Modern Pharma - 16-31 October 2012 by Infomedia18

16-31 Oct ober 2012 I Vol 1 I N o 8 I `100

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In Conversation With 10

Special Focus 11

Interface 12

Policies & Regulations 14

Pulin Shroff Managing Director, Charak Pharma

Drug delivery systems Analysing the present, predicting the future

Ketan R Patel Chairman & MD, Troikaa Pharmaceuticals Ltd

Low-cost generics Bridge to reduce India’s disease burden

Intas Pharma seeks Gujarat HC sanction for merger of four group companies

Ahmedabad-based Intas group has sought sanction of the Gujarat High Court for amalgamation of four group companies. The four companies include Intas Pharmaceuticals Ltd, Astorn Reserch Ltd, Intas Biopharmaceuticals Ltd and Celestail Biologicals Ltd.

Bharat Biotech wins patent award from Pharmexcil

Bharat Biotech, a multidimensional innovation-oriented biotechnology company has received Silver Patent Award for the year 2011-12 from The Pharmaceuticals Export Promotion Council of India (Pharmexil) in recognition of commendable contribution in biotech products and research. Dr Krishna Ella, CMD, Bharat Biotech, said, “We thank Phamexcil for recognising innovation at Bharat Biotech and the credit goes to the Bharat Biotech Team, who have worked relentlessly to make this happen.”

Sun Pharma gets nod to raise up to ` 8,000 crore

Drug firm Sun Pharmaceutical Industries said its board of directors has approved the proposal to raise up to ` 8,000 crore. According to the company, the proposal would be put for shareholders’ approval during the annual general meeting scheduled on November 8.

Optimer introduces strategic initiative to further facilitate patient access to Dificid®

Optimer Pharmaceuticals, Inc recently announced the implementation of an initiative designed to accelerate and expand patient access to Dificid® (fidaxomicin) tablets. Separately, and consistent with its goal of improving awareness and understanding of the disease, Optimer is also announcing a new project analysing the burden of Clostridium Difficile Infection (CDI).

Aurobindo Pharma receives USFDA approval for Modafinil tablets

Aurobindo Pharma Ltd has received approval from the USFDA to manufacture and market Modafinil tablets USP 100mg and 200mg. The product is ready for launch. Modafinil tablets are the generic equivalent of Cephalon, Inc’s Provigil® tablets. Modafinil tablets are for treatment of narcolepsy, shift work sleep disorders and excessive daytime sleepiness associated with obstructive sleep.

Takeda and Advinus initiate

multi-year drug discovery collaboration Takeda Pharmaceutical Co Ltd and Advinus Therapeutics Ltd jointly announced that they have entered into an agreement to initiate a 3-year discovery collaboration focussed on novel targets for major therapeutic areas including inflammation, CNS and metabolic diseases. In this collaboration, Advinus is responsible for leading the programmes to create optimal Investigational New Drugs (IND)-ready compounds for pre-defined targets. Under the terms of the agreement, Takeda will receive worldwide commercial rights to drug candidates emerging from this alliance. Advinus will receive guaranteed research

funding of $ 36 million over the term of the collaboration, $ 9 million in milestones leading to candidate selection, and is eligible to receive future clinical and regulatory milestone payments of up to $ 45 million per product, plus royalties on product sales worldwide. “Collaboration with Advinus is one of our initiatives to enhance our research productivity,” said Dr Paul Chapman, GM - Pharmaceutical Research Division, Takeda. “We are excited to partner with Advinus as

they have innovative approaches to efficiently generate INDs that will further strengthen Takeda’s drug discovery capabilities, while also enhancing our pipeline.”

Biocon featured in the global Top 20 BioPharma employers Biocon Ltd recently companies. This announced that it has company has received global recognition been ranked from the ‘Science’ magazine on six key that features Biocon in its parameters such annual global ‘Top Twenty as innovative Employer’ list for the bio leader in the pharma sector. According industry, treat to the 2012 Top Biotech and Mazumdar-Shaw employees Pharma Employers survey, with respect, Biocon has been ranked at number are socially responsible, has loyal 19. Biocon is the only Asian Company employees, does important quality to be a part of the top 20 elite list research, makes changes needed. This that includes leading global innovator global ranking reflects the growing

power of brand Biocon, which is ably supported by its valuable partners, customers, employees and all other stake holders. Kiran MazumdarShaw, Chairman & Managing Director, Biocon, said, “This is a great recognition for us as a company and a proud recognition for India as we are the only Asian biopharma company to feature in the top 20 list. We will wear this badge of honour with a sense of leadership and responsibility that will enable us to take greater strides to move up the leader board. ”

BT boots R&D cloud services with Aspera’s high-speed transfer technology BT recently announced it is working together with Aspera, Inc, a creator of next-generation data transport technologies that move the world’s data at maximum speed, to integrate their innovative file transfer technology into BT for life sciences R&D, the first cloud service designed to enable collaboration within the life sciences industry for increased R&D productivity. Life sciences companies need to optimise, manage, transfer, store and protect the vast quantity of data that is being created. To optimise the constant movement of that data, BT for life sciences R&D connect builds on BT’s global network and will now leverage Aspera’s unique fasp™ high-speed transfer technology, providing secure, predictable

Burger

and scalable transfers regardless of the size of data, the distance between the endpoints and network conditions. Aspera’s patented fasp™

protocol eliminates the fundamental bottlenecks of conventional file transfer technologies. It provides highspeed, reliable end-to-end transport over public and private networks fully utilising available bandwidth, independent of network delays. Bas Burger, President Global Commerce, BT, said, “While billions of dollars of revenue are under threat through loss of patent exclusivity and as the number of new drugs entering clinical trials is dropping, new opportunities are emerging for companies able to access the most compelling, meaningful and insightful scientific data. Scientists will be delighted by the combination of Aspera’s technology with the breadth and depth of the BT connect portfolio of intelligent network solutions.”

M o d e r n Pharma•16-31 Oc t obe r 2012

CONTENTS In Conversation With

Pulin Shroff Managing Director, Charak Pharma

Special Focus NDDS Drug delivery systems Analysing the present, predicting the future

Interface

Facility Visit

Ketan R Patel CMD, Troikaa Pharmaceuticals Ltd

Panacea Biotec Pushing the limits for innovative solutions

Insight & Outlook Policies & Regulations Low-cost generics: Bridge to reduce India’s disease burden Aman Gupta, Principal Advisor, India Health Progress

Strategy Emerging opportunities for pharma: Widening the market Dr Rajan T D, Pharma Consultant & Practising Dermatologist

Interface

Leena Menghaney India Manager - MSF Campaign for Access to Essential Medicines

Roundtable

Is industry funding intended to influence prescribing behaviour among physicians?

Event Preview

International workshop on patient safety and drug detection technology Focussing on identifying the loopholes BIO India International Conference 2012 Emphasising on collaboration and investment for the biotech industry Best Practices in Hospital Logistics, Inventory & Store Management Making a material difference to patient care Gp Capt (Dr) Sanjeev Sood, Hospital Administrator and NABH Assessor 2nd Pharma Supply Chain Forum The success barometer swings again

REGULAR SECTIONS 5 6 18 19 21 26 27 29 30

Editorial / Guest Editorial News, Views & Analysis Technology Transfer Tenders / Projects Event List Book Review Products Marketplace List of Products & Advertisers

Highlights of Next Edition Special Focus: Pharma manufacturing Note: ` stands for Indian rupee, $ stands for US dollar and £ stands for UK pound, unless mentioned otherwise

PRESIDENT & EDITORIAL DIRECTOR, TV 18 Senthil Chengalvarayan SENIOR EDITOR Manas R Bastia FEATURES EDITOR Arshia Khan

India Lab Expo 2012 Providing an ‘exchange’ platform for the pharma industry

Event Report

FOUNDER & EDITOR, NETWORK 18 Raghav Bahl

EDITORIAL TEAM Chandreyee Bhaumik, Parita Dholakia, Shibani Shah, Avinash Pandey Nikunj Sharma (Delhi) Jasleen Kaur Batra (Bengaluru) ASSISTANT ART DIRECTOR Varuna Naik DESIGN Varghees Tharakan

23 24 25

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Mo de rn Ph a rm a •16 -31 Oct o be r 2 012

Editorial

New Pricing Policy: A fine balance achieved?

Editorial Advisory Board Ajit Singh

Chairman, ACG Worldwide & Head, ISPE

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

Dr Gopakumar G Nair IPR Consultant & Advisor

Dilip G Shah

Chairman, IGPA & Secretary General, IPA

Daara Patel

Secretary General, IDMA

he Supreme Court’s intervention seems to have worked in getting the new pharma pricing policy for the country out of hibernation! Lying in limbo for several years, the Group of Ministers entrusted with this crucial task has finally (hopefully) arrived at some conclusions on the policy and is reportedly in the process of submitting the proposal soon to the cabinet for approval. Before diving deeper, let’s take a cursory look at the key points. The new guidelines aim at controlling the prices of essential pharmaceuticals by using the Weighted Average Price (WAP) of all brands having a market share in excess of one per cent. There is a sharp difference here vis-à-vis the earlier proposal (draft National Pharmaceuticals Pricing Policy 2011), which proposed the use of WAP for only the top three brands in the respective pharmaceutical segment. The other contrasting feature in the new pricing policy is that it will only cover the list of 348 essential medicines (or 654 derived formulations) as against the earlier proposal, which proposed to bring under price control the combination therapies along with formulations with non-specified strengths/dosages. Thus, it can be inferred that averaging out the pharma prices over a larger number of brands is likely to bring down the prices more than expected. Now, let’s analyse its difference in impact on the ` 60, 000-crore plus domestic formulations industry. According to the latest report from ICRA Ltd based on industry estimates, while the earlier proposal

Guest Editorial

would have impacted nearly three-quarter of this industry, the new proposal’s effect would be limited to about 30 per cent of the industry. However, a formula based on market-linked pricing mechanism compared to the earlier cost-linked mechanism should be a positive step forward for the Indian pharmaceutical industry. Then, the big question is how it will shape the business strategies of pharma companies for the domestic market. Considering a long time frame, the report points towards a surge in focus on combination drugs, in-licensing initiatives, co-marketing/ alliances with MNCs and other measures such as enhanced thrust on OTCs, vaccines, institutional segment and even biosimilars. On a company-specific basis, the impact of the proposed pricing policy is likely to vary, depending upon numerous factors. Some of these would be the company’s turnover from the domestic market, its product portfolio and pricing strategy employed, among others. While it is a bit early to accurately predict the exact impact of this proposed policy on the consumers as well as producers, the success of this policy will be based on the fine balance it manages to strike between both the key stakeholders.

Manas R Bastia manas@network18publishing.com

India emerging as a key player

ne of the fastest growing economies in the world is India, and if everything goes well it will account for 10 per cent of the growth in the global GDP by 2020. While the world has recognised India as a low-cost manufacturing location and a source of skilled manpower and no global company can afford to overlook and exclude India from their growth aspirations, unfortunately it is our own people who feel shy to accept this fact. If our people and our own government come forward with a friendly hand, India can emerge as a key player in the global business arena, for the pharma sector in particular. The credit goes to entrepreneurs and scientists engaged in the development of new molecules and its cost-effective production that has helped India emerge as a prominent global player for the manufacturing of Active Pharmaceutical Ingredient (API), intermediate etc. Availability and access to reasonably priced and quality drugs by the entire population are the basic objectives of national policies. The Indian pharma industry is not only able to meet the national demands but also caters to the needs of a large number of countries. In order to maintain the trend, the synergy between R&D, scientists, industry,

public sector, research institutions and policy maker is crucial. Although there are many efforts for formulating a long-term policy and strategy for strengthening of drugs sector in the country, there are lot other efforts required at the end of government for promoting indigenous production of API. Measures to reduce the cost of production, measures to encourage the indigenous production of critical drugs, technological support to the industry, incentives, special zones for API industry, are underway. Further, efforts to reduce heavy dependence on imports especially from China is a crucial issue that needs special attention of the government because fermentationbased products are crucial segment for all of us and we are neither able to upgrade our technologies nor able to provide uninterrupted power supply, which plays a vital role. Our total dependability on China may bring the pharma industry in a paralysed situation at one point of time. Therefore, special efforts are needed to ensure that such products are produced within our own country; if not fully, at least partly to begin with and for this the government has to earmark special power centres to reduce heavy dependence on China. Government of India needs to more proactively

nurture this sector by addressing the missing links and strengthening the policy environment to encourage the industry to find its rightful place as soon as possible. There can be suggestions such as special fiscal benefits, dedicated zones, R&D incentives for new route of synthesis, better yield, green chemistry, etc, revival of PSU units against PPP mode, improve the availability of cell lines and strains, special purpose vehicles funding through banks, cluster where world class QC lab are there, working capital norms to be flexible, priority allocation of coal, bio fuel natural gas, cheaper land availability to pharma industry, soft loan, no collateral security, less rate of interest, low moratorium, constitution of a committee of the various government departments to help the industry through single window. B R Sikri

V P (North Zone), Bulk Drug Manufacturers’ Association V P (North Zone), Indian Drug Manufacturers’ Association Co-Chairman, Federation of Pharma Entrepreneurs’ Chief Advisor, Himachal Drugs Manufacturers Association

Mo d er n P har ma•16 -31 Oc t ob er 2 012

News, Views & Analysis

Discussion on clinical research held in Mumbai The Indian Society for Clinical Research (ISCR) and Quintiles recently organised an interactive session on clinical research in Mumbai. Speakers included Dr Arun Bhatt, Executive Committee Member, ISCR’ Suneela Thatte, Executive Director, Customer Operations, Quintiles India; Dr C S Pramesh, Associate Professor and Head of Thoracic Surgery, Tata Memorial Hospital; and Dr Vyankatesh Shivane, Consultant Diabetologist, Metabolic Physician and Joint Director, Research Health Institute in Diabetes Endocrinology and Metabolism. Dr Bhatt began the session with an overview of the drug development process and explained only those medicines that are safe and effective after tests in the laboratory reach the stage of clinical testing. There are strict guidelines and regulations in place for the conduct of clinical trials in India, said Thatte. Both national as well as international guidelines govern clinical trials in the

country she added. She said that patient safety, ethics and quality are at the core of any clinical trial and it is important to protect the rights and well being of and maintain the confidentiality of patients in a clinical trial. Dr Pramesh said that the process of patient selection in a clinical trial involves a high degree of scrutiny and an extensive inclusion and deletion process of patients across all socio economic strata. He highlighted that by 2020, 70 per cent of the global cancer burden would be in developing countries and cancers such as head & neck and cervical cancer are more prevalent in India and therefore it was imperative for clinical research in these therapeutic areas to be done in India. Dr Shivane explained about the informed consent process, challenges and complexities of recruiting a patient in a clinical trial. He said that the informed consent process that involves the investigator, the patient and their family is conducted in the patient’s local language. This

is supplemented with written material pre-approved by the ethics committee which the patient can take home. In case of a patient who is illiterate, the contents of the informed consent form are explained orally in the presence of a literate witness, he added. The literate witness then co-signs the patient consent form confirming that the details communicated orally to the patient were in line with what is written in the form. Dr Shivane further clarified that all patients in a clinical trial are free to drop out of the trial at any stage without giving any justification or reason. Death of a patient in a clinical trial could occur due to a variety of reasons. The event concluded with the spokespersons appealing to the media to partner with the industry in creating greater awareness and education among the lay public about what happens during a clinical trial and the need for clinical research in a country like India.

In Brief Pharma GoM finalises pricing policy, to cover 348 drugs

A ministers panel, headed by Sharad Pawar, Agriculture Minister, recently finalised the pharma pricing policy under which 348 essential drugs will come under price control of the government. The Group of Ministers (GoM) will be sending their recommendations to the cabinet within a week for approval to bring drugs in National List of Essential Medicines (NLEM), that have a total sales of around Rs 29,000 crore, which is about 60 per cent of the domestic market, under control. At present, the government through the National Pharmaceutical Pricing Authority (NPPA), controls prices of 74 bulk drugs and their formulations.

Asia’s largest cleaning trade show is back in the IT hub, Bengaluru

The much bigger and wider Clean India Show is back in Bengaluru this year with newer technologies and cleaning solutions for industries, institutions, municipal corporations, hospitals, hotels and retail segments. Supported by the Karnataka Urban Development Ministry and the Central Pollution Control Board, the three-day show commencing from December 13 at the KTPO Exhibition Complex will showcase solutions for commercial cleaning, industrial cleaning, city cleaning, waste management, etc.

Sri Lanka invites Pakistani pharma investors for JVs

Sri Lanka has invited Pakistani pharma investors to explore possibilities of establishing JVs in the pharma industry in the country. A Sri Lankan business official visiting the Islamabad Chamber of Commerce recently has expressed Sri Lanka’s plans to set up an industrial zone in the country to manufacture pharmaceuticals. Sri Lanka is planning to set up an industrial park for pharma industry and Pakistani pharma investors should explore possibilities of establishing JVs in that facility in Sri Lanka.

