Express Pharma November 1-15, 2012

I N D I A’ S F O R E M O S T P H A R M A & B I OT E C H P U B L I C AT I O N November 1-15, 2012 ` 40

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Pharma VOL 8. NO. 1 NOVEMBER 1-15, 2012

Chairman of the Board Viveck Goenka

CONTENTS

Editor Viveka Roychowdhury*

MARKET

Photo Editor Sandeep Patil

The patent pileup PAGE 15

BUREAUS

Maharashtra to stop issuing license to branded drugs from October 20, 2012 PAGE 18

Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das Bangalore Neelam M Kachhap

PHARMA Pro&Pack Expo 2013 to co-locate PHARMEXCIL’S international exhibition IPHEX2013 PAGE 20

Delhi Shalini Gupta MARKETING Deputy General Manager Harit Mohanty

CTSE 2012 conference to showcase potential of clinical trial scenario in Southeast Asia PAGE 21

Senior Manager Rajesh Bhatkal PRODUCTION General Manager B R Tipnis

PHARMA ALLY

Production Manager Bhadresh Valia

‘An important part of our growth strategy is to increase our presence in Asia Pacific and emerging markets’ PAGE 49

Asst. Manager - Scheduling & Coordination Arvind Mane Asst. Art Director Surajit Patro Chief Designer Pravin Temble

Cognex Corporation wins 2012 Control Design Readers’ Choice Award PAGE 51

Senior Graphic Designer Rushikesh Konka Layout Rakesh Sharma C I R C U L AT I O N

PHARMA LIFE

Circulation Team Mohan Varadkar Express Pharma Reg. No.MH/MR/SOUTH-77/2010-12 RNI Regn. No.MAHENG/2005/21398 Printed for the proprietors,The Indian Express Limited by Ms.Vaidehi Thakar at The Indian Express Press, Plot No. EL-208, TTC Industrial Area, Mahape, Navi Mumbai 400710 and Published from Express Towers, 2nd Floor, Nariman Point, Mumbai - 400021.

(Editorial & Administra-tive Offices: Express Towers, 1st Floor, Nariman Point, Mumbai - 400021) *Responsible for selection of news under the PRB Act. Copyright @ 2011 The Indian Express Ltd. All rights reserved throughout the world. Reproduction in any manner, electronic or otherwise, in whole or in part, without prior written permission is prohibited.

November 1-15, 2012

Hikal wins award for ‘Best Responsible Care Committed Company 2011’ PAGE 73

MANAGEMENT GIVING WINGS TO IDEAS Express Pharma's 18th anniversary issue presents different perspectives of innovation PAGE 25

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EDITOR’S NOTE

Debating the quality of innovation

IF THERE IS A CONSENSUS, IT IS THAT RECENT CASES AND DECISIONS HAVE RESULTED IN A MUCH-NEEDED DEBATE ON INDIAN PATENT LAW: ITS INTERPRETATION AND BOUNDARIES

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In the run up to our 18th Anniversary issue, we ran a poll on our website, with the motion of the house being: The Indian patent law nurtures and promotes innovation.

Admittedly, its a loaded question, but the results are interesting. At the time of going to press, 64 per cent had voted against the motion. This is reflected in the comments expressed by thought leaders from industry within this Anniversary issue, as well as some legal eagles but every point they argue finds its counterpoint from stakeholders on the other side of the fence.

If there is a consensus, it is that recent cases and decisions have resulted in a muchneeded debate on Indian patent law: its interpretation and boundaries, pros and cons.

While Ranjit Shahani from OPPI/Novartis says that the country's patent law has miles to go before it can protect innovation, Kiran Mazumdar Shaw from Biocon makes the point that we should be nurturing innovation that “makes a difference”, which is only possible if we have “an enabling ecosystem”.

Leena Menghaney, Médecins Sans Frontières in fact thinks that the answer may lie beyond the Patent Act, in “an innovation policy that is much wider than simply a Patent Act”.

The legal eagles have argued on both sides, with Anay Shukla from Nishith Desai Associates stating that the Indian patent law has failed to promote and nurture innovation due to operational issues (such as the delays in the examination process, which is a separate story in itself, one we've covered in the Market Cover story of this issue: The patent pileup') as well as the threat of compulsory licenses and lack of data exclusivity.

But these are the features celebrated by their legal counterparts on the other side of the fence. As a perfect counterpoint, Raghu Cidambi, Advisor, Indian Pharmaceutical Alliance says that India's Patent Act does not allow monopolies and no protest against

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striking a balance between public and private interest is justified. Prof Raghavendra Lal Saha who is the Chairman of the IPR committee, of the Ministry of MSME, Government of India too advocates the “strong public policy element “ of patent law.

Dr Gopakumar G Nair of GNAs, another legal guru, emphasises the value of provisions under Section 3 of the Indian Patent Law as they discourage the “art of ever-greening” by distinguishing true innovation from 'prior art', frivolous or undeserving claims.

But there is no escaping the fact that we still do not have the ecosystem to reap the benefits of our own patent law. India has placed the “cart before the horse” analyses Reji K Joseph, by bringing in a product patent era before the drug innovation system could truly gets its act together. Joseph, as a consultant with Research and Information System for Developing Countries (RIS), Government of India think tank, lists three main gaps: lack of required human skills, science and technology and financing, among others. His analysis seems to be borne out by the fact that after the initial spurt in R&D spend of pharma companies in the early years of the last decade, there has been a stagnation.

Express Pharma was launched as the weekly Express Pharma Pulse in November 1994. Now a fortnightly, the publication has seen both the process patent era as well as the transition pains to a TRIPS- compliant regime. We hope to continue to reflect the evolving dynamics of this sector, even while we evolve ourselves. We revamped our website a couple of months back and with this issue, readers will note changes in the print issue's layout and visual elements as well. Do let us have your feedback as we continue to evolve along with the industry.

Viveka Roychowdhury viveka.r@expressindia.com

November 1-15, 2012

MARKET

W H AT ’ S INSIDE

THE BUSINESS OF PHARMACEUTICALS

Maharashtra to stop issuing license to branded drugs from October 20, 2012 PG18 AstraZeneca launches patented life-saving heart drug PG19 Lupin receives FDA approval for generic Avapro and oral contraceptive Kurvelo tabs PG20 CTSE 2012 conference to showcase potential of clinical trial scenario in Southeast Asia PG21

Rise in applications for pharmaceutical patents is a good omen for the Indian pharma industry.

However, lack of patent experts to examine these applications could hamper the morale of an innovator, as well as do injustice to their innovation.

Sachin Jagdale reports

Experts discuss future potential of bio pharma in India PG24

MANAGEMENT 25 PHARMA ALLY 49 PHARMA LIFE 73 November 1-15, 2012

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Innovations are important for the growth of an economy of any country. However, guarding these innovations through patent, is also equally important. That the pharma industry has taken the path of innovation more than any other industry has already been proved. For instance, as per www.ipindia@nic.in, while a mere 94 patents were granted to food products, a whopping 1810 patents were granted for medicines/pharma inventions in a three year period from 2009 to 2011.

Granting a patent is a complex legal process, requiring a lot of documentations, filing requests for examinations etc. However, for a long time, the Indian patent office has been at the receiving end for not being able to appoint enough resources to speed up the patent granting process.

Inevitable innovations Innovation is a good thing that is happening to the Indian pharma industry. However, looking at the quantity of the patent applications and patents that have been granted, one wonders how many patents are really genuine and truly justify the word 'innovation'.

Milind Sathe, Deputy General Manager, Projects, Unichem Laboratories, says, “There is nothing like genuine. All granted patents are valid till they are revocated.

Granted patent means it conforms to objective criteria specified by the Act and therefore the grant. If we correlate the word ‘genuine’ to working of the patents, then unless the data is provided as to how many of these granted patents are worked in this land, an opinion cannot be expressed. There is no firm relationship between quality and quantity unless the attributes of quality are specified.”

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While speaking about the procedure of patent processing, Sathe informs, “There is no separate procedure for prosecuting pharma patents. The manner of processing patents in general is specified in manual and in the Act and Rules.

The eligibility criteria for examiner as is displayed on IP office website.”

Though the number of patent applications is increasing, India's share among patents granted is still not considerable. Out of 185 product patents granted by Indian patent office in 2010, about 38 per cent of product patents were granted to the US. India's contribution is about 10 per cent. As already said, from 2009 to 2011, 1810 patents were granted for pharma innovations. A look at the list of patents granted and those pending clearly reveals a skew towards overseas applications.

There are some contradicting view as well. According to Suhas Tuljapurkar, Managing Partner, Legasis Partners & Director, Legasis Services, though the figure of 1810 pharma patents granted by Indian patent office from 2009-11 appears to be a big number, it is indeed not the case that the patent office is granting patents generously to either domestic or overseas pharma companies. Indeed the number of pharma patent granted in India is on a decline year-on-year.

Tuljapurkar informs, “The reason why a handful of examiners and controllers (less than 50 in all four branches of Indian Patent office) from the life sciences division could grant so many patents in so less time was, majority of these patent applications were filed during the black box period (1995-2005) and were already granted in major patent granting authorities. The patent examiners would very often take into cognizance the fact that the patent is granted in key jurisdictions to arrive at a decision for grant.”

He adds, “However the tripping point that led to the decline in numbers was the decision of Intellectual Property Appellate Board (IPAB) in the famous Novartis-Gleevec case (in July 2009) that incorporated additional requirements of ‘therapeutic efficacy’ in a pharma product patents. With regard to ‘quality’ of these patents, the mere grant of patent does not ensure its validity and many such patents have been revoked during the IPAB trials or found invalid in the hands of the judiciary. The most recent victim is patent for Sutent, an anticancer drug licensed by Sugen to Pfizer.”

Amit Hariani, Partner and Solicitor, Hariani and Company, feels that when a patent is granted, the test of novelty and utility is

required to be considered before any patent is granted to an invention. Therefore the number of patents granted will not affect the quality of the patents

Scouting for experts In the last ten years there is a rise of 250 per cent in patent applications. Does the Government of India have enough experts to examine patent applications? If not, is the Government putting innovators and innovations at risk in India with such an approach? According to experts such a situation prevails not just in India, but in many other countries as well.

