Modern Pharmaceuticals - January 2012 by Infomedia18

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

Editorial

Ready to ‘leap’?

t the outset, here’s wishing you a Great New Year! Perhaps it is the best time to ‘leap’ and help lead the nation become the fastest-growing economy on earth. This undoubtedly promises unparallelled opportunities to raise the present portfolio of products and services to the next level, and in the process, not only transform a multitude of cities and states but also millions of lives.

In retrospect, the year 2011 was quite eventful for the Indian pharma sector and the country, in general. Amid sweeping mega global trends – from the Jasmine Revolution to the unprecedented stress on the Euro Zone and their rising ricochets across the globe – India stood tall as one of the few key growth markets, albeit with a placid pace of economic ascent. Although the Indian pharma sector did not witness the same scale and regularity of M&As in 2011 as compared to the previous year, the emerging trends signify growing collaborative strategies with a clear focus on emerging markets, especially for generics. Moving ahead, it will be interesting to see how this shapes India’s pharma policy and the rising demand for protective measures to ensure that lower-income population gets access to affordable healthcare. Since product innovation and time-to-market increasingly emerge as the core of crucial success quotient for the pharma sector, the future will belong to those who can smartly transform their products & processes in the quest to gain a competitive edge.

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

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

Dr Gopakumar G Nair

Given this fast developing scenario, it is high time for the Indian pharma sector to adopt the approach to leapfrog rather than trying to merely catch up in the race. This will hopefully offer greater productivity, resource efficiency, innovativeness, etc by virtue of next-gen products and processes. That said, it is imperative to put into action adequate safeguards and regulatory practices to ensure that the Indian growth momentum marches ahead in an increasingly uncertain global market. This edition of ‘Modern Pharmaceuticals’ reflects all these and much more, with a focussed mix of the past, present and future. These changes should lead to smarter technology, precise products, superior service and proficient performance for the pharma sector. We will continue reviewing the trends regularly and present analysis thereof for you in the times ahead. Let the journey begin!

IPR Consultant & Advisor

Dilip G Shah Chairman, IGPA & Secretary General, IPA

Daara Patel Secretary General, IDMA

Manas R Bastia manas@infomedia18.in

January 2012 I Modern Pharmaceuticals

Contents

REGULAR SECTIONS 7 18 24 28 74 76 80 83 88 89

In Conversation With K V Venugopalan President, Waters India Pvt Ltd

Special Focus

Lab/Analytical instruments ............. 33

Editorial News, Views & Analysis Technology & Innovation Technology Transfer Projects Event List Book Review Products List of Products List of Advertisers

Newsmakers of 2011 .............................. 12 Mass spectrometers ........................................................ 34

Automation Trends

Texture analysers............................................................ 36

Case study - Pharma manufacturing Magic made simple: From development to production ..............................................................60

Interface - Dr Ganapathy Ramakrishnan ........................ 38 Interface - Gregory J Herrema ........................................ 40

Martin Künstl, Corporate Manager Pilot Plants, IKA®-Werke GmbH & Co KG

Roundtable .................................................................... 42

Energy Management

HVAC processes A stitch in time saves nine! .........................................62

Facility Visit

Policies & Regulations

J K Industries Pvt Ltd Leveraging on the exports market

Insight & Outlook

Pros & cons of Draft NPPP 2011 Tackling the aﬀordability factor meaningfully ............68

Strategy

Quality issues ....................... 51

Clinical data collection The conundrum for ‘accuracy’ .....................................70 Dr Rajan T D, Pharma Consultant & Practising Dermatologist

Tips & Tricks Compliance tips for GCP A guideline for the reseach team to follow .................72

Good Clinical Practices .................................................. 52

Partha Chatterjee, Associate Vice President, Clinical Operations, SIRO Clinpharm

Software in clinical research............................................ 54 Interface - Dr Kiran Marthak ......................................... 56

Event Preview

Roundtable .................................................................... 58

Bangalore India Bio Promoting the inherent strengths of the Indian biotech industry ..............................................78

Highlights of Next Edition A

Details on page no. 50

nn Special Focus: Pharma industry + iver sar y sector overview Insight & Outlook : Women achievers in pharma

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

January 2012 I Modern Pharmaceuticals

Event Report Indian Pharmaceutical Congress 2011 A splendid accomplishment .......................................79 Cover photograph: Srivatsa Shandilya

FOUNDER & EDITOR, NETWORK 18 Raghav Bahl

GROUP CEO, NETWORK 18 Haresh Chawla

PRESIDENT & EDITORIAL DIRECTOR, TV 18 Senthil Chengalvarayan

GROUP COO, NETWORK 18 B Sai Kumar

SENIOR EDITOR Manas R Bastia FEATURES EDITOR Arshia Khan EDITORIAL TEAM Chandreyee Bhaumik, Parita Dholakia, Michael Anthony, Abha Mishra, Paskaline Sebastian, Titash Roy Choudhury (Delhi), Jasleen Kaur Batra (Bengaluru) ASSISTANT ART DIRECTOR Varuna Naik DESIGN Sachin Bhogate CHIEF PHOTOGRAPHER Mexy Xavier PHOTOGRAPHY Neha Mithbawkar, Joshua Navalkar BUSINESS CONTROLLERS Pukha Dhawan, Lovey Fernandes, Akshata Rane, Deepak Bhatia, Shwetha ME, Jayashree N, Sugandha Kulkarni, Shefali Mahant

PRINTING EXECUTIVE VICE PRESIDENT Ananth R Iyer ASSISTANT GENERAL MANAGER - PPC Shekhar Khot

PRODUCTION TEAM Dnyaneshwar Goythale, Surekha Karmarkar, Ravikumar Potdar, Ravi Salian, Sanjay Shelar

OVERSEAS CONTACT Ringier Trade Media Ltd

CHINA 1001 Tower 3, Donghai Plaza, 1486 Nanjing Road, West, Shanghai 200040, China Tel: +86-21 6289 – 5533 Ext. 368, Fax: +86-21 6247 – 4855 (Craig Shibinsky) Email: craig@ringier.com.hk Ringier Trade Media Ltd HONG KONG 9/F, Cheong Sun Tower, 118 Wing Lok Street, Sheung Wan, Hong Kong Tel: +852 2369 – 8788 Ext. 21, Fax: +852 2869 – 5919 (Octavia Au-Yeung) Email: octavia@ringier.com.hk Ringier Trade Media Ltd TAIWAN Room 3, Fl. 12, No. 303, Chung Ming S. Rd., Taichung, Taiwan Tel: +886-4 2329 – 7318 Ext. 16, Fax: +886-4 2310 – 7167 (Sydney La) Email: sydneylai@ringier.com.hk

Ringier Trade Media Ltd

GERMANY, AUSTRIA, SWITZERLAND Tel: +41-44 734 0472, Fax: +41 44 734 0680 Email: info@islerannoncen.ch USA Tel: (513) 527-8800 Fax: (513) 527-8801 Email: dhight@gardnerweb.com

USA Alfredo Domador, 6505 Blue Lagoon Drive, Suite 430 Miami, FL. 33126, USA Tel: (305) 448-6875, Fax: (305) 448-9942

CEO-PUBLISHING, INFOMEDIA 18 Sandeep Khosla EVP-HUMAN RESOURCES Sanjeev Kumar Singh ASSOCIATE VICE PRESIDENT Sudhanva Jategaonkar ADVERTISING SALES Shashin Bhagat (Ahmedabad) shashin.bhagat@infomedia18.in Mahadev B (Bengaluru) mahadev.b@infomedia18.in Hari Hara Subramaniam (Chennai) hari.s@infomedia18.in Prakash N (Coimbatore) prakash.n@infomedia18.in Rahul Hanchate (Hyderabad) rahul.hanchate@infomedia18.in Ameya Gokhale (Indore) ameya.gokhale@infomedia18.in Durgesh Grover (Jaipur) durgesh.grover@infomedia18.in Abhik Ghosal (Kolkata) abhik.ghosal@infomedia18.in Inder Dhingra (Ludhiana) inder.dhingra@infomedia18.in Mukesh Yadav (New Delhi) mukesh.yadav@infomedia18.in Rohit Dass (Pune) rohit.dass@infomedia18.in Chirag Pathak (Vadodara) chirag.pathak@infomedia18.in MARKETING TEAM Ganesh Mahale, Prachi Mutha, Varsha Nawathe, Abhay Borkar

NEWSSTAND AND SUBSCRIPTIONS DISTRIBUTION HEAD Sunil Nair DEPUTY GENERAL MANAGER Manoj Palsay SENIOR MANAGER - SUBSCRIPTIONS Sheetal Kotawdekar CO-ORDINATORS Rahul Mankar, Anant Shirke, Sarita Quadros, Chaitali Parkar, Kamlesh Mathkar, Vaibhav Ghavale

SERVICES SUBSCRIPTION SERVICES For subscription queries, write to chaitali.parkar@infomedia18.in or call +91 22 30034631-34 or toll free 1800 200 1021 PERMISSIONS For subscription to copy or reuse material from Modern Pharmaceuticals, Write to spedit@infomedia18.in • Monthly Issue Price: ` 100 • Annual Subscription: ` 799

Views and opinions expressed in this magazine are not necessarily those of Infomedia 18 Ltd, its publisher and/or editors. We at Infomedia 18 Ltd do our best to verify the information published but do not take any responsibility for the absolute accuracy of the information. Infomedia 18 Ltd does not accept the responsibility for any investment or other decision taken by readers on the basis of information provided herein. Infomedia 18 Ltd does not take responsibility for returning unsolicited material sent without due postal stamps for return postage. No part of this magazine can be reproduced without the prior written permission of the publisher. Infomedia 18 Ltd reserves the right to use the information published herein in any manner whatsoever.

Infomedia 18 Ltd is the publishing arm of Network 18.

Printed by Mohan Gajria and published by Lakshmi Narasimhan on behalf of Infomedia 18 Ltd. Senior Editor: Manas R Bastia Printed at Infomedia 18 Ltd, Plot no.3, Sector 7, off Sion-Panvel Road, Nerul, Navi Mumbai 400 706, and published at Infomedia 18 Ltd, ‘A’ Wing, Ruby House, J K Sawant Marg, Dadar (W), Mumbai - 400 028. Modern Pharmaceuticals is registered with the Registrar of Newspapers of India under No. MAHENG / 2008 / 27125. Infomedia 18 Ltd does not take any responsibility for loss or damage incurred or suffered by any subscriber of this magazine as a result of his/her accepting any invitation/offer published in this edition.

January 2012 I Modern Pharmaceuticals

Newsmakers of 2011 Alliances Ecron Acunova forms JV with Jamjuree Innovations Sun Pharma in a JV with Merck ( January) Ecron Acunova (EA) announced a Joint Venture ( JV ) with Chulalongkorn University’s arm, Jamjuree Innovations Co Ltd ( JJI), Thailand, for clinical research in South-East Asia. The CRO is based in Bangkok, and will be conducting clinical research in key South-East Asian countries under the name of Ecron Acunova Company Ltd (EACL).

(April) US-based Merck & Co Inc and Sun Pharmaceuticals entered into a strategic collaboration to jointly develop, manufacture and commercialise new combinations of innovative branded generics in emerging markets. The JV will develop 8-10 molecules over a period of time. Dilip Shanghvi, CMD, Sun Pharmaceuticals, said that the JV reinforces its strategy of partnering to launch products using its innovative delivery technologies.

Sanofi Pasteur and IVI partner against dengue

Lupin, Natco tie-up to market breast cancer drug

(April) Sanofi Pasteur, the vaccines division of sanofi-aventis Group, announced its partnership with the International Vaccine Institute (IVI) to support the Dengue Vaccine Initiative (DVI). Sanofi Pasteur and the IVI aim to raise awareness and to work to move dengue vaccination higher on the global health agenda.“The fight against dengue requires a strong global commitment from all public health partners. The first dengue vaccine is now in the final stages of development,” stated Olivier Charmeil, Senior Vice President, sanofi-aventis, Vaccines.

( July) Lupin Ltd and Natco Pharma formed an alliance to jointly commercialise generic lapatinib ditosylate tablets used for the treatment of breast cancer in the US market. Lapatinib ditosylate tablets are sold under the brand name Tykerb in the US market. The patent of Tykerb is with Glaxo. Natco had ﬁled an Abbreviated New Drug Application (ANDA) seeking US Food and Drug Administration (US FDA) approval for marketing generic equivalent of Tykerb® in 250 mg tablets.

Pfizer enters an animal health JV in China

Boehringer and Eli Lilly sign India alliance pact

(September) Drugmaker Pfizer Inc to boost sales of veterinary medicines in China, and its global dominance in the animal health business signed a JVwith a Chinese startup company. Pfizer will jointly develop, manufacture and sell vaccines for animals with Jilin Guoyuan Animal Health Company Ltd. The JV, Jilin Pfizer Guoyuan Animal Health Co, planned to start marketing its first product — a vaccine against a reproductive and respiratory condition pigs get — next year.

(October) Boehringer Ingelheim India and Eli Lilly India (Lilly) entered into an agreement speciﬁc to India to copromote a portfolio of diabetes compounds. The collaboration includes Boehringer Ingelheim’s oral anti-diabetic agent, Linagliptin, not yet approved for marketing in India and Lilly’s insulin analogue, Humalog™ (Lispro), which is already in the Indian market. “India is clearly a market with great need and huge potential for the treatment of diabetes,” said Jacques Tapiero, President - Emerging Markets Business Area, Eli Lilly and Company.

Avesthagen forms JV with SAVA Medica

Honeywell celebrates10-year alliance with ACG

(November) Avesthagen Ltd, a fully integrated life sciences genomic healthcare company, and SAVA Medica Ltd, an emerging fast growing global pharmaceutical company with business verticals across the pharma value chain formed a 50:50 Joint Venture ( JV) in Avesthagen Ltd’s Dhanvantari Botanicals subsidiary to market and sell a line of Avesthagen Ltd bioactive products in the US and Brazil, Russia, India, and South Africa (BRIS). Dhanvantari Botanical’s products include 11 OverThe-Counter (OTC) brands.

(December) Honeywell announced the 10t anniversary of the company’s partnership with ACG-Pharmapack for converting Honeywell Aclar® film into high-value pharmaceutical packaging. Under the partnership, Honeywell provides Aclar films to ACG, and ACG laminates those films with other plastics, including PVC and PETG, to create thermoformable pharmaceutical packaging such as blister packaging, for pharmaceutical companies in India.

Announcements

IDMA signs deal with China’s CPIA

Allegra for OTC use now

(February) The Indian Drugs Manufacturers Association (IDMA) entered into its Golden Jubilee year with the signing of a Memorandum of Understanding (MoU) with the China Pharmaceutical Industry Association (CPIA) at its 49th annual meeting in Mumbai. The MoU was signed to enhance pharmaceutical trade between the two countries and help Indian companies gain access to the Chinese market. The Indian pharma industry accounts for 8 per cent of the global drugs market.

(February) sanoﬁ-aventis US, and its US Consumer Healthcare Division, Chattem, Inc, announced that the US Food and Drug Administration (FDA) has approved the Allegra family of allergy medication products for Over-The-Counter (OTC) use in adults and children. Allegra-D also relieves nasal congestion and sinus pressure, and will be available without a prescription at the pharmacy counter for use in adults and children aged 12 years and older. From March 2011, Allegra and Allegra-D will be available in their original prescription strengths without a prescription.

Modern Pharmaceuticals I January 2012

Newsmakers of 2011

Alvogen and Natco file ANDA

Announcements Glenmark enters in an exclusive agreement with IDC

(March) Alvogen with its India-based partner, Natco Pharma Ltd, filed an Abbreviated New Drug Application (ANDA) with the USFDA for the generic version of TamifluR. Robert Wessman, Executive Chairman, Alvogen Pharmaceuticals Ltd, said, “The ANDA filing of TamifluR represents a significant milestone for Alvogen in the US market. We are confident that the filing will qualify for 180-day exclusivity upon the FDA approval.”

(April) Glenmark Pharmaceuticals entered into an exclusive agreement with ImmanenceIntégrale Dermo Correction (IDC), for the distribution of a range of high-end dermatology products for India, Brazil, Mexico, South Africa, Egypt, Vietnam, Malaysia, and Thailand. Glenmark will be the sole licensee for the entire range of product portfolio across all these operating countries, thus marking the global entry of Glenmark into the high-end anti-ageing cosmeceutical care segment.

WHO signs joint statement with FIP

Piramal resolves patent litigation with Baxter

(September) The World Health Organisation (WHO) and the International Pharmaceutical Federation (FIP) signed a joint statement on the role of pharmacists in Tuberculosis (TB) care and control. The joint statement was signed at the 71st World Congress of Pharmacy and Pharmaceutical Sciences 2011, inaugurated by the President, Pratibha D Patil.The joint statement envisages a series of measures to help detect TB, oﬀer treatment support to patients and substantially reduce the number of deaths due to it.

(November) Piramal Critical Care, Inc, a subsidiary of Piramal Healthcare Ltd, announced the dismissal of patent litigation with Baxter Healthcare Corp. The patent litigation over Baxter’s inhaled anaesthetic drug Suprane (desﬂurane) was dismissed by the United States District Court for the District of Delaware pursuant to a settlement between the parties. According to the statement, Piramal may launch its generic desﬂurane product in the US market by January 1, 2014 but subject to US regulatory approval.

Thermolab’s new unit and logo launched

Expansion Dr Reddy’s expands its R&D centre at Cambridge

( January) Thermolab Group launched its new group company, Thermolab Analyticals. This new unit conducts stability storage and analytical testing of drugs & drug products. It has a fully equipped laboratory with stability storage chambers functioning as per the International Conference on Harmonisation (ICH) guidelines and complying with the US and European regulations. Sandip Mhatre, Group Managing Director, Thermolab, commented, “We aim to become closer to the customers who have placed their faith in us and have supported us till date. A new look for the brand was needed; thus, the new logo was opted for.”

Merck’s new technology centre in India

(May) Dr Reddy’s Laboratories opened its newly expanded Chirotech Technology Centre at Cambridge Science Park, UK where Chirotech has been based for the last 20 years. Dr Anji Reddy, Chairman, and GV Prasad, Vice Chairman and CEO, Dr Reddy’s Laboratories, inaugurated the new site in the presence of Chief Guest Dr Hamied, Chairman, Cipla and Honorary Fellow of Christ’s College, Cambridge. Dr Reddy marked the occasion by planting a tree outside the facility.The new 33,000 sq ft facility built specifically for laboratories and offices and has been fitted to Dr Reddy’s specific requirements .

India Entry Bausch + Lomb ventures into the Indian market

( January) Merck Ltd set up a new application and technology centre at Nerul, Navi Mumbai. This state-of-the-art facility will enable Merck to oﬀer customised application and technology solutions to its customers in ﬁelds of drug discovery, automobile and decorative paints. Prantik Mukherjee, Head, Merck Millipore, said, “The facility is equipped with state-of-the-art application, and quality control laboratories that meet the stringent international standards.”

( July) Bausch+Lomb announced its entry into the growing Indian pharma market by signing a MoU with Micro Labs India. “Our company entered the pharma vertical in the year 1986 but at that time there was less conﬁdence in the Indian pharma market from the company’s side, and also we did not get any good collaborative opportunity like this,” said Harish Natarajan, Managing Director, Bausch + Lomb - India.

Sun Pharma to expand in the US, emerging markets

Yakult and Probiotic Science in India

(August) Sun Pharmaceuticals Ind announced that it is open to acquisitions in both developed and emerging markets to fuel growth. “While organic growth is ﬁrmly in place, we also remain interested in inorganic opportunities in developed markets mainly in USA and in other large emerging markets,” said Dilip Shanghvi, Chairman & Managing Director, Sun Pharmaceutical Industries, during an investor call.

(December) A group of eminent Indian scientists have set up the Yakult India Microbiota and Probiotic Science Foundation with the primary objective of providing a thrust to the ﬁeld of probiotics in the country. The foundation will channelise international knowledge and expertise in the ﬁeld of probiotics and will promote collaborative research in the development of probiotics.

Modern Pharmaceuticals I January 2012

Newsmakers of 2011 Lincoln’s first long-acting paracetamol

Product Launch Himalaya’s first herbal drug Liv.52 HB for HBV

(February) Lincoln Pharmaceuticals Ltd launched an innovative drug delivery system in paracetamol, Pa12 – India’s first long-acting paracetamol for the treatment of fever and pain. Clinical tests have proven that Pa12 is more effective with longer acting capabilities and fewer side effects. The clinical trials for Pa12 were conducted on more than 500 patients at leading hospitals, which have proven and established the efficacy and tolerability of this product as compared to other brands currently available.

(May) The Himalaya Drug Company, launched Liv.52 HB, the first herbal drug for the effective management of Hepatitis B Virus (HBV) infection. The drug is an US patent-pending phytopharmaceutical formulation that is recommended for the treatment of HBV infection. Liv.52 HB exerts antiviral activity and enhances the antioxidant defense system. Available treatments, while effective, come with serious side-effects and are very costly.

Lincoln launches Tinnex injection in India

GlaxoSmithKline launches two drugs

( June) Lincoln Pharmaceuticals Ltd (LPL) introduced Tinnex injection in India; this is a part of its agreement with Phafag AG, Switzerland to produce the caroverine molecule for the treatment of tinnitus – commonly known as ‘ringing in the ear’. LPL is the sole manufacturer and distributor of Tinnex injection in India and the ﬁrst company in the country to introduce a cure for Tinnitus. LPL has sold 500 ampoules of Tinnex injection all over India in just one month.