Sanofi India launches specially designed re-usable insulin pen AllStar Sanofi India has launched AllStar, its indigenously manufactured reusable insulin pen in India. Developed especially for Indian patients by Sanofi’s Medical Device Development Team at Frankfurt, AllStar is indicated for use of insulinised patients using Sanofi’s insulin portfolio. The AllStar re-usable insulin pen conforms to ISO standards and is equipped with stateof-the-art, unparalleled 10-in-1 features. The company has fixed the price at ` 650 in India and it will be

manufactured in Gujarat. The company is launching AllStar in emerging markets also after regulatory approvals. Announcing the launch of AllStar, Dr Shailesh Ayyangar, MD, Sanofi India & VP-South Asia, Group Sanofi, said, “Sanofi has always been at the forefront of diabetes research and development and AllStar is a testament to our patientcentric approach. For almost three years, Sanofi’s scientists worked closely with our team here to develop a device that was ‘Made in India,’ for

India. AllStar heralds a new era of indigenous device manufacturing for Sanofi India, which we hope to utilise for other devices in future.” “The launch of AllStar is a significant milestone in Sanofi India’s diabetes growth story, and also underlines the Sanofi Group’s focus on diabetes, emerging markets and our regionalised approach to finding solutions that are adapted to local needs,” Ayyangar added. Dr Volker Korger, Head – Diabetes Device Project, (MED Frankfurt), Sanofi, shared

that, “AllStar is a combination of sleek design styling and sophisticated technology. We brought together Sanofi’s award winning Solostar design team in Germany and UK to make AllStar, the lightest reusable insulin pen in India. The German team contributed its devices, and from Taiwan we included accurate tooling, as in a device such as this, extraordinary accuracy is most vital in even the smallest of components. Finally, the manufacturing is being done in India – we recognised today

for producing high-precision components.” Sanofi India is having 12.5 per cent market share in human insulin and 8 per cent in oral insulin in India. The company is growing at a rate of 19.5 per cent CAGR during the last five years. AllStar pen will help improve both insulin initiation and compliance; and bring ease and reassurance to the lives of Indian patients, giving them the convenience of international standards at an affordable price.

Ranbaxy launches authorised generic of Quintiles, Dabl team to advance Evoxac in the US healthcare market cardiovascular safety assessment Ranbaxy Pharmaceuticals Inc, a wholly owned subsidiary of Ranbaxy Laboratories Ltd (Ranbaxy), has launched the authorised generic cevimeline hydrochloride 30 mg capsules in the US market, under an agreement with Daiichi Sankyo, Inc. Cevimeline hydrochloride is Sawhney indicated for the treatment of symptoms of dry mouth associated with Sjogren’s syndrome, an autoimmune disorder affecting the moistureproducing glands, and is presently

distributed by Daiichi Sankyo, Inc under the brand name Evoxac®. Evoxac® generated total annualised sales of $ 62.4 million in the US. Bill Winter, Vice President, Trade Sales and Distribution, North America, Ranbaxy said, “Ranbaxy is pleased to announce the launch of cevimeline hydrochloride in 30 mg capsules, as the authorised generic of Evoxac® in the US. This launch further underscores Ranbaxy’s resolve to bring high quality, affordable

generic medicines to the US healthcare system to meet the growing needs of patients and prescribers.” Regarding the launch, Arun Sawhney, CEO and Managing Director of Ranbaxy, added, “We welcome the opportunity to launch cevimeline hydrochloride in the US market. This authorised generic form of Evoxac is an excellent example of optimising operational synergies that exists between Ranbaxy and Daiichi Sankyo, while accelerating our global business efforts. We see a continuing opportunity to leverage our combined strengths of innovation and the manufacture and marketing of affordable, high quality, generic medicines through this collaboration.”

Dabl Ltd, a provider of centralised Ambulatory Blood Pressure Measurement (ABPM) services, and Quintiles, the world’s leading global biopharmaceutical services company, announced a strategic alliance that significantly enhances Quintiles’ suite of offerings in cardiovascular safety assessment. Through the alliance, Quintiles’ customers worldwide will have access to Dabl’s Dr Desai round-the-clock ABPM services to enhance the safety and efficacy of global clinical trials across the entire trial lifecycle. “Dabl’s

scientific leadership and data management techniques are setting new industry standards and complement Quintiles’ pioneering cardiac safety solutions. Together we can improve understanding of drug-induced blood pressure responses and help our customers improve trial participant safety, manage risk, and improve efficiency – all vital to meet the challenges of the new health,” said Dr Deepa Desai, Executive Director, Cardiac Safety Services, Quintiles.

Mo de rn Ph a rm a •16 -31 Oct o be r 2 012

News, Views & Analysis

Indegene named a leader in IDC MarketScape Indegene Inc has been named as a leader in the IDC MarketScape: Worldwide Pharmaceutical Social Media Analytics 2012 Vendor Assessment. This recognition comes as a validation of Indegene’s superior healthcare stakeholder engagement solutions that have helped its clients better understand stake holder sentiments and make informed decisions about their brand positioning and commercialisation. Pharmaceutical companies are increasingly looking at social media analytics as a fast growing medium to assess and better understand market dynamics and sentiments of their key stakeholders. Indegene’s social media analytics solutions cater to a wide range of pharma business needs from understanding

Gupta

stakeholder sentiments to media monitoring, competitor profiling, conference coverage, social media presence, stakeholder analytics, blog analytics and ROI research. Rajesh Nair, President, Indegene, said, “Indegene’s social analytics services have helped clients improve engagement

Prof Anant P Hardas receives national and international awards Prof Anant P Hardas, Director, Indian Pharma Guidance Academy has recently received both national and international honours on the eve of Teachers Day of 2012. Prof Hardas has received national awards and nomination from Global Society for Health & Educational Growth , New Delhi , Bharat Shiksha Ratan Award; from India International Friendship Society –New-Delhi – Bharat Jyoti Award and Rashtriya Gaurav

Award; from International Publishing House, New Delhi - Best Citizen of India Award. At international level, his nomination has been accepted by American Biographical Institute, USA – International Dictionary of Professional & Professional Hall of Fame; by International Biographical Centre, Great Britain – Top 100 Educators of 2012 & 2000 Outstanding Intellectuals of the 21st Century, 2012; and Who’sWho in Science & Engg, 11th edition -2011 - 2012 by the Marques Who’sWho Publication Board, USA.

between providers, patients and other stakeholders using proprietary webbased platforms. Our social media solutions are focussed on helping clients grow their brands more effectively and equipping them with real-time intelligence about the market place and stakeholders to make better decisions.” According to Manish Gupta, CEO, Indegene, the market is evolving such that “Custom virtual environments and collaboration platforms improve patient outcomes and promote healthcare education in addition to facilitating collaboration between healthcare stakeholders. Our deep clinical, scientific, creative and regulatory knowledge also ensures these programmes meet all regulatory requirements.”

Dr Reddy’s CPS business expands its manufacturing operations in Mirfield, UK The Custom Pharmaceutical Services a very high level of control and (CPS) business of Dr Reddy’s has been designed with the Laboratories Ltd recently announced latest manufacturing compliance expansion in the areas of activated standards in mind. Commenting mPEG manufacturing and in the on the development, Dr development and manufacture R Ananthanarayanan, Presidentof New Chemical Entities (NCE) Pharmaceutical Services and APIs for use in pre-clinical through Active Ingredients business, Dr to commercial development at its Reddy’s, said, “This expansion builds on our manufacturing facility commitment to in Mirfield, UK. expand operations The expansion in UK and puts Dr Reddy’s provide a superior at the forefront of network of cGMP activated mPEG manufacturing to manufacturing support our global and will enable customer base. manufacture of its PEGylation is one PEGtechTM range Dr Ananthanarayanan area where we felt at commercial metric tonne scale quantities the need for expanding our and beyond in a fully cGMP capabilities. We have invested in multiple technology areas and environment. Equipped with state-of- the expansion will add significant the-art DCS computer control value in the areas of mPEGs and systems, the plant operates with cGMP API manufacturing”.

Mo d er n P har ma•16 -31 Oc t ob er 2 012

News, Views & Analysis

Millions of children in Pakistan to be protected against pneumococcal disease with GSK’s Synflorix GlaxoSmithKline (GSK) recent announcement from the GAVI Alliance that pneumococcal vaccine, Synflorix TM , is to be introduced into the national immunisation programme in Pakistan. Pakistan will be the first country in south Asia to receive pneumococcal vaccines in the Expanded Programme of Immunisation. The introduction of Synflorix into the programme was made possible through the innovative financing mechanism known as the Advance Market Commitment (AMC), which is designed to bring heavily discounted vaccines to children living in the world’s poorest countries. This is the largest universal mass vaccination programme against pneumococcal disease worldwide and is expected to help protect 4.8 million children each year.

Christophe Weber, President & General Manager, GSK Vaccines, said, “We

congratulate Pakistan on the introduction of life-saving pneumococcal vaccines for children, which is possible with funding from the GAVI Alliance. Through our research and work to accelerate access to innovative vaccines, GSK continues to

play an important role in helping protect millions of children from infectious disease. Increased vaccination means more children will be able to live healthy lives.” At a recent event held in Islamabad, government officials were joined by representatives of the GAVI Alliance, UNICEF, World Health Organization (WHO) and GSK to launch the programme. Starting this month, millions of children will be vaccinated against pneumococcal disease. Pneumococcal vaccines are expected to reach more than 50 GAVI-supported countries by 2015. Kenya was the first GAVI-eligible country to introduce Synflorix, followed by Ethiopia in 2011. Later this year, Synflorix will be rolled out in Madagascar and Zambia under the AMC framework.

Lonza to develop antibody drug conjugate Lonza has received a contract from Intellect Neurosciences to develop and manufacture the antibody drug conjugate, Conjumab-A. Under the contract, Lonza will supply the preclinical study material for the drug optimisation and drug selection for Intellect’s Conjumab-A, aiming on Age-Related Macular Degeneration (AMD) with potential applications for Alzheimer’s disease. The programme is also expected to have in vitro and in vivo studies to evaluate both therapeutic and prophylactic potential in AMD testing different chemical variants manufactured by

Lonza. Daniel Chain, Chairman and CEO, Intellect Neurosciences, said, “Conjumab-A is a first-in-class drug compound intended to address an important unmet need in AMD, which is the cause of blindness in people over the age of 55. The selection of Lonza as our manufacturer, just under a year since we introduced the platform, represents an important next step in the evolution

Bosch closes acquisition of Ampack Ammann Bosch Packaging Technology has recently closed its acquisition of Ampack Ammann, a filling and packaging machine specialist. The antitrust authorities have approved the appropriate documents. “In acquiring Ampack Ammann, we are pushing strongly ahead with our strategy of diversification,” said Friedbert Klefenz, President, Bosch Packaging Technology division. “We are acquiring an attractive product portfolio that our worldwide sales and service network will allow us to offer to existing and prospective customers around the world.” Ampack Ammann’s business activities have been assigned to Bosch Packaging Technology’s Liquid Food business unit with immediate effect. Founded in 1973, the company will remain an independent unit and will be operated as a Bosch subsidiary. Its products will in the future continue to be marketed under the Ampack Ammann name.

of Intellect Neurosciences, and we are proud to be working with such a high calibre team at Lonza.”

Venus Remedies wins Patent Award in Silver category in India-Asia Pacific Pharma Business Meet Venus Remedies has won the Patent Award in Silver category for the year 201112 in the valedictory function of India-Asia Pacific Pharma Business Meet, organised by Pharmaceuticals Export Promotion Council of India (Pharmexcil). The event held in Hyderabad was conferred by Raja Shekhar, IAS, Joint Secretary Department of Pharmaceuticals, Ministry of Chemicals & Fertilisers and R P Thakur, DGDC, AP. Dheeraj Aggarwal, Chief Finance Officer, Venus Remedies, after receiving the award at the ceremony, said, “Getting such a prestigious award for the second year in a row for our commendable contributions towards R&D, demonstrated by patent grants in 2011-12, is indeed a matter of pride and great honour.”

In Brief Emergent BioSolutions to advance anthrax vaccine development

The Biomedical Advanced Research Development Authority (BARDA) of the US Department of Health and Human Services (HHS) has exercised a contract option to further develop Emergent’s new rPA anthrax vaccine candidate, PreviThrax. “We look forward to continuing to work with BARDA to develop the medical countermeasures it believes are necessary to address the nation’s security requirements,” said, Adam Havey, Executive VP, Emergent BioSolutions.

Stellar Pharmaceuticals launches new migraine treatment, CAMBIA® in Canada

Stellar Pharmaceuticals Inc and its operating division, Tribute Pharmaceuticals announced that CAMBIA®, the only available prescription NSAID with an indication for acute treatment of migraine attacks, is now available across Canada. “The prescription migraine market in Canada is valued at about $150 million and we anticipate that CAMBIA® has the potential to gain a significant proportion of Canadian sales over the life of the product’s patents,” said Rob Harris, President & CEO, Stellar.

Mylan launches first generic version of Diovan HCT® tablets

Mylan Pharmaceuticals has received final approval from the USFDA for its ANDA for valsartan and hydrochlorothiazide tablets. This product is the generic version of Novartis’ Diovan HCT® tablets. Heather Bresch, CEO, Mylan, commented, “We are proud to continue contributing to the increased healthcare savings experienced by patients, governments and payers in the US supported by the generic availability of a widely prescribed product such as this one.”

Aurobindo Pharma receives USFDA tentative approval for pioglitazone hydrochloride and metformin hydrochloride tablets Aurobindo Pharma Ltd announced that the company has received tentative approval from the US FDA for pioglitazone hydrochloride and metformin hydrochloride tablets, 15 mg (base)/500 mg and 15 mg (base)/850 mg (ANDA 200823). The product will be eligible for final approval upon the expiration of 180-day generic drug exclusivity. Hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes mellitus when treatment with both pioglitazone

and metformin is appropriate. The product has a market size of

approximately $ 433 million for the twelve months ending March 2012 according to IMS. The product has been approved out of Unit VII (SEZ) formulations facility in Hyderabad, India.

FDA clears Sigma-Tau new topical ophthalmic therapeutic The US FDA has cleared Sigma-Tau Pharmaceuticals’ topical ophthalmic therapeutic to treat corneal cystine crystals in cystinosis patients. The CYSTARAN 0.44 per cent solution, which is developed in collaboration with the National Institutes of Health (NIH), is designated as an orphan drug in the US. The FDA approval was based on the clinical safety and efficacy data of CYSTARAN in controlled 300 patients clinical trials conducted by the NIH. Dave Lemus, COO, Sigma-

Tau, said, “This new medicine will offer physicians the only

FDA-approved treatment for patients with corneal cystine crystal accumulation, many of whom are children and whose lives are seriously impacted by this debilitating chronic condition.”

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News, Views & Analysis

FDA takes action against thousands of illegal Internet pharmacies The US FDA, in partnership with international regulatory and law enforcement agencies, recently took action against more than 4,100 Internet pharmacies that illegally sell potentially dangerous, unapproved drugs to consumers. Actions taken include civil and criminal charges, seizure of illegal products, and removal of offending websites. The announcement takes place during the 5th annual International Internet Week of Action (IIWA), a global cooperative effort to combat the online sale and distribution of potentially counterfeit and illegal medical products. “Consumers in the US and around the world face a real threat from Internet pharmacies that illegally sell potentially substandard, counterfeit, adulterated or

otherwise unsafe medicines. This week’s efforts show that strong international enforcement efforts are required to combat this global public health problem. The FDA is committed to joining forces to protect consumers from the risks these websites present,” said Margaret Hamburg, Commissioner, FDA. During Operation Pangea V, the FDA targetted websites selling unapproved and potentially dangerous

Merck Millipore [India] kicks off the ‘EMPROVE® Seminar Series’ Merck Millipore [India], a division of Merck KGaA, Darmstadt, Germany, flagged off the ‘EMPROVE® Seminar Series’ at Taj Lands End, Mumbai recently. EMPROVE® is a proprietary service from Merck Millipore which combines product quality with userrelated documentation simplifying rigorous regulatory work for the pharmaceutical industry. The inaugural seminar on ‘Evolving Trends in Regulations in the USA and EU’ consisted of a panel of eminent speakers of international repute. Panelists who addressed key issues in regulations included Ajit Singh, Chairman, ACG Worldwide, who spoke on the current trends in the pharmaceutical industry with respect to Indian and international regulations. Dr Bernd Renger, Chairman, European Qualified Persons Association addressed the seminar on challenges for regulatory compliance for the EU. The EMPROVE® seminar saw reputed spokespersons such as Chandrashekar Deo, Consultant – Quality and GMP who provided an overview of the changing environment for regulatory compliance in the USA; P Manoj Kumar, AVP - R&D, Mylan Laboratories who spoke on developing complex parenteral dosage forms – a generic perspective; Dr Sandeep Tiwari, Regional Technical Manager, South Asia, Colorcon Asia Pvt Ltd who spoke at length on examining the impact of excipient variability on QbD, and Dr Ulrich Reichert, Head of Regulatory Experts and Customer Audits, Merck Millipore who gave insights into elemental impurities – perspective as per ICH/EU/US. Leading pharmaceutical companies were present to exchange notes and have discussions on the evolving regulatory scenario and tools to expedite the complex process.

medicines. In many cases, the medicines can be detrimental to public health because they contain active ingredients that are approved by FDA for use only under the supervision of a licensed health care practitioner or active ingredients that were previously withdrawn from US market due to safety issues. Among the illegal medicines identified through the operation were Domperidone, Isotretinoin, Tamiflu and Viagra. The FDA sent warning letters to the operators of more than 4,100 identified websites. The FDA is working with its foreign counterparts to address the remaining websites that continue to offer unapproved or misbranded prescription medicines to US consumers.

Transgene Biotek joins hands with FII, to delist shares Pharmaceutical company Transgene Biotek Ltd has announced that Mauritiusbased Stream Value Fund has agreed to join hands on a long-term basis to support its drug discovery activity, in return for equity participation and certain rewards on drug licensing or sale. Last week, the Hyderabadbased company stated that it is offloading undisclosed quantum of stake to a foreign institutional investor as a result of which the company’s shares will be delisted from domestic stock exchanges. The company is in the process of sending the postal ballot to all its shareholders seeking their approval.

If delisting is successful, the management of Transgene said, it will enjoy enhanced flexibility without requirement to comply with a long list of regulators’ rules and regulations, which often hinder efforts to speed up the drug development process. Transgene has a pipeline of more than six molecules in development -both novel bio-technology and bio-generic drugs. The two recent animal studies on its oral insulin project have yielded exceptional results that give rise to confidence that Transgene will soon be in strategic partnership with a large pharma company, the company said.