“It is not only India that is witnessing the rise in applications. All developing and least developed countries, more specifically, emerging economies are experiencing this rise,” opines Sathe. As the phenomenon is new, it is natural that there will be some mismatch. According to Sathe, such mismatch is observed in the US and in the developed world as well. This is a global phenomenon. The Government is not putting innovators and innovations at risk in India with such approach.

Patents are effective from the date of application. “If any country is propagating this view, it is out of hatred and selfish interest of some interested parties that are conspiring against India,” asserts Sathe.

Since January 2012, the Controller has issued approximately over 90 letters of appointments to

SUHAS TULJAPURKAR Managing Partner, Legasis Partners & Director, Legasis Services

MILIND SATHE Deputy General Manager, Projects, Unichem Laboratories

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patent examiners. Innovations are important for the growth of any country however, bringing those innovations into practical use is even more crucial. This is possible only if the patent granting process picks up pace and the applicant is free to use his innovation for the public.

“In this highly competitive world that we live in, innovation is the key and it is constantly evolving. The Government cannot afford to delay the patent grant process and needs to clear the backlog. The patent office is, nonetheless, is doing its best to deal with the rising number of patent applications.

Undoubtedly, the number of experts / examiners needs to be increased substantially, but by following due process,” says Hariani.

“The pharma patents in the Indian patent offices are processed by patent examiners that have at least a masters degree in life sciences domain. These examiners are selected through a recruitment drive mandated by Department of Industrial Policy and Promotion (DIPP) and executed by Council of Scientific and Industrial Research (CSIR),” informs Tuljapurkar. On the other hand, Tuljapurkar also highlights some flaws in the system.

He indicates that for a long time Indian patent office couldn't recruit patent examiners in sufficient quantities that might have subsequently led to delays in patent application processing.

Tuljapurkar explains, “In last attempt Indian patent office could hire only 135 of 257 mandated examiner posts. Thus there has always been acute shortage of experts that can handle the pending cases in the Indian Patent offices.”

He adds, “Though DIPP is taking steps to modernise the patent offices, equip them with up to date electronic databases and making the patent process more transparent and user friendly, the efforts are slower as compared to other countries like China or South Korea.

Majority of patent applications filed in India (up to 80 per cent) are filed by non-Indian applicants.”

Vivek Mittal, Legal Counsel, Lupin, gives the pharma perspective. He says, “The Government stands challenged to keep up with not only the pace of growth of the Indian pharma industry but also the growth of the Indian pharma market. Having said that, in my view the pace is not that bad either; however, there is large scope for improvement that could fuel further growth.” He wants the Government to keep pace with changes in the industry, with research and changes in laws and legalities globally as November 1-15, 2012

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AMIT HARIANI also make sure that the patents offices are staffed with the right scientific minds who would ensure swift processing and filings of patents.

Streamlining the process The quantity of patent applications is a pointer towards the fact that there is no dearth of talent and innovation-oriented minds in the country; however, the credibility of the respective discovery can always be challenged. On the other hand, delay in patent application processing is an injustice for those who have toiled hard to innovate something extraordinary and which also holds national importance. India has already managed to shed its image of a backward country in the field of innovation. Not just pharma, but many other industries have been adding to the list of

November 1-15, 2012

patent applications that are piling up in the Indian patent office. However, there is a common consensus among different industries that the Government needs to employ some crucial operational changes in the patent office.

Tuljapurkar says, “With the decision on the constitutionality of section 3(d) still pending with Supreme Court the existing requirements stipulated under section 3(d) shall continue to apply. So much has been said and written about section 3(d) that the industry expects the office to release interim guidelines on what is patentable under section 3(d) and by drawing various scenarios with examples that will enable an applicant to prepare a 3(d) compliant specification and also avoid heterogeneity in the judgment of patentability under section 3(d) amongst vari-

Partner and Solicitor, Hariani and Company

ous controllers in different branches of the same office.”

According to Sathe, the Intellectual property Office, Ministry of Industry and Commerce, Ministry of Finance should publish the data collected under FORM 27, action taken against patentees providing submissions and depositions which are found to be different from facts, install effective mechanism to recover the dues,

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install a mechanism where by non-worked patents are declared by Government as open for Compulsory Licensing. This will save critical time and ensure public interest, fulfilment of sovereign duties and social welfare.

Sathe insists, “The Government should declare that a patentee which contradicts the law of the land may be declared as enemy and thereby may be prevented from commissioning, continuing any litigation in any of the Indian courts. All tangible and intangible property of enemy shall be confiscated.”

The greener side There are visible drawbacks in the patent application processing system, however, Indian patent office has also taken steps to become operationally more efficient.

Even the pharma industry’s

general perception is that there is an improvement in patent processing over previous methods. “Online database is made available for searches, which was not available earlier,” informs Hariani. However he highlights that delay in clearing backlogs of applications remains the cause of concern.

Introducing an electronic module would help in imparting accuracy, efficiency and transparency to patent examination system. While such initiatives would avoid delays to some extent, it will be interesting to observe what further steps the Indian patent office will take to make the patent processing system closer to global standards.

How industry responds to them will also determine the success of these moves. sachin.jagdale@expressindia.com

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COMPANY WATCH Maharashtra to stop issuing license to branded drugs from October 20, 2012 IDMA-GSB invites associations to discuss the issue further Usha Sharma Mumbai aharashtra has received the official communication from the Union Health Ministry to stop issuing license for the manufacture and sale of drugs on the basis of their brand name.

The notice has been already communicated verbally to all the joint commissioners in Maharashtra and will get officially implemented within the state from October 20, 2012. However, states like Karnataka and Gujarat had not received any communication from the Centre.

IDMA-GSB has decided to conduct an extraordinary EC meeting action on this issue.

Speaking with Express Pharma, Prakash R

M

Uttarwar, Joint C o m m i s s i o n e r (Headquarters), Food and Drugs Administration, Maharashtra said, “We have received an official communication via email from the Centre to stop granting approvals of manufacturing license of drug formulations to branded drugs. It will be effective from October 20, 2012.”

“It will be unfair to the pharmaceutical industry to make a judgement without taking a concern from the industry stakeholders. This move may hamper the growth of the Indian pharma industry as companies may not like to invest on its research and development works. This move will substantially reduce the price of medicines,” a senior official on condition of anonymity said.

“If the pharma industry has any problems with this move then they should convey their concern to the

Centre via bodies like IDMA and OPPI. We will follow the order been given by the Centre,” Uttarwar said.

Chirag Doshi, Chairman, IDMA-GSB said, “The notification which has been issued by the Union Health Ministry needs to discuss

row and have invited all eight local associations' chairman of pharma manufacturing companies in Gujarat. We will be taking this issue further as it is not in favour of the industry.”

IDMA-GSB has invited associations from Rajkot,

ALL PHARMA FIRMS APPLYING FOR LICENCE TO MARKET OR MANUFACTURE FIXED DOSE COMBINATION (FDC) DRUGS WILL HAVE TO SUBMIT THEIR GENERIC NAME AND NOT AS BRANDS WITH IMMEDIATE EFFECT the parameters concerned with the exporters. The Centre has not even consulted with the industry stakeholders before acting on it.

To discuss all these issues, we have called for an extraordinary executive committee meeting tomor-

Sabarkantha district, Bhavnagar, Surendranagar, Navsari and Vadodara to discuss the Centre's move. In Gujarat there are more than 90, 000 branded drugs available. Today the pharma industry in Gujarat nearly contributes 28 per cent to

the total domestic market share. Also, there are 85 different pharma manufacturing plants located in the state.

Doshi continued that we are reviewing all the existing data before presenting it to the Centre. In the meeting we will discuss all the relevant matters related to this sensitive issue before in hand. Besides this agenda we do have other topics as well to discuss in the meeting.”

Dr BR Jagashetty, Karnataka Drugs Controller said, “So far, we have not received any official communication from the Centre, hence, we do not have any information on same.

All pharma firms applying for licence to market or manufacture fixed dose combination (FDC) drugs will have to submit their generic name and not as brands with immediate effect. u.sharma@expressindia.com

Polyclone Bioservices signs MoU with JSS University, Mysore To expedite research and development of new methods and technologies olyclone Bioservices has signed a memorandum of understanding (MoU) with JSS University, Mysore. This MoU establishes the framework for collaborative research and development in biological sciences between the two organisations.

Collaborations under this MoU are focused on collaborative R&D in biological sciences. The MoU is intended to expedite research and development of new methods and technologies that can be implemented and aligned with Polyclone’s

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missions as well as aimed at enhancing the quality of research and education at JSS University. The two organisations have agreed to promote exchange and coperation in all appropriate and agreed areas of research and also facilitate co-operation between the staff of both organisations.

Both JSS University and Polyclone believe that this collaboration will contribute to more efficient resource utilisation, avert or minimise duplication, and accelerate methods and technology advancement in various

fields of biological sciences.

The two organisations further believe that successful collaboration will leverage beneficial results via method and technology transfer, education, and training.

Naveen Kulkarni, CEO, Polyclone stated that, “Our experience in stem cell technologies and with recent partnership in nanotechnology applications in stem cell therapy with PSG’s Institute of Advanced Studies is further strengthened by JSS University’s addition, mainly due to the association of JSS Medical college that is actively fostering this relationship with Polyclone in the area of advanced application of stem cell therapy www.expresspharmaonline.com

THE COLLABORATION WILL CONTRIBUTE TO MORE EFFICIENT RESOURCE UTILISATION, AVERT OR MINIMISE DUPLICATION

for better clinical outcome.

The significance of having a clinical partner will only help us get closer to patient understanding and bring

innovations outside the lab and this partnership with JSS University is the key, with access to a facility of more than 1,500 beds, the company can generate insights into patient care aspects across different disease cycles ranging from ophthalmology to oncology and critical care like wound healing.”

JSS University is an institute of higher learning, offering educational programs in the area of medicine, arts, science, and commerce & business management. JSS University is widely recognised for the quality of its undergraduate, graduate and professional educational programmes.

