Modern Pharma - 16-28 February 2013

16 - 2 8 F e b r u a r y 2 013 I Vo l 1 I N o 16 I ` 1 0 0

www.modernpharma.in

Scan this code on your smart phone to visit www.modernpharma.in

In Conversation With 16

Special Focus 18

Interface 27

Policies & Regulations 28

K V Subramaniam President & CEO, Reliance Life Sciences

The cleanoom market in India Set for big growth

Sheesh Gulati Chief Executive Officer, MeasureTest Corporation

FDI in pharma: Embrace or fear?

Anup P Shah Partner, Pravin P Shah & Co

Bhasker Iyer named Divisional Vice President, India - Abbott Pharmaceuticals Business Bhasker Iyer has been named Divisional Vice President, India Commercial Operations, Iyer Abbott Established Pharmaceuticals, effective February 18, 2013. Bhasker Iyer will report into Mike Warmuth, Executive Vice President, Established Pharmaceuticals Division, Abbott.

Iyer brings over 30 years of experience in the pharma industry. He held the position of President, India and Emerging Markets, Wockhardt.

Abbott’s pharmaceuticals business in India - Abbott India Ltd, Abbott Healthcare Solutions and Abbott True Care - will report into this newly established position. Iyer will work with the business leadership teams to identify further opportunities to expand access to Abbott’s broad portfolio of quality products in India.

Warmuth said, “The establishment of this position reinforces the focus of the company’s strategy in India to bring quality medicines to patients that make a difference in their lives and to ensure patients and the healthcare community has access to these medicines.”

Tata Capital acquires minority interest in Marck Biosciences Tata Capital Healthcare Fund acquired minority interest of 13 per cent in Marck Biosciences Ltd along with 6 per cent stake in IFCI Venture making total stake holding of Tata Capital between 19 to 22 per cent in Marck Biosciences.

Bhavesh Patel, MD, Marck Biosciences, Patel said, “It is a sustained growth phase for us at Marck Biosciences as we are investing ` 80 crore in the new expansion project.

The fund infusion from Tata Capital will be invested for further expansion of capacities of the new project, which will have state-of-the-art technology.

Our entire project cost is expected to be around ` 80 crore and hence we will also be going in for further funding through debt route. We expect returns from the funds infused within 6 to 8 months.”

SCHOTT KAISHA inaugurates India’s first fully automated plant for pharma packaging With the pharmaceutical market in India expanding by approximately 14 to 17 per cent per year, the packaging market is expected to grow in line with the overall pharma market by about 11 per cent annually. Keeping in mind the growing needs of the industry, SCHOTT KAISHA inaugurated its new pharmaceutical packaging plant in Jambusar, Vadodara, Gujarat. This greenfield investment of ` 135 crore is set to increase the company’s production capacity in India by 50 per cent to around 2 billion ampoules and vials per year.

This packaging plant complements an existing production facility in Daman and enhances SCHOTT KAISHA’s competitive advantage substantially.

With high-end safety precautions in place and a strong commitment to GMP, SCHOTT KAISHA’s 20 acre completely automated plant is set to revolutionise India’s pharma packaging industry. SCHOTT KAISHA’s primary aim remains to serve the Indian market.

“We see a steadily rising demand for locally manufactured primary packaging that meets the rising quality demands,” said Kairus Dadachanji, Managing Director, SCHOTT KAISHA.

He added, “Our new state-of-the-art factory sets new standards in India.

This investment will result in better quality opportunities for our customers.

In other words, we will be helping the Indian pharmaceutical industry to achieve its own growth objectives.”

The new plant in Jambusar has 20 production lines for ampoules and 16 for vials, with scope for further expansion.

Its fully automated production process uses high-end robotic feeding technology for tube-loading as well as high-precision camera inspection systems. World market leading SCHOTT FIOLAX® tubes are used as base material. The facility is India’s first pharmaceutical packaging plant meeting global standards with an ISO 15378 certification.

“KAISHA’s deep market knowledge about India and SCHOTT’s world-class technology create a perfect partnership,” emphasises Prof Udo Ungeheuer, Chairman of the Board of Management, SCHOTT AG. “The SCHOTT group is highly committed to its pharmaceutical business. Our continuous investments in India demonstrate our ambition. More than one hundred years of experience in setting the world’s highest technology

standards turn us into the ideal partner for India’s ambitious and fast growing pharmaceutical industry,” he added.

SCHOTT KAISHA is confident of exceeding overall market growth in the future with expectations of crossing ` 240 crore mark by the end of 2013.

The Indo-German company offers a

(L-R): Prof Ungeheuer; Dadachanji and Dr Juergen Sackhoff, EVP, Pharmaceutical Systems at the inauguration

complete range of primary tubular glass packaging: Products comprise ampoules, vials, cartridges for pen and auto injectors as well as sterile prefillable glass syringes. Dadachanji added, “Although our main concentration is currently on ampoules and vials, the syringe market is expected to see a healthy growth in the near future.”

Pallavi Mukhopadhyay

iPHEX 2013 to host over 400 international buyers and regulators The Pharmaceuticals Export Promotion Council of India (Pharmexcil) has announced the launch of iPHEX 2013. Billed as ‘India’s own pharmaceutical show’, this event will be held in Mumbai from April 24-26, 2013 with the support from the Ministry of Commerce & Industry, Department of Commerce and Government of India.

Over 400 leading Indian companies are expected to showcase the best of pharma products before 5,000 business visitors including overseas buyers and drug regulators. The event is expected to offer a good opportunity for international buyers and regulators to visit India and evaluate how well structured and regulated the Indian pharma industry is at the moment.

According to Pharmexcil, iPHEX 2013 will immensely help its members to promote the quality and affordability aspect as envisaged in ‘Brand India Pharma Campaign’.

The campaign has been initiated by Ministry of Commerce and executed

by Pharmexcil in association with India Brand Equity Foundation.

Dr P V Appaji, Director General, Pharmexcil, said, “iPHEX 2013 will

Dr Appaji addressing the seminar

be a complete value chain show and Pharmexcil is creating a sustainable pharma industry platform with a special focus on export market development.

The exports growth story is one to be proud of.”

With increasing R&D spends, Indian pharmaceutical sector has become a costeffective centre for world-class research as also for contract R&D. Indian companies in recent years have produced many costeffective drugs that are affordable to the masses. In this context, Ashutosh Gupta, Vice Chairman, Pharmexcil, said, “We are making concerted efforts to promote India’s status as the manufacturing hub of the world.”

“iPHEX 2013 will be the biggest industry exposition in India showcasing the diverse range of products and will include formulations, APIs, Ayush, nutraceuticals, health services, biotechnology and biotechnology products, R&D services etc,” informed Bhavin Mehta, Committee Chief, iPHEX and CoA Member, Pharmexcil.

Pharmexcil plans to organise several thematic seminars and conferences on the sidelines as well.

“These will include pharma sector investments, R&D and innovation, overseas market entry strategies etc,” added Mehta.

0RGHUQ 3KDUPD‡ )HEUXDU \

CONTENTS Budget Wishlist

6

Need for a ‘wholistic’ approach

In Conversation With

14

K V Subramaniam President & CEO, Reliance Life Sciences

14

16

17

18

Special Focus Cleanrooms The cleanroom market in India Set for big growth Cleanroom regulations Essential to evolve and maintain standards

Interface Sheesh Gulati CEO, MeasureTest Corporation

15 16 17

Insight & Outlook Policies & Regulations FDI in pharma: Embrace or fear?

18

Anup P Shah, Partner, Pravin P Shah & Co www.modernpharma.in

Event Report BioAsia 2013 Shaping opportunities for bioentrepreneurs

23 Bangalore India Bio 2013 Providing biotechnology the needed power boost 24

FOUNDER & EDITOR, NETWORK 18 Raghav Bahl PRESIDENT & EDITORIAL DIRECTOR, TV 18 Senthil Chengalvarayan SENIOR EDITOR Manas R Bastia FEATURES EDITOR Arshia Khan EDITORIAL TEAM Chandreyee Bhaumik, Parita Dholakia, Pallavi Mukhopadhyay, Rishab Kothari, Hardik Ashar (Bengaluru), Nikunj Sharma (Delhi) ART DIRECTOR Varuna Naik DESIGN Varghees Tharakan CHIEF PHOTOGRAPHER Mexy Xavier PHOTOGRAPHY Joshua Navalkar, Nachiket Gujar BUSINESS CONTROLLERS Surekha Karmarkar, Lovey Fernandes, Akshata Rane, Deepak Bhatia, Ashish Kukreti, Shwetha ME, Jayashree N, Sugandha Kulkarni, Shefali Mahant

PRINTING

REGULAR SECTIONS 5 Editorial / Guest Editorial 7 News, Views & Analysis 19 Technology Transfer 20 Projects 21 Tenders 22 Event List 25 Products 29 Marketplace 30 List of Products & Advertisers

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

PRODUCTION TEAM

Surekha Karmarkar, Ravikumar Potdar, Ravi Salian, Sanjay Shelar

OVERSEAS CONTACT 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 Ringier Trade Media Ltd

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

GROUP CEO, NETWORK 18 B Sai Kumar CEO-NETWORK 18 PUBLISHING Sandeep Khosla EVP-HUMAN RESOURCES Sanjeev Kumar Singh ASSOCIATE VICE PRESIDENT Sudhanva Jategaonkar ADVERTISING SALES Shashin Bhagat (Ahmedabad) shashin.bhagat@network18publishing.com Mahadev B (Bengaluru) mahadev.b@network18publishing.com Hari Hara Subramaniam (Chennai) hari.s@network18publishing.com Balakrishnan S (Coimbatore) balakrishnan.s@network18publishing.com Surendra Agarwal (Delhi) Surendra.a@network18publishing.com Dominic Dsouza (Hyderabad) dominic.dsouza@network18publishing.com Ameya Gokhale (Indore) ameya.gokhale@network18publishing.com Sandeep Arora (Jaipur) sandeep.arora@network18publishing.com Abhik Ghosal (Kolkata) abhik.ghosal@network18publishing.com Inder Dhingra (Ludhiana) inder.dhingra@network18publishing.com Surajit Bhattacharjee surajit.b@network18publishing.com Olwin Dsouza (Mumbai) olwin.dsouza@network18publishing.com Rohit Dass (Pune) rohit.dass@network18publishing.com Vipul Modha (Rajkot) vipul.modha@network18publishing.com Chirag Pathak (Vadodara) chirag.pathak@network18publishing.com MARKETING TEAM Ganesh Mahale, Akshaya Jadhav

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@network18publishing.com or call +91 22 30034631-34 or toll free 1800 200 1021 PERMISSIONS For subscription to copy or reuse material from Modern Pharma, Write to spedit@network18publishing.com ‡ Fortnightly Issue Price: ` 100 ‡ $QQXDO 6XEVFULSWLRQ ` 1200

Views and opinions expressed in this magazine are not necessarily those of Network18 Media & Investments Ltd (Network18)*, its publisher and/or editors. We at Network18 do our best to verify the information published but do not take any responsibility for the absolute accuracy of the information. Network18 does not accept the responsibility for any investment or other decision taken by readers on the basis of information provided herein. Network18 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. Network18 reserves the right to use the information published herein in any manner whatsoever.

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

Printed by Mohan Gajria and published by Lakshmi Narasimhan on behalf of Network18.

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 Network18, ‘A’ Wing, Ruby House, J K Sawant Marg, Dadar (W), Mumbai - 400 028.

Modern Pharma is registered with the Registrar of Newspapers of India under No. MAHENG / 2008 / 27125. Network18 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. *Ownership of this magazine stands transferred from Infomedia18 Ltd (Infomedia18) to Network18 Media & Investments Ltd (Network18) in pursuance of the scheme of arrangement between Network18 and Infomedia18 and their respective shareholders and creditors, as approved by the Hon’ble High Court of Delhi and the necessary approval of Ministry of Information and Broadcasting is being obtained.

0 R G H U Q 3 K D U P D ‡ )H E U X D U \

Editorial

5

Low-cost drug discovery discovered! ith the patent cliff of several successful generic drugs looming large on the horizon, there needs to be an increased global thrust in bridging the gap. Also, it is time to focus greater energy and resources on R&D towards developing innovative pharma products and delivery systems, especially to meet the numerous unaddressed needs of the emerging economies. Easier said than done, the cost of drug development and time-tomarket in this context constitute critical significance to make or mar the prospect of a new product.

Historically speaking, new drug development has been a highly time-consuming and costly process.

So much so, it can take even more than a decade and cost millions of dollars from the initial ideation stage till its procedural conclusion. Moreover, the probability of bringing a successful drug to the market among hundreds of its potential peers is rather miniscule. Another requirement during early drug discovery process is to identify new chemical compounds that are potentially useful without being toxic to human beings.

That said, there is some good news in this regard! Going by a recent release from De Montfort University (DMU) – based in Leicester, UK – the cost of drug development can be reduced owing to its new technology. DMU in association with Ithaka Life Sciences Ltd (Ithaka) – a leading UK-based life sciences

W

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

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

Dr Gopakumar G Nair IPR Consultant & Advisor

Dilip G Shah Chairman, IGPA & Secretary General, IPA

Daara Patel Secretary General, IDMA

Guest Editorial

commercialisation firm – has established a new company, CYP Design Ltd (CDL).

After obtaining the licence of this new technology from DMU, CDL is set to add speed as well as reduce the cost of developing new drugs and bring these products to market.

To elaborate, Prof Bob Chaudhuri, a leading expert at DMU and inventor of this new technology, can provide useful new products and services, based on a set of proteins, named cytochrome P450s (CYPs). For the beginners, CYPs are found in the human liver and are mainly responsible for the metabolism of drugs.

Currently, CYPs need to be transported on dry ice at as low as - 80 °C temperature and are stored as cold as possible in the customer’s laboratory until their need arises.

However, thanks to this new technology, CYPs can be shipped and handled at room temperature, thereby eliminating the need for a cold chain. This should not only reduce the cost involved in such special transportation mode but also make their use in testing new drugs quicker and more convenient. It remains to be seen how positively this technology will impact the cost and time involved in the early stages of drug discovery.

Manas R Bastia manas@network18publishing.com

Innovation vs imitation ot long ago, arguably the most popular slogan for Indian business houses used to be ‘imitate and flourish’. Today, it is ‘innovate and flourish’. An add-on footnote could be ‘innovate or perish’.

The last few years have witnessed a mind-boggling change in the global pharma landscape and how much ever our pundits may wish otherwise, this tsunami is not going to leave Indian shores unwashed. But wait a minute.

It may sound automatically correct and even glamorous to vote for innovation as opposed to imitation. But expert opinion is divided on this tricky issue.

Indeed, many imitators do so well that they push the innovator out of business. Some have been able to repeat the feat time and time again, as did IBM, at first with mainframe computers and then with the personal computer.

Of course, not all imitators fare as well.

The argument for innovation seems well established. New products do three things: they lead to higher sales and growth, for instance by targetting higher margin segments; they lower costs, by marketing new and improved products to existing customers and saving the expense of attracting new ones; and they transform a firm’s capabilities so profits are sustained over a long period.

While this seems impressive, a closer look will reveal that imitators enjoy many of the same benefits, and then some. Having observed market reaction, the imitator can better calibrate a

N

product and is not encumbered by an investment in obsolete technology and infrastructure. Imitators are often better positioned to offer the customer something better/cheaper, often both.

Even if the imitator’s search costs are higher, its overall cost is lower by an estimated 60 to 75 per cent. A gap of that magnitude enables the imitator to make competitive moves ranging from passing the cost savings on to the consumer to offering superior features, distribution and service, or channel the extra margins towards, well, innovation.

‘Imovation’ This is what some experts call a winning combination of imitation and innovation. To become an imovator, a firm needs to approach imitation in a strategic fashion, devoting as much time as it does to the development of strategies for innovation. These imitation strategies can be formulated and reviewed using a simple inventory of questions, including where, what, who, when and how. The questions should be able to resolve the ‘correspondence problem’ in a way that will not jeopardise the value proposition.

Firms will also have to learn to overcome imitation deterrents, while at the same time use such deterrents to protect both their innovations and their imitations from subsequent entrants.

The first step towards imovation is to build on the platforms that are common to imitation and innovation. As PepsiCo’s Lionel Nowell acknowledges,

the two are not as far apart as the case may seem. If building an innovating/ imitating system seems contradictory, it is worthwhile to recall that many of the capabilities required of a good imitator are shared by effective innovators.

In many ways, the sources of innovation and imitation are similar.

Like innovators, imitators improve their capabilities ‘by doing’ and through other channels such as R&D, buying, training, hiring, reverse engineering and other forms of search, both find that a considerable amount of economically useful knowledge remains tacit and difficult to absorb‌and both face uncertainty. Also, like innovators, imitators struggle to mesh know-how acquired externally with their own history, capabilities and operational procedures, thereby engaging in processes of search and discovery unique to their experience.

What about pharma? Well, what’s good for the goose must be good for the gander. Never fall a prey to catchy phrases or clichÊs. Innovators do grab headlines, thanks to the electronic and print media ever-hungry for hyperbole and high decibel. But what you are good at should determine whether you will win by imitation or innovation. Neither of them is easy. Go for a clever blend and you can laugh all the way to the bank.

Pulin Shroff Managig Director, Charak Pharma Pvt Ltd

6

0R GHU Q 3KDUPD‡ ) HEUXDU \

Budget Wishlist: 2013 - 2014

Need to adopt a ‘wholistic’ approach With the Union Budget 2013 - 2014 on the anvil, the industry unfolds its wishlist

Dr Arun Singh Pulin Shroff Managing Director, Charak Pharma Pvt Ltd In a pre-budget memorandum to the Union Finance Minister, the Ayurvedic Medicine Manufacturers Organisation of India (AMMOI) has sought abolition of 2 per cent excise duty imposed on ayurvedic products in order to protect the traditional treatment system in the country. We fully endorse and support this move.

Chronic therapies are the bugbear of our growing middle-aged and senior citizen segments as they are afflicted by arthritis, asthma and several chronic conditions. Ayurvedic medicines and procedures including Panchakarma meant for these patients should be given subsidies for the urban and rural poor. Besides, Ayurvedic preparations meant for women’s health should be given additional tax relief. Tax incentives should therefore be extended to Ayurvedic clinics that focus on stress relief, wellness and lifestyle disorders. Also, traditional Ayurvedic formulations have problems of standardisation and stability in a vast country like India.

These issues should be researched in-depth so that our population stands to gain by scientific advances. As such, R&D facilities for Ayurveda should be eligible for tax exemption. Tax exemption should be extended to the cultivation of herbs as well as processing and transportation of herbal raw materials to manufacturing sites. Ayurvedic research and education needs publicprivate participation if the future needs of our society are to be met. Setting up of newer educational and research oriented academies and institutions must be given financial incentive by way of tax relief for periods up to 5 years.

Senior Economist, Dun & Bradstreet Information Services India Pvt Ltd With a view to bring down the total cost of treatments for patients, elimination of the import duty on life-saving drugs is expected. The industry also expects exclusion of customs/central excise duty for related diagnostic equipment, consumables and medical devices.

The industry expects the government to exempt the physician samples from imposition of central excise duty as these are offered free to doctors and not meant for commercial purpose.

The industry expects the government to relax the custom duty on pharma grade Un-denatured ethanol, which is used in manufacture of anticancer formulations. Currently, it is classified under ‘Beverages, Spirits and Vinegar’ product category and accordingly attracts the applicable custom’s duty.

Some clarity about its classification as per the enduse is expected.

The basic customs and excise duty on nutraceuticals and health supplements are also expected to be lower. This move is likely to make the products more affordable and increase its consumptions which in turn will help in improving the health of the general population.

In continuation with the measures announced in the 2012-13 Union Budget to boost R&D in the pharmaceutical sector, the industry expects the government to take a fresh measure to further encourage R&D investment in the sector.

