figures even in this
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economic slowdown. The overall BI market in India is at a nascent stage, with a huge untapped opportunity for vendors to capture. BI can deliver on this promise if deployed successfully because it can improve decision making and operational efficiency, which in turn drives the top line and the bottomline.As per NASSCOM ZINNOV INDIA Software Product Business Study report, BI is on the third opportunity priority list for Indian software product companies.
Some of the companies who have implemented BI software solutions are Wanbury Ltd and Glenmark Pharmaceuticals Ltd. Visible trends for further development of BI We are now looking forward to new technology wave of Rich Internet Applications (RIA)-based BI. Business users have no experience of such an intuitive Graphical User Interface (GUI). We are releasing in coming months 1KEY Touch Dashboard based on RIA platform. We have rolled out with couple of guinea pig customer for initial feedback. We want our customers to develop a deeper, longer commitment with our brands even if they are priced the lowest in the market. Emotional customers are those who care, share their views with the world, pay a premium for the products and stay for the long run. In fact, they are often the most profitable customers for a company. Simply put, BI is definitely a space to look forward in coming quarters. IInnovation in technology and delivery model disruptions have made BI software more accessible to a larger customer base. BI will be an integral part of the software bond that binds relevant information to intelligent decisions across organisations.
November 2010
Product analysis: BI analyses buying tendencies and treatment outcomes to create more drug & product variations tailored directly towards different age groups and risk factors. Supply chain analysis: It improves production schedules by analysing which products stay on the shelves for the longest time and how well each product is selling. Regulatory compliance: BI’s analytical and reporting capabilities allow companies to gather & integrate information from across the enterprise and present it in easy-to-run & easy-to-understand reports. Pharma companies, besides conforming with drug testing and health certification norms, can comply with the often rigid insurance and government standards for payment and billing with BI. Clinical data analysis: BI’s analytical capabilities enable companies to track the large amounts of information from clinical trials, identify the most efficient practices, and optimise resource allocation. By integrating data from multiple sources, BI also helps companies identify trends & anomalies and analyse risk during product development & launch. Financial analysis: BI integrates both financial & operational information, enabling companies to monitor and forecast financial performance as well as produce statutory financial reports from the same platform that enables clinical data & quality control analyses. Operational analysis: BI enables companies to track their supplier networks, inventory stocks, product quality and production levels. In addition, BI’s ability to simultaneously analyse information from multiple sources allows companies to monitor costs and operational efficiency across the enterprise, examine employee productivity and allocate resources more effectively. Sanjay Mehta, is Chief Executive Officer at MAIA Intelligence Pvt Ltd. Email: sanjaymehta@maiaintelligence.com
TECHNOFOCUS
Advancements in clean-in-place technology
Critical in automating process cleaning Clean-In-Place (CIP) facilitates automated cleaning of production and processing equipment without having to disassemble them, as the machine condition influences product quality, thus saving a lot of time and efforts in the cleaning process. It is a reliable & repeatable process used in the pharma, biotechnology, food, dairy and such other industries, which demand stringent hygiene regulations. Further, process cleaning is a critical factor in the qualification of current Good Manufacturing Practice (cGMP) production facilities. Often, noncleanable process design, inadequate process cleaning strategies and poor CIP implementation become painful obstacles blocking the way towards completion of validation for a new process.
CIP cleanable processes
Eductor-assisted CIP System
Compact-design portable CIP system
Samuel Lebowitz n-place cleaning was first applied in the dairy industry in the late 1940s and by mid-1960s, automated in-place cleaning of dairy plants was widely used. The CIP procedures led to the development of all-welded product piping systems, application of air-operated CIP cleanable sanitary valves and appreciable increase in the size of processing tanks as compared with vessels that had to be manually cleaned. Today, CIP is applied to various pharmaceutical processes both for liquid (biotechnology, fermentation, blood fractionation, IV solutions, parenteral solutions, respiratory care products, etc) and solid (crystallisation, filtration, drying, milling, blending, bulk container filling, etc) product manufacturing.
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CIP is a procedure by which chemical wash & rinse solutions are brought into immediate contact with all soiled surfaces and continuously replenished. The cleaning process is essentially chemical in nature, and generally uses recirculation to minimise water & chemical costs. Solution contact is accomplished through recirculation with the help of spray devices for tanks or pumped recirculation through process lines, all under controlled conditions of time, temperature and chemical concentration in a reproducible manner. Processing equipment and piping systems that are cleaned-in-place receive less wear and tear (damage) than comparable items, which are manually cleaned. With automated CIP, labour required for cleaning and maintenance is substantially reduced and the processing system productivity is increased through a reduction in down-time. At the same time, reproducibility increases as automation replaces manual cleaning procedures. In the last decade, end-users and equipment fabricators have been making concerted efforts to establish a level of consistency in expectations for acceptable hygienic design practices for biopharmaceutical manufacturing. Organisations
TECHNOFOCUS
like ASME BPE, EHEDG and P-3A have addressed various aspects of requirements applicable to subjects such as hygienic design, materials of construction, fabrication methods, vessels, piping, inspection, testing and certification. While design consistency is important, substantial experience has shown that successful CIP/Sterilisation-In-Place (SIP) implementation involves far more than the selection and application of cleanable pumps, tanks, sprays, valves & controls. The design of a cleanable process requires the consideration of unit operation processing equipment design conducive to CIP cleaning, process equipment layout, application of specialised CIP systems and, finally, the interconnecting piping design for the process to provide for proper cleaning via configuration into CIP circuits. Processing tanks and piping systems comprising pumps, interconnecting piping, valves & instrumentation are well understood to be CIP cleanable. CIP technology is equally applicable to any equipment in which solution contact can be achieved via recirculation through spray devices or pumped recirculation through process lines.
