Modern Pharmaceuticals - February 2012 by Infomedia18

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Editorial

Achiever extraordinaire elcome to the 6th Anniversary Edition of Modern Pharmaceuticals! As we raise a toast on this special occasion, it is time to thank our internal and external stakeholders who have made this journey meaningful! Amid these, it is important to take note of the growing focus on the pharmaceutical sector in India. While many challenges remain – ranging from drug price control, regulatory reforms, infrastructure development, et al – to rise above, many of these have tremendous potential to lead the subcontinent into a golden era of infinite opportunities.

In fact, the present phase could be an inflection point in the annals of Indian pharmaceutical industry. As the momentum builds up towards large, organised healthcare chains for a growing populace seeking quality healthcare across specialties, the increasing penetration of insurance should facilitate greater access of medicine and allied services for consumers. Besides this optimistic projection, the big question facing the country today is regarding the way forward. Hence, it will be prudent to strategise for the mid- and long-term scenario well in advance, given the steady rise of Indian economy and the multilateral implications thereof in the coming years. In order to ensure outstanding product, price and delivery, the need of the hour is an integrated forward-looking pharmaceutical policy with the right mix of external regulation and professional self-regulation. This unique edition delves deeper into the above and more such pharmerging avenues. Turn to Special Focus (with each article focussing on a distinct growth driver for the way ahead) to discern what an array of global experts have to opine, not just on the latest trends and technologies but also on the future prospects and pitfalls.

Editorial Advisory Board Ajit Singh Chairman, ACG Worldwide & Head, ISPE

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

Dr Gopakumar G Nair

This Anniversary Edition also presents several insightful facets of 10 women achievers of Indian pharma. A great deal of guts has made them get to the glory. Turn to Insight & Outlook to get up, close and personal with each of them having exceptional eminence. Of course, this forms only a part of our nation’s talent pool. Team Modern Pharmaceuticals take a bow to the spirit extraordinaire of these achievers, which goes far beyond the call of duty, and believe that you will benefit from exploring this special edition as much as we enjoyed chronicling the several wonderful aspects of these achievers. Have a good read and do let us know your valuable feedback. Cheers!

IPR Consultant & Advisor

Dilip G Shah Chairman, IGPA & Secretary General, IPA

Daara Patel Secretary General, IDMA

Manas R Bastia manas@infomedia18.in

February 2012 I Modern Pharmaceuticals

Guest Editorial

Opportunity to contribute to global health ndian pharmaceutical companies are on the cusp of a great opportunity – the opportunity to contribute immensely to global health by creating novel medicines. There could be several ways of doing this including M&As or sale of stake. One thing is certain. The future of the Indian pharmaceutical industry will see a period of consolidation whether it is between national and global companies or even between national companies themselves. A direct outcome of this will be that the Indian pharmaceutical industry could be thrust into the major global league given the market opportunities for the $ 100 billion worth of products going off patent by 2015, and the need for collaborative research alliances to bring cost of R&D down as well increase the speed to market for new chemical entities for unmet medical needs.

Worldwide the pharmaceutical industry is under tremendous pressure to keep prices down while at the same time keep investors happy by delivering blockbuster products. The industry is not in a very happy situation given that clinical development time has doubled since 1982 to an average high of 68 months. Where does the pharmaceutical industry in India stand? The introduction of product patents in India in 2005 heralded the arrival of a new era when the country had the opportunity to become the place of choice for high end innovative research and clinical trials. More than five years have since gone by but we as a nation are meandering both with implementation and enforcement. The road to drug innovation is fraught with risks. According to estimates, pharmaceutical companies spend up to $ 1.7 billion researching, developing and testing to create a single drug. The challenge or opportunity, depending on how you view it, is to shorten the amount of time it takes to bring a product to market – perhaps technology in its newer avatars will play a role here, and India is uniquely placed to take its place in the Sun. We are blessed with a large scientific talent pool to draw on for innovative research and also have a rich, treatment naïve patient pool – so valuable when one thinks of clinical trials. Both of these combined should play a role in reducing overall costs and the amount of time required to bring a drug to market. Future generations will not forgive us if we as a country choose to look the other way and give up on our chance to be not only a world class provider of authorised generics drugs but also the seat of innovative pharmaceutical research.

Ranjit Shahani Vice Chairman & Managing Director, Novartis India Ltd

February 2012 I Modern Pharmaceuticals

Contents

Special Focus

Sector overview ............................... 25

Pharma 3.0 ...............................................................................26 Status quo of SMEs...................................................................28 Indian generics industry ............................................................32 CRAMS in India ......................................................................36 New drug delivery systems ........................................................40 Pharmerging markets ................................................................42 Social media .............................................................................46

50 Facility Visit Sigma Aldrich Chemicals Pvt Ltd Building on the Indian technological expertise

Guest Editorial .......................................................................... 9

Insight & Outlook Celebrating the ‘She’ of Indian pharma .... ............... 53 Aditi Kare Panandikar ............................................................... 54 Whole-time Director, Indoco Remedies Ltd, Mumbai

Anuradha Acharya ..................................................................... 56 Founder and CEO, Ocimum Biosolutions, Hyderabad

Dr K R Rajyashri ........................................................................ 58 Founder & Director, Navya Biologicals, Hubli (Karnataka)

Dr Mary Francis ......................................................................... 60 CEO, Mascot Spin Control; Dean & Director CRIMSON; Director, Jovis Clinical Research Pvt Ltd, Mumbai

Dr Villoo Morawala-Patell ........................................................ 62 Founder & CMD, Avesthagen Ltd, Bengaluru

Nidhi Saxena .............................................................................. 64 Founder, President & CEO, Karmic Lifesciences, Mumbai

Shravanti Bhowmik ................................................................... 68 General Manager - Clinical Research, Sun Pharma Advanced Research Company Ltd, Mumbai

Suchitra K Ella ........................................................................... 70

Resolutions 2012.................................................................. 20 Energy Management

Co-Founder & Joint Managing Director, Bharat Biotech International Ltd, Hyderabad

Bio-energy Eﬃcacious utilisation of bio-waste .............................................. 74

Managing Partner, Sorento Healthcare Communications Pvt Ltd, Mumbai

Dr Razia Sultana, Director (Programs), Environment Protection Training and Research Institute, ENVIS Coordinator

Uma Javeri .................................................................................. 74

Policies & Regulations Nuances of patenting Divisional applications practices across continents ....................... 78 Migration in drug packaging A challenge for the Indian pharmaceutical industry ..................... 80 Jitesh Mehta, Director - Marketing, Label and Packaging Materials, South Asia, Avery Dennison

Susan Josi.................................................................................... 72

Managing Director, S Zhaveri Pharmakem Pvt Ltd, Mumbai

REGULAR SECTIONS 7 14 22

Strategy Clinical trial guidelines The need to emphasise on safety.................................................. 84

Tips & Tricks Marketing OTC products Ensuring the best solutions .......................................................... 86 Kamal Anand, Senior GM - Consumer Products Division, Plethico Pharmaceuticals Ltd

Event Report Bangalore India Bio 2012 Focussing on the emerging bio economy ..................................... 90 Cover photograph: Mexy Xavier, A Prabhakar Rao, Kiran Bakale, MAXIMAGE and Neha Mithbawkar

February 2012 I Modern Pharmaceuticals

Editorial News, Views & Analysis Technology & Innovation Projects

98 91 92 108 109

Event List Book Review Products List of Products List of Advertisers

Details on page no.: 24 Highlights of Next Edition Special Focus: Budget wish-list Insight & Outlook: Pharma SMEs Note: ` stands for Indian rupee, $ stands for US dollar and £ stands for UK pound, unless mentioned otherwise

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February 2012 I Modern Pharmaceuticals

News,Views & Analysis Sigma-Aldrich acquires BioReliance to extend its reach into biopharmaceutical testing and services Sigma-Aldrich Corporation, has signed an agreement to acquire BioReliance Holdings, Inc, a leading provider of global biopharmaceutical testing services, from Avista Capital Partners for $350 million in cash. The acquisition is subject to customary closing conditions, including regulatory clearance, and is expected to close in the ﬁrst quarter of 2012. The company’s ability to develop and execute global testing protocols in compliance with various regulatory

standards enables BioReliance’s clients to register products worldwide. The addition of these services is expected to result in a broader and richer value proposition for Sigma-Aldrich and have an immediate impact on its ability to provide enhanced solutions for its biopharmaceutical customers. Commenting on the acquisition, Rakesh Sachdev, President and CEO, stated, “Our

Sanofi appoints Susheel Umesh as Head Pharmaceutical Commercial Operations, India Aventis Pharma Ltd (Sanoﬁ Group) has appointed Susheel Umesh as Head Pharmaceutical Commercial Operations, India. He will be taking over the overall commercial responsibility for the Indian pharmaceutical operations including tier II operations, mass therapies as well as business excellence and strategy for the consolidated commercial organisation. These responsibilities are in addition to that of diabetes and tier I, which he had been previously managing as Senior Director – Commercial Operations since August 2010. Commenting on this appointment, Dr Shailesh Ayyangar, Managing Director

- India and Vice President - South Asia, said, “In India, Sanofi is diversifying to fulfill our commitment of bringing quality medicines and vaccines to many more patients and physicians. Under Susheel’s leadership, our diabetes franchise has transformed diabetes management in India. He has also further strengthened our presence in tier I geographies.” Speaking on his new role, Umesh said, “It is an honour for me to lead the India Pharmaceutical Operations for Sanofi. I am excited about this new responsibility and intend to work towards further accelerating our growth in India.”

vision for Sigma-Aldrich is to enhance the company’s broad product oﬀering and strong technology platforms with a compelling and specialised services platform. As the market continues its focus on biological drug development, our leadership in this area should enable us to build even better, more customer-speciﬁc solutions. We are excited to add BioReliance’s capabilities and its talented employees to our company and fully expect its addition to contribute to our long-term growth and return goals.”

SGS India opens life science lab in Mumbai SGS India has recently opened their second analytical laboratory in India in Mumbai. This lab is spread over a large area of 15,000 square meters. It has been made to meet the requirements of the pharmaceutical sector and will allow pharma as well as biopharma companies to outsource their studies, analytical chemistry and microbiology testing with the help of method development and validation projects. “We want to welcome the potential customers in India to view the new expanded facilities. We have 18 labs in11 countries and we want to further expand our reach,” said Chris Kirk, CEO, SGS. Adding to this, Dr Anne Hays, Executive Vice President - Life Sciences Services, SGS said, “The setting up of the Navi Mumbai facility reflects the growing customer demand and the fact that over the years the query -do we invest in India has changed to- how can we be a leader in India.” The life sciences lab in Mumbai is built in a way that it complements the facility present at Chennai, which provides analytical support to the pharma industry in India. The laboratory has received ISO 17025 certification in 2005 and is also a GLP certified laboratory by National GLP Monitoring Authority of India and was inspected and registered with the US FDA since 2007.

Mylan completes acquisition of two limited-competition dermatological products from Valeant Mylan Inc has recently announced that it has successfully completed the acquisition of two dermatological products from Valeant Pharmaceuticals. Mylan has acquired the Abbreviated New Drug Application (ANDA) for clindamycin phosphate/ benzoyl peroxide gel, which is the generic version of Valeant’s BenzaClin®. Mylan had previously manufactured

and marketed the generic version of this product through a licensing agreement with Valeant. It also has acquired a license to manufacture and market Fluorouracil 5 per cent USP cream as the exclusive authorised generic to Valeant’s Efudex. Heather Bresch, Chief Executive Oﬃcer, Mylan, said, “The acquisition of these two products reﬂects Mylan’s

continued strategy of creating value through increasing our position in key therapeutic areas and dosage forms, such as dermatological topicals. Further, it allows us to expand our portfolio of diﬃcult-to-manufacture or limited-competition products. We will continue to build on our existing portfolio and capabilities through opportunities such as these.”

Modern Pharmaceuticals I February 2012

News,Views & Analysis Waters and NIBRT complete work on world’s first UPLC Glycan Database Waters Corporation and Ireland’s National Institute for Bioprocessing Research and Training (NIBRT) have announced the availability of the world’s ﬁrst database for Glycan analysis by Ultra Performance Liquid Chromatography® (UPLC®). Developed by Professor Pauline Rudd’s research team at NIBRT, the new GlycoBase 3+ Database is the ﬁrst-of-its-kind repository

of chromatographic retention positions expressed in glucose units for sets of Glycan structures associated with a range of biotherapeutics. The database will be comarketed worldwide by Waters and NIBRT. Recent advances in chromatographic approaches are leading to better resolution, sensitivity, and speed during analysis of protein glycosylation.

Brookfield sets up advanced application lab in Thane

L-R: Brookﬁled and Mehta

Brookfield Engineering Labs has established the Brookfield advanced application lab in Thane (near Mumbai) powered by ANM, India. The first and only advanced application lab in South East Asia was inaugurated by David Brookfield, President and CEO, Brookfield Engineering Labs, Inc, US. Speaking on Brookfield’s latest advent in India, Brookfield said, “The opening

of this advanced lab will help Brookfield customers in India with application support and product demonstrations. This lab demonstrates Brookfield’s long term commitment to the Indian customer and is our way of saying ‘Thank You’ for the support. Apart from the Indian market, the lab will also serve our customers in West Asia, Africa and the ASEAN nations as a knowledge resource centre for viscosity, rheology and powder flow analysis.” Sanjay Mehta, Co-Founder, Amkette Analytics, said, “The lab is a milestone in Amkette’s journey towards the future as it expands its wings.” - Chandreyee Bhaumik

IISc wins AstraZeneca Excellence in Chemistry Award 2011 AstraZeneca, the global innovationdriven biopharmaceutical company, recently announced the winners of the AstraZeneca Excellence in Chemistry Awards 2011, Asian Region, which identiﬁes innovative academic research. An event recognising the winners will be held at AstraZeneca’s oﬃce in Bengaluru. Professor Govindasamy Mugesh from the Indian Institute of Science, Bengaluru and Professor Shuli You

from Shanghai Institute of Organic Chemistry, China will each receive the ‘AstraZeneca Young Investigator Award’ for the Asian region for their outstanding contributions to the art of Organic Chemistry. They will both be presented with a $50,000 unrestricted research grant to help foster the continued growth and development of their research programmes. - Chandreyee Bhaumik

The Waters® UPLC Glycan analysis solution features an Acquity UPLC® BEH Glycan Separation Technology column and an Acquity UPLC System with ﬂuorescence detection (FLR) to separate the released Glycans of biopharmaceuticals as their 2-aminobenzamide (2-AB) derivatives.

Acoris Research gets a new President Hikal Ltd, has appointed Dr Peter Nightingale as the President of its 100 per cent contract research subsidiary, Acoris Research Ltd, Pune, India. “We are pleased to announce the appointment of Dr Nightingale as the President of Acoris Research Ltd. Dr Nightingale’s extensive experience in the adaptation of new technologies in chemistry and as a veteran process development chemist will be a great asset to Acoris Research. He has over 30 years of experience with global customers and strong leadership capabilities,” said Jai Hiremath, VC and MD, Hikal.

Indoco in pact with DSM for Austrian market Indoco Remedies has entered into a marketing pact with DSM Pharmaceutical Products (DPP) NV which will sell its products in Austria and other international markets. “DPP will market and sell eight APIs and APIs manufactured by Indoco in Austria and other international markets, stated a press release.The Mumbai-based company has a portfolio of 135 products in various therapeutic segments such as diabetes, cardiovascular, central nervous system, musculo-skeletal, nutrition and dental care.

Strides Arcolab sells its generic pharmaceutical operations in Australia and South East Asia Strides Arcolab Ltd recently announced the sale of its 94 per cent shareholding in Ascent Pharmahealth Ltd, its subsidiary with operations in Australia and Southeast Asia, to Watson Pharmaceuticals, Inc. As part of the transaction, Watson also acquired the remaining 6 per cent shareholding associated with Dennis Bastas, CEO, Ascent. The transaction was signed and closed simultaneously.

The cash oﬀer from Watson values Ascent at an enterprise value of AU$ 375 million. Commenting on the transaction, Arun Kumar, Executive Vice Chairman and Group CEO, Strides Arcolab, said, “The sale of Ascent is a value enhancing and forward-looking initiative for Strides. We have been clear about our intention to focus on our highly attractive sterile segment,

which we expect to be our growth engine going forward. The transaction further facilitates the execution of this strategy and unlocks signiﬁcant value for the Group.” Paul Bisaro, President and CEO, Watson, said, “The acquisition of Ascent provides Watson with a successful commercial structure in both Australia and Southeast Asia and a broader pipeline of products to support continued growth.”

Modern Pharmaceuticals I February 2012

News,Views & Analysis Advantec® filtration now available in India from Cole-Parmer Cole-Parmer recently acquired authorised distribution rights in India to Advantec®’s wide range of ﬁltration solutions for laboratory, research and process applications. Advantec’s 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,” said Kashmira Nadkarni, Product Manager, Cole-Parmer India. “It offers

Advantec®

Omega in pact with Sienna Omega Pharma (Europe) and Sienna Biotec India (API manufacturer), have announced a strategic partnership in which Sienna Biotec will take a minority stake in Omega Pharma’s US operations in New York. Under the agreement Omega and Siena will work collaboratively on the development of Sienna Biotec’s pipeline of compounds, focused Alzheimer’s disease, Huntington’s disease and oncology. Financial terms were not disclosed. “We are delighted to strengthen our existing relationship with Sienna Biotec, which will be a valuable partner as we expand our presence, particularly in the US marketplace,” said C Timotky, Chairman and Chief Executive Oﬃcer, Omega Pharma. - Titash Roy Choudhury

Aptar Pharma expands presence in India Aptar Pharma, has announced the opening of a new facility near Mumbai, India. Located at Rabale, Navi Mumbai, this new facility is the ﬁrst of its kind. “With the launch of the second Aptar Pharma manufacturing site in Asia, after Suzhou in China, we are on track to meet our objective of better serving Indian customers by providing locally manufactured devices,” said Marc Prieur, President, Aptar Pharma Asia.

our customers an additional and valuable range of unique quality products that will enhance their processes and research.” Koichi Shiode, General Manager, Advantec MFS, Inc added, “We are pleased to extend our partnership with ColeParmer to India, and are excited about the opportunity to introduce Advantec’s highquality products to the Indian customers.”

More than 50 medicines in development for COPD America’s biopharmaceutical research companies are working on 54 medicines to treat Chronic Obstructive Pulmonary Disease (COPD),according to a report recently released by the Pharmaceutical Research and Manufacturers of America (PhRMA). These exciting therapies are in late-stage development, meaning they are either in clinical trials or awaiting review by the FDA. Today, more than 13 million American adults suﬀer from COPD. COPD is a progressive lower

respiratory disease that encompasses two main conditions – chronic bronchitis and emphysema. “Early detection of COPD is imperative, as effective treatment can change the course and progression of this devastating disease,” said John J Castellani, President and CEO, PhRMA. “The promising new therapies highlighted in this report illustrate how emerging scientific approaches to treating respiratory diseases such as COPD offer great hope to improve and save the lives of future patients.”

Unigene honoured with Drug Delivery Partnerships Industry Achievement Award Unigene Laboratories, Inc has received the 2012 Drug Delivery Partnerships (DDP) Innovation Award in the Industry Achievement category in recognition of the clinical advances in the oral delivery of peptides in 2011. Ashleigh Palmer, President and CEO, Unigene Laboratories, said, “As the pharmaceutical industry is one of the largest, longest running and most-respected drug delivery conference, acknowledgement from the DDP provides an exclamation point to Unigene’s transformational 2011, which was marked by numerous business, clinical and technological successes.”

US FDA approves VIREAD® for use by children living with HIV Gilead Sciences, Inc has announced that the US FDA has approved Viread® (tenofovir disoproxil fumarate) in combination with other antiretroviral agents for the treatment of HIV-1 infection in paediatric patients aged 2-12. “There remains an unmet need for heatstable, taste-neutral pediatric formulations that do not require cold storage, particularly in resource-limited settings, where motherto-child transmission remains a signiﬁcant challenge,” said Norbert Bischofberger,

PhD, Executive Vice President, R&D and Chief Scientiﬁc Oﬃcer, Gilead Sciences. The FDA approved a supplemental New Drug Application (sNDA) for three lower-strength once-daily tablets of Viread in doses of 150 mg, 200 mg and 250 mg for children aged 6-12. The agency also approved a New Drug Application (NDA) for an oral powder formulation of Viread for children aged 2-5. The active ingredient in Viread, tenofovir disoproxil fumarate, is currently the most-prescribed

molecule for adults receiving HIV therapy in the US. “The US FDA approval of Viread for use in children represents a signiﬁcant step forward in addressing the unmet medical need for paediatric antiretroviral formulations, particularly in the developing world, where more than two million children under the age of 15 are living with HIV,” said Erin Rau, Associate Director, Public Aﬀairs, Gilead Sciences, Inc. - Titash Roy Choudhury

Modern Pharmaceuticals I February 2012

Resolutions 2012

The roadmap for the pharma industry Predictions are galore so as to how the pharma sector will be in 2012! Companies are relying on old plans and introducing new ones to achieve their respective targets for the new year. We look at a few of such resolutions planned by certain companies. Jasleen Kaur Batra Dr Krishna Ella CMD, Bharat Biotech

The business strategy of Bharat Biotech relies on creating strong manufacturing platforms complemented by capabilities in innovative and the space of R&D. The opportunity to explore new market areas through strategic alliances and partnerships is also something that interests us and is one of our key areas at Bharat Biotech. The primary focus of the company is to address public health problems in the emerging and developing world markets, and mission 5.8 billion is the mantra at Bharat Biotech. We will continue to lay importance on region speciﬁc diseases such as chikungunya, typhoid, malaria, and JE and Chandipura virus encephalitis.

Mahaveer Chand Bafna

Dr Praveen Khullar

CMD, Bafna Pharmaceutical

Senior Director, Goa Development Centre

At Bafna we have always maintained our focus on the regulated market and have worked towards making a mark there. We are in the process of introducing fast growing anti-hypertensive Labatalol in the Indian market under the name LoPIH and Igest, a natural micronised progesterone. Bafna is also poised to bring out more and more innovative dosage forms in existing molecule. We also plan to focus our attention on rural marketing.

Our mission for 2012 is also to develop appropriate therapeutic solutions for illnesses that are either poorly covered or completely ignored. One of the key principles of the Group’s strategy towards becoming a diversiﬁed global healthcare leader is to increase innovation in R&D while being focused on patients’ needs. By focusing on patients’ needs, we intend to become the most productive R&D organisation in the healthcare sector. We also plan to continue to build on the capabilities of our current development centre in the coming years and also plan to have collaborative developmental activities with external CROs and academia.

Raj Vaidya Chairman - Community Pharmaceutical Division, Indian Pharmaceutical Association

Rajesh Warrier CEO, Activecubes

Analytics is a niche segment; it requires specialised and highly skilled resources - to be able to analyse large data using various mathematical techniques. The sudden increase around analytics has led to a high demand of analytics professionals at all levels. Hiring experience analytics resources from the Indian market is proving to be a challenge. This can be addressed by tapping into the large pool of students who are (or have) graduating in statistics and applied math. The spurt in analytics business in India is creating a lot of demand for analytics professionals who can analyse and build mathematical/statistical models. Hence, we would be focussing on increasing our man power by hiring more professionals from the ﬁeld of analytics so that we can meet the requirement of the national as well as the international market.

We are going to be putting in a lot of time and eﬀort to come up with a system where reliable yet aﬀordable information material and sources to practicing pharmacists (hospital and community pharmacists) in the country are made available. A lot of attention to the training of practicing pharmacists across the country will also be given to gradually make them capable to perform a more professional role. The law and regulations always need to be in place and so we would be also looking at making suitable changes in the drug laws related to community pharmacy, considering the drastic changes that have occurred over the years.

Umesh Pawa Managing Director, AB SCIEX India

AB SCIEX is supporting eﬀorts to discover and develop new drugs in India. The company’s recent expansion of commercial operations in India presents a signiﬁcant opportunity for AB SCIEX to have a greater impact in India. The company also plans to work more closely with a wide range of pharmaceutical and contract research organisations in India. This year, we will continue to drive forward our peptide quantitation solutions and broad array of pharmaceutical solutions by cultivating strong collaborative relationships with leading pharmaceutical companies.

Modern Pharmaceuticals I February 2012

Technology & Innovation

SANYO offers the most energy-efficient freezer A leading independent test institute in the Netherlands has measured the power consumption of the MDFU76V at 13.77 kWh/24hr. Based on current published data, this makes the MDF-U76V the most energyefficient 700 litre -86ºC freezer on the market. The advantages include greater security for precious research or clinical samples, as well as significantly lower running costs and added environmental benefits. In fact, cooling efficiency, insulation characteristics and door-open Sanyo MDFrecovery times have all been enhanced through exclusive U76V SANYO innovations- a capillary tube heat exchanger, next-generation VIP PLUS insulation, and the Cool Safe compressor. As a result, greater temperature uniformity throughout the freezer and faster temperature pull-down contribute to industry-leading sample security.