EP News Bureau November 1-15, 2012

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AstraZeneca launches patented life-saving heart drug Brilinta is indicated to reduce heart attack and cardiovascular death in patients with Acute Coronary Syndromes (ACS)

each year, Brilinta gives cardiologists a new and effective treatment to help reduce the rate of heart attack and

cardiovascular deaths in these patients. Such exciting medical breakthroughs don’t happen very often.”

To date, Brilinta has been approved in 83 countries and launched in 63 countries (including India now) under

the trade name Brilinta and in the European Union under the trade name BRILIQUE. EP News Bureau

straZeneca Pharma India launched a new patented antiplatelet drug Brilinta (Ticagrelor) in India. Brilinta is an oral antiplatelet treatment for Acute Coronary Syndromes (ACS) in adult patients.

Brilinta is competitively priced to enable ACS patients benefit from having access to this medicine.

Brilinta works by preventing the formation of new blood clots and maintaining blood flow in the body to help reduce patient’s risk of

A

BRILINTA HAS BEEN APPROVED IN 83 COUNTRIES AND LAUNCHED IN 63 COUNTRIES (INCLUDING INDIA NOW) another cardiovascular event (called atherothrombotic events) such as a heart attack or cardiovascular death.

The Drug Controller General of (India) (DCGI), based on the New Drug Advisory Committee’s (NDAC) recommendations granted its approval in May 2012 for marketing Brilinta (Ticagrelor) tablets in India.

The DCGI approval is based upon the submission of data from the landmark PLATO (Platelet Inhibition and Patient Outcomes) trial, comparing treatment with Brilinta to Clopidogrel - the current standard of care, available in the market for over a decade.

Dr Paurus Irani, Vice President Medical & Regulatory Affairs, AstraZeneca Pharma India said, “With over 40 lakh people affected by ACS in India November 1-15, 2012

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Lupin receives FDA approval for generic Avapro and oral contraceptive Kurvelo tabs Kurvelo tablets are the AB-rated generic equivalent of Teva’s Nordette tablets

upin announced that its subsidiary Lupin Pharmaceuticals has received final approval for its Irbesartan Tablets, 75 mg, 150 mg and 300 mg from the United States Food and Drugs Administration (US FDA) to market a generic version of Sanofi Aventis US, LLC’s (Sanofi Aventis) Avapro Tablets, 75 mg, 150 mg and

L

300 mg strengths.

Lupin’s Irbesartan Tablets, 75 mg, 150 mg and 300 mg are the AB-rated generic equivalent of Sanofi Aventis’s Avapro tablets.

Irbesartan is an angiotensin II receptor antagonist and is indicated for the treatment of hypertension and nephropathy in type II diabetic patients.

The company has also received final approval for its oral contraceptive Kurvelo Tablets (Levonorgestrel and Ethinyl Estradiol Tablets, USP) 0.15 mg/0.03 mg from the (US FDA) to market a generic version of Teva Branded Pharmaceuticals (Teva) Nordette Tablets (Levonorgestrel and Ethinyl Estradiol Tablets, USP), 0.15 mg/0.03 mg.

Lupin’s Kurvelo tablets are the AB-rated generic equivalent of Teva’s Nordette tablets.

Lupin’s Kurvelo

LUPIN’S IRBESARTAN TABLETS, 75 MG, 150 MG AND 300 MG ARE THE ABRATED GENERIC EQUIVALENT OF SANOFI AVENTIS’S AVAPRO TABLETS

tablets is a Levonorgestrel and Ethinyl estradiol combined oral contraceptive indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Lupin is marketing its Kurvelo tablets in 21 light orange colored active tablets containing 0.15 mg Levonorgestrel and 0.03 mg Ethinyl estradiol and seven pink inert tablets (without hormones). This dosage regimen is identical to that of Nordette.

EP News Bureau

PRE EVENT PHARMA Pro&Pack Expo 2013 to co-locate PHARMEXCIL’S international exhibition IPHEX2013 DIA to partner PHARMA Pro&Pack Expo 2013 PHEx 2013 – an international exhibition on API, bulk actives, additives, exipients, and entire spectrum of the pharmaceutical chemicals will be co-located with PHARMA Pro&Pack2013. The event will be organised by PHARMEXCIL (Pharmaceutical Export Promotion Council of India, Govt. of India) and will be held at the Mumbai Exhibition Centre, Mumbai, India from April 24 to 26, 2013. The twin international shows at one venue and on same dates will be the highly resourceful for the trade professionals from India and international.

IPHEX 2013 will be one of the largest showcases of Indian pharma products and technologies to a global

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audience. Over 400 overseas buyers from focus areas are being invited to participate in the exhibition. IPHEX 2013 will offer the industry majors from India and all across the world a great platform to connect and do business.

IPHEX 2013 will be the biggest industry event showcasing the diverse range of products in the core sectors of formulations, APIs, AYUSH, nutraceuticals, health services, biotechnology and biotechnology products, R&D services, technologies & consultancy, government / state pavilion, diagnostics / surgical dressings / medical devices, contract manufacturing/ research/ clinical trials (cros) / custom synthesis.

Amongst the target visitors will be large volume buyers seeking manufacturers, government procurement agencies, hospitals and health service providers,

drug regulators & fda officials, private sector hospitals, clinics, daycare centres and institutes, agents / distributers / dealers, financial institution banks, private equity and venture capital funds, institutional agencies and development aid agencies.

The exhibition having a special focus on promoting ‘Brand INDIA’ to both the Indian and world pharma industry is being jointly organised by the Indian Pharma Machinery Manufacturers’ Association (IPMMA) and GPE Expo.

“With the combination of PHARMA Pro&Pack Expo 2013 and IPHEX 2013 exhibitions and highly informative conference organised by the world's recognised information provider - The Drug Information Association (DIA), the overall event is for everyone whosoever concerned for the pharma formulation manufacturing,” www.expresspharmaonline.com

said Rajesh Shah, President – IPMMA. (DIA), will be the conference partner of PHARMA Pro&Pack Expo 2013 (PPPE 2013). DIA will be organising a series of must attend technical seminars alongside the exhibition focusing various aspects on the pharma formulation manufacturing process and technologies.

The seminars will have industry experts from India and abroad as the keynote speakers. DIA in India over the last four years has provided quality programmes, publications, and knowledge resources to regulatory agencies, academia, industry professionals, and patient advocates across the country and Asian continent.

Every year, DIA in India conducts workshops and training programmes in various cities such as Ahmedabad , Bangalore, Chandigarh, Chennai, Delhi, Goa, Hyderabad and

Mumbai on varied topics like eCTD Compilation, Cardiac Safety, Quality Management Systems, Project Management, Rapid Screening Methods, Generic Drug Application using QbD, Clinical research and Patenting to name a few. DIA conducts several workshops in collaboration with universities, regulatory agencies like US FDA, EDQM, WHO and Pharmexcil. Through its four flagship conferences and exhibitions held annually on Regulatory Affairs, Chemistry Manufacture and Control (CMC), Pharmacovigilance and the Regional Annual Conference, DIA has established itself as a neutral platform where thought leaders from the pharma, biotechnology, medical device, and related fields exchange ideas, network, and engage with industry professionals across Asia.

EP News Bureau November 1-15, 2012

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CTSE 2012 conference to showcase potential of clinical trial scenario in Southeast Asia Conference to be held in Mumbai on November 23, 2012 conference on Clinical Trials in Southeast Asia (CTSE 2012) will be held in Mumbai on November 23, 2012.

The conference, to be held in Hotel Sahara Star, Mumbai, will showcase the potential of clinical trial scenario in Southeast Asia.

The regulatory agencies, their expectations and their process for approvals are some of the key points in this conference.

Delegates include directors, VPs, senior medical advisors and senior staff of regulatory affairs from pharma and biotech companies and also couple of clinical research organisations as solution providers with expertise in this region.

Indian and multinational big pharma and biotech companies are taking their trials to Southeast Asia due to stringent regulatory approvals and increase in denials for conducting clinical trials in India.

The conference advisory board and the speaker faculty are leading experts from the region, with hands-on experience in clinical trials in Southeast Asia.

The agenda tackles the key strategic, regulatory and scientific issues impacting the industry today as well as perspectives about the future. Express Pharma is the media partner for the event.

Delegate invitees to CTSE 2012 include decisionmakers and influencers from big pharma, early stage and mid stage biotechs, government and regulatory bodies.

The organiser’s database includes the details of almost all companies that have ever conducted clinical trials in Asia.

EP News Bureau

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November 1-15, 2012

“Visit us at CPhI Mumbai, India, November 21-November 23, 2012, at Hall 1, Stand No. I4"

33-year history of partnership with leading pharma companies Valsartan

Telmisartan

Clopidogrel Bisulphate

Irbesartan

Form-I

active pharmaceutical ingredients & its intermediates* Commercial scale Antitubercular Pyrazinamide# * Isoniazid # *

Antimalarial Artesunate Arteether Artemether# * Dihydroartemisinin Lumefantrine# * Piperaquine

Macrolides

Antihypertensive

Azithromycin Clarithromycin Erythromycin base # # Erythromycin estolate Erythromycin ethyl succinate+ Erythromycin oxime (intermediate) Erythromycin stearate #

Irbesartan # Losartan potassium Telmisartan Valsartan

Antihistaminic

Alendronate sodium Zoledronic acid

Sedative, Hypnotic Zopiclone

#

Antifungal Flucytosine

#

Cetirizine dihydrochloride # Hydroxyzine diydrochloride + Meclizine diydrochloride

Antiosteoporotic

#

Antiepileptic Valproic acid

Antidepressant Venlafaxine hydrochloride

Under Development

#

Antiretroviral

Antidiabetic

Hypnotic

Antithrombotic

Ganciclovir Valaciclovir Valganciclovir Maraviroc

Linagliptin Vildagliptin

Eszopiclone

Clopidogrel bisulphate

*WHO APIMF

CEP / COS

* The Technical and Physical manufacturing capabilities exist with us for the above APIs and their intermediates. However these products will be offered only to the markets where any product or process patents are not infringing. During the validity of a patent the research quantities for developing products for regulatory submissions will only be offered to countries where such exemption exists (Hatch Waxman Act / Bolar exemption). While Calyx offers to work with the clients on Patent Status Verification, the final responsibility vests with the buyer. Recipients are requested to make their evaluation and determination as to the patent status prior to their use of the information or materials in their respective jurisdiction.