Tapan Ray Director General, OPPI Currently, the only tax benefit available for R&D activities is in the form of weighted deduction for in-house R&D. There are no specific tax benefits available to units engaged in the business of R&D or contract manufacturing. Benefits should be provided for units engaged in the business of R&D and contract manufacturing by way of profits-linked incentives. Further, exemption of income generated from the utilisation of IP should also be provided in order to provide an incentive for R&D in India. An amendment should be brought in to effect that entire expenditure in/for the purpose of an approved R&D facility, which is eligible for weighted deductions and clinical trials carried out in approved hospitals and institutions outside the R&D unit are also covered within the ambit of expenditure eligible for weighted deduction.

All life-saving drugs (including medical devices) should be exempted from customs duty on import into India. The central excise duty rate of API may be rationalised and made at par with pharma goods, ie, excise duty on the inputs (API) may be reduced from 12 per cent to 6 per cent. Alternatively, government should introduce a refund mechanism to enable pharma manufacturers to avail refund of excess cenvat credit especially in case of such an inverted duty structure.

Presently, all the SEZ units enjoy exemption from aforesaid import procedure by drug importer. There prevails an ambiguity with regard to extension of said benefit to EOU units. A suitable clarification in this regard would have to be issued to provide a mechanism for import of drugs by EOU units.

0 R G H U Q 3 K D U P D ‡ )H E U X D U \

News, Views & Analysis

Cipla’s Dr Hamied to step down as MD

In Brief

Dr Y K Hamied, Chairman & MD, Cipla Ltd, is stepping down as the MD of the company. According to a company statement, he has expressed his desire to retire as Managing Director. Dr Hamied, however will continue to be the Chairman of Cipla in a non-executive role effective April 1, 2013. “The board unanimously acknowledges the outstanding contribution of Dr Hamied to the company over the past 52 years, and in deference

Sun drops plan to gain full control over Taro

to his wishes, has accepted his proposal to retire as MD effective March 31, 2013,� the BSE filing said.

Cipla recently announced the appointment of Subhanu Saxena as the company’s CEO, who took over the reins this month.

The top management team at Dr Hamied Cipla includes wholetime director S Radhakrishnan.

Hamied’s nephew, Kamil, and niece Samina — children of M K Hamied — are already part of the company’s core management team. Cipla also reported a 25.5 per cent rise in quarterly profit on robust sales but slightly missed street estimates as taxes surged. The net profit grew to 3.39 billion rupees in October-December from 2.7 billion rupees a year earlier.

Richfeel Health and Beauty inks agreement with Elder Healthcare Richfeel Health & Beauty Private Ltd (Richfeel), the operator of India’s biggest chain of Trichology clinics, inked marketing & distribution arrangement with Elder Healthcare Ltd. Elder Healthcare produces an array of FMCG and skin care products through extensive R&D. The Company is also engaged in marketing of diverse products through licensing agreements with Indian and international companies.

Elder Healthcare has a strong pan-India distribution network ably supported by a strong marketing team.

Speaking on the development, Dr Apoorva

while using Elder Healthcare’s panIndia distribution reach to cater to underserved markets more effectively.�

Dr Anuj Saxena, MD, Elder Pharmaceuticals, Dr Shah Dr Saxena opined, “Elders manufacturing and Shah, Founder, Richfeel distribution network and the Health & Beauty Pvt Ltd, said, cutting-edge research and “Our association with Elder technology of Richfeel, Healthcare is a step forward in complement each other to our journey to offer world-class make the right combination products to all our customers for creating a synergy across the country. This between Richfeel and Elder association will allow us to focus to achieve cumulative on the R&D of new products growth strategies.�

Sun Pharma has decided to give up on its efforts to acquire full control over its Israeli-subsidiary, Taro Pharma. Both the companies have mutually agreed to terminate their merger agreement, which was announced in August 2012. Sun Pharma will continue to hold 66.5 per cent in the company, while the balance will be held by other shareholders like hedge funds. Sun Pharma had acquired Taro in 2007 for $ 454 million, and in 2011, first announced the intention to merge the company with itself and offered $ 24.5 per share to the shareholders (other than Sun Pharma and its affiliates). Shareholders did not show interest in the offer, which was subsequently revised a couple of times.

In its most recent offer, Sun Pharma sweetened the deal and increased the offer according to which shareholders would have received $ 39.50 per share upon the close of the merger. The minority shareholders were looking at an increase beyond $ 39.5 which Sun Pharma was unwilling to do. This is the reason why they decided to ask the special committee, which was setup to look into this takeover to mutually terminate the merger agreement. Sun Pharma and Taro (at the direction of the special committee) agreed that terminating the merger agreement was in the best interest of the respective companies and shareholders, says a company statement.

Merck and Opexa enter multiple sclerosis deal Merck has agreed a deal with Opexa Therapeutics to develop and commercialise a new personalised treatment for Multiple Sclerosis (MS). Tcelna (imilecleucel-T) is being developed as a personalised therapy specifically tailored to each patient’s individual disease profile and has been evaluated in phase I and II clinical studies in MS that included Secondary Progressive Multiple Sclerosis (SPMS) patients. Tcelna (imilecleucel-T) has fast track designation from the US FDA as a potential treatment for SPMS. Under the terms of the agreement, Opexa will receive an upfront payment of $ 5 million for granting an option to Merck for the exclusive licence of the Tcelna (imilecleucel-T) programme for the treatment of MS.

SanoďŹ delivers ďŹ rm results in 2012 despite patent expirations In the fourth quarter of 2012, Sanofi generated sales of â‚Ź 8,526 million, an increase of 0.2 per cent on a reported basis. Net sales in 2012 reached â‚Ź 34,947 million, an increase of 4.7 per cent on a reported basis. In the fourth quarter of 2012, sales of the Group’s growth platforms totaled â‚Ź 6,002 million, an increase of 11.5 per cent, with growth exceeding 20 per cent for vaccines, diabetes, new enzyme and other innovative products.

7

8

0R GHU Q 3KDUPD‡ ) HEUXDU \

News, Views & Analysis

Glenmark launches IND enabling studies for GBR 830 Glenmark Pharmaceuticals SA (GPSA), a fully-owned subsidiary of Glenmark Pharmaceuticals Ltd India (GPL), launched the clinical development programmes for GBR 830, the new antiOX40 monoclonal antibody drug candidate, to initiate IND enabling studies.

GBR 830 has been discovered and developed by the Glenmark Biologics Research Centre located in La Chaux-de-Fonds, Switzerland.

OX40 is a well-known target and the development of OX40 antagonists has been very challenging.

Glenmark has achieved a significant milestone with the successful generation of an antagonistic OX40 monoclonal antibody coupled with generation of data validating the role of OX40 in

autoimmune diseases. GBR 830 shows great promise to emerge as a valuable therapeutic option to treat patients suffering from immune pathologies such as autoimmune diseases such as Rheumatoid Arthritis (RA) and Inflammatory Bowel Disease (IBD) Commenting on this milestone, Dr Michael Buschle, CSO & President - Biologics, Glenmark Pharmaceuticals, said, “No antagonistic antibodies targeting OX40 are currently in clinical stage of development.

We are confident that the antibody expertise and product development capabilities of the Switzerland Biologics Research Centre will continue to enrich the Glenmark discovery pipeline.�

Medicines Compendium extends global outreach by forming new committees and web portal In the quest to ensure quality medicine supply across the globe, the USP announced the formation of three new Expert Committees for its Medicines Compendium (MC) along with an improved and exclusive online platform.

In addition to the initial Medicines Compendium— South Asia (MC-SA) Expert Committee formed in 2011 and chaired by Dr Antony Raj Gomas, USP, has added the Medicines Compendium—East Asia (MC-EA) Expert Committee, chaired by Dr Jaisheng Tu; the Medicines Compendium— Latin America (MC-LA) Expert Committee, chaired by Dr Maria Ines Rocha Miritello Santoro; and the Medicines Compendium— Biologics (MC-BIO) Expert Committee chaired by Dr Dhananjay Patankar. The first three expert committees comprise experts from the region on chemical medicines and excipients.

The MC-BIO expert committee comprises experts on biologics and biosimilars from Argentina, Brazil, China, South Korea, and the United Kingdom as well as biologics experts from India who were members of original MC-SA expert committee.

USP also announced the expansion and enhancement of the MC website to incorporate extensive interactive capabilities that support stakeholder comments.

Roger L Williams, MD & CEO, USP, said,“I am gratified by the advances of the Medicines Compendium Williams during its first year and a half. The MC’s innovative approaches to monograph development allow USP to create monographs using a reference procedure that may be used to test articles from multiple manufacturers. The

MC development process also has paved a way to a more rapid and effective approach to developing standards. The work of the Medicines Compendium Expert Committees, supported by USP staff in India, Brazil, China and the US, has created a strong foundation upon which we are now able to build.�

To date, approximately 70 monographs have been authorised for use, and over 30 more monographs are near final authorisation in the MC. An additional 180 more are in the initial for development phase.

The MC is a free, online resource of quality standards for medicines approved in any country. It was launched in July of 2011 with one Expert Committee (EC) based in South Asia (India).

Apollo to raise value of pharma business before entering partnership Apollo Hospitals Enterprise Ltd (AHEL) is planning to increase the value of its pharmacy retail business, Apollo Pharmacy, over the next 12-18 months.

AHEL had earlier said it was looking for a strategic partner with international experience for its pharma business. Now, the company will increase the value of the pharma arm before finalising anything on strategic partnership. “We have said that we would look at a strategic partner over next few quarters or the next couple of years. The most important thing is that today we are focussing on increasing the business, making it more profitable. Clearly, we realise that as a business, we really want to extract value out of this for our next phase of growth in the hospitals segment. So, we are going to look at it over the next 12-18 months. We are not in a hurry to do it,� said Krishnan Akhileswaran, Chief Financial Officer, AHEL, in an analysts call.

Apollo Pharmacy has managed to make profit at a time when competitors have not, according to company officials. Currently, AHEL has around 1,445 pharmacy outlets.

The pharmacy retail business has grown at around 31 per cent in the nine months ended December 2012. “With regard to investments into the pharmacy, right now we believe that we still can show a better performance so that we attract a better valuation. It will take at least another six months before we firm up any strategy,� said Suneeta Reddy, Joint Managing Director, Apollo Hospitals Group.

Revenue from the pharmacy business grew 29.3 per cent from ` 224.6 crore during the third quarter ended December 2011 to ` 290.5 crore for the quarter ended December 2012. For the nine months ended December 31, 2012, total revenue stood at ` 815.8 crore, compared to ` 622.8 crore, growth of 30.9 per cent.

The company plans to add 200 stores every year and its target is to increase margin by 1 per cent every year. Meanwhile, as part of rationalisation, the company is also shutting down unviable stores. Over the last two years, 34 stores were closed down mostly in Mumbai and Delhi.

0 R G H U Q 3 K D U P D ‡ )H E U X D U \

News, Views & Analysis

ACG Worldwide organises educational seminar for pharma students ACG Worldwide, along with Indian Pharmaceutical Association (IPA) had organised a seminar for M Pharm & final year B Pharm. students on the topic, ‘Developments in Pharma Technologies’. The seminar aimed to keep the students abreast with the latest technologies and processes and offer them insights regarding practical vs text-book solutions.

The seminar was a full-day event held on January, 25, 2013, at SciTech Centre, Jogeshwari, Mumbai. An introduction speech was given by Ajit Kanetkar, HeadTechnical Cell, ACG Worldwide, followed by an inaugural speech by the special guest of honour, Dr Rakesh Tirpude, Assistant Commissioner, FDA - Maharashtra.

The speakers gave insights about the new developments in capsule filling and tabletting, tablet coating, capsule guidelines

and ensuring quality and traceability of the products. Currently, India is a pharma hub. There are various reasons for this boom.

Intellectual Property Right (IPR) protection offered in the country is leading to higher R&D investments. Dr Tirpude addressing students India has the third largest English speaking scientific light on how pharma companies and technical manpower. Also, could ensure this along with the country has a large and traceability. He emphasised that it diverse patient base for clinical is essential for pharma companies studies and boasts of over 100 to upgrade production facilities USFDA, MCA & TGA approved to include camera inspection manufacturing facilities. India systems. As counterfeiting also has a strong global network is on the rise, various of R&D scientists and is a cost- anti-counterfeiting measures effective country. were discussed including track While most pharma & trace solutions that helps endcompanies are concentrating users identify the genuineness of their resources on upgrading the the drug via a SMS. Singh added, quality of drugs, Harpal Singh, “Companies should run a global Director, ACG Inspection, shed programme, adopt a holistic

Lilly discontinues FLEX-V study based on efďŹ cacy results Lilly has decided to discontinue the FLEX-V study. This decision comes based on the interim futility analysis of FLEX-V study, which was investigating tabalumab for the treatment of patients with moderateto-severe RA who had an inadequate response to one or more Tumour Necrosis Factor (TNF) inhibitors.

However, phase 3 lupus programme continues as planned.

US-based innovation leader Eli Lilly and Company announced the discontinuation of the Phase 3 Rheumatoid Arthritis (RA) programme for tabalumab, an anti-BAFF (B cell activating factor) monoclonal antibody, due to lack of efficacy. The decision was not based on safety concerns.

Decision comes based on the interim futility analysis of FLEX-V study, which was investigating tabalumab for the treatment of patients with moderate-to-severe RA who had an inadequate response to one or more TNF inhibitors. All ongoing phase 2 and phase 3 RA studies will be stopped. “While we are obviously disappointed by these results in RA, we continue to believe that tabalumab could have significant potential for patients in other disease areas,� said Eiry Roberts, MD, VP-Autoimmune Product Development, Lilly. The decision to stop the current RA programme for tabalumab is expected to result in a first-quarter charge to R&D expense of approximately $ 50 million. Tabalumab is one of three potential new medicines in late-stage clinical development for a variety of autoimmune conditions. The tabalumab phase 3 programme for systemic lupus erythematosus, ILLUMINATE, is ongoing and will continue as planned.

enterprise approach and chose a proven method and solution to counteract counterfeiting. This would eventually help to curb revenue losses.�

The evolution of tablet coating has also been the topic of discussion in the recent times. Today, various types of coatings are available in the market including sugar coating, polymer coating, coating of gums, plasticisers and flavours. Praveen Shetty, Senior Manager - Process, Pam Glatt, said, “Coating is essential as it gives the tablet an improved identity. It improves drug stability and prolongs shelf-life among other things.

Interaction and knowledge sharing with students is a great way to propel the growth any industry. Students were encouraged to undertake facility visits and industrial training to further their knowledge.

Pallavi Mukhopadhyay

Pergamum AB in pact with Cadila Pergamum AB and Cadila Pharmaceuticals Ltd announced a strategic collaboration to develop a novel treatment of infections with a unique targeting mechanism clearly distinguished from classical antibiotics. The two companies will collaborate on the preclinical and clinical development of a novel therapeutic peptide that has been developed by Pergamum AB. The development will be conducted at the facilities of Cadila Pharmaceuticals Ltd in Ahmedabad, India. Cadila will be responsible for all costs related to the development of the product up to phase II and global rights will be shared between the companies. “Cadila Pharmaceuticals bring their expertise in drug development and demonstrates that commitment towards developing affordable innovative compounds to the market in this collaboration�, said Rajiv Modi, CMD, Cadila Pharmaceuticals Ltd.

9

10

0R GHU Q 3KDUPD‡ ) HEUXDU \

News, Views & Analysis

Roche’s Avastin new regimen approved by US FDA for the treatment of metastatic colorectal cancer The US FDA approved the new use of Avastin (bevacizumab) in combination with fluoropyrimidine-based irinotecan or oxaliplatin chemotherapy, for the treatment of metastatic Colorectal Cancer (mCRC). Avastin in combination with fluoropyrimidineirinotecanor fluoropyrimidineoxaliplatin-based chemotherapy is now indicated for the second-line treatment of patients with mCRC who have progressed on a first-line Avastin-containing regimen.

The approval is based on positive results from the phase III ML18147 study, which were presented at the 2012 American Society of Clinical Oncology annual meeting and showed that people who continued to receive an Avastin-based regimen after their cancer worsened

lived longer than people who switched to chemotherapy alone. “The majority of people diagnosed with mCRC receive Avastin plus chemotherapy as their initial treatment,� said Dr Hal Barron, Chief Medical Officer and Head of Global Product Development, Roche. “These people now have the option to continue with Avastin plus a new chemotherapy after their cancer worsens, which may help them live longer than changing to the new chemotherapy alone.�

Avastin is approved in Europe in combination with fluoropyrimidine-based chemotherapy for the treatment of adult patients with metastatic carcinoma of the colon or rectum. In 2011, worldwide sales of Avastin hit around $ 5.5 billion.

Merck receives US FDA approval for ďŹ rst OTC patch for overactive bladder in women Merck announced the US FDA approval of OXYTROLÂŽ for women. This is the only OverThe-Counter (OTC) treatment available for OverActive Bladder (OAB) in women, a condition that affects more than 20 million American women.

OAB is characterised by a strong urge to urinate right away and the need to urinate more often. It typically affects women between the ages of 45 and 60.

The patch provides transdermal delivery of oxybutynin, an active ingredient used to treat overactive bladder for more than 30 years.

Merck licensed the exclusive rights to market, distribute and sell oxytrol as an OTC treatment from Actavis, Inc. Oxytrol was previously a prescription-only patch, but company convinced regulators about its safety and efficacy for OTC use. The safety of oxytrol was tested on more than 5,000 people across nine studies, and side effects included dry mouth, constipation and skin irritation around the area of the patch. “The approval of OXYTROL for women as an OTC treatment option

is an exciting development for the millions of women who struggle to deal with OAB every day,� said Dr Eman Elkadry, Clinical Instructor, Harvard Medical School. “This effective OTC treatment offers women an option to independently manage their condition and achieve a newfound sense of control. The approval also provides recognition that this is a real medical disorder that can be addressed.�

Merck anticipates that it will be available to customers in Fall 2013.

Cadila Healthcare tanks 6 per cent in a second session of loss Cadila Healthcare Ltd is down by 5.8 per cent after the pharma major reported lower consolidated net profit for the December quarter of the financial year 2012-2013, due

to higher tax expenses. The Gujarat-based pharmaceuticals company declared a net profit of ` 1.02 billion, lower by 31 per cent than ` 1.49 billion profit reported for the corresponding

quarter last year. Tax expenses for the quarter jumped three times to ` 0.63 billion from the ` 0.17 billion in the third quarter of 2011.

US exports likely to boost top Indian pharma cos: India Ratings

The top pharma players in the country will continue to witness substantial growth at over 20 per cent this year, essentially due to exports to the US market, according to a report by the India Ratings.

The India Ratings report on outlook for Indian pharmaceuticals for 2013 highlighted, ‘’We believe that top players of the sector will continue to grow strongly in 2013 at over 20 per cent, per annum due to exports. Of the export markets, Indian pharma will focus on the US market which presents significant opportunities for the next two years for generics, due to patent cliffs and recent changes in healthcare policies.’’ According to IMS Health, the global generic expenditure may increase upwards to $ 430 billion by 2016 against $ 242 billion in 2011.

The ratings agency has maintained that R&D expenditure will persistently rise this year, with domestic players starting to target complex chemistry products.

In addition, speculating that the growth drivers for country’s pharma market will continue to be unchanged, the ratings agency expressed that the decision of National Pharmaceutical Pricing Policy (NPPP) 2011 to raise the number of drugs under price control will not make any major differences to the profit in the sector.

0 R G H U Q 3 K D U P D ‡ )H E U X D U \

News, Views & Analysis

JSS College of Pharmacy organises DISSO 2013: A two days national seminar on ’Dissolution Challenges: Regulatory Perspective’

In Brief Lupin Q3 net proďŹ t at ` 3352.30 million Lupin Ltd has posted a net profit after taxes and minority interest of ` 3352.30 million for the quarter ended December 31, 2012 as compared to ` 2350.60 million for the quarter ended December 31, 2011.

Total income has increased from ` 18222.40 million for the quarter ended December 31, 2011 to ` 25275.70 million for the quarter ended December 31, 2012.