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In Conversation With

Over 65 per cent of patients in the US regularly take alternative medicines, most of which are Ayurvedic …informs Pulin Shroff, MD, Charak Pharma. The calm and cool-headed leader discusses the upcoming trends, competitive regulatory scenario and the future of Charak Pharma in the global Ayurveda segment.

Nikunj Sharma nikunj.kumar@network18publishing.com

What led you into Ayurvedic medicines? It is often said that the values on which we build our lives and personalities are best inculcated during the formative years right at home and then in school. My values are no exception. Values are essentially the answers to what is right and what is wrong in life. Such a fine discriminating ability was the first and foremost thing that I imbibed in my life. There was this elegant blending of personal and professional values that is in-built in Ayurveda. For example, Ayurveda expects

The most important thing that modern science and ancient wisdom converge on is the biological clock, which has to obey the movement of the Sun. you to be as sincere and pure as possible in your body, mind and soul in order to feel well and recover from illnesses. You cannot carry residues of negativity and hope to feel better with Ayurvedic treatment. This fundamental premise was and is the bedrock of the values that led me into Ayurveda, which was already there in humongous amounts at home and at the work place. Last but not the least, Ayurvedic values and our own Hindu Dharma are two sides of the same coin. While even the vedas, shastras and agamas acknowledge that man cannot become pure and perfect no matter how hard he tries because those are attributes of the divine, so it is the duty of man to strive for those characteristics. Even during my school days there was an unusual attraction from my side to go for adventure and nature trips. This really got me interested in understanding the use of plants and I respect them for their presence. Nature is

bountiful, it is larger than life…it defines our universe. At Charak, we worship nature and its healing powers. Kindly share any personal incident that influenced your professional growth. There is one incident, which sparked my professional growth, ie, when I was in business school doing marketing. ‘Customers give you your salary’ – is what we were taught. This really made me understand how important it is nurturing customer relationships. Till today, being in tune with customer behaviour is my favourite activity during the day. I still speak to three to five doctors in the day, just to keep them positive towards Ayurveda and keep a good impression towards my company. I get all my ideas from my doctors – they nourish my mind and soul. My professional growth is largely attributed to my customers who make me active through the day and keep pushing me to achieve higher goals. How do you strike a balance between work and life amid pressure? Here again, I have to draw from the time-tested wisdom of our own scriptures ,which asked us to stay in sync and harmony with nature, be it a day, a month, or a season or the phase of life like grihastha etc. The most important thing that modern science and ancient wisdom converge on is the biological clock, which has to obey the movement of the Sun. We know that the pineal gland and melatonin determine your body clock and if you stay and move along with it, your work-life balance will automatically follow. Today’s lifestyle has irreparably damaged the biological clock so much so that we have high cortisol levels upsetting our metabolism at odd hours of the day and night. This disturbs everything else including eating the right food at the right time, staying physically active in the right manner and so on. To make a long story short, ‘back to nature’, is my slogan

to strike a balance between work and family life. It is not the work load alone that matters, but the timing and manner of working that does. Despite a leading position held by the allopathic sector, India is still a land of Ayurveda and people know its importance; so how do you campaign and sell these products in foreign markets? You may be surprised to know that the awareness of the strengths and merits of Ayurveda abroad, especially in Western countries, has always been of a high order and is only increasing by leaps and bounds in recent times. This is because of the explosive rise in the number of clinics offering services in complementary and alternative medicine, a field, which is dominated by Ayurveda. For example, over 65 per cent of patients in the US regularly take alternative medicines, most of which are Ayurvedic, especially for chronic segments such as arthritis, psoriasis etc. In a way, Ayurveda has already crossed the

benchmark in terms of the basics of marketing in the West. The paradigm has now shifted to refining and streamlining the marketing strategies to meet the rising expectations of the consumer in sophisticated markets such as North America and Western Europe. Do you expect any special measure from the government to strengthen the sector? In a country like India, you cannot do anything without government approval and support, particularly for a sensitive segment such as healthcare. There is often a misconception that Ayurvedic market is not as strictly regulated as allopathic. We are subjected to the same strict control measures as applicable to not only healthcare products and services but also other areas such as cosmetics, Fast Moving Consumer Goods (FMCG) and so on. In other words, we do not expect anything ‘special’ for ourselves. However, there are some grey areas in terminology

and regulatory requirements, which the government should iron out soon so that planning becomes easier for us. The expectations for government to give thrust to this sector are very high. There is a huge gap and the industry demands are

In a country like India, you cannot do anything without government approval and support, particularly for a sensitive segment such as healthcare. always increasing. On the market front, the sector is already strengthened by a combination of increased awareness, rising per capita income in urban middle class, urge of Ayurvedic practitioners to match the allopaths in style as well as substance and so on. In short, the segment is strengthening itself continuously and Charak is a mover and shaker in this area, and we plan on continuing being the same.

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Special Focus

Drug delivery systems Chandreyee Bhaumik chandreyee.bhaumik@network18publishing.com

he method by which a drug is delivered can impact the efficacy significantly. While on one hand some drugs have an optimum concentration range within which maximum benefit is received, on the other hand, the ones with concentrations below or above the range can either be toxic or produce no therapeutic benefit at all. Therefore, the slow progress in the efficacy of the treatment of severe diseases has stimulated a growing need for a multidisciplinary approach to the delivery of therapeutics to targets in tissues. These new strategies, Drug Delivery Systems (DDS), are based on interdisciplinary approaches that combine polymer science, pharmaceutics, bioconjugate chemistry and molecular biology.

Analysing the present, predicting the future

In order to prevent harmful side effects and reduce drug degradation, several methods of drug delivery systems are under development. Read on to know how well has India kept pace with such developments...

Demand graph According to several reports by Freedonia, the US demand for drug delivery products is forecasted to expand 7.2 per cent annually to $ 133 billion by 2015. The report states that the best growth opportunities will emerge in specialised pharma formulations and administration devices that advance the nature of therapy for autoimmune conditions, cancer, heart disease, neurological disorders and other debilitating health problems. Further, included in this category are human monoclonal antibodies, polymer encapsulated nanomedicines and transdermal patches for breakthrough pain management. Also, infusion products and parenteral delivery devices with improved safety, infection prevention and ease-of-use features will also fare well in the marketplace. Among these devices are retractable syringes, needleless injectors, premixed IV systems and smart infusion pumps. Based on the complex nature of therapy and the high frequency of dosing requirements, central nervous system, respiratory and hormonal indications will command the largest and therefore the fastest growth by drug delivery products. Demand for oral drug delivery products will increase 4.3 per cent annually to over $ 52 billion in 2015. Next, the report also reveals that the demand for parenteral drug delivery products will reach $ 54.7 billion in 2015. Commenting on the focus areas, Dr R T Sane, Honorary Director, Guru Nanak Institute of Research and Development, elaborates, “Today, the focus is gradually shifting from small molecules to the bigger molecules like insulin, etc. These are primarily bio pharmaceutical drugs

toxicity and improve efficacy offers great potential benefits to patients, and opens up new markets for pharma and drug delivery companies. According to Dr Sane, India is making constant efforts to develop drug delivery system. He says that Department of Science and Technology, Government of India has contributed ` 5 crore and University Grants Commission (UGC) has given ` 1 crore to Khalsa College in order to develop a facility that will fill up the need gap. The facility has already been inaugurated but it is yet to be functional. This centre will be providing the required training to the students, teachers and engineers. He believes that this facility will take care of the need at the micro level. He emphasises, “This is the beginning. This is an initiative in the Maharashtra state. And it would be great if this is replicated in other states too.” Dr Sane reiterates that the drug delivery system is well developed in India for small molecules. However, India needs to scale up the business rate. Elaborating on how India is placed, Dr Koshia says, “India has a large number of pharma companies and most of them are focussing on NDDS. Government of India has also been co-operative in helping with the research activities and NDDS is a part of it.”

What is next? and now with time India has started developing bio pharmaceuticals.” Talking about drug delivery system, Dr H G Koshia, Commissioner, Food & Drugs Control

Today, the focus is gradually shifting from the small molecules to the bigger molecules like insulin, etc. These are primarily bio pharmaceutical drugs and now with time India has started developing bio pharmaceuticals. Dr R T Sane Honorary Director, Guru Nanak Institute of Research and Development

Administration, says, “Today, Novel Drug Delivery System (NDDS) is the main focus area in pharma industry. We must remember that finding a New Chemical Entity (NCE) is a costly affair. And only 5-10 per cent of the total NCE that reaches market. This is because NCE involves a huge investment of money, manpower and time.” He continues that this is primarily the reason why pharma companies choose NDDS where the chemical entities are known, the effect is known and thereby the risk is minimal. He affirms, “This is a safe business and it has huge acceptance too. Companies of small and medium scale can also afford to do R&D where the cost and risk is low. This has great acceptance in medical fraternity.”

Where does India stand? In order to reduce drug degradation and loss, to prevent harmful side effects and to increase drug bioavailability and the fraction of the drug accumulated in the required zone, several drug delivery and drug targeting systems are currently under development. For over 20 years, researchers

have appreciated the potential benefits of nanotechnology in providing vast improvements in drug delivery and drug targeting. Improving delivery techniques that minimise

India has a large number of pharma companies and most of them are focussing on NDDS. Government of India has also been co-operative in helping with the research activities and NDDS is a part of it. Dr H G Koshia Commissioner, Food & Drugs Control Administration

The goal of all sophisticated drug delivery systems is to deploy medications to specifically targetted parts of the body through a medium that can control the therapy’s administration by means of either a physiological or chemical trigger. To achieve this goal, researchers are continuously referring to several advances. During the past decade, polymeric microspheres, polymer micelles and hydrogel-type materials have all been shown to be effective in increasing drug targetting specificity, lowering systemic drug toxicity, improving treatment absorption rates and providing protection for pharma against biochemical degradation. Further, various other experimental drug delivery systems show exciting signs of promise, including those composed of biodegradable polymers. Talking about the future of drug delivery system, Dr Sane says that targetted drug delivery is the future of the world. The primary advantage of this technique is reduction in dose and thereby minimising the chances of side effects of the drug. Thus, with an aim to eradicate harmful side effects and reduce drug degradation, pharma companies are concentrating on NDDS.

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Special Focus: Interface

The single largest difference between India and any other market in the world is the level of competition Shibani Shah shibani.shah@network18publishing.com

What are the benefits of NDDS to pharma companies and the patients? NDDS provides: a) Increased bioavailability of the drug resulting in better therapeutic response b) Modified release of the drugs, resulting in reduction of number of doses or provide site-specific drug delivery, which provides superior outcomes and fewer side effects. What expansion strategies are you planning at Troikaa? Our company has acquired 1,54,000 sq metres of land at Virochannagar, Sanand for the purpose of setting up a state-of-the-art ‘Novel Drug Delivery Park’ at this location. The Novel Drug Delivery Park will be the first-of-itskind in India. It will be primarily dedicated to the manufacturing of our company’s innovations. The company is eligible for financial support by the Technology Development Board, Government of India and is in the process of making the necessary applications. What is the business model that you follow at Troikaa Pharmaceuticals? Since inception we have avoided the volume game, instead, we choose

niche products as well as products which are difficult to manufacture. Since 2005, our endeavour has been to develop original NDDS, and back them up with global patents. Rewards for this business model are not as fast as those generated by selling in volumes. However, our success with Dynapar AQ convinces us that while our approach may produce slow rewards in the short terms, it will give us handsome rewards in the long run. In which countries has Troikaa Pharma set its footprint? We started exporting some 4 years ago. Today, our products are exported to more than 70 countries across Commonwealth of Independent States (CIS), Asia, Africa & Latin America. However, this list continues to grow month after month. The company has more than 604 registrations worldwide and 602 products are under registration. How do you find the markets different in India and other countries? The single largest difference between India and any other market in the world is the level of competition in the pharmaceutical industry. Indian market is hyper competitive since there are thousands of pharmaceutical companies. The second difference is the awareness of quality at the doctors as well as at the patient’s levels. Doctors and patients in most other countries have been exposed to

…says Ketal R Patel, CMD, Troikaa Pharmaceuticals Ltd on the difference between the markets in India and abroad. He also talks about NDDS benefits and the future plans of his company.

products from the best players in the world. On the other hand, the policy of the Government of India ensures that imports of pharmaceuticals were restricted to bare minimum and hence for the last few decades, the Indian doctors as well as patients have been primarily exposed to products made in India, many of which may not be at par with the best in the world. Therefore, quality perception of customers in India is much lower.

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Facility Visit

Panacea Biotec

Chandreyee Bhaumik chandreyee.bhaumik@infomedia18.in

oday Panacea Biotec, India’s highly progressive, innovative health management company based on R& D, manufacturing and marketing of pharmaceuticals, biopharmaceuticals, vaccines and natural / indigenous products is proud to have 3200+ people, four state-of-theart R&D centres and manufacturing facilities and close to 280 scientists. It also has to its credit 20 patents, which are valid in around 150 countries. Dr Rajesh Jain, Joint MD, Panacea Biotec Ltd, explains, “We are among the few companies that invest close to 6 per cent of total revenue in R&D. Today, all our plants are following cGMP and almost all pharma plants are certified by USFDA, authorities of Germany, Europe and Brazil too. The company is completely automated, people savvy and as a company, we respect knowledge workers.”

Pushing the limits for innovative solutions With long-term strategies in place and with an unwavering focus on innovation, Panacea Biotec has made a substantial headway in the international market. The company plans to continue the strategic quest and ensure a powerful global presence.

The journey so far

Ever since its inception Panacea Biotec has endeavoured to become one of the leading companies of the world. It is dedicated to provide quick-response solutions to new challenges to public health, continuously delivering branded pharma formulations, vaccines and other therapeutic products. Way back in 1927, the company started as a pharmacy shop in Sialkot, which is now in Pakistan. In 1947, the family shifted to Delhi and put up their first pharmacy retail shop in Delhi once again. In 1984, Panacea Drug Pvt Ltd was set up with a commitment to make novel and innovative medicines affordable to the masses. Dr Jain says, “In 1989 we put up our vaccine manufacturing plant in Delhi under the name of Radicura Pharma and after that there is no looking back.” In 1989, a pharma formulations plant was set up as well at New Delhi, under the name of Panacea Drug (P) Ltd. In 1993 Panacea Drugs (P) Ltd & Radicura Pharma were merged to form Panacea Biotec Ltd with a vision to become one of the best healthcare companies in India. It went public in 1995. With the money that was received from IPO, there was capacity expansion by hiring more sales staff, and we introduced more products (pharmaceutical and vaccine). Further, in 1997, it went into collaboration with a Cuban company Heber Biotec and put a manufacturing plant at Lalru, Punjab for Hepatitis vaccine. After that, world’s first fully liquid pentavalent vaccine was developed that was launched in 2005. Also in 2005, the company had raised $ 100 million from the foreign convertible currency bonds to fund expansion and put up more R&D centres. The company has set up R&D centres at Mohali, Mumbai and New Delhi. The same company focussed on global expansion and it started exporting products to several markets in CIS, Africa, South East Asia and Latin America. In 1992, Panacea Biotec started exporting to other countries.

Down the years

Further, now was the time for the company to tap the international vaccine market. Dr Jain adds, “We started in licensing technology from several institutes. We started increasing

Photograph: Amit Kumar

our pipeline for not only putting up R&D centres and increasing own capability but also to see whether there was opportunity outside the company, especially in universities and other research institutes. So moving from a small pharmacy shop to a large industrial enterprise was quite a pleasant journey and the whole focus of this journey was to do something different” He highlights, “We also must remember that in 80s and 90s India did not follow patent law and India did not have the mindset to invest in research. So, how would one work on innovation without support from anywhere? It was really a difficult path and that too in the area of vaccine and pharma technology, when the world was focussing more on generic, API capabilities.” The idea of innovation actually came in early 2000 in India. Dr Jain narrates, “We picked up the area of novel drug delivery system, which

We picked up the area of novel drug delivery system, which we believed had lesser investment and Indian pharma industry had people who could work on formulations and improve them. Dr Rajesh Jain

Joint MD, Panacea Biotec Ltd

we believed had lesser investment and Indian pharma industry had people who could work on formulations and improve them. And from there the whole capability of improving vaccine formulation came.”

Building on its strength

Discussing in this regard, Dr Jain says, “The year 1995 was a milestone year for the company. We launched the first most popular brand of ours that our company is known for - Nimulid. Prior to that, we were famous, because we had put up the polio vaccine plant in Delhi in 1989. This plant continues to make us popular even today. This plant has contributed a lot in polio eradication globally. The third milestone came, when we put up a joint venture with the Heber Biotec for biotechnology. After that, it was in 2005-06 that was important when we had done $ 100 million fund raising and then it was 2008, when we have received ` 1000 crore contract from UNICEF for supply of pentavalent vaccine. In 2012 we are getting into healthcare delivery with a launch of 220 bed super- speciality hospital in Gurgaon, Haryana. Healthcare is a growing market and we would like to leverage on this too. With the education and income levels increasing in a household, the patients have become more demanding. And in this scenario, the government and charitable institutes find it difficult to cater to this demand. Thus, there is a huge opportunity in this area.” Dr Jain believes that this will act as a new innovation strategy for the company. He avers, “Panacea Biotec is an innovation-based company. And through healthcare delivery we will also be able to learn what the patients want, how do the doctors work, etc.”

OneStream Biotechnology Innovation Centre

Another achievement of Panacea Biotec is its establishment of

‘OneStream’ research centre (vaccines & biopharmaceutical R&D) in Delhi. Spread across 26,000 sq ft, it is a confluence of two R&D centres brought together by adding experience of past years, with an objective to develop novel, effective and affordable vaccines and biopharmaceuticals for prevention against various epidemic/ endemic life threatening diseases for global markets. Talking about this centre, Dr Jain says, “OneStream has around 50 scientists including 8 PhDs working in the areas of molecular biology, cell biology, immunology and peptides. This R&D started with a focus on the paediatric vaccines and is now focussing on the new biological as well as biosimilar. There are different set of people working on innovation, on new biological, on biosimilar and vaccines.”