Directionally drilled CIP spray devices Since the early days of CIP in dairies, universal coverage spray devices have been available. These off-the-shelf sprays incorporate standard patterns such as 180° upward, 180° downward or 360° all-round coverage. Universal coverage drilled sprays provide a fixed pattern, while rotating sprays provide a moving pattern. All types of spray devices rely on a falling film of solution to supplement the specific coverage. In the case of rotating sprays with gears & bearings, there is always the question of whether the device continues to provide the desired as-designed coverage over the life of the spray due to mechanical wear and damage. Thus, rotation and frequency verification are generally acknowledged as being required for cGMP facilities. The development of directionally drilled spray devices with coverage based on 3D CAD modeling has opened the way to
ensuring optimum coverage. Figure 1 shows the plan and elevation views of a typical process vessel having multiple process nozzles, manway, annular agitator flange, multi-tiered agitator blades and a baffle. Vessel spray device locations are located on opposite sides of target areas to ensure a cross-chop trajectory is available for hard to reach areas. Figure 2 shows the 3D CAD model of the same vessel, identifying the trajectory from individual holes of directionally drilled spray devices. In this manner, optimum CIP cleaning coverage can be achieved at the least possible flow rate. Figure 3 shows a collection of common spray device types. Spray balls are used to provide coverage to targeted areas as well as broad areas. Spray bubble spheres can target specific areas, and are particularly useful for hard-to-reach process equipment zones.
CIP operating flow rates The first-step of ‘sizing up’ a particular application is to assess the flow rates that will be required of the CIP system for proper cleaning. The generally accepted criterion for cleaning of price lines is to achieve a velocity of 5 ft/sec (1.52 m/s). For a half-inch (12.7 mm) Outer Diameter (OD) tubing, this velocity calculates to 1.7 gpm (6.3 lpm); for 1 inch (25.4 mm), 9.3 gpm (35 lpm); and for 2 inch (50.8 mm), it is 43 gpm (162 lpm). Dished-head vertical vessels are cleaned with the majority of flow directed with spray devices toward the upper head and sidewall area at the knuckle radius. Gravity then provides for a continuous solution sheeting over the sidewall and bottom head. Specific streams may be directed at appurtenances such as baffles and agitator impellers. To provide sufficient coverage in vertical vessels with dished heads, the following are examples of cleaning flow rate guideline that have been usually found to be adequate. v For a 3 ft (900 mm) diameter vessel, spray device flow rate will be in the order of 28 gpm (106 lpm) v For a 5 ft (1,500 mm) diameter vessel, spray device flow rate will be in the order of 47 gpm (178 lpm)
v For an 8 ft (2,500 mm) diameter vessel, spray device flow rate will be in the order of 75 gpm (285 lpm) A logical use of flow rate data is to ensure a match with equipment design. For example, it is important that tank outlets be sized commensurate with the CIP flow rate, permitting unrestricted discharge of solution to CIP return.
Return flow motivation Based on process design, facility layout, project budget and other considerations, the engineer decides on the optimum configuration for CIP return motivation. Practical field experience reveals that often it is easier to pump water into process tanks than to get it back to the CIP system through CIP return. For this reason, proper system hydraulic balance is greatly dependent on the concept of CIP return configuration. Solution return may be accomplished by gravity, return pump, eductor (vacuum created by venturi flow effect) motivation or a combination of the previous methods. Gravity return flow: Gravity return flow is applicable only when the tank being cleaned is at one or more levels above the CIP system. Flushing, washing and rinsing solutions must be continuously removed from the vessel being spray cleaned at a rate equal to the solution supply. The size of tank outlets and return piping systems must
November 2010
Figure 1: A typical process vessel
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TECHNOFOCUS
Figure 2: 3-D CAD model of directionally drilled CIP spray device coverage of vessel
be large enough to permit return by gravity alone. When properly engineered, gravity drainage is more effective than any other method for removing final traces of liquid from a circuit. Pumped return flow: Low-speed (1,500 rpm) return pumps either with the head rotated by 45° from vertical or of a ‘self-priming’ type provide effective and reliable return flow if the return header pitches continuously from the tank being cleaned to the pump inlet. CIP return pump performance is reduced by elevated water temperature. Eductor-assisted return flow: A substantial advancement in CIP for biopharmaceutical production has come through the combination of a high-speed motive pump and eductor incorporated in eductor-assisted CIP return flow systems. An eductor-assisted CIP system will pump both air and water with 15-18 inch (381-457 mm) of mercury CIP return flow vacuum motivation. While eductor return flow can be used as a sole motivating force for short CIP return runs involving minimal static head, an eductor is most commonly used in conjunction with gravity return or a CIP return pump. The eductor continuously primes the return pump, which in turn is able to handle an air-water mixture. Thus, a standard low-speed hygienic centrifugal pump is always suitable, and the more expensive self-priming pumps are not necessary. Eductor performance, relative to the vacuum capacity being generated, decreases with an eductor assist at elevated water temperature, but there is always sufficient vacuum remaining to prime the return pump.