(August) GlaxoSmithKline Pharmaceuticals Ltd announced the launch of two drugs RevoladeTM and VotrientTM targeted towards speciﬁc patient categories. RevoladeTM (Eltrombopag) is approved for the oral treatment of thrombocytopenia (reduced platelet count) in adults with the blood disorder chronic immune (idiopathic) Thrombocytopenic Purpura (ITP).

Recognition IOLCP wins National Energy Conservation Award Bafna and Orchid honoured by IDMA ( January) IOL Chemicals & Pharmaceuticals Ltd (ILOCP) won the National Energy Conservation Award 2010. It won the ﬁrst prize in the drugs and pharma sector for its continued eﬀorts towards new technology implementation so as to conserve energy resources. R K Thukral, Executive Director, ILOCP, said, “This year, we have achieved a considerable decline in energy consumption at our manufacturing units due to implementation of several energy conservation measures.”

(February) Bafna Pharmaceuticals won the ‘Indian Drug Manufacturers’ Association (IDMA) Quality Excellence Awards for 2010. In addition, the company has been bestowed with another prestigious ‘Udyog Rattan Award’ by the Institute of Economic Studies, New Delhi. On another similar occasion, Orchid Pharmaceuticals was also conferred with the prestigious ‘Icon of the Year’ award by the Institute of Cost and Works Accountants of India.

Modern Pharmaceuticals I January 2012

Newsmakers of 2011

Venus wins QC-100 TQM award

Recognition Suven Life Sciences bags Bio-Excellence Award

(April) Venus Remedies Ltd, bagged the prestigious international award QC-100 TQM in Gold Category in recognition of commitment to quality, system eﬃciency, leadership, technology and innovation. The awards were given by Business Initiative Directions (BID) International Quality Convention 2011 held in Geneva. Fifty-nine countries from around the globe participated in diﬀerent categories in these awards and Venus is the only pharmaceutical company from India to have won this prestigious award.

(May) Suven Life Sciences Ltd, a Hyderabad-based bio-pharmaceutical company, was awarded the Bio-Excellence Award under Bioservices category at Bangalore India Bio 2011, a biotech event held from May 4-6, 2011 at Bengaluru. Instituted by the department of IT-BT & ST, Government of Karnataka, the Bio-Excellence award recognises and honours biotech leaders for their outstanding achievements in the ﬁeld of science and technology.

Miscellaneous

Gracure receives EU-GMP certification

India to be among top 10 pharma markets by 2015

(May) Following an audit conducted in February 2011, Gracure has received European Union-Good Manufacturing Practice (EU-GMP) certiﬁcation for its manufacturing site in Bhiwadi, Rajasthan, by Belgium’s Federal Agency for Medicines & Health Products (FAMHP). The site has been approved for manufacturing of non-sterile dosage forms, which includes capsules, liquids, tablets, semi solid and other (dry syrup for reconstitution with water). FAMHP certiﬁcate is accepted by all EU Health Authorities.

(October) Emerging markets India and China will ﬁgure in the top 10 pharma markets of the world by 2015, an Ernst & Young report has said. The report has identiﬁed India as the preferred choice for outsourcing in the area of late stage drug discovery, shared services and complex manufacturing, while China has been the preferred market for building blocks and intermediates. The other major emerging markets are likely to be Brazil, Russia, Venezuela, Turkey and Korea, according to OPPI & Ernst & Young’s report.

January 2012 I Modern Pharmaceuticals

News,Views & Analysis Worlds’ first HIV vaccine gets approval for human trial The US FDA has given a nod to carry human clinical trials for the worlds’ very first HIV, which would be based on genetically modified killed virus. SAV001, which has been developed by Korean pharma company Sumagen and University of Western Ontario, Canada, will proceed for the first phase of human clinical trails that is likely to involve 40 HIV patients. The vaccine has been developed by Dr Chil Yong Kam and his team from the University of Western Ontario. According to the team the molecule holds tremendous promise, as preliminary reports have demonstrated a strong response and thankfully without

any side aﬀects. Sumagen, which would be funding this research, has secured patent in 70 countries including India for the trial. So far no commercialised vaccine has been developed for HIV. The other HIV vaccines evaluated through human clinical

Enlight in pact with AstraZeneca and Novo Nordisk Enlight Biosciences LLC has recently announced that it has formed new partnerships with AstraZeneca and Novo Nordisk. As partners in Enlight, AstraZeneca and Novo Nordisk will have the opportunity to collaborate and invest in the development of potentially transformational technologies with application to their therapeutic programmes. Michelle Browner, CEO, Enlight, said, “One of the keys to the success of Enlight is the rich dialogue between our network of scientiﬁc and clinical experts together with our pharmaceutical partners.

We will greatly beneﬁt from contributions of AstraZeneca and Novo Nordisk to this excellent group of industry and academic leaders.” Menelas Pangalos, Executive Vice President - Innovative Medicines, AstraZeneca said, “This partnership reﬂects our commitment to accessing and fostering innovation that exists outside our labs.Enlight provides a unique opportunity for AstraZeneca and MedImmune, our biologics arm, to collaborate with our peers and contribute to the development of tools that will fundamentally enhance R&D across the industry.”

trials have focused on either one specific component of HIV as an antigen, genetic vaccine; using recombinant DNA stated the statement released by the University. The University believes that Kangs’ vaccine is unique as it uses a killed whole HIV-1, much like the killed whole virus vaccines for polio, influenza, rabies and hepatitis. Today, there are close to 33 million people in the world, infected with HIV aids. In South East Asia, the number is 4.1 million. Pharma companies have tried to develop many vaccines, but none have become successful, if Dr Chil and its team succeed, the world might soon get its first preventive HIV vaccine.

HCL replaces IBM to manage AstraZeneca’s data operations HCL Technologies has bagged a ﬁve-year data centre hosting and migration contract from UK-based AstraZeneca. As part of the deal, HCL will replace IBM to manage AstraZenecas’ entire data centre operations spread across 60 locations globally as per the International Data Group (IDG). AstraZeneca had selected Cognizant to deliver biostatistics and medical reporting services for clinical study reports and Wipro Technologies is also learnt to be in the race to bag a part of the contract for software development. In a statement to the Bombay Stock Exchange, R Srikrishna, Executive Vice President and Head for Global Infrastructure services, said, “This win is a testimony to HCL’s leadership in global infrastructure services market and its critical investments in developing next generation intellectual properties.” HCL would also deliver server virtualisation, storage and backup transformation and implementation of a hybrid cloud for the AstraZeneca, which makes cancer and cardiovascular drugs.

Pfizer’s initiative to prevent pneumococcal disease in infants and young children Pfizer Inc has entered into a second supply agreement, which will broaden and extend the duration of the company’s commitment to help protect infants and young children in the developing world from pneumococcal disease - the leading cause of vaccine-preventable death in young children. The agreements for supply of pneumococcal vaccines have been financed by GAVI, five donor countries - Italy, the United Kingdom, Canada, the Russian Federation, Norway - and the Bill and Melinda Gates Foundation. “Pfizer is proud to broaden and extend access to our vaccine to advance public health. Public-Private Partnership (PPP) programmes like

the AMC are vital to accelerate the availability of affordable vaccines to those children who are most vulnerable We are proud to help protect even more children at risk for the potentially devastating consequences of pneumococcal disease - which claims more young children’s lives than any other vaccine-preventable disease.” said Mark Swindell, President - Vaccines, Pfizer Inc. To meet the growing global demand for Prevenar 13, Pfizer is in the process of increasing its manufacturing capabilities through a combination of capital investment, process improvements and efficiency measures throughout its supply network.

Modern Pharmaceuticals I January 2012

News,Views & Analysis Goose launches Artwork Manager for pharma industry Hyderabad-based software company Goose has recently announced that it has introduced an Artwork Manager solution that has advanced proof-reading capabilities for the pharmaceutical packaging industry. This Artwork Manager would provide dedicated support to the packaging departments of the pharmaceutical industry to automate the

labelling and packaging artwork process without any errors and would also reduce product recall pain owing to faulty print, product mislabelling and manpower costs, according to the company. “The challenges of pharmaceutical artwork management are becoming more complex globally. With intense pressure on time to market and maintain

British pharma company’s bid to patent ginger foiled India has foiled an attempt by a British pharma company to claim a patent on using ginger for the treatment of cold. Nicholas John Larkins, London, ﬁled a patent application (GB2436063) titled ‘Pharmaceutical composition for the treatment of excess mucous production’ on March 16, 2006 at the British patent

office. The firm claimed a unique finding in the use of ginger and kutki (Picrorhiza kurroa) for the treatment of cough and lung diseases. Within two weeks of India providing evidence, the attempt to pirate India’s traditional medicinal knowledge was struck down by the UK patent office.

IDMA in its 51st year to engage with regulatory authorities for the development of pharma industry As the organisation enters its 51st year, IDMA has prioritised several issues of immediate concern to the industry for which it has initiated active dialogues with the government. These issues include that on bar-coding in pharma products, Chinese competition for the Active Pharmaceutical Ingredients (API) market, pharma pricing, allowance of 100 per cent FDI in pharma market, directing the competition council to all M&A proposals, revival of pharma industry in the state of Maharashtra, and ensuring easy passage of Indian generics to Japan.

“We would like the government to give serious consideration to providing ﬁnancial assistance to help companies, especially SMEs, to cover the extra investment and cost needs to comply with the requirements. These extra burdens include a 20 per cent productivity loss and increased monthly costs including ` 20,000 in additional registration expenses and ` 100,000 for bar-coding accessories such as inks,” said N R Munjal, President, IDMA.

consistent brand appeal, organisations are on the lookout for new ways to accelerate packaging processes,” said Deb Pattnaik, Founder and Chief Executive, Goose. The Artwork Manager by Goose is currently implemented in Dr Reddy’s Laboratories, Aurobindo Pharma, Elder Pharmaceuticals, Glenmark Pharmaceuticals, Strides Acrolab and other pharma companies.

‘SevenSeaS® Original’ all set to sail under Merck in India The Indian consumer healthcare division of Merck KGaA, the world’s oldest pharma and chemical company, is set to make a strong impact in the Indian nutritional supplement L-R: Ashish Bhatt; market with SevenSeaS® Raveena Tandon, Bollywood Original pure vitamin rich Actress cod liver oil; currently the leader in the vitamin segment in over 100 countries. SevenSeaS® Original is the purest form of cod liver oil; retaining all its natural nutrients, and one of the most trusted natural sources of vitamins A and D. Remarked Dr Marek Dziki, Managing Director, Merck Ltd, “It is a highly trusted brand with a rich heritage of over 75 years and is deeply entrenched in the memories of the Indian consumer for the past six decades.” “SevenSeaS® Original pure vitamin rich cod liver oil addresses this inadequacy in nutrition and helps in building immunity levels,” stated Ashish Bhatt, Business Head - Consumer Healthcare, Merck Ltd. What makes SevenSeaS® Original unique is its patented technology called Ocean Gold. This high-end method for extracting the purest form of cod liver oil ensures that none of the oil’s original nutrient values are lost in the extraction process. Every SevenSeaS® Original pack carries the Ocean Gold Ultra Pure™ mark of assurance.

-Chandreyee Bhaumik

Dr Reddy’s launches new formulations in India Dr Reddy’s Laboratories Ltd has recently added to its existing orthopaedic product portfolio in India with the launch of SupamoveTM cream. It helps reduce pain and inﬂammation in patients with joint pain, arthritis, bursitis, tendinitis and lower back pain. The product has been inlicensed from Cymbiotics Inc USA and

will be available in a 30 gm tube. Other brands of Dr Reddy’s in that segment include Supanac– Oral NSAID and Ruﬀy- injectable opiod. Dr Reddy’s also strengthened its emollients and protective product portfolio with the launch of Venusia® Soft lotion. It provides sustained relief

from dry, itchy skin and will complete Dr Reddy’s treatment basket in the emollient and protective space which already includes Venusia® Cream, Venusia® Lotion, Venusia® Max and Venusia® Bathing Bar. Venusia® Soft lotion is in-licensed from Cymbiotics Inc USA and will be available in a 75 ml pack.

Modern Pharmaceuticals I January 2012

News,Views & Analysis Clinigene International enters into collaborative clinical research services agreement

Clinigene International Ltd, a subsidiary of Biocon, India’s largest Biotech Company, and Paciﬁc Biomarkers Inc (PBI), a Seattle, WA-based limited liability company announce a collaborative agreement to

address the specialty biomarker and highend clinical trial laboratory needs of the global pharma and biotechnology industry. Clinigene is an India-based clinical research organisation that offers end-to-end clinical and laboratory services for accelerating clinical research, and Pacific Biomarkers Inc (PBI), is a Seattle, WA-based company that provides premier biomarker and specialty efficacy testing services to the drug development industry. “This partnership with Clinigene provides us access to India, an emerging hub for

drug development and contract research. Further, Clinigene’s state-of-the-art facilities and highly qualified staff help us offer to all of our clients an economic option to conduct their biomarker and specialty clinical lab tests. We are also excited about Clinigene’s unique capabilities in cell-based assays and immunoanalytical testing services, which are of great interest to the global pharmaceutical and biotechnology community,” said Ronald Helm, CEO, Pacific Biomarkers.

Stempeutics gets DCGI nod to move to Phase II clinical trials of CLI

Uson videoconferencing for custom pharmaceutical leak detection systems announced

Stempeutics Research, a group company of Manipal Education & Medical Group, has recently announced that the Drug Controller General of India (DCGI) has granted clearance of the company’s Investigational Medicinal Product ‘stempeucel’ for conducting Phase II clinical trials in patients with Critical Limb Ischemia (CLI) due to Buerger’s disease. This trial is non-randomised, open labeled, multicentric and dose ﬁnding study. Earlier Stempeutics has completed the Phase I part of the trial approved by DCGI. Based on the outcome of Phase I trial – DCGI has granted clearance of Phase II trial. ‘stempeucel’ product is developed from allogeneic mesenchymal stem cells derived from donated bone marrow using Stempeutics proprietary technology. Commenting on the Phase II trial approval, BN Manohar, CEO, Stempeutics Research, said, “Through Phase I trial we could establish the safety of ‘stempeucel’ product for CLI patients and through this Phase II trial we would like to establish the eﬃcacy and the optimum dose.”

Pharmaceutical processors and packagers seeking best match leak test solutions can now rely on Uson’s no-cost videoconferencing consultations to facilitate discussions and visual inspection of leak-proof vials, ampoules, packaging and other drug storage and delivery components for which the appropriate leak detection equipment and all other leak test speciﬁcations are required. Uson’s videoconferencing capability is especially designed for companies that either does not want the delay in time-to-market that shipping parts to outside facilities involves or in cases where release of a proprietary pharma product design is against company policy and non-disclosure requirements.

Joe Pustka, one of the top managers of Uson’s technical support team who helped pioneer the videoconferencing capability explains that details of part geometry, sealing locations, elasticity and other part characteristics are greatly facilitated by shared and simultaneous viewing of the parts for which a leak detection solution is sought. Pustka said, “Uson goes to great lengths to ensure that quality control engineers,responsible process engineers and the entire customer team impacted by the specifications of the leak detection equipment have a detailed understanding of various equipment and fixture options and how these will affect cycle times. These video consultations also speed up design of best-match leak detection solutions.”

Ranbaxy to market Daiichi Sankyo’s innovative products in Malaysia Daiichi Sankyo Company,Ltd and Ranbaxy Laboratories Ltd announced a synergistic initiative in Malaysia where Ranbaxy will market innovative products originally discovered by Daiichi Sankyo. Following Singapore, this is the companies’ second marketing synergy in the ASEAN region.

Joji Nakayama, President & CEO, Daiichi Sankyo, said, “Our previous collaboration, in Singapore, has already proved Ranbaxy’s marketing excellence in this strongly emerging region. We will continue to explore further initiatives with Ranbaxy to serve diversifying medical needs.”

Commenting on the development, Arun Sawhney, CEO & Managing Director, Ranbaxy, said, “Ranbaxy has been acknowledged as a premier branded generics company in Malaysia and is well known for its innovative marketing strategies and professional approach. I am conﬁdent that our Malaysian team will enhance the level of customer satisfaction through this synergy.”

Modern Pharmaceuticals I January 2012

News,Views & Analysis Zydus acquires 100 per cent stake in Mumbai-based Biochem

Mylan receives WHO approval for ‘Second-Line-in-a-Box’ HIV/AIDS treatment

Zydus Cadila has acquired 100 per cent stake in Biochem Pharmaceutical Industries Ltd, one of the top 40 pharma companies in India. A privately-held company headquartered in Mumbai, Biochem is a well-integrated pharma player with a presence in the antibiotics, cardiovascular, anti-diabetic and oncological segments. Biochem has reported sales of ` 264.5 crore for

Mylan Inc recently announced that its subsidiary Mylan Laboratories Ltd (formerly Matrix Laboratories Ltd) has received approval for three AntiRetroviral (ARV) therapies used to treat HIV/AIDS under the World Health Organization’s (WHO) Prequalification of Medicines Programme. The products include Atazanavir capsule, 300 mg; Ritonavir tablet, 100 mg (heat-stable); and Tenofovir Disoproxil Fumarate and Lamivudine tablet 300 mg/300 mg, or ‘Second-line-in-a-box’; fixed-dose combination Atazanavir Sulfate and Ritonavir tablets, 300 mg/100 mg; fixed-dose combination Abacavir Sulfate, Lamivudine and Zidovudine tablets, 300 mg/150 mg/300 mg. Heather Bresch, President, Mylan, said, “With these three approvals, Mylan will further enhance our portfolio of more convenient, more affordable treatment options for people in the developing world living with HIV/AIDS. In particular, we are proud to deliver on a previous commitment that we made through an announcement with President Bill Clinton on August 6, 2009 , to lower the price of secondline treatments for patients with drug-resistant HIV in developing countries.”

the year 2010-2011. Established in 1959, Biochem has proven strengths in manufacturing and marketing of antibiotics. The top ﬁve brands of the company are Ampilox, Biotax, Monotax, Amicin and Zithrocin which together contribute to 40 per cent of the company’s sales. The acquisition strengthens Zydus’ operations in the Indian pharma market. -Titash Roy Choudhury

Bristol Myers Squibb rated as ‘The Best Big Drug Company Of 2011’ by Forbes Bristol Myers Squibb (BMS) was ranked as ‘The Best Big Drug Company Of 2011’ in the latest issue of Forbes. The share price of the leading pharmaceutical company, which is listed in NYSE, increased 32 per cent to $35 over the course of the year. On this occasion, Pheroze Khan, Managing Director, BMS India,

said, “BMS is poised to become a major player in Indian pharma space despite being a new entrant to the country in 2004.” Lamberto Andreotti, CEO, BMS, has built on the strategy put in place by drug-and-medicaldevice industry veteran James Cornelius, who ran the company for four years starting in 2006.

January 2012 I Modern Pharmaceuticals

Technology & Innovation

Inkspot Science develops software for advancement in research

3M reveals advanced bio filters setting new flow rate

Inkspot Science has recently developed a new software for the pharmaceutical as well as the science companies, which would help them in data storage and analysis. The new web-based technology is believed to help in eﬀective research, where data will be translated into innovative products thereby bringing a growth in the economy. The Sunderland University of UK has adopted the new innovative technology by Inkspot Science to support its research in pharmacy, pharmaceutical sciences, biomedical sciences and drug design and development. Roz Anderson, Professor, Sunderland University, said Inkspot’s new system would help in their research and also engage further with stakeholders.

3M has recently launched a range of bioburden reduction filters combining the high filtration performance of membrane-type media with enhanced flow characteristics, enabling lower system costs and longer operating lifetimes. The new LifeASSURE PNA Filter Series from 3M’s Purification division can be used as pre-filters or final filters, where a high level of microbiological control is required. They are designed specifically for biotech, pharmaceutical and biological applications, such as production of vaccines, laboratory fluids, blood products, fine or bulk chemicals, and purified water. “The advanced technologies we have engineered into the new LifeASSURE PNA Filter Series will enable customers in the bioprocess, pharmaceutical and other sectors to reduce capital costs and operating overheads whilst simultaneously benefiting from improved microbiological control,” said Andrew Whitehouse, Sales and Marketing Manager, 3M Purification division. The filter assemblies are available with 3M’s Advanced Pleat Technology (APT) that maximises the useful surface area of the filter. In continuous operation mode the filters achieve longer service lifetimes, saving the costs associated with frequent filter changes.

Bio-Rad’s new Immun-Blot® LF PVDF membranes improve fluorescent blot detection Bio-Rad Laboratories, Inc recently announced the launch of its Immun-Blot LF (low fluorescence) PVDF membranes, protein blotting membranes that are optimised for fluorescent and multiplex fluorescent applications. The membranes offer high signal-to-background ratio, low autofluorescence, and superior protein retention to maximise blot detection sensitivity and enable downstream quantitation. These membranes are a low fluorescent alternative specifically designed for fluorescent immunoblotting and detection in the visible light (Red/Green/Blue) spectrum and produce highly sensitive and quantitative results due to superior signal-to-background ratios, which are higher than low fluorescence membrane solutions and are three times higher than nitrocellulose and conventional PVDF. There are two primary types of protein blotting membranes used in Western blotting applicationsNitrocellulose and PVDF (polyvinylidene fluoride). The key features of this technology are that has low autofluorescence and high signal-to-background ratio and produces a stronger signal, more accurate protein quantitation, and higher quality images. It allows researchers to visualise proteins at every stage of their blotting experiment detection methods.