Products under patent offered only for exempted research, clinical and development purposes. Only non-infringing products and processes are offered, subject to patent status verification by client.

Calyx Chemicals and Pharmaceuticals Limited Reg. Office: Unit No.110, Marwah's Complex, Krishanlal Marwah Marg, Off. Saki Vihar Road, Andheri (East), Mumbai – 400072, Maharashtra, India.

Tel: +91-22-28571191, Fax: +91-22-66466416, Email: sales@calyxindia.com, crams@calyxindia.com USA Contact : 11728 E. Imperial Highway, Norwalk, CA 90650, Tel - 213-291-7773, Email: sales@calyxusa.com, crams@calyxusa.com Website : www.calyxindia.com "Calyx Chemicals and Pharmaceuticals Limited (the “Company”) is proposing to make, subject to receipt of requisite approvals, market conditions and other considerations, an Initial Public Offering of its equity shares (the “IPO") and has filed the Draft Red Herring Prospectus (the “DRHP”) with the Securities and Exchange Board of India (“SEBI”). The DRHP is available on the website of SEBI at www.sebi.gov.in, the website of the BRLMs, i.e. PL Capital Markets Private Limited at www.plindia.com and YES Bank Limited at www.yesbank.in and is also available on the website of the Company at www.calyx-pharma.com. Potential investors should note that investment in equity shares involves a degree of risk. For details, please refer to the DRHP, including the section titled “Risk Factors” of the DRHP. This publicity material does not constitute an offer of securities in any jurisdiction, including the United States of America (“USA”). Securities may not be offered or sold in the USA without registration under the U.S. Securities Act of 1933 as amended, or an exemption therefrom. The Company has not and does not intend to offer any securities to the public in the USA”.

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EVENT BRIEF API China

64th Indian Pharmaceutical Congress (IPC)

Date: November 7-9, 2012

Date: November 23, 2012

Date: December 7-9, 2012

Venue: International Conference & Exhibition Center, Xiamen, China

Venue: Hotel Sahara Star, Mumbai

Venue: SRM Institutions Campus, Chennai.

Summary: China’s leading exhibition for the pharmaceutical manufacturing sector will cover the complete spectrum of products from raw material, fine chemical, intermediate, ingredients, processing machinery and packaging machinery. It is an event for international buyers to meet Asian sellers especially Chinese ingredients manufacturers. The event will attract over 1,400 manufacturers and 30,000 professional visitors.

Contact details: Exhibitor Services Tan Zhen API China Team E-mail: zhen.tan@reedsinopharm.com Tel: 0086-10-84556693 Visitor & Media Services Shell Zhao API China Team E-mail : weilin.zhao@reedsinopharm.com Tel : 0086-10-84556692

CPhl India 2012, P—MEC India 2012 Date: November 21-23, 2012 Venue: Bombay Exhibition Centre, Mumbai Summary: CPhI India into its sixth year, with its co-located events with more than 800 exhibitors, is the largest and most comprehensive pharma industry event in South Asia.

CPhI India is a great gateway to meet with key decision makers in pharma industry from around the world including India, China, Japan, the US, the UK, Germany, France, Italy, etc. P-MEC India is South Asia’s number one pharma machinery and technology exhibition and will give those involved in pharma manufacturing an unprecedented insight into the future of mechanical equipment and machinery. The exhibition will highlight the latest knowledge and the newest trends within the industry.

Contact details: Milind Dixit Director - Exhibitions UBM India Tel: + 91 22 66122600, Fax: + 91 22 66122626 Email: milind.dixit@ubm.com

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Summary: The conference is the first exclusive Southeast Asia focused event in India and will offer delegates the chance to understand the intricacies in conducting trials in Malaysia, Thailand, Indonesia, Singapore and Philippines among other topics. The conference advisory board and the faculty are leading experts from the region, with hands-on experience in clinical trials in Southeast Asia. The agenda tackles the key strategic, regulatory and scientific issues impacting the industry today, as well as perspectives about the future. Practical information and case studies are some of the key points in this conference.

Contact details: Amita Shah B.Pharm, MBA Director SSI Events UK Ltd 145 -157 St John Street, London, EC1V 4PW Email: amita@ssievents.co.uk UK Phone: +44 7624095854 India Phone: +91 9769168972 www.ssievents.co.uk

Symposium on Evolution of Gas Chromatography in India - Past, Present and Future Date: November 23-24, 2012 Venue: BARC Training School Hostel at Anushakti Nagar, Trombay, Mumbai.

Summary: The symposium will bring together all those connected with gas chromatography. Experts will speak on various fields of GC application such as petrochemicals, natural gas, perfumeries, flavours, pharma, forensic, doping, synthetic chemistry, natural products, etc. It will provide a platform to recognise the scientists, companies and the people who have helped in placing India on the international map of chromatography.

Contact details: Dr G Ramakrishnan Convener of the Symposium, Chromatographic Society of India C-1203 Synchronicity, Nahar Amrit Shakti Road, Chandivali, Mumbai - 400072.

Mobile: +91-98200 93260 E-mail: ramakrishnan.g@ chromsocindia.org Website: www.chromsocindia.org

Summary: Association of Pharmaceutical Teachers of India will host the 64th Indian Pharmaceutical Congress.

Contact details: Prof BG Shivananda Secretary-APTI Association Of Pharmaceutical Teachers of India HQ: Al-Ameen College of Pharmacy Opp Lalbagh Main gate, Hosur Main Road, Bangalore – 560027 Email: aptienquiry@gmail.com

BioAsia 2013 Date: January 28-30, 2013 Venue: Hyderabad Summary: Biotechnology being an emerging industry, game-changing strategies and relevant application of the knowledge-intelligence resource pool, drive the process of growth.

BioAsia seeks to enhance, enrich and encourage newer innovations, pathbreaking discoveries and effective solutions in the industry by offering a vibrant global platform for convergence of the key stakeholders Biotech & Biopharma companies, research institutions, investors, service providers, policy makers, regulators and analysts.

Contact details: BioAsia Secretariat 204, Imperial Apartments Greenlands Circle, Ameerpet Hyderabad 500016 Andhra Pradesh, India Tel: +91 40 6644 6477 +91 40 6644 6577 Web: info@bioasia.in

Bangalore INDIA BIO 2013 Date: February 6-8, 2013 Venue: Bangalore, India Summary: Bangalore INDIA BIO is an annual event organised by Department of Science & Technology Government of Karnataka, under the guidance of Vision Group of Biotechnology. Since 2001, Bangalore INDIA BIO has been promoting the

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Indian biotech industry to the outside world and is one of the biggest event on life sciences.

Bangalore INDIA BIO 2013 will be an opportunity to get insights about the latest trends and biotech business opportunities in India. It will also deliberate on issues related to the latest innovations in biotechnology and focus on business opportunities that exist for companies in biopharmaceuticals, bio-industrial, bio-services, bio-informatics and agri-biotechnology in the light of the emerging bio economy.

It will also discuss about collaborative and integrative business models as well as policy, regulation, and investment challenges for biotechnology in a global bio-economy and will provide networking and knowledge sharing platform for business leaders, policy makers, research heads and academia.

Event Highlights Multi-Track Conference International Trade Show BioPartnering India TM Vision Leadership Series CEO Conclave Poster Walkway of Discovery Bio Excellence Awards BioQuiz Workshops

◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆

Contact details: MM Activ #9, UNI Building, 1st Floor, Thimmaiah Road, Millers Tank Bed, Vasanthnagar, Bangalore - 560 052 Tel: +91 80 4113 1912 / 13 Fax: +91 80 4113 1914 enquiry@bangaloreindiabio.in

PHARMA Pro&Pack 2013 Date: April 24—26, 2013 Venue: Mumbai Exhibition Centre, Goregaon Summary: PPPE 2013 is an initiative of the Indian Pharma Machinery Manufacturers’ Association (IPMMA), jointly with GPE Expo.

The event will offer a single platform for more than 200 exhibiting companies from India and across the world to showcase their products.

Contact details: Paresh Jhurmurwala GPE EXPO Global, Opp. Priyadarshini Tower, Near Judges’ Bungalows, Bodakdev, Ahmedabad 380015, Gujarat Tel: +91 792687 1390 / 4000 8253 4000 8233 Email: contact@pharmapropack. com

November 1-15, 2012

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POST EVENT Experts discuss future potential of bio pharma in India Over 100 delegates participate in the conference Dr Ranjeet S Ajmani, CEO, PlasmaGen Bioscience io-Pharma India Summit ‘Today to Future 2020’ was recently held in Mumbai, which was attended by over 100 expert delegates.

Dr Ranjeet S Ajmani, CEO, PlasmaGen Bioscience, who was the Chairperson for the event, gave the opening remarks with his presentation on blood plasma scenario in India and SAARC region. It was an event with thought provoking discussions and engaging content.

Leaders from biologics, biosimilars, diagnostics, devices and health management services and allied services took part in the conference.

Ajmani said, “India has made progress in certain areas of healthcare segment but somehow public health issue is still not addressed. This is one of the major concerns raised even by the Planning Commission of India.

Providing safe blood/plasma products is an important concern, as it deals with transmission of HIV, Hepatitis B and C and many such diseases through these medicines.

Unfortunately this issue has not been addressed well at various levels and it needs attention on an urgent basis, as it deals with patients of practically all categories. Some of the proteins fall in the category of essential medicine. It is also important for any country to have its national blood policy, blood security programme and self sufficiency for plasma protein therapy. We have major challenges in terms of availability of safe raw material, safety, affordability and out dated regulatory guidelines.

The scene is almost similar in all the SAARC nations.”

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“India can create a sustainable model, which would help other developing economies to look into this aspect of healthcare system.

This forum would help in raising/sharing the concerns and probable solutions for developing a strong base for plasma protein therapy in India and SAARC region,” added Ajmani.

Charles M Y Lim, CEO Asia/China, BIA Separations, spoke about downstream purification challenges, and strategies for increasing the Charles M Y Lim, CEO Asia/China, BIA Separations

LEADERS FROM BIOLOGICS, BIOSIMILARS, DIAGNOSTICS, DEVICES AND HEALTH MANAGEMENT SERVICES AND ALLIED SERVICES TOOK PART IN THE CONFERENCE

Panelists at the conference

capacity and quality in the production of new bio-therapeutics.