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Figure 3: Commonly used CIP spray device types
CIP systems The CIP system is designed to provide automatically controlled spray cleaning operations of storage tanks & processing vessels and pumped recirculation washing of product transfer piping systems. The integrated system makes it possible to achieve complete & uniform control of time, temperature and chemical concentration, all of which are important for success with any mechanical spray or pumped recirculation cleaning process. Proper application and engineering with respect to return pump selection, spray device selection and piping installation makes it possible to conduct such cleaning operations with a high degree of uniformity and dependability in accord with cGMP. Frequently, CIP system types are referred to as being of ‘3-tank’, ‘2-tank’, ‘1-tank’, etc. Large multi-tank CIP systems are remnants of conventional dairy equipment companies. The multi-tank CIP system concept implies that a dedicated tank is provided to serve as a ‘wash tank’ for caustic and acid detergent cleaner makeup. Additional tanks beyond the first tank would be for DI, purified and/or WFI water storage. In reality, most CIP programmes can be served from a single multipurpose tank, with as little as 50 gallons (189 ltr) capacity, if the water supplies are adequate to keep up with the requisite delivery, especially during rinses. However, if DI, WFI or other purified water supply is substantially lower than the CIP delivery rate, then the CIP system may require one or more storage tanks of the required forms of purified water.
November 2010
Also, for CIP systems that use an eductor, a minimum of two tanks is required. One tank serves to allow motive recirculation through the eductor simultaneous with rinse water supply from another tank. Thus, from the beginning of the cleaning cycle to the end, the eductor is able to continuously exert negative pressure on the CIP return flow path. Full-featured portable CIP systems are now available, which pass through a standard door opening of 3 ft (1 m) width or less. Of course, for manoeuvrability, it is advantageous for a portable CIP system to have absolutely as compact a footprint as possible. In a portable CIP application, the CIP system is wheeled to within close proximity of the process area equipment to be CIP cleaned. At the use location, utility services are required with quick-disconnect hook ups.
Future considerations With increasing regulatory attention to process cleanability and sterility, design engineers encounter greater need for automated CIP in a variety of process sectors, each with particular challenges. Examples are large-scale production chemically synthesised active pharmaceutical ingredients, dry product processes and personal hygiene products. The scope of the design challenge is less daunting and burdensome when one understands that much of what is required has been achieved previously, perhaps in another context. By utilising the resources of industry experts early in the concept design, cleanable construction and automated CIP can most effectively & efficiently be integrated into processes. Samuel Lebowitz earned a BS from Pennsylvania State University and MS from Ohio State University (Food Engineering). He has worked as a hygienic process design engineer for the last 20 years as Technical Services Manager for Electrol Specialties Company, South Beloit, IL, USA. Samuel has participated in the design, fabrication and start-up of the integrated process and CIP of more than 100 projects. Email: sam4cip@aol.com, mail@salesworth.com
CURTAIN RAISER
Where South Asia meets With its global appeal, CPhI India along with co-located events expects visitors from local markets, and also companies outside the pan-Asia region. They aim to concentrate on the needs of pharma ingredients, machinery & equipment and several bio-solutions. A preview. be held alongside the CPhI India exposition at Westin Mumbai Garden City.
Reaching out While CPhI India is well attended by visitors from the local markets and industries, its appeal is global, the event attracts a great deal of interest from visitors from outside the pan-Asia region, who interact with domestic and international exhibitors on a wide variety of issues. With more than 700 exhibitors from various countries like Belgium, Japan, USA, UK, Germany, Italy, China, Russia, Switzerland, Canada, India and many more participating in this event, CPhI gives visitors a chance to learn about the newest market trends, technologies, products and opportunities through technical presentations.
Highlights
ollowing its success in 2009, UBM India will be organising South Asia’s biggest pharma event once again. CPhI, along with co-located events, P-MEC, ICSE and BioPh (access to which is included free with registration), allows visitors to source all their pharmaceutical ingredients, outsourcing, machinery & equipment and biosolutions needs in one location.