Bio-Rad introduces Mini-PROTEAN® TGX stain-free™ precast gels Bio-Rad Laboratories, Inc has launched its Mini-PROTEAN TGX (TrisGlycine eXtended) stain-free precast gels, providing researchers with the fastest separation and imaging capabilities available for Laemmli PAGE. The gels include a unique trihalo compound that allows rapid fluorescent detection of proteins in gels or on membranes without the need for staining. When researchers use the Mini-PROTEAN TGX as part of Bio-Rad’s V3 Western Workflow™ they can achieve complete protein separation, gel imaging, and data analysis in 20 minutes. The V3 Western Workflow increases speed at every step — from protein separation to transfer verification. “It is critical for experiments to be both time- and cost-effective,” said Dr David Warren Pryce, PhD, Principal Investigator, North West Cancer Research Fund Institute, Bangor University, Wales UK. “Since using Bio-Rad’s precast gels and buffers and the Trans-Blot Turbo transfer system, I have found that analysis that once took — at minimum — 1.5 hours to prepare and perform can now be completed in 20 minutes. We routinely use slightly less sample and far fewer reagents and continue to see excellent gel-togel consistency and significantly faster experimental throughput without a considerable overall cost increase per result.”

Nano-UHPLC system to increase productivity during proteomics research Thermo Fisher Scientific Inc announced that the Center for Experimental Bioinformatics (CEBI) at the University of Southern Denmark is using Thermo Scientific nano-ultra high performance liquid chromatography (UHPLC) technology to accelerate productivity and improve efficiencies during its proteomics research. EASY-nLC 1000 has enabled 34 per cent more peptide and 22 per cent more protein identifications within the CEBI laboratory, significantly increasing productivity. Additionally, the instrument has improved separations and facilitated the analysis of more complex samples within the laboratory. “The EASY-nLC 1000 is a highly robust instrument offering nanoUHPLC performance dedicated to proteomics scientists. We decided to implement the new system in our laboratory as we felt that it would revolutionise the way we perform LC-MS analyses. The instrument has allowed our laboratory to increase productivity considerably in a way that would never have been possible before. Implementation was a very smooth process requiring minimal configuration effort and the Thermo Fisher Scientific team of experts provided valuable support both throughout and after this process,” said Lasse Falkenby, Research Assistant, CEBI.

Shaking incubators now with IQ/OQ Stuart’s SI500 combined shaker/ incubator and the SI505 model for microtitre plates are now available with IQ/OQ documentation, meeting the requirements of customers in regulated industries such as the pharmaceutical sector. Installation qualiﬁcation documentation will help users install their incubator correctly, in accordance with the manufacturer’s guidelines. Issues such as location of the unit, environmental requirements and initial

Stuart SI500 and SI505 set-up are covered in the IQ document, with provision for all stages to be recorded for audit.

Operational qualification is used to verify and document that the shaking incubator functions within the defined specifications. The compact benchtop Stuart SI500 and SI505 shaking incubators have a unique retractable platform providing easy access to samples, a digital display showing the independently controlled temperature and speed, and USB connectivity for long-term monitoring of the incubator temperature via a PC.

Modern Pharmaceuticals I February 2012

Special Focus

Sector overview Pharma 3.0 Is the industry future ready? ..........................................................26 Status quo of SMEs PPP approach: The way forward ....................................................28 Indian generics industry Highs and lows in the next decade .................................................32 42

CRAMS in India A diďŹ&#x20AC;erentiated cost value proposition ..........................................36 New drug delivery systems Towards sustainable growth .........................................................40 Pharmerging markets The upcoming global trends ..........................................................42 Social media Driving pharma marketing ...........................................................46

46 February 2012 I Modern Pharmaceuticals

Special Focus: Pharma 3.0

Is the industry future ready? The Indian pharma industry has been a leading industrial sector of the country, with a paralleled dominance of both domestic as well as international companies. The predictions for revenue generation have been witnessing an upward trend with time. A report by Ernst & Young proves the same.

he Indian market is expected to reach $ 24 billion (pessimistic estimate) to $ 49 billion (optimistic estimate) by 2020. Even if we assume the base case, the market presents an opportunity of almost $ 25–$ 30 billion over the next eight to nine years. The global pharma market is in a state of transformation with its focus changing from a blockbuster drug (Pharma 1.0) to a healthy outcome (Pharma 3.0)based approach.

Evolution of Pharma 3.0 The industry is responding to the challenge of a patent cliﬀ, decreasing R&D productivity, pricing pressures, globalisation and changing demographics with the implementation of new strategic initiatives.

Market: Drug companies are counting on emerging markets and the increasing middle class population to drive future growth. They are looking at extending the life of mature products and identifying strategies to approach patients who are at the middle and bottom of the income pyramid Science: With the impending patent cliﬀ, most companies are trying to invigorate their pipelines and have adopted measures to prioritise therapeutic areas and disease categories. They are also breaking down silos, collaborating with biotech companies and licensing late stage molecules Customer: There is increasing focus on understanding the needs of the customer (payer, provider and patient) and moving from a product- to a customer-centric approach

This transformation has been an evolutionary process, with each business model fueling the next, and subsequent models drawing from the strengths of their predecessors.Depending on each company’s strategy, these models may co-exist at different times. These initiatives have led companies to evolve from a traditional vertically integrated blockbuster model —Pharma1.0 — to a cost-efficient, diversified product and market model with a focus on emerging markets and finding new ways to service underserved patients — Pharma2.0. The industry is now at the cusp of another transformation — Pharma 3.0, spurred by the convergence of new trends such as healthcare reform, demographics, health information technology and consumerism. Pharma 3.0 is an ecosystem wherein companies are likely to move from simply producing new medicines to demonstrating improvements in health outcomes and creating new and effective business models. Their success will be driven by not just how many units they are able to sell, but also on their ability to improve health outcomes, with patients and payers being at the centre of their model. This transformation has been an evolutionary process with each business model fueling the next and subsequent models. Pharma 1.0 has been and is still a highly successful model that has driven the industry’s growth, producing margins unmatched by other sectors. Pharma 2.0 has helped the industry change its approach to customers, alleviating some present day pressures and laying the ground for Pharma 3.0 and a collaborative, outcome-centered perspective. Depending on each company’s strategy, these models may co-exist at different times.

Emerging markets to emerge in the coming years Historically (in 2003), China and Brazil were the only two countries that featured among the top 10 pharma markets worldwide. However, by 2015, four of these emerging markets are expected to rank among the top 10 global pharma markets, with China and India emerging as the largest gainers. The other major emerging markets are forecast to be Brazil, Russia, Venezuela, Turkey and

Modern Pharmaceuticals I February 2012

Pharma 3.0 Korea. Mexico, on the other hand, is likely to drop out of the list of the top 15 markets during this period. Pharma companies have realised the importance of these markets and are clearly focusing on emerging market requirements. And in order to tap these opportunities, companies have adopted a three-pronged strategy to realign their organisational structure, increase M&As in these markets and collaborate with local companies. Organisational structure:Companies have established business units that are focused on emerging markets. In addition, in the case of organisations that have not set up separate business units to focus on these geographies, a team has been identified internally, whose mandate is to evaluate opportunities in these markets and identify potential growth options in them. An analysis of the top 10 big pharma companies indicates that half of them preferred establishing emerging marketspecific business units to capture market opportunities, whereas the other half preferred a region-specific structure with an increasing focus on emerging markets. M&As: Companies have been increasingly using acquisitions as a strategy to increase their presence in emerging markets. China and India have emerged as the top two destinations for acquisitions for local and MNCs. China has seen the largest percentage (60 per cent) of domestic acquisitions. While it has witnessed the maximum number of acquisitions, some supernormal valuations have been for companies that were based out of India, eg, Abbott’s acquisition of Piramal at 8.7 times the latter’s revenues; Reckitt’s acquisition of Paras at 8.1 times the latter’s revenues; and Daiichi’s acquisition of Ranbaxy at 4.9 times the latter’s revenues. These high valuations can be attributed to the limited availability of attractive assets in these countries. Collaborations: In addition, companies have tried to align their product portfolios with the requirements of emerging countries by collaborating with local companies.

Shifting trends Besides collaborating with local companies in emerging markets, big pharma companies have also been focusing on emerging

February 2012 I Modern Pharmaceuticals

Evolu on of the pharma market Drivers of change R&D productivity Patent cliﬀ Globalisation Demographics Pricing & reimbursement

Business models Value proposition

Pharma 1.0 Blockbuster drugs

Health care reform Health IT Consumerism Value mining

Pharma 2.0 Diversiﬁed drug protfolios

Pharma 3.0 Healthy outcomes

Payor Customer

Physician Patient

Source: Ernst & Young, Progressions building Pharma 3.0

markets, especially China and India, as destinations for outsourcing and oﬀ shoring across the pharma value chain from New Chemical Entity (NCE) research to late stage manufacturing. India has been the

Besides collaborating with local companies in emerging markets, big pharma companies have also been focusing on emerging markets.

preferred choice for outsourcing in the area of late-stage drug discovery, although is only marginally better than China in terms of outsourcing development activities (including clinical trials). The country has taken the lead in providing IT-enabled R&D services in areas including clinical data management, biostatistics and medical writing to one or more Indian service providers. India scores in complex manufacturing (formulations), whereas China is preferred for building blocks and intermediates

(APIs). However, China has taken the lead in the area of biologics. China has seen more oﬀ shoring than India across most areas. This can be attributed to the country’s better infrastructure and the incentives provided by its government. As emerging markets become increasingly important and India’s role among them becomes more signiﬁcant, pharmaceutical companies will need to adapt their business models, organisations and processes to align with these new environments. Companies have adopted multiple levers to tap emerging markets for product portfolios, sourcing or innovation. However, their ability to understand these markets and drive revenue growth will be the key determinant of the extent of their investment and participation. (ajit.mahadevan@in.ey.com)

Ajit Mahadevan Partner – Life Sciences, Ernst & Young

Special Focus: Status quo of SMEs

PPP approach: The way forward For Indian pharma SMEs to become the MNCs of tomorrow, the government needs to extend support by way of tax sops, incentive schemes, cheaper land rates, R&D subsidy, etc. More so, partnerships with the private sector will fuel growth.

segment, which can come to the rescue of government and public at large. Focus on Public Private Partnership (PPP) can also be initiated by the government with SMEs, since it is the SMEs segment that can fulfill the dream of government of having affordable, accessible and quality medicines. To help the SMEs segment, government should not have any price control on the products which are manufactured by them. If SME comes forward for new drug discovery area, it should be encouraged with financial aids, subsidies and tax exemption, etc. Since drugs are cheaper in India when compared to other developing and developed countries, government should encourage SMEs sector instead of bringing control. We have to ensure that the proposed pharma policy should shift focus from cost-based price control to basically only monitoring of prices. At times, trade bodies create hindrance in launching and distribution of new products, so government should come forward to help the marketing companies particularly SME so that they do not face such problems in future.

Focus areas

mall and Medium Enterprises (SME) is the backbone of pharma industry in India. Even organised companies such as Zydus, Lupin Ltd, Dr Reddys Laboratories, Aurobindo Pharma, Sun Pharma, etc, were once upon a time SMEs and over a period of time they have achieved the status of organised segment. Since pharma sector is becoming stringent due to regulatory requirements, it is becoming diﬃcult for SME sector to cope up with the pressure, and hence, it is advisable that SMEs become the right and left hands of bigger pharma companies and help the aggressive companies to compete in the international market. In a country of 1.2 billion, with 17,300 hospitals, 164,000 primary health centres, more than ﬁve lakh chemists and with more than 350,000 medical sales representatives, it is not possible for the organised and bigger

companies to cope up with the demand of the nation and thus government as a whole and public at large has to depend upon SME sector.

Status quo At present, the Indian pharma industry ranks third in the world market but this gap can be narrowed down to second position with SMEs being encouraged by the government through various incentives. Government has to come forward to reserve some of the government institutions and hospitals only for SMEs sector so that medicines by such hospitals/ institutions are procured only from SMEs. Since expenditure on lifestyle is increasing day-by-day, aﬀordability for the common man to buy expensive medicines from bigger companies and MNCs is becoming diﬃcult. Therefore, it is the SME

Task force for formulating longterm policy: Government of India has constituted a task force to formulate a long-term policy and strategy for strengthening the drug sector. Similarly, there should be a separate task force specifically for the SME sector. SMEs have their different priorities, different problems when compared to MNCs. Thus, creating a specific task force focusing on the needs of the SME sector will help in emphasising the need of this sector Bar coding: The government announced in January that bar coding would be made mandatory from July 1, 2011 for all pharma products as per GS1 standards for tracing and tracking. It will be difficult for SME sector to agree to this proposal of government and it will be cost prohibitive, especially for SMEs since there would be huge investments in imported machinery and technology, which may not really provide the required results to tracking and tracing. Also, regulatory requirements vary from country to country. So it would be

Modern Pharmaceuticals I February 2012

MPh (February_2012) 1Tab-29

MPh (February_2012) 1Tab-30

Status quo of SMEs bar-coding on tertiary packs and it is physically not possible Encourage the SME in pharma sector in every to put 2D serialisation on all possible way the primary packs. So, there Reduce taxation was no significant justification Infrastructure to be improved to implement such procedure Reduction in transaction cost by offering better as the main goal of tracking and and improved procedures and cutting the redindividual pack was not ensured tapism CC, PC, PL and PM norms: Government could consider changing the Although government through policy of price control to price monitoring National Pharmaceutical Cheaper finance through banks Pricing Association (NPPA) Provide support to SME sector by way of has revised Conversion Cost financial assistance through CLCS Scheme (CC) and packing charges Technology up gradation scheme and better (PC) norms but the impact of support from the banking sector cost of power, which is The SME sector also needs encouragement in 30.16 per cent, gas is increased selling of their goods by removing cumbersome by 206 per cent and wages tender conditions in supplies to government have gone up to 154 per cent hospitals or so in last three years, it is R&D support by way of subsidies from the unviable for industry to work on government for R&D efforts the CC, PC norms announced by NPPA. Government has to be liberal best if this exercise be kept in abeyance till enough to encourage the SMEs sector the matter is discussed in detail with the if they want SME to be pro-active in pharma manufacturers. It should also be pharma sector pointed out that it was agreed to implement

Ways to strengthen the SMEs

February 2012 I Modern Pharmaceuticals

Dependability on China: The balance of trade between India and China was in favour of China, more so in case of pharma sector. Hence, the Government of India should come forward with a special incentive scheme to encourage SME sector by way of allotting cheaper land, providing long-term moratorium for repayment of term loan, soft loan on less percentage of interest, subsidy on R&D. Government has to announce new ﬁscal policy scheme to support the SME sector of pharma industry. (sikribr@yahoo.com)

Bodh Raj Sikri VP - North Zone, IDMA; VP - North Zone, BDMA; Co-Chairman, FOPE (Tax Free Zone Body); Chief Advisor, HDMA

Special Focus: Indian generics industry

Highs and lows in the next decade

India has evolved to become the capital for generics manufacturing, and with favourable opportunities in the future this market is poised for a higher growth trajectory. This will be further fulled by increased focus of the population on regular health check-ups and intake of nutraceuticals and health supplements.

f we go to 1970s, we will see that the Indian pharma market was driven by product patent and not process patent. In the 70s, the Government of India took the decision to change product patent to process patent, and that was the starting point of generics companies gaining prominence. During the last 35 years India has become a force to reckon with in the generics market. Switching to process patent allowed Indian pharma companies to grab the opportunity and enter the global generics market in diďŹ&#x20AC;erent segments and newer products, which in turn helped them to grow considerably. The shift provided the right platform for the Indian pharma companies to learn the ropes of the generic market and master it.

Looking back In the 1970, MNCs occupied almost 80 per cent of the total Indian pharma market, which has completely changed today and Indian companies now occupy a signiďŹ cant position in the market place. The change in patent laws provided the environment and the opportunity which was seized by the Indian entrepreneurs. Given the knowledge, power and expertise, Indian companies quickly understood the nuances of the market. This helped them to grow rapidly. We are now recognised as a force to reckon with not only in the domestic market but also in the global market and have become the capital of the global generics market. The change from product to process patent by the government was a strategic

move undertaken since they realised that if they had to take the Indian pharma industry to higher level this was necessary. In a country like India there are not many domestic companies that can invest in R&D and develop new products; if the product patent regime was maintained then all these companies would have had to wait till the patent expired thus giving them little scope to grow. In the absence of the change India would have been highly import dependent and in contrast today it is self-suďŹ&#x192;cient when it comes to the production of medicines. Thus, the government provided the environment, which was capitalised by Indian pharma companies.

Growth drivers The generics business, which is currently about $125 billion globally, has grown over the years and is expected to grow to $235 billion by 2017. Another statistics that shows the growth of the Indian pharma sector is that the top domestic companies have 85 US Food and Drug Administration (USFDA) approved major facilities; 40 for

Modern Pharmaceuticals I February 2012

Indian generics industry Market growth

Retail prices of generic ciproﬂoxacin 500mg 15.6

300

13.7

250

200

150

100 50 0

7.2

11 14 12

4.6

1.7

8 23

4.6 3.1

12 11

104

2010

2015

China

India

Russia

Turkey

Brazil

Venezuela

Mexico

South Korea

Source: IMS health prognosis, 2011; Ernst & Young analysis

Active Pharmaceutical Ingredients (APIs), 34 for formulations and 10 for APIs and formulations, as opposed to its competitor China, which has only 50 USFDA approved manufacturing units. There are several factors that have been propelling the growth of generics market worldwide as well as in India. Considering the global generic market, rise in the number of prescription for generics is a major one. The share of prescriptions of generics to brands is about 67:33, which means 2/3rd of the prescriptions are for generics, clearly showing the rising demand for the generics. Besides, there is also pressure on pricing from the governments of various countries since the ever rising healthcare budget is under scrutiny. Governments around the world are looking at various ways to cut healthcare cost, which provides a huge opportunity for the generics to play a major role in the global market. The number of products coming oﬀ-patent in the coming years is large thus creating a favourable situation for the generics market, worldwide. The Indian generic market, which has attained a prominent position in the global scenario, is also growing domestically. Only a little over 35 per cent of the Indian population has access to modern healthcare, which provides a huge population with unmet healthcare needs.These people are not looking for high-end niche products but require the

10.3

13 15

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Af r

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as ssia Af rica eric m h t A Sou

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Bra

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Source: Health Action International, as of 30 November 2009, 14 doses

basic products, thus giving the generics market a growth opportunity. The average life expectancy in the country has increased from 60 to 75+ years and with this there is an increase in the chronic diseases related with the elderly population. At the same time given the density of population, prevailing sanitation and hygiene conditions, the acute therapy segment in India continues to grow. With

The generics business, currently about $125 billion globally, has grown over the years and is expected to grow to $235 billion by 2017.

both the segments growing simultaneously there is opportunity for generic companies to play a major role in future. Additionally, the increasing aﬀordability of the Indian population, who are today willing to invest in quality healthcare (vaccines or wellness drugs such as nutraceuticals or vitamins), there is enormous scope for the generics industry to grow.

and in building hospital infrastructure. Increase in coverage by insurance can also create a favourable growth environment. Another major factor which will contribute to the growth in the future is the increased awareness on wellness and protection. This will spur the growth of vaccines that is currently in its infancy. The trend of regular medical check-up and medicines for any deﬁciency will only increase as we go ahead. The product life cycle is not the traditional bell-shaped curve, which means that older products will continue for a long time. This is obvious from the fact that Penicillin is still available in the Indian market. The longer product life cycle augurs well for generics. Bulk of the domestic market is catered to by 50 companies with a number of small players with fractional market share. Going forward, there will be consolidation. The Indian sector will continue to grow well both domestically and globally and number of MNCs that were hitherto sticking only to their own innovative products and branching out into branded generics will also become major players in this segment in the country. (iyer.ranga@gmail.com)

Factors fuelling future growth Growth will be further fuelled by increase in the government expenditure on healthcare from the present 1.2 per cent of Gross Domestic Product (GDP), which will result in higher spending on medicines

Ranga Iyer President, Organisation of Pharmaceutical Producers of India (OPPI) Modern Pharmaceuticals I February 2012

Special Focus: CRAMS in India Ranbaxy Pharmaceuticals by Dai-ichi Sankyo ( Japan); Piramal Healthcare by Abbott Laboratories (US); and Matrix Laboratories by Mylan (US), to name a few Outsourcing from low-cost providers with world class standards in line with international regulatory norms. It is taking place across the entire value chain with API manufacturing constituting larger portion (>50 per cent) of total outsourcing followed by drug discovery CRAMS offers excellent growth opportunities to India, besides China, and make it a preferred destination because of its low cost R&D and manufacturing base, strength in the process chemistry, regulatory and manufacturing skills and availability of highly qualified scientific manpower at a considerable cheaper rate.

Market structure

A differentiated cost value proposition What started as a tactical option has become a strategic business imperative by large pharma MNCs to maintain their profitability over a period of time. To stay ahead of China in the race, a strong focus on niche areas and technology is required.

RAMS has become a proﬁtable business model both for service providers from India and China as well as global pharma majors. Last two decades has seen a gradual transition in the business model of major pharma companies from a model where a global major pharma company performed all functions from discovery of the new chemical entities to distribution and sales on their own to emerging collaborative networking across boundaries. The transition in the business model has been necessitated due to the following: Economic downturn Declining R&D productivity due to

increasing failure rate of new molecular entities and high costs in developing new drugs Increased penetration of generics Fewer and smaller blockbusters (drugs with sales of over $ 1 billion) to replace existing ones going oﬀ-patent to decelerate market growth Sequel to above, bottom lines of pharma companies came under pressure. To meet these challenges, pharma majors are now looking at: Investing in new technologies Increasing presence in emerging markets by way of M&As. Eg: The last few years has witnessed acquisitions of Indian pharma majors such as

Global CRAMS market, other than clinical, in 2010 was estimated at $60 billion with a Compounded Annual Growth Rate (CAGR) of nearly 8-10 per cent. Contract research accounted for nearly $20 billion and contract manufacturing accounted for nearly $40 billion. APIs and intermediates account for nearly 67 per cent of global contract manufacturing of $40 billion with an estimated CAGR of 10-12 per cent. India’s custom manufacturing market in 2010 was estimated at $0.95 billion with a CAGR of nearly 30 per cent. India’s share of custom manufacturing, which is less than 3 per cent of global contract manufacturing is expected to increase to nearly 5 per cent during the next 3 to 4 years. Indian custom manufacturing organisations focus more on oﬀ-patent molecules and advanced intermediates. With changes in the IPR, pharma majors will get conﬁdence gradually for protection of their technologies and get their patented APIs outsourced from India. More and more big pharma companies are entering into strategic alliances for longterm contract manufacturing services with Indian companies.

Growth pillars India has emerged as a preferred destination

Modern Pharmaceuticals I February 2012

CRAMS in India for CRAMS due to its ability to create a differentiating cost value proposition, which is powered by: Low manufacturing cost: Indian manufacturing costs in US FDA approved plants have been nearly 40 per cent of the cost in the US or 50 per cent of the cost in Europe. This is supported by the cost for setting up of a manufacturing plant in India, which is nearly 70 per cent of the cost in the US Availability of highly skilled manpower for manufacturing with degrees and diplomas from technical institutes/ colleges/universities Project management capabilities IP protection due to changes in IPR in line with global requirements for product patents and life of patents Technical capabilities: As reflected by the number of DMF and ANDA filings and approvals where India’s share is 34 per cent and 30 per cent of the total filings Response time Regulatory environment Availability of nearly 120 US FDA approved manufacturing units which are next only to US FDA approved manufacturing units in the US Increasing capabilities in high potency active pharmaceutical ingredients such as oncology products, some hormones, prostaglandins Increasing capabilities in biosimilars These technical capabilities have attracted CMOs from abroad to work in India and some of them have already set up their units; eg, Albany Molecular Research Institute, USA has already set up its unit for drug discovery near Hyderabad and acquired the manufacturing unit of Ariane Orgachem in Aurangabad. Drug discovery and development outsourcing, also referred to as contract research, encompasses target identification and lead optimisation to clinical trial phase IIa. India is well positioned to provide services in the area of late stage discovery (research chemistry) and drug development services. India’s advantage of offering cost value proposition is powered by: Strong capabilities in process chemistry ranging across a wide range of reactions

spanning old technology-based chemistry, complex and hazardous chemistry and high-end reactions involving asymmetric synthesis and other modern methodologies practiced in organic chemistry synthesis Strong analytical chemistry capabilities, eg, method development, method validation and transfer Strong process development and scale up capabilities for manufacture of APIs required for pre-clinical and clinical studies Growing pool of scientists with doctorate and masters degree in chemistry, and chemical engineers Availability of cGMP-complaint laboratories for the synthesis of low volume APIs Availability of GLP compliant laboratories for method development and method validations

Challenges IPR: Although India has implemented the WHO –TRIPS patent regime, some pharma majors still perceive a risk on protection of their IP in the country. As a consequence, come companies are still reluctant to outsource certain parts of their value chain to India. One of the reasons of the risk perception for big pharma is due to the Para IV filing by Indian generic players. This concern is gradually waning as some companies have started launching their on-patent products in India. Infrastructure: This is an area of concern as India ranks the lowest among the major players in CRAMS. The Government of India is trying to improve the infrastructure but it has a long way to go Early stage drug discovery: There is a need to improve capabilities in the area of research biology which is required for early stage drug discovery. Efforts are being expended to improve this area Besides these a few hurdles that have been hindering growth are: Attracting and retaining highly skilled workforce Ensuring pharmaceutical supply chain effectiveness Governance, risk and compliance Maximising revenue growth

Optimising commercial operations R&D and the innovation culture: Unlike western countries where there is a constant interaction among universities, public institutions and industry for innovation, India lacks coordination in these three key centres of research and innovation. There is some co-ordination between the national laboratories and the industry, but a lot more is needed to create a culture of innovation which requires co-ordination in all the three centres of research

Critical success factors Technical capabilities Project management Availability of scientists Availability of US FDA approved manufacturing units GLP-compliant analytical laboratories equipped with modern instrumentation Well-equipped process R&D laboratories

Future outlook The country’s competitor in CRAMS is China, which is also investing continuously in improving its capabilities. Infrastructure, a quality of culture and niche technology capabilities, eg, biology required for drug discovery, fermentation technology and HPAPIs are some areas that need immediate attention and all efforts should be expended to stay ahead of the curve. Services such as bioinformatics software development and regulatory filings can be offered. A way forward for India is to shift from old generics to specific generics, HPAPIs requiring specialised handling and containment facilities and biosimilars. Focus on HPAPIs and biosimilars will contribute to improving the global market share. (rrsobti@yahoo.com)

Ravi R Sobti Independent Pharmaceutical Consultant Modern Pharmaceuticals I February 2012

Special Focus: New drug delivery systems

Towards sustainable growth From being a pure reverse engineering industry focused on the domestic market, the Indian pharma industry is moving towards basic research driven, export-oriented global presence, providing wider range of value-added quality products and services, innovation, product life cycle management and expanding market reach.

ndia gained its foothold in the global scene with its innovatively engineered generic drugs and Active Pharmaceutical Ingredients (API), and it is now seeking to become a major player in outsourced clinical research as well as contract manufacturing and research in development of novel drug delivery systems. The current global market for Novel Drug Delivery System (NDDS) is estimated to be to the tune of more than $ 100 billion. According to forecasts, the global drug delivery systems market is projected to reach $ 196.4 billion by 2014. Researchers armed with a never before array of sophisticated technologies and the wealth of knowledge accumulated over years are developing potential drug delivery systems at breakneck speed. NDDS include attempts to reformulate and adding new indications to the existing

blockbuster drugs to maintain positive scientiﬁc outcomes and therapeutic breakthroughs. Old business model for pharmaceutical research has lost its value and market potential; hence, there is a probing need for development of new, viable, sustainable and growthoriented research models. Innovations, in the form of NDDS, are increasingly proving key elements to diﬀerentiate drug products and ensure their presence in the market thereby forming the basis for sustainable growth.