Speakers from Reliance Life Sciences, Marken, ICON, Realisation, TTubes and Sanofi, took part on the first day of the event. Day two of the forum saw presentations from speakers involved in clinical research and vaccines.

The panel discussions witnessed interesting exchange of perspectives between panelists and audience.

EP News Bureau www.expresspharmaonline.com

November 1-15, 2012

MANAGEMENT

W H AT ’ S INSIDE

THE BUSINESS OF PHARMACEUTICALS The price of innovation: Which way pharma? PG38 ‘Collaborative commercialisation of incremental innovation could help bring affordable new drugs’ PG40 ‘The need of the hour is product innovation’ PG42 'Non-working of patent a blot on knowledge economy' PG43 Can Indian SMEs address healthcare solutions? PG44 ‘Indian innovation – Stay the course’ PG48

PHARMA ALLY 49 PHARMA LIFE 73

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‘INDIA’S PATENT LAW HAS MILES TO GO’

RANJIT SHAHANI President, OPPI and Vice Chairman and Managing Director, Novartis India ndia introduced product patents for the pharmaceutical industry in 2005.

In less than three years we will complete a decade of product patents. As we move closer to 2015 there is no doubt in my mind that we still have a long way to go before we can look at ourselves with pride as a country that fosters innovation.

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When India introduced product patents after a hiatus of 35 years, the research-oriented pharma industry heaved a collective sigh of relief. Finally, innovation would be recognised. Finally, the Indian patient would benefit from innovation. Finally, the pharmaceutical industry would come into its own.

However, the developments

since then have proved otherwise.

It is a common truth that the ultimate beneficiaries of pharma research are the patients. It is the patients who benefit from advances in science and it is a sad travesty of justice that there are still thousands of unmet medical needs in a country that has such a large pool of scientists. Product patents serve to stimulate and foster innovation and India needs to create a climate and provide the infrastructure where science and scientists will be allowed to bloom.

There are those who would like to position India as the pharmacy of the developing world. My question to them is why do we short sell ourselves? Why do we not aspire for greater things?

Why do we not want to be

the pharmacy of the world?

We certainly have the wherewithal—if only we believed more in ourselves.

It has been argued in some quarters that by denying product patents, India will actually improve access to medicines and encourage domestic producers of generics. It is a no brainer that generics alone are not the solution to access. India needs to do much more to improve access to medicines.

We need to increase our healthcare funding and we need to put in place the proper infrastructure for healthcare delivery.

Without addressing these two fundamental lacunae, access to medicines for our people will continue to remain a mirage.

More importantly, without product patents there would be no new pharma products

and without new pharma products there would be no new generics.

A world class IPR regime will actually be to the benefit of India leading to sustained foreign investment and newer and better drugs for its citizens. We have too much at stake here to be myopic – the health of our fellow citizens; the future of the pharma industry, India’s ability to attract and retain top-notch scientific talent and the opportunity to be among the top global players in the world economy.

As Robert Frost said, “The woods are lovely, dark and deep but I have promises to keep and miles to go before I sleep, miles to go before I sleep.” That is exactly how it is with the state of product patents in our country. We have miles to go.

‘NURTURING INNOVATION THAT MAKES A DIFFERENCE’

KIRAN MAZUMDAR-SHAW CMD, Biocon

he economic challenges that confront us today –healthcare, education, development, and environment, among others – call for extraordinary measures. If we are to change things for the better, we need to innovate. In order to be viable and effective, innovation must have

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two key attributes: differentiation and affordability.

In the context of healthcare, the IP of a drug often detracts from its affordability.

Drug innovation is usually an enormously expensive exercise – developing a new medicine can cost up to $800 million in the developed world.

Reimbursement guidelines – not the need of the patient – decide the availability of a new drug in the market. Thus, even as the West leads the way, its dollar-denominated innovation has inherent limitations.

In a developing country like India, innovations enabling cheaper drugs and low-priced healthcare infrastructure can work wonders in patient care. Thus, as we try to bridge the chasm between medical advances and health inequities, India must harness the potential of innovation based on differentiation and affordability to maximise reach and impact. Only then can we ensure access to healthcare for all, at all times and in all places. This calls for innovation in discovering www.expresspharmaonline.com

drugs, in developing therapeu- patented novel molecules – tics, and in delivering health- are affordable and have care. Narayana Hrudayalaya changed the lives of thouand the Tata Nano – albeit in sands. At the same time, our another industry – epitomise innovation-led business this union of affordstrategy has providability and differened us premium tiation. returns whereIn a developin we have ing country like leveraged Affordability India, innovations our IP for and differenenabling cheaper drugs market diftiation at and low-priced ferentiation.

Biocon healthcare infrastrucBiocon ture can work wontook this path Innovation ders in patient care to innovation risk matrix because we Our riskrealised that withbalanced innovaout affordability it tion matrix plays a would serve no purpose. Our critical role in our highproducts developed on this value-low-cost drug discovphilosophy – from patented ery and development endeavenzymes to generic statins, our. The matrix has enabled and from biosimilar insulins us to invest in research and and monoclonal antibodies to development (R&D) and November 1-15, 2012

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ascend the value curve even as we manage the cost of risktaking. We start with a low investment in high-risk research which can offer breakthrough innovation in the form of therapies like bifunctional antibodies. At a lower level on the curve, we invest in what we call incremental innovation that has a high probability of success, such as generics. The third quadrant represents medium risk or evolutionary innovation; biosimilars are an example here. The final quadrant is the highest risk which includes our novel molecules such as oral insulin and T1h.

This strategy has allowed us to develop a robust pipeline with novel and biosimilar programmes at various stages of development. Even as we achieve research objectives, our inherent cost-effectiveness and minimal risk exposure ensures affordability.

and incubation funding 3. Proven ideas and discoveries are taken to market through business intervention backed by venture funding This financing cycle can start rolling if we address the

lack of access to capital markets. Science and technologybased start-ups – biopharma companies included – that do not have revenues are not eligible to apply for listing. Such start-ups are stuck in an eter-

Let us take a look at each of these aspects Funding: Innovation requires capital – that is obvious. But where will this money come from? India requires a national innovation ecosystem that puts in place a financing cycle: 1. Academia generates ideas in partnership with industry 2. These are nurtured to proof of concept through Government-sponsored seed November 1-15, 2012

investor-friendly environment that can fund innovation, India needs an ancillary stock exchange to help start-ups access new markets. Such an exchange can leverage upcoming technologies to

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Need for an enabling ecosystem India must similarly foster innovation that is differentiated and affordable if it wants to move up the value chain and assume global leadership. However, innovation is about applied creativity and India, traditionally, has imitated – not innovated. Even in the biotech sector, most companies operate in the low-risk services and generics space.

For innovation to make a difference we require an enabling ecosystem that incubates and nurtures the innovation process – from ideation and research to funding and development. Such an ecosystem must fulfill a range of requirements: It must provide funding, offer infrastructure support, ensure a facilitating regulatory setup, and encourage and train talent.

nal loop – venture capitalists won’t fund these companies since there is no exit to capital markets and capital markets are not available to such companies owing to listing regulations. To cultivate an

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Chennai

Cochin Goa

Hyderabad Kolkata

New Delhi Pune EXPRESS PHARMA

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drive entrepreneurship and catalyse growth.

Infrastructure: Our dilapidated infrastructure needs to be upgraded with a sense of urgency if it is to support a strong and innovative industry. Biotechnology and other high-tech sectors need continuous and quality power and water supply and well-connected roads. The growth India has witnessed so far has been in spite of its infrastructure.

Public-private Partnership (PPP) can be a viable and efficient model

with which to improve the infrastructure, with the private and public sectors drawing on each other’s expertise.

Regulations: While innovation-driven models can churn out products that are affordable and accessible, businesses require external support.

India has multiple regulatory bodies leading to confusion over clearances. We need to act now to create enabling regulations and enhance recognition between international regulators. A stream-

lined regulatory environment that can approve products without delays – along with attractive tax incentives for R&D –could be the first step to encourage innovation. R&D is a critical success factor for knowledge-based industries like biotechnology and the government must enable international patenting and encourage investment.

Talent; We must encourage our scientific community to create and market intellectual property.

Commercialising

academic research is still not an accepted practice in our country. Academics need support to market their ideas but industry-academia connections remain lacking. With PPPs, research work can realise its true value through the market. The government must encourage our network of universities and research organisations to undertake collaborative programmes and share key findings among themselves.

Conclusion: With a large pool

of world-class talent and resources, India is a fertile ground for entrepreneurs.

They can transform our numerous challenges into opportunities by developing innovative products that can benefit millions and drive economic growth. What is missing is an ecosystem that catalyses the process of innovation.

The potential can be realised only if the government and industry work together and draw up a roadmap to facilitate innovation that makes a difference.

‘NO DEVIATIONS FROM THE PROVISIONS OF TRIPS’

DR P MURALI President, ABLE and CEO, Evolva Biotech

ost 2005, Indian patent regime got itself aligned to comply with TRIPS obligation that requires all WTO countries to allow patenting of pharma products and processes.

This was instrumental in opening the flood gates for innovation.

More than 800 out of 1,000 global companies involved in innovation have some kind of R&D presence in India, as they believe that the system could support an innovative ecosystem. Since life sciences industry is one of the highest R&D spenders of the world and thrives primarily on innovation, the new product patent regime assumes a lot of significance that offers protection and exclusivity to true innovation.

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ecosystem supporting frugal innovation, the patent regime is geared to protect products and processes emerging out of this ecosystem with a view on affordability as well.

While Indian patent law is cognizant of true innovation, it also aims to reserve its right in providing critical and life saving innovation to its citizens without being prohibitively expensive. Global extension of pharma patents, which will be the effect of TRIPS when fully implemented, has fuelled concerns about drug prices and, subsequently, access to lifesaving medications. To address this concern, India also introduced a clause designed to restrict the number and type of pharma patents granted: Section 3(d) of the Patent Act prohibits patents on variants of existing compounds that do not show enhanced effica-

cy. It has been extremely contentious since its introduction in 2005.