Not so good times

Discussing the revenue figures, Dr Jain says, “In 1983 we were less than a crore company and in 10-11 years we had a top line of close to ` 1100 crore. Last 2 years had been relatively not good, as few of our vaccine were delisted by WHO due to quality assurance issues and we lost almost 70 per cent of our revenues. During their routine audit, WHO found that the quality assurance processes had not evolved from the time they left us in 2008, and few of their recommendations were not followed. Before the WHO delisted a few of our vaccines, we were the leaders; we were the third largest biotechnology company till last year and we are sure that we will regain the lost position soon.” Fortunately, Panacea Biotec has not lost its optimism. Dr Jain continues, “We are expecting the WHO to come to us in the October 12 and by DecemberJanuary, 2013 and we should be back on track.” Thus, with stringent quality control, Panacea Biotec aims to attain international reputation.

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14 Insight & Outlook: Policies & Regulations Low-cost generics

Bridge to reduce India’s disease burden

he importance of access to generic medicines highlight numerous critically important issues related to meeting India’s unmet health needs. Particularly for the hundreds of millions living below the poverty line, low-cost generics could play a crucial role in reducing the burden of disease. Over the past decade, India’s disease burden has increasingly shifted from communicable diseases to chronic ailments such as diabetes, cardiovascular diseases and other conditions that can be treated and managed by many older proven and effective low-cost generic medicines. Ensuring access to low-cost generic medicines must be an important priority for India’s universal healthcare reforms. Lately, India’s drug policy debate has largely focussed on the price and availability of newer innovative medicines. This debate, however, misses the key point that the ultimate legacy of pharmaceutical innovation is safe and effective low-cost generic medicines to which many diagnosed patients in India have little or no access.

Actor Aamir Khan recently appeared before the Parliamentary panel examining Foreign Direct Investment (FDI) in pharmaceuticals and pitched for low-cost generic medicines, contending that the issue was how the poor could get cheap medicines. This is a good plan considering the poor access to medicine that people have, but better distribution system is needed to ensure actual delivery of generics to poor people. on pricing, shortfalls within India’s healthcare system should be addressed – such as the cumulative shortfall of about 17,000 PHCs, which forces rural patients to travel almost 20 km to visit the nearest PHC. In many instances, ill health and poverty preclude the commute, particularly because the transport system is virtually non-existent in rural areas.

Rising against all odds

Castles in the air?

The country recently tried to implement drug policies that benefit low-income groups through programmes such as the governmentsponsored Jan Aushadhi programme. But like many other programmes regarding access to healthcare in India, the capacity of the healthcare system to effectively implement new ideas has been lacking. In the case of Jan Aushadhi stores, irregular supplies from inadequate distribution systems, lack of sufficient generic prescriptions from physicians and low consumer awareness all conspired to ensure the programme failed to take off and has been largely ineffective till date. Keeping past experiences in mind, we need to learn from them and make certain better mechanisms are first put in place to ensure the quality and effectiveness of generic medicines so that low-income people derive the full benefits of low-cost generic medicines. The authorities need to make certain that delivery systems across India are adequate and functioning smoothly so that drugs in short supply are promptly replenished to meet any patient requirements 24/7 without interruptions whatsoever. The importance of delivery systems is clear from the fact that more than 50 per cent Indian women suffer from the highest levels of malnutrition

globally, in spite of iron supplements being distributed free in Primary Healthcare Centres (PHCs). The Institute of Applied Manpower Research’s ‘India Human Development Report 2011’ observes that more Indian women are turning anaemic over the years. The unequivocal message: without drug delivery systems even free medicines will not reach the needy.

Catering to other pressing demands

Physicians also need to be sensitised about the importance of prescribing low-cost generics for patients, particularly those without insurance support. Unless a sufficient number of physician prescriptions are generated every month, programmes such as Jan Aushadhi may always remain a non-starter. The key role of robust delivery mechanisms and the support of doctors for generics become clear from a recent study of a sample of patients across the globe, which revealed that less than

20 per cent patients with Cardiovascular Disease (CVD) from low-income nations were using secondary prevention drugs. This was despite the fact that the CVD is manageable with inexpensive medicines in the form of readily available generic drugs. In other words, even with ready availability of generics, there is gross underutilisation. Surprisingly, a majority of the sampling of low-income nations comprised patients from India – the biggest supplier of low-cost generic drugs to the world. Less than 5 per cent of these patients were using either diuretics or statins available in their generic versions. Medicines in India are among the cheapest today even when compared with developing countries. But more than 46 per cent patients travel beyond 100 km to seek medical care. Then there is the National Immunization Programme that provides six vaccines free of cost, yet only 60 per cent of the population is covered. NACO provides free anti-retroviral treatment to the poor, but the

drugs still do not reach all those in need. Such examples make it clear that drug affordability is not the biggest barrier to healthcare access – a fact revealed by a D Y Patil Medical College (Pune) 2011 study citing inadequate infrastructure as the primary hurdle to access quality healthcare. The study indicated that if PHCs in rural regions and medical facilities in urban zones were created, there still would not be sufficient doctors to examine patients, prescribe medications and manage these medical centres. Given the circumstances, pricing policies would still fail to boost access. Besides, drug prices in India are already one of the lowest anywhere in the world, which is apparent from a comparison with drug prices in India and elsewhere, even those of developing nations. Based upon purchasing power parity, an analysis of 53 drug prices found India was cheaper than countries such as Pakistan, Philippines, China, Thailand, Malaysia, and Indonesia. Clearly, instead of focusing

Different countries, different pricing India

Pakistan

Indonesia

Diclofenac Sodium 50 mg (10 pack)

` 3.50/-

` 84.71/-

` 59.75/-

` 674.77/-

` 60.96/-

Omeprazole, 30 mg capsules (10 pack)

` 38.40

` 578.00

` 290.75

` 2,047.50

` 870.91

Apart from inadequate health facilities and diagnostics as well as trained healthcare personnel, healthcare hurdles can appear in other forms too – such as geographical, socioeconomic and gender barriers. Geographic barriers include constraints in transportation and infrastructure. Socioeconomic barriers include not just healthcare costs but social factors such as the lack of culturally-sensitive services, language or ethnic hurdles and the inherent prejudices of healthcare providers. In many of these nations, widespread gender discrimination leads to women having minimal access to healthcare, making them more susceptible to a slew of diseases and the associated higher mortality rates. Besides the above factors, awareness needs to be increased among patients about the availability of numerous genuine effective low-cost generic medicines. It should be highlighted that India has thousands of generic drug makers and some Indian multinational generic drug producers supply most of the world’s quality low-cost generics. A focus on improving quality standards and ensuring more stringent regulatory oversight for domestic generic manufacturers in India would mean that millions of needy people could benefit from better access to quality lowcost generic medicines, greatly reducing the economic and social burden of disease. In the prolonged war to reduce India’s disease burden, no stone should be left unturned – including the use of low-cost generic medicines, which can play a major role in boosting affordability and improving access to healthcare. Aman Gupta Principal Advisor, India Health Progress amangupta@indiahealthprogress.in

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Insight & Outlook: Strategy

Emerging opportunities for pharma

Widening the market

Will the proposed new medical coursework move to help all doctors practice allopathy, be beneficial for the pharma industry? A ‘rural’ MBBS course or something on similar lines can provide a good power boost to the pharma industry. Here’s how?

ecent estimates by the Medical Council of India (MCI) reveal that India has a doctor-patient ratio of 1:1700 as compared to the world average of 1.5:1000. According to a vision document prepared in March 2011, within two decades MCI has targetted to achieve a national average of one doctor for a thousand people. A major problem affecting healthcare delivery in India is the excessive concentration of medical personnel in the metros with an acute paucity of doctors in rural areas. Nurses, paramedical workers, etc who work in the Primary Healthcare Centres (PHCs) too double up as doctors in their homes not simply to earn a quick buck but to ensure that some sort of medical facility is available in their hamlet. Despite the mandatory government bond for fresh MBBS graduates to serve in rural areas, PHC are devoid of doctors. Consequently, medical treatment in remote areas is provided by native vaidyas, ayurved acharyas, homoeopaths or quacks. There are several reasons for MBBS doctors’ failure to settle in rural areas. Also, since current recruitment norms prohibit qualified practitioners of alternative medicine (BAMS, BHMS, BUMS, Siddha) the healthcare system in the country is unable to make use of their services. This is a colossal waste of human talent in a country where the healthcare delivery facility is dismal.

Proposed move

Two recent announcements by the government bring hope to improve the situation. There is a move by the Government of Maharashtra to allow doctors qualified in alternative medicine to practice allopathy after they undergo a short training in allopathic pharmacology and medicine. The idea is to ‘upgrade’ these physicians to practice modern medicine and use their services in rural areas. The union government too has been toying with the idea of introducing a short course, likely to be called ‘B Sc (Medicine)’, to produce doctors specifically meant for rural areas. A few years ago, it was reported that there was a move to start a 3-year ‘MBBS (Rural)’ degree course. Fortunately, it was shot down due to the obvious fact that any qualification which appeared identical to the existing 5½-year MBBS course would lead to

malpractice. Besides, these short-course personnel would use their semi-MBBS certificate to illegally practice in metros, thereby undermining the very purpose for which the course has been started.

Opportunities galore

For pharmaceutical companies, both these proposals are a shot in the arm. It ensures that rural areas will get good quality medical service and the number of qualified prescribers of allopathic medicines will increase. Pharmaceutical companies will have access to a greater pool of patients in villages who get quality medicines from genuine medical personnel. In order to understand the actual impact of these government decisions, one needs to understand the differences in the existing medical courses. While the five-and-half year course includes one year of rotating internship after the elaborate academic training, the proposed 3-year course will have a cursory teaching of human body, pharmacology, basic life support, first aid and general medicine. The latter will ensure that this ‘doctor’ is able to give primary care in any medical situation after which he will seek the help of the appropriate expert. This short course throws in ample opportunity to the

pharmaceutical industry to upgrade the knowledge of these medical personnel while simultaneously providing succor to the suffering villagers.

Basic differences

All courses, including the traditional and alternative ones have an extensive academic syllabus spread over 4½ years. The syllabus of anatomy and physiology is similar in all the courses as they include the structure and function of the human body. The variation in different streams of medicine lies in the subjects such as pathology, pharmacology and general medicine. The differences are complex since the pathology described by ayurvedic or homoeopathic system may not have an identical equivalent in allopathic system. For this reason, the treatment recommended will follow distinctly different principles in some diseases. Treatment principles in traditional systems such as ayurveda (BAMS degree) seek to rebalance the altered levels of certain ‘humours’ in the body. MBBS students learn modern (allopathic) pharmacology wherein pure, refined, chemical substances derived from various sources are used to correct imbalances in blood or specific tissues / organs. Homoeopaths (BHMS degree) give significant

weightage to the emotional/ mental aspect of the patient’s history prevailing from birth to childhood to adolescence and adulthood. The pills in homoeopathic medicine are potentised, energised, highly diluted chemicals, which enter the system through the tongue. While allopathy has a systematic approach to classifying disorders based on different functional systems (circulatory, gastrointestinal, etc) and treat primarily with chemicals, the others have a more holistic approach where greater stress is placed on diet and exercise than on medications. However, the most significant difference is in the realm of emergency medicine where modern allopathic medicine scores over the others.

Capitalising the market

The pharmaceutical industry has always strived to build up the practice of young physicians so as to ensure their own sales objectives. This was done by conducting medical camps on specific diseases, providing literatures, drug samples etc. These efforts produced a two-fold response: more goodwill with the budding physician as well as increasing the patient flow into the clinic. The same methodology could be adopted by the pharmaceutical industry in the mofussil areas. Whether it is a BSc doctor, an ayurvedic

physician or a homoeopath, so long as he or she is authorised to prescribe allopathic drugs, drug manufacturers can support his practice and consequently help the villagers to have better medical care. Most of these physicians would be hungry for allopathicknowledge and hence would be willing to attend lectures, seminars and workshops. Specialists from nearby cities can be engaged professionally to deliver lectures to these groups at regular intervals. Such an arrangement can help the pharmaceutical company in multiple ways: Strengthen bond with the specialist enhancing their goodwill with him Provide platform to experts who are willing to teach but do not have attachments to teaching hospitals Provide a source of professional income from the pharmaceutical company particularly for youngsters in the early days of private practice Increase the level of knowledge of the attending ‘half-doctors,’ which helps them to leverage their practice Improve the quality of health-care service in the interiors of the country And finally, increase bottom line by getting more prescriptions from the teacher as well as the taught!

Magic number: 70 per cent

As with all government relief and welfare schemes, it is not clear whether the new course would start from the forthcoming academic year. Yet, in all probability, it should take off soon as this is an easier option for the cash-strapped government rather than start new MBBS medical colleges from scratch. The MCI vision to have a doctor population ratio of about 1 per 1000 by the year 2031 is a massive leap in the number of legitimately prescribing physicians. For the pharmaceutical industry, it could mean a massive 70 per cent spike in drug sales, provided they have been able to capitalise on the new generation of upgraded physicians. By the time the government is ready with its proposed plans to boost healthcare, if the drug industry too complements its efforts, everyone stands to benefit. In the final analysis, it is rural India that will be the real winner. Dr. Rajan T.D Pharma Consultant & Practising Dermatologist rajan.td@gmail.com

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Insight & Outlook: Interface

Health activists are pressing to remove ambiguities to protect access to generic medicines Nikunj Sharma nikunj.kumar@network18publishing.com

Is the term ‘counterfeit drugs’ deviating the focus from drug quality? MSF relies primarily on generic medicines. So does the major procurers of AIDS medicines worldwide - the Global Fund and PEPFAR. Many developing countries have no domestic pharmaceutical manufacturing capacity and governments and patients rely on imported generic medicines. Generic competition is the main driver of pharmaceutical price reductions. MSF has been increasingly concerned by the proliferation of anti-counterfeit measures that harm access to generic medicines and which have been pushed in a number of different forms– as a part of free trade agreements, international treaties (Anti-Counterfeiting Trade Agreement), domestic legislation (Kenya Anti-Counterfeit Act 2008) and customs regulations (EC Council Regulation no. 1383/2003). Such measures fail to clearly distinguish between counterfeit and generic medicines and are - using increased enforcement of intellectual property - to clamp down on the legitimate procurement and trade in quality, affordable generic medicines. Such measures confuse affordable generic medicines with counterfeits that may result in arbitrary barriers and seizures of generic medicines under the guise of fighting counterfeits. Health activists are pressing to remove ambiguities to protect access to generic medicines. The discussion on terminology and the confusion it creates has been taken up by the Intergovernmental Working Group on substandard/spurious/falsely labelled/falsified/counterfeit medical products, a body set up by WHO member states. This fatal confusion must end. The term ‘counterfeit’ must be changed to reflect concerns about the quality of medicines. And the international community must give greater attention to substandard medicines — a pressing problem in developing countries. While addressing the issue, are the anti-counterfeiting initiatives also leading to confusion? Today there is a real attempt by certain actors to confuse the debate. You will often see articles in the media that discuss counterfeit, spurious and substandard medicines as if they are all one problem and the same solution can be used for all of them. Often these articles deliberately try to confuse the issue of counterfeit drugs with generic drugs. Of course, this confusion can have a negative impact – because if the public believes that generic medicines are the same as counterfeit medicines or fake medicines, they will lose confidence in generic medicine, which may be problematic given the huge positive impact generic medicines have had for access to medicines in the world. Another negative consequence of confusing counterfeit and generic drugs is that this often leads to calls for stronger intellectual property

enforcemement, which then creates problems for access to medicines. In reality, campaigns and legislation against counterfeit drugs often have nothing to do with concerns about drug quality. Major US and European pharmaceutical companies have a vested interest in limiting competition from generic drugs, and are using increased counterfeit laws, which are focussed on enforcement of intellectual property as a tool to clamp down on the legitimate trade in high-quality generic medicines between developing countries. The dangers of this approach are clear. We have seen that even at the level of policy makers; these confused messages can have a negative effect. Today, in a number of East African countries there are draft legislations before lawmakers designed to combat counterfeiting of medicines. But the definition of counterfeit medicine used in the legislation is so confused that if the Bill actually passes, access to legitimate generic health products may be hampered. Another example is the European customs regulations put in place in 2003 (EC Council Regulation no. 1383/2003), under which, almost 20 shipments of generic drugs, including basic antibiotics and anti-retrovirals, were detained while in transit from India to several developing countries

The problem of spurious drugs, if handled wrongly, will have a negative impact. Purported data based simply on media reports conflate various terms (substandard, counterfeit etc), and thus give a wrong impression about the size of the problem. via Europe in 2008 and 2009. The European Union first claimed it was fighting trade in counterfeit medicines. But an official response by the Dutch government to a Freedom of Information Act request, filed by Health Action International, revealed that these shipments contained generic medicines detained on allegations of infringing intellectual property.