The ‘looking forward’ factors The Indian pharma industry has enormous growth potential due to large population of over a billion and increasing demand for quality health care services. Changing lifestyle has led to changes in disease patterns, and hence increased demand for new medicines to combat lifestyle related

diseases. However, in recent years, it has become more difficult and expensive to discover, develop and launch New Chemical Entities (NCEs). Failure rates for NCEs in clinical development have reached levels as high as 80 per cent, and the approval of NCEs by the FDA has declined drastically. This has put tremendous pressure on pharma companies to look for new business opportunities within their marketed product portfolio to balance this risk. Novel drug delivery-based products offer real product differentiation, patent protection and branding opportunities for product manufacturers. This product category addresses an important market need to expand the availability of important therapies and reduce time to market.

Why NDDS? For many years, the generics market has been considered the low margin end of the pharma industry, with companies competing solely on cost with little vision for innovation. While this assumption may still remain valid for some commodity generics players, rising competition in the major markets, coupled with increasing payer pricing pressures, has driven increased corporate diversiﬁcation in generics companies drive to sustainable proﬁt margins. On the other hand, patent

Modern Pharmaceuticals I February 2012

New drug delivery systems expiry and no blockbuster drugs in the pipeline are two of the major challenges facing the big pharma. This is compounded by lack of R&D productivity. Innovator pharma companies are focusing on NDDS as a tool for life cycle extension of products when challenged by generic competition and oﬀ-patent period.

Bottlenecks in NDDS development NDDS offers unprecedented advantages over conventional DDS, however, they still have their own limitations such as high cost, risk of dose dumping, lack of robustness in manufacturing, difficulty in transfer of the technologies and non-feasibility of rapid and automated production activities. There is a need for process optimisation and hence more focus is required on process research for such sophisticated products. Many pharmacy institutions in India have extensive research programmes but number of technologies transferred from institute to industry is insignificant. The lack of mindset for cross hybridisation in research is another drawback for Indian researchers. Leading pharma firms have to shift their strategy from ‘business-driven innovation’ to ‘research-driven business’ with focus on developing innovation, non-infringing processes and NDDS.

drug delivery systems to deliver value. Pharma companies in the past have been reluctant to work with entirely new class of drugs because of their high risk and high investment factors. Indian companies now use NDDS to gain a long-term competitive advantage and lower barriers for an entry into the international market. Reformulation as super generics and novel drug delivery strategies are utilised for enhancing product value and patient compliance. The fundamental factors necessary for innovations include R&D skills, the exchange of knowledge and opportunities for mutual learning as part of the interaction between companies and research institutions.

Leading pharma firms have to shift their strategy from ‘business-driven innovation’ to ‘researchdriven business’ with focus on developing innovation and NDDS.

Implementing innovative, long-term sustainable future growth Sustainable growth in this context is longterm economic growth, which may be achieved through following strategies: Innovation in the form of NDDS as the basis for sustainable growth The transformation of knowledge and new ideas into commercial applicationsis a key driver in enhancing the growth and the competitiveness of the industry and economies. Firms may use their internal sources to acquire patented technology and know-how either from collaborators or open market both domestic and foreign for diﬀusion of product and process innovation. Faced with high costs, long development times,regulatory uncertainty and the need to diﬀerentiate products, pharmaceutical manufacturers are banking on innovative

February 2012 I Modern Pharmaceuticals

Outsourcing opportunities Outsourcing in the ﬁelds of R&D and manufacturing is the next best event in the pharma industry. Spiraling cost, expiring patents, low R&D cost and market dynamics are driving the MNCs to outsource both manufacturing and research activities. India with its apt technical skills and low cost advantages, both in research and manufacturing coupled with skilled manpower will attract a lot of business in the days to come. Generic substitution The pharma industry will experience a signiﬁcant reduction in the revenues associated with their blockbuster products as generic competition captures market

share. As a result, given that R&D productivity is low and the cost of developing new drugs at an all time high, the pharma industry faces considerable hurdles with respect to maintaining revenue and earnings growth in the future. R&D incentives Both the Indian central and state governments have recognised R&D as an important driver in the growth of pharma business and conferred tax deductions for expenses related to research and development. Indian pharma companies should avail of this facility. There is a need to adopt a more comprehensive long term policy-based approach. This will help companies to boost proﬁtability, drive market share and enhance R&D productivity.

The road ahead... Pharmaceutical industry is one of the high-performing knowledge-based segments of the manufacturing sector in India. Strategies such as greater level of R&D activities, patent ﬁlings, contract manufacturing, contract research, inorganic growth strategy through acquisitions, co-marketing and co-licensing arrangements could help to surge as a global player. Fostering increased collaboration among R&D institutes, universities and pharma companies would help bring NDDS based products to market. With the shift of focus on R&D strategy from reverse engineering to patent driven technologies, Indian pharma industry has to become increasingly innovative rather than imitative. (bajajamrita@gmail.com)

Dr Amrita Bajaj Adjunct Professor-Pharmaceutics, SPP, SPTM, SVKM’s & NMIMS

Special Focus: Pharmerging markets US, parts of Europe and Japan once dominated this space, a group of seven emerging markets—Brazil, India, Turkey, Mexico, Russia, South Korea, and, of course, China are now seen as important sales drivers. IMS Health predicts that emerging markets will see their pharmaceutical spending rise from $ 154 billion in 2010 to $ 298 billion by 2015. Within the next decade, Asia is expected to overtake Europe in pharmaceutical sales, driven by growth in key emerging markets. Such observations help to explain why many large pharma companies have increased their presence in emerging markets in recent years.

Scouring for the best

The upcoming global trends New emerging markets such as Turkey, South Korea, Mexico will add to the BRIC nations further propelling growth. The global pharma sector will see the Asian market overtaking the European market as leaders by the next decade. An analysis of the upcoming trends that will sweep the global pharma scenario.

uring the last ﬁve years, the Indian pharma industry has emerged as the best quality manufacturer of generic formulations globally. According to various industry reports, the market is ranked 10t in the world by value, but what is more pertinent and often

goes unnoticed is the fact that Indian pharma has emerged as the third largest manufacturer of drugs globally by volumes. The Indian pharma industry is expected to grow at a rate of close to 16 per cent on an average by 2015. It is safe to say that the face of global pharma is changing, while the

Indian drug companies are enthusiastically exploring newer markets, strengthening and consolidating their positions in advanced markets of the US and Japan and fast emerging as the hotbeds for drug research and drug delivery systems. What is also important to note is that MNCs from across the globe are keen to explore opportunities in emerging economies as they present a powerhouse of potential as compared to their own parent countries, ie developed economies. Generic is a business that has created and will continue to create opportunity all around the world - whether it is the US or Europe or Japan. The market will always remain competitive irrespective of how many players join it simply because the number of drugs going oﬀ patent is far greater compared to the strength of companies’ drug pipelines. For this reason, many MNCs are also interested in this space. The coming year, for pharma, promises to bring many alliances and tie ups; the most optimal way for Indian companies to handle this is by embracing smart alliances that give them access to a more robust portfolio of products. There is also a disease element wherein emerging economies are seeing a move to chronic diseases such as diabetes, cardiovascular disorders, which is relatively lucrative business for pharma.

Modern Pharmaceuticals I February 2012

Pharmerging markets

10% 8% 6% 4% 2% 0%

Years Source: IMS Health Market Prognosis, March 2011

Pharmerging markets While the potential is, no doubt, tremendous, pharmerging markets come with their fair share of challenges many of which are quite complex and difficult to tackle. Competition from local players already exists; many of these players have better knowledge of the local system. Then, each of these markets has different access rules and many of the emerging economies are often subject to sporadic, arbitrary price cuts that can heavily impact the pharma players involved if risks are not properly mitigated. That said, emerging markets should see strong sales thanks to higher demand for medicines. Several factors such as government initiatives for healthcare, new patient population and increasing use of generics should help drive demand. Growth in emerging markets could help stabilise the base business during the industry’s 2010-15 patent cliff.

Focus on different markets Among emerging markets, India continues to be a star attraction for pharma companies across the globe. With a compelling market size of $ 7-8 billion, the potential is, clearly, tremendous. For Lupin, India contributed 27 per cent of gross sales and registered a growth of 16.5 per cent over the previous ﬁscal. This growth was driven by strong performance and increasing market share in the cardio diseases, diabetes, CNS, asthma and gastro therapy segments. With robust

Growth of pharma market, 2006 –2010 (region-wise) 14.50%

Growth rate

1,000 800 600 400 200 0 2003 2004 2005 2006 2007 2008 2009 2010

Market size $ billion

Global pharma market size and growth rate

4.60%

or N

ica

5.60%

p ro Eu

12.10%

2.60%

ric

f /A

tin

ica

Source: IMS Health Market Prognosis, March 2011

infrastructure and a relatively welcoming regulatory environment, the South African pharma market is valued at about $ 2.5 billion. The market is equipped with a promising road map for the future, which is reﬂected in its FY 2011 growth of 8 per cent. Not only is pharma dynamics (a wholly Lupinowned subsidiary) among the fastest

Several factors such as government initiatives for healthcare, new patient population and increasing use of generics should help drive demand.

growing Top 10 generic company in the market with a clear leadership in the cardiovascular segment, the company has grown an astounding 144 per cent since acquisition. Valued at $2.8 billion, and growing at 3.3 per cent, the Philippines pharma market experienced a slower growth rate in FY 2011 following implementation of Maximum Drug Retail Price (MDRP) regulations for several new molecules. The growing CIS pharmaceutical market represents a strong and lucrative business opportunity, with an estimated market size of $20 billion.

Good times rolling In terms of entry into new geographies, a company can look at an entry into the $ 40-50 billion large Latin American market and some new markets in Asia. In early 2011, Lupin entered into an agreement with Farmanguinhos, Brazil’s largest PSU in health care and the Department of Health, Government of Brazil, for the supply of its 4 in 1 combination drug for tuberculosis. In Argentina, it has arrangements with third parties to distribute WHO-approved TB drugs. Organic routes of growth such as these are important for Lupin in the Latin American market, which is the second largest market for Oral Contraceptives (OC) as Lupin has a growing basket of OC products to oﬀer. Both Mexico and Canada are lucrative markets from a Lupin standpoint and have great synergies with our market leadership and current strengths in oral contraceptives, central nervous system and diabetes therapy segments. While in Asia, key focus areas will include Malaysia and Thailand where we are anticipating organic growth. (hocommunications@lupinpharma.com)

S Ramesh President - Finance & Planning, Lupin Ltd Modern Pharmaceuticals I February 2012

Special Focus: Social media

Driving pharma marketing The emergence of new media and technology has been a revolutionary phenomenon as far as marketing and customer engagement go; yet there are few industries that have shown as much prudence in adopting social media practices as the healthcare and pharmaceutical industry.

led them to ask a doctor new questions or seek a second opinion. These thousands of conversations on health, published each day on social networks have dramatically shifted the decision-making landscape for pharmaceutical purchases, as it was a decade ago. It has opened new avenues for pharmaceutical marketers to better understand the changing needs of their customers and to participate in virtual focus groups.

Those that dared

he modesty of the pharma and healthcare sector in making social media a regular part of their marketing and communication efforts can largely be contributed to the highly regulated profile of the industry and the lack of clear guidelines from the US Food and Drug Association (USFDA). Despite years of wait, there is ambiguity over the appropriateness of online behaviour and inconsistency in enforcement of existing rules. Yet, as far behind as we are lagging, the fear of regulations or the lack thereof, can no longer be used as an excuse to sit on social media sidelines. Despite the absence of guidelines, there is significant opportunity to create transparent and ethical social media campaigns to meet pharma companies’ marketing goals.

Changing patient profiles Several studies are now indicating an increasing reliance among patients on online social communities for information on illnesses and therapy. A survey conducted in 2008 by iCrossing, a digital marketing agency, revealed the Internet as the most preferred choice of patients as the primary source of health information. Startlingly, doctors came in second with 55 per cent preferring personal consultation, and only 20 per cent trusting traditional media such as television or print ads. A similar study by the Pew Internet and American Life Project found that about 80 per cent of Internet users looked online for health information, 31 per cent claimed to know someone who had signiﬁcantly beneﬁtted by following online medical advice and 59 per cent said that online information

The biggest hurdles to social media use by pharma and healthcare companies are questions about the reliability of information and concerns about patient privacy. However, a number of ﬁrms are now stepping up to dispel the alarm by getting involved with existing communities or creating more secure and reliable ones. One of the early adopters of social media has been Merck, which in 2008 created a Facebook page to promote a vaccine. Merck was also a pioneer in creating a passwordsecured website, called MerckEngage, for patients to obtain information about diseases, set health goals, monitor progress and connect with their physicians through the site. Others such as the Mayo Clinic Online brought more focus on facilitating patient communities, while some looked at educating users such as Webcina which publishes curated social media blogs, podcasts, videos, etc. Patient-oriented communities include general health sites such as WebMD, HealthCentral, specialty platforms such as CureTogether, PatientsLikeMe, Inspire and general social networks Facebook, MySpace and others. New social platforms such as Vitals.com allow patients to grade their physician’s practice. Not only have these burgeoning community spaces fostered physician-patient relationships but also encouraged patients to interact with each other, discussing medication, treatments, symptoms, etc.

Social media and pharma: The India story The Indian pharmaceutical industry is the world’s second-largest by volume and is set to lead the Indian manufacturing sector.

Modern Pharmaceuticals I February 2012

MPh (February_2012) 2Tab-47

MPh (February_2012) 2Tab-48

Social media However, despite the steps taken by their international counterparts in leveraging the Internet population for healthcare engagement, Indian pharma marketers have been highly wary of partaking in social media. Unfortunate, considering that there are 65 million active Internet users in India with 45,000 new users being added every day. In emerging markets such as India, communications regarding pharmaceuticals have generally been restricted to doctors and pharmacists only. While there is a large population that dominates global social media statistics, healthcare advice on the Internet has not been taken seriously by many. Also, unlike Western markets, the mindset of people in India has traditionally been more conditioned to treatment areas and cures as opposed to prevention. But as more Indians change their perception towards preventive healthcare, there appears to be a spurt in online communities and focus on ‘wellness.’ With India gaining popularity as a destination for medical tourism, the setting up of international standard pharmacy chains and wellness centers and a booming economy and a middle-class, Indian pharma companies can increase their reach exponentially through the online arena.

and consult them about appropriate social media conduct Work with an agency or have atleast one internal employee who understands the dynamics of social media. Prior to launching any campaign, establish your own internal guidelines for acceptable social media behavior and make sure it is followed Social media offers several areas for innovation and out of the box thinking. Some pointers to getting started are: Define your objectives There is a lot that social media has to offer but it is not necessary to engage every channel at once. Define smaller goals, it could be as simple as ‘create a positive impact about our customer service by responding to every customer online within 36 hours.’

Roche, AstraZeneca have launched their own guidelines for pharma marketers wishing to engage to social media.

Plan your move! While the lack of FDA guidelines has slowed the adoption of social media by pharma companies, it has not been able to put a complete halt to it. In the absence of standard regulatory guidelines, some ﬁrms have created their own policies. Roche, AstraZeneca and most recently medical blogger Dr Bertalan Mesko have launched their own guidelines for pharma marketers wishing to engage to social media. Working within the guidelines speciﬁed by any of them can help pharma companies to stay within the strict regulatory environment. A few best practices that pharma companies could incorporate to steer clear of any violations while indulging in social media activities are: Involve everyone within the company by educating and training them on the importance of social media, its possibilities and limitations Work in close contact with your legal team, discuss campaigns and community activities

February 2012 I Modern Pharmaceuticals

Define an audience Facebook, Twitter and MySpace are not half the social media platforms where you can find your audience, neither the most important. While they do attract the maximum number of general subscribers, the audience for your services might be active somewhere completely different. GlaxoSmithKline was among the first pharma companies to innovate and use YouTube video sharing to successfully launch marketing campaigns. Create a visually appealing website In some ways, having a website can be seen as having a defined online identity; it communicates trust with the audience. Where do your subscribers from Facebook go if they are trying to look you up online? Be real The thing about social media that makes it so popular is that people feel a real

connection with others and it is easy to tell when someone is not being real. Connect with your audience by sharing in their problems, sharing real life employee stories, etc.

Explore new opportunities The market for mobile health and pharma apps is forecast to grow 70 per cent over the next ﬁve years to $ 392 million. As new technologies emerge, pharma companies cannot hang up their boots and be content with their existing eﬀorts. Mobile technology is touted as the next big thing with over 800 million mobile users in India alone. Pharma companies have challenging but exciting opportunities to discover as far as audience engagement goes.

Final thoughts The best opportunities for social media in the pharmaceutical business lie in community and innovation. By engaging in social media, companies can brainstorm for new products and campaigns, ﬁnd new brand advocates and gain a better understanding of their market needs and discover what people are saying about their competition. It allows them not only to educate their customers, but to be educated by them. The importance of creating a community of brand advocates who will support the company in good times and bad is priceless. As members of these communities go through and cope with various health conditions, supporting each other, they become your brand’s greatest advocates. The modest use of social media by the pharmaceutical industry today, hints at a huge growth potential in the months to come. Hopefully, pharma companies are able to harness this potential and execute responsibly to create a win-win situation. ( John.Cahill@Mccann.com)

John Cahill Chief Executive Oﬃcer, McCann Healthcare Worldwide

Facility Visit: Sigma Aldrich Chemicals Pvt Ltd

Building on the Indian technological expertise Providing chemical and biochemical products that help in the formulation of various molecules is a niche but critical sector. Over the years this has been mastered by Sigma-Aldrich, a global company that has recently entered the Indian pharmaceutical space as well. Jasleen Kaur Batra Journey in India

igma-Aldrich is one of the leading life sciences and high technology company. Its biochemical and organic chemical products & kits are used in scientiﬁc and genomic research, biotechnology, pharmaceutical development, the diagnosis of disease & chemical manufacturing. It has customers in life science companies, university and government institutions, hospitals & in industry. Sigma-Aldrich sells to over 160 countries, and operates directly in 40 countries and has over 8,300 employees.

Sigma-Aldrich commenced its operations in India in 1992 as a liaison oﬃce, which in 2003 was converted to a subsidiary. Initially, the Indian operations were limited to import and distribution of its products through the bonded warehouse to various customers in India. The bonded warehouse was a boon to customers since they could now buy the Sigma Aldrich range of products in Indian currency and the hassles of import were avoided. As part of the expansion, in 2006, Sigma Aldrich set up laboratories in

India to manufacture many of the organic compounds listed by it in its catalogue. The products were made and then exported back to its parent company in the US, from where they were distributed worldwide. Dr Pintoo Ganguly, General Manager, Lab Operations, Sigma Aldrich informs, “After the initial years of making products for our parent company we felt the need to explore the opportunities in India, especially in the Indian pharmaceutical and Contract Research Organisations (CRO). The Indian ﬁne chemical and pharma industry has been growing steadily witnessing an increased demand for specialised niche chemicals. The highly regulated pharma industry requires superior and consistent quality products with reliable and dependable service. The SigmaAldrich lab in India with its seamless ability to adopt best practices and processes from across the globe could meet the stringent requirement of the pharma customers and provide diﬀerent products required for kilo scale to bulk manufacturing. The ability to scale up complex chemistries and make available bulk quantities of products hitherto available in small packs at competitive prices

Modern Pharmaceuticals I February 2012

Sigma Aldrich Chemicals Pvt Ltd We have been successful in partnering with multiple pharma companies in the development of new molecules and processes. With the industry poised to grow over the next few years we hope to continue to grow with it.

The initial successes give us the conﬁdence that we will be able to add more bulk products to our offerings in the near future for pharma and ﬁne chemicals industry. Raja Ram Managing Director

Dr Pintoo Ganguly General Manager, Lab Operations

helped build a large pharma customer base in India. The lab operations in India are continuously working to add more specialised bulk products for the pharma industry,” informs Dr Ganguly. Adding to this he mentions,“Our labs are equipped with state-of-the-art instrumentation facilities and we follow very high standards of EHS.”

Partner of choice He continues to explain, the manpower comprises scientists from the foremost universities in India and abroad and have experience in process research, route design and complex multi-step organic synthesis. He adds, “The team has developed several new breakthrough technologies to make processes simple and cost competitive. The initial successes give us the confidence that we will be able to add more bulk products to our offerings in the near future for pharma and fine chemicals industry.” Agreeing to this, Raja Ram, Managing Director, Sigma Aldrich India says, “Over the last year or so we have been successful in partnering with multiple pharmaceutical companies in the development of new molecules and processes. With the Indian pharma sector poised to grow over the next few years we hope to continue to grow with them.” Apart from the manufacturing plant in India, globally Sigma Aldrich has facilities in Arklow, Ireland and Madison, US, etc where a range of steroidal and custom Active Pharmaceutical Ingredients (APIs) are manufactured under cGMP. Over the years CROs have been growing rapidly in India. Major pharmaceutical companies are outsourcing many components of their research of new molecules to Indian companies. Ram says, “Being a global company we

February 2012 I Modern Pharmaceuticals

fully understand the need of major pharmaceutical companies. We are fully equipped to handle all of their requirements, be it technical expertise, the quality of people, conﬁdentiality, documentation or regulatory aspects. We have worked with many companies to help them scale up their processes and also in developing green chemistry for many of their processes.”

in January 2012; to provide a complete package of services to our customers. With the help of ZFN one can create its own cell line but these cell lines also need validation. Hence, acquiring BioReliance will help us not only provide cell lines but also validate these cell lines for our customers,” concludes Ram. (jasleen.batra@infomedia18.in)

Adding wings One of the most exciting products developed by Sigma-Aldrich has been Zinc Finger Nucleases (ZFNs) technology. This technology is innovative and its primary focus is on animal modeling. “For any kind of work related to drug discovery a molecule has to be tested on animals. For a variety of reasons, a number of companies has been using mice for trials, whereas in reality rats are the most appropriate animals since their genome is more akin to humans. With ZFN technology we can actually develop rats with speciﬁc characteristics so that the clinical trial tests can be conducted on them. Sigma Aldrich Genetic Engineering (SAGE) Lab is where these animal models are bred,” informs Ram. Recently Sigma-Aldrich acquired BioReliance Holdings Inc, from Avista Capital Partners for $350 million. BioReliance provides critical services that include biologic, specialised toxicology and animal health testing to pharmaceutical, biopharmaceutical, diagnostics, and other life science customers worldwide. As a service provider of toxicology studies, BioReliance also enables its clients to launch new small molecule drugs worldwide. “We acquired this company

Custom bonded warehouse

Quality at par - R&D lab

NMR in the QC lab

An invite that rewards as well...