Commenting on the results, Dr Kamal K Sharma, Managing Director, Lupin Ltd, said “We had a record quarter driven by strong operating performance and growth in the US. Importantly, we continue to improve on margins consistently.�

MDI Labs to invest ` 150 crore in Indian unit Inaguration ceremony and distinguished guests in an interactive session

Disso 2013, a two-day national seminar on ‘Dissolution ChallengesRegulatory Perspective’ was held during January 24-25, 2013. The seminar was organised by Department of Pharmaceutics, JSS College of Pharmacy, Udhagamandalam.

The event witnessed distinguished guests such as Dr V P Shah, Former, Senior Research Scientist, USFDA, VPS Consulting, MD,USA; Dr Suresh Venkataram, CEO, Semler Research India Pvt Ltd; Dr L Ramaswamy, General Secretary, SPDS & Managing Director, Sotax India Pvt Ltd; Ramsingar Pal, General Manager (Technical), Sotax India (Pvt) Ltd, Mumbai; Aditya Marfatia, Director, Electrolab; H Raghunandan, Associate Professor, JSS College of Pharmacy, Mysore; Dr K Elango, Principal, JSS College of Pharmacy, Ooty;

Dr B Suresh, Vice Chancellor, JSS University, Mysore and President, Pharmacy Council of India; Prof K Chinnaswamy, Emeritus Professor and Guest of Honour, and Dr K Gowthamarajan, Prof and Head, Department of Pharmaceutics, JSS College of Pharmacy, Udhagamandalam.

More than 250 delegates from across the globe attended the seminar. The welcome address was delivered by Dr K Elango, Principal, JSS College of Pharmacy, Udhagamandalam.

Dr Gowthamarajan gave the genesis of the conference and highlighted the importance and need of dissolution.

Prof K Chinnaswamy, addressed the audience and also highlighted scholarships offered by Tamil Nadu Pharmaceutical Sciences Welfare Trust and seven students were awarded with cash prize and certificates.

Dr B Suresh gave the presidential address. He highlighted the recent trends in dissolution and monographs for herbal drugs in upcoming Indian Pharmacopoeia. He also addressed the challenges being faced by industry in times of bio waivers and generic drug development with particular emphasis on biological, vaccines and monoclonal antibodies.

Dr L Ramaswamy, introduced the Society for Pharmaceutical Dissolution Science (SPDS) and activities conducted by the Society. Pal gave a talk on Flow-through cell (USP IV) methods and its application for novel drug delivery systems. Marfatia and team, Electrolab, Mumbai, discussed topic on dissolution apparatus (hands on training).

Largest German clinical laboratory, the Medizinisch Diagnostiche Institute (MDI) plans to invest ` 150 crore in its Indian subsidiary. The company is also planning to achieve a turnover of ` 350 crore in 2015.

Devendu Mehta, Director, MDI Laboratories India, said, “We have drawn up ` 150 crore expansion plans over the next three years period, of which our German parent MDI will invest ` 50 crore. We plan to install world-class automated machines and web-based software in 25 hospital labs across the country.� The expansion will be funded through internal accruals only, he added.

The company has inaugurated its collection centre and processing unit in Karnataka, with opening of first centre at Indiana Hospital & Heart Institute in Mangalore, he said.

According to CII-KMPG recent report, India’s pathological laboratory sector is estimated at $ 4.8 billion by 2015. The diagnostic and pathological laboratory (path lab) test services market holds 52.1 per cent of share. The pathological sector is projected to contribute $ 2.5 billion by 2012.

Shasun Pharma Q3 net falls to ` 8.2 crore Shasun Pharmaceuticals’ third quarter consolidated net profit fell nearly 67 per cent year-on-year to ` 8.2 crore.

Consolidated net sales too came in weak, slipping 13 per cent to ` 257.1 crore from ` 295.8 crore during the same period.

Shasun Pharmaceuticals Ltd (formerly known as Shasun Chemicals and Drugs Ltd) was incorporated in 1976 and is headquartered in Chennai, India.

It is an integrated, leading global supplier of development and manufacturing services for intermediates, API and formulations to the pharmaceutical industry.

11

12

0R GHU Q 3KDUPD‡ ) HEUXDU \

News, Views & Analysis

US FDA approves generic version of anti-cancer drug DoxilÂŽ The Mumbai-based generic drug maker, Sun Pharmaceutical Industries announced that its subsidiary, Sun Pharma Global FZE received the US FDA approval for its Abbreviated New Drug Application (ANDA) for generic version of DoxilÂŽ, Doxorubicin HCl Liposome Injection USP, 2 mg/mL, packaged in 20 mg/10 mL and 50 mg/25 mL single-use vials.

The generic doxorubicin HCl liposome injection USP, 2 mg/

mL is therapeutically equivalent to Doxil liposome injection, 2 mg/mL of Janssen Research and Development, LLC. Doxorubicin HCl liposome injection is used to treat patients with ovarian cancer that has progressed or recurred after platinumbased chemotherapy. Doxil earned around $ 280 million peak sales in CY11 and Sun’s doxorubicin is the first generic drug to get approval for this product.

Commenting on this approval, Captain Valerie Jensen, Director-Drug Shortage Staff, Center for Drug Evaluation and Research, FDA, said, “The agency is committed to doing everything we can to address drug shortages so that patients can get the medicines they need when they need them.

For the past year, the FDA has been working to ensure that supplies of doxorubicin HCl liposome injection were not interrupted.�

Sun Pharma Q3 net proďŹ t at ` 881 crore Sun Pharma has reported a consolidated net profit of ` 881.30 crore for the third quarter ended December 31, 2012. The company had posted a net profit of ` 668.30 crore in the corresponding period previous fiscal, Sun Pharmaceutical Industries Ltd said in a filing to the BSE. Consolidated net sales of the company stood at ` 2,852

crore for the third quarter ended December 31, 2012. It stood at ` 2,145.13 crore for the same period of 2011-12 fiscal. “All our businesses continue to perform in-line with our expectations,� said Dilip Shanghvi Managing Director, Sun Pharma.

The company said the third quarter results were not comparable to the previous

year due to the US-based Dusa Pharmaceuticals becoming a subsidiary of the company during December 2012.

The results for the current period include results of Dusa from the date it became subsidiary of Sun Pharma and, therefore, the corresponding figures for the previous period are not comparable, the company said.

In Brief Aanjaneya Lifecare bags ‘Asia’s Emerging Pharmaceutical Company on Innovations Award 2013’ Aanjaneya Lifecare Ltd received a rare distinction of being Asia’s Emerging Pharmaceutical Company on Innovations at a Associated Chambers of Commerce and Industry of India (ASSOCHAM) that recently concluded at Vigyan Bhavan in New Delhi. The meet was presided by Pranab Mukherjee, The President of India. Aanjaneya Dr Vishwanath Lifecare bagged two prestigious awards by being ranked No 2 industry wise & grabbed the 9th position in Asia-Pacific region at The Global Investor Relations (GIR) Summit Coordinated by KPMG and MZ associates. The event was organised by the ASSOCHAM who conferred the prestigious Asia’s Emerging Pharmaceutical Company on Innovations Award 2013 among a power-packed gathering of the industry leaders. Dr Kannan Vishwanath, Vice Chairman & Managing Director, Aanjaneya Lifecare Ltd, said, “This is a rare distinction & has a significant bearing on all our future initiatives, as a corporate entity and a responsible Company, our responsibility will increase manifold as we have wide & bigger plans ahead, which we plan to achieve in the first quarter of this year. This recognition reflects our overall commitment to adhere quality norms, corporate ethics, investor relations besides our long bonding with internal & external stakeholders.�

Teva Pharma sets up OTC manufacturing plant in India

Teva Pharm India Pvt Ltd recently hosted the groundbreaking ceremony of its new multi-product, Over-The-Counter (OTC) manufacturing facility in Sanand, Ahmedabad district. The new Teva plant will be one of the largest, state-of-the-art OTC medicine manufacturing sites in the world.

Speaking on this occasion, Eran Katz, EVP - Strategy and Operational Excellence, Teva Global Operations, who hosted the event, said, “Teva is delighted to be building a state-of-the-art, multipurpose plant in India to support the growing demand for our nonprescription healthcare products across Asia. The Sanand facility represents a critical component of PGT Healthcare, Teva’s international partnership and joint venture with Procter & Gamble.�

Teva’s Sanand plant will be devoted to OTC manufacturing and will initially satisfy OTC production requirements for the domestic and Asia Pacific markets.

This will include liquid, oral solid dosage and inhaler production including P&G’s current Vicks range of cough & cold medicines and throat drops in India, along with potentially other OTC products for India and other markets.

The construction of the plant is expected to take approximately two years. The new plant will complement the existing network of Vicks contract manufacturers in India as the company plans to continue working with their current contract manufacturers even after this plant is operational. The modular design of the plant will enable Teva to further expand the plant as demand for consumer health care products continues to grow across the region and the globe.

0 R G H U Q 3 K D U P D ‡ )H E U X D U \

News, Views & Analysis

ABLE to set up a clinical trial committee Realising the urgency for the industry to take a pro-active stance to create patient awareness and education about clinical research, The Association of Biotechnology Led Enterprises (ABLE) is planning to set up a clinical trial committee.

This move is to assist the government and the industry to share information arising from drug trials in public domain in an accessible and properly anonymised form. However, this must be balanced with the need to ensure disclosure policies protect patients’ personal data, companies’ Intellectual Property Rights (IPR) and confidential commercial information in order to continue to develop innovative medicines in areas of unmet clinical need.

Dr Kiran MazumdarShaw, CMD, Biocon, and Executive Committee Member,

Dr Mazumdar-Shaw

Dr Murali

ABLE, said, “This initiative would significantly ease the concerns as well as ensure smooth and safe conduct of clinical trials to not only make new drugs available for Indian citizens but also meet the aspirations of scientists, researchers and the industry to enable India to remain a credible destination for clinical research.�

While patients in other countries actively seek

information about the latest medical advances and clinical trials, patients in India too should be empowered with adequate knowledge on clinical trials and reports on the trials that are being conducted in specific disease areas to make an informed decision in terms of participation. Hence, it is crucial for the industry to actively support such a cause.

Waters Corporation introduces new peptide separations chromatography columns Waters has introduced a novel series of UltraPerformance LCÂŽ (UPLCÂŽ) and High-Performance Liquid Chromatography (HPLC) columns for peptide mapping and proteomics as well as for the analysis and lab-scale purification of synthetic peptides.

WatersŽ ACQUITY UPLCŽ CSH130 C18 and XSelect™ HPLC CSH130 C18 columns set a new standard in the analysis and purification of peptides and for the quality of information generated by UPLC, LC and LC-MS assays.

Waters introduced this new column chemistry at the ‘Well-Characterized BioPharmaceuticals’ Symposium, January 28 – 30, 2013, Washington, DC. This column will be available with variety of particle sizes and column dimensions.

Waters’ synthesis process for its Charged Surface Hybrid (CSH™) particles imparts a low level positive charge to the surface of each particle making the new CSH130 chromatography columns unique. This technology allows the columns to be used with a weaker acid modifier such as formic acid to deliver greater resolving power and improved method sensitivity – especially when compared to standard LC-MS methods. With formic acid the CSH130 C18 columns produce significantly better peak efficiency than all other columns at all temperatures/flow rates.

AZ-BMS merges diabetes marketing teams AstraZeneca (AZ) and Bristol-Myers Squibb (BMS) have deepened their diabetes-drug partnership by merging their diabetes marketing teams and moving them to a new headquarters in Philadelphia, USA separate from either company. “That is on purpose because we want them to think diabetes,� said Pascal Soriot, the new ED & CEO, AZ. “We want them to have their own company, in a way - Diabetes Inc,� he added.

Dr P M Murali, President, ABLE, commented, “To ensure smooth operations, we are keen to support the regulatory body in terms of providing training (both classroom and on-site) as well as provide a more neutral platform for exchange of ideas between the regulator and the industry and also maintain a registry of Clinical Research Organisations (CROs), SMOs, ethics committees, labs and bio-pharma.�

Given the delays in settlement in case of any untoward event, it is imperative to set up a quick, time-bound, fact-supported mechanism that uses scientific methods and reasoning to resolve issues. As per the Association, clinical trials represent an example wherein all stakeholders can and should work together with a common goal of making the whole clinical research process safe and transparent.

13

AstraZeneca, Bristol-Myers Squibb’s FORXIGATM not recommended by NICE British health agency, National Institute for Health and Clinical Excellence (NICE) rejected to recommend the use of FORXIGATM or dapagliflozin, as an add-on therapy for use with other anti-diabetic medicines.

NICE is requesting further information from the companies before an appraisal committee meeting in April. AstraZeneca, Bristol-Myers’s FORXIGA is the first of a new class of anti-diabetis medicine called SGLT2- inhibitors. The drug received European Union (EU) approval both as monotherapy and as add-on therapy to improve glycaemic control in November after the EU drug regulator said the medicine’s benefits outweighed the risks of infection and some cancers.

FORXIGA helps the body flush out excess sugar through the urine. Final guidance on the drug will be published in June, said the agency.

14

0R GHU Q 3KDUPD‡ ) HEUXDU \

In Conversation With

The greatest motivation for team members comes from the quality of work and inherent challenges involved Chandreyee Bhaumik

‌says K V Subramaniam, President & CEO, Reliance Life Sciences. In this conversation, he discusses the vital facets of the life sciences industry along with its dominating trends.

pallavi.mukhopadhyay@network18publishing.com

personal and professional lives – ranging from prolonged illness and death of immediate family members, impediments in career choices to stellar performances by my teams.

How has your journey been so far?

My life’s journey so far has been demanding yet exciting. I have had several opportunities; having high-quality chemical engineering and business management education at premier institutes (Madras University and IIMA), being part of expansive and path-breaking organisations (IPCL and Reliance Group), being entrusted all along to build new initiatives, especially Reliance Life Sciences, and above all, in being constantly challenged at the learning, intellectual, strategic and execution levels.

At a personal level, I have had the priceless benefit of a strong value-based upbringing, unstinted support from all immediate family members and have experienced living in several cities in India and have been exposed to diverse cultures globally through travel.

How do you tackle the difficult moments of your life?

I tell myself, as also to family members and colleagues, that the more one looks back the less one would move forward.

So, it is best to quickly move beyond a difficult moment or adversity and focus on the way forward. Excitements are fleeting, but frustrations linger and have to be overcome.

What/who has been your inspiration?

How was the influence?

I have never looked at being inspired by any one or more persons. For me there is something inspirational in most people and in most situations. To me, every interaction is a source of learning. As for influence, I have always been encouraged by my father to think on my own, weigh options, exercise my choice and be responsible for my actions. As a result, I generally do not tend to get swayed or influenced and try to think through issues before taking a call.

What is your ideal success mantra?

I try and practise the principles of action learning propounded

by Prof Reg Revans – being honest is crucial to successful dialogue, each individual is a source of creativity and ideas, acceptance of individual differences is necessary for productive collaboration, questioning is essential for gaining new perspectives, it is important to ask for help, ideas must be turned into practice and working through adversity brings unity.

Every person has a turning point in his/her life. What incident can be regarded as such a juncture in yours?

It is hard to ascribe life’s turning point to one incident.

To my mind, every incident and interaction is a source of learning. It is the degree of impact that varies in a continuum of experiences.

How has been your association with Reliance Life Sciences?

I have been associated with Reliance Life Sciences from its very inception till date, and have been responsible for building the initiative over the last 10 years from scratch - through formulating its vision, developing strategies, hiring people, engaging teams, creating programmes, designing the organisation, building facilities, instituting systems, processes and policies and motivating performance.

It has been extremely

challenging and exciting to say the least. We had to address several challenges – from researching and developing a wide range of products in several biotechnology domains, developing an array of people competencies, creating manufacturing facilities, obtaining Indian and international regulatory approvals, getting market acceptance and, above all, creating an organisational culture of innovation, enterprise, excellence and global market orientation.

Today, there is growing recognition in the pharma community of the complex and differentiated nature of the products that Reliance Life Sciences deals with, the competitive advantage that it has in plasma proteins, biosimilars and speciality pharma and the foundation that it has created for sustained growth and profitability.

It is best to quickly move beyond a difďŹ cult moment or adversity and focus on the way forward. Excitements are eeting, but frustrations linger and have to be overcome.

Discuss the life science industry in India. How is Reliance placed in this segment.

The life sciences industry in India primarily spans medical, plant and industrial biotechnology. The industry is heavily weighted on medical biotechnology with a strong play in vaccines, biosimilars, molecular medicine, regenerative medicine, bioinformatics, diagnostics and devices. In plant biotechnology, the traditional

genetic engineering techniques are much in vogue, but strides made by India in transgenic crops have been stunted recently due to public activism.

Industrial biotechnology has been strong in fermentationbased products, but biopolymers and biofuels have had to contend with issues around cost competitiveness, although technologies have been developed. Further, marine biotechnology and environmental biotechnology are relatively less developed.

Reliance Life Sciences has a strong medical biotechnology play – covering plasma proteins, biosimilars, novel proteins, speciality pharma, regenerative medicine, molecular medicine and clinical research services.

What are the highest and the lowest points in your life?

I have had several setbacks and successes in both my

How do you motivate your team members?

The greatest motivation for team members comes from the quality of work and inherent challenges involved.

I tend to constantly focus on these two aspects. I also tell employees that they should see their growth in the growth of the organisation.

As a result, the challenge for leadership is to constantly grow the business and make opportunities available for team members. At another level, motivating team members also comes from an emotive connect because I believe that at the end of the day, people work for people more than for an organisation.

What according to you is an ideal work environment?

An ideal work environment is one where, first of all, one looks forward to getting to work, relishes the quality of work, challenges involved and team interactions, is respected and there is a fun element as well. In addition, the physical work environment space has to be pleasing and aesthetic and not drab.

0RGHUQ 3KDUPD‡ )HEUXDU \

Special Focus

15

The cleanroom market in India Nikunj Sharma nikunj.kumar@network18publishing.com

ccording to the McIlvaine Company’s report World Cleanroom Markets, Asia is projected to be the largest buyers’ hub by 2015 in terms of cleanroom consumables sales, registering fastest growth rate across the globe in both consumables and hardware segments.

Cleanrooms consumables sales are expected to surpass $ 8 billion through 2015 and pharmaceutical and biotechnology sector would be the third largest consumers of cleanroom products. On the other hand, the cleanroom hardware sales are forecast to reach to $ 4.9 billion through 2015.

A

Set for big growth Cleanroom market mainly comprises consumables and hardware products and continues to explore the hidden potential of Indian bio-pharma industry. With regulatory authorities tightening the noose over drug manufacturing specifications to enhance the export of medicines, the market for cleanrooms in India offers significant prospects due to its indispensible attribute.

Dr Ruchi Dass, Founder & CEO, HealthCursor Consulting Group, says, “Cleanroom refers to providing contamination-free and temperature-controlled room facilities in different industrial environments. It was medicine that first realised the potential relationship between good hygiene and healing. The technique in the cleanrooms is to minimise the number of particles released by humans and equipment, and eliminate them immediately.

In medicine, a slightest contamination may result in loss of function, reliability, medical compatibility or other essential quality characteristics.

The aim of cleanrooms is to protect patients, products and processes against contamination of any sort, ie, the number of airborne dust particles, pollen, bacteria, viruses and aerosols must be as small as possible.�

Cleanroom technology is essential to safeguard the product at various stages such as in the filling of pharmaceutical dosage containers as well as for the worker’s safety who handles potent drugs. Asian pharmaceutical industry is widely adopting minienvironment technology after the US, with Europe being the foremost in implementation. “One of the basic criteria for the requirements placed on equipment in cleanrooms is the nature of the airflow system.

Air should enter the cleanroom with a turbulent flow, thereby providing continuous dilution and cleaning. The expensive cleanrooms with lowturbulence displacement flow allow air to initially enter the cleanroom with low turbulence.