…says Leena Menghaney, Access Campaign India Co-ordinator, Médecins Sans Frontières (MSF). The new EU guidelines on import of APIs are going to change the paradigm of export from India. She sees the directive from a different perspective and strongly condemns the use of term counterfeit drugs for spurious or substandard medicines. At the recent PSM conference in New Delhi besides the confusion around terminology, there was a lot of discussion around spurious drugs. What do you think is the real problem in India? The true extent of the problem of spurious medicines is unknown. The problem of spurious drugs, if handled wrongly, will have a negative impact. Purported data based simply on media reports conflate various terms (substandard, counterfeit etc), and thus give a wrong impression about the size of the problem. It is important for India to review data and focus policy efforts and resources on the public health problems they actually face. At the meeting, representatives from the People’s Health Movement called for more action on what they consider is the real problem in India substandard medicines. In the area of spurious or fake drugs the most important measure is to actively identify and remove them from the supply chain without creating a public scare about it. Besides track and trace technologies, strong supply chain management by procurers and pharmacies could go a long way towards that. Could you suggest possible reforms from an Indian perspective? Both substandard and fake medicines present serious concerns for public health. Médecins Sans Frontières (MSF) comes across many medicines that are substandard or of unassured

quality in our activities in more than 60 countries across the world. However, we see or suspect fake drugs or vaccines more rarely. Substandard medicines represent the larger problem from a public health perspective. The circulation of substandard medicines is a neglected problem and hits mainly vulnerable populations in resourcelimited setting. Substandard medicines are genuine drugs produced by legitimate manufacturers – whether patented or generic - which do not meet the standards set for them with regards to quality, strength, purity and packaging. So efforts from the Indian Ministry of Health and Drug Regulatory Authority (DRA) should be focused on the area of sub-standard medicines. Track and trace technologies heavily promoted by partnership of safe initiative in the Indian context, will have limited use in addressing the problem of sub-standard medicines as they are simply designed to provide confirmation that the medicine comes from a legitimate manufacturer. They cannot confirm the quality of the medicine itself. India has achieved significant progress in amending its Drugs & Cosmetic Act to introduce domestically WHO’s Good Manufacturing Practices. But this is not enough. The role of the Indian DRA or DCGI, is paramount. Particularly as it needs to ensure that medicinal products used domestically and exported from India meet WHO quality, safety and efficacy standards. A major underlying reason for both substandard and fake medicines is the weak capacity of medicine regulatory system to implement the laws that are in fact in place. There has not been nearly enough investment in the Indian DRA. The Indian DRA is often underresourced and that a real investment in capacity is needed urgently. The Indian DRA must be strengthened and have the political support at the national level to be an autonomous agency. This should be a national priority with support from WHO. To improve the quality of medicines and protect patients, the WHO and governments must push drug companies to comply with the WHO’s GMPs, increase local capacity for technical evaluation and actively identify and remove substandard and fake drugs from the supply chain. This could be a supply chain issue as well. How drugs are stored and distributed can also affect the quality of the medicine. In India, Tamil Nadu along with some other states are investing in supply chain management with proper storage and distribution. This will not only address quality issues but also prevent stock outs of medicines in the public programme. In the international arena, when policy recommendations on this issue are on the agenda, it is essential that India pushes for measures that address the issue of strengthening DRAs to address genuine public health problems and that counterproductive and harmful solutions are not adopted out of confusion.

Mo de rn Ph a rm a •16 -31 Oct o be r 2 012

Insight & Outlook: Roundtable

Is industry funding intended to influence prescribing behaviour among physicians? Jasleen Kaur Batra jasleen.batra@network18publishing.com

Dr Radheshyam Naik

Dr Ajit Dangi

President & CEO, Danssen Consulting The symbiotic relationship between the medical profession and the pharmaceutical industry exists all over the world. As long as it is kept at a professional level like imparting continuous medical education, communication about new products and medical therapies, latest advances in medical research, etc it will benefit the physicians as well as the patients. Once this line is crossed and the industry uses it to influence the prescribing habits of the physicians it becomes unethical and will harm the reputation of the industry as well as the interest of the patients in the long term. It is in industry’s interest to clean up its act and adopt a voluntary code of ethical conduct in promoting its products. Many reputed pharma companies in the west have started publishing all their promotional expenses on their website, thus bringing transparency in their dealing with the medical profession. We should emulate this practice in India as well. The medical profession is also equally responsible and need to introspect. Practices such as seeking huge donations for medical conferences from the industry, receiving consideration for referrals to pathological laboratories and consultants, unwanted surgeries, etc need to be curbed. Endorsing a particular healthcare product (eg, toothpaste, antibacterial soap, water purifier etc) by a Medical Association for an endorsement fee is also questionable. It might be a good idea to consider having an ‘Ombudsman’ as in some European countries to guard the interest of the patients.

Consultant, Medical Oncologist, HCG Today, healthcare has become an industry rather than a service. The pharmaceutical industry like any other industry is competing with each other to generate higher revenues and create a strong brand name. Though pharma companies do try to influence the decision of the doctors, I wish to believe that the ultimate decision even today lies in the hands of the doctor, or the hospital at large. Today, to some extent the pharmaceutical companies can influence the prescription behaviour of drugs. This can be done in various ways-by meeting the doctors again and again, giving more literature about the drug. The Also, a number of pharma companies sponsor the doctors programmes, for instance there pharmaceutical is a Continuing Medical Education (CME) industry has been facing conference, group meetings and more. rigorous competition with It is more like a promotion, and today most pharma companies try to influence regards to establishing their the doctors along with the hospital brand name. Thus, they have begun administrators as the goodwill they receive from this channel lasts for a long to offer contributions in ways more period of time. However, if the drug is than providing the sample drugs. We not effective it will not sustain itself in find out whether such contribution by the market. Thus, I feel that to some extent, sample drugs and other benefits pharma companies has given rise that the pharmaceutical companies to change in the prescription provide to doctors and hospitals does influence the prescribing behaviour but patterns among physicians. it is unfair to make this a blanket rule and include all doctors in this.

Vikram Gupta Anil Kamath

Founder Chairman, Esemcee Advisors I feel doctors always prefer to use drugs from various companies just to understand whether they get any sizable benefits out of the use of the drug in terms of patient outcome. There are a few categories, one is where the product profile is very similar to each other and it will not make any difference as they are standard products, so it becomes more of a drug of comfort for the doctor. As far as prescriptions are concerned, if there is a new product then tremendous interest is generated within the industry as the doctors want to try out the drug and see if it will be a better drug for the patient but this does not affect the prescription matter. If you go to any private hospital today, one would find that the doctors do not go by the medical representative of the pharmaceutical companies. The hospital selects a few products to provide proper treatment to their patients. Also, the hospitals today ensure that they prescribe the drug that will help in speedy recovery of the patients, is effective, has less side effects and is affordable. Thus, the contribution made by the pharmaceutical companies is not at all affecting the prescription patterns among the physicians today.

Editorial take

Founder & Managing Partner, IvyCap Ventures The pharma companies in India today not just give free samples to the doctors but a number of other benefits as well. They give them free trips to international destinations and more so it is an inbuilt activity, which is becoming a part of the system. These practices are definitely bringing about a wave of change and are impacting the prescription pattern among physicians today. However, from a long-term perspective it is the drug that has to do well in the market. If the drug is not effective and is not doing well it will automatically fade away. Also, a lot of visibility in terms of conferences and seminars is given to the doctor or the hospital. Doctors these days tend to enjoy this; for example, if a cardiologist is invited to give a lecture in a cardiology conference it gives the doctor a lot of publicity and exposure. Thus, these are the kind of perks that the pharmaceutical companies offer the doctors and some doctors do opt for it. Also, today within a defined generic drug there are a number of drugs available and across multiple brands. I feel until there is a huge defect in terms of the side effect, there is not really much of a difference in terms of what you prescribe over the other. This is why doctors feel that it does not really make a difference if they prescribe A over B as the effect will be the same. But, as they get added benefits on A they go ahead with it. Thus, the pharmaceutical contribution is influencing the behaviour pattern among physicians today, which should ideally not be the case.

The healthcare and pharmaceutical industry are interdependent. Although there are a few doctors who may be giving in to the benefits and contributions of the pharmaceutical companies, there are also doctors who consider the well being of the patient over everything else. Thus, it is important that the pharmaceutical companies keep the physicians updated on the latest medicines in the market without influencing them.

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Technology Transfer As part of our endeavour to spread the technology culture, this section provides a means to promote and facilitate exchange of select technologies. We strive to bring together suppliers of such technologies with suitable users for negotiations and industrial collaboration.

Technology Offered A novel process Foramides Synthesisamides synthesis The present technology provides with an amidation reaction of unprotected a-amino acids in water under neutral conditions with various aliphatic, aromatic and heteroaromatic amines in the presence of coupling reagent l,l’-carbonyldiimidazole (CDI) at ambient temperature to obtain the corresponding a-amino acid amides. Areas of application Medical and pharmaceutical industry Forms of transfer Technology licensing 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 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 Detection and analysis of heavy metals in the industrial effluents The present technology relates to a device and method for detecting and also measuring the concentration of copper in an industrial effluent. This device comprises of an ion selective electrode (ISE) coupled to immobilise Bacillus sphaericus strain characterized in producing Urease on its one end and to a voltage measuring device which is calibrated to indicate the concentration of the heavy metal in the solvent at its other end. Areas of application Industrial effluents, accumulates Forms of transfer Technology licensing Filter cleaning system An Indian company offers an automatic filter media cleaning equipment with drying system. It consists of air wash, water wash and drying facilities. Areas of application Filter media cleaning Forms of transfer Joint venture, equipment supply Formulation for leucoderma It is well known that these diseases have property of recurrence and most of the medicines used for cure have various side effects and also the disease

is not fully cured. The company offers the formulation that is quite effective in curing all the above three diseases in short period of time. In case of leucoderma after application of the formulation there starts formation of patches (natural colour of skin) within a week. Areas of application Pharma and medical industry Transfer terms Joint Venture, technology licensing, research partnerships Herbal formulation for psoriasis and eczema An Indian company offers an innovative herbal formulation that has the ability to control & cure psoriasis and eczema within one month of application of the formulation. Areas of application Herbal medicine Forms of transfer Joint venture, technical services, technology licensing 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. Areas of application Pharmaceutical industry Forms of transfer Equipment supply Process of preparation of nanoparticles for drug delivery system The present invention is related to a process for the preparation of the novel nanoparticles of apotransferrin or transferrin which are useful for the preparation of a pharmaceutical composition facilitating easy delivery of the drug. Areas of application Medical and pharma industry Forms of transfer Technology licensing Pharmaceutical composition for the treatment of ophthalmic disease A company can offer technology for manufacturing a drug useful in the treatment of opthalmic disorders. A composition comprising Lithium chloride is the product which causes retinal cell regeneration. Areas of application Pharma and medical industry Transfer terms Consultancy, technical services, technology licensing

Technology Requested Biotechnology for wastewater treatment system A Thailand-based company, a wastewater service provider, is involved in the R&D of new technology for water, wastewater and waste treatment. It requires new ideas related to technology for developing its strength in the field of wastewater. Areas of application Biotechnology, engineering Forms of transfer Consultancy

Manufacturing technology of hepatits B, tetanus, diphtheria and pertussis vaccines An Indian company is interested in a complete technology for start up of manufacturing of combination vaccines from bulk to formulations including supply of protocols for manufacturing and production strains. Areas of application Human vaccines Transfer terms Others

Calcium Gluconate A company needs technology for manufacturing of Calcium Gluconate Areas of application Pharmaceutical industry Forms of transfer Technical services, project report, others

Manufacturing of liquid bio fertilisers An agro biotech company is looking for a proven technology for manufacturing of liquid bio fertilisers. They would like to know the kind of technology that could be offered and a procedure of buying the technology along with the cost incurred. Areas of application Biotechnology Transfer terms Others

Extract of medicinal and aromatic plants A 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 IV fluid manufacturing as SME An Indian company needs new and good technology to start which is a subservient of genetic manufacturing of IV fluids. Areas of application Medical technology Forms of transfer Technical services, others Kite grading engineering A company is looking for kite grading, which is a subservient of genetic therapy research particularly for the cardiovascular novice. Areas of application Medical research Transfer terms Others Manufacture of intravenous fluids A company requires know how and technological requirements for the manufacture of intravenous fluids. Know how should include where to obtain appropriate grade raw materials. Areas of application Pharma/medical Forms of transfer Others

Manufacturing technologies for montelucast, rosuvastatin, ursodeoxy cholic acid, D-biotin A company needs API/bulk drug manufacturing technologies for montelucast, rosuvastatin, ursodeoxy cholic acid and D-biotin Areas of application API/bulk drug Forms of transfer Others Pharma grade mannitol knowhow A company is on the look out for a commercially proven latest technology & know how (turnkey) mannitol in India. The estimated production capacity is 600 tonnes per annum. Areas of application Pharmaceuticals Forms of transfer Others Pharmaceutical Lyophilisation plant A Peru based company is looking for a Lyophilisation plant for pharmaceutical use. Capacity shall be around 175 to 200 square feet, for the lyophilisation of 20,000 vials of 10 mL per day. Areas of application Pharma and food processing industry Forms of transfer Others

Information courtesy: Dr Krishnan S Raghavan, In-Charge, Technology Transfer Services Group, Asian and Paciﬁc Centre for Transfer of Technology (APCTT) of United Nations Economic and Social Commission for Asia and the Paciﬁc (UNESCAP), APCTT Building, C-2, Qutab Institutional Area, New Delhi – 110 016, India.Tel: +91-11-3097 3758 (Direct), +91-11-3097 3710 (Board), Fax: +91-11-2685 6274 E-mail: srinivasaraghavan@un.org, Web: www.apctt.org. For more information on technology offers and requests, please log on to www.technology4sme.net and register with your contact details. This is a free of cost platform provided by APCTT for facilitating interaction between buyers and seekers of technologies across the globe. After submitting technology offer or request to this website, you are requested to wait for at least two weeks for receiving a response from a prospective buyer / seeker through this website, before contacting APCTT for further assistance. Share and Solicit Technology The mission of Modern Pharma is to spread the technology culture. Here is an opportunity to be a part of this endeavour by sending your technology on offer or technology requirements. If you belong to any of these two categories, you are invited to furnish the techno-commercial details for publication. The write-up needs to be as per the format of this section with information about the particular technology offered or requested, its areas of application and forms of transfer. Contact us: Modern Pharma, Network18 Media & Investments Ltd, ‘A’ Wing, Ruby House, J K Sawant Marg, Dadar (W), Mumbai 400 028. Tel: 022-3024 5000, 3003 4695 Fax: 022-3003 4499 Email: spedit@network18publishing.com

Mo de rn Ph a rm a •16 -31 Oct o be r 2 012

Projects

New projects and expansion activities are the barometers of industrial growth. These also present business opportunities to service providers like consultants, contractors, plant & equipment suppliers and others down the value chain. This feature will keep you updated with vital information regarding new projects and capacity expansions being planned by companies in the pharma/lifesceinces industry. Manufacture empty hard gelatine capsules Project type: New facility Project news: Golden Sands Bio Sciences LLP is planning to set up a new pharmaceuticals project at South Goa in Goa. The project involves manufacturing of drugs medicine & allied products (empty hard gelatine capsules). Project location: Cuddalore, Tamil Nadu Project cost: NA Implementation stage: Planning Contact details: Golden Sands Bio Sciences Llp 97 A D”costa Road,

Margao, Salcete, South Goa – 403601 Manufacturing of indomethacin 25 mg oral capsules Project type: New facility Project news: Raptim Research Ltd is planning to set up a new pharmaceuticals project at Greater Mumbai (Mumbai) in Maharashtra.

Projects A-226, TTC Industrial Area, Mahape MIDC, Navi Mumbai 400 701 Tel : +91-22-2778 1887/1889 Website: www.raptimresearch. com/ Manufacturing of ketoconazole Project type: New facility Project news: Sharon Bio Medicine Ltd is planning to set up a new pharmaceuticals project at Solapur (Sholapur) in Maharashtra. The project involves manufacturing of Ketoconazole. Project location: Solapur(Sholapur), Maharashtra Project cost: NA Implementation stage: Planning Contact details: Sharon Bio-Medicine Ltd C-312, BSEL Tech Park, Sector 30(A), Vashi, Navi Mumbai- 400703 Tel : 91 22 67944000 Fax : 91 22 67944001 Email : info@sharonbio.com Website: www.sharonbio.com Manufacturing of lactofrex capsules Project type: New facility

Project location: Greater Mumbai (Mumbai), Maharashtra Project cost: NA Implementation stage: Planning Contact details: Raptim Research Ltd

Project news: Raptakos Brett & Co Ltd is planning to set up a new pharmaceuticals project at Raigad (Kulaba) in Maharashtra. Project location: Raigad (Kulaba), Maharashtra Project cost: NA Implementation stage: Planning Contact details: Raptakos Brett & Co Ltd 253,Dr Annie Besant Road Hanuman Nagar, Worli, Mumbai- 400030 Mahrashtra Tel : 022 4085 6000 Website: www.raptakos.com Manufacturing of tablets and capsules Project type: New facility Project news: Cosmas Research Lab Ltd is planning to set up a new pharmaceuticals project at Ludhiana in Punjab. The project involves manufacturing of tablets and capsules.