Dear Reader, ‘Modern Pharmaceuticals’ solicits original, well-written, application-oriented, unpublished articles that reflect your valuable experience and expertise in the pharmaceutical industry. You can send us Technical Articles, Case Studies and Product Write-ups. The length of the article should not exceed 1,500 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. The final decision regarding the selection and publication of the articles shall rest solely with ‘Modern Pharmaceuticals’. Authors whose articles are published will be sent a complimentary copy of that particular edition. Published by Infomedia 18 Ltd, ‘Modern Pharmaceuticals’ is one of the leading monthly magazines exclusively meant for producers and user fraternities of the pharmaceutical industry. Well supported by a national readership of over 80, 000 and our strong network of 26 branch offices across India, this magazine reaches out to key decision makers among the Indian manufacturers of pharma products, machinery and allied sectors. Brought out in association with Hong Kong-based Ringier Trade Media Ltd (one of the world’s largest trade publishing houses with more than 200 special interest titles and offices in every major country), it ensures that advertisers are able to promote their products and services across the globe at no extra cost. So get going and rush your articles, write-ups, etc… Thanking you, Yours sincerely,

Manas Bastia Senior Editor Infomedia 18 Limited ‘A’ Wing, Ruby House, J K Sawant Marg, Dadar (W) Mumbai 400 028 India

D +91 22 3003 4669 T +91 22 3024 5000 F +91 22 3003 4499 E manas@infomedia18.in W www.infomedia18.in

Insight & Outlook

Years ago, ‘she’, the quintessential Indian woman, was labelled as an achiever if she could cook ‘international cuisines’ or manage ‘laundry cabinets’ swiftly. Cut to today, and she is an achiever who is the best manager of her life, career and business. Today, she is apt in handling a business deal as apt as she is while making chai at home. There is a steady rise in the number of women entrepreneurs and executives in the pharma industry, and believer of Robert Frost that she is …her achievements and careers have miles to go before she sleeps! February 2012 I Modern Pharmaceuticals

Insight & Outlook: Aditi Kare Panandikar

A business magnate Arshia Khan

“I

have been in the business for more than a decade and have worked right from the lowest level to my rank here. I was inﬂuenced by my father during the early stages of life and we share a very close relationship; not like father-daughter but more of friends. I always wanted to emulate him and for me pharma never meant being a part of the lab. We used to come home and discuss business, so I always wanted to come and be a part of Indoco,” reminisces, Aditi Kare Panandikar, Whole-time Director, Indoco Remedies Ltd. She continues, “I remember this discussion I had with my father while choosing my career, when he stated that, “Do not take away a seat from someone who needs it. If I had to get into medicines 20 years of my life would be stuck with it. I was more into management, right from planning, trips, meetings, and that is what deﬁnes my role at Indoco now.” She continues, “I used to love watching cricket, get up in the middle of the night to watch football. I always wanted to travel the world, learn classical music, etc. My mother is a complete homemaker and if I had to choose from all these facets of life, I thought coming to Indoco would be a good deal.”

Like father, like daughter While she completed her graduation she always knew that science is not something that she would want to pursue. States Panandikar, “At any given point of time in my life I always knew that I wanted to do a lot more things at the same time.” Has working in the family

A mixed formulation! Strength: Committed to whatever I do. I rarely get diverted from work Keep ﬁt: Eat good (low carbs, as I have a tendency to put on weight), rigorous walk Change you would want to see: If people were to have more civic sense, we can go places

An avid fan of cricket and football, Aditi Kare Panandikar, never anticipated of being a pharma professional. But her father, Suresh G Kare influenced her at every stage of her career. She carries the legacy forward by aiming to make Indoco a ` 1000 crore company by 2014.

business been easier than thinking of working at any other corporate house? And she replies, “Yes and no. It would have been easier. First ten years of my life I started working at the shop ﬂoor.” She continues to narrate, “It was my father’s philosophy that if I did not know how an organisation works, he was not sure if there would be a place for me at Indoco.” She completed B Com from Mumbai then went to the US and completed her postgraduation in administration. She says, “After post graduation all my friends completed their studies and joined some MNCs. But I came down and worked in a very small company, which I felt was quite rudimentary. But my father convinced me that I had to carry the organisation along, it was a long journey and it could not have happened over night. After working for 13 years in the organisation I came on the Board of Directors.”

Living in compartments A mother of two Mahika (13) and Megh (11), she loves to cook, as that relieves her from stress. She avers, “I live in compartments. On a Sunday morning you might just pass me and not recognise me.” She feels that she may have compromised at home due to work, as she shares, “At times I miss out on important things at home, but never at work because I always have to be there. I have always felt that I have compromised on the time that I should have been with my children, when I look at other mothers. But I make sure that I spend quality time with them whenever I am at home. This also teaches children to be on their own, which is very important. They are very independent now. All my roles are shared at home, as I am married to a doctor, where work is a culture.”

Moving in space… “As a child I wanted to be an architect, or join NASA,” reminisces Panandikar. But Indoco has completely changed her life.

She remarks, “It defines what I am today. Sometimes I wonder what I would have been without Indoco. For the first 8 – 10 years it was my aspiration to work right from the lowest level of the organisation.” And being a women was no easy she feels. “I feel that there is a difference in what one does; a woman at the top management and one that does a clerical role. As at that level they work more for money and what we do is more out of choice,” she says. Panandikar continues, “I feel money should be an outcome of success. More than money I feel it is the cultural environment of doing business, taking risks, and to grow. I have seen children coming from good homes, but still do not have the capacity of doing well because they have been raised in a closed environment. Money can infact be a deterrent for ambition.”

Balancing with ease Global uncertainties and competition are a part and parcel of life. And for Panandikar it has been no different as she has swiftly balanced all with the right dose. More so, she feels that more women need to get into business and work. As she quips, “Women at work always find it relatively easy to maintain their balance at home in good measure. I always tell my male colleagues in terms of an extreme situation that you will go home and live with it, but I will have to make chai, coffee, food. So that is the advantage. That is a relief and one has to have a happy home life.” (arshia.khan@infomedia18.in)

Photographer’s take: Aditi is an excellent art collector, she has inherited an eye for art from her grandfather. Seen here with her Subhash Awchat painting.

Modern Pharmaceuticals I February 2012

Aditi Kare Panandikar Whole-time Director, Indoco Remedies Ltd, Mumbai

February 2012 I Modern Pharmaceuticals

Photo : Mexy Xavier

Aditi Kare Panandikar

Insight & Outlook: Anuradha Acharya

The young leader Chandreyee Bhaumik

s soon as we decided to meet Anuradha Acharya, Founder & CEO, Ocimum Biosolutions, I realised the busy schedule that she has. The next day was her twelve-yearold daughter, Neha’s birthday and on the same day she was leaving for the US. So, she gave me time for a telecon. Acharya currently serves as a governing board member at the Council for Scientiﬁc and Industrial Research (CSIR), and is also a governing board member at the National Institute of Biomedical Genomics (NIBMG). A woman achiever among many avers, “I do not believe in feminism in a strong feminism sort of way but I believe in equality of women. We do not have to necessarily make it a bra-burning sort of purpose but may be it is necessary in some form in order to motivate certain people. Like us, who have been fortunate enough to get the opportunity of education, and reach a certain position in life, we have a responsibility towards a lot of women who did not have that opportunity.”

Achievements Since establishing Ocimum in 2000, Acharya has led the company through three strategic international acquisitions, two capital raises for equity investments and launch of several innovative products, solutions and services-through its proprietary platform called Research as

Age is definitely not the criterion to determine the success quotient of a person. A personification of ‘Where there is a will there is a way’, read on to find more about the journey of Anuradha Acharya, a young veteran.

a Service (RaaS). She was recently named a ‘Young Global Leader’ by the World Economic Forum for its class of 2011. She was selected by Red Herring Magazine in the list of ‘25 Tech Titans under 35’ in 2006. She has also been awarded the Asia Life Science Innovators Award in the same year. She currently serves on the board of Association of Biotech Led Enterprises (ABLE). Prior to founding Ocimum Biosolutions, Acharya has had rich experience in the telecom, IT and entrepreneurship arenas. Her experience is backed by education at premier institutions such as the IIT Kharagpur and University of Illinois where she holds post graduate degrees in Physics and Management Information System.

An ode to success Acharya says, “The industry was not too conducive for us to go and start the business. In fact, we had to actually build the industry. However, at the same time being a diﬃcult industry, it had its own challenges such as funding and many others.” She adds, “My husband, Subash Sulingareddy has always been my support. He is also my partner in the business. We had been classmates and have been together for the last 20 years.”

Take aways Happiest moment: Birth of two daughters Interests: Getting the latest gadgets, table tennis (in school days) Writing ﬂair: I like writing that is more of public interest. I have lot of interest areas like equality; politically where we are heading as a country and so on. There are other aspirations and interests but right now I have a strong interest in health and genomics Music: Hard rock to classical

Poetry: I like Shakespeare,Wordsworth, Kabir. I read different types of poetry Culinary skills: I do cook a lot and different types of cuisines and mostly experimental types Politics: I believe in honest politics. Currently in India it is a difficult phase. But I still have some hope. We have a good Prime Minister and if the Lokpal movement creates some positivity, we will be having some decent equilibrium Favourite holiday destination: Bali

She adds, “I did not have a single person as my inspiration. In one’s life there are always some people who mentor you and there are some whom you look up to.” She does not believe in any philosophy for success. She remarks, “It is important to believe in what you do - be passionate.” She continues, “In January 2000, we had a baby. It was then that we decided that we either move back right then or do not come back at all. I think both of us were fairly patriotic in some form or the other. We came back to Hyderabad because this is where my husband’s family lives. I am from Rajasthan.” She adds, “I prefer witnessing both high and low points rather than sitting at the mediocre position. For me, it works well, for many others it might not be the case.”

Maintaining a balance? Managing a company and a mother of two daughters- both have been challenging in their respective ways. She says, “I do not think being a mother has been more challenging than running a company because both my daughters are fairly independent. Though 70 per cent of the time I am out of home I still enjoy the moments that I spend with them. Running the business has been more challenging because we are working from multiple locations.” When asked about maintaining a work-life balance, she aﬃrms, “You do not have to have a balance. You live a life that is not balanced in certain form. I believe in doing things that keep me happy. One is not required to do everything; you have to ﬁgure out ways to outsource most of the things.” (chandreyee.bhaumik@infomedia18.in)

Photographer’s take: Anuradha is not only a voracious reader of poems and prose, but also likes to compose (scientiﬁc articles!)

Modern Pharmaceuticals I February 2012

Anuradha Acharya Founder and CEO, Ocimum Biosolutions, Hyderabad

February 2012 I Modern Pharmaceuticals

Photo : A Prabhakar. Rao

Anuradha Acharya

Insight & Outlook: Dr K R Rajyashri

The born scientist Jasleen Kaur Batra

r K R Rajyashri is someone who can sweep you of your feet with her simplicity and the great passion that she possesses towards science. With an experience spanning more than 22 years in pharmaceutical, she truly epitomises simplicity, dedication and passion.

Scientist dreams She says she always loved science. “In the late 70s, the time when I was studying, a sense of national pride surrounded me. At that time, all people wanted to do was be of help to the nation and bring glory and pride to India. It was a great time to be in, as the sense of nationalism always surrounded me; I had the strong urge of doing something for my nation. At that time, a handful of professions were looked upon, and science was one of them. During my journey through diﬀ erent schools, I had the privilege of studying under great teachers who inspired me to go a head and fulﬁll my dream. My parents wanted me to become an engineer or get into medicine, but I was determined towards becoming a scientist, and so I went

Inside-Out Favourite holiday destination: Travelling to UK Favourite book: To Kill a Mockingbird Culinary skills: I enjoy cooking Italian food after a long day of work Favourite actor: I am a Shah Rukh Khan fan and I love to watch Chak De India Favourite pass time: I enjoy going for long drives with my daughter, Shruti. She is in her second year of medical studies What is next for you? It is my dream to help women willing to set up their enterprise.

ahead with my dreams,” she asserts.

Some people do not know where their interest lies, while some find their passion in their 40s. Only a few lucky ones know what they want since the beginning. One such achiever in the pharmaceutical field is Dr K R Rajyashri, who knew as a child that she wanted to be a scientist.

Why an entrepreneur? Why choose the tough path? “After I completed my education I started working with Avesthagen as a group leader and then became the Director of Research there. When Vinay Konaje (Founder, Navya Biologicals) joined Avesthagen he came in with an interest in pharmaceuticals; when we started working together we realised that it was fun to work together as a team and also to work for the pharmaceutical sector. We wanted to do things differently and so we thought of starting a company together,” she informs. Has it been an easy ride? “Though we had a few hurdles that came our way, today it feels great that we have been in the industry for more than five years. We are in the process of expansion and would soon be setting up our very first manufacturing unit in Belur. The feeling of being an entrepreneur is something I treasure today, the freedom to work on projects we like and bring forth our ideas to the nation is what made us start this company and we are extremely proud of where we are today,” she says happily.

Other interests Journalism was one profession that interested me a great deal, she says. “I am extremely fond of reading, children, generally enjoy dancing, singing but for me reading was on the top and even today irrespective of how hectic or tiring my day goes, I always make time to read. There was a time in between where I did consider the option of becoming a journalist, but my passion towards science was more and so I went in that direction,” she avers.

Personal hurdles The only challenge I faced was with my daughter. Once my daughter came to my life I knew I was not giving her the time I should, and so I lived in a dilemma about whether my profession should take a back seat or my family. For me both were extremely important and so one day I asked my daughter if she would like to have me home all the time. She said she was very proud that I was a scientist and wanted me to continue working, and that was the end of it for me. That was the only problem I faced and thankfully it was taken care of; thanks to my daughter.

Dreams unlimited Sky is the limit to her dreams. Dr Rajyashri avers, “My dream for Navya is that it should be the best scientific company in the world and should do well scientifically as well as socially.” She continues to add, “We want to make the biologics so cheap that a labourer can afford a diabetes medicine or any other medicine for that matter without thinking twice. I want to fulfill my dream of making the cheapest drugs available to the maximum number of people.” A simple person, she is fond of travelling and exploring new places.“As for my personal life I love to travel and after we started Navya I have not got the time to travel as much, so I wish to travel the world in the years to come,” she signs off. (jasleen.batra@infomedia18.in)

Photographer’s take: Dr Rajyashri loves to relax under the shade of a tree at her home in Hubli.

Modern Pharmaceuticals I February 2012

Dr K R Rajyashri Founder and Director, Navya Biologicals, Hubli (Karnataka)

February 2012 I Modern Pharmaceuticals

Photo: Kiran Bakale

Dr K R Rajyashri

Insight & Outlook: Dr Mary Francis

Conquerer of all quarters Chandreyee Bhaumik

“O

and a beautiful life lay ahead of me.” These are not the lines from any inspirational book but are the pages from Dr Mary Francis’s life. Dr Francis had never lost hope in whatever she did and this time was not an exception. Next morning she

consulted her best friend Dr Aparna. Dr Francis continues, “She too did my breast examination and took me for Fine Needle Aspiration Cytology (FNAC) tests to

Photo : Mexy Xavier

n February 27, 2011, while getting ready to go for a party, sheer intuition made me examine my left breast, and to my utter horror, I felt a lump. I decided not to press the panic button. I was 42-years-old then

Prioritising responsibilities in life is the way to maintain a perfect worklife balance. Dr Mary Francis has never allowed the two worlds to overlap. Here is the journey of a true winner who has battled against all professional and personal odds to emerge successful.

Dr Mary Francis CEO, Mascot Spin Control; Dean & Director CRIMSON; Director, Jovis Clinical Research Pvt Ltd, Mumbai

Modern Pharmaceuticals I February 2012

Dr Mary Francis check the malignancy. The reports showed what I feared the most. I tested positive for duct carcinoma, epithelial malignancy on my left breast.”

A brave heart Fifteen years of marriage - a loving husband Biju Francis, a ten-year-old son, Bryan, and a circle of close relatives and friends made her life perfect. Determination and strength of mind together with God’s help and family’s prayers were enough to bravely face this trauma. She boosted her spirits by reading books and articles on the

power of positive thinking. She went for movies, shopping and get togethers. She says, “After my third chemotherapy and getting a green signal from my doctors, I went on an oﬃcial trip to France for four days, followed by other business trips to Hyderabad, Delhi and Kerala.”

Then and now Born on December 13, 1968, Dr Francis has always been focussed in life. After earning her doctorate in Analytical Chemistry, within a span of 10 years, she had reached from the position of an analyst to Assistant Director of Therapeutic Drug Monitoring Laboratory, a sister concern of Ramnarain Ruia College. Later, she was heading the clinical research projects of the Indian region for Pliva. She says, “I was also the CEO of AceBiomed. My ambition was to become an entrepreneur in the clinical research ﬁeld. With this in mind I set up Jovis Clinical Research Pvt Ltd. Apart from this I have my own training institute - CRIMSON. Other than all these, I am also the CEO of Mascot Spincontrol Pvt Ltd.” With time Dr Francis has realised that God has made her an instrument to serve others. She says, “I decided to share my experiences to the needy patients as a counselor and help others in whatever way I can. On these lines, at the Oncology Day Care centre, where I was undergoing chemotherapy, I started soothing the fears of the patients lying on the next beds.” Dr Francis is an innovative thinker, with broad-based expertise in operation, ﬁnance, and business development. She has proven her ability to quickly analyse key business drivers and develop strategies to grow the bottom line. She is visionary and goal oriented, with demonstrated experience in planning, developing and implementing result-oriented solutions for business opportunities.

Feminism? Dr Francis says, “I am proud to be a woman. Along with the society, it is a

February 2012 I Modern Pharmaceuticals

Quick bytes Inspirational ﬁgure: Mother Teresa and in the industry Dr Kiran Mazumdar-Shaw. But the main inspirational ﬁgure was my Dad Believe in: Money is not the only thing in life. Concentrate in your work and money will come in Success: Hard work Motherhood: Every woman should be a mother. It is challenging Areas of interest: Sports (particularly cricket and football) Culinary skills: French fries Regret: I do not have any regrets but I wish I had done a management course from a management school Shopaholic: Whenever I am down I go to the mall and start shopping. I love spending money. If I love anything I just pick it up Priciest possession: My son male-dominated industry. But women can do multi-tasking better than men because God has given us the ability to face any situation.” Dr Francis reiterates, “Feminism to me is a mother, wife, and daughter. To be a female is not an easy task at all.”

Three men in her life Dr Francis is fortunate to share a wonderful relation with three men. She says, “We are coming from a conservative South Indian family and a woman gets married after she is 18 years. But my father was keen that I study. There was an agreement between me and my father that after I complete my PhD, get a job and then get married. My husband was a marine engineer. So, at that time I was taking care of my parents, my married life. Then came my son. We are extremely close to each other.” While parting she quotes Anne Frank, “I do not think of all the misery but of the beauty that still remains...!” (chandreyee.bhaumik@infomedia18.in)

Photographer’s take: Dr Francis’s most passionate moments are spent in teaching and interacting with her students at her alma mater, Ruia College.

Insight & Outlook: Dr Villoo Morawala-Patell

A charismatic persona Arshia Khan

he enjoys reading, visiting book stores, swimming, movies, hanging out at anything new that opens up whether a pub or restaurant or a store, loves design, art and shapes. This may barely come out when you see her. Dr Villoo Morawala-Patell, Founder & CMD, Avethagen Ltd, for whom the most important factor to maintain her life balance is her grandson Zahaan whom she takes care of two evenings in the week, has three wishes that she wants to fulﬁll.

A well-knitted bond Dr Morawala-Patell was born on June 18, 1955 in Navsari, Gujarat and grew up with her parents Dara Dinshaw Morawala and Daulat Sorabji Kasad, brother Mahiyar, and sister, Bakhtawar in Nizamabad, Telangana District. She went to boarding school at age 6. In 1978, she married Zareer, a jazz pianist, son of Dr Rashida Reporter and Minoo Patell. As she underlines, “My family and friends are a big source for me

Mixed bag What would be your strength? My capacity to manage and persevere is my strength. Fame or money, what would be your passion? My passion is neither. My passion is to achieve a beautiful piece of art. Fame is interesting as it allows you to accelerate and achieve the impossible and money is the glue that makes the painting possible. How important is money to be successful? Appropriate financing and at the right time is critical. This is one of the most important needs to fulfill in India if this industry is to take off.

Studying in a boarding school since the age of 6, Dr Villoo Morawala-Patell, a scientist cum business woman, reminisces her earliest memory of school and disapproves of the men-women distinguishing factor.

to relax.” She rewinds, “I joined the boarding school at the age of 6; watching my parents and little brother wave good bye to me is a memorable moment. From that day on it has been me alone and it has never been easy for me. Nine years with Italian nuns who instilled in us that the way to salvation is through hard work (Sicut Apris Operosa was the school motto in Latin that means ‘Busy as a bee’). When I reflect back I see a little girl always trying to be good, friendly and busy, an aspirational girl. After working with scientists from all around the world, that really sparked off her entrepreneurial spirit. She then returned to India with an idea rooted in her mind – to create a platform that would bridge academia and industry. Thus was the seed sown that gave birth to Avesthagen in 1998. She recollects her school days, “As we used to walk around the trees after dinner singing, ‘Oh my darling Clementine’ I would set these goal points for a big step and try to jump to get my foot on the spot I had picked.” And she has carried this with her till now, with Avesthagen. As she feels, “Competition will always be there. I have never looked out for competition or felt the need to compete. We are an innovative company and we are flexible and move fast and have shown capacity to survive against odds.”

Backed by a strong vision A combination of scientist and businesswoman, she certainly faced challenges to be at the fore front of Indian biotechnology. As Dr Morawala-Patell, shares, “I had mixed feelings! The ability to shift from a scientist to businesswoman requires a split mind. I compromised it in my brain as Business of Science and Science to Business. With this I could live and work.”

She feels that the Indian biotech industry has the potential and will grow in size over the next few years. “It will be a key in driving forward significant policy changes in the world due to the large numbers of people who will be exposed to new drugs,” remarks Dr Morawala-Patell. When we ask her about women leaders and how it is different for the fairer sex, she strongly outdoes the comparison. She reckons, “I do not like being classified into separate categories of women entrepreneurs and men entrepreneurs. An entrepreneur is born and we do injustice to women with this classification. So my advice to women is do not allow yourself to be boxed in by such classification. Be one with the rest of them, and persevere and rise to the top of the tree as my mother– in-law, Dr Rashida Reporter Patell used to tell me.”

Reminiscing the child within the scientist Though she is a steadfast woman with leadership skills what worries her most is the dishonesty in people and being let down by the ones you love. But she continues to hope and wish the best for her family and company. She desires to fulﬁll her three wishes; her family being together happy, healthy and at peace, Avesthagen emerges at the top and bring good products to the market soon, and last but not the least she would want to travel the world and see all the special regions and places. (arshia.khan@infomedia18.in)

Photographer’s take: Sitting at her desk, Dr Morawala-Patell radiates glow as bright as the picture above.

Modern Pharmaceuticals I February 2012

Dr Villoo Morawala-Patell Founder and CMD, Avesthagen Ltd, Bengaluru

February 2012 I Modern Pharmaceuticals

Photo: MAXIMAGE

Dr Villoo Morawala-Patell

Insight & Outlook: Nidhi Saxena

An impatient achiever Chandreyee Bhaumik

‘D

o not just think you are the one; just know you are the one.’ These are the lines from the popular movie, ‘Matrix’ and features on the Facebook page of Nidhi Saxena, Founder, President & CEO, Karmic Lifesciences. Adept at envisioning and establishing new businesses from scratch, she founded Karmic Lifesciences in 2005 and has built a robust customer base comprising several global pharma and biotechnology companies as well as a scalable clinical operations and data management group in India. Saxena holds an MBA from SP Jain, Mumbai and is a certiﬁed Six Sigma Black Belt from KPMG. Referring herself as impatient, she says, “I was born impatient. I was a premature child of seven and a half months and indeed I am not ready to wait!!!”

Women at par? Saxena explains, “I have never believed in any boundaries so I am not for any pseudo quasi feminism. I think men and women have their own set of strengths and weaknesses. Correct feminism would be equality for me. And over doing that equality is not appreciated. ” She continues, “When I ask

Following the unbeaten track had been the main zeal that drove her to make big in life. In spite of coming from a small town it was the creative bit that brought Nidhi Saxena so far.

myself if my mother were so much independent that she could not have had time for me, would I have appreciated that and the answer is always no. I would want both my parents to focus on the family.”

Flashback Saxena always wanted to be an entrepreneur. She explains, “Right from the beginning I have been highly independent; I wanted to have a company of my own. None of my decisions were based on any convention. I come from Allahabad, a small town. Most of my friends today are married. I have always been diﬀerent and I believe that as my strength.” She adds, “My parents were doctors and both of them were education oriented. They wanted me and my brother to either do an IAS or MBA, and I did my MBA.” She also mentions the names of her cousins Rusi Brij and Sanjeev Verma who have mentored her. Ashok Bildikar, CEO, Neeyamo, has also helped her in her journey. She continues, “When I completed my MBA I decided to channelise it into something constructive and positive.”

Snippets Interests: Travelling, photography, reading ﬁction and poetry. At present, I am writing a book and I will be sending the manuscript to Penguin and Rupa. I love reading poetry (Kamala Das) along with ﬁctions of Ayn Rand, Milan Kundera and many others Book: ‘The Joke’ by Milan Kundera Happiest moment: Professionally, I would be most happy when my company becomes a $ 100 million company. I think the birth of my twin nieces (Diza and Sania) Other than Karmic: I want to start a gig company. I have seen Nikhil

Chinappa for this and I also want to create a social venture fund Holiday destination: Mountains. I remember going to Rishikesh or Nainital. Goa is my favourite Movie: Jaane Bhi Do Yaaro Politics: More youngsters should come into politics. Currently, Indian politics is in a very sorry state. We need transformational leadership. I am a party agnostic Culinary skills: Chicken biriyani Message: Follow your dreams; risk is a part of life First few things you will notice at home: Library and wine collection

Discussing what a perfect life is to her, she says, “There is nothing called perfect life. If there is any situation when I am out of transaction completely, it would be because there are competent people handling it and I can concentrate more on the strategic and innovative aspects - that would be a perfect life. Also, if I have time to pursue my personal interests.”Talking about the regrets in life, she says, “There is no regret as such. Personally I could have been more sensitive. Professionally, if I started a little earlier, like if I started at 25, there could have been more contribution. Of course, experience has its own value.”