f Venue
CPhI India 2010 will take place from December 1-3, 2010 at the Bombay Exhibition Centre, whereas CPhI India Conference Series 2010 will
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November 2010
P-MEC India is the leading event for pharmaceutical machinery & equipment in South Asia that will feature over 175 exhibitors from around the world offering quality machinery and equipment at competitive prices. The ICSE expo concentrates on outsourcing and contract services – a sector growing at 43 per cent annually in India, three times the global rate. Besides contract manufacturing and contract research, the other main services provided in India are packaging, clinical trials, laboratory services, drug discovery and marketing services. Further, ICSE will focus on how an organisation can benefit from outsourcing to India and provide a platform & networking opportunities to an organisation for arranging
CURTAIN RAISER
it. Also featuring at the event will be the P-MEC Virtual Factory and CPhI Technology Seminars, presented by the exhibiting companies. The dynamic growth of Indian pharma industry along with the recommendations from four major Pharma associations has made the Ministry of Commerce & Industry realise the requirement for a separate export promotion council. Accordingly, Pharmaceuticals Export Promotion Council (PHARMEXCIL) has been set up and in this event , the Pharmexcil pavilion will have participation of over 50 companies. Over 125 exhibitors will form part of the China Chamber of Commerce for Import & Export of Medicines & Health Products exhibition(CCCMHPIE), a national trade association that is actively involved in trade promotion, coordination and playing an increasingly significant role in the
Reflections of CPhl 2009
pharmaceutical & health products trade. China Council for the Promotion of International Trade (CCPIT) pavilion will feature over 50 exhibitors. The council promotes foreign trade, foreign investment and introduces advanced foreign technologies in order to conduct activities of Sinoforeign economic & technological cooperation in various forms and promote the development of economic & trade
relations between China and other countries of the world. Furthermore, the CPhI India Conference Series 2010 has been developed to provide focussed information related to the most critical issues of the Indian pharma industry. Last year, the event was a big success wih 26,303 attendees from 86 countries, 2,495 of which were international visitors.
November 2010
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EVENTS CALENDAR
National MUMBAI PUNE
AHMEDABAD
INDORE
CHENNAI
Maharashtra Nov 19-22, 2010
Gujarat Dec 10-13, 2010
Madhya Pradesh Jan 7-10, 2011
Tamil Nadu Mar 11-13, 2011
Auto Cluster Exhibition Ctr, Chinchwad
Gujarat University Exhibition Hall
Maharaja Shivajirao School Grd, Chimanbaug
Chennai Trade Centre
India’s premier industrial trade fair on products and technologies related to Machine Tools, Hydraulics & Pneumactics, Process Machinery & Equipment, Automation Instrumentation, Packaging & Auxiliaries, IT Products, Electrical & Electronics, Material Handling and Safety Equipment.
For details Infomedia 18 Ltd Ruby House, 1st Floor, J K Sawant Marg, Dadar (W), Mumbai 400 028. • Tel: 022 3003 4651 • Fax: 022 3003 4499 • Email: engexpo@infomedia18.in
Concurrent Shows
Maharashtra February 17-19, 2011 Bombay Exhibition Centre
One of the largest advanced design and manufacturing events in India featuring Machine Tools, Material Handling and Safety Equipment, Automation & Instrumentation, Hydraulics & Pneumactics, Process Machinery & Equipment, Packaging & Auxiliaries, IT Products, Electrical & Electronics.
For details HiTech Manufacturing
India Pharma Summit 2010 The event will be held with CPhI and PMEC. The summit will offer a platform to address key issues, identify opportunities & challenges and chart a roadmap for India to take a rightful place, as a destination of choice for discovery research, development and manufacturing; November 30, 2010, Nehru Centre Auditorium, Mumbai For details contact: India Pharma Summit UBM India Pvt Ltd Tel: + 91 22 66122640 Fax: + 91 22 66122626 Email: indiapharmasummit@ubmindia.com Website: www.indiapharmasummit.com
P-MEC India 2010 An exhibition showcasing state-of-theart pharma machinery and equipment for pharmaceutical operations; December 01-03, 2010; at Bombay Exhibition Centre - NSE Exhibition Complex, Mumbai For details contact: CMP India (UBM India Pvt Ltd), Mumbai Tel: +91 22 66122600, Fax: +91 22 66122626 Email: deepalim@ubmindia.com Website: www.pmec-india.com
ingredients and allied industries. The event is an opportunity for the exhibitors to display their novel and innovative technologies that are useful for formulation of pharmaceutical dosage forms; December 01-03, 2010; at Bombay Exhibition Centre - NSE Exhibition Complex, Mumbai
An exhibition on the pharmaceutical
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series, and this event will highlight the key developments & growth of the plastics industry; January 20-24, 2011; at NSE Complex, Mumbai
For details contact: CMP India (UBM India Pvt Ltd), Mumbai Tel: +91 22 66122600 Fax: +91 22 66122626 Email: deepalim@ubmindia.com Website: www.cphi-india.com
For details contact: AIPMA, Mumbai Tel: +91 22 67778899, Fax:+91 22 28252295 Email: marketing@plastivision.org Website: www.plastivision.org
2nd India Lab Expo 2010
PHARMAC INDIA 2011
A scientific and laboratory instruments exhibition in India, this expo will have more than 250 exhibitors from different countries showcasing their innovative products; December 10-12, 2010; at Pragati Maidan, New Delhi
This Indian pharmaceutical industry exhibition provides a unique platform and resources to the organisations in the pharma industry with a futuristic understanding of the Indian pharmaceutical industry and market potential for their products across the world; February 12-14, 2011, Ahmedabad Education Society Ground, Ahmedabad
For details contact: Scientificdealers.com Tel: +91 11 2760 4500, Fax: +91 11 2760 4600 Email: info@indialabexpo.com Website: www.indialabexpo.com
Plastivision India 2011 CPhI India 2010