Although it may sound simple, in practice this requires an extensive stack of technical and organisational measures, ie right from the expensive

Courtesy: MeasureTest Corporation

Understanding the technology

ventilation and air conditioning systems to designing codes of conduct for employees and extremely exacting quality requirements for equipment,� avers Dr Dass.

Healthcare sector offers significant potential for the consumption of cleanrooms, which largely remains untapped in India, as the sector needs cleanroom technology to isolate patients carrying potential disease.

Cleanroom hardware is developed to match different

The aim of cleanrooms is to protect patients, products and processes against contamination of any sort.

Dr Ruchi Dass Founder & CEO, HealthCursor Consulting Group

Healthcare sector offers signiďŹ cant potential for the consumption of cleanrooms, which largely remains untapped in India.

stages of cleanliness such as High Efficiency Particulate Air (HEPA) filters, special materials walls, perforated flooring for laminar room along with biological safety cabinets, clean benches or mini-environments.

Dr Dhanalkshami Iyer, Director, Lateral-i, comments, “Processes for biopharmaceutical manufacturing have evolved with latest technologies, and so have the cleanrooms concept. While the open room operations have changed to closed and functionally closed in the recent years, the expectations have risen to want of classified cleanrooms.

So, industries are gearing up in terms of coming up with better and safe biopharmaceutical processes, which is executable at a relatively lower cost and environment friendly too.�

Helping hand from government In January 2013, the GEF South Asia Clean Energy Fund

announced an investment of ` 45 crore in Integrated Clean Room Technologies Ltd (IClean), a provider of turnkey cleanrooms and associated equipment to biotechnology, pharmaceuticals and microelectronics sectors.

IClean is planning to utilise the corps to enhance the production capacity, improved R&D and increase its market standing. “With the government becoming sensitive to the environmental hazards and

With the government becoming sensitive to the environmental hazards and health issues related to a toxic environment, new legislations are laid down.

Dr Dhanalkshami Iyer Director, Lateral-i

health issues related to a toxic environment, new legislations are laid down.

The initiative by the United Kingdom Government is a milestone indeed, namely the Clean Neighbourhoods and Environment Act 2005.

These steps will definitely go a long way in safeguarding our environment and at the same time act as a stringent check on the biopharmaceutical industries as well. Good manufacturing practices can be strengthened and improved by persistently bringing up newer technologies, coming up with science-based evaluations and a controlled plus classified environment. The Controlled Not Classified (CNC) environment of the status quo should strictly be amended to a Controlled and Classified Environment,� informs Dr Iyer.

In addition, Heat Ventilation Air Conditioning (HVAC) systems are also required for close control of temperature, humidity and pressure on regular basis.

Exclusively designed fans can be combined with separate filter modules to ensure smooth flow distribution. Cleanrooms consume a significant amount of power, which is fuelling the demand for smart technology that can minimise the energy loads in industry environments.

0RGHU Q 3KDU PD‡ ) HEUXDU \

16

Special Focus

Cleanroom regulations Nikunj Sharma nikunj.kumar@network18publishing.com

leanroom practices in industry environment are always subjected to human intervention, which leads to contamination at various stages. Regulatory bodies and industry continue to exercise different norms to maintain a microbe free working environments, as common ambience are the potential sources of infection such as water and air.

Dr Radhakrishna Tirumalai, USP Principal Scientific Liaison, USP General Chapters, informs, â&#x20AC;&#x153;In any environment where human operators are present, microbial contamination at some level is inevitable. Cautious cleanroom environment design and operation will not eliminate the shedding of microorganisms if human operators are present. An important resource for manufacturers, the US Pharmacopeial Conventionâ&#x20AC;&#x2122;s (USPâ&#x20AC;&#x2122;s) General Chapter <1116> Microbiological Control and Monitoring of Aseptic Processing Environments provides guidance on the evaluation of cleanrooms and ways to support microbiological control of aseptic environments.

Products manufactured in such environments include pharmaceutical sterile products, bulk sterile drug substances, sterile intermediates, excipients and, in certain cases, medical devices. The information found in General Chapter <1116> applies to cleanrooms, Restricted-Access Barrier Systems (RABS), and isolators used for aseptic processing.â&#x20AC;?

C

Quality factors: Holding importance In the pharmaceutical industry, cleanrooms ensure quality in manufacturing and control operations, and these need to be installed with perfection to attain microbial limitation with a specified area. Pharmaceutical production involves a series of highly controlled environments of cleanrooms to reduce the particle count and the microbial count with preshowers of air. In addition to the architecture, cleaning protocol for cleanrooms is also an important aspect by applying adequate disinfecting agents.

Dr Tirumalai comments, â&#x20AC;&#x153;A large proportion of products labelled as sterile are manufactured by aseptic processing rather than terminal sterilisation. Because aseptic processing relies on the exclusion of microorganisms from the process stream and prevention of microorganisms from entering open containers during processing, product bioburden as well

Essential to evolve and maintain standards Contamination control is an area that receives and needs continuous upgradation and regulatory advisory. Controlling microbial and particulate matter contamination is a crucial aspect of any sensitive product manufacturing process to deliver quality products.

as the bioburden of the manufacturing environment are important factors governing the risk of unacceptable microbial contamination. In General Chapter <1116>, types of aseptic processing are differentiated by the presence or absence of human operators.

Recommendations described in <1116> include an emphasis on a routine microbiological evaluation programme for controlled environments; good performance and training of personnel working in controlled environments; and the introduction of the use of contamination rates in place of straightforward microbial counts with regard to microbiological control and monitoring.

Main components of cleanrooms design and maintenance include architecture, Air Handling Units (AHUs), and cleaning SOPs.

In the pharmaceutical industry, cleanrooms ensure quality in manufacturing and control operations, and these need to be installed with perfection to attain microbial limitation with a speciďŹ ed area.

Architecture The design of a cleanroom should be contemplating with the ambience structures such

as ceilings, enclosures and flooring. Ceilings and enclosures must be inert to the microbes, smooth surface must be used for partition purposes and thickness ranging from 25 to 100 mm with metallic, melanine and thermostable synthetic resins finishes. The density range of panel filling also varies with the material of filling. Floorings inside the cleanrooms should be resistant to chemical exposure, moisture, durable and free from charge carriers.

AHU units Temperature and humidity control is another key measure in cleanroom maintenance and prevent unnecessary microbial growth. An effective AHU unit also ensures the efficient and frequent utilisation of the cleanrooms, with adequately sealed air circulation systems.

â&#x20AC;&#x153;The purpose of an evaluation programme is to verify a â&#x20AC;&#x2DC;suitable state of control.â&#x20AC;&#x2122; Use of contamination recovery rates can track performance and indicate the need to improve microbiological control.

The objective must always be to reduce contamination incidence rates to the lowest level that can be attained in any environment. Control is achieved through the reduction of human-borne contamination risk by minimising operator interventions. General Chapter <1116> also includes improved description of high risk sites and when to sample them, clarification of limitations of counting methods used in

Cleaning SOPs With all design and operational specifications maintaining a cleanroom is another equally important aspect. Cleaning of cleanrooms need specific products and trained personnel adhering to strict SOPs and guidelines.

Designing a cleanroom is a tedious exercise, as extraneous matter is evaluated by different standards, which impacts the cleanliness of the clean room chamber.

The presence of particulate matter must not interfere in the productâ&#x20AC;&#x2122;s sterlisation, as absence or presence of both non-viable and viable particles is harmful to effective cleanroom operations.

Cautious cleanroom environment design and operation will not eliminate the shedding of microorganisms if human operators are present.

Dr Radhakrishna Tirumalai USP Principal Scientific Liaison, USP General Chapters

microbiological evaluation, including sampling, recovery, data tracking and trend analysis,â&#x20AC;? says Dr Tirumalai.

Periodical audits are required in order to assess the protocol follow-up and routine entry, exit and cleaning practices for maintaining cleanroom environment.

ISO 14644 cleanroom standards According to the first cleanroom standards and classification published by the US Federal Standard 209E in 1963, there were six categories of cleanliness ranging from 1 to 100,000, based on the varying particle size and subsequent air quality. The objective of Standard 209E was the â&#x20AC;&#x2DC;standardisation of plants, operational protocols and equipment for cleanrooms and related controlled environments comprising of operational limits, procedural limits and testing methods to attain required attributes to reduce micro contaminationâ&#x20AC;?.

The ISO 14644-1 was published in the year 1999, which officially took over 209E. Later on, several recommendations were proposed in ISO 14644-1.

The ISO 14644 covers cleanroom testing and classification and has been revived several times in the past, which will be implemented in 2013, pertaining to calibration policy, SOP, equipment selection or IQ/OQ associated with the production environments adhering to EU-GMP and ISO 14644.

0RGHUQ 3KDUPDÂ&#x2021; )HEUXDU \

Special Focus: Interface

17

Awareness about using the right kind and quality of equipment is lacking as several Indian manufacturers still opt for the cheapest equipment Pallavi Mukhopadhyay pallavi.mukhopadhyay @network18publishing.com

Tell us about your journey in the instrumentation industry.

I have been in the instrumentation industry since 1966; initially with a large scientific instrument distributor. Then I started Measure Test Corporation in 1990 with my family members. We concentrate on specialised imported instruments particularly for the pharma and electronics industries. Our main focus is on cleanrooms. We supply air borne particle counters, nontoxic smoke generators, Dioctyl Phthalate (DOP) photometers, liquid particle counters, among various other instruments.

I disseminate knowledge on cleanrooms across the country by holding seminars and workshops and have also conducted these in Thailand, Singapore, Malaysia, Taiwan, Bangladesh, Indonesia.

Even after four decades in instrumentation, I still feel that I am learning something new every day and am eager to share this knowledge with others. Today, the cleanroom industry is seeing an annual growth of 9-10 per cent.

Background of MeasureTest Founded in 1990, MeasureTest Corporation acts as exclusive distributors in India for American, British and Chinese manufacturers of scientific, analytical and process control instruments.

Which equipment, pertaining to cleanrooms, are in demand today?

The need for cleanrooms is in mainly two markets; namely health sciences and electronics. Essentially, the pharma and biotech market are major users of the cleanrooms in India.

The equipment in demand currently is the air borne particle counter, which is used to test dust particles in the air, the aerosol photometer used for leak testing of High Efficiency Particulate Air (HEPA) filters, non-toxic smoke generators to visualise airflow patterns within the cleanroom, differential pressure sensors to measure the difference between the pressure within the cleanroom and outside or between two or more clean zones and the air velocity meter used to measure the rate of air flow within the cleanroom.

What kinds of design changes have you seen in cleanrooms over the years?

There has been a gradual shift over the last 10 years from manual particle counting to automated environmental monitoring. This was initially prompted by the need to comply with guidelines such as European Union GMPs. However, pharmaceutical firms soon realised the side benefits which accrued by adopting these systems, in

terms of higher profits due to improved quality, lower contamination and lesser product recalls.

In the past, manufacturers would opt for a hand-held particle counter in order to make spot checks in the cleanroom once a day. Over the last 10 years, most pharma companies have switched over to continuous monitoring wherein the cleanroom is monitored throughout the production process.

Facility monitoring systems today continuously measure parameters such as airborne particles, relative humidity, air velocity and differential pressure. The results are fed to the central computer. In case of any problems, an alarm or buzzer system goes off. Also, pharma companies are increasingly using isolators or glove boxes. These are meant to isolate the product from the operator, and are useful while handling biohazardous materials. The glove box is kept under negative pressure so that the air is unable to flow out of the unit. New technology such as the blow fill seal technology is also in use today. These new technologies reduce human error and contamination risk to a large extent, and in turn help in reducing batch rejects, thus cutting costs.

What goes into setting up a cleanroom?

An architect, Heating, Ventilation and Air Conditioning (HVAC) consultant and cleanroom contractor will meet with the pharma company and finalise a design. Later, the quality control and instrumentation department will come in. The class of the cleanroom will be decided (ISO Class 5 or 6 or 7 etc), and after construction it will be validated.

Since inception of the company, have you seen any fundamental changes in the clients?

Today, we are seeing a change in the client mindset largely due to necessity.

Export products, if rejected by FDA or other bodies, can cost billions of dollars worth of losses to the manufacturers. Thus, companies today are focusing a lot more on quality.

There has also been an increasing awareness about the need for annual calibration and maintenance checks of the instruments.

However, awareness about using the right kind and quality of equipment is lacking as several Indian manufacturers still opt for the cheapest equipment. This could also occur as drug prices are limited by the government and there is a need for them to economise. Equipment of a substandard quality could hamper the production process.

Tell us about the difference in standard and quality of cleanrooms in India and the West.

The Indian quality and instrumentation standards have considerably improved in the last 10 years. Most major Indian manufacturers have adopted the latest technology. The Indian factory designs are at par with foreign manufacturing units. Many foreign and Indian firms now manufacture most of the

â&#x20AC;Śsays Sheesh Gulati, CEO, MeasureTest Corporation.

After being in the instrumentation industry for 47 years, Gulati, who is also the Secretary of the Contamination Control Society of India, a not-forprofit association with over 100 members drawn from users, constructors and validators of cleanrooms, he shares his knowledge about the trends in the market, policies Indian companies are adopting today and the latest developments in the field.

There has been a gradual shift over the last 10 years from manual particle counting to automated environmental monitoring.

This was initially prompted by the need to comply with guidelines such as European Union GMPs.

equipment required for cleanrooms in India including Air Handling Units (AHUs), passboxes, panels, flooring, partitions, laminar flow benches etc and their quality is comparable with the Western countries.

How is the competition in the domestic market?

There is severe competition in India, in fact the prices at which particle counters, aerosol photometers, etc are sold in India are probably the lowest in the world. Lately, a few Chinese products have also entered the market,

but their quality, according to me, leaves a bit to be desired. Our USP has always been full technical and servicing backup.

What is the training need of the hour?

Pharma companies today are aware about the importance of employee training and continually conduct training sessions for knowledge upgradation. I have conducted in-house training programmes for most of the large Indian pharma manufacturers free of charge.

Various industrial bodies and associations are engaged in organising seminars across the country. Instrument manufacturers and distributors have their principals travel to India from abroad for knowledge sharing. However, at present, more pharma colleges and universities should incorporate theoretical and practical courses on cleanrooms so that students do not need to grapple at the workplace.

The younger generation is thirsty for knowledge and should be moulded in the right manner for being a better fit in the system.

0RGHUQ 3KDUPDÂ&#x2021; ) HEUXDU \

18 Insight & Outlook: Policies & Regulations

FDI in pharma

Embrace or fear?

Foreign Direct Investment (FDI) inflows are relatively more long-term in nature. FDI worth $ 186 billion found its way to India during April 2000 to November 2012. During the same period, the cumulative FDI in â&#x20AC;&#x2DC;Drugs & Pharmaceuticals Sectorâ&#x20AC;&#x2122; was $ 9 billion, constituting 5 per cent of the total FDI and ranking as the 5th largest sector in the top 10 sectors receiving FDI.

oreign Direct Investment (FDI) is often considered to be one of the more desirable forms of foreign investment in a country as compared to Portfolio Investment Schemes (PIS) on the Indian Stock Exchanges.

FDI means investment by a person resident outside India in the capital of an Indian entity. FDI can be bifurcated on the basis of its approval into automatic route, ie, where FDI does not require the prior approval of the government and approval route, ie, where the prior approval of the government is required.

F

Regulations and agencies Indiaâ&#x20AC;&#x2122;s FDI regime consists of three regulations ~ the Foreign Exchange Management Act, 1999 (FEMA)/its regulations, the Consolidated FDI Policy (CFDIP), and the Circulars to Authorised Person issued from time to time by the Reserve Bank of India. The FEMA and its regulations are superior to the FDI policy.

Three agencies are involved in the FDI regime, namely, the Reserve Bank of India, the nodal regulatory authority for all matters connected with foreign exchange transactions; the Department of Industrial Policy and Promotion, which frames the CFDIP; and the Foreign Investment Promotion Board (FIPB), Ministry of Finance, which approves all cases of FDI requiring government approval.

The directions issued by the RBI to various banks, etc, are known as â&#x20AC;&#x2DC;A.P.(DIR Series) Circulars.â&#x20AC;&#x2122;

Instruments One question to be addressed is the instrument for FDI. This includes: Equity shares Compulsorily convertible preference shares Compulsorily convertible debentures Warrants and partly paid-up sharesâ&#x20AC;&#x201C;These require prior FIPB permission Non-voting sharesâ&#x20AC;&#x201C; Permissible under an automatic route The instruments must be issued within 180 days of the receipt of funds or else the funds are liable to be refunded.

It would be advantageous if Indiaâ&#x20AC;&#x2122;s pharma sector gets a â&#x20AC;&#x2DC;shot in the armâ&#x20AC;&#x2122; by way of a clear FDI Policy devoid of confusion and vagueness!

Policy for FDI in pharmaceutical sector Earlier FDI in the pharma sector was on the automatic route. An amendment was carried out to the CFDIP in November 2011 after which the Policy is as follows: FDI in Greenfield pharma companies is allowed up

to 100 per cent on the automatic route FDI in existing pharma companies is allowed up to 100 per cent only with the prior FIPB approval The above Policy was slated to be reviewed after a period of 6 months but there has been no change till date.

What is a â&#x20AC;&#x2DC;Greenfield companyâ&#x20AC;&#x2122; has not been defined under the Policy. Hence, we must understand it as per the general commercial definition to mean a â&#x20AC;&#x2DC;new companyâ&#x20AC;&#x2122;.

Thus, if a foreign investor wants to set up a new Indian pharma company, then it can do so. Such a company can even be 100 per cent held by the foreign investor. It may be noted that unlike the earlier Aviation FDI Policy, which restricted FDI by existing foreign airlines, there is no restriction on the type of investor in the pharma sector.

Hence, it could be a strategic (an existing pharma player) or even a financial investor (a private equity fund).

On the other hand, if a foreign investor desires to invest any stake in an existing Indian pharma company, then the same would require prior government approval.

Approval would be required whether the investment is a fresh issue of shares to or an acquisition of shares from the Indian promoters by the foreign investor. Thus, every primary market investment as well as secondary acquisition requires prior approval. It is submitted that there must be a minimum percentage

If a foreign investor wants to set up a new Indian pharma company, then it can do so. Such a company can even be 100 per cent held by the foreign investor.

threshold, say 49 per cent, or a minimum investment stake, over which the FDI would require approval. Requiring a nod for every investment is a classic case of over regulation.

An interesting situation arises as to what would be the position if an existing pharma company makes a sale of its business to a wholly owned subsidiary of a foreign pharma company? It may be noted that this restriction does not apply to FII investment in listed pharma companies. The embargo is only on FDI. Thus, an FII can acquire shares of any listed Indian company, say, Cipla Ltd, without any approvals.

Till a few months there was a confusion as to who would be the regulatory authority for approving FDI in pharma â&#x20AC;&#x201C; the FIPB or the Competition Commission of India?

Ultimately, the government decided that it would be the FIPB till such time as the Competition Act, 2002 is amended to permit the CCI to approve such deals.

Jurisdiction A bulk of the FDI (according to DIPP, over 52 per cent of

the total FDI during 2000 to 2012) is structured through favourable tax jurisdictions, such as Mauritius, Cyprus, Singapore, etc, because of the concessional tax treatment.

Put & call options: Contrasting stands Exit options have been a norm in FDI. However, of late, the RBI has taken a view that put and call options, attached to FDI instruments, are not valid. The CFDIP saw a flip-flop on this issue. Now, even instruments having in-built options, would qualify for FDI. However, the RBIâ&#x20AC;&#x2122;s stance on this issue has yet not been clearly spelt out.

Will it make or mar?

Indiaâ&#x20AC;&#x2122;s FDI Policy is myriad, complex and ambiguous at times. The flip-flop in the pharma sector being a classic example. Should not forces of free competition and free spirit be allowed even in the pharma sector? Is an FIPB approval for FDI in pharma, not an example of the colonial hangovers which modern India suffers from?

It would be advantageous if Indiaâ&#x20AC;&#x2122;s pharma sector gets a â&#x20AC;&#x2DC;shot in the armâ&#x20AC;&#x2122; by way of a clear FDI Policy devoid of confusion and vagueness!