Qiagen releases new sample preparation automation system Qiagen, a provider of sample and assay technologies has launched QIAensemble Decapper sample preparation automation system. The new system is said to facilitate the handling of liquid-based cytology and other types of liquid samples that are processed by clinical laboratories across the globe. According to the company, QIAensemble Decapper enables laboratories to automate many tedious manual steps required for unscrewing

(or decapping) the lids of clinical sample vials, extracting the sample material and pipetting it into testing vials and then recapping the clinical sample vial. In addition, the instrument will also help reduce the risk for injuries to laboratory staﬀ from repetitive motions,

while also eliminating the risk for variation among laboratory staﬀ and improving productivity. It is believed to improve laboratory workﬂow by providing an automated solution for transferring clinical samples from closed primary vials to compatible tubes for downstream processing.

Modern Pharmaceuticals I January 2012

Technology & Innovation Ambry Genetics launches Illumina MiSeq Next-Gen sequencing services Ambry Genetics, a global leader in clinical diagnostics and genomic services, announced that they have oﬃcially launched their Illumina MiSeq NextGen sequencing services. The Illumina MiSeq uses the reversibleterminator sequencing by synthesis chemistry as the HiSeq2000. Researchers have a wide range of sequencing read options ranging from 36 bp singleton to 150 bp paired-end reads. The system is capable of generating over 2 Gb data per

run with a high percentage of bases over Q30. The high data yield and superior quality allow scientists to conduct a

Tris Pharma announces US patent grant covering platform technology Tris Pharma, an emerging specialty pharma company, recently announced the US grant of its core technology patent for its OralXR+™ platform. This is the first patent grant of a substantial estate filed by Tris Pharma and covers a multitude of actives having modified release formulations comprising drug-ion exchange resin complexes. While the benefits of modified release are well understood, these benefits were largely limited to patients who can swallow traditional solid dosage forms. The OralXR+ technology bridges the gap for patients who have difficulty swallowing ‘pills’ and thereby helps to extend the market for modified release products. Tris is working with multiple pharma partners to develop products based on this patented technology in the areas of respiratory, pain, cardiovascular, Over-TheCounter (OTC) cough/cold and many others.

New software aids RNA cocktail against cancer With drug developers aiming to make cancer treatment more personalised, German researchers have implemented a software tool to spot genetic mutations for a program, which aims to bring individualised RNA therapies to combat tumors. According to the group reports the technology helped it concoct its first RNA drug cocktail for personalised cancer treatment The German researchers at TRON, the translational oncology group at the University Medical Center of the Johannes Gutenberg University Mainz, tapped Ingenuity’s software to pinpoint genetic variants in genomic data that are driving cancer progression. Their first RNA cocktail therapy, of course, is experimental and must be proven to be safe and effective in homing in on the misfit genes behind tumors. The Variant Analysis tool, which is available in a limited release, gives researchers the ability to search through data on millions of known variants with information on how those variants relate to disease pathways, genes and biological processes. The tool strives to help researchers overcome the challenge of deriving meaning from the troves of data from Next-generation Sequencing (NGS) experiments.

wide variety of sequencing applications including: highly multiplexed PCR amplicon sequencing, small genome sequencing and de novo sequencing, small RNA sequencing, targeted resequencing and 16S metagenomics. “Our scientists have spent the last few months validating sequencing runs and getting amazing results so we can deliver and work with multiple types of samples that ﬁt on the MiSeq,” said Ardy Arianpour, VPBusiness Development, Ambry Genetics.

Life Technologies’ latest DNA sequencer targets informatics ‘bottlenecks’ Life Technologies ($LIFE) announced its latest DNA sequencing machine based on the semiconductor tech that Life scooped up in its acquisition of Ion Torrent, saying that the bench top machine could read an entire genome in less than a day for $1,000—the target price that experts have said for years would take genomics to new heights. The maker also said the advanced machine, called the Ion Proton Sequencer, provides a tonic for IT headaches involved in analysing sequencing data. Illumina ($ILMN) responded with its own announcement today of its new HiSeq 2500 sequencing system, saying that the machine can sequence a genome in a day. “Just six months after our ﬁrst semiconductor sequencing chip was released, people used it to solve the German E. coli outbreak, sequencing the toxic strain in just a couple of hours,” said Dr Jonathan M Rothberg, Founder and CEO, Life Technologies’ Ion Torrent unit.

Modern Pharmaceuticals I January 2012

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

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

omeprazole magnesium and esomeprazole magnesium for operations in manufacturing processes. Areas of application Formulation industries Forms of transfer Consultancy

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

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

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

Filter cleaning system An Indian company offers an automatic

Technology Requested IV fluid manufacturing as SME An Indian company needs new and good technology to start manufacturing of IV fluids. Areas of application Medical technology Forms of transfer Technical services, others Disposable Syringes An Indian company is interested in cost-effective production line for disposable syringes for both ribbon and blister options.

Areas of application Medical industry Forms of transfer Others Biotechnology for wastewater treatment system A Thailand-based company, a wastewater service provider, is involved in the R&D of new technology for water, wastewater and waste treatment. It requires new ideas related to technology for developing its strength in the field of wastewater; which includes cleaning canals,

removing sediments from waterways, biogas, microbiology detector. Areas of application Biotechnology, engineering Forms of transfer Consultancy Calcium gluconate An Indian company requires the technology to manufacture calcium gluconate. Areas of application Pharmaceutical industry Forms of transfer Technical services, project reports, others

Information courtesy: Dr Krishnan S Raghavan, In-Charge, Technology Transfer Services Group, United Nations - Asian and Pacific Centre for Transfer of Technology (APCTT), APCTT Building , C-2, Qutab Institutional Area, New Delhi 110 016, Tel: 011 - 2696 6509, Fax: 011 - 2685 6274, Email: krishnan@apctt.org, Website: www.apctt.org, For more information on technology offers and requests, please log on to www.technology4sme.net and register with your contact details. This is a free of cost platform provided by APCTT for facilitating interaction between buyers and seekers of technologies across the globe. After submitting technology offer or request to this website, you are requested to wait for at least two weeks for receiving a response from a prospective buyer / seeker through this website, before contacting APCTT for further assistance.

Share and Solicit Technology The mission of Modern Pharmaceuticals is to spread the technology culture. Here is an opportunity to be a part of this endeavour by sending your technology on offer or technology requirements. If you belong to any of these two categories, you are invited to furnish the techno-commercial details for publication. The write-up needs to be as per the format of this section with information about the particular technology offered or requested, its areas of application and forms of transfer. Contact us: Modern Pharmaceuticals, Infomedia 18 Ltd, â&#x20AC;&#x2DC;Aâ&#x20AC;&#x2122; Wing, Ruby House, J K Sawant Marg, Dadar (W), Mumbai 400 028. Tel: 022-3024 5000, 3003 4695 Fax: 022-3003 4499 Email: spedit@infomedia18.in

Modern Pharmaceuticals I January 2012

In Conversation With: K V Venugopalan

“I follow the 4D principle, which is Do, Dump, Delegate, Delay” …says K V Venugopalan, President, Waters India Pvt Ltd. He has been associated with the company since 1983 and has presided from 1997. An Electronics Engineer with an MBA degree in Marketing, he has led Waters to become the largest analytical company in India. He reveals his 4D strategy at work and his dream of making Waters a $ 500-million company by 2020. Excerpts. Jasleen Kaur Batra

Photo: Srivatsa Shandilya

Modern Pharmaceuticals I January 2012

K V Venugopalan Elaborate on the pharmaceutical segment of Waters. Waters addresses various application segments in the industry such as food, environmental, clinical, chemicals, plastics, pharmaceuticals, among others. Out of these various verticals that we provide services to, the pharmaceuticals sector forms the major part of our business and globally accounts to approximately 60 per cent and more than 70 per cent of our business in India is generated from the pharma industry. In order to meet the standards of quality laid by various regulatory agencies and authorities around the world one should have a system that meets these requirements and only Waters provides such products and services.

What are the things that have changed over the years for the sector? The pharmaceutical industry in India has gone through diﬀerent phases. In the 80s there were a number of MNCs manufacturing products according to the domestic requirement; during this phase there were barely any Indian companies that were visible. During the 90s, the Indian pharmaceutical sector did witness a few big companies emerging but the actual development started taking place from 1995 when India signed the Intellectual Property Rights (IPR) agreement with WTO and had 10 years time to follow the IPR regime. It was in these 10 years that a lot of investment was made in areas like R&D for new product development, ANDA, etc that lifted the Indian pharmaceutical industry. Before 2000, in the list of top 10 pharmaceutical companies one could barely see one or two Indian companies but today one can ﬁnd a minimum of six or more companies topping the list in India. In the coming three years almost $150 billion patented drugs would expire giving a great opportunity to the Indian market to grow and capture the national as well as international market.

How will you compare the Indian and the US market? In terms of volume, US continues to be

January 2012 I Modern Pharmaceuticals

the single largest manufacturer and is dominated by MNCs. Indian pharma companies take time to adapt themselves to new technology because they have to keep in mind the stringent regulatory standards. The Indian companies so far have been producing generic drugs and so they have to follow the techniques and methodology originally used by the innovator of the drug using technologies prevalent at that point in time which is 10 – 15 years back. One of the biggest plus points of the Indian pharma industry is their ability to manufacture high quality drugs at an aﬀordable cost. If we look at the Western countries a number of pharmaceutical companies are closing down their operations in the UK, US, etc, and are setting up their plants in India. The reason for this being India is well equipped and has the expertise and manpower to manufacture the same quality product but at the fraction of the cost.

Why did you choose to enter the field of analytical instruments? Waters has been the pioneer and leader in the ﬁeld of chromatography and mass spectrometry for the past 50 years. Since pharma industry requires highly precise and accurate equipment for research and quality control applications Waters was the ideal choice and that gave us a leading position in the market. Being niche instruments the quantity required worldwide for both HPLC and mass spectrometry are in thousands and not a mass produced instruments, there are not many players in these segments in the world. Also due to high investment cost for manufacturing as well as product design, the entry barrier for high technology instruments are high.

Quick Pick Enjoys reading spiritual books Enjoys classical music Is interested in writing and maintains a blog up on the projects they are working on, the progress of the projects, etc. The third thing is to work on the long term plans of the company and plan new strategies to innovate and provide better services to all our stakeholders.

What are the changes that you have made in the company, which you are proud of? I have been the President of Waters from 1997 and obviously a lot has changed since then. A few changes I have lived through and a few I have brought in the company. I started my journey with this company as an engineer and at that time I did not have many resources for learning the product or technology or for reference. However, today the scenario has changed; the engineers have advanced tools and technology. Another interesting change has been with training; the amount of training we give to our engineers is unique and not usually provided by many other companies. Employees are the most important resource for any organisation and we invest constantly in employee development and progress. Transparency while dealing with employees and customers is another important cultural change we have implemented in Waters that has paid rich dividends to us all these years.

What is your dream for Waters? What are the three things you do everyday in office? The ﬁrst thing I do is answer all my mails; I will go to the next mail only after action has been taken on the one that I am reading based on the 4D principle, which is ‘Do, Dump, Delegate, Delay’. The second thing I do is to speak to the managers of every department and follow

Being a part of an organisation for 26 years, gets you attached to the company. I want Waters to achieve at least a 20 per cent growth every year so that by 2020 we become a $500-million company. Today, we are close to $100 million and I have full faith and conﬁdence that this dream is achievable. (jasleen.batra@infomedia18.in)

Single-use pharma Special technology Focus

Lab/Analytical instruments Mass spectrometers Increased R&D boosting demand ........................................................... 34 Texture analysers Tracing the shift from food to pharma ..................................................... 36 Interface Dr Ganapathy Ramakrishnan President, Chromatographic Society of India ................................................ 38 Interface Gregory J Herrema Senior Vice President, ThermoFisher ScientiďŹ c and President, Analytical Instruments Group ..................................................... 40 Roundtable Is it safe to use already used lab/analytical equipment? ............................. 42

January 2012 I Modern Pharmaceuticals

Special Focus: Mass spectrometers

Increased R&D boosting demand Mass spectrometry is the leading technology for the characterisation of molecules. In effect, it helps in determining the molecular weight of the compound. Read on to find out more about this technology.

Chandreyee Bhaumik

ass spectrometry is a highly sophisticated instrumentation technique that has emerged as the premier method for the analytical deﬁnition of biomolecules. In order to measure the characteristics of individual molecules, a Mass Spectrometer (MS) converts them to ions so that they can be moved about and manipulated by external electric and magnetic ﬁelds. In 1912, Sir J J Thomson invented the technique of mass spectrometry; however, it was introduced for molecular weight determinations only during the 1950s.

Thus, with time, the diversity of operations performed by MS widened. Commenting on the advantages of the MS, K Subbi Reddy, Regional Director, Pharmaceutical Export Promotion Council (Pharmexcil), set up by Ministry of Commerce, Government of India, says, “MS helps in estimating elements like carbon and oxygen in a substance.”

Looking back The commercialisation of MS started with the single magnetic sector instruments. As time progressed came the double focussing electrostatic MS that were so large and those interfaced with Gas Chromatographs (GC) gave the required results to investigators.

But, for several years the MS could not keep up with the speed of the capillary GCs and Quadruple MS became suited for this combined technique. The later form of MS excels at applications where particular ions of interest are being studied because they can stay tuned on a single ion for extended periods of time. These instruments often make good multi-purpose instruments. With the availability of computers this gradually strengthened. With time the decrease in the cost of quadruple instruments resulted in market explosion of MS in 1970s. During the 1980s because of import restrictions the completion of the buying process of MS took at least 1-2 years. Today, there are several quadruple and ion trap MS used in various laboratories in India. These instruments are in constant usage in the pharma industry. Further, MS are involved in water analysis, petroleum and petrochemical, pesticide residue analysis in food, in educational and research institutes and many others. Another important area of primary growth with respect to MS is HPLC. Various LC-MS interfaces were tried, but the most successful one was Atmospheric Pressure Ionization (API/electrospray). This technique also allowed the use of volatile and non-volatile buﬀers in the HPLC methods. Another technique that gained prominence is the Time of Flight Mass Spectrometry (TOFMS). In its initial years it was not so popular, and one of the limitations was the computer usage. However, in the mid 90s this technique gradually started to gain importance. This technique emerged especially when the matrix assisted laser desorption ionization as a special introduction system to the TOF MS were made available. Dr Ganapathy Ramakrishnan, President, Chromatographic Society of India, says, “Before MS, elemental analysers were in use. These would determine the carbon, hydrogen content in the substance and eventually the molecular formulae were derived. This was extremely diﬃcult and exhaustive.”

Quality, the watchdog The quality issues may diﬀer in areas such as design dependability of the parts used, ruggedness, sensitivity, automation,

Modern Pharmaceuticals I January 2012

Mass spectrometers

MS instruments are essential for research purposes. These instruments are used as reference equipment. The regulatory bodies will emphasise more on the technicalities of MS. K Subbi Reddy Regional Director, Pharmexcil software, etc. Elaborating on the quality issues, Dr Ramakrishnan avers, “The instrument should not allow anyone to tamper with the settings while it is taking some measurement and any change made in any of the parameters should be captured by the software of the instrument and reported. There should also be online diagnostics available and if the defect can be fixed by the software it will be most welcome.” Further, continuing with the discussion on the quality issues of the equipment, Dr Ramakrishnan adds that the software should be regulatory compliant in such a way that one should not be able to make any manipulation in the set parameters of the instrument once the instrument is started and there should not be any possibility of making any manipulations in the results. Elaborating on the average cost of the MS, Dr Ramakrishnan says, “The cost of an MS depends upon the configuration of the instrument. An average GCMS will cost from ` 25 lakh onwards. A LCMS will cost from ` 50 lakh onwards and a LCMSMS will cost ` 70 lakh onwards.” He adds that some of the vendors for GCMS are Agilent Technologies, Broker, Thermo Scientific, Perkin Elmer, Shimadzu, and many others. And some of the vendors of LCMSMS are Agilent Technologies, Applied Biosystems, Shimadzu, Waters and Thermo Scientific.

Required skill set Today, most of the operations of analytical instruments are all software based and automated to a large extent. Thus, it is not the educational qualiﬁcation that is a must for operating these instruments. It is the combination of the interest and skills that is

January 2012 I Modern Pharmaceuticals

In order to understand the method, development of various instrumental analyses, and comprehensive understanding of chemistry of the compounds to be analysed will be useful. Dr Ganapathy Ramakrishnan President, Chromatographic Society of India

required for understanding and operating such instruments. Commenting on the importance of education and the skill set required for operating these equipment, Dr Ramakrishnan clariﬁes, “In order to understand the method, development of various instrumental analyses, a good and comprehensive understanding of chemistry of the compounds to be analysed will be useful. This will help in understanding the functional groups present in the compounds, the polarity of the mobile phase in chromatography, column selection, etc.” Continuing in the same vein, Dr Ramakrishnan adds that especially in the area of bioanalysis, the stability and metabolism of the molecule is very important and crucial to be understood. He emphasises, “In the interpretation of the data obtained, it is important to have good and sound knowledge of the structure and properties of the substance being analysed. As far as the complexity of the analysis and interpretation is concerned, the course work done during BSc, MSc, PhD will be very helpful.” Dr Ramakrishnan opines, “On the job training is an absolute requirement. As of now PhD course has the opportunity of hands-on training depending upon the institute.” However, having said that, he also mentions that there is nothing equivalent to the relevant working experience and guidance one can get from the experts in the respective ﬁelds.

The following years The future of MS in India looks interesting. The primary growth drivers of this industry are the pharma and biotech industries; especially the CRO segment.

Other areas that will be witnessing the growth of MS are proteomics research in national research centres, research departments in universities and many others. Since MS is more universal in nature as compared to any other GC or LC detector, there will be more focus on MS. Reddy says, “MS instruments are essential for research purposes. In R&D department these instruments are used as reference equipment. And the regulatory bodies will emphasise more on the technicalities of MS Dr Ramakrishnan says, “One of the areas where a lot of time and money are spent is the area of sample preparation. More options for sample extraction, puriﬁcation and preparation especially online are required so that a lot of time and money can be saved in the total cycle time taken for each analysis by using MS. Manufacturers of instruments also should take into consideration the time lost and inconvenience caused due to unexpected breakdown of the instruments.” He adds that to avoid break downs better reliable electronics and technology in controlling leakages of gases and liquids should be used. He continues, “R&D must also be directed in order to reduce the footprint of the instruments, their transportability, ease of installation and maintenance. By footprint one refers to the amount of area occupied by these equipment. Initially, an MS would occupy the full room but now it can be placed on a small table. By taking advantage of the latest materials research, the components can be made more sturdy and reliable and deﬁnitely more economical. ” (chandreyee.bhaumik@infomedia18.in)

Special Focus: Texture analysers

Tracing the shift from food to pharma Although initially developed for the food industry, texture analysers have gradually proved their presence in the pharma industry. Today, the pile of benefits is on a gradual rise. Read on to know more…

texture analysis has grown considerably into cosmetics, packaging, personal care products and medical devices. Instruments feature a range of attachments that are ﬁtted to the machine in order to perform various tests on diﬀerent products. Some of the various physical properties that can be analysed using these analysers are absorption, swelling, adhesion, tackiness, etc.

Entry into pharma space

Chandreyee Bhaumik

exture analysis was originally developed for the food industry as manufacturers required a sophisticated and improved method of assessment for their products. The deﬁnition of texture and man’s perception of texture required more than just human

sensory test panel, and as a result the food industry invested heavily into instrumental texture analysis. The science behind texture analysis has been under investigation in academia for more than 50 years. Texture analysers are testing instruments for measuring the textural and physical characteristics of pharma products and pharma packaging. With time, the scope of

The pharmaceutical need for sophisticated product testing for R&D, production and quality control, has arisen a requirement for the industry to adopt texture analysis using specially designed attachments and software programs in order to analyse the quality of raw materials, semi-finished, final product and packaging. Elaborating on the prevalence and significance of texture analysis in the pharma industry, Dr Ajit Dangi, President & CEO, Danssen Consulting, avers, “Use of texture analysers has been an established technique for several decades and originated in the food industry to assess the textural properties such as hardness, elasticity, viscosity, mouth feel, thixotropy, etc.” Today, pharma industry routinely uses sophisticated and automated instruments for measuring rheological properties of powders and granules, viscosity of suspensions, gels, creams, etc. Continuing in that strain he opines, “Previously these tests were carried out by experienced individuals using subjective methods. But as science advanced, more precise and accurate measurements became necessary, particularly in the pharma industry, in order to maintain product consistency and shelf life of product during transportation.” Seconding the above thought, Shruti Pande, Clinical Research Associate, International Clinical Research, Wockhardt Ltd, says, “As the nature of a pharma product varies (from tablet, capsule, ointment to any other form) the danger associated with them also differs. Therefore, it is required to change the packaging material accordingly. Texture analysers help in the designing of the packaging material and prevents loss from the predicted danger.” The flexibility of texture analysis in the pharma industry has widened considerably.

Modern Pharmaceuticals I January 2012

Texture analysers While many of these instruments are imported and thereby expensive, investment in such techniques can reduce cost of non-conformance due to recalls, rework, etc and above all increase customer satisfaction. Dr Ajit Dangi President & CEO, Danssen Consulting

For a long time there had been continuous efforts to develop and enhance the quality control measures that will help to analyse and refine the product stability. In this context texture analysis equipment have played a significant role. These offer repeatable, scientific quantification of material robustness and the results of which can identify product weaknesses.Commenting on the technicalities of texture analysers, Dr Dangi opines, “Texture analysers use a hemispherical probe that simulates the force applied by the fingers to extract the tablet from the blister pack thereby providing an objective measurement. Many of these instruments are provided with software so that data can be recorded and a trend analysis can be generated.” Since product texture is often related to sensory perception, its accurate measurement helps in customer appeal, and thus it has become an integral part of product quality. Further, discussing the advantages, he says, “Texture analysis plays an important role particularly in Over-The-Counter (OTC) products as customers perceive good textural characteristics synonymous with good quality.” He adds that a new development called Multivariate Wavelet Texture Analysis (MWTA) is now being used for tablet cores, wet granules and control release tablets. He reiterates, “MWTA helps in understanding the manufacturing process and gives accurate prediction of final product performance such as tablet dissolution.” Emphasising on the advantages of texture analysis, Dr Dangi says, “Analysers are also useful in studying the characteristics of Novel Drug Delivery Systems (NDDS) such as measuring skin adhesion of transdermal patches, dose release pattern of metered dose devices used in asthma, rhinitis, etc.”