Choice to be single When asked about her choice to stay single, she says, “I have seen most people who are successful and are attached to others only to a certain extent. Their whole focus is on internal growth. So, time and focus on a second person can be demanding. And unless the second person is understanding, problems are bound to happen.” She continues, “Moreover, there are people who are inclined to marriage and in certain aspects I am not social at all. There have been times when I have not turned on the television for 28 days at length.”

Success tips Saxena believes that there is no short cut to success. She says, “There is no short cut to success. One or two big ideas might be the game changers.” She adds, “Creativity is extremely important. I tell everyone in my oﬃce that whatever you do it is essential to put that extra thinking.” (chandreyee.bhaumik@infomedia18.in)

Photographer’s take: Nidhi an avid cycler, and she sees it as her means of keeping ﬁt!

Modern Pharmaceuticals I February 2012

Nidhi Saxena Founder, President and CEO, Karmic Lifesciences, Mumbai

February 2012 I Modern Pharmaceuticals

Photo: Neha Mithbawkar

Nidhi Saxena

Insight & Outlook: Shravanti Bhowmik

The agile manager Chandreyee Bhaumik

“T

he journey has been interesting and rewarding. I treasure every moment of it,” begins Shravanti Bhowmik, General Manager, Clinical Research - Sun Pharma Advanced Research Company Ltd. Born on February 5, according to her friends, Bhowmik is a true Aquarian. Believing in the philosophy ‘Live each day as it comes’ she has come a long way.

Journey Talking about her journey, Bhowmik says, “In school, I was quite the nerd, a topper, and a teacher’s pet, and I tell my friends from school days that I am

Interesting points Feminism: Feminism is standing for women’s rights and gender equality Politics: Is interesting, good to know, but would never get into it Perfect weekend: Outside Mumbai, to a mountain or hillside with no crowd Favourite holiday destination: Europe Happiest moment: When my nephew Shantanu was born Low point: When I lost my parents Strength: Can make conversation with anybody, like working in a team, strong willed Weakness: Too accommodating at times, forget friends’ birthdays, need to be a bit less focussed on work, need to carve out time to pursue other interests Fetish: Shoes Priciest possession: As of now, a Madhubani painting that was gifted. This is by an artist from Bihar who is no more. It was bought at an exhibition at the Prince of Wales museum Culinary skills: Not too elaborate but can do justice to ﬁsh curry

With right determination and ample confidence Shravanti Bhowmik had set out on her journey. Though frequented with several hardships it is her selfbelief that has never made her lose her way.

so glad to have moved on. My parents were very keen on me being a doctor, and though I was not too happy about leaving them and moving to a hostel in a different city, I did join Government Medical College and Hospital, Nagpur.” She continues, “I have bitter-sweet memories of the years in medical school. My mother lost her battle with cancer during that time. I got to train at one of the best medical schools in the country. The training and exposure that a medical student gets is not just useful for medical practice but can also help shape attitudes and relationships with fellow beings. I had developed an interest in drug development and research by the time I completed graduation and decided to train in pharmacology.” Though this would mean moving away from the conventional role of a doctor treating patients, and would be in conflict with what her parents had envisaged; her father supported the decision. She says, “My father passed away a few years ago and I am glad he could see that the career choice I made worked for me.” She continues, “After completing MD in Pharmacology, I had a job of teaching students at a medical school in Pune. I was glad to be at home in Pune, however, after 3 years of teaching I was ready to move on.” In the industry, her first job was in the Medical Affairs division of a company called Macleods Pharmaceuticals Ltd. She says, “After a year, I joined Sun Pharmaceuticals and was one of the first employees recruited in the clinical research division. Today, we are a team of 18 and growing with clinical research, global pharmacovigilance and medical writing.” Talking about her inspiration she reiterates, “I have had two mentors, both eminent clinical pharmacologists; Dr Arun Nanivadekar and Dr Bhikhaji Udwadia. They have been instrumental in

shaping the way I think. Even today when I need advice, I call Dr Nanivadekar or his wife Sucharita (my foster mother); a few minutes of conversation and I see things in perspective again.”

Modern Pharmaceuticals I February 2012

Shravanti Bhowmik

While discussing about her interests and hobbies in life, she says, “I love hiking though I am hard pressed for time.” Her other interests lie in reading. Bhowmik says, “P G Wodehouse is an all time favourite and I can read his books over and over again. Of late two books that I have loved reading are Steve Jobs biography, and Siddhartha Mukherjee’s ‘The Emperor of All Maladies: A Biography of Cancer’.

Looking forward For Bhowmik success is earning respect from the peers in the industry, and

people working together in the team. While responding to the question what she would have been if not a researcher, she smiles and explains, “If not a researcher I would have been a practising doctor- probably an ENT surgeon! After 9 years of medical school, I can not think of anything else I would have liked to do.” Talking on where she wants to see herself in the next few years, she says, “Professionally I am the part of a growing clinical research team. Someday, I would like to have a more global role in research and development function in the pharma industry.”

Additionally, on a personal level Swami Gahananandaji and Swami Prabhanandaji (my grandfather’s brothers) were instrumental in setting up and propagating Ramakrishna mission. The Mission at Shella (in the Khasi hills near Cherrapunji, Meghalaya) was founded by them. I would like to set up a fund for the school there and keep their legacy alive.” (chandreyee.bhaumik@infomedia18.in)

Photographer’s take: Shravanti loves to have an artistic touch at her home.

Shravanti Bhowmik General Manager - Clinical Research, Sun Pharma Advanced Research Company Ltd, Mumbai

February 2012 I Modern Pharmaceuticals

Photo: Neha Mithbawkar

Interests and passions

Insight & Outlook: Suchitra K Ella

Resonating responsibilities Chandreyee Bhaumik

“I

in India,” are the opening lines of Suchitra K Ella, Co–Founder and Jt Managing Director, Bharat International Ltd.

Biotech

Proficiency at her very best At Bharat Biotech she has handled almost

all core functions such as project planning & implementation, administration, marketing services, corporate communications & corporate strategy. She has been awarded ‘The International Women Entrepreneurial

Photo: A Prabhakar. Rao

was not a very smart student in school and could not get into IIT or medical school programme. I was always an above average performer, maybe touched a distinction here and there. But my second interest was always social sciences. And that is what kept me in the ﬁeld of Economics

With set priorities, Suchitra K Ella, had always focussed on the quality and details of whatever she did, be it at her work place or personal home space. And today, she is an achiever of various dimensions.

Suchitra K Ella Co-Founder & Joint Managing Director, Bharat Biotech International Ltd, Hyderabad

Modern Pharmaceuticals I February 2012

Suchitra K Ella Challenge 2007’, ‘Women Power & Entrepreneurship Award 2007’, ‘Women Entrepreneur of the Year 2007, SAARC Women Entrepreneur Award’, ‘The FLO GR8 Women Achievers Award 2008 for Excellence as an Entrepreneur’ and many others. Ella is passionate about organising blood donation camps, donating blood to the Red Cross, Thalassemia & Sickle Cell Society of Andhra Pradesh. She is also a life member of the Red Cross. She is a member of AIKYA at the Indian School of Business, has been a founding member of the Hyderabad 10K Run Foundation. She has co- founded two foundations - Ella Foundation for higher

education & discovery in life sciences, Krishna & Suchitra Ella Foundation for health & social empowerment.

Returning to the motherland Discussing her journey to the US she says, “When I went to the US, I was in a wonderful situation on a J2 visa and I could pursue employment there. So, for my husband while he was pursuing research, I was pursuing employment, continuing education, skills up gradation, etc. I could start working in the US in a month’s time because my visa status permitted me to do so. I used this opportunity to build a career in business development, customer service, back-end operations in retail & ﬁnancial services.” Talking about her married life she says, “Ours is a Made/Met in India story. We got married here before moving to the States. Dr Krishna Ella was a Rotary Foundation scholar & pursued his PhD from University of Wisconsin in the US. After staying there for a decade my thought process was that I had gone there for a set purpose and I felt that at that time we had achieved it, to whatever an extent possible. Thus, there was no need for me to stay over there. The goal was not to go and settle in the US. It was primarily to enhance our knowledge, skills, training and exposure. I was always drawn to come back to India.”

Interesting facts Success: If I can be grounded and rooted as a human being first, visualise things for the mankind, and if I can deliver something that can bring substantial change in the quality of life to others around me, either mankind or the ecosystem Interests and passions: Travelling, listening to music, performing arts, light reading, and contributing time, energy & personal resources for a worthy cause. I also take an active part with other agencies, United Way of Hyderabad Chapter and the other is Red Cross Society Music: Formally learnt carnatic music. Have learnt an instrument called Veena Holiday destination: Whereever I find tranquillity and peace, where I can connect to nature really draws my attention. Bali is a favourite! Inspiration: My father. He was a senior officer with the Government of India. He inspired me to do what I am doing today. He was a mining engineer by profession Culinary skills: Very bad because I do not spend much time in the kitchen nowadays, though I wish could. I can make some decent coffee for my husband

What is feminism? Talking about her views on feminism Ella says, “As a woman, I do not tolerate injustice to a woman. I do not bother about what modern feminism talks about. I am a professional and an entrepreneur and gender does not matter - as long as one can equally contribute by means of intellect or hard work.” She continues that the general perception socially is that people do not think women as an achiever. She highlights, “I think my mother is an achiever; my grandmother is an achiever because their contribution is intangible to the society. But it is perceived as being natural. But I think if a male person had done something diﬀerent or new, the recognition is more evident. I think there is a need to have positive role models and project the right kind of role models to the youngsters.”

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A graduate in Economics from the University of Madras, she pursued her academic interests in the US at Wisconsin and South Carolina in the areas of Business and Marketing. She also started her career alongside specialising in Business Development & Marketing Operations, putting in more than a decade of professional service in US Corporations. Ella’s leadership and organisational capabilities has been a key driver for Bharat Biotech’s success as a fore runner in developing new generation vaccines, bio pharmaceuticals and therapeutics. (chandreyee.bhaumik@infomedia18.in)

Photographer’s take: Suchitra seen her in her family home at Hyderabad on an artistic swing.

Insight & Outlook: Susan Josi

Tackler of ‘ad’versities Chandreyee Bhaumik

“I

Josi, Managing Partner, Sorento Healthcare Communications Pvt Ltd, Mumbai. She has come a long way since the start of her career post her MBA. Explaining the success rule that laid the foundation of her achievements, she says, “I am passionate about what I do. And when there is passion, there is commitment; when there is commitment you

give your best, and when you give your best success is bound to come.”

Visiting the memory lane Josi says, “When I was in class XII, I was

Photo: Neha Mithbawkar

t may not be exactly what you can call ‘regret’ but I always feel that if I were a medical doctor I could have been more qualified to help the less unfortunate. I have huge empathy for the poor. I always tell my son, who has finished his medical school that it is easy to run after money but India does not have sufficient doctors. Plus there is poor access to healthcare facilities,” says Susan

An amalgamation of empathy, emotion and professionalism makes Susan Josi a definite achiever. Learn about her journey of plans to be a medical doctor to becoming an entrepreneur.

Susan Josi Managing Partner, Sorento Healthcare Communications Pvt Ltd, Mumbai

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Susan Josi keen on joining the medical ﬁeld. However, because of grade issues getting into medicine did not happen, so by default I joined pharmacy in UDCT, Mumbai. She adds, “I had the choice of either continuing with an M. Pharm or moving into an organisation. For two months post my B. Pharm I did sales management with one of the premier companies associated with capsules.But during these two months I also came to know that I was the second rank holder in pharmacy in UDCT University.” She received scholarship for her M. Pharm. She highlights, “Coming from a middle class background any form of educational aid is a big thing. This is how I did my masters in pharmaceutical technology.” In

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June 1986 she received the scholarship for UNIDO Scholar at Belgium, University of Ghent for Advanced Pharmaceutical Technology. She had varied experiences in several companies from Production Officer, Themis India, to Formulations Development Officer, Unichem India, to Formulations Development Supervisor, Hoechst India (now Aventis); Marketing Manager, NPD, Tata Pharma. Further, she independently started and managed Sohum Communications, a healthcare communication agency. Then, she was the Executive Director, Ogilvy Healthcare, India, a division of Ogilvy & Mather and finally Managing Partner, Sorento Health Care Communications Pvt Ltd. She did her masters in management from Narsee Monjee College, Mumbai. She adds, “In pharma industry everything is done by the brand manager. For any FMCG company be it Unilever, Procter & Gamble, it is always given to an ad agency. After research, I observed that in the international arena there were full-fledged agencies serving only the pharma industry. In 1994, it was almost a $ 2 billion industry and that was huge. And that set me thinking why not start my own agency.”

Interesting facts Happiest moment: When I went abroad for the first time. I had never seen places beyond Mumbai since my parents were never the travelling types. Also, when I got my kids. I love children. I do support an orphanage Music: Indian classical beats. I was a Bharatnatyam dancer in school Gardening: Love anything to do with nature Inspiration: Steve Jobs. I am not sure about his leadership style but definitely about his spirit. And N R Narayana Murthy. He brought in the concept of wealth creation. You do not have to have a silver spoon to start your own outfit, and when it is time you should move out of the business so that the next generation can take it up Perfect day: Relaxing with a lovely book with my ipad, with music on, seaside, with lot of greenery Recent read: The Help Culinary: All kinds from Malayali food to continental Last seen movie: The Dirty Picture

Support system

Feminism

Managing an independent outﬁt is not an easy task. But the job becomes easier with the support of the family members. She reiterates, “My husband has been extremely supportive. He told me when everything is going right, why do I wish to venture into marketing? When I told him that this (independent outﬁt) is where my heart lies and I will be very happy, he respected the decision. All along, till today, he has always supported me.” Josi continues, “His entire family is with me. Yesterday my son cleared passed his MBBS and more than me my mother-in-law was happy for me since she knew of my desire to become a doctor!” She continues, “My mother was a teacher and my father was in transport services. They come from to a traditional middle-class background and were always by my side. However, my father could not accept the fact that I was starting my own company. He was of the opinion how can we get into entrepreneurship?”

Josi says, “A woman learns to do multitasking from the moment she becomes a mother or wife along with managing work at her workplace.” She adds, “It does bog you down when you have to become the fulcrum of everything. From a maid not coming at home, to a child’s lack of performance in school, to someone in oﬃce misbehaving, the stress sometimes stretches too much. For a man, it is given that he is a provider. If you ask me, there is an identity crisis for her, whether she is the provider or someone who has to manage the house.” Feminism is just not about ﬂaunting an attitude. Josi says, “I have an individual way of conducting in the society. God has given you some skills as a woman. It is important to use them rightfully and at the same time keep the dignity.” (chandreyee.bhaumik@infomedia18.in)

Photographer’s take: Susan loves to keep herself healthy with various yoga techinques.

Insight & Outlook: Uma Javeri

Luminating with elegance Chandreyee Bhaumik

“N

o MBA school would have taught me what my father has taught me,” were the words of Uma Javeri, Managing Director, S Zhaveri Pharmakem Pvt Ltd. She boasts of awards like the Woman Entrepreneur of the Year Award - 2007 at Emerging India Awards in her kitty. Javeri, a student of The New Era School, Mumbai, and a commerce graduate from Sydhenam College, Mumbai, joined her father’s business in 1984 to help its expansion. She says, “I never liked science, I was an average student in science but overall I was a first class student. I do not mean first class of today with 90 per cent. At our time getting a 65 per cent would be like a topper.” She adds, “I got married when I was 21. In fact I gave my final exam after my marriage.”

Rewind… Discussing her entry in to the pharma industry she says, “After my schooling and

Believing in the strength of the relationship with people around her, Uma Javeri has traversed a long road. With innumerable ups and downs on the way, through her multi-tasking skills she has reached the victory lap.

before my college started there was a gap of three months. It was during this time that I started going to my father’s office.” At the time when Javeri joined, S Javeri & Co was representing international companies from across the world. Although a small business firm with only three employees in the 80s they were the pioneers in introducing film coating technology in India. Pharma companies were using sugar coating technology at that time. Aware of the magnitude of change that would be required, Javeri enhanced her marketing skills by attending several interactive workshops on formulation development.

When the going gets tough Recounting her earlier days, she shares, “Initially when I was helping my father, everything was done on phonogram. There were no computers. Gradually with time came the facility of telefax.” She continues

Interesting facts Next in line: Planning to build a new plant in Dombivli, Mumbai Turning point: When we established our R&D centre at Lower Parel Being a mother: Every day for years we would sit together and talk for an hour regarding what we did that day. No business dealings, just what was the experience of the day. My husband and my mother-in-law would also be with us Interests: Reading (ﬁction), watching sports (football and basket ball), used to be an athlete in school; I wish to learn swimming Recently read: The Confession by John Grisham Priciest possession: I would say my daughters are priceless possessions. Also, my son-in-laws (‘they are gems’)

further, “After my marriage I did not like sitting back at home and it was diﬃcult to go outside. I used to make jewellery boxes, dresses at home. I did the Nirmala Niketan course for a year on stitching. But at that time though I was enjoying, I was not really happy.” She told her husband why she cannot join her father again. She highlights, “My husband has always been very supportive. There were challenges both on the professional as well as on the home space. There were no fax machines at that time so I had to wake up early in the morning, write the letters drop them to the typist and so on.” Along with these, she had to manage activities at home also because by then she was the mother of two daughters too. She says, “I feel women in general can do multi-tasking. If they decide to do anything they will do it.”

Name game Happiest moment: When I took my father to our New Mumbai R&D centre and he said that this is what he had dreamt of Culinary skills: I am good both at basic cooking as well as other cuisines such as Italian and many others. I used to make bread at home Strength: People around me Weakness: Emotional If not this profession: Something more with charitable institutes; already help Vatsalya, K J Somaiya Hospital, an institute for children of lesser God, had adopted one girl (but had to forgo for people handling were not the right choice) Favourite holiday destination: New Zealand Feminism: Not a feminist activist. It is the contribution of both the partners

Talking about the name of the company she says, “S Javeri was established by my father in 1951. ‘S’ for ‘Seth’ was my maiden family name and Javeri was my father’s partner’s name who was there in the company for a year. My father’s partner had quit in one year’s time yet my father continued with the same name. So we continued with S Javeri till 1990. And it is then one of my uncle suggested why not change it. We changed it to S. Zhaveri (numerological reasons).” She laughs and says, “It is just a co-incidence that my last name post wedding is Javeri. My husband has never been in this business!” (chandreyee.bhaumik@infomedia18.in)

Photographer’s take: Uma has an equal penchant for Gayatri Devi Solitaire earrings and eating at a roadside dhabha . She blends these and how!

Modern Pharmaceuticals I February 2012

Photo: Neha Mithbawkar

Uma Javeri

Uma Javeri Managing Director, S Zhaveri Pharmakem Pvt Ltd, Mumbai

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Energy Management: Bio-energy

Efficacious utilisation of bio-waste Effective utilisation of bio-waste produced around us and in industries is a central component in the development of a sustainable world. Various ways of utilising bio-waste to generate bio-energy are enumerated here.

Biomass-based energy Biomass originates from the photosynthetic activity. The biomass-based energy sources are herbaceous plants, algae, aquatic plants, agriculture, forest residues (straw, husk, corn cobs, roots, animal droppings, etc), wastes (municipal solid waste, sewage, industrial waste) and biodegradable organic eﬄuents (sugar mills, meat, breweries, distilleries, etc). Fermentation is the process that produces alcoholic beverages or acidic products. It is a way of getting energy without using oxygen. In general, fermentation involves the break down of complex organic substances into simpler ones. Methods to produce fuel from biomass (solid organic wastes) are: Anaerobic fermentation of animal or agricultural wastes to produce methane Treatment of municipal solid waste to produce bio-fuel Crop residues and agro-forestry to produce bio-fuel Pyrolysis of municipal solid waste gives fuel gas and bio oil Treatment of municipal wastes with hydrogen gives substituted natural gas Organic materials used for methane production are crop residues, animal waste, human waste, agro-industrial wastes, forest litter and aquatic plants etc. Anaerobic digesters are large fermentation tanks provided with mechanical mixing, heating, gas collection, sludge addition, withdrawal ports and supernatant outlets. The anaerobic digesters are conventional single stage anaerobic digester and two stage anaerobic digester.

Advantages of anaerobic digestion

he vital components of human civilisation are energy, environment and development. Any material that can be transformed in a way that it becomes more valuable and useful can be termed as ‘resource’. Coal, natural gas, oil, hydro power and nuclear ﬁssion are conventional energy resources. The non-conventional energy

resources are solar energy, wind power, tidal power, geothermal energy and bio-energy. Renewable energy resources are wood, geothermal, wind, tidal, solar, ocean currents, nuclear fusion, gobar gas, biomass, vegetable refuse etc. The non-renewable energy resources are coal, ores, petroleum, timber, natural gas, electricity, lignite, uranium, etc.

Treatment of a wide range of organic waste including wet waste such as municipal solid waste and industrial wastewater Biogas production It uses readily available CO₂ as an electron acceptor. It requires no oxygen

Waste to energy The various kinds of bio-waste can be converted into energy through various processes and each of them has unique properties and advantages.

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Bio-energy Incineration: It is the process of direct burning of wastes in the presence of excess air (oxygen) at temperatures of about 800ºC and above, liberating heat energy, inert gases and ash. Net energy yield depends upon the density and composition of the waste, relative percentage of moisture and inert materials. Around 65 to 80 per cent of the energy content of the organic matter can be recovered as heat energy, which can be utilised either for direct thermal applications or for producing power via steam turbine-generators. Waste burned solely for volume reduction may not need any auxiliary fuel except for start up. When the objective is steam production, supplementary fuel may have to be used with the pulverised refuse, because of the variable energy content of the waste or in the event that the quantity of waste available is insufficient. Mass burn: About three-fourths of the waste-to-energy facilities in the US and a few other countries are ‘mass burn’, where refuse is burned just as it is delivered to the plant without processing or separation. These plants are sized to incinerate up to 3,000 tons of refuse per day and use two or more burners in a single plant. While facilities are sized according to the expected volume of waste, they are actually limited by the amount of heat produced when the garbage is burned. Some mass burn plants remove metals from the ash for recycling. Mass burn plants have operated successfully in Europe for more than 100 years. Refuse Derived Fuel (RDF)-based power plants: In an RDF plant, waste is processed before burning. Typically the non-combustible items are removed, separating glass and metals for recycling. The combustible waste is shredded into a smaller, more uniform particle size for burning. The RDF thus produced may be burned in boilers on site or it may be dipped to off site, if it is to be used off site it is usually densified into pellets through the process of pelletisation. This involves segregation of the incoming waste into high and low calorific value materials and shredding them separately, to nearly uniform size. The different heaps of the shredded waste are then mixed together in

suitable proportion and then solidified to produce RDF pellets. The calorific value of RDF pellets can be around 4000 kcal/ kg depending upon the percentage of organic matter in the waste, additives and binder materials used in the process, if any. Since pelletisation enriches the organic content of the waste through removal of inorganic materials and moisture, it can be an effective method for preparing an enriched fuel feed for other thermo-chemical processes such as pyrolysis/gasification, apart from incineration. Additional advantage is that the pellets can be conveniently stored and transported. RDF plants involve more sorting and handling than mass burn facilities, and therefore provide greater opportunity to remove environmentally harmful materials from the incoming waste prior to combustion. However, it is not possible to remove the harmful materials completely.

About three-fourths of the waste-toenergy facilities in the US and a few other countries are ‘mass burn’.

Slurry carb process: This process has been developed by a company in the US to convert municipal solid waste into fuel oil. It is used in conjunction with a wet resource recovery process to separate out the recyclables. The received waste is ﬁrst shredded and placed in an industrial pulper. The heavier and denser inorganic material sink to the bottom of the water ﬁlled pulper from where it is easily removed. The remaining waste slurry (organic fraction) is subjected to violent pulping action, which further reduces the size of its constituents. The pulped organic waste is then subjected to high pressure and temperature whereby it undergoes thermal decomposition/carbonisation (slow pyrolysis) to fuel oil.

Plasma arc process: This is an emerging technology utilising thermal decomposition of organic wastes for energy/resource recovery. The system basically uses a plasma reactor, which houses one or more plasma arc torches which generate, by application of high voltage between two electrodes, a high voltage discharge and consequently as extremely high temperature environment (between 5,000 – 14,000ºC). This hot plasma zone dissociates the molecules in any organic material into the individual elemental atoms while all the materials are simultaneously melted into molten lava. The waste material is directly loaded into vaccuum in a holding tank, pre-heated and fitted to a furnace where the volatile matter is gasified and fed directly into the plasma arc generator where it is pre-heated electrically and then passed through the plasma arc dissociating it into elemental stages. The gas output after scrubbing comprises mainly CO and H₂. The liquefied produce is mainly methanol.