Implementation stage: Planning Contact details: Cosmas Research Lab Ltd B-1/1446/10-B, Y- Block Crossing, Hambran Road, Ludhiana - 141001 Punjab Tel : +91 (161) 2306571-72-73-74 Fax : +91 (161) 2300495 Email : info@cosmas.in Website: www.cosmas.in Cyclophosphamide for Injection project Project type: New facility Project news: Sushen Remedies Pvt Ltd is planning to set up a new pharmaceuticals project at Ujjain in Madhya Pradesh. The project involves medicine pharmaceuticals such as tablets, capsules, syrups etc. Project location: Ujjain, Madhya Pradesh Project cost: ` 40 crore Implementation stage: Planning Contact details: Sushen Remedies Pvt Ltd 224, Appolo Tower, Indore, Madhya Pradesh

Project location: Ludhiana, Punjab Project cost: NA

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Mo de rn Ph a rm a •16 -31 Oct o be r 2 012

Event List

N AT I O N A L E V E N T S Indian Lab Automation conference and exhibition ILA 2012 will feature three technical conference tracks; ‘Drug Discovery and Development’, ‘Advances in Bioanalysis’ and ‘Advances in Genomics and Informatics.’ The event will also provide excellent networking opportunities. Each track will provide attendees with the opportunity to listen to presentations on cutting edge research in specific application areas, with an underlying theme of automating the technique, equipment or associated informatics; October 30-31, 2012, Renaissance Hotel & Convention Centre, Mumbai For details contact: Select Biosciences Ltd Tel: +44 1787 315110 Fax: +44 1787 315111 Email: enquiries@selectbiosciences.com Website: www.selectbiosciences.com

Automation 2012 This is a prolific trade show that strives to present a wide range of scientific, laboratory, biotechnology equipment. The visitors will be highly benefitted from the event as there will be a conference too at the event. The event will also provide excellent networking opportunities. The event will be focussing on clinical research and will be attended by industry leaders; November 2-4, 2012, Hyderabad International Trade Exposition Centre, Hyderabad

For details contact: S D (India) Corporation Tel: + 91 11 4703 4600 Fax : +91 11 4705 6500 Email: info@indialabexpo.com Website: www.indialabexpo.com

P-MEC India P-MEC India, the most well attended and talked about Pharmaceutical Machinery, Equipment and Technology event. In this event the leading Indian and international pharmaceutical machinery exhibitors showcase their latest technologies and announce product launches. P-MEC focuses on key challenges in pharmaceutical services to develop more efficient production routes and systems of increasingly complex healthcare products. Technology demonstrations and onsite seminars will complement your visit to the show floor; November 21 - 23, 2012, Bombay Exhibition Centre For details contact: Chaitali Davangeri UBM India Pvt Ltd Tel: +91-22-6612 2642 Email: chaitali.patil@ubm.com Website: http://www.pmec-india.com/

Pharma Biotech Expo & Conferences Pharma Biotech Expo & Conferneces is an exciting new networking platform & international exhibition for pharmaceutical machinery & equipment, biotechnology & applications industry. The event will be a preferred destination for the pharma

AHMEDABAD

PUNE

CHENNAI

LUDHIANA

Gujarat, Oct 5-8, 2012

Maharashtra, Nov 2-5, 2012

Tamil Nadu, Nov 22-25, 2012

Punjab, Dec 21-24, 2012

INDORE

AURANGABAD

RUDRAPUR

HYDERABAD

Madhya Pradesh, Jan 11-14, 2013

Maharashtra, Feb 1-4, 2013

Uttarakhand, Feb 23-26, 2013

Andhra Pradesh, May 31- June 3, 2013

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

For details

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and biotech and it will attract more than 10,000 visitors & exhibitors with 100 stalls; November 21-23, 2012, Hotel Le Mariet, Baddi

Tel: +91 80 41131912 Fax: +91-80-41131914 Email: jagdish@mmactiv.in Website: www.mmactive.in

For details contact: Paramount Exhibitors Tel: + 91 172 2274801 Fax: + 91 172 2274803 Email: contact@paramountexhibitors.com Website: www.paramountexhibitors.com

Pharma Technology Show – Delhi

Bangalore Nano Bangalore Nano event has truly emerged as the premier event for research fraternity and industry to come together and explore emerging opportunities in this sector. The event comprising of exhibition & conference will encompass two full days of presentations and discussions and interactive networking activities; a meeting place for the global scientists, industry, academia & government with a focus on ‘Frontiers of Nanotechnology: Impact on India’; December 5-7, 2012, Hotel Lalit Ashok, Bengaluru For details contact: MM Active Bengaluru

The event aims at bringing together world renowned companies as well as newly launched companies on one platform. It is an invitation to all those who want to seize this opportunity and to further galvanizing their position to take share of this lucrative market. The expected visitors will be the CEOs & top executives from pharma manufacturing industry, executives from production, quality control, R&D & purchase departments, professionals from R&D institutions, pharmacists from trade & profession, biotechnology specialists, top officials from regulatory agencies; December 7-10, 2012, India Expo Centre and Mart, Greater Noida For details contact: Print Packaging.com Pvt Ltd Tel: +91 22 27812619 Fax: +91-11 41722130 Email: info@indiapackagingshow.com Website: www.print-packaging.com

I N T E R N AT I O N A L E V E N T S 2012 Nanotechnology Conference The event aims to bring together a panel of highly-accomplished nanotechnologists and well recognised authorities in various aspects of nanomedicine. This unique international conference offers an opportunity for pharma scientists, clinical researchers, physicians, therapists and industrial leaders to discuss the important international breakthrough developments in drug discovery, drug development, drug delivery, drug therapy and commerce to share their thoughts and exchange ideas and knowledge. It will also serve as a platform for networking. The fourday conference will focus on the basic studies through translational efforts and clinical trials and address topics of novel issues concentrating more on recent advances, difficulties, and breakthroughs. October 31- November 3, 2012, Riviera Maya, Mexico For details contact: Zing Conferences Tel: +44 1223 750020 Fax: +44 1223 280270 Email: info@zingconferences.com Website: www.zingconferences.com

International Conference of National Strategies for Torch International Conference of National Strategies for Torch, Chlamydia trachomatis and human papilloma virus will address the latest clinical

diagnostic, economic and scientific achievements in the practical and scientific medicine to meet the needs and interests of immunologists, allergists, laboratory specialists, gynaecologists, dermatovenereologists, infectology, microbiologists, health professionals. In addition, there will also be a large industrial exhibition in the new and interesting way; November 15-16, 2012, Kiev, UK For details contact: NBScience Ltd Tel.: +38 044 233 27 70 Email: med@nbscience.com Website : www.nbscience.com

ICAR2012 The second International Conference on Antimicrobial Research (ICAR2012) will be a forum for the presentation, exchange and dissemination of information and experiences on anti-microbe strategies, in biotic or abiotic environments, in planktonic or adhered states, in biologically specific or unespecific ways, in vitro or in vivo, in a general context marked by the threat posed by the increasing antimicrobial resistance of pathogenic microorganisms; November 21-23, 2012, University of Lisbon, Portugal For details contact: Formatex Research Centre Tel: +34 924 258 615 Fax: +34 924 263 053 Email: info@icar-2012.org

ICBMS’12 International Conference on Biological and Medical Sciences (ICBMS’12) aims at presenting the current research being carried out in that area. This conference is covered under International MultiConference on Chemical, Ecological and Biological Sciences (IMCEBS’12). The idea of the conference is for the scientists, scholars, engineers and students from the universities all around the world and the industry to present ongoing research activities, and hence to foster research relations between the universities and the industry. This conference provides opportunities for the delegates to exchange new ideas and application experiences face to face, to establish business or research relations and to find global partners for future collaboration; December 29-30, 2012, Grand Seasons Hotel, Kuala Lumpur, Malaysia For details contact: International Scientific Academy of Engineering & Technology Email: at info@isaet.org Website: www.isaet.org

Bioinformatics 2013 The purpose of the international conference on bioinformatics models, methods and algorithms is to bring together researchers and practitioners interested in the application of computational systems and information technologies to the field of molecular biology, including for example the

use of statistics and algorithms to understanding biological processes and systems, with a focus on new developments in genome bioinformatics and computational biology; February 13, 2013, Barcelona, Spain For details contact: Bioinformatics Secretariat Tel.: +351 265 100 033 Fax: +44 203 014 5436 Email: bioinformatics.secretariat@ insticc.org Website :www.bioinformatics.biostec.org

International Conference on Life Science & Biological Engineering The aim objective of LS&BE 2013 is to provide a platform for researchers, engineers, academicians as well as industrial professionals from all over the world to present their research results and development activities in networking and digital society. This conference provides opportunities for the delegates to exchange new ideas and application experiences face to face, to establish business or research relations and to find global partners for future collaboration; March 15-17, 2013, Tokyo, Japan For details contact: Kwansei Gakuin University Tel: 81 798 54 7394 Fax: 81798 54 6082 Email: craig.mark@kwansei.ac.jp Website : www.lsbe.org

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

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Event Preview

India Lab Expo 2012

Providing an ‘exchange’ platform for the pharma industry With increasing inventions being made in the field of biotechnology, India Lab Expo felt the need to bring forth a platform where not only local people, but from all over the world can come together and share the inventions to benefit each another. Here’s what the event withholds this year. Glimpse from the past

Jasleen Kaur Batra jasleen.batra@network18publishing.com

ndia Lab Expo, one of the largest exhibition and conference in South East Asia for laboratory, analytical, biotechnology and scientific instruments is scheduled to be held from November 2-4, 2012 at Hitex Exhibition Center, Hyderabad, India. India lab Expo has become the biggest platform within a short span of time and is growing continuously at the rate of 25 per cent every year in terms of number of exhibitors and visitors. The last three exhibitions were held in the year 2009, 2010 and 2011 at Pragati Maidan, New Delhi, but on the demand of exhibitors

and many end users of these equipment from South India, it has been shifted to Hyderabad for its 2012 edition.

Focussing on a 360 degree coverage

The purpose of this exhibition and conference is to bring together all the manufacturers, importers and exporters from all over the world with latest instrumentation and technology on a common platform in India. The exhibition was started in the year 2009 with only 135 exhibitors but this year, the India Lab Expo is expected to have more than 270 exhibitors from India as well as abroad. This year, the event is expecting more than 40 foreign companies such as Germany, US, UK, Hungary, Switzerland, Italy,

Canada, China, South Korea, Russia, Taiwan, Sweden, Nederland and more. Also, more than 25 foreign principals are participating through their channel partners in India. There are four International pavilions, which includes Germany and China.

The plus points

Most of the regular exhibiting companies use India Lab Expo as a platform to conduct business and conclude successful business deals. The event also showcases an array of leading scientific experts and dignitaries who attend the exhibitions and conferences. David, International General Manager, Grand Instruments UK, said, “India Lab Expo continues to be the exhibition of the year for Grant

and we intend to participate in 2012 with a larger presence that reflects our image and our commitments to our customers and partners in the region.” India Lab Expo is the unique showcase, drawing buyers, specifies endusers and trade suppliers from around the world. All the industry’s foremost companies are keen in visiting in 2012 show. Extending their full support to the exhibition are associations and International partners like Scientific & Surgical Instruments Dealers and Manufacturers Association (SIDMA) Mumbai, Scientific Instruments Dealers & Manufacturers Association (SIDMA) Delhi, Bulk Drug Manufacturer’s Association (BDMA), Karnataka Drug’s & Pharmaceutical’s Manufacturer Association, Korea Scientific Instruments Industry Cooperative (KSIIC), Arab Lab (Dubai), Lab Asia (Malaysia), CISILE (China), Korea Lab (South Korea) and Thailand Lab (Thailand), etc. Apart from these associations and international exhibitions, almost all the major trade magazines and portals are supporting us. India Lab Expo 2012 will present speakers from top organisations who will educate and deliver lectures on latest development and trends in laboratory instrumentations and applications. The conference programme will feature a series of branded seminars dedicated to presentation networking platform delegates. The event is sure to be a big success.

Mo de rn Ph a rm a •16 -31 Oct o be r 2 012

Event Report

International workshop on patient safety and drug detection technology

Focussing on identifying the loopholes

Spurious drugs are becoming a major public health concern across the globe, and India is no exception. Partnership for Safe Medicine India (PSM), in collaboration with WHO and Ministry of Health, Government of India, tries to trace a blueprint to curb the circulation of sub-standard and false drugs in the supply chain.

Misra addressing the International Workshop on Patient Safety and Drug Detection Technology

Nikunj Sharma nikunj.kumar@network18publishing.com

he market for spurious drugs in India accounts for nearly 15-20 per cent of the overall medicine trade in the country reaching $ 600 billion, according to a FICCI report in 2012. However, the 2007 report of WHO survey restricts this projection to 3.1 per cent of total suspected drugs samples, while only 0.3 per cent of medicinal products were found deviating from the pharmacopoeia standards. The International workshop on patient safety and drug detection

technology was held on September 10-11, 2012 at India Habitat Centre, New Delhi to provide a blueprint for medicine safety and stringent regulatory system in the Indian marketplace. The objective of the conference was to devise an effective mechanism to stop falsely drug manufacturing and supply in India. A brochure of PSM was released during the event, which contains various measures and awareness programme conducted by this organisation along with a toll free helpline number for drug authentication.

The ‘spuriousity’ menace

Factually, every third drug of overall drugs sold in India is spurious, according to the survey of several NGOs, which is

definitely a huge deviation from official data. The role of state legislature is more vital to handle the issue through improved co-ordination with the central government. More consumer education and awareness, enhanced supervision throughout the supply chain, and better prosecution & regulatory environment is needed for checking the circulation of these drugs in the domestic and global markets. As India is a leading exporter of APIs in various global marketplaces, the issue becomes more complex with respect to the individual brand integrity and country’s image on global platform. Speaking on the issue, Bejon Misra, Founder Director, Partnership for Safe Medicines India, said “The partners will work closely to develop a blueprint with a specific timeline to design a strategy to implement the use of detection and authentication technologies to make spurious and unsafe medicines easily detectable and take prompt action against all such manufacturers who violate the laws and standards of our country by working closely with the state regulators and law enforcers.” “No doubt technology can play a major role to track and trace the menace of spurious drugs but the need of the hour is to evolve a more holistic approach that ensures involvement of all stakeholders in the supply chain,” said Jeffrey Gren, Director, Office of Health and Consumer, Goods, US Department of Commerce.

Streamlining the essentials

First day of the conference addressed some major issues related to the regulatory enforcement on spurious drugs that comprised three technical sessions including challenges involved in accessing quality medicine, regulatory outlook and long-term strategy based on drug detection technology. On day two, the discussions emphasised on early drug detection technologies and importance of serialisation followed by a concluding remark on creating a roadmap to deliver improved patient safety. Till date, globally, there is no single panacea is available that can analyse all aspects of a specific drug. A combination of various technologies is needed for thorough identification and authentication of a medicinal formulation, not only from ingredients perspective but also from packaging and labelling point of view. Many countries, including the US, UK and Singapore are dealing the issue with stern regulatory enforcement and have been able to reduce the presence of spurious drugs in their respective marketplaces. On a success note, comparing with its market complexity and consumer base, India also fared well in handling this issue. However, given the complex legislative and distribution infrastructure inthe country, the regulators need to smartly select the practical and effective means of implementing stringent norms for drug supply and manufacturing in India.

invite that

rewards as well... Dear Reader, ‘Modern Pharma’ solicits original, well-written, application-oriented, unpublished articles that reflect your valuable experience and expertise in the pharmaceutical industry. You can send us Technical Articles, Case Studies and Product Write-ups. The length of the article should not exceed 1,200 words, while that of a product write-up should not exceed 100 words. The articles should preferably reach us in soft copy (either E-mail or a CD). The text should be in MS Word format and images in 300 DPI resolution & JPG format.

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In Conversat

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Sohang Chatter jee Director and Chief Inbiopro Solution Executive, s Pvt Ltd

India gener cancer drugics giant wins patent case CIPLA has

Special Focu

s 19

Regulations in parenterals and injectables manufacturing conundrum

Managing the

Interface

Murali Sundra ni Business Director , BD Pharma ceutical Systems

Automation

BD to enhanc e val with specia ue of biotech delive lised pre-fi ry llable syring devices es