January 2012 I Modern Pharmaceuticals

As the nature of a pharma product varies the danger associated with them also differs. Texture analysers help in the designing of the packaging material and prevents loss from the predicted danger. Shruti Pande Clinical Research Associate, International Clinical Research, Wockhardt Ltd

Keeping the pace Traditional tests have enabled the analysis of parameters such as tablet hardness, gel strength and many such factors. However, with time as the demands and expectations continue to change upgradation is not only required but mandatory. While these tests continue to provide valuable data, texture analysis experts are now required and expected to respond to the rapid innovation within the pharma industry, since new delivery and encapsulation formats are introduced. Therefore, with these the scope and capabilities of testing instruments have widened significantly. One of the latest developments in testing is the capsule tensile rig. Available in high or low tolerance variants, this rig accurately measures the force displacement required to compress powders into tablets. Using exponent software, the powder compaction rig produces precise measurements that enable pharma product manufacturers to produce powder compacts with consistent porosity. It accurately assesses the force needed for the punch to travel a specified distance, or can be used in target force mode to assess the effect of fill level on tablet thickness. Further, there are sophisticated methods for powder characterisation, which along with analysis techniques for hardness and coating adhesion, have enabled manufacturers to obtain valuable data on the stability of standard tablet formats. But, with time the development of bi-layer tablet formats containing isolated immediate and controlled release component layers has lead to new analytical requirements. Such formulations are gaining popularity as they provide efficacy for consumers

and they are also easy for production for the manufacturers.

Cost factor While discussing the advantages of equipment it has been an age old practice to assess the possibility of the cost incurred. And it has been more than one occasion when the heavy cost burden has restricted the introduction of the equipment. But one should be aiming at the long term advantages instead of restricting it to immediate benefits. Discussing the cost aspect of the equipment, Pande avers, “Texture analysers assume a big role in the large manufacturing units. Opting for these equipment is definitely a costeffective choice. It might sound expensive initially but looking at the larger scenario it is definitely beneficial.” Justifying the cost of the equipment, Dr Dangi says, “While many of the texture analysis instruments are imported and thereby expensive, investment in such techniques can reduce cost of non-conformance due to recalls, rework, withdrawals etc and above all increase customer satisfaction.” Giving an estimation of the cost, he continues, “Cost of texture analysers can vary from few lakh of rupees to several lakh depending on the degree of sophistication involved.” He signs off saying, “While selecting a supplier for these analysers, apart from cost, attention should be given to technical support and training available , future up gradation, compliance with Food and Drug Administration (FDA) guidelines if any (eg US FDA 21CFR PART 11 for electronic data recording ), easy availability of accessories and spares and efficient after sales service.” (chandreyee.bhaumik@infomedia18.in)

Special Focus: Interface - Dr Ganapathy Ramakrishnan

“The growth in the analytical industry has opened up a large market for employment of technical staff in various industries ” ...says Dr Ganapathy Ramakrishnan, President, Chromatographic Society of India. He discusses the development of analytical equipment industry and his decision to work in this segment. Chandreyee Bhaumik What prompted you to choose this segment of the industry? As I was doing my PhD in the area of natural products, it was necessary for me to use chromatographic techniques for the isolation and purification of chemical constituents in plants and use various spectroscopic techniques for their structural elucidation. These techniques played a significant role during my post doctoral research in the US, where I had an opportunity to operate high field and the high resolution Mass Spectrometers (MS). This enticed me further in learning about analytical instruments. After coming back to India in the early 80s, I observed that there was a void in the field of technical marketing of sophisticated analytical instruments especially high field Nuclear Magnetic Resonance (NMR) and high resolution MS. The importance of these instruments in research was increasing, which prompted me to get into the marketing of analytical instruments rather than continuing my research in the chemical industry. Further, it was also my belief that by marketing instruments such as NMR and MS, I will be able to interact with scientists doing research in various disciplines, which will provide me an opportunity to learn about diverse topics of research and the application of various chromatography and spectroscopy techniques. Oft-noticed trends I have observed that with time, there are stringent demands coming from the regulatory bodies; customers are demanding better sensitivity, better productivity, ease of use and better price in the pharma industry. Thus, in order to cater to these demands, there is a need

analysts will be challenged to upgrade their knowledge of instrumentation and interpretation of results. This will lead to faster discovery of active molecules to address various illnesses in the coming years.

for reliable electronics, reduction in size of the instruments, better performance and pricing. Further, these demands have also raised the bar for the level of knowledge of chemists in the laboratory in understanding the analytical methods and the operation of the instruments. The growth in the analytical industry has opened up a large market for employment of technical staﬀ in various industries. How have these trends been changing in the recent times? The above trends will continue especially in the areas of automation and laboratory networking that helps in the management of laboratory equipment, their operation and the data generated. The use of hyphenated techniques such as GC-MS-MS, LC-MS-MS, hybrid MS, ICP-MS, etc will ﬁnd wider applications and new MS techniques such as Orbitrap and its combination with Linear Traps and Quadrupole analysers will push the envelope of research in pharma, bio pharma proteomics, etc, and thus the

What are the areas in lab and analytical equipment that need to be improved? What is the future of this segment? It is important that one understands the needs one has regarding the analytical requirements and select a suitable instrument with the necessary accessories. For example, if a particular analysis could be done either by Gas Chromatography (GC) or HighPerformance Liquid Chromatography (HPLC), it is important to find out which will be better in terms of quality of result, cost, ease of use, etc. The instruments should be periodically serviced and maintained in good condition so that accurate results are obtained consistently. From the vendor side, they must provide end-to-end product solutions. It is definitely not a good idea to go for a piece meal arrangement by going to a few vendors in order to build a good instrument configuration. The analytical industry is going through more consolidation and that will lead to less number of companies competing in the market place. This should not lead to fewer investments in the design of new products or the extinction of some of the existing products. The analytical industry is still in an exciting period of its development and with the demands for tougher regulations for analysis, I am sure that the development and competition will continue. (chandreyee.bhaumik@infomedia18.in)

Modern Pharmaceuticals I January 2012

Special Focus: Interface - Gregory J Herrema process, bringing us closer to a world of personalised medicine. In addition, proteomic research, which characterises the complex metabolic pathways of proteins, is aiding pharmaceutical companies to identify targets for which a new chemical entity can mediate. How does ThermoFisher Scientific respond to the above in terms of solutions? ThermoFisher Scientific (TFS) has always been a pioneer in introducing innovative technologies to help our customers in solving critical analytical and scientific challenges. Keeping the trend we have recently launched a new High Resolution Accurate Mass Spectrometer (HRMS) bench-top system based on our patented Orbitrap technology. This is a unique and affordable system for ‘Quanfirmation – Confirmation and Quantification’ called QExactive. With this new technology we not only address the needs of pharmaceutical customers for advanced DMPK research but also support our high-end ‘OMICS’ research customer with the hybrid version of the new technology. This new technology is quite popular globally and the Indian industries are investing in these high-end technologies for advanced research in drug discovery and life science.

“We are fully committed to growing our presence in India” ...avers Gregory J Herrema, Senior Vice President, ThermoFisher Scientific and President, Analytical Instruments Group. An alumnus of Harvard Business School, he also serves as Chairman of the Analytical and Life Science Systems Association. He was in India recently to commemorate over 30 years of ThermoFisher Scientific’s association with the country. Excerpts of the conversation… Manas R Bastia Tell us about the recent global mega trends impacting the analytical instruments, especially for the pharma industry. The global trend in analytical instrumentation like all others has been faster, better and cheaper. To help scientists expand their horizons of research, analytical instruments have now become more sensitive, speciﬁc and fast. The pharma industry has its challenges

in terms of both analysis and regulatory compliance. Although chromatography technique is widely used, the demands for complete characterisation and lower levels of detection will see increased use of sophisticated spectroscopy instruments in research and quality control. Increasing investments in large molecule drugs will make work ﬂow solutions more popular. The use of genomic and proteomic data continues to impact the drug discovery

What are the top three focus areas of your Group at present? Our focus has always been customers and our efforts have always been in developing technologies that support our customers to solve their toughest analytical challenges. If I need to point top three focus areas, the first and foremost would be bringing the new technologies at an affordable cost to ensure our customers use these technologies. Second would be to ensure that we provide focussed after-sales service to each and every customer across the globe. For the same, we have decided to launch a new brand called ‘Unity Lab Services’. Third would be increasing our technical resources and improving our application support to our customers. How do you plan to position yourself for chromatography application areas? To support our customers in the Asia Pacific region to develop new analytical

Modern Pharmaceuticals I January 2012

Gregory J Herrema methods, we have recently established a new Chromatography Center of Excellence at Ahmedabad. This facility is equipped with state-of-the-art infrastructure and instrumentation. We aim to work closely with customers within the Asia region to develop rugged and economical methods for difficult molecules. What are the important challenges faced by your Group globally? The current global economical trends put pressure on the organisations to continue to develop new technologies and still be profitable. Global slowdown of pharma and academic research stunts the growth and pushes the companies to be more creative for being profitable. How do you plan to improve on the delivery time for spare parts? We work on optimising inventory tools to keep up the inventories of spares. We also follow a continual process improvement tool called ‘Practical Process Improvement’ (PPI). With this we ensure that we identify and remove

January 2012 I Modern Pharmaceuticals

roadblocks and develop a robust process for customer satisfaction. We have also invested in a 70,000-sq ft warehouse in India, with a specially dedicated area for spares so that our turnaround time for the same is improved. How do you ascertain an industry trend? Which are the emerging verticals globally that you consider to have greater prospects for your Group’s products and services? We constantly track the changing scenarios and environmental factors aﬀecting our customers & their markets. We also look for customers’ feedbacks as strong indicators of change in trends. I would say that life science research, pharmaceuticals, food safety, environment and renewable energy would remain strong in the near future. What are the three key focus areas for you in driving the growth strategies of TFS? We believe that our growth in Asia will contribute signiﬁcantly towards the overall growth for TFS. The top three focus areas for

us in Asia would be innovation in technology, application and technical support, and faster response times in services. What are the future plans for your Group’s expansion in Asia Pacific, and in particular for India? We are focussed on growth in Asia Pacific region and will continue to invest here. India has emerged as one of the most important countries demonstrating continuous growth and a healthy business environment. Most of our global customers have set up their base in India and some of them have even located their global R&D activities here. India has a rich pool of scientific talent and a rich history of technical education and research. Many of our Indian customers are also trying to achieve global scale and compliance by spreading their presence across the US and Europe. We are committed to enable our customers to make this world healthier, cleaner and safer by offering world-class technology and services. We are fully committed to growing our presence in India. (manas@infomedia18.in)

Special Focus: Roundtable

Is it safe to use already used lab/analytical equipment? Opinions differ on the decision to reuse laboratory or analytical equipment. The main concern is whether it is safe and are the results provided accurate? Experts discuss both the sides of the coin. Chandreyee Bhaumik

Dr Ajaykumar Sharma Practice Head-Pharma, Healthcare, South Asia Middle East, Frost & Sullivan In practicality there is no strict protocol, which states that reusing of laboratory and analytical equipment is prohibited. In fact, it entirely depends on the type of equipment that we are dealing with. In most of the cases, after due sterilisation, the equipment can be put to efficient usage. Further, it is noticed that if the laboratory or the analytical equipment is in proper working condition then it can easily be put to use again. In most of the cases the equipment are not utilised to its maximum usage on the first go. Any equipment should be put to optimum usage, even if it means reusing the equipment. Therefore, whether the laboratory or the analytical equipment can be used again completely depends on the condition of the instrument that is concerned. Usually, there is no serious issue regarding the efficacy or the safety of the instrument.

S Thyagarajan President, Indian Analytical Instruments Association

Dr Sameer Upadeo Country Manager, Malvern-Aimil Instruments

Today, laboratories in India depend on the latest instrumentation in order to compete globally. With this impending competition and the pressure to raise the bottom line of their respective business, scientists work overtime under tremendous pressure so that they can complete their respective work and thus quite naturally expect 24x7 functioning of the instruments that they are using. With this situation as the backdrop, there may not be market in India for refurbished or pre-owned instruments and equipment. It is important to consider that non-availability of original spares, lack of trained man power to provide the much-needed tech-support, absence of upgradation options and deﬁciency of warranty will make the concerned market untenable in Indian scenario. Therefore, keeping all the above conditions in mind, it should be determined whether the equipment can be used or not.

I believe that there is hardly any company that uses already used laboratory equipment. As far as the safety and accuracy of these equipment are concerned, it totally depends on what type of equipment is to be used. For a company to reuse an equipment, they have to be assured of the support services. The company buying the equipment should be assured of the existing quality. It must be remembered as long as the life cycle of the equipment is not over the equipment can be used and there are no issues. However, as far as the particle size and particle characterisation market is concerned, buying second hand equipment is not a common occurrence. These equipment basically do not have any resale value. In India, there is a tendency to use the equipment more than its lifecycle and hence it does not have any high value monetarily. Thus, most of the companies rely on using new equipment for their needs.

Editorial take

It is the working condition of the equipment that determines whether it can be used again. With most industries in India utilising the products for the maximum lifecycle, refurbished equipment does not hold a high resale value. However, with assurances of services and quality the same can be considered.

Modern Pharmaceuticals I January 2012

new business opportunities invites you to

17 - 20 Feb 2012 CUT HERE

Invitation

AURANGABAD Garware Stadium, Chikkalthana Business Visitors: 10 am to 3 pm General Visitors: 3 pm to 7 pm

Engineering Expo organised by Infomedia18 is one of the engineering industryâ&#x20AC;&#x2122;s biggest events in country. The 2010-11 edition of Engineering Expo saw business transactions worth over Rs. 161 crores. Launched in Ahmedabad in the year 2002, the event today boasts of a fabulous visitor turnout. The Expo is a preferred destination for SMEâ&#x20AC;&#x2122;s and manufacturing & engineering companies to transact, network, tie-up and exchange ideas for the growth of the industry.

TV Partner

Online Media Partners

CUT HERE

Supported By

For Further Details, Call Varsha + 91 98195 52270 Or Email engexpo@infomedia18.in

Facility Visit: J K Industries Pvt Ltd

Leveraging on the exports market J K Industries Pvt Ltd - a manufacturer and exporter of machines and process equipment for pharmaceutical, chemical, cosmetics, food and distillery industries has come a long way since inception. After visiting its plant at Gandhinagar, Gujarat, we explore not only how the company benefits from exports but also how it continously innovates. Parita Dholakia hile riding on the Gujarat-Mehasana highway, the building of J K Industries Pvt Ltd is hard to miss. Set in the major industrial area of Gujarat, Kalol, the company has come far since inception in the 1970s and has four plants set up in the area.

Thereafter, a similar plant was started in Kalol, the present building, in 1984. Initially, J K Industries Pvt Ltd was involved in fabrication of all types of pharma equipment. Eventually, it moved onto making special and on-demand pharma equipment. Today, all the four plants are divided according to the type of equipment being manufactured.

The inception

Pride factors

The company was known as Kamal Pharma Equipment Pvt Ltd in 1972, the year of its establishment, and was set up in erstwhile Bombay. It has introduced a wide range of machinery and has served a large segment of industries. The company was established by Jayantibhai Panchal.

At J K Industries, scientific sophistication and experience come together with flexibility, responsiveness and innovation. It provides pharmaceutical equipment manufacturing services and the manufacturing along with the final product conform to various quality norms and GMP requirements.

Its services are characterised by a core commitment to meeting the customer’s objectives with the highest quality while maintaining the most efficient use of time and controlling costs. The young team applies its extensive experience in developing creative solutions for the customer’s unique challenges. Throughout the project, it works to advance and optimise the end product through scientific and customised approaches. J K Industries has a highly trained staff, detailed scheduling processes, and a broad array of equipment, to ensure that the undertaken project is successfully completed with quality and on time.

Manufacturing meets quality Considering that the exports in the company generates around 85-90 per cent of the company’s total production, it regularly pays host to several international customers. Generally, customers visit the plant to check out the facilities provided or the type of work that is carried out. They then specify their demands and requirements based on which a sketch of the desired equipment is made by their expert consultants. These sketches are then

Photo: Vijay Soneji

Modern Pharmaceuticals I January 2012

J K Industries Pvt Ltd sent for approval, post which a prototype machine is manufactured. Changes, if any, are incorporated and the final manufacturing is started. “Many a times, we have third party inspections for quality. Clients pay consulting firms to ensure quality adherence. Audits are conducted regularly in the premises. We follow FDA and GMP norms,” informs Pramod Panchal, Director – Sales and Maketing, J K Industries Pvt Ltd. In this fast-paced world, with everchanging norms the company tries to keep itself abreast with the latest developments by keeping in touch with fellow manufacturers. It is also a member of the Indian Pharma Machinery Manufacturers Association (IPMMA), attends the regular meetings held and events related to pharma manufacturing. “It is essential to keep ourselves up-to-dated. More than local threat, international competition is stiff,” says Panchal. According to him, the biggest competitors for the Indian manufacturing are China for the low cost factor and Germany for the optimum quality work they provide.

Vision The shop floor is already filled with equipment of all types – fulfilling almost all requirements of a pharma company. “We look forward to provide complete

We are providing a wide spectrum of equipment to companies. All needs and demands are taken care of by our experts. Hence, at this stage we will continue doing so. Pramod Panchal Director – Sales and Maketing

solutions to pharma companies. Currently, what we do not manufacture includes a few machines such as the dry heat stabiliser or the cartoning machine. In the near future, we shall be manufacturing all of these,” believes Panchal. Situated in Gujarat and being involved with the pharma sector, he also believes that the company is at the right place at the right time. “We are happy with the subsidies the government provides. A few months ago, some RBI norms had created problems for export to Iran, but eventually it was settled,” informs Panchal. “We are providing a wide spectrum of equipment to companies. All needs and demands are taken care of by our experts. Hence, at this stage we will continue doing so. Also, a pharma company dealing with liquid and oral formulations may be on the cards next,” he informs.

J K Industries takes great pride in supporting pharmaceutical companies at every step of the of the drug development process, and with no wrong reasons whatsoever. (parita.dholakia@infomedia18.in)

Liquid manufacturing tanks

Equipment manufactured at diﬀerent facilities Facility No.

Equipment covered

Details

Filter press

Sparkler ﬁlter press, zero hold up ﬁlter press, vertical plate & frame type

Process equipment

Reactors, heat exchangers, storage vessels & tanks

Powder blending and drying

Fluidised bed dryer, rapid mixer granulator, double cone blender, V-shape blender, mass mixer, sifter, octagonal blender, ribbon blender, tray dryer

Ointment and liquid/ oral manufacturing

Liquid/oral manufacturing plant, ointment, cream, toothpaste manufacturing plant

Automated bottling machine

Washing machine, liquid ﬁlling machine, sealing machine, labelling machine, turn table, inspector table, packaging conveyor belt

Fabrication of stainless steel

Machining of stainless steel rod January 2012 I Modern Pharmaceuticals

Insight & Outlook

Quality issues Good Clinical Practices Driving the clinical research industry ...................................................... 52 Software in clinical research Will it replace human power? .................................................................. 54 Interface Dr Kiran Marthak Global Head - Clinical Development and Board Member, Lambda Therapeutic Research Ltd .................................... 56 Roundtable Is quality an issue with the Indian pharma sector? .......................................... 58

January 2012 I Modern Pharmaceuticals

Insight & Outlook: Good Clinical Practices

Driving the clinical research industry The clinical research outsourcing market is expected to grow at a CAGR of 17 per cent during 2009-2015, according to a report by ASSOCHAM. And the Indian GCP is going to further propel this growth, if followed and adhered to judiciously.

K V Subramaniam, President and CEO, Reliance Life Sciences. According to Dr Shubhangi Desai, Associate Vice President – Clinical Operations (India & Malaysia), Siro Clinpharm,“India has made signiﬁcant advances in clinical research and currently the country has a good infrastructure set up of investigators, sites and patient pool.” With the establishment of numerous CROs, adherence to quality assumes high importance and for the same India introduced Good Clinical Practices (GCP) in 2005. “The number of sites conducting GCP trials has increased signiﬁcantly and many have gained experience of regulatory inspections. There are many positive changes in regulatory framework and guidelines. The health authority has established GCP guidelines for compensation for research participants and is initiating steps for EC and CRO registration. Post 2005, Indian regulatory authority amended Schedule Y and permitted concurrent global trials and also became signatory to GATT, ie Patent Protection Act. Many CROs saw this as a big opportunity as MNCs would like to conduct concurrent global clinical trials and also conduct trials for marketing the products,” says Dr Desai. This set of guidelines has laid down a framework for complying with high quality for clinical practices in India and we need to explore how GCP is being followed currently and what are the possible changes required.