Ruby House, 1st Floor, J K Sawant Marg, Dadar (W), Mumbai 400 028. • Tel: 022 3003 4650 • Fax: 022 3003 4499 • Email: hitech@infomedia18.in
An exhibition organised by AIPMA, Plastivision India 2011 is the 8th in
November 2010
For details contact: Orbitz Exhibitions Pvt Ltd Tel: +91 22 2410 2801 Fax: +91 22 24102805 Email: amd.exb1@orbitzexhibitions.com Website: www.pharmacindia.com
EVENTS CALENDAR
International LOGIPHARMA ASIA 2010 This event will focus on pharmaceutical supply chain across Asia and bring over 200 international and domestic key players together this year; November 30 - December 02, 2010, Hilton Hotel, Singapore For details contact: WBR (Worldwide Business Research) Tel: +44 020 7368 9400 Fax: +44 020 7368 9401 Email: pives@wbr.co.uk Website: www.wbresearch.com
Arab Health Arab Health is the premier exhibition and congress in the Middle East. The event will showcase the new products, innovations and technologies to one of the fastest growing healthcare markets in the world; January 24-27, 2011, Dubai International Convention & Exhibition Centre, United Arab Emirates For details contact: IIR Middle East Tel: +971 4 407 2410 Fax: +971 4 336 4021 Email: terri.delia@iirme.com Website: www.arabhealthonline.com
ARABLAB 2011 ARABLAB is the global buying source for tomorrow’s decision reaching technology makers & end-users, as well as being a truly unique research source. Connecting people from over 75 countries, this expo showcases the very latest lab and instrumentation equipment from the world’s leading manufacturers; March 7-10, 2011, Dubai International Convention & Exhibition Centre, United Arab Emirates For details contact: The ARABLAB Group Tel: + 971 4 397 5418
Fax: + 971 4 397 5419 Email: info@arablab.com Website: www.arablab.com
BIOTECH WORLD 2011 The exhibition will show processes and devices for biotechnological productions and laboratory researches, wide range of biological preparations for pharmaceutical, food industry, agricultural sector and also biological agents, bioactive additives, test-systems, alternative energy sources, nanomolecular energy converters, specialised devices of the industrial and laboratory safety; March 21 - 24, 2011, The House of Moscow Government, Russia For details contact: JSC Expo-Biochim-Technologies Tel: +7 (495) 933-90-51 Fax: +7 (495) 933-90-54 Email: atv@biomos.ru Website: www.mosbiotechworld.ru/eng
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 Limited Tel: + 1 (980) 2198449 Email: gviniconis@arosa-group.com Website: www.charlotteconventionctr.com
CPhI China 2011 CPhl China is a platform where pharmaceutical manufacturers, biopharmaceutical companies biotechnology companies & API manufacturers can display variety of products and services. About 89 per cent of visitors are expected to attend CPhl China 2011. This is a meet which enables business partnerships, launch new products and showcase innovations; June 21-23, 2011, SNIEC, Shanghai, China
DUPHAT 2011 Dubai International Pharmaceuticals and Technologies Conference and Exhibition (DUPHAT) is an annual pharmaceutical event since its inception in 1995; March 22-24, 2011, Dubai International Exhibition Centre, UAE
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
For details contact: Index (Conferences and Exhibitions Organisation Est) Tel: +971 4 3624717 Fax: +971 4 3624718 Email: index@emirates.net.ae Website: www.duphat.ae
Bio-Europe Spring 2010
International Pharmaceutical Exhibition
For details contact: BIO (Biotechnology Industry Organization) Tel: +1 202 962 9200 Fax: +1 202 488 6301 Email: cbeckman@bio.org Website: www.bio.org/events
Bio Europe Spring 2011, a three day exhibition, is a forum to promote business development between pharmaceutical, financial and biotechnology companies in Italy; November 14-16, 2011, Milano Convention Centre, Milano, Italy
The International Pharmaceutical Exhibition will bring together the manufacturers and suppliers of process plant and equipment. This exhibition
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
November 2010
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TECHNOLOGY TRANSFER
Technology Offered this section provides a means to promote and facilitate exchange of select technologies. We strive to bring together suppliers of such technologies with suitable users for negotiations and industrial collaboration. Anti-ulceritic APIs An Indian company offers anti ulcer drugs like omeprazole, pantaprazole, omeprazole sodium, omeprazole magnesium and esomeprazole magnesium for operations in manufacturing processes. Areas of application Formulation industries Forms of transfer Consultancy
Natural preparation for anxiety relief A company offers food supplement in the form of tablets that effectively relieves mild to moderate anxiety problems. The ingredient is an herbal extract, which has been scientifically proved for its efficacy. Efficient decrease of anxiety symptoms, quick onset of action and no side effects are reported to be the advantages of this product. Moreover, this product has already been launched in American market. Areas of application Pharmaceutical industry Forms of transfer Equipment supply
Clorsulon and its intermediates An Indian company offers clorsulon, a highly potent anthelmintic drug, which is administered to de-worm the intestines of sheep and cattle. Areas of application Pharmaceutical industry
Forms of transfer Consultancy
Filter cleaning system An Indian company offers an automatic filter media cleaning equipment with drying system. It consists of air wash, water wash and drying facilities. Areas of application Filter media cleaning Forms of transfer Joint venture, equipment supply
Herbal formulation for psoriasis and eczema An Indian company offers an innovative herbal formulation that has the ability to control & cure psoriasis and eczema within one month of application of the formulation. Areas of application Herbal medicine Forms of transfer Joint venture, technical services, technology licensing
Intravenous fluids An Indian company offers the technology for the production of intravenous fluids (IV). The company has a large volume IV plant and can offer complete support for setting up a new IV plant. Investment required for the fully automatic plant is around ` 15 crore. The company can offer consultancy services/technical support to set up an IV plant on loan and license basis initially. Later, the collaborating party