- Shibani Shah

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Trends 21

Pharm‘a Reducing manual utomated’ intervention for better productivity

GoM appr Pharmaceu oves the National tical Pricin g Policy

scored a landma win in a rk court patent challen by Switzer land’s Roche ge launched Holding over the Mumb ai firm’s version cancer drug. of a lungDelhi High Manmohan Court Justice Singh ruled THE Group drug, Erlocip that Cipla’s of , Sharad Pawar, Ministers (GoM) under Roche patent did not violate the Chairman, government, on its anti-lun Ministers Group of medication Ranjit Shahan – National g cancer Tarceva due Organ isation i, President, Pharmaceutic Pricing Policy to its differen molecular of Pharm (IPA), said, al Produ (NPPP) have make-up. “It t aceuti cal approved the is a judgment in finally “We cers of India “1. All formul NPPP to contro (OPPI) said, a patent case. landmark of all 348 acknowledge ations (654) has taken The court essential drugs l the prices the of 348 drugs specifie all efforts to the rights Government the weight and adopte d in the Nation bulk analyse claims of both parties of ed average d medic to of Essential al List price to cap the ines availab make essential Medicines scientific evidencin terms of legality and prices. This mechanism vulner 2011 (NLEM le to the are brough the All India able section t under price ) comes after most a patent lawyer e,” said Pratibha Singh, Organisation s of society control. This will constit affordable who represe and Drugg of Chemists ute about prices. The at nted Cipla. ists 30 of the total will have new propos (AIOCD) pharmaceutic per cent an impact Quintiles ranks al had Currently, on industr written a 6th in Inform about 18 per al market. y as tion Week letter amarket is 500 to under price cent of the QUINTILES Shara d 2. The prices contro Pawar , of these formull. InformationW ranks 6th in this year’s to will be fixed ations urgently finalise top techno eek 500, a list of the Average Price by taking Weighted logy the new United States. innovators in the (WAP) of drug having all brands The annual at least pricing policy revealed on list was Market Share 1 per cent or more September that seeks (MS) by an awards 11, 2012, 3. This will to at ceremony determine impact about volume. in CA. The 62 per cent of the NLEM driving factor Dana Point, prices year’s Inform behind this a other words, market by value. In ationWeek which pharm t prices will was Quinti 500 rankin a for almost be reduced les’ g companies two-th Lilly on an collaboration with value of NLEM irds of the sales Eli sell essent re-engineer IT-enabled project medicines. ial 4. The averag to the medicines e price reduct planned and way clinical trials are in the be about designed. retail marke 11 per cent. ion will The ultimat goal of this price reducti However, e collaboration This will dispelt. on of some develop an was to for many medicines integrated Shahani the uncert large compa approach eliminates ainty that domestic costly ineffici presently prevail and foreign nies, both uses ‘big Shah , will be high as up ing in the data’ to drive encies and benefit the as to 75 per development better drug patient fratern market and the cent. A study shows that decisions. span of price industry at ity and the prices of 60 large. contro NLEM medici per cent of increase to In the letter cover around l will now Biological E by more than nes will be reduced to Pawar, of the pharm Ltd launch 30 per cent President, J S Shinde JEEV, a vaccine aceutic es JEEV AIOCD, has 5. The averag 20 per cent. , marke the need also reitera t-based policyal market. Still, a to tackle e revenue Encephalitis for ted formul loss to the industry is is a balanc was launch Japanese pricing policy a market-based drug a and will estimated Indian pharma ed ed by an help improv at to best addres per cent to availability needs and e the 17 per cent.” about 15 the country , Biological E Ltd. It of essenti balance industr s patient for ’s first indigen is al The patient medicines envisioned GoM would y growth as s.” to tackle JE ous vaccine in the soon send recommendatio priced at ` Highlighting the Acknowledgi draft NPPP 2011. 985, the vaccine will be availab ns to the the special for a final ng the move the policy, Cabinet le features of DG call market. In due in the private domest by the essential drugs to bring all 348 ic Indian PharmShah, Secretary Genera course, it will The drug is l, be exported. aceutical Ministry under listed by the Health based on a Association vaccine made by Austrian price contro vaccine maker l. Hyderabad-ba Intercell. The - Arshia Khan sed vaccine set to produc producer is e can be up scaled10 million doses, which It also produc based on the deman d. es vaccines IN its’ series diphtheria, for tetanus of Hib, etc. , fillable syring BD Hypak glass prees Becton Company Dickinson Governmen has design & t approves ed syring es foreign pharm eight conven ience, for biotec specialised a investments h drugs order to regula tory INDIA has and pharm in provid e agenci es approved better patien a customer convenience eight investments years ago needs. Few t in drugmakers foreign we realise compa tibility through auto injecto 333 million d that tungst worth $ can form r in en residu e in interac tions , reduce d contai ner finance ministr total, signalling the syringes if the norma due to low tungst filled with l and reduce battle to open y may be winning biotech drug. The biotec en d number a h defects. of cosme growing market up the country’s fastlarge protein drugs mostly have tic s and molecules giving Adding new global drugm tendency and have akers hungry a boost to to interact BD has come feathers to their cap, However, for growth with impur a like tungst up with BD the govern . ities en, biotec ment said Hypak for foreign compa h and BD protein aggreg which can lead the Neopak. BD nies includi to is curren ation that Pfizer and ng US-based Hypak the efficac tly used can hampe Germany’s Business y as r of produ a the B-Brau standa rd have to contin product.” ct for n would Director BD has done Medic al , ue produc systems. BD pre-fil lable delive drugs and – ing cheap ry System Pharm aceuti B D and developed extensive research maintain alread y commHypak for biotech s proces cal spending ongoing R&D in s capabilities to offer is “BD India, in Hypak market, includ erciali sed in world said, fillable these next genera Indian partner projects run by their tion preing India. Neopa k are for biotech and syringe system s for five years. Murli BD help two advan pharm a partne s, which can keepin ces made Sundra rs to better n i , nature g in mind the positio n and offer sensiti of biotech the sensiti drugs, patien ve biotech formu ve lations. ce

Senior Editor Modern Pharma

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D +91 22 3003 4669 T +91 22 3024 5000 F +91 22 3003 4499 E manas@network18publishing.com W www.network18publishing.com

Mo d er n P har ma•16 -31 Oc t ob er 2 012

Event Report

BIO India International Conference 2012

Emphasising on collaboration and investment for the biotech industry This year BIO India International Conference, held during September 12-13, 2012, aimed to discuss ways through which the US and Indian industries can work together to facilitate the development of new biotechnology products and commercialisation. A glimpse…

Chandreyee Bhaumik chandreyee.bhaumik@network18publishing.com

he 3rd annual BIO India conference, organised by Biotechnology Industry Organization (BIO) in partnership with Association of Biotechnology Led Enterprises (ABLE) witnessed the industry body addressing key issues in tandem with major industry players. At BIO India International Conference 2012, views were expressed on public policies that are intended to bring about innovation, collaboration and investment in the biotech sector, particularly strong Intellectual Property (IP) protections and regulatory mechanisms.

Major highlights

The industry captains led by Kiran Mazumdar – Shaw, Chairman and Managing Director, Biocon; H Thomas Watkins, Former President & CEO, Human Genome Sciences, Inc along with industry organisation heads – Alan

L-R: Watkins, Kiran Mazumdar, Eisenberg, Dr Murali

Eisenberg, E VP, Emerging Companies and Business Development, BIO and Dr P M Murali, President, ABLE lay thread bare issues like strong IP as well as patent enforcement, strong tax and regulatory system, strong support for R&D, streamlined safety and efficacy testing and approval process. Further, the event witnessed discussion on issuance of India’s guidelines on similar biologics is a step in the right direction. Commenting in this regard, Eisenberg said, “The guidelines recognise the scientific and regulatory complexities presented by the development and manufacture of biologic medicines. What follows next is industry collaboration in the implementation of these guidelines in a manner that continues to protect patient safety and ensure continued research and development of new cures and treatments.”

Plethora of opportunities

The two-day conference offered opportunity for large and small biotech companies to gather in one place and engage in partnering discussions with biotech leaders from around the world. The second day of the event saw a session on ‘Commercializing Stem Cell Therapies and Regenerative Medicine’ with B N Manohar, Managing Director and CEO, Stempeutics Research Pvt Ltd; Virender S Sangwan, Associate Director, L V Prasad Eye Institute (LVPEI); and Chandra Viswanathan, Head of Regenerative Medicines Group, Reliance Life Sciences as panelists. Next, a keynote and plenary luncheon on ‘Strategies for Success: India’s Global Role in Innovation’ was held with Achin Gupta, Director, Strategic Planning, Abbott Laboratories; Phil Kearney,

Director, External Scientific Affairs, Worldwide Licensing, Merck; Chaitanya Saxena, CEO, Shantani Proteome Analytics; Renu Swarup, Adviser, Department of Biotechnology, Ministry of Science & Technology, Government of India; and Holly Vineyard, Deputy Assistant Secretary for Africa, the Middle East, and South Asia, US Department of Commerce, International Trade Administration as panelists. Thus, in the event the participants came from varied segments ranging from the US and Indian industry, academia and government, who shared their views on critical issues important to the development of the Indian biotechnology sector, including IP, R&D collaboration and regulation of biotechnology products.

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Event Report

Best Practices in Hospital Logistics, Inventory & Store Management

Making a material difference to patient care With an objective to achieve academic excellence, the Department of Hospital Administration, AIIMS in collaboration with Research Foundation of Hospital and Healthcare Administration (RFHHA) had organised a two-day HxMDP on ‘Best Practices in Hospital Logistics, Inventory and Stores Management’ at India Habitat Centre, New Delhi during September 14-15, 2012.

FHHA is founded with the aim to function as a scientific body promoting research and other academic activities that are likely to benefit art and science of profession of hospital administration and management in India and South-East Asia. The conference was held with the objective to make healthcare professionals including medical directors, medical superintendents, hospital administrators, stores and purchase officers aware about such practices so that these can be implemented in different organisations to contain costs and improve quality of patient care. The event was partnered by TAHPI and CIPLA. The conference was unique as it had expert speakers drawn from various prestigious organisations namely, Ministries of Health & Family Welfare, Defence, Commerce, TN Medical Services Corporation Ltd. (TNMSC), Central Vigilance Commissioner (CVC), National Informatics Centre (NIC) and AIIMS.

Experts’ point of view

Speaking on the occasion, Dr Surinder Singh, Director, National Institute of Biological Sciences, Ministry of H&FW, GOI and former Drug Controller Governor of India (DCGI) highlighted the strengths of the Indian pharmaceutical industry. He apprised that with over 8,000 manufacturing units, the Indian pharmaceutical industry is 3rd largest in the world volume wise and 12th largest value wise; thus proving that India is undoubtedly the hub of cheap drugs exported globally. Indian vaccines are exported to 151 countries across globe. He further stated that the cost of ART per patient has come down to $ 316 from $ 50,000 with initiative of Indian pharmaceutical companies. Qualitatively also, Indian pharmaceutical companies are not lagging behind and have invested ` 3,000 crore into R&D, which is 100 times more than the sum invested only a few years ago. The companies are moving up the R&D ladderfrom drug formulations to drug discovery development and ever greening of patents. Dr Singh assured the audience that the Indian generics (generic- generic

Dignitaries on the dais

and branded -generic) were as safe and efficacious as their expensive branded counterparts and must be promoted by physicians to make medical treatment affordable. Quoting the example of ‘Nagaur model’, he stated that the district administration of Nagaur, Rajasthan, has managed to free the public health system from the stranglehold of pharmaceutical companies by adopting a multi-pronged approach. Doctors were persuaded to prescribe only generic medicines, which were made available by opening government medical stores in state run health centres and hospitals. Busting some of the misperceptions associated with pharmaceutical industry, he clarified that Indians are not made guinea pigs in clinical trials contrary to general impression. Only 1.5 per cent of 2,812 drug trials are being conducted in India. The figures of subjects dying during drug trials quoted in lay press are inflated, since deaths are not due to adverse effect of drugs per se, but due to primary illness of the participating subjects. On the controversial issue of counterfeit drugs, he challenged the exaggerated figures of up to 40 per cent being quoted in industry. He conceded to only 0.46 per cent drugs are spurious, based on studies carried out by CDSCO. However, the DCGI has refused to collaborate with Interpol in clamping down on sub standard drugs. He apprised the audience about DGCI initiatives like eGovernance, mobile drug testing labs, bar coding and UID, ‘trace and track’ technology to authenticates drug samples, opening of generics retail outlets ‘Jan Aushdhalyas’ to make drugs affordable to masses and need to strengthen pharmacovigilance in the industry. He exhorted States to follow ‘Thiruvanathapuram Declaration’, wherein five states have decided to collaborate on all issues related to drug policy and efficient inventory management of drugs.

Evaluating DCGI’s role

Speaking on Day-2 of the conference, Dr S Eswara Reddy, Asstt DGCI, elaborated on ‘Good manufacturing practices and drug regulations’. He stated that GMP and QA are the corner stone of a good pharmaceutical industry. It pertains to entire value chain of manufacturing and supply from procurement of raw materials, prevention of contamination/cross contamination, APIs, and quality of indoor air, effective quality control, a system of proper documentation and proper storage and distribution of drugs. However, the country’s drug regulator, DCGI, as of now is not in pink of health, admitted both the speakers. Out of the 27 drug testing labs in the country, only seven are available for carrying out proper checks. There are shortfalls in the number of drug inspectors also. Ideally, the ratio between drug inspectors and chemist’s shops should be 1:60 but in our country the ratio is much more. The Ministry of H&FW seeks to introduce a quality mark for the ` 35,000-crore generic drugs market to enable consumers distinguish between quality and substandard medicines. DCGI has also failed to create a conducive environment for indigenous manufacturing and trial of medical devices- so vital for accurate diagnosis and clinical outcome. As of now, only 14 medical devices have been notified under Drugs and Cosmetics Act. Due to unfavourable policies and ineffective regulation, the sophisticated medical devices and biomedical equipment has to be imported making healthcare delivery unaffordable for most people. The Indian industry’s long pending demand of creating a device management regulations authority –DMRA and put it under Ministry of Science and Technology, has not been accepted. However, Drugs and Cosmetics Act is to become amended to include devices as well, hopefully in next session of parliament, not

withstanding that management of medical devices requires expertise of biomedical engineers. Dr Shakti K Gupta, HOD of Hosp Adm and MS, Dr R P Centre for Ophthalmic Sciences & JPNA Trauma Centre, AIIMS, spoke on ‘Medical Equipment Management Issues, Challenges & Strategies’. He emphasised the need for involving all stakeholders in decision making and considering life cycle cost during evaluation process of medical equipment procurement. He advocated that a tripartite agreement be signed between the user (hospital), vendor (MMA) and OEM with a Comprehensive Maintenance Contract (CMC) for 5 years including software upgradation, training of staff and additional contact of 5 years with free service and paid spares. He added that the role of biomedical engineers and technicians cannot be overemphasised in entire equipment management lifecycle. He also shared his successful experience of running a 24*7 pharmacy outlet at AIIMS offering discount of 56 per cent on drug MRP.

Lengthening the yardstick

There were about 200 select senior level officials from public as well as private sector hospitals, leading luminaries including directors and deans of various hospitals, principals of medical colleges, logistics and supply chain management and inventory management, IT and inventory experts, stores and purchase officers. Overall, the conference offered a great learning opportunity in effective and efficient management of materials in containing cost, optimum utilisation of equipment, achieving efficiencies in hospital logistics operations and improving quality of patient care.

Gp Capt (Dr) Sanjeev Sood Hospital Administrator and NABH Assessor Assessor (doc_ssood@yahoo.com )

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Event Report

2nd Pharma Supply Chain Forum

The success barometer swings again Discussing several facets of supply chain management, the 2nd Pharma Supply Chain Forum saw another year of success. Reflecting on how important is supply chain for the pharma industry, the experts from the industry shared their views during the event. Read on… Chandreyee Bhaumik chandreyee.bhaumik@network18publishing.com

he 2nd edition of Pharma Supply Chain Forum was successfully held on September 27, 2012 at Taj Lands End, Mumbai. The theme of the forum was ‘Agile, Efficient Supply Chain.’ This forum was a part of the 6th Express, Logistics & Supply Chain Conclave that was held on September 27-28, 2012. The 2nd Pharma Supply Chain Forum was conceived & managed by Kamikaze B2B Media and supported by Startrek Logistics Pvt Ltd & Penta Freight Pvt Ltd.

Audience in rapt attention

Forum of experts The entire event forum had a mix of panel discussion sessions and individual presentation sessions. Wellknown industry experts spoke on various topics.

Take aways These prominent industry veterans shared their views and expertise on the topics such as ‘Collaboration with strategic partners to manage your supply chain on a global level’, ‘JIT in Pharma SCM’, ‘Supply Chain Capability

Building in the Pharmaceutical industry’. The panel discussion on ‘Building an integrated supply chain network to achieve high level of accuracy in forecasting, sourcing and inventory management’ discussed that in order to get an organised supply chain management what is important is integration, planning and forecasting. It advocated that one should always remember that the products of the pharma industry are varied in nature. Formulation of a strategy is easy but what is difficult is the execution part

of it. Further, the experts remarked that accuracy is the main aspect of this integration and what is needed is electronic, workflow and people integration.

Summarising Talking about how the logistics segment is vital for every industry, especially the pharma industry, the event proved to be a huge success. The event reinstated that the supply chain and optimisation go hand in hand.

Book Review

Editor: David M Bliesner Price: ` 6,700

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

Identification and Determination of Impurities in Drugs

Editor: S Gorog

An important task of an analytical chemist is the assessment of impurities related to the finished formulation. This is an integral part of the safety evaluation of any formulation. This book elucidates most of the techniques; new and old, involved in this process. The initial introduction to the topic details the types of impurities, their toxicities, the role in drug development and regulatory requirements. The second part deals with organic impurities and the multiple techniques of analysis. The chapters on HPLC, its modifications, chromatography and NMR spectroscopy are most informative among the plethora of techniques described in the section. The later parts deal with inorganic impurities, impurities arising from residual solvents, and degradation products. Each explores the methodologies involved in assessing the specific impurity. The chapter on enantiomeric impurities is good for Indian analysts as there is a huge enantiomer industry in India. The chapter on polymorphisms gives an insight into the revival of older concepts such as the C V Raman effect and its modern application using newer technology. The review of biological impurities in antibiotics, animal products and biologicals also gives a good insight into the needs and regulations of that industry. The book concludes with a special look into antibiotics, steroids, peptides and biologicals. A good book for an analyst to review the historical as well as latest techniques available for the evaluation of impurities in drug formulations.

Price:

Establishing A CGMP Laboratory Audit System In the present regulatory scenario, pharmaceutical companies and their laboratories need to be compliant with GMPs in its strictest sense. There is a need to establish a good audit system in the lab to ensure compliance with cGMP. The book is a ready reckoner of all the aspects of a lab audit with respect to cGMP. The author has used tables, flow charts and checklists to provide ready solutions to the lab audit process. The introductory chapter sets the pace of the book with exploring quality systems, need for lab audit, phases and integration – modification – scale up of existing programmes. The chapters on audit preparation, data capture, organising data & result reporting, and development and implementation of corrective action plan, verification plan and monitoring plan take a step by step approach to the issue being explored. Every step in the process is discussed separately with flow charts and checklists designed to make sure there is minimum commission of error or omission of a vital step. The book also comes with proprietary software that gives easy solutions and faster problem solving tips to audit-related issues. This is a good practical guide for laboratories to ensure cGMP compliance, faster lab audits and troubleshooting. Reviewer: Dr Mandar Kubal, Director, Infectious Diseases & Pulmonary Care Pvt Ltd

` 1,895

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

Mo de rn Ph a rm a •16 -31 Oct o be r 2 012

Products Ultra-low temperature freezer Ultra-low temperature freezer provides outstanding sample protection, sample storage capacity and energy efficiency for ultra-low temperature storage requirements. The freezer is equipped with a unique touch screen control panel that features an event log, health monitoring system and controlled access options which provide constant updates on sample integrity and the health of the freezer compartment. It has a built-in USB port to download freezer temperature and event logs or transfer freezer settings from one freezer to another. Its capacity ranges from 421 - 949 ltrs (14.9 - 33.5 cu. ft.) and has a number of options to suit most storage and lab space requirements. The new cabinet design and vacuum panel insulation of the freezer can store up to 70,000 2 mL tubes or 118,300 1 mL cryobank tubes. Thermo Fisher Scientific India Pvt Ltd Mumbai – Maharashtra Tel: 022 – 67162200, 67162259 Fax: 022 – 67162244 Website: www.thermoscientific.com

Pouch sealing machine Pouch sealing machine (rotary sealer) can be used in all hospitals for ETO sterilisation process. The machine has a continuous sealing process to seal any heat sealable rill or pouch with a 6 - 12 mm sealing width at a speed of 0 - 12 mtr/min. It is suitable for BOPP, multi layer, laminated, polyester poly, aluminium foil, LD, PP, HD, HM and all types of sealable materials available in all thickness combinations. It has a name and logo embossing facility, unlimited sealing length and reliable sealing quality. The machine is compact in design having dimensions of 17 x 34 x 12 inches and weighs about 30 kg. It requires a single phase power supply of 220V/ 50 Hz and its power consumption is around 500 Watts. Monarch Appliances Rajkot - Gujarat Tel: 0281-2461826, 2462585 Email: info@monarchappliances.com , monarchrajkot@gmail.com Website: www.monarchappliances.com

Filtration and separation products

Advantec’s wide range of filtration solutions are used for laboratory, research and process applications. These products are used in a wide variety of scientific capacities and applications, such as microbiological analysis, air/gas filtration, and environmental monitoring. Advantec’s range of filtration products

fits comfortably within Cole-Parmer’s own product range. It offers customers an additional and valuable range of unique quality products that will enhance their processes and research. Cole-Parmer India Mumbai - Maharashtra Tel: 022-67162222 Email: vinita.singh@coleparmer.in Website: www.coleparmer.in

Capsule filling machine T h e s e automatic capsule filling machines also known as encapsulat ion equipment are compact, sturdy, covered with stainless steel panels, and hood covered with acrylic guard. The fill weight adjustment takes place within seconds. These machines are provided with tamping mechanism for powder filling, which enables capsules to be filled with a weight variation with ±2 per cent. Anchor Mark Pvt Ltd Mumbai – Maharashtra Tel: 022-28682001 Email: sales@anchormark.com Website: www.anchormark.com

Pharma inspection machine

Insulation materials

The paper folding, shrink pack and pharma inspection machines are tested for CE marking, and thus fulfill one of the major statutory requirements of European Union. A range of customised solutions as per pharma industry requirements is also offered. Pharma inspection solutions include: pharmacode readers, leaflets and cartons. These have been specially designed for online checking of pharma codes printed on tubes, cartons, leaflets, labels, etc.