Utilisation of bio gas Main constituents of biogas are methane (about 60 per cent), carbon dioxide (about 40 per cent) and small quantities of ammonia and hydrogen sulphide. The calorific value of biogas is about 5,000 kcal/m³ and depends upon the methane percentage. The gas from landfills generally has a lower calorific value. The biogas, by virtue of its high calorific value, has tremendous potential to be used as fuel for power generation through either IC engines or gas turbines can be utilised for this purpose. (emailrazia@yahoo.com)

Dr Razia Sultana Director (Programs) Environment Protection Training and Research Institute ENVIS Coordinator

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Policies & Regulations: Nuances of patenting

Divisional applications practices across continents

Divisional applications are filed to enable applicants to render the same priority date to their multiple inventions initially included in the subject matter of a patent application. It is to be noted that while the underlying concept of divisional applications is significantly the same across all jurisdictions around the world, it is the practice that differs in some aspects from place to place.

oday, since most of the patent applicants aim to seek protection for their inventions in almost all progressive markets of the world, it will be imperative to familiarise oneself about the practice that exists across various jurisdictions with regard to the treatment of divisional applications. This article discusses the provisions available in the Indian patent system and also draws comparison of the Indian practice vis-à-vis that existing in

European and US so as to enable applicants to clearly chart out their strategies with respect to ﬁling of applications and their divisional(s).

Indian scenario Section 16(1) of the Indian Patents Act, 1970 stipulates that a divisional application to an existing application may be ﬁled voluntarily by the applicant or with a view to remedy the objection raised by the Patent Oﬃce that the claims of the

existing application relate to more than one invention. Under the Indian practice, it is important to note that the divisional application is required to be filed any time before grant of patent. However, the Act does not define the exact meaning of the instance that can be referred to as ‘grant of patent’ and the same is open to. As held in Dr Snehlata Gupte Vs Union of India and others, a patent is said to be granted when the Controller passes an order in the file accepting the application. Thus, with regard to the time limit for filing the divisional application, the applicant has ideally the option of filing the divisional application until the Controller writes his decision on the parent application. While Section 16(1) does not define as to what is meant by stipulation that the divisional application may be filed ‘before the grant’, in absence of any judicial interpretation it

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Nuances of patenting may be broadly interpreted to mean that divisional applications may be filed before the order regarding refusal or grant is written by the Controller. A divisional application in India is required to be filed when the parent application relates to a plurality of distinct inventions irrespective of the fact whether the divisional application has been filed suo moto by the applicant or to meet the objection of the Patent Office regarding plurality of distinct inventions. In a recent Controller’s decision in divisional patent application for Sustained Release Morphine Sulphate Microcapsules, the issue was that the divisional application included the same set of claims as that of the parent application and thus the divisional was rejected. The applicant’s argument was that for voluntary divisional applications there is no requirement to check whether the parent contains plurality of distinct inventions and such requirement was to be checked only when the Controller requires divisions of the parent application to be made. The Controller referred to provisions of section 16(1) along with the section 16(3) that mandates that amendments may be made either in the parent application or the divisional application(s) to ensure that they do not contain any overlapping matter. The Controller, thus, concluded that the combined reading of the two provisions substantiate that for filing a divisional application it was essential that the parent application must relate to more than one inventions. Also, it was held that any overlapping matter in either of the parent or divisional application was to be amended by appropriate amendments wherever required. The divisional application, in the instant case, was held to be invalid since the claims of the parent and divisional were exactly alike and no objection regarding existence of plurality of distinct inventions was ever raised in respect of the parent application. Indian practice does not allow divisional applications originating from already filed divisional applications.

European practice The practice in EPO is on similar lines and is governed by Article 76(1) of the EPC, which mandates that divisional applications

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may be filed for subject matter that does not go beyond the scope of the parent application from which the divisional has been derived. Further, similar to the Indian practice, the divisional applications in EPO may be filed any time during the pendency of earlier European patent application. However, the criterion for determining pendency of the earlier patent application is different from that in India. In decision G 1/09 of the Enlarged Board of Appeal, it was stated that ‘the pending status of the European patent application normally ceases on the day before the mention of its grant is published.’ Thus, contrary to Indian practice, the pendency of the parent application ends with the day before the mention of the grant of the European patent in the European Patent Bulletin. However, in Europe, it is possible to file a divisional of a divisional during pendency of its parent

It is important for the applicants to be aware of the specific difference in practice, in each of the target markets.

but it should be ensured that the divisional is ﬁled within two years of a communication or an objection relating to non-unity raised ﬁrst time by EPO examination division in case of any application in the chain.

Practice in the US The US practice is governed by 35 USC 121 that states that if an application claims two or more independent and distinct inventions, the Patent Office may require the application to be restricted to one of the inventions. Divisional application(s) may thus be filed in response to this restriction requirement of the Patent Office. As per chapter 201.06 of the Manual of Patent Examining Procedure (MPEP) of the USPTO, divisional application must claim

subject matter disclosed in the earlier or parent application, the practice being similar to that in EP and India. 35 USC 121 further clarifies a ‘safe harbour’ approach wherein an application in which restriction requirement was raised or an application filed in view of said requirement cannot be used to anticipate the divisional application, which ideally is the intent behind the practice of divisional applications all over the world. However, as per chapter 804.01 of MPEP, the safe harbour option is available only where the Patent Office has raised a restriction requirement and not in the case of voluntarily filed divisional application.

Boehringer vs Barr The scope of 35 USC 121 was clarified by the US Federal Circuit in their January 2010 decision wherein it held that while the safe harbour option is available to a divisional application filed as a result of restriction requirement, the said option is also available to a divisional of a divisional, even if filed voluntarily, of a parent application in which a restriction requirement was raised. Thus, going by this decision, there are only limited circumstances when the USPTO would allow voluntary divisional applications, unlike the practice in EP and India.

Points to be remembered Though the practice of divisional applications is more or less similar across the three continents, it is important for the applicants to be aware of the specific difference in practice, in each of the target markets, so as to strategise filing of divisional applications in each of these jurisdictions in an economical and efficient manner without risking loss of their rights on their patentable matter. (salhotra@lls.in)

Anuradha Salhotra Managing Partner, Lall Lahiri & Salhotra

Policies & Regulations: Migration in drug packaging

A challenge for the Indian pharmaceutical industry

Courtesy: Avery Dennison

Today, India is considered the ‘pharmacy of the world’ as it supplies one third of all the pharmaceutical products sold worldwide. Indian drug manufacturers attribute this success to continuous R&D on products and standardised process infrastructure. What next needs to be tackled? patent protection on major blockbuster drugs worth $120 billion, with Indian generic drug manufacturers planning to capture more of this market. The country is committed to a free market economy and globalisation and, for the ﬁrst time in many years, the international pharmaceutical industry is ﬁnding great opportunities in India. It was once an extremely fragmented market with severe price competition and government price control. Now, the process of consolidation, which has become a generalised phenomenon in the world pharmaceutical industry, has started taking place in India.

Risks and issues

ndia has the largest number of Food and Drug Administration (FDA)-approved manufacturing plants outside the US. Combined with a low cost of production, innovative scientiﬁc manpower and increased outsourcing of manufacturing processes to India, this makes Indian pharmaceuticals a powerful industry group. The sector is currently experiencing an annual growth rate of around 16 per cent. This phase of rapid expansion is due to the anticipated loss over the next few years of

Over the past decade, pharma companies have entered a difficult period where shareholders, the market and regulators have created significant pressure for change within the industry. The Indian industry has had to contend with several challenges, including the effects of new product patents, drug price control, infrastructure development, regulatory reforms, quality management and conformance to global standards. The pharmaceutical business is a global one and, if manufacturers’ markets include the US and Europe, they must

abide by the regulatory requirements set by the US FDA, and the European Medicines Agency (EMEA), as well as national boards such as the Drug Controller General of India (DCGI). In particular, compliance with the regulations dealing with the migration of contaminants from packaging to contents should be a major focus for India.

The migration process Where glass containers are impervious to chemicals leaching through, the same does not apply to the new generation of drug containers and delivery systems that are made of plastics such as LDPE, HDPE and PP. Plastic containers are convenient, especially for small units and where squeezing is required. They also offer increased efficiencies and reduced breakages and costs, but it is possible that components from label inks, laquers, top coats, adhesives, paper or film facestocks, or even the container itself, will leach through and contaminate or react with the medicine inside. The highest potential for migration has been observed with solvent-based inks, UV inks, top coats and laquers.

Threat to India’s sales of pharmaceutical products The purpose of packaging is to keep medicines and personal care items fresh, and to protect them from direct contamination. It is important, therefore, for pharmaceutical manufacturers in India to be aware of the potential risks in changing from glass to plastic containers. Companies need to consider the threat to consumer safety represented by chemicals migrating from the packaging of all pharmaceutical products. Drugs might no longer have the expected effect, or there could be health-related reactions to the presence of unwanted chemicals. Such problems could cause loss of consumer confidence in the particular brand, resulting in reduced market share. By ensuring that all pharmaceutical packaging meets industry regulations, manufacturers can be confident in the safety of their products. Although many Indian pharmaceutical companies are not aware of the stringent

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MPh (February_2012) 3Tab-81

MPh (February_2012) 3Tab-82

Migration in drug packaging regulations and requirements regarding the migration of chemicals from packaging, others are realising the importance of this issue and are meeting the challenge. Enhanced consumer protection is the main aim of these guidelines, so those in the Indian industry who are leading the change will be in a strong position to beneﬁt from increased market share.

Testing for migration The purpose of interaction and E&L studies (testing for extractables and leachables) is to demonstrate whether the packaging of a pharmaceutical product is safe under normal storage conditions and/or whether the drug contained within is being contaminated by migrating chemicals. Extractables: When testing for extractables, the pack is subjected to solvents of varying polarity and at high temperatures, without destroying it. The solvent used for extraction should have the same propensity to extract substances as the active substance/dosage form as appropriate. In the case of medicinal products, the preferred solvent would be the medicinal product or placebo vehicle. The obtained extracts are analysed extensively to gain as complete a picture as possible of all the compounds that might contaminate the drug. Interaction studies: Interaction studies can include migration studies to monitor the leaching of substances from the plastic material into the formulation/active substance and/or sorption studies to evaluate a possible loss of drug quality due to adsorption or absorption eﬀects. They detect any reactions between the plastic packaging components and product that lead to unacceptable changes in the quality of the product under normal usage conditions. Migration studies: If the plastic material is composed of layers of diﬀerent plastic materials, the possibility of migration of components of the external layers into the medicinal product should be evaluated, depending on the nature of the product and its intended use. Furthermore, it should be demonstrated that no components of ink or adhesives applied to the outer surface of the container/closure system will migrate into the medicinal product.

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Migration studies during development are necessary when extraction studies have resulted in one or several extractables. In these situations, it should be demonstrated that in conditions representative of the intended use, substances will not migrate in such quantities as to alter the eﬃcacy and stability of the active substance/medicinal product or to present a toxicological risk. Tests should be performed on at least one batch of the active substance/medicinal product, as appropriate. A leachables study follows a toxicological evaluation of the extractables. Substances classiﬁed as critical are analysed within the pharmaceutical itself, under conditions that reproduce those of the intended use.

Sorption studies Developmental studies may be necessary to investigate interactions between the packaging material and the formulation due to sorption of the active substance or an excipient to the packaging material, leading to changes in product quality. Sorption studies have to be performed when changes in the stability of the medicinal product are observed during stability studies, which may be aﬀected by adsorption or absorption of formulation components to the plastic packaging. Migration tests and E&L studies are, to some extent, based on oﬃcial standard methods and regulations, with numerous techniques needed to get a complete picture. Once all this information is correlated, it can be used to optimise any packaging system with regard to migration properties. Good packaging design provides stability and shelf life to the drug and the delivery systems, and becomes fundamental to the safety convenience and compliance of drugs.

and expertise to provide compliant labels. Avery Dennison has dedicated R&D facilities in the US, Europe and Asia, where skilled and experienced scientists and technicians work together with customers to develop sophisticated, cutting-edge labeling solutions. As a result, Avery Dennison is able to oﬀer a guaranteed product portfolio of dedicated pharmaceutical label materials and adhesives that meet the regulatory and compliance requirements of the highest industry standards.

A sophisticated range It produces a sophisticated range of lightweight variable information products, as well as removable adhesives and flexible facestocks that are suitable for thermal transfers, direct thermal and laser printing. The portfolio features both film and paper facestocks, which deliver good print quality. Extraction studies, comparing a range of adhesives available on the market, have shown that Avery Dennison S692NP™, a clear permanent adhesive, has the lowest risk of migration. One international pharmaceutical company tested it during qualification for use on containers of animal eyedrops. The extraction test delivered such excellent results that it decided not to continue testing other adhesives.

Opportunities for packaging manufacturers The burgeoning pharmaceutical market presents packaging manufacturers in India with huge opportunities for business growth, provided that they meet the stringent regulatory requirements of world markets. (jitesh.mehta@ap.averydennison.com)

Providing right solutions Faced with the potential loss of lucrative local and export pharmaceutical markets, it is vital that packaging designers and manufacturers in India ensure that any new pharmaceutical packaging they develop complies with the relevant standards and regulations. It is just as important to choose a label manufacturer that has the experience

Jitesh Mehta Director - Marketing, Label and Packaging Materials, South Asia, Avery Dennison

Strategy: Clinical trial guidelines

The need to emphasise on safety The increasing disease burden along with escalating population has made India a preferred destination for clinical trials in the world. But along with such opportunities also comes the associated risks of safety especially of the participants and monitoring the trial that India needs to focus on. Titash Roy Choudhury

linical research and clinical trials has contributed signiﬁcantly to the growth of the Indian pharmaceutical market. According to a new research report, ‘Booming Clinical Trials Market in India’, the number of clinical studies by domestic and global players has sharply risen. The M&A activities, service agreements and strategic collaboration have increased over the last four years. In addition, on the back of favourable government support and eﬀective

regulatory mechanism provided by the Indian Council of Medical Research (ICMR) and Central Drug Standard Control Organization (CDSCO), health care providers ﬁnd it worthwhile to locate their trials in India. Besides, availability of skilled manpower and good medical infrastructure will augment the number of clinical trials from 1,300 in 2009 to more than 1,900 by 2013.

India shining A KPMG report also points out the government initiatives of starting to develop an infrastructure for clinical

trials in India, with amendments made recently to Schedule Y of the Drugs and Cosmetics Rules of 1945 to allow for multicentre concurrent clinical trials in India and address the protection of trial participants, and the integration and quality of data. Among other developments, Good Clinical Practice (GCP) guidelines have been published and made mandatory. “India continues to be a strong player in the clinical trials domain. Market pressure and growing stringency of regulatory processes are weeding out players who are not serious; leaving behind professional organisations recognised for their quality and speed of service delivery. Hospital sites are now better trained in globally accepted diagnostic procedures and treatment protocols due to their participation in clinical trials. This has strengthened the infrastructure in hospital sites and given them depth of expertise,” says K V Subramaniam, President & CEO, Reliance Life Sciences. But there are certain roadblocks in the clinical trails sector in India that needs to be focused on. “Currently India is going through a turbulent weather as far as clinical research is concerned. There is lot of uncertainty in the oﬃce of regulatory agency, which delays the approval process,” says Dr Kiran Marthak, Global Head-Clinical Development and Board MemberLamda Therapeutic Research Ltd.

Emphasis on safety of participants in clinical trials “We believe that adequate measures are in place to ensure safety of clinical trial participants in India. When ethical clinical research organisations and pharmaceutical companies conduct clinical trials, they ensure that molecules and protocols with correct beneﬁt to risk ratio are selected. Studies are subject to suﬃcient oversight in order to safeguard safety and well-being of human participants,” says Subramaniam. The point of safety comes under the scanner when there are adverse situations leading to any injury or death of the participant. According to Subramaniam,

Modern Pharmaceuticals I February 2012

Clinical trial guidelines

The Regulatory Agency has prepared a Draft Rule, which will be in a gazette soon about the SAE including death and the compensation to be paid for the same.

Studies are subject to sufﬁcient oversight in order to safeguard safety and well-being of human participants. K V Subramaniam President & CEO, Reliance Life Sciences

“This varies from trial to trial as different trials accrue participants with various inherent levels of morbidity. For example, Serious Adverse Events (SAE) as well as death are not uncommon in clinical trials in cancer. All enrolled patients in a phase 1 cancer clinical trial would probably ultimately die from the disease. By definition, such subjects are invariably selected since they have no further therapy available for the type of cancer. All participants in phase 1 cancer agree to participate in clinical trials with altruism and with a faint hope that they may benefit during the process.” All unexpected SAE are reported to regulatory authorities and ethics committees within a short period of time. Adverse events such as injuries are treated and followed-up to resolution. “If there are unplanned pregnancies during a study, the offspring are followed-up to check for congenital birth defects. The patient’s heir or Ethics Committees recommend reasonable compensation to be paid, and pharmaceutical companies pay the prescribed amount. All these terms and conditions are spelt out in the study protocol and plan, which is reviewed and approved by investigating doctors, Ethics Committees, regulatory agencies and the participant himself/ herself before the study is undertaken,” informs Subramaniam. Participants are subject to the best standard of care and follow-up while on clinical trials. They undergo more health check-ups than they would normally do, and this helps discern the slightest of clinical abnormalities. Also, the

February 2012 I Modern Pharmaceuticals

Dr Kiran Marthak Global Head-Clinical Development and Board Member-Lamda Therapeutic Research Ltd

healthcare-giver to patient ratio is high in clinical trials as compared to routine medical practice. This allows the patient to receive a relatively better personalised treatment and support.

Need of a separate guideline It is mandatory for all clinical trial sponsors to purchase insurance cover for their clinical trials. All patients are covered by this insurance and therefore have access to treatment and care for trialrelated injury or death. Compensation over and above the treatment of injury can be claimed from such a policy on a case-to-case basis. ICMR is in the process of drafting a detailed guideline on the subject and also a gazette notiﬁcation on the same topic is to be issued. This is over and above the guidelines that cover the topic as part of ‘Indian Good Clinical Practice guidelines’. “The Regulatory Agency has prepared a Draft Rule, which will be in a gazette soon about the SAE including death and the compensation to be paid for the same,” informs Dr Marthak.

Worth considering Both the industry experts point out certain factors that need to be taken into account while formulating the draft. According to Subramaniam, “The viewpoint of the industry, investigators and community should be considered while formulating guidelines. Mandating a compensation for each injury (regardless of whether it arose from the patient’s participation in the trial or whether it arose as part of the patient’s pre-existing condition) will discourage pharmaceutical companies

from including India in studies involving high morbidity and mortality levels. Hospitals and doctors would refuse to participate in such studies as it would involve frequent reviews of compensation for patients. This would lead to denial of care for patients for whom participation in clinical trials is the only available line of treatment.” In early phase cancer trials, enrolled patients are terminally ill and have no capacity for further employability. Hence, it is diﬃcult to determine compensation, if any. In terminally ill cancer patients, several trials may be conducted on nutrition, infection, pain, cachexia, anorexia, depression, mood and fever. Such patients typically have a 3-6 weeks projected life expectancy. Invariably, most of such patients would die during the study. It would be inappropriate to compensate them simply for participation in study, as this would go against the principles of informed consent and unbiased selection of subjects. While Dr Marthak suggests, “There are various factors which should be considered while forming the guidelines. Such as the nature of SAE, causality assessment of SAE, reporting of the SAE to the concerned Ethics Committee, timely reporting of SAE to regulatory body, placebo treatment arm, insurance of the subjects, keeping subjects informed at the time of enrolment in the study among others.” Steps are being taken in considering the plight if the participants and we can wait and watch so as to when and how this draft is being implemented. (titash.choudhury@infomedia18.in)

Tips & Tricks: Marketing OTC products

Ensuring the

PricewatershouseCoopers (PwC) report shows that the Over-The-Counter (OTC) market is expected to grow at 18 per cent a year to reach about $3 billion in 2012. Hence, emphasis should be laid on marketing of OTC products. A few tips such as client

est solutions understanding, market statistics, etc need to be considered. India currently ranks eleventh in the global OTC drug market. OTC medicines require no prescription, and hence require sufficient brand building to grab the public’s attention. Here are some marketing tips to help with the selling of these medicines.

Need-Gap analysis: Before launching any new OTC product or getting any OTC product in the market a research of the market and understanding the need of the market is essential. The company should ﬁrst comprehend the need of the consumers and then design the product or concept around it.

Tips& Tricks

Product development: The next step for OTC marketing will be developing the product according to the need. If the research suggests say in cough and cold problem lozenges of ginger ﬂavour are more preferred by Indian population then the product should be developed accordingly, which will ensure better acceptance of the product. So the product needs to be developed in accordance with the preference of the consumers.

Tips& Tricks

Product positioning: After developing the product it needs to be positioned in the mind of the consumers. It is important to know how the consumer visualises the product vis-à-vis competition or other like products. For example, a cough syrup may be positioned as pure herbal, fast acting with no side eﬀects.

Tips& Tricks

Product differentiation: Since OTC products are ultimately products for self-medication the product differentiation has to be distinct for the consumer to try it out. For example, there are many herbal or ayurvedic cough syrups in the market, so it is important to position it differently. We emphasise say the fact that the cough syrup has 14 herbs in it and make that the USP of the product.

Tips& Tricks

Kamal Anand Senior GM - Consumer Products Division, Plethico Pharmaceuticals Ltd

Product packaging: The need to grab the attention of the consumers has become essential. Attracting consumer eyeball through innovative packaging is also gaining importance. Packaging of OTC products over the years has noticed a change in colours that have become more vibrant and the looks more contemporary.

Tips& Tricks

Pricing: For effectively marketing the product, pricing of OTC products is crucial. The price of any OTC product depends on a lot of factors- it primarily depends on what extra you have to offer and what extra the consumer is willing to pay for the offering. The price should be in sync with market dynamics, There have been instances of product failures because of very high-end consumer prices. A clear-cut understanding of the Indian market is essential.

Tips& Tricks

Distribution strategy: One needs to distribute the product basis its appeal and acceptance- whether it is a mass market product/SKU or a niche one, whether it is rural centric or urban centric, etc. OTC products have a limited shelf-life so the need to have a robust distribution strategy is of utmost importance.

Tips& Tricks

Product promotion: Identifying the strategy to promote the product among the consumers is essential whether one should go for pull strategy or push strategy. The primary aim is to sustain the product recall in consumer’s mind and ensure repeat purchase. Piloting a launch in a limited geography often helps us understand the nuances of the market better.

Tips& Tricks

Modern Pharmaceuticals I February 2012

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.

Cadila Pharmaceuticals Ltd

Project news

Unijules Life Sciences Ltd

Project type New facility Project news The project will involve manufacturing of Grays mouthwash-Mint Xtreme.

Mumbai-based Piramal Healthcare plans to set up a manufacturing unit to process raw opium for pharmaceutical use.

Project type New facility Project news The project will involve manufacturing of herbal liquid products. Project location Nagpur, Maharashtra

Project location Ahmedabad, Gujarat Project cost Unknown Implementation stage Planning Contact details: Cadila Pharmaceuticals Ltd Sarkhej-Dholka Road, Bhat, Ahmedabad-382 210, INDIA. Tel: 2718-225001 (15 Lines) Fax: 2718-225039 E-mail: website@cadilapharma.co.in ----------------------------------------

Kores (India) Ltd Project type New facility Project news Kores (India) Ltd project would involve manufacturing of gliclazide. Project location Pune, Maharashtra Project cost Unknown Implementation stage Planning Contact details: Kores (India) Ltd 301/302 Ashford Chambers Lady Jamshedji Road, Mahim (West) Mumbai 400 016 Tel: 022 24476800 Fax: 022 24476999 E-mail: response@kores-india.com

Piramal Healthcare Ltd Project type New facility

February 2012 I Modern Pharmaceuticals

Project location Baddi, Himachal Pradesh Project cost $ 14 - 20 million Implementation stage Construction Contact details: Piramal Healthcare Ltd 247 Business Park A - Wing, 6th floor, LBS marg, Vikroli (West) Mumbai 400 083 Tel: +91 22 3095 6666 E-mail: investor.relations@piramal.com ----------------------------------------

RPG Life Sciences Ltd Project type New facility Project news The project involves manufacturing of diphenoxalate HCl. The company has received industrial licence from Secretariat of Industrial Assistance (SIA), Department of Industrial Policy and Promotion, Government of India. Project location New Mumbai, Maharashtra Project cost Unknown Implementation stage Planning Contact details: RPG Life Sciences Ltd Ceat Mahal, 463, Dr Annie Besant Road, Worli, Mumbai 400 030 Tel: 022 2498 1650 Fax: 022 2497 0127 E-mail: info@rpglifesciences.com ----------------------------------------

Project cost Unknown Implementation stage Planning Contact details: Unijules Life Sciences Ltd Universal Square, 1505-1 Shantinagar, Nagpur 440 001 Tel: 0712 276 8512 Fax: 0712 2763212 E-mail: info@unijules.com ----------------------------------------

Praxair Project type New facility Project news US-based industrial gas company Praxair plans to set up a new R&D lab in Bengaluru. Project location Bengaluru, Karnataka Project cost ` 1, 200 crore Implementation stage Planning Contact details: Praxair India Pvt Ltd â&#x20AC;&#x2DC;Praxair Houseâ&#x20AC;&#x2122; PO Box No 4251 No 8, Ulsoor Road Bengaluru Tel.: +91-80-3057-6821 Fax: +91-80-2559-3499 E-mail: rakesh_srivastava@praxair.com Website: www.praxair.co.in ----------------------------------------

Event List

NATIONAL AURANGABAD Maharashtra, Feb 17-20, 2012, Ayodhya Nagari Ground 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

EU and the US; February 28-March 2, 2012, Holiday Inn, Mumbai For details contact: UBM India Pvt Ltd Tel: +91 22 4046 1466 Fax: +91 22 4046 1477 Email: conferences-india@ubm.com Website: www.pharmaregulation-india.com

Infomedia 18 Ltd

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

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

Global Pharma Regulatory Summit India 2012 A must-attend interactive workshop for new entrants or companies planning to enter into regulated markets focussing on the basic regulatory protocols and critical documentation needs that will lead to successful and swift approvals of your generic products. There will be discussion on global regulatory regimes and developments, most recent regulatory updates and ever-changing regulations in key export markets, effective query handling strategies for DMF and generic applications filing in both regulated and semi-regulated countries, pharmacovigilance compliance in key markets along with clarifying requirements for hybrid and 505(b) (2) applications in

ICBBB 2012 2 nd International Conference on Bioscience, Biochemistr y and Bioinformatics aims to bring together innovative academicians and industrial experts in the field of bioscience, biochemistry and bioinformatics on a common forum. The primary goal of the conference is to promote research and developmental activities in bioscience, biochemistry and bioinformatics. Another goal is to promote scientific information interchange between researchers, developers, engineers, students, and practitioners working in India and abroad; March 10-11, 2012, JP Hotel, Chennai For details contact: APCBEES Tel: +852-30697291 Fax: +86-21-56436721 Email: icbbb@cbees.org Website: www.cbees.org

IPA Convention 2012 Indian Pharmaceutical Convention 2012 is one of the premier events of the pharma industry aiming to address various issues of the industry. There will be discussion on globalisation, contract manufacturing and clinical trials, bridging the gap in pharmacy education, evolving regulator y paraphernalia, adopting technologies to enhance quality in manufacturing, challenges in TB prevention and care and many others; March 17-18, 2012, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal.