Anup P Shah Partner, Pravin P Shah & Co anup@ppsco.in

0 R G H U Q 3 K D U P D Â&#x2021; )H E U X D U \

Technology Transfer

19

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

Technology Offered A novel process Foramides Synthesisamides synthesis The present technology provides with an amidation reaction of unprotected a-amino acids in water under neutral conditions with various aliphatic, aromatic and heteroaromatic amines in the presence of coupling reagent l,lâ&#x20AC;&#x2122;-carbonyldiimidazole (CDI) at ambient temperature to obtain the corresponding a-amino acid amides.

Areas of application Medical and pharmaceutical industry Forms of transfer Technology licensing Anti-ulceritic APIs An Indian company offers anti-ulcer drugs like omeprazole, pantaprazole, omeprazole sodium, omeprazole magnesium and esomeprazole magnesium for operations in manufacturing processes.

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

sheep and cattle.

Areas of application Pharmaceutical industry Forms of transfer Consultancy Detection and analysis of heavy metals in the industrial effluents The present technology relates to a device and method for detecting and also measuring the concentration of copper in an industrial effluent.

This device comprises of an ion selective electrode (ISE) coupled to immobilise Bacillus sphaericus strain characterized in producing Areas of application Industrial effluents, accumulates Forms of transfer Technology licensing Filter cleaning system An Indian company offers an automatic filter media cleaning equipment with drying system. It consists of air wash, water wash and drying facilities.

Areas of application Filter media cleaning Forms of transfer Joint venture, equipment supply

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

Areas of application Biotechnology, engineering Forms of transfer Consultancy Calcium Gluconate A company needs technology for manufacturing of Calcium Gluconate Areas of application Pharmaceutical industry Forms of transfer Technical services, project report, others Extract of medicinal and aromatic plants A company is interested in putting up a multi-purpose herbal extraction

plant for the extraction of medicinal and aromatic plants and herbs like artemisinin/quinine sulphate and other alkaloids.

Areas of application Pharmaceutical industry Forms of transfer Others IV fluid manufacturing as SME An Indian company needs new and good technology to start which is a subservient of genetic manufacturing of IV fluids.

Areas of application Medical technology Forms of transfer Technical services, others Kite grading engineering A company is looking for kite grading, which is a subservient of genetic therapy research particularly for the cardiovascular novice.

Areas of application Medical research Transfer terms Others

Information courtesy: 'U .ULVKQDQ 6 5DJKDYDQ ,Q &KDUJH 7HFKQRORJ\ 7UDQVIHU 6HUYLFHV *URXS $VLDQ DQG 3DFLĂ&#x20AC;F &HQWUH IRU 7UDQVIHU RI 7HFKQRORJ\ $3&77 RI 8QLWHG 1DWLRQV (FRQRPLF DQG 6RFLDO &RPPLVVLRQ IRU $VLD DQG WKH 3DFLĂ&#x20AC;F 81(6&$3

$3&77 %XLOGLQJ & 4XWDE ,QVWLWXWLRQDO $UHD 1HZ 'HOKL ²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hare and Solicit Technology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œ$¡ :LQJ 5XE\ +RXVH - . 6DZDQW 0DUJ 'DGDU : 0XPEDL 7HO )D[ (PDLO VSHGLW#QHWZRUN SXEOLVKLQJ FRP

20

0RGHU Q 3KDU PDÂ&#x2021; ) HEUXDU \

Projects

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.

Bulk drugs manufacturing unit Project type: New facility Project news: Delta Finochem Pvt Ltd planning to manufacture bulk drugs manufacturing unit.

Project location: Nashik, Maharashtra Project cost: NA Implementation stage: Planning Contact details: Delta Finochem Pvt Ltd, 121, MIDC, Satpur, Nasik 422 007, Maharashtra Multi-speciality hospital Project type: New facility Project news: B M Birla Heart Research Centre plans to construct a multi-speciality hospital.

Project location: Darjeeling, West Bengal Project cost: NA

Manimajra, Chandigarh (U.T.) Tel : +91-172-3933090, 3933094 E-mail : info@venusremedies.com, ib@venusremedies.com Website : www.venusremedies.com

Implementation stage: Planning

Modern vaccine facility Project type: New facility Project news: Shantha Biotechnics Ltd focusses on R&D of generic biologicals, novel therapeutic antibodies, proteins and vaccines.

Contact details: B M Birla Heart Research Centre 1/1 National Library Avenue Kolkata-700027, West Bengal Tel: +91-(033)-24567890/30403040 E-mail: bmbhrc@birlaheart.org

Project location: Andhra Pradesh Project cost: NA Implementation stage: Planning

Manufacturing of drugs Project type: New facility Project news: Venus Remedies announced that it targets gaining returns close to $ 100 million over the next half decade, from the latest drug it launched â&#x20AC;&#x201D; Elores. The drug has been designed to ďŹ ght bacterial infection. India is the ďŹ rst country that has seen its launch.

Contact details: Shantha Biotechnics Ltd 3rd Floor, Serene Chambers, Road No.7, Banjara Hills, Hyderabad, Andhra Pradesh, Tel: +91-(40)-23543010, 23548507 Fax: +91-(40)-23548476

Project location: India Project cost: $ 100 million Implementation stage: Planning Contact details: Venus Remedies Ltd SCO 857, Cabin No. 10, 2nd Floor, NAC

New compression moulding facility Project type: New facility Project news: West Pharmaceutical India Packaging Pvt Ltd, an indirect subsidiary of West Pharmaceutical Services, Incorporated, has started construction of its new compression moulding facility located in Sri City, India.

Project location: India

Information courtesy: www.tendersinfo.com 1, Arch Gold, Next to MTNL Exchange, Poisar, S V Road, Kandivali (W), Mumbai - 400 067, Maharashtra, India t 5FM t 'BY t &NBJM QBSNFFU E!UFOEFSTJOGP DPN

Project cost: NA Implementation stage: Planning Contact details: West Pharmaceutical India Packaging Pvt Ltd 530 Herman O. West Drive, Exton, PA 19341 Tel: +001-610-594-2900 Fax: +001-800-345-9800 Rivastigmine transdermal patches manufacturing unit Project type: Facility expansion Project news: Sparsha Pharma International is planning for capacity expansion of rivastigmine transdermal patches manufacturing unit.

Project location: Medak, Andhra Pradesh Project cost: NA Implementation stage: Planning Contact details: Sparsha Pharma International # 8-2-408, D-3, Sri Krishna Apts Road No: 6, Banjara Hills, Hyderabad - 500 034 Andhra Pradesh Tel: 040- 23352581/ 83 Fax: 040-23352880 Email: info@sparsha.com

0 R G H U Q 3 K D U P D Â&#x2021; )H E U X D U \

21

Tenders

Latest Popular Tenders Brought to you by www.tendersinfo.com Spectrophotometer Org : Department Of Atomic Energy TRN : 14393035 Desc : Supply, installation and commissioning of microcontroller-based spectrophotometer BOD : February 25, 2013 Loc : Hyderabad, Andhra Pradesh BT : Domestic (NCB)

Desc : Supply of mid and far Fourier Transform Infrared spectrophotometer with ATR capability.

BOD : February 26, 2013 Loc : Bhubaneswar, Orissa BT : Domestic (NCB)

Laminar flow cabinet Org

Microcentrifuge Org : Tata Memorial Centre (TMC) TRN : 14503196 Desc : Supply of microcentrifuge with lid angle rotor BOD : February 25, 2013 Loc : Navi Mumbai, Maharashtra BT : Domestic (NCB)

Liquid chromatography tandem mass spectrometer Org

: Sandwell And West Birmingham Hospitals Nhs Trust TRN : 14336190 Desc : Provision of ultra performance liquid chromatography tandem mass spectrometer BOD : February 25, 2013 Loc : United Kingdom BT : Global (ICB)

Fourier transform infrared spectrophotometer Org

: Institute Of Minerals And Materials Technology TRN : 14505167

: Department Of Defence Research And Development TRN : 14525316 Desc : Supply of air stream horizontal laminar flow cabinet BOD : February 26, 2013 Loc : Dehradun, Uttaranchal BT : Domestic (NCB)

Centrifuge Org

: Regionalne Centrum Krwiodawstwa I Krwiolecznictwa Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Lublinie TRN : 14445603 Desc : Purchase of atomic absorption spectrometer along with complete accessories.

BOD : February 26, 2013 Loc : Pakistan BT : Global (ICB)

Mass spectrometer system Org : Public Works And Government Services Canada TRN : 14363834

Desc BOD Loc BT

: : : :

Supply of mass spectrometer system February 27, 2013 Canada Global (ICB)

Gas chromatograph mass spectrometer Org : RIKEN TRN : 14314885 Desc : Supply of gas chromatograph mass spectrometer.

BOD : February 28, 2013 Loc : Japan BT : Global (ICB)

Liquid chromatograph Org : FakultnĂ­ Nemocnice Olomouc TRN : 14133406 Desc : Supply of liquid chromatograph with a mass spectrometer BOD : February 28, 2013 Loc : Czech Republic BT : Global (ICB)

Nuclear magnetic resonance (NMR) spectrometer Org : Uppsala Universitet TRN : 14467604 Desc : Supply of 400 mhz Nuclear Magnetic Resonance (NMR) spectrometer.

BOD : February 28, 2013 Loc : Sweden BT : Global (ICB)

Org: Organisationâ&#x20AC;&#x2122;s name; TRN: Tendersinfo Ref No; Desc: Description; DSLD: Doc Sale Last Date; BOD: Bid Opening Date; Loc: Location; BT: Bidding Type Information courtesy: www.tendersinfo.com

1, Arch Gold, Next to MTNL Exchange, Poisar, S.V. Road, Kandivali (W), Mumbai - 400067 Maharashtra, India Tel: t Fax: t Email: parmeet.d@tendersinfo.com

An

invite that

rewards as well...

Dear Reader, â&#x20AC;&#x2DC;Modern Pharmaâ&#x20AC;&#x2122; solicits original, well-written, application-oriented, unpublished articles that reflect your valuable experience and expertise in the pharmaceutical industry.

1-15 Februa ry

2013 I Vol 1 I No 15 I `100

www.mode

rnpharma.i

Scan this code on your smart phone to visit www.mod ernpharma.in

In Conversat ion With 16 Dr Krathis h Bopanna President & CEO, Semler Research Center

GSK-WADA in

s 18

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.

Interface 27

Tips & Trick s 28

Ganesh Sambas ivam Co-Founder & CSO, Anthem Bioscien

Checklist for best cleanro

infrastructure anti-doping ces The World pact Right steps Anti-Doping to follow (WADA) Agency has with GlaxoS inked an agreement mithKl banned substan ine to help detect ces in sports. had signed GSK an agreem The author WADA to ent with ity for drug support in India has detection doping compo directed the regulation in Octobe of in the industr manufacturers r 1, 2012 withou Subsequent unds in the early stage. y to take a t approval of to the new to tighten stronger stand DCGI, the scientists safety and will identif pact, GSK same of efficacy will be consid This directiv Health standards. y substan with a probab and Famil e comes in ered ces for being Welfa re le or high risk Fixed Dose the contex y prohibited (MoH t of for of abuse Combination issued repeat FW) had In absence in sports. manuf (FDC) issues. of sanctions ed statuto and market acturi ng directions in terms of standard, the Commenting ing in the under Section ry safety countr on to the stand the risk licenses of manufactures the develo y.â&#x20AC;? The state govern 33P pment, SME of being banned sector could to instru ments John Dr G N ct benefit Fahey , Singh, DCGI, . from this. drug licensi their respec tive regards the President, said, â&#x20AC;&#x153;As ng author WADA, new FDCs, refrain from ities to A notice by the state said, if any, licence from the granting licence licensing author â&#x20AC;&#x153; autho rity for manuf work with O u r ities after acture reveal of new ed, Fahey â&#x20AC;&#x153;The and FDCs pharmaceutic the M i n i s t r y Dr Singh covered underdrugs al definition the industry is of new drug to staying withou due approv one step ahead critical al of the DCGI. t dopers, who of the have â&#x20AC;? level of scienti an ever increasing fic experti Drug firm delighted Ranbaxy Labora to be enterin se. We are its Japane tories and partnership g into this se with GSK As per the will integra parent Daiichi Sankyo play a signific as it will te their busine Ranbaxy would plan, Daiichi Sankyo in Thailand ss operations and WADA achievant role in helping integrate the as The part of compa Daiichi manage e of maximise its missio ny was founde strategy to Sankyo ment and doping -free synergies. n of a had sales of d in 1994 Daiichi Sankyo â&#x20AC;&#x2122;s subsidiary in Thailan sportin g Both the $ d, WADA (Thailand) On the other 13 million in FY201 and Ranbax also inked cultur e.â&#x20AC;? integrate their companies intend (DSTH) 1. hand, RUCL yâ&#x20AC;&#x2122;s Thailan such agreem severa l markets to Ranbax business operati d subsidi which Thailand to yUnichem ary, primar generic medicines drug compa ents with different ons in leverage and focusin Co (RUCL y healthcare nies. synergies maximise ). and pharma g on of hybrid the cies, was â&#x20AC;&#x153;The business model, which is established Aurobindo Pharm expected in 1983 and new repres to comm had business on sales of $ 14 a receives ďŹ nal approvals for ence propo entativ e of the million in 2011.

April 1, 2013, oxacillin injecti said in a statem sed Ranba xy Ranbaxy Aurobindo on ent. entity will integr ated becam e Pharma Ltd a part of â&#x20AC;&#x153;The planne announced be recentl Suthas the d integra y Thong praser that the compa operations Sankyo Group Daiichi tion of received final t, ny has will provid who presently in 2008 approvals foundation e a strong after Japanâ&#x20AC;&#x2122;s heads DSTH, US FDA to for third largest the compa â&#x20AC;? manufacture from the group expans future Daiichi Sankyo drug-m aker ny said. oxacillin for and ion in Thaila bough t injection USP, market The pharm statement a majori nd,â&#x20AC;? the in 1 g and aceutical added. The ty 2 g vials (ANDApackaged marke t would be development ` 22,000 crore.stake for in Thaila and oxacill 201539) mutually nd in for injectio is the Ranbaxy beneficial Under the vial pharm n and to among second largest acy bulk packagUSP 10 g/ it is expect Daiichi Sankyo business model hybrid ASEAN countr 201538). e (ANDA as has ies, and DSTH, adopted built its competitivene ed to enhance their by The produc presence primarily focusse the two firms, Ranbax ss, the compa targetin mainly ts g healthcare y are ready ny said. s launch. Oxacil facilities througby research both for on generic medicin for innovative lin for injectio e itself pharmaceutic is a Sterile h while n USP the new drug and its parent firm, als.

Semisynthetic discovery program (SSP) indicat Penicillin is undertaken ed in the me taken up by treatment infections Daiichi Sankyo of caused by India is . penicillinase producing staphylococc pharmaceutic aiming to export have demon al products patent, which strated suscep i which billion in the drug. tibility to would offset 2012-13 fiscal,worth $ 15.5 the decreas some of around 17 es in orders, Indian pharm per cent compa a jump of Jain added.

Under lining aceutical produc billion in red to $ 13.22 Par Pharma Jain, 2011-1 the adding that ts,â&#x20AC;? said governmentâ&#x20AC;&#x2122;s target, howeve 2. â&#x20AC;&#x153;The $ 25 billion the produc tablets in thelaunches lamotrigine policy of â&#x20AC;&#x2DC;zero Indian shipped ts were on quality to some toleranceâ&#x20AC;&#x2122; 2013-14 wouldr, for pharma exports of pharma Par Pharm US market in said The Indian 220 countries. be a challen products, aceutical â&#x20AC;&#x2DC;track and in view of she industr ging task Companiesâ&#x20AC;&#x2122; opera ting pharm aceuti the y reported been introdu trace barcodesâ&#x20AC;&#x2122; Mridul Jain, global slowdownâ&#x20AC;? said has about business growth cal Pharmaceutic subsid iary, ced on consig Par Ministry of 15 per cent exported of nments and Industr to the global received final al, Inc has recentl on compo aggregated y Joint Secreta Commerce part y unded market as growth of the ongoin ry. â&#x20AC;&#x153;Our industr FDA for its approval from the US 07 and 2011-1 rate between 2006y has told g promotions and quality ANDA for economic us about the 2. Furthe 25 mg, 50 assurances lamotrigine initiatives impact r, market mg, Indiaâ&#x20AC;&#x2122; produc of â&#x20AC;&#x2DC;Madewere underw orders especia s on pharmaceutic in- export mg and 300 100 mg, 200 mg, 250 ts. ay to promo al lly s, especia from mg â&#x20AC;&#x153;We te Extended-Rel least develo Africa and lly the Interna continue (ER) tablets Exhibition ease ped countr to stress efficiency, . tional health campai ies where efficacy and on (IPHEX for Pharma and Health Lamotrigine quality of pharmaceutic ER is the it would be gns have slowed down; the 2013 ) to be held on April care version of al products,â&#x20AC;? generic challenging in Mumbai.

GSKâ&#x20AC;&#x2122;s Lamict 24-26, said Jain.

The Europe $ 25 billion to meet the is indicated al XR and export target â&#x20AC;&#x153;We will markets accoun an and American as adjunctive Jain for be 2013-1 told partial onset therapy for PTI after address hostin g ted for 55 international 4,â&#x20AC;? of the seizures with 300 per cent buyers and Indian pharmaceutic ing an Indian secondary or without 100 regulat from major al seminar genera exports, reflectipharmaceutical produc in Singapore.

The industr Par has begun lisation in patient t to showca markets at the exhibit ors ng that most s. products se Indian produc ion of these capture other y is in a position of the produc shipping all strengths to specific were made to the ts,â&#x20AC;? she said.

Over 600 emerging opport t. highest especially manufa ation of the unities, would partici Indian companies USFDA. cturing of â&#x20AC;&#x2DC;off â&#x20AC;&#x153;The export pate in IPHEX products patentâ&#x20AC;&#x2122; organised or produc volumes , being European ts with expired by to the and Export Promo the Pharmaceutic volumes about US markets speak als tion Counc the high set up by il of India, quality of the and Industr Ministry of Commerce y.

DCGI direct s manufac safety standturers to tighten ards

Ranbaxy, Dai

ichi Sankyo

India aims at

You can send us Technical Articles, Case Studies and Product Write-ups. The length of the article should not exceed 1,200 words, while that of a product write-up should not exceed 100 words.

Special Focu

Inadequate IT infrastr ucture Challenges faced by small startups and ways to overcome them

achieving $ 15.5

to maximise

billion pharma

synergies in

Thailand

exports in FY2

013

The final decision regarding the selection and publication of the articles shall rest solely with â&#x20AC;&#x2DC;Modern Pharmaâ&#x20AC;&#x2122;.

Authors whose articles are published will be sent a complimentary copy of that particular edition.

Published by Network18 Media & Investments Ltd, â&#x20AC;&#x2DC;Modern Pharmaâ&#x20AC;&#x2122; is one of the leading fortnightly 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 worldâ&#x20AC;&#x2122;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, etcâ&#x20AC;Ś Thanking you, Yours sincerely,

Manas R. Bastia Senior Editor Modern Pharma Network18 Media & Investments Limited â&#x20AC;&#x2DC;Aâ&#x20AC;&#x2122; Wing, Ruby House, J K Sawant Marg, Dadar (W) Mumbai 400 028 India

n

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

om

22

0R GHU Q 3KDUPDÂ&#x2021; ) HEUXDU \

Event List

N AT I O N A L E V E N T S 4th Annual Biosimilars India 2013 With over 100 attendees in 2012, the 4th Annual Biosimilars is all set to be bigger and better with special focus on process development and analytics to suggest best strategies for developing the first commercially successful molecule. This three day meet will serve as a platform to understand practical solutions that will help minimise the risks associated with highest spend areas of the biosimilar development cycle; March 6-8, 2013, Holiday Inn Mumbai International Airport, Mumbai For details contact: UBM Medica India Pvt Ltd Tel: +91-22-66122600 / 66122673 Fax: +91-22-66122626 Email: info.india@ubm.com Website: www.ubmindia.in

March 13-16, 2013, Taj President, Mumbai

Vivanta

by

For details contact: M M Activ, Bengaluru Tel: +91-80-41131912 Fax: +91-80-41131914 Email: vinay@mmactiv.in Website: www.mmactiv.in

Pharma Pro&Pack 2013 PHARMA Pro&Pack Expo 2013 will offer an excellent opportunity to expand business in the Indian and international pharma industry. Various industry majors from India and across the world will be present at the Technology Show.