can set up its own factory when it is ready for investments. Areas of application Pharmaceutical industry Forms of transfer Joint venture, technical services
Purified microfine red sanders wood powder An Indian company offers red sanders wood, which is a precious crude drug in the ayurvedic system of treatment. Pulverising by conventional technologies generates very high temperature, which in turn leads to high ash in the sanders wood powder. Red sanders powder so produced will be rich in drug and colour values. The powder will be microfine and free from ash and other impurities. Red sanders wood powder is used to apply on the face and skin to remove chicken pox marks, marks from burns, skin discolourations and pimples. It is also used to add in several drugs, processed foods, cosmetics and toiletries. The powder can be exported in large quantities as a value added item. The technology for microfine pulverising of red sanders wood was developed with the support of DSIR, under the Ministry of Science and Technology. Areas of application Ayurvedic pharmaceutical, food and cosmetics industries Forms of transfer Turnkey, others
Share Your Technology Propositions The mission of Modern Pharmaceuticals is to spread the technology culture. We offer you an opportunity to participate in this endeavour by publishing the best technology ideas. Technology developers/sellers are invited to furnish the techno-commercial details (with environmental benefits, if any) for publication in the Technology Transfer column of Modern Pharmaceuticals. R&D organisations, technical consultancy organisations and individuals assisting small and medium enterprises may send the relevant literature, indicating the scope & services and the areas of specification. Contact: Modern Pharmaceuticals Infomedia 18 Ltd, ‘A’ Wing, Ruby House, J K Sawant Marg, Dadar (W), Mumbai 400 028. Tel: 022-3003 4669/4671 Fax: 022-3003 4499 Email: spedit@infomedia18.in
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November 2010
TECHNOLOGY TRANSFER
Technology Requested Biotechnology for wastewater treatment system A Thailand-based company, a wastewater service provider, is involved in the research and development of new technology for water, wastewater and waste treatment. It requires new ideas related to technology for developing its strength in the field of wastewater; which includes cleaning canals, removing sediments from waterways, biogas, microbiology detector and treated system quality. Areas of application Biotechnology, engineering, new technology Forms of transfer Consultancy
Areas of application Cell culturing - molecular biology Forms of transfer Material supply
Extract of medicinal and aromatic plants An Indian company is interested in putting up a multi-purpose herbal extraction plant for the extraction of medicinal and aromatic plants and herbs like artemisinin/quinine sulphate and other alkaloids. Areas of application Pharmaceutical industry Forms of transfer Others
Glove automation equipment Calcium gluconate An Indian company requires the technology to manufacture calcium gluconate. Areas of application Pharmaceutical industry Forms of transfer Technical services, project reports, others
An Indian company requires technology to produce glove by automation process. Areas of application Manufacturing industries, especially rubber industry and latex industry Forms of transfer Consultancy
Cell lines
Kite grading engineering technology
A Thailand-based, ANH Scientific Marketing Co Ltd has been working in the field of life sciences in the country for more than 20 years. In order to complete the company’s product lines and service customers/researchers/ scientists from the beginning to the end of the process, it would like a company to provide commercial cell lines of human and animals.
A Fiji-based company offers the technology of kite grading, which is a subservient of genetic therapy research particularly for the cardiovascular novice. It seeks assistance from a potential partner to provide equipment and technical support staff. Areas of application Medical research Forms of transfer Joint venture, partnership
Medical products An Indian company wants to manufacture intravenous fluids, saline, dextrose and related products used in the medical field. The company is involved in non-medical activities at present. The only medical involvement is its general practice in the UK. It plans to commence a nursing home project in Sri Lanka and would be interested in a joint venture with a suitable partner for its saline project. The project has been approved for tax concessions and its partner is expected to contribute in machinery production and know-how. Areas of application Medical and surgical Forms of transfer Others
Methyl cobalmine An Indian company requires technology for production of methyl cobalamine, which is an important basic drug. Areas of application To be used in pharmaceutical industries Forms of transfer Others
Pharma grade mannitol An Indian company requires the know-how for manufacturing pharma grade mannitol. The estimated production capacity is 600 tonne per annum Areas of application Pharmaceuticals Forms of transfer Others
Information courtesy: Dr Krishnan S Raghavan, In-Charge, Technology Transfer Services Group, United Nations - Asian and Pacific Centre for Transfer of Technology (APCTT), APCTT Building , C-2, Qutab Institutional Area, New Delhi 110 016 Tel: 011 - 2696 6509, Fax: 011 - 2685 6274, Email: krishnan@apctt.org, Website: www.apctt.org
For more information on technology offers and requests, please log on to www.technology4sme.net and register with your contact details. This is a free of cost platform provided by APCTT for facilitating interaction between buyers and seekers of technologies across the globe. After submitting technology offer or request to this website, you are requested to wait for at least two weeks for receiving a response from a prospective buyer / seeker through this website, before contacting APCTT for further assistance.