For details contact: Indian Pharmaceutical Association Tel: +91-22-2667 1072 Fax: +91-22-2667 0744 Email: ipacentre@ipapharma.org Website: www.ipapharma.org

3rd Annual Biosimilars With a 2-day strategic conference and post-conference workshop on clinical trials, Biosimilars India 2012 will bring together key stakeholders in the biopharmaceutical industry to learn about the latest industry developments and innovative commercialisation strategies that will propel your biosimilar strategies to the next level; March 27-29, Hyderabad For details contact: UBM India Pvt Ltd Tel: +91 22 4046 1466 Fax: +91 022 4046 1477 Email: conferences-india@ubm.com Website: www.biosimilars-india.com

Pharma Rural Marketing India 2012 This is a dedicated platform of its kind that will bring together seniorlevel decision makers f rom across the marketing and strategic planning functions within the Indian pharma industry. During these action-packed two days with high-value networking and business-focussed content, Indian and multinational pharmaceutical companies, health care providers, marketing consultants, communication agencies and supply chain and logistics management companies will identify key challenges within the industry and discover businesscritical solutions to overcome them; June 20-22, Mumbai For details contact: UBM India Pvt Ltd Tel: +91 22 4046 1466 Fax: +91 22 4046 1477 Email: conferences-india@ubm.com Website : www.pharmaruralmarketing.com Modern Pharmaceuticals I February 2012

Event List

INTERNATIONAL Cell Line Development & Engineering Asia The event brings together experts and top scientists from biopharma/biotech companies, CMOs and research institutes as well as leading technology providers from Asia and globally. This event aims to provide a forum where industry experts share lessons learned through case studies, strategic discussion groups and interactive roundtables to collectively collaborate and provide solutions to your most pressing challenges. Bring back new ideas to do better business; February 2123, Grand Hyatt Shanghai, China For details contact: IBC Asia Tel: +86 21 2326 3680 Fax: +86 21 2326 3699 Email: register@ibcasia.com.sg Website: www.celllineasia.com

Pharma Source 2012 This event aims to bring together some of the most experienced sourcing professionals in the industry. There will be conferences on the key strategies they have developed to create a world-class procurement operation, including capitalising on the global sourcing market and understanding the risks, achieving cost-effective supply alongside high quality service; February 21-23, The Hilton Munich City Hotel, Munich, Germany For details contact: UBM Conferences Tel: +44 (0) 20 7921 8039 Fax: +44 (0)20 7955 3949 Email: conferences@ubm.com Website: www.cphi-pharmasource.com

Biosimilar Drug Development World The event aims to provide one with the strategy and science to take biosimilars

from bench to market. There will be discussions on biosimilar product development, comparative analysis and many others. Further, there will be seminars on considerations for biosimilar manufacture, process development, scaleup and validation, non-clinical studies for biosimilars, best practice in clinical trials design and execution, the use of immunogenicity tools and techniques in development and the clinic, proven strategies in biosimilar pharmacovigilance and risk management, global regulatory requirements, the resulting impact on drug development, manufacture & clinical trials and many other related topics; February 28-March 2, 2012, Millennium Gloucester Hotel, London, UK For details contact: Health Network Communications Ltd Tel: +44 0 207 608 7055 Fax: +44 0 207 608 7050 Email: customerservices@ healthnetworkcommunications.com Website: www.healthnetworkcommunications. com

Nanotechnology, Biotechnology and Spectroscopy: Tools of success in the coming Era The event aims to be a worldwide gathering of pharma specialists. The specialists will also discuss the winning business strategies and examine the challenges and opportunities in the field. The conference will take place over 3 days, and will be divided into sections that allow focussing on the conference topics. The conference will consist of invited oral presentations and poster presentations selected from abstracts; March 1-3, 2012, Cataract Pyramids Resort, Cairo, Egypt For details contact: Nakaa Nanotechnology Network NNN

Tel: 01521684185 Fax: 98-21-66465132 Email: nakaa.nanotechnology.network@ gmail.com Website: www.nakaanetwork.webs.com

BioNanoMed 2012 The event aims to be a platform for knowledge transfer in emerging nanotechnology for medical and biological applications. The purpose of this conference is to bring together researchers and practitioners from natural science, medical science and engineering subjects. Further, there will be discussion on nanostructured materials for regenerative medicine, multi disciplinary nano technologies; March 1-2, 2012, Danube University Krems, Krems, Austria For details contact: Danube University Krems Department for Clinical Medicine and Biotechnology Tel: +43 0 2732 8932600 Fax: +43 0 2732 8934600 Email: office@bionanomed.at Website: www.donau-uni.ac.at

BioPharma Asia Convention BioPharma Asia puts one in front of the largest number of biopharma business decision makers in Asia. With 4,000+ attendees expected; it is the ideal opportunity to keep in touch with the customers, introduce them to the team and demonstrate new products or services. Additionally, the conferences bring together the experts in the field; March 19-22, Marina Bay Sands, Singapore For details contact: Terrapinn Pte Ltd Tel: +65 6222 8550 Fax: +65 6226 3264 Email: enquiry.sg@terrapinn.com Website: www.terrapinn.com/exhibition/ biopharma-asia

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

February 2012 I Modern Pharmaceuticals

Event Report: Bangalore India Bio 2012

Focussing on the emerging bio economy Bangalore India Bio with the mission to further strengthen the biopharmaceutical industry made its way into the 12th edition by focussing on India as the emerging bio economy and the need to innovate. Jasleen Kaur Batra

angalore India Bio (February 6-9, 2012) entered its 12t edition with a grand inauguration at the Lalit Ashok Hotel, Bengaluru. The who’s who of biotechnology were present at the event, which was inaugurated by Ghulam Nabi Azad, Minister of Health and Family Welfare, Government of India; S V Ranganath, IAS, Chief Secretary of Karnataka; Dr Kiran Mazumdar Shaw, CMD Biocon and Chairman, Karnataka Vision Group on Biotechnology; Ron Somers, President, US-India Business Council (USIBC); Dr M K Bhan, Secretary, Department of Biotechnology, Ministry of Science and Technology, Government of India; Dr V S Acharya, Honorable Minister, IT & BT, Higher Education, Planning and Statistics, Muzrai, Government of Karnataka; and D V Sadananda Gowda, Chief Minister, Karnataka. A short ﬁlm was featured during the inauguration titled Kalpavriksha (human life), which showcased the progress been made in the ﬁled of biotechnology and the need to further enhance it to make India the epicenter of biotechnology. Adding to the urgent need for innovation and better infrastructure, Somers, said, “We are facing great

challenges in our global economy, but innovation will enable us to overcome these obstacles and achieve success in the 21st century. With Karnataka’s youthful demographic, its dizzying array of ﬁne educational institutions, R&D taking place in virtually every industry, and a perfect climate, the only element requiring further attention is the need to develop world-class infrastructure and putting in place a welcoming policy environment. Given the right policy environment there is no question that Bengaluru will be the magnet for foreign direct investment in innovation and R&D.”

Collaborate to grow One of the biggest events that took place during Bangalore India Bio 2012 was the signing of Memorandum of Understanding (MoU) between Karnataka and Pennsylvania Biotechnology Association (PBA). It was signed to jointly create and promote the biotechnology opportunities present in Karnataka as well as the US. Th e Karnataka Government with the intent to create a health learning environment and a space where government as well as private ﬁrms have the freedom to experiment and innovate declared that it would be providing incentives as well as concessions to the biotechnology sector. The state has also promised to

provide various schemes and policies, for instance setting up various biotechnology finishing schools in Karnataka, setting up a Bengaluru Biotech Park and have also proposed the setting up of biotech parks in tier II cities. Striking a similar chord, Dr Bhan said, “Biotechnology is an important field as it fulfills the human and environment needs. It is of critical importance that we attend to the need of the students and provide them a platform that gives them the liberty to innovate. We need to work as a team to engage in the power of technology and take it to new heights, and for this one needs support from all possible directions, and now when the state and the centre has joined hands, I am confident that there is nothing that can stop us from achieving our dreams.”

New pages turned A number of informative seminars such as: Indian Biotech Vision 2015, the biosimilar opportunities and regulatory harmonisation, investments in innovation, next generation genomics, clinical and contract research capabilities, transforming through companion diagnostics, stem cells and regenerative medicine, biomedical instrumentation and many more were witnessed over the three days. The seminars provided a wholesome approach and various perspectives. “Biotechnology demands quality, innovation, molecular diagnostics and many more. It is not just one company that needs to focus on innovation; it is India as a nation that needs to strive for the same goal for us to be the emerging bio economy. Hence, Bangalore India Bio took the initiate to create awareness and will continue to do so in the years to come,” remarked Dr Shaw. (jasleen.batra@infomedia18.in)

Modern Pharmaceuticals I February 2012

Book Review Developmental Biology Editor: Scott F Gilbert Price: ` 4200 Developmental biology is one of the fastest growing and most exciting fields in biology, creating a framework that integrates molecular biology, physiology, cell biology, anatomy, cancer research, neurobiology, immunology, ecology and evolutionary biology. The book contains 23 chapters grouped into four focus areas. The first area covers the basic ‘Principles of Developmental Biology.’ This section includes the basic concepts of the life cycle, reproduction and cellular interactions in volvox, dictyostelium, vertebrates (amphibians) and plants (angiosperms). There are also details on differential gene expression and explanation of past and present techniques used in experimental embryology. Throughout the text there is in-depth coverage of the many genes and proteins involved in the building of an organism, whether the natural way or by way of transgenics and cloning. Part 2 covers early embryonic development in more detail, focussing on gamete formation, fertilisation, and early developmental stages (cleavage, gastrulation, neurulation and organogenesis) in sea urchin, snails, tunicates, Drosophila, amphibians, fish, birds, and mammals. Part 3 treats later embryonic development and meticulously covers the derivatives of each germ layer. This section also covers the formation of the tetrapod limb, sex determination, metamorphosis, regeneration and ageing. The final section ‘Ramification of Developmental Biology’ includes a chapter on plants, as well as a look at how the rapid expansion of knowledge in this field has allowed advances in biomedical technology and stimulated much ethical debate. The book tackles complex concepts with clear understandable language and informative images. It is wonderfully illustrated with thorough figure legends that complement the text. A must-have book for anyone interested in developmental biology.

Plant Physiology Editors: Lincoln Taiz, Eduardo Zeiger Price: ` 4675 Plant physiology is a part of the essential core curriculum every botanist has to master. Usually non-motile organisms, in most cases, are fixed to a single locality for their entire lifetime. Plants have special needs to cope with widely disparate, and often highly changeable environmental conditions. Physiological adaptations play as great a role in the evolutionary struggle for life of a plant as morphological ones. Plant physiology by Taiz and Zeiger (and a plethora of contributing expert authors) is a well-received, established textbook aimed at students taking introductory courses in the field. The book is subdivided into 25 chapters, grouped into three larger sections (water, metabolism and development) that cover the major topics of modern plant physiology. Starting with the basics of each subject, the reader is taken to the forefront of current knowledge. The writing style is succinct and lucid throughout, and the text is arranged in a twocolumn format that is reader-friendly. Specific topics are easy to find using the detailed table of contents or index. Plant Physiology is a modern textbook with a refreshing style and layout. The overall impression is one of a well-thought-out teaching aid. Reviewer: Sreya Sen M Sc Biotechnology, St. Xavier’s College, Kolkata

February 2012 I Modern Pharmaceuticals

Products Shaking incubator The compact benchtop Stuart SI500 and SI505 shaking incubators have a unique retractable platform providing easy access to samples, a digital display showing the independently controlled temperature and speed, and USB connectivity for long-term monitoring of the incubator temperature via a PC. Removable water reservoirs increase the humidity in the chamber of the Stuart SI505, dramatically reducing sample evaporation. The Stuart SI500 incorporates a versatile clamping system for securing flasks of most sizes, while angleadjustable stainless steel accessory tube racks with magnetic locking system providing quick coupling and de-coupling. Bibby Scientific Ltd Staffordshire - UK Tel: +44-1785-812121 Email: info@bibby-scientific.com Website: www.bibby-scientific.com

Rotary vane vacuum pump The Minivac SVL series of low vacuum pump is a sliding vane-type direct/belt-driven vacuum pump mounted on common base frames. It is compact in size, vibration-free and hence can also be mounted inside the machine. The pump attains maximum vacuum levels up to 29” of Hg with capacities ranging from 50-2000 lpm. Unique design of the lubrication system positively feeds minimum required oil to all rotating and frictional parts. The pump is useful in applications like capsule ﬁlling/capsule printing machines and other pharmaceutical machineries, packaging/labeling machines, screen printing/plate making, book binding/folding machines, vacuum chucking, etc. Shree Siddhivinayak Industries Dist Thane - Maharashtra Tel: 022-28458372 Email: minivac@rediﬀmail.com Website: www.minivacpumps.com

Diaphragm vacuum pump The chemical-resistant diaphragm vacuum pump has oil-free vacuum option for laboratory and pilot scaled application. Typical applications include evacuating chemically aggressive gases and vapours from such equipment as rotary evaporators, vacuum drying cabinets and centrifugal concentrators. The diaphragm

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vacuum pump is available in various options of materials, like EPDM, neoprene, Viton and Teflon coated neoprene rubber. It is also available in the range of 15-33 lpm and generates a maximum vacuum of 30 Torr. Chemical resistant vacuum pump is supplied with three-phase flameproof motors. Sri Vishnu Pumps Manufacturing Co Mumbai - Maharashtra Tel: 022-28458373 Email: vishnupump@rediffmail.com Website: www.minivacpumps.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

Walk-in humidity chamber The unit has double-walled 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. Newtronic Equipment Company Pvt Ltd Mumbai - Maharashtra Tel: 022-28679326, Mob: 09821089932 Email: nmehta@newtronic.in Website: www.newtronic.in

Modern Pharmaceuticals I February 2012

Products Vial inspection machine In the vial inspection machine (model SMPL-AIM-72) all contact parts are made of stainless steel and approved engineering plastics. Magniﬁed view with back lighting is available and rotation of spinners can be adjusted to give desired vortex in liquid. The vial inspection machine has separate counters for placing good and rejected products. Snowbell Machines Pvt Ltd Thane - Maharashtra Tel: 0250-6456141, Mob: 09322777625 Email: marketing@snowbellmachines.com Website: www.snowbellmachines.com

Walkable ceiling system Iclean ceiling system is designed to fit every requirement and adhere to stringent quality standards that fit in seamlessly with the rest of the room paneling. The ceiling panels are fastened to profile that are placed on a particle-tight extruded aluminium grid matrix with caulked silicone sealant. Materials of construction include GI powder-coated & SS-304,

February 2012 I Modern Pharmaceuticals

Products 40 mm thick ceiling panels, 0.8 mm thick skin pass powder-coated GI sheets, factory-made cutouts, ﬁre-retardant PUF as in-ﬁll, etc. Integrated Cleanroom Technologies Ltd Hyderabad - Andhra Pradesh Tel: 040-3213478, Mob: 09989212162 Email: srinivas@cleantech.com Website: www.icleantech.com

Vial and bottle cap sealing machine This machine is compact, versatile and elegantly ﬁnished machine for sealing vials and bottles of various sizes and BT (transfusion) bottles or similar containers with aluminium/plastic caps. Some of the features include uniform sealing, no manual involvement, no repeated setting, while the sealing rollers rotate on bearings to give smooth motion for uniform sealing. Minimum time is required to change over from one size of vial to another. It also does not require any lubrication. Anju Pharmaceuticals Indore - Madhya Pradesh Tel: 0731-2523968, Mob: 09893562415 Email: anjupharma@hotmail.com Website: www.anjupharma.com

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Modern Pharmaceuticals I February 2012

Products Work bench The work bench features steel frames, panels and shutters made from prime quality CRCA steel. This steel is coated with epoxy paint and a special encapsulated powder that has a ﬁlm thickness of 40-60 microns. This imparts a high scratch-resistance and the encapsulated powder ensures that no oil or chemical marks are formed on the surface. Every shelf on the cabinet is equipped with a load carrying capacity of 40 kg UDL to ensure maximum eﬃciency in the cabinet drawer. High-precision double-extension ball slides are used. Godrej & Boyce Mfg Co Ltd Mumbai - Maharashtra Tel: 022-67964363, Mob: 09920113138 Email: arunp@godrej.com Website: www.godrej.com

Metal analyser The 7700 series ICP-MS metal analyser is productive, simple-to-use, high sensitivity, low background, better interference removal, increased ﬂexibility, easier to maintain and service. This workhorse 7700x is used for most applications, and in high-throughput commercial labs. It

February 2012 I Modern Pharmaceuticals

Products is designed specifically for semiconductor applications. The new 7700e offers a simplified and easy-to-use system for routine analysis. Featuring a new, configurable MassHunter software platform and a host of hardware developments, including a new frequency-matching RF generator and 3rd generation Octopole Reaction System (ORS3), all three 7700 series mainframes provide unrivalled levels of performance and ease-of-use. Agilent Technologies India Pvt Ltd New Delhi Tel: 011-51496664 Email: agilent@agilent.com Website: www.agilent.co.in

Screening machine The tumbler and vibration screening machines are available as per GMP and FDA-regulations for applications in pharmacy, food and fine chemicals. This machine is are used for treatment of valuable powders, pellets and granules. The hygienic design includes solutions for WIP-cleaning devices and ATEX certification. The tumbler screening machine is a high-performance screening machines for fractionating, protective screening and dedusting. The three-dimensional tumbling movement creates exceptional fine cuts for the bulk solids. Modular design allows the production of additional fractions through additional

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Modern Pharmaceuticals I February 2012

Products screening desks in one machine. For simple applications vibration screening machines, type VTS or Vibrall, are economic alternatives. Allgaier Werke GmbH Uhingen - Germany Tel: +49-7161-301353 Email: siebtechnik@allgaier.de Website: www.allgaier.de

Automatic capsule filler The model-A25 high-speed automatic capsule filling machine is compact, sturdy, covered with stainless steel panels, and the hood is covered with acrylic guard. It is provided with tamping mechanism for powder filling, which enables capsules to be filled with a weight variation within 2 per cent. Variable AC frequency drive for main motor ensures speed adjustment. The faulty capsule and filled capsule ejection stations are equipped with individual air controls. This machine is simple to operate and easy to maintain. The special purpose gauges ensures quick and easy changeover. Karishma Pharma Machines Mumbai - Maharashtra Tel: 022-24181490, Mob: 09821069064 Email: capsulefiller@karishmapharmamachines.com Website: www.capsulefiller.net

February 2012 I Modern Pharmaceuticals

Products Coating pan The coating pan is totally enclosed with SS cladding and comes with standard gearbox, motor and hot-air blowing arrangement. This coating pan is provided with interlocked electrical circuit so that the heaters can be operated only after the blowers are switched ON to avoid burning.The coating pan is manufactured from SS-304 AISI 2B prime material quality with adequate mouth opening and depth. Coating machine is also provided with the control panel, which comes with indicating lamps, coating pan main ON/OFF switch, blower ON/OFF switch, thermostat, heater switch, etc. The entire panel can be mounted on the stand. Allegro Pharmachem Equipment Dist Thane - Maharashtra Tel: 022-40146872, Mob: 09223488913 Email: allegro@allegroindia.com Website: www.allegroindia.com

Sieves These are silicon-moulded sifter sieves, ﬂuid bed dryer (FBD) sieves and FBE dryer sieves. Silicon moulded sifter sieves are available in various sizes from 12” to 48” diameter. The silicon, which is of foodgrade quality, transparent in appearance & non-toxic, is moulded on the stainless steel ring. These are available in rivetted and special non-

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rivetted design. The mesh size varies from 4-500 mesh with ASTM & BSS standards. The FBD sieves are available in various sizes, from 30-200 kg. FBE dryer sieves are available in various sizes from 125 ltr to 800 ltr. Atlanto Enterprises Mumbai - Maharashtra Tel: +91-022-23096098, Mob: 09819942853 Email: atlantoent@yahoo.co.in Website: www.atlanto.net

Mini bilayer press The mini bilayer press is designed to represent twolayer 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

Modern Pharmaceuticals I February 2012

Product Inquiry Card

EASY STEPS TO GET PRODUCT INFO

Product Sourcing Just Got Simpler

1 See the index page in this issue. Every product carries a number. 2 Choose products of your choice from the list. 3 Write their serial numbers (as per the index page) of your chosen product/s one-by-one in the boxes. 4 Fill in your complete contact details. 5 Send it to us at the address printed overleaf.

-1 TIPIN THE BDOUXCETS

UR O L FIL TH PR OF YO D WI ER/S EN S ND MB NU OICE A CH

-2 TIP SE ENSUILRLEIN Name:___________________________________________________Designation:_________________________________________ Company:_______________________________________________________________________________________________

F A PLE T YOU ETAILS THA THE D RED ALL REQUI

Address:_______________________________________________________________________________________________

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02/2012

City:_________________________________________Pin:_______________________State:__________________________

POSTAGE WILL BE PAID BY ADDRESSEE

Business Reply Inland BR Permit No. 555 Bhavani Shankar Post Office, mumbai 400 028.