The event will help facilitate meetings with clients & prospective customers at one place on one platform thus expanding business to new customers locally & internationally; April 24-26, Bombay Exhibition Centre, Mumbai

Nutra India Summit Nutra India Submit enjoys its 8th successful year in showcasing health care and wellness products, nutritional food supplements and natural products.

There will be conferences, forums, award ceremonies and several other programs that will be running simultaneously with the exhibition and the summits will be visited by 500 delegates from across 12 countries of the world such as Canada, Japan, USA and others. The show will be hosted by over 60 exhibitors coming from different departments in the nutritional sector. 95 percent amongst the suppliers think that this event is the optimum place where new contacts and business networking opportunities can be conducted;

AURANGABAD Maharashtra, Feb 22-25, 2013

Indiaâ&#x20AC;&#x2122;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 Network18 Media & Investments Ltd

Ruby House, 1st Floor, J K Sawant Marg, Dadar (W), Mumbai 400 028.

R5 &95fhh5iffi5jlkg5R5 295fhh5iffi5jjoo5R5 ' #&95 (! 2*)H( .1),%gn*/ &#-"#(!8 )'

24-26, 2013, Bombay Exhibition Center (BEC), Mumbai For details contact: Pharmaceuticals Export Promotion Council Tel: +91-40-23735462/23735466 Fax: +91-40-23735454 Email: sales@iphex-india.com Website: www.iphex-india.com

PHARMAbiotika For details contact: GPE Expo Pvt Ltd Tel: 91-79-40008253 Email: contact@pharmapropack.com Website: www.pharmapropack.com

iPHEX 2013 iPHEX plays a major role in introducing the Indian market to the advanced medicinal products. This show coverS up the entire medical industry, starting from hospital services, medicines, pharmaceuticals and surgical sectors.

250 companies have already registered to participate in this event as they think that this podium is best way to reach out to the customers and publicize their brand name; April

HYDERABAD

Andhra Pradesh, May 31- June 3, 2013

Pharmabiotika 2013 is an exhibition with an in built buyer and seller meet which will help one in networking with 10000+ business visitors, 600 delegates and 400+ exhibitors, attending the global exhibition. There are around 30+ thought leaders from across the world sharing their valuable experiential learning in the 3 days conference. The event will help in meeting the potential customer requirements mapping for developing new trade leads and analySing the exhibiting plan and help execute trade objectives, September 16-18, 2013, Mahatma Mandir Convention & Exhibition Center, Gandhinagar For details contact: Human Crayon Management

Services Pvt Ltd Tel: +91- 120 â&#x20AC;&#x201C; 6528801 Email: info@crayon4.com Website: www.pharmabiotika.com

Indian Pharma Expo The Indian Pharma Expo 2013 will be one of the a unique pharma events inIndia that will serve as a perfect platform for pharma entrepreneurs andinvestors, eager to be a part of the pharmaceutical business through franchisee and distributorship opportunities in the India pharma market. The two-day expo will bring together drug manufacturers, pharma companies and the largest suppliers and distributors of pharma products under one roof in order to facilitate the exchange of ideas for better growth of the industry; September 20-21, 2013, Pragati Maidan, New Delhi For details contact: UBM Medica India Pvt Ltd Tel: +91-22-66122600 / 66122673 Fax: +91-22-66122626 Email: info.india@ubm.com Website: www.ubmindia.in

I N T E R N AT I O N A L E V E N T S International Conference on Drug Discovery & Therapy International Conference on Drug Discovery and Therapy is going to be the second major international conference and exhibition of this series, which aims to present cutting edge advances in various disciplines of drug design and discovery that have been recently achieved. Therefore, this event will be a perfect meet for all the industry experts and the professionals. It will bring together leading chemists, pharmacologists, biotechnologists, and other allied professionals to discuss and present the latest important developments in drug design and discovery; February 18-21, 2013, Dubai Mens College, Dubai For details contact: Eureka Science Ltd Tel: +971-6-5571132 Fax: +971-6-5571134 Email: info@icddt.com Website: www.icddt.com

Infarma Expo Infarma Expo showcases the rapidly progressing scenario of the pharmaceutical industry of Spain.

It aims at bringing together world renowned companies as well as newly launched companies on one platform.

CEOs & top executives, purchase executive, manufacturing engineers of pharmaceutical companies, R&D professionals, pharma machinery suppliers & distributors, pharma

consultants, scientists, government experts are the target audience; March 5-7, 2013, Fira de Barcelona Gran Vi, Barcelona, Spain For details contact: Interalia Ferias Profesionales Y Congresos SA Tel: +34-93-4161466 Fax: +34-93-4150095 Email: ferias@interalia.es Website: www.infarma.es

EAHP â&#x20AC;&#x2DC;Improving patient outcomes: a shared responsibilityâ&#x20AC;&#x2122; is the theme of the 18th Congress of European Association of Hospital Pharmacists (EAHP). This topic covers two of the major goals of the association: the commitment to the patient and the importance of collaboration with other health professionals. Hospital pharmacists are the stakeholders in optimising the medication of inpatients, but their responsibility does not end at the interface to primary care. Due to the fact that this is prone to errors, the Congress will focus on the different aspects of the interface with the scope of helping all participants to understand the origin of faults, March 13-15, 2013, Paris, France For details contact: EAHP Tel: +32-2-741-6827 Fax: +32-2-734-7910 Email: taviana.caminiti@eahp.eu Website: www.eahp.eu

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

International Congress of Toxicology 2013 The theme for the conference is â&#x20AC;&#x153;From Basic Science to Clinical and Environmental Outcomesâ&#x20AC;?.

This conference encompasses novel approaches and technologies being used to properly assess the safety, toxicity, and risk for human health.

The scientific programme will consist of keynote/distinguished lectures, symposia, workshops, round table discussions, debate and poster sessions. This meeting

will provide attendees with ample opportunities to exchange the ideas and to launch collaborations; June 30-July 4, 2013, Coex, Seoul, Korea For details contact: ICT XIII Secretariat Tel: +82-2-557-8422 Fax: +82-2-566-6084 Email: ict@ict2013seoul.org Website: www.ict2013seoul.org

Pharma Trials World Korea 2013 Pharma Trials World Korea 2013 is where pharma companies, trial sponsors, regional and international CROs and clinical trial sites gather to strategise in accelerating clinical development, accessing emerging markets, enhancing clinical operations through effective offshoring and outsourcing in Korea; July 8-11,2013, Korea For details contact: Terrapinn Pte Ltd Tel: +65 6222 8550 Fax: +65 6226 3264 Email:enquiry.sg@terrapinn.com Website: www.terrapinn.com

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

0 R G H U Q 3 K D U P D Â&#x2021; )H E U X D U \

Event Report

23

BioAsia 2013

Shaping opportunities for bioentrepreneurs Hardik Ashar hardik.ashar@network18publishing.com

The 10th edition of BioAsia, Asiaâ&#x20AC;&#x2122;s biggest technology and bio-business platform, was held from January 28-30, 2013 at Hyderabad International Convention Centre (HICC), Hyderabad. BioAsia 2013 leveraged the theme of â&#x20AC;&#x2DC;Technologies. Business.

Nextâ&#x20AC;&#x2122; in a well-organised manner, thus triggering the next required change in vision and innovation in the life sciences sector.

Stalwarts from the industry at BioAsia 2013

H

yderabad, the pharma and bulk drug capital of the country, witnessed another success story of BioAsia. BioAsia 2013 was hosted by the Government of Andhra Pradesh with support from Federation of Asian Biotech Associations (FABA) and Pharmaceuticals Export Promotion Council of India (Pharmexcil), Government of India, from January 28-30, 2013. It kept its promise of delivering a dynamic and future-oriented global discussion on vivid areas of biotechnology, biosimilars and patents.

N Kiran Kumar Reddy, Chief Minister, Andhra Pradesh inaugurated this three-day event in the presence of Carmen Vela Olmo, Minister of State â&#x20AC;&#x201C; Research, Development & Innovation, Government of Spain; InKyo Kim, President, Gangwon Technopark, South Korea; Dr George John, Senior Advisor - Department of Biotechnology (DBT) Government of India, and others. â&#x20AC;&#x153;Asia is progressing rapidly towards establishing itself as a major hub of biotechnology. The biotechnology industry is at the threshold of tremendous growth and India is quickly emerging as an important player in this sector globally,â&#x20AC;? said Reddy in his inaugural speech. He also praised the organisers of BioAsia for taking up the agri-biotech initiative, which is first of its kind taken up for deliberations during the past one decade.

Dignitaries at the valedictory ceremony

Global participation BioAsia 2013 attracted leading industry giants and major state level partners.

The event witnessed participation of over 500 delegates including regulators, from 47 countries such as Spain, Australia, US, UK, Germany, Singapore, South Africa, Sweden, Korea, Malaysia, Jordan, Republic of Lithuania, Ghana, Nepal, Sri Lanka, Philippines and many more. The next happening life sciences segments - biologics and biosimilars - found an added impetus through valuable inputs, discussions, interactions and perspectives by industry thought leaders and key stakeholders. The official results of the first Indo-Spanish call for industrial R&D proposals in biotechnology were announced.

Among proposals selected for funding were the projects Aptafood, Naturindia and FUNFRUT.

Event highlights D Purandeswari, Minister of State for Commerce and Industry, released the special report by BioAsia â&#x20AC;&#x201C; Grant Thorton on the key trends and alliances in the biologics and biosimilars markets. It covers the recent developments in the biosimilars opportunities particularly partnerships and regulatory dynamics in key global markets. He also released BioAsia â&#x20AC;&#x201C; Indian School of Business

report on Intellectual Property Regime (IPR) and lifesciences, which captures the impact of the changes in Indian Patent Law on strategies and competitiveness of local players.

While regulators are in the process of framing policies and guidance across the globe, the industry is facing several challenges such as product differentiation, meeting requirements for inter-changeability, increasing cost of good manufacturing practices, requirements on facility/ manufacturing as compared to traditional drugs etc. Expert sessions brought thought leaders from the life science industries to debate on leading perspectives and put forward their thoughts and ideas on emerging trends in like biologics and biosimilars.

In 2012, the Indian biopharmaceuticals market was worth nearly $ 2 billion and is showing further significant growth. About 20 companies in India are developing biosimilars of which approximately 50 products are available in the domestic market. On the same line, several Indian companies are in the process of developing a large portfolio of biologics and biosimilars. Panel discussion analysed the current scenarios that define the industry challenges and the possible solutions.

The CEO conclave focussed on views and perspectives on key trends in the

biopharmaceutical industry that will reshape the future of this industry.

Further, the International Trade Show was truly unique. It helped companies to showcase their products, strengths, services to a large and captive global audience. BioAsia 2013 also featured a dedicated buisness to business (B2B)portal that facilitated 450 B2B meetings and helped these industries in the business development and licensing activities. Commenting on the event, S Raghavan, Joint Secretary, Department of Biotechnology, Government of India, said â&#x20AC;&#x153;Department of Biotechnology was extremely happy to support this global event. The 10th edition of BioAsia attracted a wider participation from across the industry that will culminate into more holistic discussion, debate and decision on the growth of the biotech industry.â&#x20AC;? Another key development was the signing of MoU with the Government of Korea for information, knowledge sharing, facilitation of companies and Institutes and desiring partnership and education and training.

Key awards Event also witnessed the presentation of various awards to scientists, entrepreneurs and researchers who have outperformed in their respective fields. Dr M K Bhan and Pfizer were awarded the Genome Valley Excellence Awards for their contribution not just to the industry but to the global society at large.

Another important awardee was Dr Vijay Datla, CMD, Biological E Ltd, who was presented with Federation of Asian Biotech Association (FABA) special award.

BioAsia 2013 innovation award was presented to Paritosh Parashar of Indian Institute of Technology (IIT) Kanpur. It carried a cash prize of ` 1 lakh. Meghna Kumar, St. Patricks Junior College, Hyderabad bagged BioAsia Young Minds award which carried a cash prize of ` 50,000 for her work on self-retracting clothesline.

24

0R GHU Q 3KDUPDÂ&#x2021; ) HEUXDU \

Event Report

Bangalore INDIA BIO 2013

Providing biotechnology the needed power boost The 13th edition of Bangalore INDIA BIO concluded with a comprehensive plan to boost biotechnology and with a vision to make India a $ 100-billion biotechnology hub by 2025. It was truly a remarkable event bringing global participants from industry, academia and various stakeholders, all under one roof.

CEO conclave in session at Banglore INDIA BIO 2013

Hardik Ashar hardik.ashar@network18publishing.com

I

ndian biotech players have evolved over the past few decades budging the sector to a more mature stage.

According to the Association of Biotechnology Led Enterprises (ABLE) report on Indian biotechnology, sectorâ&#x20AC;&#x2122;s revenue has rapidly increased from $ 500 million in 2003 to $ 4 billion in 2011. On the global front, the market is set to surpass $ 320 billion by 2015. Considering that India is already leading the pharma manufacturing, the next big happenings will be led by biotechnology and allied sectors. The science capital and biotech hub of India witnessed Indiaâ&#x20AC;&#x2122;s biggest biotech gathering at the Bangalore INDIA BIO 2013, which was held between February 4-6, 2013 at The Lalit Ashok, Bengaluru. The event was organised by the Department of Information Technology, Bio-

Exchange of MoU between KBITS and SDI

Technology and Science & Technology, Government of Karnataka in association with Vision Group on Biotechnology and MM Activ Sci-Tech Communications.

Grand opening Key dignitaries at the inauguration included Dr Kiran Mazumdar Shaw, Chairperson, Karnataka Vision Group on Biotechnology and CMD, Biocon Ltd; Prof K Vijay Raghavan, Secretary, Department of Biotechnology, Ministry of Science & Technology, Government of India; S V Ranganath, IAS, Chief Secretary Karnataka; David Flores, Co-Founder, President & CEO, BioCentury, USA; Anne MacColl, CEO, Scottish Development International, Scotland; Mark Lytle â&#x20AC;&#x201C; Division Director, Georgia Centers of Innovation; Georgia Department of Economic Development, Atlanta, Georgia, USA; and I S N Prasad, IAS, Principal Secretary, Department of Information Technology, Biotechnology and Science & Technology, Government

of Karnataka. â&#x20AC;&#x153;Out of the top 10 industries in India, top 5 are in Bengaluru and hence it is truly called the science capital of India.

The Government of Karnataka is proud to give the required leverage for innovating biotechnology,â&#x20AC;? said Jagadish Shettar, Chief Minister, Karnataka.

Key highlights The event witnessed the release of three industry reports - â&#x20AC;&#x2DC;Funding Your Science Ideaâ&#x20AC;&#x2122; by Atharva Life Sciences Consulting; â&#x20AC;&#x2DC;Indian Biotechnology: The roadmap to the next decade and beyondâ&#x20AC;&#x2122;; and â&#x20AC;&#x2DC;Opportunities for Fermentation Industry & Biotechnologyâ&#x20AC;&#x2122;

by ABLE. Two MoUs were signed with Karnataka Biotechnology and Information Technology Services (KBITS) Government of Karnataka; one

by Scottish Development International (SDI), an international economic development arm of the Scottish Government and the other by the Georgia Department of Economic Development, Atlanta, Georgia, USA. Conveying his pleasure, Prasad, said, â&#x20AC;&#x153;MoUs will play a significant role to demonstrate a collective commitment to ensure Karnataka and India are more competitive and continue to benefit from the rapidly growing global biotech industry.â&#x20AC;?

Further, CEO Conclave was a highprofile meeting between the heads of industry such as Biocon, Strand Life Sciences, Sea6 Energy, AstraZeneca, Quintiles, IKP Knowledge Park and Pfizer.

A session on â&#x20AC;&#x2DC;Biosimilar guidelines for development of safe, affordable and efficacious biosimilars for the worldâ&#x20AC;&#x2122; was chaired and moderated by Dr V P Kamboj - Chairman, Biotech Consortium India Ltd, Former Director, Central Drug Research Institute. India has these guidelines which are the combined efforts of companies and academia. Talking about these guidelines, he said, â&#x20AC;&#x153;Biosimilar guidelines in India

were drafted in five intensive sessions by the regulators and academia along with the participation of companies and law so as to make India as competitive as possible in the world. India has found a definite place in generics and is one of the leading group to take generics to the global market particularly US, Europe and Japan.â&#x20AC;&#x153; Bangalore INDIA BIO 2013 observed 22 sessions with 110 speakers, 878 delegates and over 500 participating organisations. The exhibition attracted over 3,000 business visitors to check the offerings of 100 exhibitors from various verticals of life science industry such as biopharmaceuticals, bio-suppliers, bioinformatics, bio-medical devices. The gathering was truly global with delegates coming from more than 20 countries including Scotland, USA, Canada, Australia, Germany, UAE, France, UK, Spain, Israel, Mexico, Japan, Malaysia and Singapore and few other European and South East Asia countries.

Awards and workshop The prestigious bioexcellence awards were presented to Serum Institute of India Ltd (biopharma and healthcare), Metahelix Life Sciences Pvt Ltd (agribiotechnology), Quintiles Research India Pvt Ltd (bioservices category), Praj Industries (bio-industrial), Strand Life Sciences Pvt Ltd (bioinformatics and systems biology). An inspiring workshop on biopreneurship was also conducted by NSRCEL - IIM Bangalore to nurture entrepreneurial opportunities in biotechnology.

Expressing her happiness upon successful completion of this event, Dr Mazumdar-Shaw said, â&#x20AC;&#x153;Bangalore INDIA BIO has grown in stature; we have seen a huge surge in number of delegates, the number of country participation, the number of forums created within this conference. I believe it is making a huge difference so as to how the Indian biotech sector is being perceived globally.â&#x20AC;?

0 R G H U Q 3 K D U P D Â&#x2021; )H E U X D U \

Products

25

Looking For A Specific Product?

Searching and sourcing products were never so easy.

Just type MPH (space) Product Name and send it to 51818 eg, MPH Laboratory software and send it to 51818

PP-R plumbing system

Clean Room Monitor

Plumbing pipes and ďŹ ttings is produced out of p o ly propy l ene r a n d o m copolymer m a t e r i a l .

The physical character istics of material such as working temperatures upto 95°C along with excellent chemical resistance as well as providing a deďŹ nite solution for oxidation and calciďŹ cation, make it an ideal material, primarily for hot and cold water plumbing systems in buildings and industrial piping installations ensuring a high quality performance.

Various advantages are no leakage, no corrosion, no scaling, no maintenance, no insulation, low frictional resistance, low hammering effect and low cost in installation. They certify DIN 16962 - Part 5 and IS15801 speciďŹ cation for GREENFIT polypropylene random copolymer pipes for hot & cold water supplies. Application industries are pharmaceuticals, textile, paper pulp and sugar factory.

These are high accuracy 3 parameter clean room instruments to measure the temperature, humidity and differential pressure in a single compact unit. The clean room monitor comes with the option of built-in sensors for all 3 parameters or with external transmitters for humidity, temperature and differential pressure. The humidity measuring range is 0.0 to 100.0% R.H. with an accuracy of +/-1.8% R.H. , temperature measuring range is from -30.0 to +60.00C with an accuracy of +/-0.5 Deg. C and differential pressure range is -50.0 to +50.0 mm.W.C. or -500 to + 500 Pascals with an accuracy of +/-0.5% F.S. Customised differential pressure ranges are also available.