Clinical research and quality

Titash Roy Choudhury

ver the last decade India has become a hub for clinical trials and has seen signiﬁcant growth in the clinical research market. Since there is growing demand for clinical research we have seen mushrooming of clinical research organisations in India in the recent past. “The industry is in a growing

phase as India has been recognised as an attractive destination for conducting clinical trials. For this reason, specialised organisations providing contract services have mushroomed in India, just as they have in other members of the BRIC nation. A few of these are full-service providers, some are niche players such as IT solution companies, central laboratories, warehouses or site management organisations. There has also been signiﬁcant activity in the M&A space among Indian CROs,” says

This field is at an advanced stage in India as Indian firms have participated in various technical domains and have been recognised for the quality of data they generate in clinical trials. “Clinical research is carried out in a regulated manner in India. The country continues to be a key participant in global clinical trials. Large pharmaceutical companies are focusing on BRIC nations for cost-effective clinical research that delivers results as per international quality standards,” comments Subramaniam. Indian GCP is written keeping India in context and it has evolved from guidelines of WHO, International Conference on Harmonisation (ICH), US FDA and

Modern Pharmaceuticals I January 2012

Good Clinical Practices

Large pharma companies are focusing on BRIC nations for cost-effective clinical research that delivers results as per international quality standards. K V Subramaniam President & CEO, Reliance Life Sciences

European GCP guidelines as well as the Ethical Guidelines for Biomedical Research on Human Subjects issued by the Indian Council of Medical Research and it is one document which gives direction to all companies planning to conduct clinical research in India. “Indian GCP is based largely on ICH-GCP. Eﬀorts are being made to customise Indian GCP in key areas such as compensation to subjects and safety reporting. This shows that the industry and regulators are actively involved in evolving a set of guidelines that works for all,” says Subramaniam. And these guidelines will help ensuring the quality of clinical research, which is the marker for any clinical research market. “Quality could be a potential issue with CROs as the demand increases. However, all serious players understand that they cannot disregard quality in their race to secure contracts. The market tends to have a moderating eﬀect on the industry; CROs that perform to stated quality and customer satisfaction benchmarks tend to have better stability and market share,” comments Subramaniam. To maintain quality of clinical research, adherence to GCP is not only preferable but should be actively pursued.

Adherence to GCP and loopholes Just setting up guidelines is not suﬃcient, the question that arises is, are CROs following the guidelines and ensuring the quality according to the set norms. GCP is a scientiﬁc and ethical quality standard that is applied to clinical research. “It lends itself to both theoretical and practical aspects of clinical research. It is designed to

January 2012 I Modern Pharmaceuticals

India has made signiﬁcant advances in clinical research and currently the country has a good infrastructure set up of investigators, sites and patient pool. Dr Shubhangi Desai Associate Vice President – Clinical Operations (India & Malaysia), Siro Clinpharm

facilitate use of consistent methodology in generating, monitoring and reporting clinical trial data, to ensure that the data is credible, accurate and reproducible. It is oriented to meet the demands of not just Indian CROs but all stakeholders in clinical trials,” says Subramaniam. “All the good and ethical CROs follow GCP practices religiously. Indian GCP is a part of Schedule Y and hence is a part of law and needs to be

Since the concerned authorities do give the industry an opportunity to comment on all guidelines when they are in the draft mode, all the loopholes are covered during that initial checking period.

strictly followed, failing which it can be punishable,” says Dr Desai. Quality is an ongoing continuous endeavour of all stakeholders. “In India the DCGI oﬃce is carrying out frequent inspections of CROs to ensure compliance with GCP. Results of these inspections have been made public,” says Subramaniam. “Along with monitoring the CROs the Indian GCP has been designed keeping trials being run in India and strict adherence to the same has led to improvement in ongoing research,” comments Dr Desai.

When it comes to any loopholes, the industry stalwarts fail to point out any. “Indian GCP is quite in line with ICHGCP, it has areas which are stricter than ICH-GCP. It all depends on adherence and compliance,” says Dr Desai, while Subramaniam thinks that Indian GCP is probably more prescriptive in areas of ethics committee composition and functioning, timelines for serious adverse event reporting and process of regulatory review of clinical trial applications than ICH-GCP. “All clinical trials that have been conducted as per local regulations have also been compliant to ICH-GCP and applicable laws. That is, there do not seem to be irresolvable contradictions between Indian GCP and any of the other internationally accepted guidelines/ regulations that pertain to clinical research,” says Subramaniam. In spite of pointing out loopholes or scope for improvement, the industry believes that the guidelines are eﬀective if strict adherence and compliance is done. Since the concerned authorities do give the industry an opportunity to comment on all guidelines when they are in the draft mode, all the loopholes are covered during that initial checking period. As far as Indian GCP goes, they have been laid out keeping Indian clinical trials in mind and the guidelines are strict and full-proof in maintaining the quality of the various CROs. While the market forces are driving most of the CROs to comply with Indian GCP. Hence, keeping the current scenario in perspective the Indian clinical research industry as predicted will experience unhindered growth and progress. (titash.choudhury@infomedia18.in)

Insight & Outlook: Software in clinical research

Will it replace human power? With India’s CRO segment expected to be a billion dollar market by 2015, according to a Frost & Sullivan report, market penetration will increase manifold in India, but so does the concerns over quality. Software in this sector have spread far and wide, but human involvement still forms the backbone of quality assurance in this field. Titash Roy Choudhury

linical practices in the pharma market include various processes like drug discovery, clinical trials, manufacturing, among others. India today is booming with the mushrooming of clinical research organisations and is undertaking extensive clinical research work for international companies. With an increased ﬂow of clinical research, quality becomes a concern in that scenario, and quality maintenance not only during clinical trials but also for presentation of data. “Quality in clinical research is a broad term encompassing

generation, documentation and reporting of all data generated during a clinical trial,” says Sidharth Handa, Associate Director – Clinical Data Management, Clinical Research, GVK Biosciences. In the process of maintaining quality we see the use of manual workforce as well as various software, thus the question arises that with the help of software is it possible to maintain or probably enhance the quality of clinical research. For coming to that conclusion a detailed knowledge of the software that come into play is essential.

Software at work Drug development has various stages and for each stage there are diﬀerent software

that aid the process. The first component of a clinical trial is the operations team performing clinical and medical monitoring services. This team uses several software that administers, tracks and ensures quality of activity performed. “These software are commonly referred to as Clinical Trial Management Systems or CTMS, which bring in the critical project management and quality control aspects. These software define the scope of the entire clinical trial in sequential pieces of information, which is continuously checked for errors automatically and designed to flag issues /attract attention,” informs Handa. The next phase of the clinical trial sees a Clinical Data Management Group which databases the entire clinical trial data. This group uses a Clinical Data Management System or CDMS, which helps maintain the integrity of the data. “These systems are designed based on regulatory guidelines and are highly customisable to ensure the quality of data produced. They maintain an audit trail to track every instance of data change to ensure quality of data that goes for final analysis. CDMS also offers electronic/remote data capture feature, which cuts down on data handling and entry time, and provides more quality to the data being used for analysis,” Handa further adds. Then for training of the personnel, Learning Management System (LMS) ensures that all the personnel are adequately trained to perform their respective functions in a clinical trial, which is a typical example of quality management software. “Quality management software is an automated system that connects all business lines of a clinical research organisation into a single system. Such a system can connect each phase of a product’s lifecycle with each business line. This gives an opportunity to everyone to provide their feedback. These software are usually loaded with features like automated routing (with escalation), ensuring rapid responses incase inputs are needed by bringing quality checks at each stage,” informs Handa. CTMS,CDMS,document management systems, project management systems, learning management systems, etc are

Modern Pharmaceuticals I January 2012

Software in clinical research

The financial component plays a major role in usage of software as most of these software come highly priced and require year-on-year charges to maintain, upgrade and support. Sidharth Handa Associate Director – Clinical Data Management, Clinical Research, GVK Biosciences different tools used by the clinical research industry. According to Handa these software allow pharmaceutical companies to speed up the entire drug development process and cut the timelines in half from lead identification to regulatory submission thus bringing in efficiency and quality control at every stage of research.

Does software enhance quality? “Software used in the clinical research industry are designed based on regulatory guidelines and are highly customisable to ensure Good Clinical Practices (GCP) are followed,” says Handa. But Dr Arun Bhatt, President, ClinInvent Research, opines, “Software help in enhancing the eﬃciency of clinical research but at the end of the day the data is entered into the computer by humans, and till now no software has been designed to reduce human errors. At the end, quality rests on human labour more than software.” He further adds that, “In documentation some software have come up that stores data electronically, but apart from that all other software that are used for clinical data are dependent on human labour for entering the data.” While Handa comments that, “These software are validated prior to their usage to ensure they function the way they are designed and to ensure compliance with GCP and other regulatory requirements and guidelines, and helps CROs in maintaining quality.” Dr Bhatt emphasises on the training aspect and gives stress on how meticulous training will result in better quality of clinical research than implementation of more

January 2012 I Modern Pharmaceuticals

Software are there to increase the efﬁciency but when it comes to assuring higher quality of clinical research it is human power that counts. Dr Arun Bhatt President, ClinInvent Research

software. When it comes to achieving high quality for clinical research training becomes the utmost important factor. He says, “Training should be imparted immaculately and eﬃciently to reduce human errors. Training forms an integral part of maintenance and assurance of high quality of clinical research and training not only of people working in CROs but of doctors and investigators too who provide the data. Software are there to increase the eﬃciency but when it comes to assuring higher quality of clinical research it is human power that

Other factors such as phase, size and location of the trial also dictate usage of systems, as Internet connectivity plays a big role in usage of these software.

counts.” Thus, although software are increasing the eﬃciency of human work and assisting in bringing about higher quality of clinical research, training is still the aspect that requires more attention as better trained professionals will directly impact the quality of research.

Indian scenario in the global context From a software perspective, the global clinical research industry is no diﬀerent

from that of India as the same guidelines and principles dictate the industry. Regulatory guidelines laid down by FDA, MHRA, DCGI, etc are all on the same lines, and require identical level of ethics and clinical research techniques. Software usage in India is dependent on a number of factors namely financial, phase of clinical trial, size of the clinical trial and location. All these factors come together to finalise what kind of a software a company utilises to render trial services. “The financial component plays a major role in usage of software as most of these software come highly priced and require year-onyear charges to maintain, upgrade and support. Major IT companies, who have forayed in the allied services arena of clinical research, ie clinical data management, biostatistics, medical writing, deploy well known and reliable software to execute their business, while small players at times compromise on the quality of software being used,” says Handa. Other factors such as phase, size and location of the trial also dictate usage of systems, as Internet connectivity plays a big role in usage of these software. Many clinical trial sites are remotely located in villages and as such necessitate the use of paper. For appropriate implementation of software in Indian CROs, various factors have to be taken into consideration and finance is a major factor. With the growth of Indian economy we may see more usage of software among the CROs and more dependence on software than human participation. (titash.choudhury@infomedia18.in)

Insight & Outlook: Interface - Dr Kiran Marthak

“The clinical research industry in the country has progressed tremendously and has undergone a massive metamorphosis” ...says Dr Kiran Marthak, Global Head-Clinical Development and Board Member – Lambda Therapeutic Research Ltd. Before starting his career in clinical research, Dr Marthak cleared his medicine with specialisation in chest diseases. But instead of starting his own private practice he followed his instincts and joined Novratis as Medical Advisor. Here are his takes on the past, present and future of the Indian CRO industry. Titash Roy Choudhury How has the clinical research segment evolved since you have joined this industry? When I started my career in clinical research it was in a primitive stage with very few people actually understanding it. I was one of the lucky ones who were sent for training to UK and Switzerland to learn about the various aspects of clinical research, along with being a part of an organisation called the Association of Medical Advisors to Pharmaceutical Industries (AMAPI) where for four years I organised various seminars and symposia for exchange of knowledge. This further widened my expertise and knowledge about the ﬁeld. We also trained prospective investigators about how to conduct clinical trials, documentation, investigations and to some extent we also had good exchange with the Regulatory Body in India. Your activities over the years have not been restricted to clinical research, eg, you have got innovative changes like CRFs. What made you undertake such multi-faceted role? If one wishes to progress he/she has to move as per the market needs and develop the skills accordingly. During earlier days there was no demarcation between the work of a Clinical Research Associate (CRA), medical monitor, QC, QA, biostatistician, report writer, etc. We used to do everything right from protocol designing to report writing, even following up to get permissions from the regulatory authorities.

As we progressed, I started with the e-case record forms (CRFs), data entry, and in one of the organisation we started with scanning of CRFs from abroad doing data entry here taking advantage of the time diﬀerence, data management, report writing, evolving central lab concept for safety, etc. We also helped the regulatory agencies to upgrade their knowledge and to bring them to the international standards. Then I initiated the clinical study-BE/BA for US-FDA submissions in India, which earlier the pharma companies were carrying out in USA. This saved good amount of foreign exchange of the country. I also started the clinical trials for US FDA submissions. Clinical trials can be conducted economically, with good quality and also by saving the time. It became a successful idea for the upgradation of the clinical research industry in India.

How has the industry evolved over the years and what are the major changes that have taken place in this sector? The clinical research industry in the country has progressed tremendously and has undergone a massive metamorphosis. There are now clinical research organisations who can do all the work for you as per the International standards. There are audits taking place from various regulatory bodies, investigators are well trained, there are dedicated employees, good infrastructure including laptops, note pads, patient diaries, mobile phones, e-CRFs, centralised safety labs and centralised imaging labs, training institutes in clinical research, etc. One of the important aspects is the increase in awareness about clinical trails among patients who know their rights and the ethics committees are geared up to evaluate the complicated molecules and the protocols. Media has become more aware about this field while a number of conferences organised in the country are propagating both education as well as business development. Do you believe that there are enough regulatory guidelines to monitor the mushrooming of CROs in India today? The regulatory guidelines need to evolve as the clinical research science and industry is expanding. They are trying to do their best but there are certain drawbacks like lack of technically qualified and dedicated staff who would concentrate on one specific application or action in the whole clinical research procedure. Besides, the technical staff needs to perform all tasks like

Modern Pharmaceuticals I January 2012

Dr Kiran Marthak working on applications like Investigational New Drug (IND), taking part in generic manufacturing and marketing, granting of test license, export/ import permissions for the drugs, samples, etc. The Drugs Controller General of India has created centralised registry of all the clinical trials (except bio availability (BA)/bio equivalence (BE) studies) and the audits of CROs and clinical trial sites have already started. The registration of ethics committee is already on pipeline. These all factors indicate that they have good intentions but due to lack of knowledgeable, technical staﬀ the timelines are suﬀering to some extent.

How would you forecast the growth potential of this sector in India? I see a good future for the clinical research industry. However, every important organisation needs contribution, and the following mentioned changes can be brought about: Regulatory agency: Has to have trained knowledgeable staff, improve the efficiency in granting ‘No-ObjectionsCertificates’ for the clinical trials, place checks and balances in place, make strict but practical rules, allow first-in-man study for the molecules from abroad since that will benefit the outsourcing of early phase clinical research in India. Currently in India, for the locally discovered molecules testing on humans for the first time is allowed but for foreign molecules only phase II or phase III trials on human is allowed. So allowing first–in-man study of molecules from abroad will further propel the growth of the outsourcing market of clinical research CROs: Should conduct the clinical trials as per the law of the country, adhere to ICH-GCP guidelines and conduct the study as per international standards, more open with the investigators and patients Pharma/Biotech companies: All above as per CROs but also to insist on quality data, audit checks at every point, train the investigators on ICH-GCP guidelines, utilise accredited central labs for safety evaluation, for imaging and for ECGs. Ethics committees: Constitution as per ICH-GCP guidelines, regular meetings, keep patient’s safety as the major criteria for approval of the protocols, regular follow up of the on-going studies Investigators: Trained in their respective field and in ICH-GCP guidelines, keep safety of subjects in mind, consult CRO/ companies if they find anything unusual in efficacy and safety, keep up the enthusiasm in clinical research India can become a leader in clinical research industry if everyone plays their respective role in a proper manner keeping in mind quality, quality and quality in every aspect of this science. (titash.choudhury@infomedia18.in)

January 2012 I Modern Pharmaceuticals

Insight & Outlook: Roundtable

Is quality an issue with the Indian pharma sector? The domestic pharma market has grown to nearly $ 11 billion/annum and total turnover has grown to nearly $ 18 billion. Along with increased sales and production, quality is an aspect that should not be overlooked. Adherence to appropriate quality measures is mandatory. Industry experts express their views on whether quality is an issue with the present pharma market in India. Titash Roy Choudhury

Dr Amit Rangnekar General Manager, Centaur Pharmaceuticals

Ganadhish Kamat VP- Corporate Quality Assurance, Lupin Ltd

Quality issues have plagued several Indian generic-drug majors exporting to the US in the recent past, which have had a signiďŹ cant impact on the earnings visibility of such pharma companies. Hence, they would only sharpen the learning curve for India to emerge as a quality-driven pharma hub. India, with the highest number of USFDA-inspected plants, has arrived on the global quality scene, and its growing share of the generic, API and clinical trials space is vindication of its quality standards and credibility. In the domestic market, the amendments to Schedule M to ensure compliance with GMP will help India upgrade the quality of its pharmaceutical manufacturing standards. India has the lowest prices in the world for quality medicines, which is a sustainable advantage.

Our industry understands the importance of quality, ensures that products manufactured meet global standards and we continue to take the necessary steps to ascertain that all requisite compliance is in order. For many Indian pharma companies, important business comes from global quarters. This, matched with a stringent global regulatory framework, has made it imperative for manufacturers to ensure that facilities, production techniques and quality systems comply with high standards and with international quality benchmarks. The regulatory environment will only get more stringent with a greater emphasis on quality standards in manufacturing and research â&#x20AC;&#x201C; the companies that are able to maintain and comply with the new regime will emerge winners.

Dr Ravi Sobti Pharmaceutical Professional Indian pharma companies exporting generics to the regulated markets of USA and Western European companies need to comply with the quality standards as documented by International Conference on Harmonisation (ICH). The problem of compliance arises from most of midsize or small pharmaceutical companies who either lack an in-depth knowledge of quality or lack resources to comply with the quality systems. In some of the mid-size and small pharmaceutical companies involved in the loan-license arrangement or contract manufacturing for leading pharma companies, non-compliance has been observed in various areas. Hence, severe repercussions are felt on domestic front as well as exports. The issues of counterfeit drugs, substandard and expired drugs, are major quality issues that need to be addressed.

Editorial take

Quality certainly is an important aspect of the pharma industry that companies should focus on and adhere to; but does not seem a major issue for the Indian pharma market. After a few cases of non-compliance by major pharma companies, the industry seems to have learnt its lesson.

Modern Pharmaceuticals I January 2012

Automation Trends: Case study - Pharma manufacturing

Magic made simple: From development to production With many products, dispersing and homogenising are the first steps of production. But since many substances display a different behaviour during production than in the laboratory test phase, the transition from the lab to actual production can be very critical. Here’s how one machine can make this transition easier.

system that can handle dispersing and homogenising tasks for development as well as production: IKA®’s magic LAB® describes this practically magical formula. However, this is not a production machine on a large scale, but rather a small laboratory device. With it, one can not only test mixtures, but, due to many, constant work parameters, said compositions can also be carried over with a secure scale-up to large systems.

Procedure principle always the same – Modules are adapted IKA®’s magic LAB® oﬀers a variety of techniques for mixing and crushing.

Several different modules assure that one can work with batch processes as well as inline processes. The magic LAB® offers unchanged work methods from composition development all the way to large-scale production. Work is done based on the rotor-statorprinciple of an inline dispersing machine. The product to be processed is fed centrally from the top and, from there, runs through the shearing zone. Depending on the type of tools, one to three mixing tools are used. After the product has run through the many shearing zones, it is radially discharged at the bottom end of the machine. The tools’ geometry is maintained with all sizes. Even the circumferential speed of 23 m/s stays steady. For micro-plant configurations, amounts of 200 millilitre can be dispersed. As an inline device, the IKA® magic LAB® enables flow capacities of up to 120 litre per hour. The magic LAB® and the continuative dispersing devices of IKA®’s 2000 series have a lot in common. They are both constructed

the same way; they have the same circumferential speed and tool geometry. By way of seven diﬀerent sizes, IKA® technology assures a seamless scale-up from the lab to industrial production, which oﬀers numerous advantages; the raw materials used in pharmaceuticals, cosmetics or the food industry, are often very expensive. Due to the use of small amounts of sample materials during dry runs, an enormous cost reduction is made possible. Furthermore, the problems, that often arise when carrying over production methods from batch- to inline processes, are prevented by the scale-up option.

Seven modules for any particular mixing job The spectrum of usage options ranges from the production of foods like ketchup to the production of cosmetics to the processing of polymers. Therefore, by means of the usage of several different modules, the magic LAB® can be optimised for each individual operation. When simple stirring and mixing is not enough, the module ULTRA TURRAX® (UTL) comes to the rescue. The mixing effect of the single-level ULTRA TURRAX® relies on the dispersing principle. Due to varyingly fine-toothed generators and varying circumferential

Modern Pharmaceuticals I January 2012

Pharma manufacturing speeds, the machine can adapt to any particular dispersing task. Due to its flexibility and adaptability to the products that are to be mixed, the DISPAX REACTOR® (DR) is the allrounder when it comes to a smooth distribution with narrow distribution spectra. Optimal emulsion and suspension homogenity and stability are the result. Wet and fine grinding of hard and grainy raw materials and the production of fine emulsions and pastes are made possible by the modules colloid mill (MK) and conical mill (MKO). The colloid mill consists of two cones, which are equipped with grinding channels at their surface. The cones can be shifted against each other up to a minimum distance, whereby the flow rate and friction change. By adjusting the refiner gap, the particle size can be varied. The conical mill works based on the same principle as the colloid mill. The cones, however, are equipped with an abrasion-proof, raw and fine-pored surface in their outlet. Thus, a larger friction surface is created, which makes it possible for even finer suspensions to be produced in the event of a reduced flow rate. The discontinuous module CMS, used for powder entry, takes over the batch-by-batch mixing of solids and liquids. A dust- and lump-free entry of the material is therefore ensured. The CMS works in a re-circulation process in which the existing liquid is fortified with powder. Due to the re-circulation of the liquid, a low pressure is generated, which enables the independent suctioning of powders without additional dosage sys-tems. Also suited for the mixing of solid and liquid substances is the patented module powder entry system MHD.