Special Project modern Pharmacuticals

InfomedIa 18 LImIted ‘A’ Wing, Ruby House, 1st floor, J K Sawant marg Dadar (W), mumbai 400 028 INDIA

NO POSTAGE STAmP NEcESSARY If POSTED IN INDIA

Products Temperature data logger The data logger for pharmaceutical industries has measuring capacity ranging from -35-80°C, accuracy of ±0.5°C and resolution of 0.1°C with sensor Pt1000. The measuring rate is selected from 1 min to 8 hours. It can store 4,000 value data in memory. The measuring mode is automatic with loop, start/stop or start with set measuring rate. It comes with a battery life of 3-5 years. The data logger is housed in stainless steel, PEEK. It has IP68 protection class/housing for pharmaceutical industries. Ambetronics Mumbai - Maharashtra Tel: 022-28371086 Email: ambetronics@vsnl.com Website: www.ambetronics.com

Liquid filling machine The four-head liquid filling machine is a highly versatile machine for filling foamy as well as other liquids into containers. It has a unique bottle separation method in which no turret or holding slides are used. This machine fills the liquid using the syringe principle and is very easy to use. Turntable is provided for bottle filling. This liquid filling machine is provided with variable speed conveyor and is suitable for filling

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Products all types of liquids with less density. It is equipped with 1.5 HP motor with gear box and the diving nozzles is used for prevention of spillage and for foamy liquids. Harshika Industries Dist Thane - Maharashtra Tel: 0250-3246533, Mob: 09869457909 Email: harshad.g@rediﬀ.com Website: www.ﬁlling-machinemanufacturer.com

Fluid bed dryer This dryer is used for drying of wet material. It is equipped with air handling unit. The inlet air filtration is through pre, micro vee and hepa filter. It performs uniform and harmonious drying operation in a specified time. It has applications in tablet-granulation section of pharma industries. This dryer is compliant with cGMP under WHO and USFDA. Also offered is diversified novel advanced techno-upgraded qualitative model of fluid bed dryer like PLC operated, semi-automated and manually operated dryer with multi faceted and user-friendly features. Ratnakar Pharma Machinery Ahmedabad - Gujarat Tel: 079-22892614, Mob: 094270 31284 Email: ratnapd@yahoo.co.in Website: www.ratnakarpharmamachinery.com

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Capsule filling machine The automatic capsule filling machine is an encapsulation equipment. Its features include compact, sturdy, covered with stainless steel panels, hood covered with acrylic guard. The fill weight adjustment takes place within seconds. It is provided with tamping mechanism for powder filling, which enables capsules to be filled with a weight variation with ±2 per cent. The variable AC frequency drive for main motor ensures speed adjustment. Faulty capsule and filled capsule ejection stations come with individual air controls. It is simple to operate and easy to maintain and has special purpose gauges for quick and easy change over. Anchor Mark Pvt Ltd Mumbai - Maharashtra Tel: 022-28682001, Mob: 09320036904 Email: sales@anchormark.com

Tablet compression machine The tablet compression machine (tablet press) is used to make tablets according to a pre-determined design. Punches and dies set into the tablet press to actually shape the tablets. The machine makes tablets for a

Modern Pharmaceuticals I February 2012

Products variety of industries; but its largest application is in pharmaceuticals and vitamins. It is provided with turret made of special grade SG iron casting and interlock switches to all guard for safety of operator. Features include paint-free compression zone, variable speed step pulley, dust extraction nozzles, anti-vibration mounting, etc. Shiv Pharma Engineers Ahmedabad - Gujarat Tel: 079-29092380, Mob: 09377535927 Email: sales@shivpharma.com Website: www.gmpmachines.com

Blister packing machine The model PBM-140C 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, multi-stage cylinder heat sealing, automatic indenting, batch number printing and aluminium alloy double heating. Advanced Liquid Packaging Arizona - USA Tel: +1-602 -4900220 Email: sales@induction-sealers.com

FRP storage tank The FRP storage tank is manufactured by hand lay-up and/or by filament winding process for the storage of highly corrosive chemicals, acids and wastes. It is available in capacity up to 250 kl in various shapes, like square, round, rectangular vertical and horizontal with flat bottom or conical bottom. The key feature of this tank is that it offers resistance to chemical and weather. It is lightweight, easy-to-maintain featuring good physical and mechanical strength. The reaction vessel is available with suitable lined agitator, gear box and electric motor. EPP Composites Pvt Ltd Rajkot - Gujarat Tel: 02827-287059 Email: marketing@epp.co.in Website: www.atikagroup.com

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Products Bottom discharge centrifuge This centrifuge is ďŹ tted with a cake scrapping arrangement, which can be motorised or hydraulically operated to enable to scrape the stickiest of cakes. The cake is discharged through the bottom chute provided. This results in reducing manual labour, less cake handling loss and uniform cake washing. The centrifuge is oďŹ&#x20AC;ered in vapour-tight construction with nitrogen blanketing for hazardous chemicals. CIP design with built-in cleaning nozzles ensures no product cross-contamination. The centrifuge is oďŹ&#x20AC;ered in three-point pendulum suspension and four-point inertia plate mounted designs to suit application considerations. United Engineering Enterprises Mumbai - Maharashtra Tel: 022-23083990, Mob: 09820761808 Email: uenggent@gmail.com Website: www.united-centrifuges.com

Hydrogen gas generator Series WM-H2 hydrogen gas generator use the latest polymer electrolyte membrane (PEM) technology to produce pure hydrogen. The exclusive double gas column dryer regeneration system eliminates all downtime for maintenance. Standard features are models available in 120, 180, 260, 400, 500, 650, 800, 900, 1000, 1200 cc/min, purity is > 99.99999

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Modern Pharmaceuticals I February 2012

Products per cent, has automatic dryer regeneration, oﬀers pressure up to 12 bar (16 bar on request), etc. The instrument has patented gas/water separator electronically controlled. It provides LCD touchscreen, real-time outlet pressure, water quality, water level, auto-diagnostics with alarms. Remote PC monitoring is standard via RS232 or RS485 to interface the unit with customer’s PC software. Lab Intelligence Appliances Ahmedabad - Gujarat Tel: 079-26561557, Mob: 09377729989 Email: kamal@lia.net.in Website: www.lia.net.in

Sanitary tubes fittings A wide range of stainless steel sanitary tube fittings for pharma, food, beverages, breweries, cosmetics and allied industries are offered. The range includes bends, Tees, reducers, pipe, support and sight glass, etc. These are available in tube OD sizes ranging from ½” to 6”. End connections available are tri-clamp, DIN and SMS. These fittings are manufactures from SS-304, 316 and 316L, duly electro polished. All these products confirms to cGMP and FDA standards. Elastomers offered are of food grade and can be offered in EPDM, neoprene, silicon and viton. Cris Engineering Works Mumbai - Maharashtra Tel: 022-2685 9440, Mob: 09892273314 Email: roque_ferns@rediffmail.com Website: www.criseng.com

Pallets These pallets are oﬀered as per GMP & USFDA norms and are used for multifarious applications in diﬀerent industries. Designed for optimal load bearing capacities, the pallets are manufactured on state-of-the-art plants. The pallets have many outstanding features and can also be tailor-made to meet customers’ special requirements. Sintex Industries Ltd Kalol - Gujarat Tel: 02764-253500 Email: icontainers@sintex.co.in Website: www.sintex-plastics.com

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

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List of Products To know more about the products featured in this magazine, fax us on 022-3003 4499 or tear and post to us the ‘Product Inquiry Card’ by following the 5 easy steps given there. Alternatively, you may also write to us at michael@infomedia18.in or call us on 022-3003 4684, and we will send your inquiries to the advertisers/companies directly to help you source better. Sl No 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84

Product

Pg No

AC motor .............................................................. 33 Accent lighting ............................................................. 31 Acoustic enclosures ...................................................... 48 Agitator......................................................................... 19 Air filter ..................................................................21, 23 Air treatment ......................................................37, FGF Analytical instrumentation products ........................... 35 Analytical instruments ............................................... 110 Autoclave gasket........................................................... 94 Automatic capsule filler ............................................... 97 Automatic carton over-printing machine ................. 106 Automatic label gumming machine .......................... 106 Automatic label overprinting machine...................... 106 Axial flow fan ............................................................. 105 Bad conductor of electricity ................................... 17 Bag filter ....................................................................... 93 Ball check valve ............................................................ 97 Ball valve....................................................................... 97 Batch disperser ............................................................. 19 Bearing.......................................................................... 12 Better ergonomics ........................................................ 17 Biological safety cabinet.........................................21, 23 Blister packing machine............................................. 105 Blower ........................................................................... 98 Blowers and fans ........................................................ 105 Booklet and leaflet label..................... 11, 108,109, BGF Bottom discharge centrifuge...................................... 106 Braided hose ................................................................. 94 Brake motor............................................................33, 81 Bulk bag filler ............................................................. 103 Bush .............................................................................. 97 Butterfly valve............................................................... 97 Cable carrier.......................................................... 12 Cable connector ........................................................... 12 Cable ............................................................................. 94 Calorimeter................................................................... 19 Capsule filling machine ............................................ 104 Carbon filter ................................................................. 93 Carton dispensing machine ....................................... 106 Cartridge filter.............................................................. 93 Caster wheel ................................................................... 8 Centrifugal air blower ................................................ 105 Centrifugal fan ............................................................. 45 Chain pulley block ....................................................... 94 Chains........................................................................... 12 Chemical processing equipment.................................. 95 Chemical/acidic fumes resistance ................................ 17 Chlorine gas cylinder/tonner ....................................... 96 Chromatography ........................................................ 110 Clamp ........................................................................... 93 Clean attire ..................................................................... 6 Cleanlite - screwless cleanroom lumianaire ................ 31 Cleanroom apparel ......................................................... 6 Cleanroom door .....................................................21; 23 Cleanroom garment ....................................................... 6 Coating pan .................................................................. 98 Coloumns and chemistries .......................................... 35 Columns ..................................................................... 110 Commercial lighting .................................................... 31 Compressor................................................................. 105 Connector and cable assembly .................................... 10 Connector ..................................................................... 12 Consumer lighting ....................................................... 31 Conveying blower ...................................................... 105 Cooling tower.....................................................37, FGF Cord .............................................................................. 94 Corona treater sleeve.................................................... 94 Corrosion resistance ..................................................... 17 Counters and power supplies.................................... FIC Crab .............................................................................. 94 Crane ............................................................................ 94 DC motor ............................................................. 33 Dehumidifier .............................................................. 103 Diaphragm vacuum pump and compressor .............. 107 Diaphragm vacuum pump ........................................... 92 Diaphragm valve .......................................................... 97 Differential pressure transmitter .................................. 10 Digital temperature controller ................................... 106 Dispensing booth ...................................................21, 23 Disperser ....................................................................... 19 DPT with LCD display .............................................. 10 Drives......................................................................8, 106 Dry vacuum pump ....................................................... 95 Dry vane pump ............................................................ 48

Sl No 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168

Product

Pg No

Dual channel with modbus ....................................... 106 Duo label ............................................ 11, 108,109, BGF Dust collector system ................................................. 105 Dynamic controller .................................................... 106 Electronic chlorine dosing system and chloroscope...96 Elemental analysis ...................................................... 110 Emergency lighting system.......................................... 31 Empower ...................................................................... 35 Encoder...................................................................... FIC EOT/HOT cranes....................................................... 94 Exhauster ...................................................................... 98 Exhibition - EngineeringExpo.................................... 24 Fan filter unit ...................................................21; 23 FBD gasket .................................................................. 94 FEP/PFA/PVDF materials ......................................... 97 Filling equipment ......................................................... 75 Filter housing and assembly ........................................ 93 Filter press .................................................................... 97 Filtration and separation products............................... 92 Fittings .......................................................................... 97 Fixtures.......................................................................... 93 Flag label ........................................... 11, 108, 109, BGF Flameproof hoist .......................................................... 94 Flameproof motor ........................................................ 33 Flange mounting motor............................................... 33 Flood lighting system .................................................. 31 Fluid bed dryer........................................................... 104 FRP storage tank ....................................................... 105 Fuel burner ................................................................. 105 Gas chlorinator-gravity & vacuum feed ................ 96 Gasket .....................................................................94, 97 Gear pump ................................................................... 39 Gearbox ........................................................................ 94 Geared motor ............................................................... 33 Goliath crane ................................................................ 94 Goods lift...................................................................... 94 Grip plier ...................................................................... 93 Hall/MR sensor .................................................... 10 Hand/power-operated label gumming machine....... 106 Hanger label ...................................... 11, 108, 109, BGF Heat transfer equipment.............................................. 45 Heating bath ................................................................ 19 Heating range............................................................... 93 Hepa filter terminal housing .................................21; 23 High-pressure blower................................................... 45 High-pressure homogeniser......................................... 19 High-pressure transducer............................................. 10 High-purity water solutions and pharma grade resins15 High-speed automatic carton overprinting machine 106 High-speed automatic label counting machine ........ 106 High-speed automatic label overprinting machine .. 106 High-speed automatic lid dispensing machine ........ 106 High-speed automatic wallet dispensing machine ... 106 High-strength of weight ratio ..................................... 17 Horizontal handle clamp ............................................. 93 Hot plate....................................................................... 19 HPLC...................................................................35, 110 Hydrogen gas generator............................................. 106 Inductive sensor .................................................... 10 Industrial control and sensing devices...................... FIC Industrial cooler..................................................37, FGF Industrial fitting ............................................................. 8 Industrial lighting......................................................... 31 Industrial pump .......................................................... 104 Industrial vacuum clearing solution .......................... 105 Inflatable gasket............................................................ 94 Informatics.................................................................... 35 Injectable manufacturing line ................................21, 23 Inline disperser ............................................................. 19 Integrity plus attire......................................................... 6 Inverter/variable frequency drive .............................. FIC Jib crane ................................................................ 94 Jigs................................................................................. 93 Junction box wireless.................................................... 10 Junction box.................................................................. 10 Kamlok and drylok couplings .............................. 104 Kneading machines ...................................................... 19 Lab equipment - analytical range .......................... 93 Labelling equipment .................................................... 75 Laboratory reactor........................................................ 19 Laboratory software ..................................................... 19 Laminar air flow workstation ................................21, 23 Landscape lighting ....................................................... 31 Level controller.......................................................... FIC

Sl No 169 170 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187 188 189 190 191 192 193 194 195 196 197 198 199 200 201 202 203 204 205 206 207 208 209 210 211 212 213 214 215 216 217 218 219 220 221 222 223 224 225 226 227 228 229 230 231 232 233 234 235 236 237 238 239 240 241 242 243 244 245 246 247 248 249 250 251 252

Product

Pg No

Liquid filling machine ............................................... 103 Liquid injectable equipment ........................................ 75 Liquid manufacturing plant......................................... 75 Liquid ring vacuum pump......................................... 105 Loading arm ............................................................... 104 Machines and plants for dry and wet preparation .BC Magnetic stirrer ............................................................ 19 Mass spectroscopy ...................................................... 110 Measuring and monitoring relay .............................. FIC Mechanical vacuum booster ........................................ 98 Metal analyser .............................................................. 95 Mill ............................................................................... 19 Mini bilayer press ......................................................... 98 Modbus I/O junction box ........................................... 10 Molecular spectroscopy .............................................. 110 Monoblock high-vacuum pump ................................. 95 Monorail trolley............................................................ 94 Motion control .......................................................... FIC Motor vibrator................................................................ 8 Motor............................................................................ 33 Motorised chain pulley block ...................................... 94 Multi-stage centrifugal air blowers............................ 105 Nozzles ............................................................... 104 Oil seal high vacuum pump ................................... 95 Oil seal .......................................................................... 94 Oil/gas firing equipment............................................ 105 Ointment/lotion/cream manufacturing plant ............. 75 Optical range ................................................................ 93 O-ring ........................................................................... 94 Overhead stirrer ........................................................... 19 Packaging solution ...........................................29, 30 Pallets .......................................................................... 107 Pass box ..................................................................21, 23 Peristaltic pump............................................................ 82 Persona - hospital bedlight .......................................... 31 Pharma lighting............................................................ 31 Pharma manufacturing solutions..............................BIC Pharma packaging solutions .....................................BIC Pharmalux - cleanroom luminaire............................... 31 Photoelectric sensor .................................................. FIC Photosensor .................................................................. 10 PID controller ............................................................ 106 Pilot plant ..................................................................... 19 Pipe ............................................................................... 97 Piping system from polypropylene................................ 5 Platinum cured silicon tubing ..................................... 93 Pleated filter ................................................................. 93 Plug valve...................................................................... 97 Pneumatic conveying system ..................................... 105 Polypropylene filter plate ............................................. 97 Polypropylene recess plate............................................ 97 Portable loader............................................................ 105 Powder and granule packing equipment..................... 75 Powder granulation equipment ................................... 75 PP-recess chamber type fully automatic filter press ... 97 PP-recess chamber-type filter press ............................ 97 Precision fabrication work ........................................... 93 Pre-engineered and pre-fabricated modular panel21, 23 Pressure sensitive paper and film label ..................29, 30 Process gas blower........................................................ 45 Profile controller ......................................................... 106 Profile............................................................................ 94 Programmable logic controller .........................FIC, 106 Programmable terminal ............................................ FIC Proximity sensors....................................................... FIC PTFE............................................................................ 97 Pull action clamp ......................................................... 93 Pump ................................................39, 48, 95, 105, 107 Pumping filtering unit vacuum pump ...................... 105 Pumps and valves ....................................................... 107 Quick change terminal house ...........................21, 23 R&D solutions .................................................. BIC Rapid endotoxin detection system .............................. 96 Receptacle ................................................................... 104 Return air riser .......................................................21, 23 RFID ......................................................................... FIC RH and temperature display ....................................... 10 Road lighting................................................................ 31 Rod ............................................................................... 97 Roots blower................................................................. 48 Roots vacuum pump .................................................... 95 Rotary dry vacuum pump ............................................ 45 Rotary evaporator......................................................... 19 Rotary gear pump ........................................................ 39

Sl No 253 254 255 256 257 258 259 260 261 262 263 264 265 266 267 268 269 270 271 272 273 274 275 276 277 278 279 280 281 282 283 284 285 286 287 288 289 290 291 292 293 294 295 296 297 298 299 300 301 302 303 304 305 306 307 308 309 310 311 312 313 314 315 316 317 318 319 320 321 322 323 324 325 326 327 328 329 330 331 332 333 334

Product

Pg No

Rotary pump ................................................................ 95 Rotary vane vacuum pump .......................................... 92 Safe change housing ..............................................21, 23 Safety light curtain with controller ............................. 10 Safety light curtain .................................................... FIC Sampling booth ......................................................21, 23 Sanitary tubes fittings ................................................ 107 Screening machine ....................................................... 96 Sealing equipment........................................................ 75 Sections ......................................................................... 94 Self-adhesive tape......................................................... 43 Shaker ........................................................................... 19 Shaking incubator ........................................................ 92 Sheet .......................................................................94, 97 Side-channel blower................................................... 105 Side-channel vacuum pump & compressor.............. 107 Sieve .............................................................................. 98 Sight flow meter......................................................... 104 Silence flow package .................................................... 45 Silicone rubber sleeve ................................................... 94 Silicone transparent platinum cured tubing................ 94 Single stage monoblock vacuum pump ...................... 95 Single stage vacuum pump .......................................... 95 Slipring crane-duty motor ........................................... 33 Solid-liquid mixer ........................................................ 19 Sponge .......................................................................... 94 Spun filter ..................................................................... 93 Square ........................................................................... 94 Stainless steel filter ....................................................... 93 Sterilising/depyrogenating tunnel..........................21, 23 Straightline action clamp ............................................. 93 Strip .............................................................................. 94 Swing check valve ........................................................ 97 Switching relay .......................................................... FIC Swivel .......................................................................... 104 Syrup manufacturing plant .......................................... 75 Tablet compression machine ............................... 104 Tablet/capsule packing equipment .............................. 75 TC gasket ..................................................................... 94 Technical garment.......................................................... 6 Tefzel HHS isotactic PP material................................. 5 Temperature controller......................................106, FIC Temperature data logger ............................................ 103 Thermoplastic valve ........................................................ 5 Thermostat and vacuum dryer/mixer .......................... 19 Timers........................................................................ FIC Toggle action clamp ..................................................... 93 Toggle press .................................................................. 93 Transfer trolley ............................................................. 94 Transparent tubing ....................................................... 94 Tri lobe roots blower.................................................... 98 Trim handling system ................................................ 105 Trolley wheel .................................................................. 8 Truck blower ................................................................ 45 Tube .............................................................................. 97 Twin lobe roots blower ................................................ 98 Two-stage vacuum pump............................................. 95 UHPLC .............................................................. 110 Universal controller .................................................... 106 UPLC ........................................................................... 35 UV stabilised ................................................................ 17 Vacuum booster pump ........................................... 48 Vacuum conveyor ....................................................... 103 Vacuum pump .............................................................. 95 Vacuum range ............................................................... 93 Vacuum system............................................................. 48 Valve.............................................................................. 97 Vane damper............................................................... 105 Ventilator .................................................................. 8, 43 Vertical handle clamp .................................................. 93 Vial and bottle cap sealing machine ........................... 94 Vial inspection machine............................................... 93 Vision sensor ............................................................. FIC Walkable ceiling system......................................... 93 Walk-in humidity chamber ......................................... 92 Water-ring vacuum pump ......................................... 105 Wire rope hoist ............................................................ 94 Wired connection......................................................... 10 Wireless products ......................................................... 10 Wireless receiver........................................................... 10 Work bench .................................................................. 95 Zero liquid discharge effluent treatment ................ 47

BC-Back cover, BGF-Back Gate Fold, BIC-Back inside cover, COC-Cover on cover, FGF-Front gate fold, FIC-Front inside cover

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Modern Pharmaceuticals I February 2012

List of Advertisers Advertiser’s Name & Contact Details

Pg No

Advertiser’s Name & Contact Details

Pg No

Advertiser’s Name & Contact Details

Pg No

Advertiser’s Name & Contact Details

Pg No

ACG Worldwide BIC T: +91-22-26780127 E: shabir.badami@acg-worldwide.com W: www.acg-worldwide.com

Engineering Expo T: +91-9819552270 E: engexpo@infomedia18.in W: www.engg-expo.com

Joyam Engineers & Consultants Pvt Ltd T: +91-79-26569533 E: joyam@joyamvactech.com W: www.joyamvactech.com

Sreelakshmi Traders T: +91-44-24343343 E: sreelakshmitraders@gmail.com W: www.sreelakshmitraders.com

Acme Air Equipment Co Pvt Ltd T: +91-79-25831985 E: info@airequipments.com W: www.acmeairequipments.com

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Katlax Enterprises Pvt Ltd T: +91-2764-286784 E: info@katlax.com W: www.katlax.com

Aeron Composite Pvt Ltd T: +91-79-65258500 E: info@aeroncomposite.com W: www.aeroncomposite.com

Enterpneurer Everest Transmission T: +91-11-45457777 E: info@everestblowers.com W: www.everestblowers.com

Sri Vishnu Pumps Manufacturing Co 107 T: +91-22-28458372 E: vishnupump@rediffmail.com W: www.minivacpumps.com

Ani Engineers T: +91-2752-241479 E: anivarya@sancharnet.in W: www.anivaryapumps.com

Aqua Services T: +91-265-2331748 E: aquaas@satyam.net.in W: www.aquaservicesindia.com

Avery Dennison India Pvt Ltd T: +91-124-2215581 E: lpm.in@ap.averydennison.com W: www.enhanceyourbrand.com

29; 30

Blowtech T: +91-22-28458372 E: blowtech@hotmail.com W: www.vaccumcleanerindia.com

105

Bonfiglioli Transmissions (Pvt) Ltd T: +91-44-67103800 E: sales.buins@bonfiglioli.com W: www.bonfiglioli.com Bry Air (Asia) Pvt Ltd T: +91-11-23906777 E: bryairmarketing@pahwa.com W: www.bryair.com

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Fabtech Technologies Intl Pvt Ltd T: +91-22-61592900 E: mails@fabtecheng.com W: www.fabtecheng.ae Fluid Energy Controls Inc T: +91-44-42083536 E: sales@fecindia.com W: www.fecindia.com Gem Equipments Ltd T: +91-422-3267800 E: sales@gemindia.com W: www.gemindia.com Hapman India T: +91-265-2517505 E: info@hapman.in W: www.hapman.in

21; 23

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MGM-Varvel Power Transmission (P) Ltd 81 T: +91-44-64627008 E: ravik@mgmvarvelindia.com W: www.mgmvarvelindia.com Mifa Systems T: +91-79-26870825 E: sales@mifasystems.com W: www.mifasystems.com

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Netzsch Technologies India Pvt Ltd BC T: +91-44-42965121 E: anton.benjamin@nti.netzsch.com W: www.netzsch-grinding.com/pharma Omron Automation Pvt. Ltd. T: +91-80-40726400 E: in_enquiry@ap.omron.com W: www.omron-ap.com

FIC

Heattrans Equipments Pvt.Ltd. T: +91-79-25840105 E: info@heattrans.com W: www.heattrans.com

Pierlite India Pvt Ltd T: +91-79-22782623 E: pradeep@pierlite.co.in W: www.pierlite.co.in

Igus India Pvt Ltd T: +91-80-39127800 E: info@igus.in W: www.igus.in

Plus Ventilation Pvt.Ltd. T: +91-40-23812152, 23812153 E: director@plusventilation.com W: www.plusventilation.com

IKA India Private Limited T: +91-80-26253900 E: process@ika.in W: www.ika.in

Ravel Hiteks Pvt Ltd T: +91-44-24961004 E: sales@ravelhiteks.com W: www.ravelhiteks.com

Ion Exchange India Ltd T: +91-22-39890909 E: ieil@ionexchange.co.in W: www.ionindia.com

Reynders Label Printing India Pvt Ltd 11; 108;109;bgf

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

Charles River T: +91-80-25588175 E: india.customercare@crl.com W: www.criver.com

J B Sez Pvt Ltd T: +91-422-3267800 E: sales@gemindia.com W: www.gemindia.com

Chitra Precious Machine Pvt Ltd T: +91-79-25840315 E: contact@chitramechtech.com W: www.chitramechtech.com

Jacsons Engineers T: +91-79-25841814 E: info@jacsonsengrs.com W: www.jacsonsengrs.com

T: +91 149 3305400 E: india@reynders.com W: www.reynders.com FGF

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Shah Brothers T: +91-22-43560400 E: coupling@shahbros.com W: www.shahbros.com Shree Siddhivinayak Industries T: +91-22-28458372 E: minivac9@hotmail.com W: www.minivacpumps.com

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SSP Pvt Limited T: +91-129-4183700 E: info@sspindia.com W: www.sspindia.com

Supremo Line & Control T: +91-79-22205282 E: supremoproduct@gmail.com W: www.supremoproduct.com

Suresh Enterprises T: +91-2762-224814 E: info@sevitsil.com W: www.sevitsil.com

Swam Pneumatics Pvt Ltd T: +91-120-4696222 E: swamatic@airtelmail.com W: www.swamatics.com

Techno Industries T: +91-79-25830742 E: info@technoind.com W: www.technoind.com

The Indian Electric Co T: +91-20-24474303 E: icemktg@indianelectric.com W: www.indianelectric.com

Thermo Fisher Scientific Sid Div T: +91-22-67429494 E: pradeep.kumar@thermofisher.com W: www.thermofisher.com UNP Polyvalves India Pvt Ltd T: +91-265-2649248 E: mktg@polyvalve.com W: www.polyvalve.com Vacunair Engineering Co Pvt Ltd T: +91-79-22910771 E: info@vacunair.com W: www.vacunair.com Waters (India) Private Limited T: +91-80-28371900 E: waters_india@waters.com W: www.waters.com

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February 2012

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February 2012

RNI No: MAHENG / 2008 / 27125 Postal Regd No: G / NMD / 122 / 2011 - 13 Posted at P.C Stg. OfďŹ ce, GPO, Mumbai 400 001 On 19th & 20th Of Every Month Date Of Publication: 16th Of Every Month

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