T h e s e insulation materials include flexible foam produced from melamine resin. The three dimensional structure of the foam is made up of a microscopic, slender skeletal structure that delivers insulation properties. As a result of its unique design and inherent nature of the design, it offers properties such as high temperature resistance, low bacterial growth, 25/50 fire rating, ASTM C-1410, etc.

Pratham Technologies Pvt Ltd

Pune - Maharashtra Tel: 020-24352624 Mob: 09822047399 Email: enquiry@prathamtech.com Website: www.prathamtech.com

Online washing/cleaning/ drying system This Online system has the following sections: Washing section which is equipped with large-opening plastic modular belt conveyor with side-walls where high washing efficiency is achieved,

Sieves

These are 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. These are available in rivetted and special nonrivetted design. The mesh sizes vary from 4 mesh to 500 mesh with ASTM & BSS Standards. Atlanto Enterprises Mumbai – Maharashtra Tel: 022-23096098, Mob: 09819942853 Email: atlantoent@yahoo.co.in Website: www.atlanto.net

Ultrasonic online cleaning section where ultrasonic waves generating transducers are built into the chamber of this section, just under the side-wall conveyor belt, Hot air drying section where continuous drying of wet components is done & Inspection conveyors which is equipped with belt suitable conveyors driven with a variable frequency drive for online inspection of components. NTB International Pvt. Ltd. Pune-Maharashtra Ph: 02135 309 201 / 235, Fax: 02135 309 200 Email: conveyor@ntbindia.com

IUS Equipments Pvt Ltd Navi Mumbai - Maharashtra Tel: 022-56116626, Mob: 09960110373 Email: iusequip@vsnl.net Website: iusequip.com

Lyophiliser The lyophiliser is used for pharmaceuticals, biotechnology and allied industries. Lyophilisation is the preferred drying process, for heat labile substances or where any physical, chemical or enzymic changes are detrimental to the products and its applications. Sublimation of frozen ice directly in the form of vapour under high vacuum is the basis of lyophilisation process. The system offers optimal flexibility in programming the recipe to suit a wide variety of products. The drying chamber is designed for full vacuum and overpressure of 2.5 bar. Machinfabrik Mumbai - Maharashtra Tel: 022-25555596 Email: machinfabrik@vsnl.com Website: machinfabrik.com

Syringe pumps

Suspension centrifuge

The unit has doublewalled insulated PUF modular panels, which can be easily assembled at site. Interior is made of stainless steel and exterior is either made of mild steel finished with powder coating or stainless steel. The unit has full-length inner glass door and outside metal door with magnetic gasket and lock. It is provided with perforated stainless steel trays and has forced air circulation for uniform temperature. The intelligent controlling system has PLC base and PC communication. It has long lasting stainless steel tubular heaters with SS fins.

The four-point suspension centrifuge is mounted on an inertia plate with antivibration mounts, thus eliminating the cost of heavy foundation. It also eases relocation of the machine. Only a few bolts are to be grouted to prevent lateral movement of the machine during operation. Maintenance of suspension system associated with pendulum suspension machine is eliminated. The centrifuge is employed in medium-tohigh output processes in bulk durgs, pharmaceuticals, food, flavours and chemical industries. It is offered in complete stainless steel construction and conforms to GMP standards.

The world’s first single syringe pump has a touch screen interface and a new clamping mechanism which holds a single syringe (glass, plastic, or stainless steel) from 0.5 µL to 60 mL. The large color display allows the user to see all the operating parameters. Syringe sizes, flow rate, volume delivered & the elapsed time are easily displayed. When used with check valves, the pump draws fluid from a reservoir while opposite side dispenses fluid. After dispensing the user-settable volume, the pump automatically switches direction and dispenses from the other side while the just-consumed side is being refilled. Full-metal chassis provides noise isolation and anti-vibration features for increased reliability.

Newtronic Equipment Company Pvt Ltd Mumbai - Maharashtra Tel: 022-28679326, Mob: 09821089932 Email: nmehta@newtronic.in Website: www.newtronic.in

United Engineering Enterprises Mumbai - Maharashtra Tel: 022-23083990 Email: uenggent@gmail.com Website: www.united-centrifuges.com

Cole-Parmer India Mumbai - Maharashtra Tel: 022-6716 2222 Email: vinita.singh@coleparmer.in Website: www.coleparmer.in

Walk-in humidity chamber

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Products

Air classifier

Blister packing machine

The air classifier is a screenless machine used for grading offline powder into distinct coarse and fine grades from 60 mesh down to 40 microns. This air classifier-type separating machine is operated in closed circuit with existing equipment, such as feed from the hopper, bins pulveriser, cyclone, etc. It is manufactured in closed tolerance and well balanced to give trouble-free operation. The material is fed through the top input pipe down on a revolving distributor plate. The fluidised particles are propelled to the sides of the inner cone by whizzer blades and separated from the re-circulating air stream between inner and outer ring.

The model PBM140C high-speed mass production blister packing machine is designed to pack all types of capsules, tablets, soft gels, injection solution, syringe and other small laboratory or hospital preparation products. It packs small products in different types of clamp shell packages. It is widely used in pharmaceutical, herbal, food and other related industries. It is also suitable for packing with aluminum/ PVC, paper/plastic laminated materials. This machine consists of aluminum foil automatic feeding, upper and lower cobweb male and female joining, multistage cylinder heat sealing, automatic indenting, batch number printing and aluminium alloy double heating.

Premium Vijimech Pvt Ltd Ahmedabad - Gujarat Tel: 079-40083450, Mob: 09712987467 Email: sales@vijimech.com Website: www.vijimech.com

Advanced Liquid Packaging Arizona - USA Tel: +1-602 -4900220 Email: sales@induction-sealers.com

Mini bilayer press

Rotary bottle washing machines

The mini bilayer press is designed to represent two-layer tablet productions at a small scale. With its larger turret diameter, variable speed allows for realistic scale up to larger rotary presses. It is provided with two force feeder system, which helps in maintaining uniform die fill and represents production equipment. It is provided with pressure compensation hydraulic system. Tablet thickness and weight adjustment settings are outside the machine. It is designed as per cGMP norms. All parts in the compression zone are of SS-304 or electroless nickel-plated. Aayush Techno Pvt Ltd Ahmedabad - Gujarat Tel: 079-25898901 Email: contact@aayushtechno.com Website: www.aayushtechno.com

Aerosol generator The aerosol generator (fogger machine) is used for sterilising air in the production shops of pharma, food, biotech and healthcare industry. This fogger machine takes care of 5,000 cu ft volume in single fill giving 100 per cent efficacy. The portable fogger machine is tested for droplet size of aqueous formulations in sub-microns. It generates droplet size in sub-microns and is approved by nuclear division of BARC, nuclear power stations and is patronised by leading hospitals and pharmaceutical industries. The machine comes with a 5 ltr capacity tank made out of best grade disinfectant tank & wetted parts. Gouri Engineering Pvt Ltd Navi Mumbai - Maharashtra Tel: 022-27701285 Email: gouriengg@vsnl.com

Formaldehyde analyser

Formaldehyde analyser provides absolute concentrations for formaldehyde (HCHO) in aqueous media. It has RS232 serial port for computer interface The measurement ranges from 0 to 5 µ g/ml.The analyzer is widely demanded in the market for numerous applications.It can be available in varied specifications as per their requirements and needs.The equipment is available at pocket friendly price. Formaldehyde analyzer is suitable for the measurement of formaldehyde in aqueous solution. Uniphos Envirotronic Pvt Ltd Mumbai - Maharashtra Tel: +91-22-61233500 Mob: 9909994063 Email: gasdetection@uniphos.com Website: www.uniphos-she.com

De-humidifier

The rotary bottle washing machines - NRWM – 96 are multifunctional machines that meet the GMP requirements of washing glass and plastic bottles. These operate on the rotary principle ‘GENEVA’ mechanism and require manual loading and unloading of bottles. The output consists of 4300 to 9000 numbers & direction of the machine is clock wise. National Pharma Machinery Ahmedabad - Gujarat Tel: +91-079-3090 3433, 3093 3433 Email: sales@nationalinda.co.in Website: www.nationalpharmamachinery.com

Dual wavelength diffractometer Its Mova source is up to 2.5x more intense than a standard Mo sealed tube X-ray source. Its Nova source (Cu) up to 3x more intense then a 5kW rotating anode with optic. It has simple and automatic switching between wavelengths. This is ideal for small molecule and protein crystallography and is fast, high resolution, automated data collection and processing. It has optional aircooler radiator for a self-contained system independent of any external water supply. Agilent Technologies India Pvt Ltd New Delhi - Delhi Tel: 91-011-46237100 Email: agilent@agilent.com Website: www.agilent.co.in

The AD 420 dehumidifier is incorporated with fully hermetically sealed rotary compressor, protected against overloading and vibrationinsulated bearings. It has an axial fan with plastic fan wheel (with winding protection). Condenser and evaporator are made from copper piping covered with aluminium fins. Cooling circuit is made from copper piping with capillary tube and filter dryer. There is a service connector on the suction side. Automatic defrosting is controlled by Dry-Logic. The casing is aluminium, powder-coated & offers protection class IP X4. Origin Dehumidifiers Mumbai-Maharashtra Tel.: 022 – 22044156, Fax: 022 – 22875114 Email: sales@origincorp.com Website: www.origincorp.com

Spectrophotometer

programming updates and other accessory connections. It has universal sample cell holder that holds 8 cells. It has superb optics for maximized accuracy, exceptional precision and reliability. It has user-friendly software with scanning and time course capacities with versatile data processing. Jay Instruments & Systems Pvt. Ltd. Navi Mumbai-Maharashtra Tel: +91-22-2767 2955/0092 Email: ledsales@jayinst.com Website: www.jayinst.com

Ball valve This ball valve comes with pneumatic rotary actuator. The valve is of on/off type with screwed, flanged, socket weld, tri-clover end in three-piece design. It is available in SS-304 and SS-316 investment castings and is fitted with doubleacting pneumatic rotary actuator that operators through 90-degrees angular movements of ball valve or butterfly valves. Pneumatic actuator is mounted directly on the shaft of the valve. The actuator is supplied with solenoid valve mounted on it. It is available in different sizes up to 4” to control fluids such as steam, chemicals, oil, air, and water. Madho Controls Pvt Ltd Thane - Maharashtra Tel: 022-25883252, Mob: 09820066046 Email: madho@vsnl.com Website: www.madhocontrols.com

Pumps E-Series AirO p e r a t e d D o u b l e Diaphragm ( A O D D ) pumps are selfpriming and provide gentle displacement of fluids. They are equipped with the patented PERSWING P® air control system, which ensures accurate reversal of the main piston and is characterized by low noise levels. They are created from a solid plastic block, offering advantages like increased pump security due to an innovative ring-tightening structure, increased capacity, decreased air consumption, reduced noise level, optimized flow pattern and a pulsation damper suitable for flange connection. Dover India Pvt Ltd Chennai - Tamil Nadu Tel: +91-44-26271020 Email: akmurthy@destaco.com Website: www.doversolutions.co.in

The Optizen 3220UV is used for analyzing components that require multiple wavelengths, time course operations and getting stable data sheets. It has USB ports for user-friendly

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

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Advance foundry & CNC machine shop .......... 29

Horizontal handel clamp....................................... 29

Pull action................................................................ 29

Syringe pumps ........................................................ 27

Aerosol geneartor.................................................... 28

HP printers ............................................................FIC

Pumps ................................................................. 28,29

Toggle action clamp ............................................. 29

Air classifier ............................................................. 28

Insulation materials ............................................. 27

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

Analytical instruments .........................................BIC

Jigs .......................................................................... 29

Roots vacuum pump ............................................. 29

Ball Valve .............................................................. 28

Lab water sysytem .................................................. 3

Rotary bottle washing machine ............................ 28

Toggle press ........................................................... 29 Triplex plunger........................................................ 29 Tubes ........................................................................ 29

Barcode patient ID bands...................................... 29

Labels........................................................................ 29

Rotary gear .............................................................. 29

Blister packing machine......................................... 28

Laboratory equipments ......................................... 29

Rotary lobe pump .................................................. 29

Blow-fill seal machines ............................................ 7

Laboratory glassware............................................BIC

Rotary pump ........................................................... 29

Capsule filling machine ....................................... 27

Large diameter welded pipes................................. 29

Sanitary centrifugal ............................................. 29

Centrifugal monoblock.......................................... 29

Liquid handling products .............................. 29,BIC

Screw pump ............................................................ 29

Chromatograohy instrument ................................ 29

Lyophiliser ............................................................... 27

Seamless pipes ......................................................... 29

‘U’ tubes ................................................................. 29

Clamp....................................................................... 29

Mini Bilayer press................................................. 28

Selp priming monoblock....................................... 29

Ultra-low temperature freezer .............................. 27

De- humidifier ...................................................... 28

Monoblock high vacuum pump .......................... 29

Sieves ........................................................................ 27

Vacuum pump ...................................................... 29

Dry vacuum pump................................................. 29

Oil seal high vacuum pump ............................... 29

Single stage monoblock vacuum pump .............. 29

Dual wavelength diffractometer ........................... 28

Online washing/cleaning/ drying system ............ 27

Single stage vacuum pump ................................... 29

Twin - screw co-rotating extruder.......................... 9 Twin - screw element ............................................... 9 Twin - screw extruder .............................................. 9 Two stage vacuum pump ...................................... 29

Vertical handle clamp............................................. 29 Vertical inline .......................................................... 29

Filtration and separation products ................... 27

Pallets ..................................................................... 29

Spectrophotometer ............................................ 28,29 Walk in humidity chamber ................................. 27

Fixtures..................................................................... 29

Pharma inspection machine ................................. 27

Stainless steel pipes................................................. 29

Formaldehyde analyser .......................................... 28

Pouch sealing machine .......................................... 27

Straight line action ................................................. 29

Grip pliers ............................................................. 29

Precision fabrication work .................................... 29

Submersible ............................................................. 29

Heart valve frame ................................................... 9

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

Suspension centrifuge ........................................... 27

Water analysis instrument ..................................... 29 Welded pipes ........................................................... 29 Zero liquid discharge effluent treatment............BC

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Chamunda Equipments

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T: +91-79-27522437 E: clamp@chamundaequip.com W: www.chamundaequip.com

Charles River

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Great Eastern Impex Pvt Ltd

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E: Benjamin.margot@pamasol.com

E: info@steerworld.com

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Hewlett Packard India Sales Pvt. Ltd FIC

Salesworth India Pvt Ltd(Rommelag)

T: +91-0124-4932900

Loba Chemie Pvt. Ltd.

BIC

T: +91-022 66636663 E: info@lobalife.com

E: info@devpumps.com

Steer Engineering Pvt Ltd

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E: india.customercare@crl.com

T: +91-79-26403839

T: +91-80-23723309

W: www.hp.com

Pamasol Will Mader Ag

Advertiser’s Name & Contact Details

T: 41-55-417-4040

T: +91-80 - 25588175

Dev Engineers

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T: +91-011-2347431/32

W: www.criver.com

Advertiser’s Name & Contact Details

W: www.lobalife.com

Network18 W: www.network18online.com

Sunjay Technologies

T: +91-80-25274495

T: +91- 22 6662 4330

E: mail@salesworth.com

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W: www.rommelag.com

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Sintex Industries Ltd

Suraj Limited T: +91-79-27540720

E: pallets@sintex.co.in

E: suraj@surajgroup.com

W: www.sintex-plastics.com

W: www.surajgroup.com

T: +91-2764-253500

SSP Pvt Limited 20

Pg No

Thermo Fisher Scientific India Pvt. Ltd. 3

T: +91-129-4183700

T: +91-2-67162200

E: info@sspindia.com

E: reply.lpg.india@thermofisher.com

W: www.sspindia.com

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