Suitable for development of process cycles But the magic LAB® can be used for more than just your typical dispersing tasks. The magic LAB® is a full-ﬂedged production unit, as a micro plant as well

January 2012 I Modern Pharmaceuticals

as an inline device. It oﬀers an enormous ﬂexibility for the calculation of operating parameters for an extensive scaleup. Compositions can be developed and processes can be determined. At the same time, users determine process parameters like the rotation speed, shearing frequency, temperature, pressure, time or energy. The magic LAB® is also suitable for standard beaker glass preparation. Here, the device stands upside down and is equipped with the module ULTRA TURRAX® UTC. This enables batches of up to two litre.

In pharmaceuticals, testing on a small scale with eventual production using machines and the same procedural principle can result in high savings.

Ready to use in just a few steps The magic LAB® is equipped with an operational and information centre and can therefore be operated fully self-sufficiently. With only a few hand movements and adjustments, the magic LAB® is ready to use. It can even be controlled from a PC with IKA®’s lab software, LabWorldSoft®. Thus, the magic LAB® is controllable via a remote control, registers all important process data, and can carry out comparable experiments. Furthermore, it can recall stored, predefined pro-cedures. As the minor space requirement enables a lot of flexibility with the set-up location, the device is delivered in a transport box. The individual modules lie in drawers with pre-formed inserts. This saves time with searching and eases the quick assembly and converting. The drive mechanism itself is integrated into the side of the case. At the

backside of the box, the electrical plug connections for the magic LAB® and also for the electrical power supply can be found.

Magnificent even on a small scale Particularly in pharmaceuticals, testing on a small scale with eventual production using machines and the same procedural principle can result in high savings Salves, pastes or suspensions for the production of vaccines, penicillin emulsions or antibiotics in oil are only a few examples from this product line-up. With established methods, batches in labs have so far been produced in a beaker glass with batch dispersing devices. However, during up-scaling, the problem often arose that the product’s mixing results, which were tested with a batch dispersing device in a beaker glass, did not show the same consistency when carried over to a continuous work method. Particularly when it comes to emulsions, surprises often arise, as, for example, emulsifiers require a certain activation time in order to work properly. When they are not pre-mixed during one of the two phases but rather added as a concentrate with a separate pump directly into the disperser, different product characteristics are often the result. Cautious users therefore prevent all scale-up issues when using the magic LAB®, as it has the same design, generates the same circumferential speed, and possesses the same tool geometry as its IKA® counterparts. Therefore, the results are absolutely identical, from testing to production. IKA® production ma-chines fulfill all the essential guidelines of the pharma industry, EHEDG and FDA, for example. The user’s investment security is therefore assured even on a small scale. (marketing@ika.com)

Martin Künstl Corporate Manager Pilot Plants, IKA®-Werke GmbH & Co KG

Energy Management: HVAC processes

stitch in

time saves

nine!

Energy is not an expense to live with but definitely an asset to manage. Effective strategies for monitoring, measuring and managing energy within pharma manufacturing facilities are a must. Chandreyee Bhaumik

ccording to a recent report by the Lawrence Berkeley National Laboratory (Berkley Laboratory), pharma companies in the US spend approximately $1 billion each year on energy in their manufacturing facilities. With passing time, energy conservation for drug manufacturers is gradually becoming more signiﬁcant. With greenhouse gas regulations various companies are trying to reduce their energy usage and the resulting emissions while remaining competitive.

Understanding energy saving When it comes to energy saving, energy management is the process of monitoring, controlling and conserving energy in a

building or organisation. Typically this involves the following steps: Metering the energy consumption and collecting the data Finding opportunities to save energy, and estimating how much energy each opportunity could save. One would typically analyse the meter data to find and quantify routine energy waste, and one might also investigate the energy savings that one could make by replacing equipment (eg lighting) or by upgrading your building’s insulation Taking action to target the opportunities to save energy (ie tackling the routine waste and replacing or upgrading the inefficient equipment) Tracking the progress by analysing your meter data to see how well energy-saving efforts have worked

The significance To remain competitive in the marketplace, pharma manufacturers must set and achieve energy objectives for usage, along with the constant focus on minimising operational costs. By leveraging existing automation and power-system assets, manufacturers can better measure and monitor energy consumption by individual loads, machines and lines. Next, the visualisation of the data achieved will facilitate better management and, ultimately, improve automation of production processes for optimal energy consumption across the enterprise or the company. Commenting on the importance of energy management, Dr H G Koshia, Commissioner, Food & Drugs Control Administration, avers, “The energy consumption of any process or operation is in diﬀerent forms such as steam (fuel), electric energy or combination of both by direct or indirect application for heating, cooling, chilling or motion and drives.” Processes that consume the largest energy for pharma manufacturers are Heating, Ventilation and Air

Modern Pharmaceuticals I January 2012

HVAC processes

Technology selection-design decides the energy consumption, but the techniques of operation and maintenance control often helps to reduce the energy and thereby offer savings. Dr H G Koshia Commissioner, Food & Drugs Control Administration Conditioning (HVAC) systems for R&D and manufacturing operations. Thus, there should be strategic energy management initiatives that most of the companies have been neglecting since a long time. This is primarily because accurately defined information on where, when and how much energy is being consumed and should be consumed was not clear to them. But with Internet, seminars, conferences, energy management campaigns on energy consumption several concepts pertaining to energy management are gradually getting clarity. This information is at the core of a successful and effective energymanagement campaign. While many companies are involved in collecting and profiling energy data, some of these methods may involve timeconsuming manual processes. Thus, the companies should conduct energy audits that would track all types of consumption from electricity to water, steam, air and gas. The audit information gathered will then help companies to identify a wide range of changes that they can make to reduce their consumption and thereby improve their bottom lines. Compressed air is one of the least energy-efficient applications in any drug manufacturing plant. By reducing line pressure to the minimum pounds per square inch (psi) required by nonoperating devices energy management can be achieved. Further, pharma companies should install power monitors so that usage data can be collected continuously. And this can be measured against the standards that were identified during the audit process. with this information the manufacturers are in a position to find the latent energy cost and as a result identify opportunities for significant cost

reductions through direct energy savings or via compliance with government directives. Power monitors also can help identify ‘energy events,’ such as when a line is running out of speciﬁcation, helping maintenance engineers catch problems faster and reduce the amount of energy wasted.

Believing in conservation The design of energy using equipment plays a critical role in the energy costs, and limitations of design are difficult to overcome by administrative and operative measures, subsequently. Emphasising the importance of design in energy management, Dr Koshia avers, “The process and equipment when designed should consider the appropriate source of energy, ie gas, fuel, solar energy, etc, and the application of such energy source to the equipment is an appropriate manner.” He says that the selection of equipment such as boilers, chillers, motors connected to equipment, etc play vital role in energy management of operating units. He adds, “Technology selection-design decides the energy consumption, but the techniques of operation and maintenance control often helps to reduce the energy and thereby offer savings.” A technique refers to operating style and training to the operators. Dr Koshia clarifies the above point by citing an example. He elaborates, “It is similar to the way we see different drivers driving the same vehicle and ending up spending differently on fuel and maintenance. The same concept is applicable to every operating technique for process or operation.”

Why planning matters? Further, the production planning also

plays significant role in reduction of energy wastes by way of reducing change over time. Dr Koshia says, “The well planned Production Planning and Inventory Control (PPIC) or what is referred to as Supply Chain Management (SCM) facilitates the efficient utilisation of man, machine and materials.” He adds, “Controlling activities with a view to minimise stoppages, breakdowns and effective preventive maintenance and progressive strategy of identifying the components for replacement and up gradation by modern gadgets and tools play a vital role.” He says that the ultimate approach to control operations, which not only improves productivity, but indirectly reduces energy consumption significantly, is process automation. Further, web-based reporting, trending, and dash boarding tools are part of an Enterprise Energy Management (EEM) solution that can help predict the effect of various changes on consumption, and enhance the overall efficiency of utility usage. In addition, Enterprise Manufacturing Intelligence (EMI) systems connect users to databases in addition to control systems, devices and historians, allowing manufacturers to build comprehensive energy-efficiency solutions that monitor and manage energy usage in real time. Pharmaceutical manufacturer should use an EMI software solution in order to compare energy usage data with production information to help drive significant operational cost savings. Weather-normalised predictive modelling software can also factor into energy usage reductions, helping the manufacturer compare what energy consumption should be with what it actually is. With a more accurate picture of actual product costs, managers are able to make faster, more intelligent business decisions that can help significantly impact the bottom line. Thus, by assimilating all these processes and techniques in unison there can be energy consumption of a considerable percentage. (chandreyee.bhaumik@infomedia18.in)

Modern Pharmaceuticals I January 2012

Policies & Regulations: Pros & cons of Draft NPPP 2011

Tackling the affordability factor meaningfully Essentiality of drugs, market-based pricing (from cost-based pricing), and controlling formulation prices are the main features of the proposed National Pharmaceuticals Pricing Policy (NPPP) 2011 draft, which if approved will replace the Drug Policy of 1994. We try to decipher the pros and cons of this controversial draft. Parita Dholakia and Chandreyee Bhaumik

he Department of Pharmaceuticals (DoP) recently announced the draft policy that was open to feedback, and received a mixed bag of responses from the industry. After giving ‘due respect’ to all the received suggestions, the ﬁnal policy will be

What the policy offers? The draft policy envisages bringing the 348 (from the current 74) National List

Mandar Kubal

Nidhi Saxena

Vikram Gupta

Consultant - Infectious Diseases and HIV AIDS, Infectious Diseases and Pulmonary Care (IDPC)

President & CEO, Karmic Lifesciences

Founder & Managing Partner, IvyCap Ventures Advisors Pvt Ltd

The pricing based on formulations rather than bulk manufacture would encourage entry of new players in the manufacturing segment. Due to stiﬀ domestic competition in the highly competitive therapeutic segments, the present pricing of the Indian formulations are not too far away from the ‘ceiling price’ and hence they are not expected to have major impacts. The NPPP 2011 thus seems to address many issues of the common man and at the same time does not bleed the industry too much.

forwarded soon. Although the much needed reforms in the drug policy is something to cheer about, the rationale and reach of this policy in improvising the healthcare industry in India is much debated.

of Essential Medicines (NLEM) – 2011 and associated medicines under price control. With the Indian advantage of low cost for drug prices, introducing more control of over 60 per cent is uncalled for. It may result in slow industrial growth in the long term and leaves a window open for the manufacturing of non-essential and irrational medicines. Further, experts believe that the pharmaceutical companies may suﬀer sales loss of ` 3,000 crore if the government’s span of control increases. Also, reduction in drug prices will have corresponding impact on export realisation as the importers benchmark their purchase price to the domestic market. The proposal of ceiling prices only for end-use formulations, based on a Weighted Average Price (WAP) of top three brands, where the capped

Pros: Rationalising of taxes and duties on pharma products could work in favour of balancing drug prices to a small extent. Cons: The proposed drug pricing policy is an attempt to liberalise pricing issues and is likely to hurt the lower class as most companies will increase their brand prices to match up to price limits set by a competitor company. In a country like India, it is vital that drugs be aﬀordable and easily available in rural areas.

This policy is largely driven by several deals that are taking place in this industry in the last few years. Personally, I feel that this deal will deﬁnitely have a positive impact. If one considers on short term basis it might appear to have negative impact but in the duration of 4-5 years it will have strong impact. This policy will make the pricing of the drugs much more structured. Now, the drugs can easily be identiﬁed in to two categories ethical and Over-The -Counter (OTC) drugs.

Modern Pharmaceuticals I January 2012

Pros & cons of Draft NPPP 2011 prices would be inﬂation indexed for manufactured goods will make calculating ceiling prices of the many medicines not in NLEM a wearisome task. If the ceiling price is ﬁxed at a higher rate, this would only scale up the drug prices as companies selling drugs at a cheaper rate would also sell their products at a rate close to or equal to the ceiling price. However, some industry experts believe this move will ensure quality as well as price control, since taking WAP of low-selling drugs could be a compromise on quality. On the contrary, most companies making top-selling drugs will be hit and have a high domestic market share. For drugs that are not under proposed price control, the policy allows manufacturers to increase price up to 15 per cent annually, from the current limit of 10 per cent. This may lead to irrational prices of medicine. Will this also go against encouraging R&D in pharma space?

Left out Associations such as Indian Pharmaceutical Alliance (IPA) have

appreciated the decision to exempt bulk drugs from the purview of price control. It will also boost investment in local production of bulk drugs and thus reducing reliance on imports. At the same time, this move may lead to cartelisation if there are less manufacturers of a particular bulk drug. The policy does not cover patented products. It recommends the formation of a separate committee to ﬁx the prices of patented drugs. This announcement is like a double-edged sword for several MNCs who are in the phase of launching new patented molecules in the market. It will negatively impact the overall investment climate. MNCs majorly dependent on domestic formulations and premium pricing policy, will have a higher impact.

The futile long wait? The overall impact of this draft seems limited in all terms. Intense competition in the industry shall hopefully ensure that the drug prices remain at par with ceiling prices for most of the therapeutic segments.

The policy does hint at adopting a more practical and transparent approach for drug pricing, and this may be a benefit in the long run, and at the same time it gives a unfinished and hurriedly done appearance. The announcement of this draft policy aroused hope from the policy paralysis that had gripped the centre. However, with several questions being raised and the ‘affordable and accessible medicine to all’ factor still seemingly out of reach, it leaves a bitter taste. Along with drug pricing, the government should focus on bringing out a comprehensive healthcare policy that includes prevention, improving the health infrastructure, increasing the healthcare spend of Gross Domestic Product (GDP), expanding health insurance, and reducing the transaction costs. The one-third population living below the poverty line and the uninsured section of the population will be much happier with that. In the next few weeks, the final approved policy shall be announced and let us hope that the wait will be worth it. (parita.dholakia@infomedia18.in)

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

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

January 2012 I Modern Pharmaceuticals

Strategy: Clinical data collection

The

conundrum for

‘accuracy’

Field sales executives and their managers are expected to report developments at their monthly sales meets so that the research wing can get cracking to provide a befitting response. Lack of timely intervention may make the company ‘miss the bus!’ And the task of accurate data collection is complex to say the least!

harma companies send Medical Representatives (MR) and managers into the ﬁeld with the primary motive of increasing the output of prescription. In addition, they are entrusted with another important job of studying the prescription pattern of physicians in a given set of indications. A regular visit to doctors, chemists and distributors ensures that their sales targets are met periodically. Drugs are launched and some become successful blockbusters, while

others simply linger on in the market. The area manager and his deputies usually become a little lethargic once the prescription follows a steady growth. Any dip in the sales is a signal for them to tighten their belts and ﬁnd out which product has been out of favour or whether there is a new trend in prescriptions.

Changing trends In addition to this, they are on the prowl for new information about new molecules and

innovative combinations of existing drugs launched by competitors. A new product, which is forcefully promoted, may make some physicians shift to this drug sending the sales figures of the older molecule dipping. Failure to spot the change in time could put the company’s future at stake Also, they have to keep a tab on newer indications for which physicians have started prescribing some older drugs. This widens the scope of the company to promote it to a wider range of patients. If the trend catches on, it could be a windfall for the drug manufacturer An astute physician may make use of an existing drug for an off-label indication and after studying a few cases he may publish a report to document his successful experimentation. Meanwhile, even before the report appears in print, some of his students and colleagues may get wind of this use and copy the pattern. Also, if the physician happens to be a medical college teacher, he could wield a wider influence among his students and resident doctors.

Modern Pharmaceuticals I January 2012

Clinical data collection Gradually the off-label use gets scientific acceptance as a proper ‘indication.’ This is an unexpected extension of the drug usage and a shot in the arm for the drug manufacturer An unexpected allergic reaction in a group of patients receiving the same drug may force a physician to shift to another drug. A comment on the subject at a local medical event could spread the ‘bad news’ and affect prescription by other colleagues of the doctor as well

Data gathering Some events like the above continue to occur in most busy clinics all the time. Also, they unfold over and over again in a wide geographic area and in a varying time frame. Only an alert ‘field force’ can detect these changes as they happen. Most lethargic sales teams discover this only when they take a quarterly review and discover that their brand has slipped 50 per cent of their previous sales even as a similar drug has shown a tremendous upswing. Regular marketing team: Pharma companies try to gather data on these developments by compelling MRs and their managers to discuss clinical trends with doctors periodically. Engaging doctors in conversation may help them to get such clues. National and regional sales managers too try to draw doctors into a dialogue and understand what is happening with their molecules in patient’s bodies Product Management Team (PMT): Some companies depute individuals from the PMT with specific questionnaires to elicit responses from physicians. Besides questioning the doctor on the efficacy of their recently launched brand, they also tap the physician’s minds on missing links in the clinical armamentarium. Any potential drug which could have a huge market in the near future is what the PMT goes knocking for! Queries pertaining to adverse drug reactions of recent molecules also interest the PMT Market research agency: Others engage private agencies to collect data on clinical disorders, prescribing habits of doctors and adverse effects. Nowadays, most

January 2012 I Modern Pharmaceuticals

smaller agencies employ MBA students to conduct these surveys

Limitations It does not need to be emphasised that the collection of data on clinical issues is a complex task. The original data is stored in the deep, dark corners of some physician’s brain. To retrieve the data in a few moments when the doctor is not busy and without making him feel distressed is almost equivalent to performing some acrobatic feat. When regular MRs and managers visit the physician, the latter is usually waiting to tell him that his brands are well remembered and prescribed. This attitude leaves little room for the MR to discuss anything else unless he opens a leave-behind literature regarding some study and then traps the doctor into a discussion.

To retrieve the data in a few moments when the doctor is not busy and without making him feel distressed is almost equivalent to performing some acrobatic feat.

Product managers sometimes have highly technical queries which not all physicians may be able to respond speciﬁcally. Also, a long-winded discussion during busy clinic hours does not get the best out of the general practitioner or specialist.

an opportune moment, like a conference or when he is invited to speak to an audience. National sales managers and zonal managers tend to meet just physicians who are busy practitioners whose prescriptions swell their bottom line. Field managers should also identify others who may have limited their practice but have sound clinical judgment about drug bioavailability, pharmacodynamics etc. Unfortunately, MRs find it easier to avoid spending much time in these doctors’ cabins and naturally steer clear of taking the senior managers when they come visiting to their city or town! Questionnaires of MBA students have lost its value due to overkill. In the process the study suffers and the pharmaceutical company on whose behalf it was conducted gets lopsided data. In all these cases where the appointment for data collection is not specifically taken, the data obtained will be far from accurate. Senior marketing managers must seek out the ‘thinking’ doctor specifically away from his consulting time. However, it is well understood that no practising general practitioner or specialist would skip his consultation hours without being financially rewarded for picking his brain. Therefore, drug manufacturers should have a structured system for paying fees to such physicians, if necessary, so that useful insights into current and future pharmacological trends are obtained. In conclusion, field assessment is the cornerstone of drug marketing. Unless accurate data is obtained from clinicians, retail chemists and distributors, the industry will produce more ‘goofed up’ brands, like Doxy 1 Up and advertisements like those of Nizral Blue will spell loss for its owners. (rajan.td@gmail.com)

Probable solutions MRs and managers should be trained to jot down drug-related issues spoken by physicians. They should be periodically assessed by their superiors about the happenings in clinics across their area. Clinical points raised by physician, however casual, should be assessed by seniors in order to decide whether it merits deeper thought by the company. Wherever the issue is unclear but appears to have some signiﬁcance, senior level oﬃcers can zero-in on the subject with the physician at

Dr Rajan T D Pharma Consultant & Practising Dermatologist

Tips & Tricks: Compliance tips for GCP

A guideline for the

In today’s world of cut-throat competition, it is not merely a matter of providing quantitative results; the ones with qualitative work lead the pack. A look at how companies can achieve the best.

research team to follow

ood Clinical Practice (GCP) is a set of guidelines for biomedical studies, which encompasses the design, conduct, termination, audit, analysis, reporting and documentation of studies involving human subjects. It aims to ensure that the studies

are scientifically and ethically sound and that the clinical properties of the pharmaceutical substances under investigation are properly documented. So adherence to GCP by clinical research organisations is of utmost importance and here are some compliance tips for the same.

Protocol and study requirement: A well-written protocol with a clearly defined study objective and study requirements is primary requirement for the success of the clinical trial. The protocol should ensure that it takes care of patient safety and well being, collecting enough preclinical and clinical data (in case of late phase trial) to suggest the justification to conduct the present study. Every stake holder should be convinced with the design and outcome of the protocol which in turn will lead to better compliance, both at investigator as well as patient level. The data generated at the end of the trial is beneficial for research purpose and might lead to further development of the investigational product.

Partha Chatterjee Associate Vice President, Clinical Operations, SIRO Clinpharm

Tips& Tricks

Need of a robust infrastructure: There is also a need for a robust infrastructure to carry out any clinical trial. These may include the production of the investigational product in a controlled environment in compliance with GMP requirements, well-controlled storage and administration of investigational product and other clinical trial supplies. A state-of-the-art clinical and data management team supported by IT infrastructure to track various activities in the clinical trial and also to capture and manage the data generated from the investigational sites.