The instrument comes in a sleek 40mm

Prince Pipes & Fittings Pvt Ltd Mumbai - Maharashtra Tel: 022 â&#x20AC;&#x201C; 66022222 Fax: 022 - 66022220 Email: sales@princepipes.com Website: www.princepipes.com

Level indicator Float and board type tank level gauge (indicator) is suitable for large nonâ&#x20AC;&#x201C;pressurised liquid storage tanks.

It is sometimes also known as ďŹ&#x201A;oat and cord type level gauge. The ďŹ&#x201A;oat is designed as per the speciďŹ c gravity of the liquid, ďŹ&#x201A;oating on the liquid levels. This ďŹ&#x201A;oat is connected to a pointer through rope via sets of pulley. The pointer slides over a CM marked board, installed parallel to the tank. For more than 3 metre height of the tank, two guide wires ďŹ rmly anchored to the tank bottom is provided so that horizontal movement of the ďŹ&#x201A;oat is restricted. In this level gauge, when the tank is full, the pointer is at bottom position on board and when tank is empty, the pointer will be at top position. The scale bracket is M.S powder coated and measurable tank height of the indicator is from ½ meter to 15 meter.

Flowtech Instruments Services Vadodra â&#x20AC;&#x201C; Gujarat Tel: 265 â&#x20AC;&#x201C; 6508171 Fax: 265 â&#x20AC;&#x201C; 2636795 Mob: 09824049988, 09824459988 Email: ďŹ&#x201A;owtechinstruments@yahoo.com, ďŹ&#x201A;owtech01@gmail.com Website: www.ďŹ&#x201A;owtechinstruments.com

depth enclosure with front stainless steel ďŹ&#x201A;ush plate for modular clean room walls or optionally for brick wall mounting. Built â&#x20AC;&#x201C;in buzzer for process limit violation alert is a standard provision. RS 485 Modbus protocol communication is provided for interfacing to SCADA/BMS/PLC. Ace Instruments Hyderabad â&#x20AC;&#x201C; Andhra Pradesh Tel : 040-23078848, 32901226 Fax : 040-23830848 Email : sales@alwaysace.com Website : www.alwaysace.com

constructions. It is manufactured to API 610 and 685 as well as non-API pump standards. Typical applications are in oil and gas, chemical, pharmaceutical, industrial refrigeration, offshore-platform, electronic and galvanising and nuclear plant areas amongst others. The company also offers dry-running protection, temperature monitors on rear casing and ATEX certiďŹ cation as options for many models.

These pumps are available in 26 designs with over 350 basic models.

M PUMPS M pumps is seal-less, magnetic driven pump and is offered in centrifugal, peripheral, sliding vane, self-priming, centre-line mounted, inline and vertical pump versions. The pumps are manufactured in metallic and non metallic

Shanbhag And Associates Mumbai â&#x20AC;&#x201C; Maharashtra Tel: 022-28346604, 28340071, 28218008 Fax: 022-28388334, Email: info@shanbhags.com Website: www.shanbhags.com

26

0R GHU Q 3KDUPDÂ&#x2021; ) HEUXDU \

Products

Stainless steel pipe and tube Stainless steel seamless welded pipe, tubes and â&#x20AC;&#x2DC;Uâ&#x20AC;&#x2122; tubes, large diameter welded pipe in various sizes, grades and speciďŹ cations are available. Materials used are austenitic, ferritic, duplex and super duplex stainless steel. They conform to ASTM, ASME, DIN, NFA, JIS standard.

Size range for welded ranges from 6.0 mm OD â&#x20AC;&#x201C; 1016 mm OD and for seamless 6.0 mm OD â&#x20AC;&#x201C; 323.9 mm OD. Similarly thickness varies from 0.6 mm â&#x20AC;&#x201C; 25 mm for welded and 0.8 mm â&#x20AC;&#x201C; 25 mm for seamless. Length is upto 30 metre long.

Application industries include reďŹ nery, petro-chemical, food, pharmaceutical, fertilizer, oil & gas, breweries, sugar, ship building.

Suraj Limited Ahmedabad â&#x20AC;&#x201C; Gujarat Tel: 079 - 27540720/21 Email: suraj@surajgroup.com Website: www.surajgroup.com

pH meter Advanced ph meter for research g r a d e applications is a GLPcompliant m e t e r with pH measurement capability along with temperature.

The pH range varies from -2.000 to 20.000 pH with accuracy of Âą 0.002 pH. It features a new compact design that is over 40% smaller than other benchtop meters. The large display makes reading from distance possible. All measurements include temperature display.

The meter includes auto-buffer recognition for both USA and NIST pH buffer sets upto 5 points calibration. There is also a calibration due alarm function which skips out-dated calibrations issue. Water-resistant membrane keypad offers password protection for both set-up and calibration.

Provisions for report generation is also present.

Cole-Parmer India Pvt Ltd Mumbai - Maharashtra Tel: 022-67162209 / 2222 Fax: 022-67162211 Email: response@coleparmer.in Website: www.coleparmer.in

Pneumatic stirrer Pneumatic stirrer can be operated automatically as well as manually, depending on the requirement. They are designed as per client speciďŹ cation.

The design is Current Good Manufacturing Practices (CGMP) compliant and product contact parts are AISI 316 and non contact parts are AISI 304 compliant. AC frequency variable drive is also present. Pneumatic stirrer is operated on pneumatic compressor air, for homogeneous mixing of paint, to avoid

settling heavy particles, metallic particles, resin, pigmentation, etc. at the bottom of the container. Stirrer can be mounted on stand, PFT and container.

Shefa Industries Mumbai â&#x20AC;&#x201C; Maharashtra Tel: 022-25942473 Email: shefaindustries@yahoo.co.in Website: www.indiamart.com/shefaindustries

Molecular weight detector

lockable MDF, scratch-proof painted drawer box.

Different box or tray are adjusted according to needs due to specially designed proďŹ le of tapped strip.

Because of aluminium metallic structure, earthing is afďŹ rmative and provides safe working for electrical and electronic appliances.

Envair Electrodyne Ltd Pune - Maharashtra Tel: 020-30688117 Email: envairelectro@vsnl.net Website: www.envairelectrodyne.com

Ultra-low temperature freezer Zetasizer ÎźV is a versatile size and molecular weight detector that can be added to any system to boost experimental productivity by maximising information flow from a single experiment. It is a dual integrated light scattering system with particular value for protein characterisation. It uses dynamic light scattering to secure precise molecular size measurement while at the same time offering static light scattering for absolute molecular weight measurement. It allows the characterisation of discrete samples with only 2 ÎźL of material.

The instrument can be added to any protein SEC system to bring absolute molecular size and molecular weight capability to the chromatography experiment, and avoid the need to calibrate the column.

Malvern Aimil Instruments Pvt Ltd Mumbai - Maharashtra Tel: 022 - 39183596 Fax: 022 - 39183562 Mob: 09867368075 Email: soloni.gosalia@malvernaimil.com Website: www.malvernaimil.com

Mini bilayer press The mini bilayer press is designed to represent two-layer tablet productions at a small scale. With its larger turret diameter, variable speed allows for realistic scale up to larger rotary presses. It is provided with two force feeder system, which helps in maintaining uniform die ďŹ ll and represents production equipment. It is provided with pressure compensation hydraulic system. Tablet thickness and weight adjustment settings are outside the machine. It is designed as per cGMP norms. All parts in the compression zone are of SS-304 or electroless nickel-plated.

Aayush Techno Pvt Ltd Ahmedabad - Gujarat Tel: 079-25898901 Email: contact@aayushtechno.com Website: www.aayushtechno.com

Sanitary tubes ďŹ ttings A wide range of stainless s t e e l sanitary tube fittings for pharma, food, beverages, breweries, cosmetics and allied industries are offered.

The range includes bends, Tees, reducers, pipe, support and sight glass, etc. These are available in tube OD sizes ranging from ½â&#x20AC;? to 6â&#x20AC;?.

End connections available are triclamp, DIN and SMS. These fittings are manufactures from SS-304, 316 and 316L, duly electro polished. All these products confirms to cGMP and FDA standards. Elastomers offered are of food grade and can be offered in EPDM, neoprene, silicon and viton.

Cris Engineering Works Mumbai - Maharashtra Tel: 022-2685 9440, Mob: 09892273314 Email: roque_ferns@rediffmail.com Website: www.criseng.com

Ultra-low temperature freezer provides outstanding sample protection, sample storage capacity and energy efďŹ ciency for ultra-low temperature storage requirements. The freezer is equipped with a unique touch screen control panel that features an event log, health monitoring system and controlled access options which provide constant updates on sample integrity and the health of the freezer compartment.

It has a built-in USB port to download freezer temperature and event logs or transfer freezer settings from one freezer to another. Its capacity ranges from 421 - 949 ltrs (14.9 - 33.5 cu. ft.) and has a number of options to suit most storage and lab space requirements. The new cabinet design and vacuum panel insulation of the freezer can store up to 70,000 2 mL tubes or 118,300 1 mL cryobank tubes.

The model SGA100 symmetrical gravimetric analyser is a continuous gas flow adsorption instrument specially designed for the study of water or organic vapour isotherms at temperatures ranging from 0°C to 80°C (standard version) and 250°C (high temperature version), at an ambient pressure.

This gravimetric analyser is available in a size of 18â&#x20AC;?width x 30â&#x20AC;? height x 20â&#x20AC;?diameter with a weight of 125 lbs.

The symmetrical gravimetric analyser finds applications in pharmaceuticals, chemicals, drugs, food products, paper, fibres, powders, carbon, catalyst, etc.

Thermo Fisher ScientiďŹ c India Pvt Ltd Mumbai â&#x20AC;&#x201C; Maharashtra Tel: 022 â&#x20AC;&#x201C; 67162200, 67162259 Fax: 022 â&#x20AC;&#x201C; 67162244 Website: www.thermoscientiďŹ c.com

Smart Instruments Company Thane - Maharashtra Tel: 0251-2801123,Mob: 09323509969 Email: smartins@vsnl.net Website: www.smartinsrument.com

Sysmac Automation Platform

Temperature and process controller

Symmetrical gravimetric analyser

It is a new automation controller NJ-Series t h a t integrates motion, sequencing, networking, RFID tracking, and vision inspection.

It comes with new software - sysmac studio - that includes configuration, programming, simulation and monitoring and a fast machine network - Ether CAT - to control motion, vision, sensors and actuators.

The NJ-Series incorporates an Intel processor with fan-free operation. It delivers a true integrated development environment (IDE). Sysmac studio also offers an advanced 3D simulation environment to develop and test off-line motion profiles such as cams & complex kinematics. Intellectual property (IP) can be safely secured using 32-character passwords.

Fuji Electricâ&#x20AC;&#x2122;s self-tuning temperature and process controller has low-cost options that include RS485 communications, digital input, timer function, heater burnout alarm, dual outputs and programmable alarms. The faceplate is watertight and corrosionresistant. The three-button keypad allows programming and the screw-terminal on the back eliminates the need for sockets.

In addition to auto-tuning and fuzzy control, it has self-tuning control, which automatically retunes the controller under certain conditions, without the need to revert to auto-tuning. It accepts temperature and process inputs and offers two control outputs and two programmable alarms.

Omron Automation Pvt Ltd Mumbai - Maharashtra Tel: 022-4228 8400 Email: in_enquiry@ap.omron.com Website: www.omron-ap.co.in

Procon Technologies Pvt Ltd Ahmedabad- Gujarat Tel: 079-27492566, Mob: 09824310188 Email: info@procon.co.in Website: www.procon.co.in

Multi-purpose trolley Multi-purpose trolley is used for ICU/ hospital/surgery. It comes with multipurpose aluminum extruded legs, heavy-duty designed castor wheels, MDF monitor top with anti-skid rubber mat,

0 R G H U Q 3 K D U P D Â&#x2021; )H E U X D U \

Products Rotary tablet press Rotary tablet press with double-output and bi-layer tableting features the patented E xch a n g e a b l e Compression M o d u l e (ECM) technology. It offers increase in productivity due to a very short changeover time, enhanced operator protection due to ECM, exceptional ďŹ&#x201A;exibility because same basic machine can be equipped with different ECMs. There is a zero-gap closed powder feeder to minimise crosscontamination between layers and to minimise powder loss, specially designed extraction nozzles and scraper ďŹ ngers for optimal cleaning of the die table. It can undergo manual or fully automatic ďŹ rst-layer sampling. It also features the patented weight control system, which is exceptionally sensitive and accurate even at low compression forces. Its production capacity lies from 35,000 tablets/hour to 875,000 tablets/hour depending upon the model. Machine size and weight speciďŹ cations are W = 2000 mm x D = 1500 mm x H = 2250 mm - 6000 kg.

Shefa Industries Vadodara â&#x20AC;&#x201C; Gujarat Tel: 265 â&#x20AC;&#x201C; 3074270 Fax: 265 â&#x20AC;&#x201C; 3074255 Email: pharma-india@gea.com Website: www.gea-ps.com

Swiss eco-friendly disinfectant The product Virosil Pharma is based on Hydrogen Peroxide (H2O2) with Silver ions. The combination of these two ingredients gives a synergistic broad spectrum of activity on all

kinds of viruses, bacteria, fungi, yeasts, molds, protozoa and algae. It is a clear, colourless, odourless, tasteless disinfectant which is noncarcinogenic, non-mutagenic, and revolutionary.

Virosil Pharma is presently being used as a very effective fumigant and disinfectant providing an environment with microbial containment and a completely safe and sterile environment. The added beneďŹ ts of Virosil Pharma is that it does not give any foul odor, irritation to the eyes, requires no de-fumigation and is very easy to handle. A room of 1000 cubic feet can be ready and completely sterile within a maximum period of 60 minutes using a 20% of solution of Virosil Pharma.

With a recommended ULV fogger which gives a very ďŹ ne mist that even penetrates between cracks of surfaces ensuring a safe and sterile environment.

Sanosil Biotech Pvt Ltd Mumbai Tel No: 022 22872295, Mob: 9820016292 Email: info@sanosilbiotech.com Website: www.sanosilbiotech.com

Rotary evaporator Rotary evaporator is used for efďŹ cient and gentle removal of solvents from samples by evaporation. The evaporator has a safe, innovative design with unique reversing feature for better evaporation. Motorised lift has a â&#x20AC;&#x153;safety stopâ&#x20AC;? function. If the power cuts out, the evaporator piston is automatically lifted out of the heating bath. Rotation speed ranges from 20-270

rpm. The bath heats from 20 to 180°C adding versatility by allowing use of water or oil.

Digital rotation speed display is on all models.

In digital models, temperature control of the heating bath is done by a micro-controller eliminating sudden uncontrolled boiling or â&#x20AC;&#x153;bumpingâ&#x20AC;?. They have an infrared interface for data transfer from the heating bath to the drive unit and RS 232 interface for PC remote operation with Labworldsoft software. Control models offers additional functions like integrated vacuum controller, integrated solvent library, automatic boiling point recognition, color graphic display, display of distillation curves, USB interface etc.

27

One must identify the product that best suits his/her organisation with regards to the cost and quality.

Suhas Kulkarni (Product Manager - Marketing) Kohler India Corp Pvt Ltd

Newtronic Equipment Company Pvt Ltd Mumbai - Maharashtra Tel: 022-28679326 Mob: 9821089932 Email: nmehta@newtronic.in Website: www.newtronic.in

Deep freezers Cole-Parmer India Pvt Ltd Mumbai - Maharashtra Tel: 022-67162224 / 2222 Fax: 022-67162211 Email: response@coleparmer.in Website: www.coleparmer.in

Pharma refrigerator The pharma refrigerator has double walled chamber, with two different inner chambers. The two chambers are connected with common wall between the two chambers. Interior and exterior is made of stainless steel. Upper chamber temperature is â&#x20AC;&#x201C; 20° C, lower chamber temperature is 2 to 8°C and temperature uniformity is Âą 1°C.

These deep freezers are designed for storage of biological samples in biotech, life science, clinical research as well as medical & pharmaceutical specimens, serums, vaccines, blood components. These freezers are available with temperatures up to -20°C and â&#x20AC;&#x201C; 40°C. It has features such as microprocessor controller with LED display, adjustable trays, electrical circuit breaker, overload cut off relay for compressor and sensor failure alarm.

Remi Elektrotechnik Ltd Mumbai - Maharashtra Tel: 022-40589888 Mob: 09820627422 Email: sales@remilabworld.com Website: www.remilabworld.com

28

0R GHU Q 3KDUPDÂ&#x2021; ) HEUXDU \

Products

Tablet coating system The tablet coating system is available in various models from laboratory scale up to tonnage capacity.

All models are in compliance with GMP requirements.

Features include pan construction with air-tight cover to provide good condition for mixing and drying. For sugar-coating, the hot air supply and the exhaust can be automatically controlled by the auto damper and the sequence spray-pause-1, pause-2, dry is automatically operated by the preset timer. The reverse rotation discharge system, discharges with simple operation without any damage of tablets.

Umang Pharmatech Pvt Ltd Thane - Maharashtra Tel: 0250-6450835 Email: info@umangpharmatech.com Website: www.umangpharmatech.com

Three phase thyristor power controller It features 15KW and 30KW models, operates on 3 phase supply with auto/manual operation. It is suitable for 3 or 4 wire star conďŹ guration / 3 or 6 wire delta conďŹ guration. It accepts (4-20)mA / (0-5)VDC / (0-10) VDC control input and has an adjustable voltage limit per phase. The design is simple and modular for easy servicing of cards and thyristors. Thyristor power pack has a varied application and can be used with heating elements like Nichrome, Tungsten, kanthal, super

kanthal, silicon carbide, molybdenum, infrared, etc. where precise and accurate power control is required. There is signiďŹ cant power savings with respect to conventional contactor type temperature control system.

Libratherm Instruments Pvt Ltd Mumbai - Maharashtra Tel: 022 - 28963823, 28960569 Fax: 022 â&#x20AC;&#x201C; 28964769 Email: sales@libratherm.com, libratherm@libratherm.com Website: www.libratherm.com

Reels for conďŹ ned sanitary spaces The SSN800 series stainless steel hose reel features a narrow frame that makes it ideal for mounting in smaller spaces.

With no paint to chip or potential for rust and corrosion, these reels are ideal for the food and beverage, dairy, pharmaceutical and cosmetics industries. Typical applications include washdown, chemical transfer, potable water, food ingredient transfer and even ďŹ re protection.

It is constructed of ďŹ ne grade 304 stainless frames, discs and drum. It handles single ID hose from 3/4 to 1 inch, accommodates pressure up to 1000 psi and sustains temperatures from 200F to 4000F (-70C to 2040C).

Hannay Reels U.S.A Tel: 518 797 3791 Fax: 518 797 3259 Email: catalogs@hannay.com.

Website: www.hannay.com

Capsule ďŹ lling machine

sizes up to 4â&#x20AC;? to control ďŹ&#x201A;uids such as steam, chemicals, oil, air, and water.

The automatic capsule ďŹ lling machine is an encapsulation equipment. Its features include compact, sturdy, covered with stainless steel panels, hood covered with acrylic guard. The ďŹ ll weight adjustment takes place within seconds. It is provided with tamping mechanism for powder ďŹ lling, which enables capsules to be ďŹ lled with a weight variation with Âą2 per cent.

The variable AC frequency drive for main motor ensures speed adjustment. Faulty capsule and ďŹ lled capsule ejection stations come with individual air controls. It is simple to operate and easy to maintain and has special purpose gauges for quick and easy change over.

Madho Controls Pvt Ltd Thane - Maharashtra Tel: 022-25883252, Mob: 09820066046 Email: madho@vsnl.com Website: www.madhocontrols.com

Pharma print cartridge The pharma print cartridge and felt pad/roller are made for blister packaging machine, FFS machine and coding machine.

Absorbing material used is poly porous in various microns varying from 1 micron to 25 micron, depending upon the requirement of customer. The absorbing capacity of these cartridges is quite high and the cartridges are hard so the impression is good as there is cotton cloth knitted sleeves (covering) which is used to avoid direct contact of stereo with roller. The cartridges are made in various ID, OD and length depending on customerâ&#x20AC;&#x2122;s requirement. The maximum OD can be 85 mm, length up to 300 mm.