Several transnational pharma companies feel this as an unacceptably high barrier to patenting, as do many foreign governments. Some critics also point to the fact that since India has set a high barrier in recognising incremental innovation, more than 50,000 patent applications were being affected and that it could stifle innovation. This is in comparison to other nations such as Germany, Australia and Japan who recognise incremental innovation. Yet another point of view indicates the high cost involved in innovation. For instance, many multi-national pharma companies incur more than $1.2 billion to innovate a single drug and close to $4 billion including the cost of failed ones and hence incremental innovation is key to protecting their future earnings to recover this cost. But many observers, including the United Nations Programme on HIV/AIDS and civil society groups, defend 3(d) and point to India as a model for developing countries attempting to use TRIPS flexibilities to promote public health.

It is also now dawning www.expresspharmaonline.com

upon several groups that research and innovation costs could also be brought down considerably. For instance we have proposed a 'sub-$100 million' based innovation model wherein a 'people’s drug' could be innovated for less than $100 million in India given its cost effective discovery ecosystem. Also UN observers indicate that India should aim to tap into its skill base to encourage competitive and open innovation wherein the entire cost of innovation should not exceed a fraction of what is incurred elsewhere. This is one amongst many reasons for several transnational companies are now actively setting up research base here.

The idea is to reach bottom of the pyramid with affordable innovative products that could also improve quality of life.

The volumes would eventually drive future earnings.

Compliant and unbiased implementation alongwith thorough scrutiny The recent developments such as Novartis not being issued patent on Gleevec under Section 3(d), an unfavourable order against Roche on Erlocip, Bayer being issued a compulsory licence on Nexavar, revoking

of Pfizer’s patent on Sutent may all be construed internationally as India not adhering to a strong IP protection, it is worthwhile pointing out that Indian law has not deviated from the provisions of TRIPS in each case – be it preventing evergreening of patent or recognising a truly inventive step – without ignoring the criticality of their life saving nature and reviewing each and every case by its own merit without any bias. This points to a thriving compliance, unbiased implementation and thorough scrutiny of the IP and also a redressal mechanism via judiciary of the world’s largest democracy.

As per 2010-11, out of the total granted patents of 7,486, foreigners walked away with 6,214 while Indians got 1,272 patents forcing the Prime Minister to push institutions to strive for innovation, while the industries ministry now has a concept of 'utility models' in the present Indian patent regime, that could provide a framework for providing limited protection to those innovations, which may not meet the standards of the Patents Act and yet are commercially exploitable and socially relevant.

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‘NEED INNOVATION POLICY WIDER THAN A PATENT ACT’

LEENA MENGHANEY India Campaign Manager Access Campaign Médecins Sans Frontières ritical legal battles between multinational pharma companies and India—whether it’s Indian companies, the Indian government or Indian

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patient groups - are now taking centre stage in an ongoing struggle over the interpretation of India’s medicines patent law. The country is testing its new patent

law which has re-introduced patent protection for drugs and other health technologies after a gap of more than three decades. Under the amended law, product patents on new pharma compounds are allowed; patents on new forms of existing medicines are strongly discouraged.

What is adding to the multinationals’ heartburn is India’s legal approach to examining pending patent applications. Companies file separate patent applications relating to different aspects of the same medicine as a strategy to obtain and extend monopolies in India.

This strategy – popularly

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known as evergreening – is designed to block Indian generic companies from offering competition to their highly priced medicines. But to counter this practice, generic competitors and patient groups in India are entitled to file ‘patent oppositions’— a legal challenge to prevent or overturn the granting of unwarranted patents. This is starting to show results, with a number of patent applications on cancer and HIV medicines failing the tough standards of patentability set under Indian law. This has opened up generic competition leading to major price reductions on these drugs; for

example, the price of a first line HIV medicine has fallen from over $ 5000 in 2005 to less than $100 in 2012.

Unsurprisingly, rumbles of discontent are being heard from multinational pharma companies, claiming that Indian patent law stifles innovation. That predictable claim is untrue.

India grants patent protection to new compounds but also recognises that generic competition drives incremental innovations - such as putting two or three separate medicines into one pill, or using known industry practices to formulate paediatric versions of a drug. These incremental

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innovations that come without a new 20-year patent monopoly are in fact vital to treatment providers such as Médecins Sans Frontières (MSF) who work in resource poor settings. However, this legal approach is not something that pharma companies like Novartis appear to agree with; and the patent law is being challenged through a court case in the Supreme Court of India.

But this response from industry also gives us the opportunity to debate the

innovation system for pharma itself. At the heart of the debate is the intellectual property-driven research and development (R&D) system itself. Evidence is mounting that governments are saddled with a R&D system that suffers from declining rates of innovation; a mismatch between research investments and the medical needs of society; and dramatically high drug prices as patents block the introduction of low-cost generic versions.

Under a patent system such as the one India has implemented as part of its obligations under international trade rules, innovation by definition is a market driven model and requires private monopoly for any medicines or technologies that are in fact developed for rich markets.

R&D for domestic public health needs such as malaria, tuberculosis and kala azar suffer neglect and are mostly left to private foundations such as Drugs for

Neglected Diseases Initiative (DNDi).

And access to newer medicines which are increasingly being patented locally depends purely on the will and charity of a few US, EU and Swiss-based pharma companies.

What is needed in India is an innovation policy that is much wider than simply a Patent Act and system; it needs to incentivise new innovative models of drug development and health technologies research, tar-

geted to public health needs.

Such models will involve serious public investment in research, as well as mechanisms through which such investments can lead to treatments that are non-proprietary, making them available for generic production.

India would be better served not by blindly implementing the patent system, but by a policy which encourages research labs, pharma companies and governments to share resources, the risks, and rewards of R&D.

‘LAW HAS A STRONG ELEMENT OF PUBLIC POLICY’

PROF RAGHAVENDRA LAL SAHA Chairman, IPR committee Ministry of MSME Government of India he evolution of patent system in India is not a natural choice of independent India unlike the drive towards investing in research and development, import substitution, indigenous development of knowhow and adaptation of technology. India has had its patent law since 1856 and continues to have it after independence with due amendments from time to time. Inventions are not necessarily dependent on existence of a patent law, although the patent law is certainly a big contributing factor in promoting inventions which can lead to innovations.

Innovations are inventions plus, and generally understood to be in terms of products or processes which are successful in the market

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or have the potential to be successful. An invention needs to be followed by many more steps such as scale up, prototyping, testing, characterisation, and safety studies to meet regulatory requirements and standards etc. These steps have to be followed by effective manufacturing and marketing to remain competitive.

The Indian patent law is compatible with TRIPS and takes care of essential features of an invention namely novelty, inventiveness and utility. In its philosophy and character, it is no different from patent laws of other countries. The growth in patent filing by Indian residents in the post WTO period is testimony to the fact that inventive activities have grown primarily due to

larger awareness and better understanding of ever increasing competition. This is further corroborated by a study which reveals that 16 per cent of MSME drug companies have been filing patent applications in the last 10 years.

The Indian law is very sensitive to the inventiveness aspect and therefore has stipulated that some inventions are not patentable in India. The laws of many countries do not spell out such exclusions but do attach importance to inventiveness or non-obviousness. For example, re-arrangement of known devices or components not leading to a new effect is not patentable in India. The same concept was followed by the US Supreme Court in deciding the KSR vs Teleflex case.

It must be remembered that the patent law has a strong element of public policy as it gives exclusive and monopolistic rights to an individual or a company for exploiting inventions while denying/limiting the remaining population the right to use and practise the invention.

The Section 3(d), perhaps more commonly applied to drugs as it talks www.expresspharmaonline.com

of efficacy, is an example of ensuring inventiveness in inventions dealing with drugs and chemicals, and the balance with public policy is achieved in most cases. The law has, however, not provided any direction towards interpretation of efficacy and left it to competent authorities like the Patent Office, Intellectual Property Appellate Board and courts. This needs to be looked into as efficacy is linked with scientific and technical aspects and a common rule may not be applicable to all cases.

The provisions of compulsory licensing and working of patents are meant to avoid misuse of patents by the patent holder in specific situations. These provisions are, prima facie, not antiinventions or anti-innovation. A company aspiring to get a patent in India should take into consideration these aspects, because they may affect its business prospects in very specific cases.

However, a high degree of judiciousness based on reliable data and analysis of social and market aspects is called for, while arriving at the decision of awarding compulsory license.

The process of patent granting in India takes a lit-

tle longer and that has been a cause of concern for inventors and companies, especially MSME. Whether the law should stipulate stricter timelines is a matter for consideration by the competent authority. This is an operational aspect and does not in any way affect the intrinsic character of the law. Like any other patent law, the Indian patent law promotes and nurtures inventions; there is no evidence to conclude otherwise. If the level of inventive activities which the patent system protects, has not grown in the manner expected by us, the answers may lie elsewhere.

Prof Saha headed the Patent Facilitating Centre, TIFAC for many years starting from its inception and has been a pioneer in leading the national efforts in policy making and capacity building in the area of IPR. He was also the MHRD Chair Professor in IPR at the Tezpur University. He is the Chairman of IPR committee set up by the Ministry of MSME, GoI and also the Chairman of a committee set up by Department of Information Technology, for providing IPR support to start ups.