Quality control system : Every trial should have a group of personnel who are responsible to monitor the clinical trial and ensure the proper consenting of eligible subjects, adherence to the protocol, timely and complete adverse event reporting /subject’s safety management and maintenance of good medical records and documentation practice. The key qualities of a good monitor are eye for detail, excellent written and oral communication skills, assertiveness, domain knowledge and most importantly to identify issues and subsequently applying logic and common sense to resolve/prevent them to satisfaction.

Local regulation: One of the key stake holders of the clinical trial are the regulatory agencies and the Institutional Ethics Committees. These group of members should be knowledgeable enough to weigh the scientiﬁc rational against the risk and beneﬁts of conducting a clinical trial before issuing an approval to conduct the trial. They should be unbiased in their decision and have a close oversight during the conduct of the trial to ensure patient safety.

Tips& Tricks

3 T

Research team and infrastructure: Each ips and every stake holder of the clinical trial; ricks be it sponsor, investigator site staffs or data management and statisticians should be well trained, experienced and qualified research team, to carry out the trial with a clearly defined standard operating procedure for each activity. This automatically will lead to organised and accurate documentation.

Tips& Tricks

Audit: Another independent team of personnel called the auditors / inspectors are needed to finally attest that trial data can be accepted world over. Their main aim is to establish the credibility of the data and see to it that the trial conclusions presented in the final report are traceable to the raw data generated at the site level. Ultimate goal for any clinical research team is to have a successful audit at the end of the day with no critical or major finding, which might otherwise lead to rejection of the data and in turn all the efforts might go in vain.

Tips& Tricks

Modern Pharmaceuticals I January 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.

3B Blackbio Biotech India Manufacturing Plant Project type New Facility Project news The Indo-Spanish Joint Venture ( JV ) company 3B Blackbio Biotech India has opened a new biotech plant, which is a JV between Indian agrochemical company Kilpest India and Spanish biotechnology companies 2B Blackbio and Biotools B&M Labs. Project location Bhopal, Madhya Pradesh Project Cost ` 30 million Implementation stage Planning Contact details: 3B Black Biotech India Ltd, 7-C, Industrial Area, Govindpura, Bhopal Tel: +91-755-6456207 Fax: +91-755-4282659 Email: info@3bblackbio.com Website: www.3bblackbio.com ---------------------------------------------

Dishman Pharma Project type New Facility Project news Dishamn Pharma would be developing a new Active Pharmaceutical Ingredients (API) facility, which will develop a range of oncology APIs and other associated Highly Potent (HiPo) products. The facility is expected to be fully operational by the end of 2012. Project location Bavla, Ahmedabad Project cost ` 1.20 billion Implementation stage Construction

Contact details: Dishman Pharmaceuticals and Chemicals Ltd Bhadr-Raj Chambers Swastik Cross Road, Navrangpura Ahmedabad Tel: +91-79-26443053 Fax: +91-79-2642-0198 Email: dishman@dishmangroup.com Website: www.dishmangroup.com ---------------------------------------------

Government of India for setting up the project.

Praxair

Contact details: Ceat Mahal, 463, Dr. Annie Besant Road, Worli, Mumbai Tel: +91 22 2498 1650 / 51 Fax: +91 22 2497 0127 Email: sachin.raole@rpgls.com Website: www.rpglifesciences.com ---------------------------------------------

Project type New Facility Project news US-based industrial gas company Praxair plans to set up a new R&D lab in Bengaluru, as India has a lot of potential. Project location Bengaluru, India Project cost ` 1, 200 crore Implementation stage Planning Contact details: Praxair India Pvt Ltd “Praxair House” PO Box No – 4251 No 8, Ulsoor Road Bengaluru Tel.: +91-80-3057-6821 Fax: +91-80-2559-3499 Email: rakesh_srivastava@praxair.com Website: www.praxair.co.in ---------------------------------------------

Project location New Mumbai, Maharashtra Project cost Unknown Implementation stage Planning

Sharp Menthol India Ltd Project type New Project Project news Sharp Menthol India Ltd is planning to set up a new pharmaceutical project. The project would involve manufacturing of Menthol Crystal BP/USP Menthol USP, Levo-Menthol Rectified Peppermint Oil Mint Blend.

RPG Life Sciences Ltd

Project location Alwar, Rajasthan Project cost Unknown Implementation stage Planning

Project type New Facility Project news RPG Life Sciences Ltd is planning to set up a new pharmaceuticals project and would involve manufacturing of Diphenoxalate Hcl. It has received industrial license from Secretariat of Industrial Assistance (SIA), Department of Industrial Policy and Promotion,

Contact details: Plot No.9, Lsc, Sharp House, Gujran Wala Towen-1, Delhi Tel: +91-11 - 27131325 Fax: +91-11-27226406 Email: menthol@del3.vsnl.net.in Website: www.sharpmenthol.com ---------------------------------------------

Modern Pharmaceuticals I January 2012

Event List

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

Pharma IPR 2012 This unique conference aims to unveil all the critical intellectual property related queries in the pharma and biopharma sectors and target at the on-the-spot solutions by leading global industry experts. This event will also offer opportunity to take advantage of panel debates, interactive sessions, practical case studies and facilitated Q&A sessions. This conference will bring the latest updates and relevant in-depth information on the most vital subjects including patentability, pre-grant and post-grant opposition, US patent systems and many other aspects; January 31-February 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.pharmaipr-india.com

Lab Expo & Conferences It is a one of its kind event in the sector of lab equipment manufacturing, which will take place for two days and will include several informative sessions and workshops. These educative inclusions will be playing an important role in enriching the knowledge base of the professionals and entrepreneurs, who have been related to this profession for quite some time now. Lab Expo & Conferences - Chandigarh will be an

important step forward for the makers of equipment used in professional and academic laboratories. Apart from being a platform where the industry representatives will display their products and services, this event will also make an attempt to be as much informative as possible for the first time visitors and participants; February 3-5, 2012, Parade Ground, Chandigarh

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 For details contact: Paramount Exhibitors Tel:+ 91 172 2274801/2274802/2274803 Fax: + 91 172 2274803 Email:contact@paramountexhibitors.com Website: www.paramountexhibitors.com

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

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,

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 regulatory 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 Modern Pharmaceuticals I January 2012

Event List

INTERNATIONAL 9th Annual Specialty Pharmaceuticals, Oral Therapies and Injectables This conference brings together leaders from the healthcare and pharmaceutical industry to share best practices and learn how to provide quality care while also maintaining a sustainable bottom line; January 18-19, 2012, Planet Hollywood Resort & Casino; Las Vegas, Nevada, USA For details contact: CBI 600 Unicorn Park Drive Woburn, MA 01801 Tel: +001- 339-298-2100 Fax: +001- 781-939-2490 Email: spex@cbinet.com

and industry to discuss cutting-edge research, immuno-strategies and novel therapeutics against various diseases. Topics such as cytokines, inflammation, cancer immunotherapy, immunomonitoring, biomarkers, immunosuppression, allergy and asthma will be discussed at the summit; January 30-31, 2012, Paradise Point Resort and Spa, San Diego, California, USA For details contact: Global Technology Community Tel: 626-256-6405 Fax: 626-466-4433 Email: infogtcbio@gtcbio.com Website: www.gtcbio.com

Biosignals 2012 CBI’s 9th Annual Pharmaceutical Compliance Congress CBI’s Compliance Series addresses all aspects of a corporate compliance programme to bring together Chief Compliance Officers and their teams to share best practices and evolve compliance efforts across the industry. This series is headlined by this flagship meeting, CBI’s Annual Pharmaceutical Compliance Congress; January 24-25, 2012, The Ritz-Carlton, Washington, District of Columbia, USA For details contact: CBI 600 Unicorn Park Drive Woburn, MA 01801 Tel: +001- 339-298-2100 Fax: +001- 781-939-2490 Email: spex@cbinet.com

Novel Immunotherapeutics Summit The Novel Immunotherapeutics Summit brings together experts from academia

The purpose of the international conference on bio-inspired systems and signal processing is to bring together researchers and practitioners f rom multiple areas of knowledge, including biology, medicine, engineering and other physical sciences, interested in studying and using models and techniques inspired from or applied to biological systems. A diversity of signal types can be found in this area, including image, audio and other biological sources of information. The analysis and use of these signals is a multidisciplinary area including signal processing, pattern recognition and computational intelligence techniques, amongst others; February 1-4, 2012, Hotel Tivoli Victoria, Vilamoura Algarve, Portugal For details contact: INSTICC Tel: +351 265 520 184 Fax: +44 203 014 5436 Email: biosignals.sectariat@insticc.org Website: www.insticc.org

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

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

January 2012 I Modern Pharmaceuticals

Event Preview: Bangalore India Bio

Glimpses from the previous edition

Promoting the inherent strengths of the Indian biotech industry The biggest biotechnology exhibition in India, from the past 12 years has been the largest congregation of the biotech industry. After 11 successful editions of knowledge exchange, Bangalore India Bio is all set to enter its 12th edition with great force. Jasleen Kaur Batra

angalore India Bio (BIB) is an annual event organised by the Department of Science and Technology Government of Karnataka in association with Vision Group of Biotechnology. Since 2001, BIB has been instrumental in promoting the inherent strengths of the Indian biotech industry to the outside world and is now known as the biggest event on life sciences. The 12t BIB for the year 2012 is scheduled from February 6-8, 2012 at the Lalit Ashok Hotel, Bengaluru and huge participation is expected. Bangalore India Bio is a perfect blend of technology, industry knowledge and also oﬀers great knowledge bank to the attendees with the organised conferences and lectures.

Highlights of the show Bangalore India Bio 2012 will deliberate on issues related to the latest innovations in biotechnology and would focus on business opportunities that exist for companies in biopharmaceuticals, bio-industrial, bio-services, bio-informatics and agribiotechnology in the light of the emerging bioeconomy. The event will also discuss

issues such as collaborative and integrative business models as well as policy, regulation, and investment challenges for biotechnology in a global bioeconomy. International delegations are expected from USIBC, USA; Penssylvania State, SUA, Georgia State, USA, UK and Germany. Various eminent speakers like Ron Samers, President, US India Business Council, Washington, US; Terri Bresenham, President and CEO, GE Healthcare and many more would talk about the changing scenario in the ﬁeld of biotechnology in India. Some of the focus areas of the conference would be: Transforming healthcare through companion diagnostics Stem cells and regenerative medicine Mobile technologies and access to healthcare Next generation sequencing: Latest innovative developments in genomic analysis Clinical and contract research: Building capabilities through strategic partnerships Making sense of clinical trial data : Latest trends and technologies in analysis and management Vaccines: Breakthrough technologies for preventing and treating diseases

Scientiﬁc evidence based natural and traditional knowledge in healthcare Medical technology, devices and biomedical instrumentation: Can India lead in this sector? Biosimilars and regulatory harmonisation Bio nations: Biotechnology policies around the World Innovation, entrepreneurship and bio business: Skilling & fostering the next generation of Indian Bio–entrepreneurs Synthetic biology: How should India leverage this transformational technology ? Triggering investments in biotech innovation Another highlight of BIB is the CEO Conclave. It is one of the most sought after components of Bangalore India Bio. This programme is scheduled on the very ﬁrst day of the event and gives an opportunity for the senior members of the biotech and pharmaceutical fraternity to mix freely with one another and exchange ideas and news.

Statistical feats Last year, the 11t edition of BIB had 764 delegates from across the globe participating in 21 conference sessions; with over 112 international and national speakers; and 12 podium presentations. More than 22 foreign delegates from countries such as Germany, Europe, Canada, UK, USA, Australia, South America, South East Asia participated last year. The past 11 years have been exciting and the event has provided an opportunity to various experts to debate & discuss the future & vision. What Bangalore India Bio has in store this year is worth waiting for. (jasleen.batra@infomedia18.in)

Modern Pharmaceuticals I January 2012

Event Report: Indian Pharmaceutical Congress 2011

A splendid accomplishment Over the years, the Indian Pharmaceutical Congress (IPC) has made a benchmark for itself. This editon of the IPC presented views to make India a super power from the pioneers of the industry and also gave the young ones a platform to express their plans and strategies. L-R: Ramadass; Priolkar; Dr C Gopala Krishnamurthy, President, IPA; Anand Surana, MD, Micro Labs and Dr Jagashetty

Jasleen Kaur Batra

he 63rd Indian Pharmaceutical Congress was held at the Bangalore International Exhibition from December 16 - 18, 2011 witnessed a great gathering of delegates and esteemed professionals from the pharmaceutical and education industry, prestigious associations, international thought leaders, Nobel laureates and students. IPC 2011 witnessed more than 8,000 participation from delegates as well as students. S A Ramdass, Minister - Medical Education, Government of Karnataka, inaugurated the programme by lighting the lamp and extended a warm welcome to all the students, teaching faculty, regulatory, industry, community pharmacy and clinical pharmacy professionals present. Following the lamp lighting, Subodh Priolkar, President, IPCA, delivered the presidential address and welcomed other dignitaries including Dr Rashmi Bharbhaiya, CEO and MD, Advinus Therapeutics; Dr Kiran Mazumdar-Shaw, Chairman and Managing Director, Biocon; among others. Following this Ramdass released the souvenir and scientiﬁc abstracts CD and inaugurated FICCIs’ Pharma Expo 2011, where companies from all over the country showcased their products.

Vision 20-20 The seminar on Vision 20-20 attracted a

January 2012 I Modern Pharmaceuticals

number of visitors as it discussed relevant topics like the various methodologies and strategies that India needs to adopt to ensure that India is a super power by 2020, the challenges in pharmaceutical education is facing today, how lack of colleges and specialised courses for pharmaceutical is hampering the growth of the India pharma sector, the roadmap that we need to follow to become global leaders, the importance of world-class facility and more. The speakers were another highlight of this event, as experts such as Subodh Priolkar, General Manager, Colorcon Asia Pvt Ltd, Goa and President IPCA 2011; Dr B Suresh, Pharmacy Council of India andVice Chancellor,JSS University,Mysore; Dr M D Nair, Pharmaceutical Industry Consultant, Chennai; Dr P M Naik, ExPresident, IPA/IPCA, Zydus Cadila; and Dr Vinod P Shah, Pharmaceutical Consultant, North Potomac, MD, USA were in the panel and provided helpful insights throughout the seminar. Dr M D Nayar, Consultant, Pharmaceutical Industry, said, “The Indian pharmaceutical sector has grown from a ` 10 crore to a ` 110-million crore industry in 2011, which in itself is a positive and promising growth. We deﬁnitely have the potential to become a super power by 2020.”

IPC & Karnataka Karnataka has been one of the hubs for the pharmaceutical industry and has also been creating high revenues.

The IPC announced that Karnataka would be one among the first few states to surface a state pharma policy, to further provide better facility and education to ensure the growth in the pharma sector. The Karnataka government has also taken upon themselves the task to set up an institute of excellence in the same lines as that of NIPER, and would name the institute Karnataka Institute of Pharmaceutical Education and Research (KIPER). “India as a whole in on the path of growth and development and has been demonstrating remarkable growth in various sectors. Pharmaceutical sector is one where a lot of development can be constantly felt but we need to take a leap now, and need to reach the top. Our high quality and low cost services has already helped us make a huge space for ourselves in the market. An important area which needs our attention is education as it also determines the growth of a nation. Hence, the decision to set up KIPER would definitely benefit Karnataka,” expressed Ramdass. This years’ IPC also witnessed participation from college students in large numbers. The exhibition as well as the conference was packed during all the three days as every day presented a different approach to the pharma industry in India. IPC with the success of 2011 has definitely increased its standards and have proven to be one of the best pharma conferences of the year. (jasleen.batra@infomedia18.in)

Book Review Kuby Immunology Editors: Thomas J Kindt, Richard A Goldsby, Barbara A Osborne Price: ` 4000 It is not very often that one finds a science textbook wherein it is possible to sit down and read, chapter by chapter as one would with fiction books. ‘Kuby’s Immunology’ is an obvious exception. The book is divided logically into chapters, which cover (more or less) one topic at a time, allowing you to read about one subject in one sitting, without having to check back in seven other parts of the book. The ‘Kuby Immunology’ textbook is valuable for a number of reasons, but the two most prominent ones are: its broad content and simplistic outlook. The strength of the book is largely in the brilliant illustrations. Concentrated study of the figures in this book elucidates many concepts that seem difficult to describe otherwise. Additionally, the book is divided into many short chapters on subjects like B and T cell maturation, hypersensitivity, the T-cell receptor, etc. The superb organisation is logical and easy to follow, making independent study a pleasure. There are certainly more advanced books on specific topics, but Kuby Immunology is a great starter and basic reference.

iGenetics: A molecular approach Editor: Peter J Russell Price: ` 3400 With its modern chapter organisation and new ‘Focus on Genomics’ boxes, iGenetics: A Molecular Approach reflects the increasing molecular emphasis in today’s experimental study of genes while helping students develop problem-solving skills and an appreciation for classic experiments. The book covers basic genetics principles with balanced coverage of Mendel, historical experiments, and cutting-edge chapters on Genome Analysis and Molecular Evolution. After the introductory chapter, a core set of nine chapters covers the molecular details of gene structure and function and the cloning and manipulation of DNA, before the Mendelian genetics, gene segregation and gene mapping techniques are developed. Features such as chapter opening, ‘Key Questions,’ and strategically placed ‘Keynotes’ help students efficiently master genetic concepts. This easy-to-read introduction to genetics presents full coverage of the subject in a brief and manageable format. Readers develop and apply critical thinking skills as they work stepby-step through a number of solved genetics problems. Readers can also apply the principles and techniques learned to a variety of problems at the end of each chapter. Though many more advance books are available for genetics study, this book is definitely worth a read as a starter and even for experienced learners at a certain level.

Reviewer: Jayeeta Saha M Sc in Botany, Specialisation in Biochemistry, Physiology and Molecular Biology, University of Calcutta

Modern Pharmaceuticals I January 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:_______________________________________________________________________________________________

Tel:________________________________________Mob:_______________________________Fax:_________________________ Email:__________________________________________________Web:_______________________________________________

01/2012

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 Cleanroom moulds

Precision melt supermix

Adapplicator, Alu cap, Snap cap, PE bottle pack cap, PE twin port cap are only some of many cleanroom moulds from Braunform. Highly sensitive packaging and measuring components, caps for use in dental and insulin ﬁelds, dialysis components, hygiene products and the Adapplicator system developed by Braun, the spray alternative to needle injection, are few examples.

The new precision melt supermix delivers robust high resolution melt performance for sensitive and accurate detection of single nucleotide polymorphisms and CpG methylation for epigenetic studies. The PCR reagent is compatible with all HRM-capable thermal cyclers. Traditional genotyping methods, such as denaturing highpressure liquid chromatography and single-strand conformation polymorphism, involve lengthy protocols and require multiple days for completion.

Neejtech India Ahmedabad - Gujarat Tel: 079-26561312 Mob: 09825040231 Email: info@neejtech.com Website: www.neejtech.com

Bio-Rad Laboratories California – USA Tel: +1-800-2246723 Email: diagcs@bio-rad.com Website: www.bio-rad.com

Steam boiler The fully automatic package steam boiler (IBR) has capacity ranging from 100 kg/ hr to 2000 kg/hr with operating pressure of 10 kg/cm² g. Smoke tube & water tube version is also available. Coil is made from seamless tube of asthma 106 GR-B pipes. The unit is equipped with high eﬃciency oil/gas burner with air pre-heater arrangement which gives high thermal eﬃciency. Aero Therm Systems Pvt Ltd Ahmedabad - Gujarat Tel: 079-25890158 Email: contact@aerothermsystem.com Website: www.aerothermsystem.com

Pharma inspection machine The paper folding, shrink pack and pharma inspection machines are tested for CE marking, and thus fulfill one of the major statutory requirements of European Union. A range of customised solutions as per pharma industry requirements is also offered. Pharma inspection solutions include: pharmacode readers, leaflets and cartons. These have been specially designed for online checking of pharma codes printed on tubes, cartons, leaflets, labels, etc. Pratham Technologies Pvt Ltd Pune - Maharashtra Tel: 020-24352624 Mob: 09822047399 Email: enquiry@prathamtech.com Website: www.prathamtech.com

January 2012 I Modern Pharmaceuticals

Disposable bioreactor These are single use systems made of medical grade plastics, which are presterilised and ready for use, therefore not needing cumbersome SIP and CIP. Agitated by means of an external gyrational motion, which uses gravity naturally to make the contents ﬂow in a uniform circumferential direction in a specially shaped round bag. Lablinks Biotech Pvt Ltd Bengaluru - Karnataka Tel: 080-32440830 Mob: 09343748099 Email: ravindranath@lablinksbiotech.com Website: www.lablinksbiotech.com

Rapid mixer granulator These are designed to meet the requirements of GMP. The contact parts are made of SS-304/316. These granulators come with specially designed control panel with display system and microprocessor. The bowl, lid mixing agitator and discharge housing are made of stainless steel. Al MS parts of the machine are cladded/covered with stainless steel. Avon Pharma Machines Pvt Ltd Thane – Maharashtra Tel: 0250-2450638 Email: contact@avonpharmamachines.com

Products Freezer

Stoppering machine

The MDF-C2156VAN freezers provide stable and highly uniform ultra-low temperatures for the longterm preservation of viable cells, tissues and biological materials. Oﬀering signiﬁcant advantages, these large capacity 150°C freezers combine exceptional performance and durability with reduced energy consumption and quiet operation. The freezers incorporate patented thirdgeneration VIP PLUS insulation panels.

These servo rotary stoppering machines are crafted for cleanroom productions. The compact size allows for a sideby-side configuration, doubling the speed and matching the speed of the liquid filling machines for over 200 vials per minute side. These systems perform full and partial insertion and can be easily changed over to different stopper and bottle sizes.