November 2010
Modern Pharmaceuticals 103
BOOK SHELF
Oral Controlled Release Formulation Design and Drug Delivery: Theory to Practice Editors Price
: Hong Wen, Kinam Park : ` 5346
Considering the fact that the usages of drugs employing oral controlled release formulations continue to grow, the pharmaceutical sector must adapt itself to the novel developments in order to select the most scalable & stable technology for achieving the desired pharmacokinetic profiles. Thus, the book “Oral Controlled Release Formulation Design and Drug Delivery: Theory to Practice” deals with almost every attribute of oral controlled release formulations. Divided into several chapters, written by some of the leading experts in the field, the book covers aspects of oral controlled release formulations, including preformulation, controlled released mechanisms, biopharmaceutics. Further, some of the other chapters deal with concepts like In Vitro-In Vivo Correlations (IVIVC), Quality by Design (QbD), and regulatory affairs. The concepts in the book are made all the more clear & comprehensive with additional details through a mixture of tables, figures and several other references. The book also discusses how oral formulations can be made based on physico-chemical & biopharmaceutical properties of a drug and why the oral controlled release formulations are the subjects of concern for both Research and Development (R&D) and commercial delivery products. The book can be a good companion for a student as well as a medical practitioner because it will assist them to know about the progressive drug delivery field, which will help them to enhance their knowledge about the medicinal benefits. It can further be a guide to the scientists and researchers as it offers the theoretical and applied practical information regarding the development of oral controlled release formulations.
Focussing on the various advancements in biotechnology that have provided scientists and researchers with an increasing number of biopharmaceuticals such as new protein drugs and peptide along with the nucleic acid based drugs for gene therapy, the book “Delivery Technologies for Biopharmaceuticals: Peptides, Proteins, Nucleic Acids and Vaccines” elaborates on the ways and methods to break through the obstacles that usually tend to bar the successful delivery of therapeutic proteins, peptides and nucleic acid-based vaccines or drugs related to the site of administration & the target site. Divided into 21 chapters, the book discusses several novel formulation approaches for peptide and protein injectables, non-viral chemical vectors and viral technology for delivery of nucleic acid based drugs, challenges in delivery of biopharmaceuticals. It also illustrates immune response, adjuvant and delivery system for vaccines. Besides, the book consists various examples of delivery systems for different biopharmaceuticals. It offers a comprehensive and critical assessment of delivery technologies for biopharmaceuticals. The book can cater to the needs of the scientists and researchers so that there is an efficient delivery of the new class of drugs. It can also help the students in subjects like drug delivery, formulation, medicinal chemistry, biopharmaceuticals and other new materials development.
Delivery Technologies for Biopharmaceuticals: Peptides, Proteins, Nucleic Acids and Vaccines Editors : Lene Jorgensen, Hanne Morck Nielsen Price : ` 8505
Detech Media, 22’ Rajmahal, 4th Floor, Sir M V Road, Opp.Telly Gully Park, Andheri (East), Mumbai 400 069 Tel: 022-6575 4649/98336 73979 • Telefax: 022-2265 4657 • E-mail: detechmedia@vsnl.net
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PRODUCT UPDATE
Gravity feed metal detector
Coating pans
Target Innovations offers gravity metal detector, which is designed to detect metal contamination in dry, powdery or granular free-flowing products that can be gravity fed through a pipe. It is provided with rotary activated valve, inspection tube, metal detector search head and air controls. It can be ceiling suspended or mounted on a mobile floor stand. The control unit can be mounted either to the system frame or remotely in the plant. Both the reject chute and frame are of stainless steel. The inspection chute going through the metal detector is made from polypropylene, nylon, teflon or plastic depending on the application. The metal free product passed straight through the mechanism and diverts the ferrous, non-ferrous and stainless steel contamination from the main flow. The system is available in aluminum or stainless steel casing. The diverter valve reject system is typically used to divert contaminated product into a reject tank. Its features include high sensitivity, automatic rejection of contaminated product, compact design, straight through flow design, does not have crevices or traps, fast acting electronics, comprehensive self diagnostic system, automatic noise compensation and reject confirmation. This detector is used in pharmaceuticals, bulk drugs, chemical & dyes, food ingredients, etc.
Allegro Pharmachem Equipment offers coating pans, which are totally enclosed with SS cladding and are available with standard gear box, motor and hot air blowing arrangement. These coating pans are provided with interlocked electrical circuit so that the heaters can be operated only after the blowers are switched on to avoid burning of the heaters. The coating pan is manufactured from SS-304 ‘AISI’ 2B prime material quality with adequate mouth opening and depth. The coating machine is also provided with the control panel, which comes with indicating lamps, coating pan main on-off switch, blower on-off switch, thermostat, heater switch, etc. The entire panel can be mounted on the stand. The machine is designed as per GMP standards, with all arrangements inside the enclosure, except electric control panel and SS pan.