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‘INDIA YET TO BENEFIT FROM THE NEW PATENT SYSTEM’

REJI K JOSEPH Consultant RIS, a think tank with Government of India trengthening of patent rights would promote innovation only when other elements in the innovation system have grown sufficiently. The experience

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of developed countries has been that building up of capabilities in human skills, science and technology, financing, etc. which have always preceded strong

patent regimes. The contention in India on joining WTO was that whether the country had a vibrant innovation system to reap the gains of a strong patent regime. Proponents argued that the move to a stronger regime would not only usher in foreign investment in R&D but also incentivise those Indian firms, which are otherwise capable of engaging in new drug development but are holding on due to lack of protection of intellectual property. Put differently, the underlying assumption behind the demand for a strong patent regime was that the pharma

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innovation system in India investment by Indian firms has grown enough to take as percentage of their sales turnover increased sudadvantage of the proddenly from 1.5 per uct patent system. cent to 5.2 per Although the cent by 2005response of the 06. Leading Indian pharThe experience of firms such ma industry developed countries as Ranbaxy in the first has been that building and Dr half of last up of capabilities in Reddy’s decade gave human skills, science Laboratories the impresand technology, (DRL) also sion that financing began to enter Indian firms into a number were indeed of out-licensing of taking advantage molecules deals with of the new regime, MNCs earning millions of later developments showed dollars as license fee, indithat they were not, as has been expected. In the first cating that Indian pharmahalf of last decade the R&D ceutical industry is reaping

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the benefits of new patent regime. But after 2005-06, the R&D investment of Indian pharma industry stagnated. Most of the outlicensed molecules were either abandoned or returned by the partnering MNCs as they were lacking clinical potency. A direct outcome of this set back was reduction in R&D investment by leading firms. R&D investment by DRL came down from the peak of 18 per cent in 2004-05 and Ranbaxy’s from 20 per cent in 2005-06 to about 9 per cent. They also down sized considerably their R&D human resources; for example DRL has now only 30

scientists working on new drug development compared to 280 in the early years of the last decade. Efforts in India to raise venture funds to finance R&D projects also failed miserably.

DRL established India’s first integrated drug development firm 'Perlecan' in 2005 in collaboration with Citigroup Venture and ICICI Venture, putting together $52.2 million. But the firm had to be closed down in just three years when Citigroup and ICICI pulled out. Perleccan debacle probably have desisted other leading firms like Ranbaxy, Torrent and Wockhardt which were toying the idea

of spinning of R&D venture argued, one should note that it has created new firms from doing so. businesses for All these indicate Indian firms in that unlike the After the form of developed 2005-06, the contract world, India R&D investment of research has placed Indian pharma indusand conthe cart try stagnated. Most of tract manubefore horse the out-licensed molefacturing. by bringing cules were either abanWith the in product doned or returned by new patent patent rights the partnering regime, MNCs at a time when MNCs feel confident the drug innovato contract out tion system is still production of propristruggling to put it eleetary bulk drugs as well as ments together. low end works (in terms of While concluding that the new patent system has technology sophistication) not promoted innovation in in the new drug R&D the country as the propo- process. These businesses nents of such a regime had however do not directly

promote innovation.

Reji K Joseph is a consultant with Research and Information System for Developing Countries(RIS), a think tank with Government of India.

He has worked earlier at Centre for WTO studies in Indian Institute of Foreign Trade, National Commission for Enterprises in the Unorganised Sector and Centre for Development and Human Rights.

His current areas of research include public health, pharmaceutical industry, and bilateral investment treaties.

‘FAILED TO PROMOTE, NURTURE INNOVATION’

ANAY SHUKLA Member, Pharma and Life Science team, Nishith Desai Associates irst, let us lay down the context in which this debate is set.

Innovation is commonly understood as the act of innovating. An innovation may be of the end product or a new process. However, it is our understanding that this debate is set in the backdrop of the first meaning.

With this understanding, it is our submission that the Indian Patent Law (Patent Law) has failed to promote and nurture innovation.

At the outset, we concede that any patent law does reward the innovator by granting limited but

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exclusive license to exploit his or her innovation and consequently encourages innovators to innovate, thereby promoting innovation. The Patent Law is no exception. It grants an exclusive license to exploit a patent for twenty years.

Unfortunately, our patent grant system is encumbered with delays in examination process, and the pre- as well as postgrant oppositions, due to which the grant of patent is considerably delayed, sometimes by three to four years, which acts as a disincentive.

Moreover, there are several inventions in the

healthcare sector that are that in relation to the pharentitled to patent grant, e.g. ma innovations, many inno‘method of medical treat- vators live in the fear of ment for an ailment’ but are compulsory license throughnot considered patentable out the patent - life, and this under law. This has curbed feeling is worsened by any scope of innovation in absence of definitive guidethe said fields. On similar lines for determination of lines, invention of ‘new use’ situations in which the CL may be granted and for of existing substance is not determination of patentable unless ‘reasonable roythere is an alty’. ‘enhancement Unfortunately, E v e n of the known our patent grant after an e f f i c a c y ’. system is encuminnovation What constibered with delays in receives a t u t e s examination process, patent, the ‘enhanceand the pre- as well as innovator ment’ is post- grant remains u n c l e a r. oppositions uncertain Several patents about his abilhave been ity to commerrefused in India cially exploit his on this ground alone. innovation at the fullest.

Further, what good is an The Patent Law does not exclusive license if the envisage extension of exclusivity is conditional?

Under the ‘compulsory patent duration on grounds licensing’ provision of of time spent for receiving Patent Law, the innovator marketing approval to sell may be forced to license his patented product. Marketing innovation to a third party, approval for products such and in return receive ‘rea- as pharmaceuticals may sonable royalty’ from him. It take years. That is to say, won’t be a stretch to say under the IPL (Intellectual www.expresspharmaonline.com

Property Law) the tenure for commercial exploitation of the product is effectively a fraction of the total tenure of the patent. This isn’t the case in the US and many European countries where exists a provision for ‘supplementary protection’.

Lastly, there is no data exclusivity in India.

Therefore, the generic players are in position to take a piggy back ride on the data submitted by the innovator.

Thus, there are many Indian comings under the Patent Law and other laws relating to patentability and commercial exploitation of innovation, which have resulted in its failure to promote and nurture innovation.

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‘DISCOURAGES THE ‘ART OF EVER-GREENING’’

DR GOPAKUMAR G NAIR Founder, Gopakumar Nair Associates (GNAs) and CEO, Patent Gurukul he Indian Patent Lawthe Patents Act, 1970 and Rules thereunder, truly encourages innovation.

The Patent Statute has been instituted to encourage

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innovation and reward the true inventor. Innovation to be patentable needs to have novelty and inventive step (non-obvious) along with industrial applicability (util-

ity).

Distinguishing the innovation, which necessarily originates from a new or novel idea as opposed to what is already known is prior art or state-of-the-art, is essential for such an innovation to be rewarded with a ‘Patent’, which is a limited monopoly for a limited period of time over the jurisdiction of the country, subject to other laws of the country.

With the extreme dependency on and the increased use of Internet/web-based searches for problem-solution approach of innovation, very often the Teaching, Suggestion and Motivation

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(TSM test) for an ‘innova- Indian Patent Law is ideally tion’ comes from the prior designed to encourage such innovations and proart in the web. Such vide protection of patent application the IP in them. involving ‘frivoW h a t lous’ invention Indian Patent or ‘extremely Distinguishing the Law is disn a r r o w innovation as couraging is incremental’ opposed to what is the abuse of innovations already known is essenthe statute are not to be tial for such an innovato gain confused tion to be rewarded u n f a i r with innovawith a ‘Patent’ advantage tions which and the ‘art of meet the novelever-greening’ ty, inventiveness which has been veryand industrial applicawell mastered by extensive bility criteria. Innovations, ‘research’ in overseas which have originated from creative original ideas truly (developed) countries to the protection merits grant of a patent. extend

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beyond the statutorily validated period of 20 years.

When a molecule or product is already marketed and is protected under a patent for 20 years, to seek extension of the same patent by tinkering with the molecule or the product so as to frivolously seek extension of the life of the patent in the ‘tinkered’ molecule for another 20 years is not what the Patent Statute is meant for.

Indian Patent law has the same benchmark for novelty, inventive step and utility comparable to patent law of US or EU. The additional filters for patentability in the Indian Patent Law are in Section 3 of the Patents Act, 1970. These sub-sec-

tions of Section 3 are designed to knock out frivolous and undeserving innovations which disturb the inherent balance of Right and Obligations, especially since the negative right granted against the public will need to be compensated by the benefit of quality innovation in the claimed invention in the patent applied for. Further, once a patent protecting an innovation expires, the said innovation needs to be made available to the public, especially ‘the person interested’ to practise the invention in the expired patent. The Indian Patent Law nurtures and promotes innovation, the debates and disputes

which are raging are related incorporated the provision for post-grant opposition to the transition times, under the newly where nonconstituted patentable (PreP a t e n t 1995 discloTribunal is a sures elseIndian Patent law d i r e c t where) prodhas the same acceptance uct patent benchmark for and validar e l a t e d novelty, inventive step tion of the inventions and utility comparable I n d i a n attempted to to patent law of Patent Law squeeze in, US or EU Provisions. In in the guise of fact, the ‘new innovachanges and tions’. amendments made Ad d i t i o n a l l y, in the 35 USC in recent Indian Patent Law provides times as well as the recent for pre and post grant opposition, revocation through judgements of the US IPAB and Counter-claim in Supreme Court as well as an infringement suit. The US those from the Federal Patent Law (America Circuit Appeal Court, valiInvents Act) has newly dates the provisions of the

Indian Patent Law. Dr Gopakumar G Nair was the Dean of Institute of Intellectual Property Studies (IIPS) at Hyderabad, India.

Presently he heads his own IP boutique firm, Gopakumar Nair Associates (GNAs) and is also CEO of Patent Gurukul, reputed and well-known training centre for Patents. Dr Nair is also Chairman, Gnanlex Hermeneutics Pvt Ltd, a KPO/LPO/IP consultancy firm, Consultant to Pharmexcil on IPR as well as an advisor to nearly 15 pharma/biotech/agrotech companies.

‘STRIKE A BALANCE BETWEEN PUBLIC & PRIVATE’ INTEREST

RAGHU CIDAMBI Advisor Indian Pharmaceutical Alliance

atents are monopolies for a limited period of time granted by the State. It has for long been universally recognised that such a monopoly stimulates useful research and innovation by providing a commercial reward. It is important to recognise that patents do not promote and reward all kinds of innovation – only those that can benefit commercially from a period of monopoly. Indian patent law is no exception.

If the inventor gets a commercial benefit of a

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monopoly by the grant of a patent, there must be a quid pro quo – he must give something in return. That something is disclosure – the new and useful knowledge disclosed in a patent so that everybody can practise the invention after the period of monopoly.

The grant of patents is therefore a delicate balancing act – the ‘price’ that is paid by the grant of monopoly and the resulting profits to the innovator and the interests of consumers who actually pay the price.