Sanyo E&E Europe BV Etten-Leur – Netherlands Tel: +31-76-5433833 Email: sales.nl.seee@sanyo.com Website: www.eu.sanyo.com

Automated Machine Technologies, Inc North Carolina – USA Tel: +1-919-3610121 Email: office@amtliquidfilling.com Website: www.amtliquidfilling.com

Coating pan Starch paste kettle These are specially designed for preparation of binder materials. The hemispherical kettles with jacket are mounted on trunion supports with the help of shaft. These kettles have a small cylindrical top shell with a spout for pouring out binder mass. The starch paste kettles are made of SS-304/SS-316. These come with anchor type beater for paste mixing. Bombay Pharma Equipments Pvt Ltd Mumbai – Maharashtra Tel: 022-28594877 Mob: 09820124804 Email: bombaypharma@vsnl.net Website: www.bombaypharma.com

These are totally enclosed with stainless steel cladding and are available with standard gearbox, motor and hot-air blowing arrangements. The coating pans are provided with interlocked electrical circuit so that the heaters can be operated only after the blowers are switched ON to avoid burning of the heaters. These coating pans are manufactured from the SS-304 AISI 2B prime material quality with adequate mouth opening and depth. Allegro Pharmachem Equipment Thane – Maharashtra Tel: 022-40146872 Email: allegro@allegroindia.com Website: www.allegroindia.com

Linear vial washing machine These high-speed linear vial washing machines are totally fabricated from SS materials, including the basic frame. The machines are suitable for handling wash of 5 ml to 30 ml vials without changing parts. These are provided with high-pressure spray nozzles that enter into the vials during washing time. The linear vial washing machines are equipped with safety devices to ensure smooth and silent operation. Laxmi Industries Ahmedabad – Gujarat Tel: 079-22893810 Email: laxmiindustries_ad@yahoo.com

84 84

Bottle cappers Rotary chuck style bottle cappers are designed to apply and rotate a presorted cap on a container, based on a predetermined applied torque. The containers are fed onto the rotary chuck style capper and are separated and positioned on individual capping stations. Caps are pre-sorted and fed on the sliding table of the machine. US Bottlers Machinery Company North Carolina – USA Tel: +1-704-5884750 Email: info@usbottlers.com Website: www.usbottlers.com

Modern Pharmaceuticals I January 2012

Products Sieves These are silicon moulded sifter sieves, ﬂuid bed dryer (FBD) sieves and FBE dryer sieves. The silicon moulded sifter sieves are available in various sizes from 12” to 48” diameter. These are available in rivetted and special non-rivetted design. The mesh sizes vary from 4 mesh to 500 mesh with ASTM & BSS Standards. Atlanto Enterprises Mumbai – Maharashtra Tel: 022-23096098 Mob: 09819942853 Email: atlantoent@yahoo.co.in Website: www.atlanto.net

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

Gravity feed metal detector These are designed to detect metal contamination in dry, powdery or granular free-ﬂowing products that can be gravity fed through a pipe. The detectors feature high sensitivity, high throughput and is compact in size. Both the reject chute and frame are of stainless steel. The metal detectors are designed to minimise system space. Target Innovation Navi Mumbai - Maharashtra Tel: 022-27790077 Mob: 09823309636 Email: rajesh@targetinnovations.com Website: www.targetinnovations.com

January 2012 I Modern Pharmaceuticals

Sticker labelling machine These automatic vertical sticker labelling machines are user-friendly and suitable for labelling on round vials, bottles and other round objects The machines are capable of labelling up to 150 containers per minutes depending on product size and label size.These are equipped with roller spacing device and the in-built automated label length detection systems. Denmark Machine Tools Ahmedabad – Gujarat Tel: 079-22201140 Mob: 09727716599 Email: info@denmarkmachine.com Website: www.denmarkmachine.com

Products Capsule filler & encapsulation machine The CPT CF50 capsule ﬁlling and encapsulation machines are equipped with PLC control system with 10” colour touchscreen control panel mounted on swing out arm. These machines are available with AC variable speed frequency control, four swing-up acrylic doors, two capsule magazines with 9 feeding trucks, two capsule raceways, side pushers and down pushers. Capplus Technologies Arizona – USA Tel: +1-623-5822800 Email: info@capplustech.com Website: www.capplustech.com

Aseptic machine Bottelpack 4010M aseptic machines are for making unit dose eye drops and, high-voltage leak detector HVLD 926 for the non-destructive leak testing of large-volume containers. A complete range of packaging solutions and services for ﬁlling liquids, gels and pastes is oﬀered. These are tailored to the individual needs of the customers. Rommelag Ag Buchs – Switzerland Tel: +41-62-8345555 Email: claus.munk@rommelag.ch Website: www.rommelag.com

Inline filling & stoppering machine Sterifill F200 inline filling and stoppering machines are used for aseptic environments that can reach an output of up to 320 pieces per min. These machines are standard in design to accept LAF, RABS or isolator. There are no change parts in a defined vial range due to the puck transport system. IMA - Industria Macchine Automatiche SpA Bologna – Italy Tel: +39-051-783111 Email: corporate.communications@ima.it Website: www.ima.it

86 86

Cap welding system These are available in both fully automated and manual load cap version to mate with the ASEP-TECH blow/ﬁll/ seal machines to produce a multi-entry insert format for LVPs. The units can be supplied as an integrated package along with a new machine, or provided as stand-alone unit for an existing machine. Weiler Engineering Inc Illinois – USA Tel: +1-847-6974900 Email: creed@weilengineering.com Website: www.weilerengineering.com

Filling & capping machine Steril 400 filling and capping machines are meant for sterile applications in the pharmaceutical industry. These machines can be installed under an isolator. The machines consist of three modules and are suitable for different layout requirements. These machines are completely accessible from the front and are protected by laminar flow recycling. Marchesini Group Bologna – Italy Tel: +39-51-6518711 Email: sales@marchesini.com Website: www.marchesini.com

Tablet compression machine These machines are used to make tablets according to a pre-determined design. Punches and dies are set into the tablet presses to actually shape the tablets. The machines are provided with turret made of special grade SG iron casting and interlock switches to all guard for safety of operator. Shiv Pharma Engineers Ahmedabad – Gujarat Tel: 079-29092380 Mob: 09377535927 Email: sales@shivpharma.com Website: www.shivpharma.com

Modern Pharmaceuticals I January 2012

Products Electric blanket Aristocrat electric blankets are waterproof, shockproof, autocut, soft underlay to provide constant slow motherly warmth. It is a relief for the patients of asthma, goutarthritis, backaches, bodyaches & pains, patients of diabetes, low blood pressure, and the aged alike. These blankets supplement the much needed body energy and are useful for senior citizens. Medico Pharmaceuticals Processors Amritsar – Punjab Tel: 0183-2258586 Mob: 09356000059 Email: info@medico.co.in Website: www.medico.co.in

Conductivity meter The mhoCounter CT-10 is a conductivity indicator and mhoCounter CT-11 is the meter with relay output option, which is programmable. Microprocessorbased electronics allow wide operating range and long term signal stability. Optional relays provide control for adjustment or alarms. These meters come with saddle mounting option or standard ﬁttings to adopt to any process ﬂow solution. Vatturkar Industrial Pune – Maharashtra Tel: 020-25380568 Mob: 09422320551 Email: response@vatsmeter.com Website: www.vatsmeter.com

Digital flow meter With these digital flow meters and digital conductivity meters, operators can easily install and recalibrate the meters online. The flow meters are proven in harsh industrial environment and are service free units based on the state-of-the-art advance microprocessor technology. Both field-mounted as well as panel-mounted meters are available. MTS Engineers Pvt Ltd Ahmedabad – Gujarat Tel: 079-26400063 Mob: 09879407970 Email: sanjay.prajapati@mtsengrs.com Website: www.mtsengrs.com

January 2012 I Modern Pharmaceuticals

Pharmaceutical medicines A wide assortment of pharmaceutical medicines that are known for their effective results are offered. Made in proper hygienic conditions, these medicines are categorised into topical, oro-dental, gynaec & haemostats, intravenous fluids, anti-allergic, cold & cough medicines, antibiotics & quinolones & cephalosporins, antacids, anti-ulcerants & laxatives and appetite stimulants enzymes. Schwitz Biotech Ahmedabad – Gujarat Tel: 079-27493057 Mob: 09825374233 Email: schwitz_rkb@rediffmail.com Website: www.schwitzbiotech.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

Modern Pharmaceuticals 87

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

Product

Pg No

Sl No

Product

Pg No

Sl No

Product

Pg No

Sl No

Product

Pg No

AC motors ...........................................29

Duct mounts .............................................. 8

116 Laboratory software ................................. 19

173 Rock drill hoses ....................................... 65

Accent lighting systems ........................... 17

Duel fuel burners ..................................... 85

117 Laminar air ﬂow workstations .......... 25, 27

174 Roots blowers ........................................... 75

Acoustic enclosures .................................. 75

Duo labels ................................................ 67

118 Landscape lighting systems ..................... 17

175 Rotary evaporators ................................... 19

Agitators ................................................... 19

Electric blankets ..................................87

119 Level controllers.................................... FIC

176 Safe change housings ..................... 25, 27

Air die grinders ........................................ 65

Elemental analysis.................................... 90

120 Linear vial washing machines ................. 84

177 Safety light curtains .............................. FIC

Air ﬁlters ............................................ 25, 27

Emergency lighting systems .................... 17

121 Machines and plants for dry & wet

178 Sampling booths ................................ 25, 27

Air treatment systems ................. FGF, BIC

Empower .................................................. 43

preparation ........................................16

179 Shakers ..................................................... 19

Analytical instrumentation ...................... 43

Encoders ................................................ FIC

122 Magnetic stirrers ...................................... 19

180 Sieves ........................................................ 85

Analytical instruments ............................. 90

Evolved gas analysis ............................... BC

123 Mass spectroscopy.................................... 90

181 Simultaneous thermal analysis .............. BC

Aseptic machines ..................................... 86

Exhibition - Bioasia 2012 ....................... 44

124 Measuring & monitoring relays........... FIC

182 Slipring crane duty motors ...................... 29

Axial ﬂow fans ......................................... 85

Exhibition - Engineering Expo .............. 50

125 Mills.......................................................... 19

183 Solenoid valves ......................................... 65

Bag ﬁlters ............................................41

Fan ﬁlter units ............................... 25, 27

126 Molecular spectroscopy............................ 90

184 Solid-liquid mixers................................... 19

Ball valves ................................................. 65

Filling & capping machines .................... 86

127 Motion controls .................................... FIC

185 Sprinkler systems ..................................... 32

Batch dispersers ....................................... 19

Filling machines ....................................... 23

128 Motors ...................................................... 29

186 Spun ﬁlters ............................................... 41

Biological safety cabinets ................... 25, 27

Filter housing & assemblies .................... 41

129 Multi-postion stirrers................................. 6

187 SS hose clips ............................................ 65

Blow-ﬁll-seal machines............................ 13

Flag labels................................................. 67

130 Nano mills ...........................................23

188 Stainless steel ﬁlters ................................. 41

Boilers ....................................................... 32

Flameproof motors .................................. 29

131 Online b2b marketplace................. 21, 88

189 Starch paste kettles .................................. 84

Booklet & leaﬂet labels ........................... 67

Flange mounting motors ......................... 29

132 Optical range............................................ 41

190 Steam boilers ...................................... 83, 85

Bottle cappers........................................... 84

Flood lighting systems............................. 17

133 Overhead stirrers...................................... 19

191 Steel wire & duct hoses........................... 65

Brake motors ............................................ 29

Fluid bed dryers ....................................... 85

134 Packaging machines.............................47

192 Sterilising/depyrogenating tunnels .... 25, 27

Calorifers.............................................32

Foot valves ................................................ 65

135 Packaging solutions.................................. 73

193 Sticker labelling machines ....................... 85

Calorimeters ............................................. 19

Freezers..................................................... 84

136 Pass boxes ........................................... 25, 27

194 Stoppering machines ............................... 84

Cap welding systems ............................... 86

Gas detectors .......................................57

137 Patented diﬀusion bonded transducer .... 59

195 Strring hot plates ....................................... 6

Capsule ﬁller & encapsulation

Gravity feed metal detectors ................... 85

138 PBEGL geared motors ........................... 29

196 Switching relays .................................... FIC

machines ................................................ 86

Hand valves .........................................65

139 Persona-hospital bedlights....................... 17

197 Tablet compression machines ..............86

Capsule ﬁlling machines.......................... 85

Hanger labels ........................................... 67

140 Pesticide spray hoses ................................ 65

198 Technical garments .................................. 10

Carbon ﬁlters ........................................... 41

Heating baths........................................... 19

141 Pharma grade resins................................. 39

199 Tefzel HHS isotactic PP material ............ 5

Cartridge ﬁlters ........................................ 41

Heating range of products....................... 41

142 Pharma inspection machines................... 83

200 Temperature controllers ........................ FIC

Centrifugal air blowers ............................ 85

HEPA ﬁlter terminal housing........... 25, 27

143 Pharma lighting systems ......................... 17

201 Thermal conductivity ............................. BC

Chromatography ...................................... 90

High-eﬃciency mills ............................... 23

144 Pharmaceutical medicines ....................... 87

202 Thermic ﬂuid heaters ............................... 85

Clean attire............................................... 10

High-end DSC performance .................. 59

145 Pharmalux - cleanroom luminaire .......... 17

203 Thermo-gravimetric analysis ................. BC

Clean room doors ............................... 25,27

High-pressure homogenisers ................... 19

146 Photo electric sensors ........................... FIC

204 Thermoplastic valves .................................. 5

Cleanlite screwless cleanroom

High-pressure systems ............................... 8

147 Pilot plants ............................................... 19

205 Thermostats & vacuum dryers/mixers .... 19

lumianaires ............................................. 17

High-purity water solutions .................... 39

148 Pipe lines .................................................. 32

206 Timers ................................................... FIC

Cleanroom apparels ................................. 10

Hot plates................................................. 19

149 Piping systems-polyproplene..................... 5

207 Transducers................................................. 8

Cleanroom garments ............................... 10

Hot water generators ............................... 85

150 Platinum cured silicon tubings................ 41

208 Tray dryers................................................ 85

Cleanroom moulds .................................. 83

HPLC ................................................ 43, 90

151 Pleated ﬁlters............................................ 41

209 UHPLC ..............................................90

CNG dispensers......................................... 8

Hydraulic hoses........................................ 65

152 Precision melt supermix........................... 83

210 UPLC ....................................................... 43

Coating pans ............................................ 84

Hydraulic solenoid valves ........................ 65

153 Pre-engineered & pre-fabricated modular

211 Vacuum booster pumps ........................75

COD anaylsers......................................... 57

Indirect air heaters ...............................85

panels ............................................... 25, 27

212 Vacuum pads ............................................ 65

Columns & chemistries........................... 43

Industrial control & sensing devices .... FIC

154 Pressure gauges......................................... 65

213 Vacuum range of products....................... 41

Columns ................................................... 90

Industrial coolers ......................... FGF, BIC

155 Pressure sensitive paper & ﬁlm labels..... 73

214 Vacuum systems ....................................... 75

Commercial lighting systems .................. 17

100 Industrial lighting systems....................... 17

156 Programmable logic controllers............ FIC

215 Vision sensors........................................ FIC

Conductivity meters................................. 87

101 Industrial ovens ........................................ 85

157 Programmable terminals....................... FIC

216 Walk-away automation ........................59

Consumer lighting systems ..................... 17

102 Informatics ............................................... 43

158 Proximity sensors .................................. FIC

217 Welding guns ........................................... 32

Coolant pipes ........................................... 65

103 Injectable manufacturing lines .......... 25, 27

159 PTFE Teﬂon braided hoses .................... 65

Cooling pads ............................................ 32

104 Injection moulding machines .................. 32

160 PU tubes................................................... 65

Cooling towers ......................FGF, 32, BIC

105 Inline dispersers ....................................... 19

161 Pumps....................................................... 75

Counters & power supplies .................. FIC

106 Inline ﬁlling & stoppering machines ...... 86

162 PVC pipes ................................................ 32

DC motors ..........................................29

107 Inspection systems ................................... 15

163 Quick-change terminal house........ 25, 27

Diﬀerential pressure transducers ............... 8

108 Integrityplus attire.................................... 10

164 Rapid endotoxin detection systems ......87

Diﬀerential scanning calorimetry.......... BC

109 Intuitive display-revolutionary user

165 Rapid mixer granulators .......................... 83

Digital ﬂow meters .................................. 87

interface.................................................. 59

166 Regulators................................................. 65

Dilatometry ............................................ BC

110 Inverter/variable frequency drives ........ FIC

167 Reliable machines .................................... 59

Dispensing booths ............................. 25, 27

111 ISO cylinders ........................................... 65

168 Return air risers.................................. 25, 27

Dispersers ................................................. 19

112 Kneading machines .............................19

169 RFID ..................................................... FIC

Disposable bioreactors ............................. 83

113 Lab equipment analytical range ...........41

170 Rh & temperature displays ....................... 8

Drip irrigation .......................................... 32

114 Laboratory mills....................................... 23

171 Rh & temperature transmitters................. 8

Dry vane pumps ...................................... 75

115 Laboratory reactors .................................. 19

172 Road lighting systems.............................. 17

Looking for a speciﬁc product? We will ﬁnd the product for you. Just type MPH (space) Name of the Product and send it to 51818 eg, MPH (space) Bioreactor and send it to 51818.

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

Modern Pharmaceuticals I January 2012

List of Advertisers Advertiser’s Name & Contact Details

Pg No

Advertiser’s Name & Contact Details

AB Diachem Systems Pvt Ltd T: +91-11-25155456 E: sales@scalewatcher.in W: www.scalewatcher.in

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

Aerotherm Systems Pvt Ltd T: +91-79-25890158 E: contact@aerothermsystems.com W: www.aerothermsystems.com

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

Katlax Enterprises Pvt Ltd T: +91-9328197614 E: info@katlax.com W: www.katlax.com

Charles River

Milltech Engineering Pvt Ltd

J B Sez Pvt Ltd

E: mail@salesworth.com W: www.seidenader.de FGF

Shah Brothers T: +91-22-43560400 E: coupling@shahbros.com W: www.shahbros.com

TA Instruments-Thermal Analysis T: +91-80-23194177 E: india@tainstruments.com W: www.tainstruments.com

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

T: +91-44-42965111

Thermo Fischer Scientific Sid Division

E: Yasotha.palanisamy@netzsch.com W: www.netzsch.com

T: +91-22-67429494

E: sales@milltechengg.com W: www.milltechengg.com

Engineering Expo T: +91-09819552270 E: engexpo@infomedia18.in W: www.engg-expo.com

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

Netzsch Technologies India Pvt Ltd

T: +91-44-42965121

E: anton.benjamin@nti.netzsch.com W: www.netzsch-grinding.com/pharma

25, 27

Netzsch Technologies India Pvt Ltd

Omron Automation Pvt Ltd

FIC

T: +91-80-40726400

E: mails@fabtecheng.com W: www.fabtecheng.ae

E: in_enquiry@ap.omron.com W: www.omron-ap.com

Federation Of Asian Biotech Association 44 T: +91-40-66446477 E: info@bioasia.in W: www.2012.bioasia.in

Pierlite India Pvt Ltd

Gem Equipments Ltd

Plus Ventilation Pvt Ltd T: +91-40-23812152

E: director@plusventilation.com W: www.plusventilation.com 19

Reynders Label Printing India Pvt Ltd

T: +91-80-26253900

T: +91 149 3305400

E: process@ika.in W: www.ika.in

E: india@reynders.com W: www.reynders.com 21, 88

T: +91-80-25274495

E: pr@indiamart.com W: www.indiamart.com

E: mail@salesworth.com W: www.rommelag.com

E: singhrv@unipos.com W: www.uniphos-she.com UNP Polyvalves India Pvt Ltd

E: mktg@polyvalve.com W: www.polyvalve.com Waters (India) Private Limited

T: +91-80-28371900

E: waters_india@waters.com W: www.waters.com

Looking for a speciﬁc product? We will ﬁnd the product for you. Just type MPH (space) Name of the Product and send it to 51818 eg, MPH (space) Bioreactor and send it to 51818.

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

January 2012 I Modern Pharmaceuticals

T: +91-265-2649248

Salesworth Synergies Pvt Ltd(Rommelag) 13

T: +1800-200-4444

T: +91-22-6123500

E: pradeep@pierlite.co.in W: www.pierlite.co.in

E: sales@gemindia.com W: www.gemindia.com

E: pradeep.kumar@thermofisher.com W: www.thermofisher.com Uniphos Envirotronic Pvt Ltd

T: +91-79-22782623

T: +91-422-3267800

IKA India Private Limited

Nichrome India Ltd T: +91-20-66011001 E: marketing@nichrome.com W: www.nichrome.com

T: +91-22-61592900

BIC

Salesworth Synergies Pvt Ltd (Seidenadger) 15

E: india.customercare@crl.com W: www.criver.com 6

Pg No

T: +91-80-25274495

E: sales@gemindia.com W: www.gemindia.com

Cole-Parmer India T: +91-22-67162222 E: response@coleparmer.in W: coleparmer.in/3125

Advertiser’s Name & Contact Details

Samson Extrusion Ind Pvt Ltd T: +91-22-23422238 E: samson7@vsnl.com W: www.samson-grp.com

T: +91-22-41610099

IndiaMART InterMESH Limited

T: +91-422-3267800

T: +91-80 -25588175

Fabtech Technologies Intl Pvt Ltd

Pg No

Our consistent advertisers

Modern Pharmaceuticals

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

January 2012