Anchor Mark Pvt Ltd Mumbai - Maharashtra Tel: 022-28682001, Mob: 09320036904 Email: sales@anchormark.com Website: www.anchormark.com

Ball valve

This ball valve comes with pneumatic rotary actuator. The valve is of on/off type Process Instrumentation & Controls with screwed, ďŹ&#x201A;anged, Vadodara - Gujarat socket weld, tri-clover Tel: 0265-235 7228, 232 0756 end in three-piece Mob: 09228753005 design. It is available in Email: batchprinting@yahoo.com SS-304 and SS-316 investment castings Website: www.piccode.com and is ďŹ tted with double-acting pneumatic rotary actuator that operators through 90-degrees angular movements of ball valve The information published in this or butterďŹ&#x201A;y valves. Pneumatic actuator is section is as per the details furnished by mounted directly on the shaft of the valve. the respective manufacturer/distributor. In The actuator is supplied with solenoid valve any case, it does not represent the views of Modern Pharma mounted on it. It is available in different

Yes! I would like to subscribe to Modern Pharma for... Â&#x2026; 1 year (24 issues) `1200/Fill all details in capital letters Name : Mr/ Ms. :.........................................................................................................................................................

Organisation : ...........................................................................................................................................................

Please send my copy to : Â&#x2026; Residence

Â&#x2026; OfďŹ ce

Â&#x2026; Factory ( Kindly tick only one )

Mailing Address : .......................................................................................................................................................

City : .............................................................................. State : .................................................................................

Pin : ..........................................................................................

16-3 1

Janua r

y 2013 I Vol 1 I No 14 I `100

Telephone : (O) ........................................ (R) .......................................... Mobile : ................................................. www.mod ernp

harma.in

Scan this your smartcode on phone to visit www.mo dernpha rma.in

In Convers

ation With

Manish Gupta CEO, Indege Lifesystems ne Pvt Ltd

E - mail : ............................................................. Subscriberâ&#x20AC;&#x2122;s Signature :..............................................................

13 Special

Focus 14

Nanotech in pharm Aiming a for sizeab le benefits in India

Policies & Regulatio Pharmaceuti ns 16 cal Scanning

tradem arks: the changi ng trends

Interface 19

MCC-Sou th Africa markets approval opens up for Marck Bioscien key African ces

Pulin Shroff Managing Director, Charak Pharma

Marck Biosciences chapter in Africa has opened a 3QFY13 of the new Preview with Marck Biosc Earnings Medicines South Afric the award the oppor iences, the appro an sustained momentum to be approval Control Coun tunity of val large-cap by most cil accessing carries appro manufacturfor six produ Africaâ&#x20AC;&#x2122;s some of val, Bhave cts Accordinggenerics ed at its most Volume sh Patel, Biosc economies. stable growt to Kotak Equit ies Parenterals Small MD, h Africaiences, said, Institution facility â&#x20AC;&#x153;The MCC Marck (SVP) MCC -Sout at Khed approval expected earni ngs a, Gujar grow th al -Sout for will The certif icatio h Afric at. y-o-y for to stay over is aâ&#x20AC;&#x2122;s currenprovide furthe our Kheda facilit h 20 will also MCC appro recog nised n is r impet y t expan val Ranbaxy. large-cap gener per cent also enabl us to our Biosc ience region and sion effort e Marc ics excep The strong participatin by s will be performan t g autho 43 also augm PIC/S count in the African immediate s to achie k driven of the ries. We by launc rities share ve ce access Pharm gains marke would hes/m filing and ent our effort Inspe to aceut ical ts includ arket in key s by growth ction licensing ing Nami Botsw ana, in SA. in dome the US, stable Conv and with new our own bia, I see and a stic formu Phar mace entio n in Zimb abwe Patel favou Swaz iland Inspection these understrong revenue partners lations utica l and Lupin rable curren , , potential -served Zambia, Co-o believ cy.

Leso tho, Scheme acquisition will also benef Cadila (PIC/S). peration contr e that we can markets and MCC approMalawi and facilitate we it from This may make a ibution EBITDA s on a y-o-y val is expec Madagasca export quantum to health waiver these basis. The margin Biosc r. by care produ countries.â&#x20AC;? ted to result of Marck iences of to PIC/S expand too is expec of these inspection by y-o-y cts in certified partic in well Six produ ted the weak base/c for Cadil SVP as non-P ipating autho a (350 to registration countries and authorities from MCC cts have obtain urrency), bps, IC/S autho rities as accep product ed appro an of certifi -Sout sterile mix/curren Cipla (150 bps, rities ed produ easier partic t GMP certifi water for h Africa, includvals bps, Trico cy), Lupin cates from who ml; cts. For ipating ing injections ciprof (260 PIC/S product r) and Glenmark Speaking authorities. mix). Dr. timolol loxacin eye drops BP 5/10 (244 bps, on the (0.25 and expected Reddyâ&#x20AC;&#x2122;s MCC-Sout ml; lidoca 0.5 %) eye 5/10 ml; to remai margi h Africa n flat y-o-y n is Abbo tt and lidoca ine injection BP drops 5/10 .

Domestic (1%) ine inject separ ation has comp ion BP)2% 5/10 ml A growt growth to rema ) 5/10 ml. of its leted based h the Abbo in stable pharm is expec in domestic formu resea rchtt aceut ted to be whic is one lations icals h becam Pharma scien ce-ba the of the e AbbV busin ess, indep enden large st (20 perce highest for Sun reported healt hcare sed, diver ie, a nt y-o-y t bioph AbbV ie a arma comp new mark comp anies sified than Bioch 24 per cent growt ). Cadila is et-lea that speci ality a resea , with any. h, highe is underlying em, which is expec diagn ostics ding offer r alrea dy biop harm rch-b ased ings in maki ng comp any growth ting an Lupin, nutri tiona , medi cal a devic es, differ ence, signif icant medi cines with a broad aceu tical s Glenmark of 18 per cent. ls and also likely gener ic portf olio and Cipla focus sing bran ded on highl immu nolog, inclu ding pharm to post leade rship of are (17-18 y â&#x20AC;&#x153;We wish aceut icals. healthy y and per mark et-leaspeci alised , pipel ine growt our is expec cent y-o-y). of break virolo gy, and in at AbbV Dr. Reddy h thera pies ding ted to ie conti collea gues throu gh a as grow in industry â&#x20AC;&#x2122;s thera pies. for some they becom nued succe of the growth line with ss world Ranbaxyâ&#x20AC;&#x2122;s new, indep of 15 per e part diffic ult-to â&#x20AC;&#x2122;s most cent and of a growth ende nt (11 per comp any White disea ses,â&#x20AC;? -treat cent y-o-y may stay muted ).

D Whit said Miles MĂŠdecins US appr e, Chair and CEO, man welcomed Sans Front may holdovals, competitio ières (MSF Abbo tt. of bedaq the approval by ) this n stock perfothe key to uiline, the impor against Tuber the first new US FDA For Lupin rmance as possib tant medical advan le. since 1963. culosis (TB) to drug active , the launc Tricor use bedaq The onus is on ce as soon be registe h of has uiline to TB in 50 â&#x20AC;&#x153;The first new red regim all In with focus been an expec generic devise new of us to develo addition years is an drug to ens for treat said Dr to bedaq treatm drug-r ped competitionshifting to entry ted event shorter, Manica immense milest uiline, more tolerabesistant TB that ent drug that by Janssen, a Balase one,â&#x20AC;?

Director, second OC produ . The launc of further are more are TB MSF Acces garam, Execu is active new h effective,â&#x20AC;? le for patients fact that tive â&#x20AC;&#x153;With s Camp against key factor cts and ramp of more and Otsukcalled delam the drug said Dr aign. â&#x20AC;&#x153;The MDRbetter anid, up will Balasegaram resistant is US launc s. Dr. Reddyâ&#x20AC;&#x2122;s should be treatment on forms of active against drug. the a, is undergoing developed by execution be the way, hes potential all the more the diseas European registration there Additional has gained up of game e our makes Medicines incent efforts to changer.â&#x20AC;? expected by it a The Todayâ&#x20AC;&#x2122;s limited momentum.

Agency to treat MDR ive to scale launches treatment scale and is competitio Together, be approved for resistant for multid pipeline (in 4QFY13) huge, with of the DR-TB -TB today.â&#x20AC;? use n TB (MDR an unprethe two new drugs in 2013. rugvisibility epidemic course and US 310,000 -TB) is likely trigge of in 2011. cedented repres for But global new cases notifie is improve day and up to 20 differe a two-year rs. A stable FY2014 are opportunity ent for the treatm of people around ly, only nt pills d ensur perfor quarter eight month injections.

19 per per receiv thoug ing the ent for MDR-TB, to the US and execu mance drugs are s of daily ing treatm ht to be infecte cent introd pipeline and excruciating Patients are tion on uced comb ent. d are Cadila. will be subjected â&#x20AC;&#x153;Scal The is extrem in the most effecti ined and the key permanent side effects, to treatm e-up of for ely urgen base busin quarter will ranging ve mann globa deafness ent has provide from t. nausea er Access to and remained l DR-T B the after the ess performanc low, to psych large degree new drugs will e 48 per osis. Globapersistent curre to a large shock over the benefit from escitafor Cipla cent of on the manu depend to lly, only nt treatm degree becau ingly calls on past two treatment a people lopram se the facture the ent will be quarters. comp for manu who rs. regimen lex and MSF required drugs availab facture Glenmark start programmes DR-TB are cured. is so to sustai earnings progr costly le for resear rs to make the , the cure develop n â&#x20AC;&#x201C; 53 per rate is slightlIn MSF for ammes and difficu for health ch shorter, heightened performance its strong cent â&#x20AC;&#x201C; patients,â&#x20AC;? more effecti in order to to registe lt to tolera expectation given the â&#x20AC;&#x153;Ministries but still unacceptably better Leade said Dr r them in ve te as Francis r - TB s. high-burden regimens, y low. of regulators quickly Varaine, Working â&#x20AC;&#x153;With need to health and drug Group, been appro as possible once countries simpler, work sure people MSF. effective shorter ved, and they have with MDR together to make afford treatment and to -TB benefi be able regimens, more neede able in countries ensure they are t from to d most. we will where they more peoplscale-up treatm MSF patients ent e with in 36 countr treated 26,600 are DR-TB.â&#x20AC;? and cure of TB ies in 2011 whom â&#x20AC;&#x201C; 1,300 the diseas had drug-resistan e. t forms of

Abbott com pletes sep aration of resear ch-based pharma

MSF cal ls for

http://e

shop.in

rapid reg istration in countr ies with

fomedia

business

Please ďŹ nd enclosed cheque/DD no ........................................................................................................................ drawn on (name of bank) ......................................................................................................................................... dated...................................................... or ` ........................................................................................................... favouring Network 18 payable at Mumbai.

high DR -TB

18.in

OR charge my Â&#x2026; VISA

Â&#x2026; Mastercard Â&#x2026; American Express

Card No. : ............................................................................. Card Expiry Date : .....................................................

DOB ..................................................................................... CardHolderâ&#x20AC;&#x2122;s Signature :............................................

Modern Pharma, Subscription Department, Network 18, A Wing, Ruby House, JK Sawant Marg, Dadar West, Mumbai 400 028.

4EL s &AX E-mail: customersupport@network18publishing.com or customercare@network18publishing.com Terms & Conditions : Your subscription will start from the next available issue. Network 18 will take utmost care to dispatch the copies safely. Network 18 does not take the responsibility of any postal delays and damaged copies dispatched. For more information contact Network 18 subscription department. Above rates are valid in India only.

0 R G H U Q 3 K D U P D Â&#x2021; )H E U X D U \

Marketplace

29

0R GHU Q 3KDUPDÂ&#x2021; ) HEUXDU \

30 List of Products & Advertisers Looking For A Specific Product?

Searching and sourcing products were never so easy.

Just type MPH (space) Product Name and send it to 51818 eg, MPH Laboratory software and send it to 51818 Product

Pg No

Product

Pg No

Product

Pg No

Product

Pg No

Access control ....................................................... 29

Dynamic pass box ................................................FIC

Multipostion stirrer ................................................ 11

Stainless steel pipe and tube.................................. 26

Acoustic enclosure ............................................. 19,27

Electro de-ionisation..........................................BIC

Multi-purpose trolley ............................................. 26

Steam and efďŹ&#x201A;uent treatment plant ....................... 8

Activated carbon ďŹ lter..........................................BIC

Filling equipment ................................................. 10

Ointment / lotion / cream

Strring hot plate...................................................... 11

Air shower controller ............................................. 29

Fire alarm ................................................................ 29

manufacturing plant............................................ 10

Swiss eco-friendly disinfectant .............................. 27

Air sterilisation.......................................................BC

Fire resistant door.................................................FIC

Pass box inter lock system .................................. 29

Symmetrical gravimetric analyser ........................ 26

Analytical instrument .............................................. 3

Flameproof clock .................................................... 29

pH meter ................................................................. 26

Synchronised digital clock ..................................... 29

Atlantis ..................................................................... 29

Flowtech instrument service ................................. 25

Pharma print cartridge .......................................... 28

Syrup manufacturing plant ................................... 10

Ball valve................................................................ 28

High purity water treatment

Pharma refrigerator ................................................ 27

Sysmac automation platform................................ 26

Blow-ďŹ ll seal machine .............................................. 9

system for injectible ............................................... 8

Physical testing .......................................................... 7

Tablet coating system........................................... 28

Capsule ďŹ lling machine ....................................... 28

Humidity and temperature transmitter .............. 29

Pneumatic stirrer .................................................... 26

Tablet/capsule packing equipment ....................... 10

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

Humidity pressure indicator ................................. 29

Powder and granule paking equipment .............. 10

Clean room clock ................................................... 29

HVAC and MEP ....................................................BC

Powder granulation equipment ............................ 10

Clean room door ..................................................FIC

Infomedia Yellow Pages ....................................... 25

PP-R plumbing system .......................................... 25

Clean room monitor ......................................... 25,29

Labelling equipment ............................................ 10

Pressure sand ďŹ lter ...............................................BIC

Cleanroom testing equipment ................................ 6

Laboratory equipment ........................................... 29

Pump..............................................................13,19,27

Compressor ............................................................. 13

Laboratory glassware................................................ 3

Pure water.................................................................. 8

Container sterilisation............................................ Bc

Laminar air ďŹ&#x201A;ow unit...........................................FIC

Reels for conďŹ ned sanitary space ....................... 28

Content uniformity testing ..................................... 7

Large diameter welded pipe .................................. 29

Reverse laminar air ďŹ&#x201A;ow ......................................FIC

Data logger ............................................................ 29

Level indicator......................................................... 25

Reverse osmosis unit ............................................BIC

Deep freezer............................................................. 27

Liquid handling product .................................... 3,29

Roots blower ...................................................... 19,27

Demineralisation plant ........................................BIC

Liquid injectable equipment ................................. 10

Rotary evaporator................................................... 27

Digital differential pressure transmitters and

Liquid manufacturing plant.................................. 10

Rotary tablet press .................................................. 27

indicator................................................................... 29

M pump ................................................................. 25

Sanitary tube ďŹ tting ............................................. 26

Digital GPS clock.................................................... 29

Metal doorset ........................................................FIC

Sealing equipment .................................................. 10

Waterâ&#x20AC;&#x2122;s sunďŹ re......................................................... 29

Digital magnahelic gauge ...................................... 29

Mini bilayer press ................................................... 26

Seamless pipe .......................................................... 29

Welded pipe............................................................. 29

Dissolution testing.................................................... 7

Modular clean room ............................................FIC

Softening unit........................................................BIC

Wireless clock .......................................................... 29

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

Molecular weight detector..................................... 26

Spectrophotometer ................................................. 29

X select HPLC column ........................................ 29

Dry van pump ................................................... 19,27

Motor ....................................................................... 13

Stainless steel pipe .................................................. 29

Xâ&#x20AC;&#x2122;bidge ..................................................................... 29

Advertiserâ&#x20AC;&#x2122;s Name & Contact Details

Advertiserâ&#x20AC;&#x2122;s Name & Contact Details

Temperature and differential pressure indicator ................................................... 29 Temperature and process controller .................... 26 Three parameter display ........................................ 29 Three phase thyristor power controller ............... 28 Tube.......................................................................... 29 Turnkey solution for biotech and pharma industry ....................................................BC Uâ&#x20AC;&#x2122; tube.................................................................... 29 Ultra ďŹ lteration system ........................................BIC Ultra-low temperature freezer .............................. 26 Vacuum booster pump ................................... 19,27 Vacuum system .................................................19, 27 Water analysis instrument .................................. 29

BC-Back cover, BIC-Back inside cover, FIC-Front inside cover

Advertiserâ&#x20AC;&#x2122;s Name & Contact Details

Pg No

ACE Instruments T: +91-40-2307 8848 E: sales@alwaysace.com W: www.alwaysace.com

Advertiserâ&#x20AC;&#x2122;s Name & Contact Details

Pg No

29

Everest Blower Systems 27 T: +91-11-45457777 E: info@everestblowers.com W: www.everestblowers.com

Measuretest Corporation T: + 91 22 23645282 E: measuretest@yahoo.com W: www.measuretest.com

Chemical & Process World 12 T: +91-022-3003 4650 E: cpw@network18publishing.com

Everest Blowers 19 T: +91-11-45457777 E: info@everestblowers.com W: www.everestblowers.com

Network18

Chitra Precious Machine Pvt Ltd 10 T: +91-79-2584 0315 E: contact@chitramechtech.com W: www.chitramechtech.com

Fabtech Technologies Intl Pvt Ltd T: +91 22 61592900 E: sales@fabtecheng.com W: www.fabtecheng.com

BC

P R Corporation T: +91-22-24109921 E: prc_rcshah@yahoo.co.in W: www.indiamart.com

Cole-Parmer India T: +91-22-6716 2222 E: response@coleparmer.in

GMP Technical Solutions Pvt Ltd

FIC

Praj Industries Ltd

11

W: www.coleparmer.in/3125

Eltech Services Pvt Ltd T: +91-40-2775 9895

29

Pg No

6

Shanbhag and Associates T: + 91-22-28346604 E: info@shanbhags.com W: www.shanbhags.com

13

25

Sotax India Pvt Ltd T: + 91 022-42950191 E: sotaxindia@sotax.com W: www.sotax.com

7

T: +91-1800 200 1010 (toll free) E: mcc@network18publishing.com W: www.yellowpages.co.in

29

8

Sunjay Technologies Pvt Ltd 29 T: +91- 22 6662 4330 E: info@sunjaytechnologies.com W: www.sunjaytechnologies.com Suraj Limited

29

T: +91 -22 66083790

T: +91-020-2290 5000

T: +91-79-27540720

E: prashant@gmptech.net

E: info@praj.net

E: suraj@surajgroup.com

W: www.gmptech.net

W: www.praj,net

W: www.surajgroup.com

Loba Chemie Pvt Ltd T: +91-022 66636663

3

Pg No

Salesworth Synergies Pvt Ltd (Rommelag) 9

TSA Process Equipments Pvt Ltd

T: +91-80-25274495

T: +91-022-28593808

BIC

E: sales@eltechservices.com

E: info@lobalife.com

E: mail@salesworthsynergies.com

E: base@tsapepl.com

W: www.eltechservices.com

W: www.lobalife.com

W: www.rommelag.com

W: www.tsawatersystems.com

BC-Back cover, BIC-Back inside cover, FIC-Front inside cover

Our consistent advertisers

RNI No: MAHENG / 2008 / 27125, 3RVWDO 5HJG 1R * 10' 3RVWHG DW 3 & 6WJ 2I¿FH *32 0XPEDL 2Q WK WK 2I (YHU\ 0RQWK 'DWH 2I 3XEOLFDWLRQ WK 2I (YHU\ 0RQWK

32