Target Innovations - Navi Mumbai - Maharashtra Tel: 022-2779 0077; Fax : 022-2779 1313 Email: targetmumbai@gmail.com
Capsule filling machine
Allegro Pharmachem Equipment - Thane - Maharashtra Tel: 022-4014 6872-73, Fax: 022-4014 6874 Email: allegro@allegroindia.com
Allgaier Werke offers tumbler and vibration screening machines, designed according to GMP and FDA-regulations for applications in pharmacy, food and fine chemicals. These specialised machines are used for the treatment of valuable powders, pellets and granules. The hygienic design includes solutions for WIP-cleaning devices and ATEX certification. The tumbler screening machines are high-performance screening machines for fractionating, protective screening and de-dusting. The three-dimensional tumbling movement creates exceptional fine cuts for the bulk solids. The modular design allows the production of additional fractions through additional screening desks in one machine. For simple applications, the company offers type VTS or Vibrall vibration screening machines.
Anchor Mark offers automatic capsule filling machine (encapsulation equipment). Its features include compact, sturdy, covered with stainless steel panels, hood covered with acrylic guard, etc. The fill weight adjustment takes place within seconds. It is provided with tamping mechanism’ for powder filling, which enables capsules to be filled with a weight variation with ± 2 per cent. The variable AC frequency drive for main motor ensures speed adjustment. The faulty capsule and filled capsule ejection stations come with individual air controls. It is simple to operate and easy to maintain and has special purpose gauges for quick and easy changeover. The company also offers powder processing, granulation and coating equipment, whose design and finish confirms to cGMP standards. It comes with special air-purged shaft seals which keep powder away from mechanical drives and prevent product contamination.
Allgaier Werke GmbH - Uhigen - Germany Tel: +49-7161-301353; Fax: +49-7161-34268 Email: siebtechnik@allgaier.de
Anchor Mark Pvt Ltd - Mumbai - Maharashtra Tel: 022-2868 2001, Fax: 022-2868 2250 Email: sales@anchormark.com
Screening machines
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Analyser TTL Technologies offers ‘DIPA 2000’ particle size and shape analyser from Donner Technologies. It combines two complementary measurement techniques by integrating laser and video channels. It provides complete sample information on particle size distribution and numerous particle shape parameters with the help of high analytical resolution (analysing each sampled particle individually) and real-time sample visualisation. The analyser has a wide measurement range of 0.1-5,000 microns. It comes bundled with the software for comprehensive data analysis and report generation. The instruments can be fitted with a variety of modular measurement cells, which can be manually interchanged to allow for particle analysis in liquids, emulsions, creams, dry powders, fibres, heated liquids, aerosols and more, with minimal (or no) sample intervention and original state analysis. Analytical data can be displayed in a wide variety of tables and graphs. TTL Technologies Pvt Ltd - Bengaluru - Karnataka Tel: 080-2525 1859, Fax: 080-2529 1285 Email: analyticaldirect@ttlindia.com
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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
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Vibratory finishing systems Niraj Optical Machinery offers vibratory finishing systems, which incorporate a rubber or polyurethane lined bowl of ‘U’ cross section mounted on accurately calculated springs. These systems are driven by a highly efficient vibratory motor. The open top of the bowl can be loaded with suitable ceramic/ plastic or steel media and parts to be processed. Vibratory finishers shake parts and media at high speeds, causing the media to scrub the surface of the parts in an action similar to lapping. Since the parts and the media are moving at small increments on each stroke, the parts are not subject to severe stress or damage. Vibratory finishers produce very smooth surfaces, are safe for delicate or heavy (metallic/non-metallic) parts, and have good action inside recesses & holes. Vibratory finishing is preferred for general deburring, finishing, pre-plate finish, etc of delicate or heavy parts and for precision deburring/finishing. Vibratory finishing is also safer for threaded parts. Niraj Optical Machinery - Ahmedabad - Gujarat Tel: 079-2929 5747, Fax: 079-2583 3659 Mob: 9825554860, 9909904148 Email: badrakia@rediffmail.com
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Sieves Atlanto Enterprises offers silicon moulded sifter sieves, Fluid Bed Dryer (FBD) sieves and FBE dryer sieves. The silicon moulded sifter sieves are available in various sizes from 12� to 48� diameter. The silicon, which is of food grade quality, transparent in appearance, non-toxic is moulded on the stainless steel ring. These are available in rivetted and special non-rivetted design, the mesh sizes varies from 4 mesh to 500 mesh with ASTM & BSS Standard. The fluid bed dryer sieves are available in various sizes, from 30 kg to 200 kg. The FBE dryer sieves are available in various sizes from 125 ltr to 800 ltr. The sieves used are dutch woven screen, hollander screen, the most common sieve used is 30 * 150 mesh. All these are available with complete set of certificates. Atlanto Enterprises - Mumbai - Maharashtra Tel: 022-2309 6098, Fax: 022-2307 3537 Email: atlantoent@yahoo.co.in
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Modern Pharmaceuticals
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Modern Pharmaceuticals
November 2010