The result was that it was India has had a Patents Act since long, but the con- open to the fledgling Indian troversies erupted only in industry to freely take advan1970 when a new Patents Act tage of innovation and the replaced the earlier one Indian industry did so with enacted some 60 years previ- gusto, particularly the Indian pharma industry. The ously in 1911. The new latest medicines Act made a far were made reaching change The available to – it denied Patents Act the Indian p r o d u c t does not allow public, and patents for monopolies and grant indeed the food, media commercial reward developing cines and for all innovations, but world, at a agrochemionly for such innovafraction of cals, primaritions that offer an the prices ly because it acceptable quid pro charged by the was found that quo innovators. The the grant of Indian Patents Act monopolies was in 1970 did promote a largely being exploited great deal of innovation in for commercial gains withIndian industry, by leaving out any benefit flowing from corresponding investments the field open to them to and dissemination of the innovate economical and new technology disclosed in efficient processes to manuthe patent. The high prices of facture medicines and access patented medicines and the market.

35 years later, in 2005 agrochemicals put these beyond the reach of most another far reaching change people. There was no benefit was made in the Patents Act. to the vast majority of the India agreed to provide prodpublic, so the State scrapped uct patent for medicines and agrochemicals as a part of the monopoly. www.expresspharmaonline.com

the WTO Agreement. But the change came with an important limitation – patent could not be granted for trivial ‘innovations’ in pharmaceuticals and agrochemicals that merely resulted in the extension of patent monopolies without a corresponding benefit in terms of increased efficacy flowing from the innovation.

Clearly, the Patents Act does not allow monopolies and grant a commercial reward for all innovations, but only for such innovations that offer an acceptable quid pro quo – a benefit in terms of more effective and useful medicines and agro-chemicals. No protest against striking this balance between public and private interest is justified.

Raghu Cidambi was legal affairs advisor to Dr Reddy Laboratories prior to joining IPA as an Advisor. A graduate from Indian Institute of Management, Calcutta he also has a Bachelor's Degree in Law from the Osmania University, Hyderabad.

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'’HELPS DECIDE ON RIGHT OF MONOPOLY TO INNOVATION'

PRIYANKA GUPTA Solution Consultant, IP & Science business of Thomson Reuters he primary objective of any patent system is to foster the nation’s economic and technological development by creating an opportunity for monopolistic

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exploitation of inventions for a limited period of time in return for public disclosure of the invention. Although the potential of the patent system has been widely recognised in the

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Pharma HEAD OFFICE MUMBAI Rajesh Bhatkal Business Publications Division, The Indian Express Limited., 1st Floor, Express Towers, Nariman Point, Mumbai-400021. India Tel: 67440503 / 02 Fax: 022-22885831 Mobile: 98213 13017 E-mail : rajesh.bhatkal@expressindia.com Branch Offices NEW DELHI Ambuj Kumar Business Publications Division, The Indian Express Limited, Basement, Express Building, 9 & 10 Bahadur Shah Zafar Marg, New Delhi, 110 002 Direct Line: 011-2346 5727 Board Line: 011-2370 2100-107 Ext-727 Mobile: 09999070900 E-mail: ambuj.kumar@expressindia.com CHENNAI Vijay Kulkarni The Indian Express Limited, Business Publications Division, New No.37/C (Old No.16/C) 2nd Floor, Whites Road, Royapettah, Chennai - 600 014 Tel: Board: 28543031/28543032/

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context of dynamic innovation activities, critics often suggest that the current Indian patent system stifles R&D and technological advances. However, in my opinion, India’s patent system has been successful in disseminating technical information and increased productive and healthy competition in the market.

In 2005, India introduced product patenting as a member of the World Trade Organization (WTO) and a signatory to the agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Prior to that, India had developed a world-class generic drug industry. Global

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extension of pharmaceutical patents, the effect of TRIPS, fuelled concerns about prices of lifesaving medicines. One of the landmark cases closely watched by the world and on which the Indian Supreme Court will soon hear final arguments is a challenge raised by pharma company. Novartis against the Indian Patent Office’s (IPO) rejection of a patent for the leukemia drug, Glivec. The outcome of this case is likely to have a significant effect on patent terms and access to drugs in the developing world.

With poverty and public health crises as some of the developing world’s biggest

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challenges, the product patent regime has created a plethora of controversies. However, one thing has remained central to the Indian patent system – its ‘mosaic view’ with numerous factors deciding on the right of monopoly to innovation.

These include the need to maintain affordable prices for a billion people in India, the importance of promoting indigenous innovation, and continuing to strengthen India’s strong national commitment towards innovation in comparison to its Asian neighbours.

In view of complex and dynamic social and economic challenges, the purpose and

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impact of any patent system needs to be constantly reviewed, adjusted and implemented so that the optimal balance between the monopoly holder, new entrants, and the public is achieved. In order to foster R&D in new technologies, such as information and communication technologies and biotechnology, the patent system needs to be shaped to

strategically respond to new challenges while remaining robust.

To this end, it is essential to strengthen public R&D activities and promote better collaboration between the private and public sectors. An example of this is ‘Open Source Drug Delivery’ (OSDD), an initiative of the Council of Scientific and

Industrial Research (CSIR). It is becoming increasingly essential to launch policies which provide a balance by offering incentives to the key stakeholder ‘inventor’ to stimulate R&D and ensuring a competitive environment for pioneers, for down-stream researchers and for suppliers and producers at the end of the value-added chain.

In conclusion, the Indian patent regime, when wisely implemented, will see a blend of TRIPS-enforced laws and laws addressing the concerns and challenges of the Indian public; this can lay a strong foundation for the future of India’s evolving patent system – to nurture innovation and maintain economic growth.

Priyanka Gupta is Solution

Consultant with the IP & Science business of Thomson Reuters. She provides intellectual property management training, specifically patent education, to professionals in academic universities, technology transfer offices, pharmaceutical companies, and R&D centers of top corporations in India and other countries of Asia.

‘We are sure that Indian IP laws would favour innovation and protection of IP’ Dr PM Murali, President, ABLE and Managing Director and CEO, Evolva India describes to Express Pharma the potential of the biotechnology industry in India, ABLE's initiatives on the policy framing front and the need to take a leap of faith How has the biotechnology industry weathered the economic headwinds of the past few years?

Indian biotech industry in my opinion is growing at a good pace in spite of the global economic turmoil. A 14 per cent upward growth currently is very good and from ABLE we see growth peaking at about 30 per cent around 2025 making India enter the $ 100 billion exclusive club of nations in this field. The key reasons in my view the way the Indian industry has worked is on account of its fundamentals: frugal innovation, focus on affordable health and also excellent middle and top management skills. In a world where the industry is going through a cash crunch and formidable costs for development, the Indian approach has made the biotech industry grow at a steady pace here without caving in like the rest of the world. I think how a lot of Indian biotech companies are managed by competent CEOs can serve as useful lessons for managing biotechs globally.

In India, we are shy to talk about our achievements but it is useful in the context of bringing about learning. We should not confuse frugal innovation (competitive advantage) with cheap labour costs (comparative advan-

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tage). This is not what India is all about. We have the DNA to have practical financial models and also adapt very quickly to the environment around us.

What are the challenges going forward? Will innovation be starved of the funds it needs?

Biotech industry at various levels involves spend on capital expenditure and this involves high capital infusion. Due to the time it takes for biotech products to reach market, ROI in biotech is one of the longest. Most funds in India have a choice of investing in diverse areas and hence they look at low hanging fruits which, unfortunately is not biotech. If the country believes that the next set of game changing technologies for clean energy, public health and wellness will have to come from the biotech industry then there has to be creative ways to make this happen here. One needs to make large funds to set apart a small percentage to fund biotech start ups. These funds can be incentivised for this initiative. Only with bold and non traditional approaches can we bring in a climate that is conducive for the growth of this Industry. Right now except funding from Government departments like

DBT, there are very little funds for biotech start ups.

This does not auger well for the country which has an immense challenge ahead of it.

This year has seen many legal milestones which will shape the futures of the pharmaceutical industry, not just here in India, but across the world. Do you believe that the Indian patent law nurtures and promotes innovation?

Indian patent laws are now gearing up to be in line with Government’s policies to provide affordable healthcare and access to cost effective technologies for mass consumption. This assumes significance given the recent events such as Natco’s victory of compulsory licence over Bayer, Cipla’s victory in a patent infringement case against Roche and a very recent victory for Cipla against Pfizer over Sutent.

This could be interpreted world wide as anti innovation. In my view it is imporwww.expresspharmaonline.com

tant that our laws should balance innovation and affordable health. Otherwise, we may risk the development of new products as people will be afraid to invest in this space.

share this view.

What have been ABLE’s initiatives to sensitise the Indian government on policies needed to spur growth?

Several initiatives have been taken by ABLE in the Evolva’s mission is to dis- last two years. We have cover and provide innova- worked on the pharma policy tive, sustainable ingredients for the Department and also for health, nutrition and published our road map and wellness building on vision for 2025 in association biosynthetic technologies – with DBT. We have taken using yeast to create prod- emphatic steps in bringing ucts via fermentation. Given about the biopharma policy that Evolva’s approach is of the Government. ABLE has protected by a broad IP been part of nurturing and estate and includes multiple mentoring young entreprepending and granted patent neurial talent along with the families, will India's patent Government. In addition we laws, as they stand today, now have about 11 working groups in ABLE who offer sufficient proare working on tect ion for This their verticals Evolva's techyear has seen to bring out nologies? many legal mileregular white We believe stones which will papers senthat India’s IP shape the futures of sitising the climate is the pharmaceutical requirement m a t u r e industry, not just here and issues. enough to in India, but across We have a nurture innothe world continuous vation that f e e d b a c k could benefit its mechanism with populace. This is most departments of likely to get more the Government of India. refined going forward since We are also writing several the country is likely to witness an innovation avalanche useful policy documents that in the next decade. More than would be a good guiding prin800 out of top 1000 multina- ciple for a number of biotech tional companies now have initiatives that the governsome form of presence and ment is planning. investment into R&D into India and this could spur all What innovations can the round innovation across sev- biotech industry offer in eral industries with biotech terms of affordable quality being no exception. We at medication, given that the Evolva are sure that Indian IP medicines of the future will laws would favour innovation be biologics rather than and protection of IP. And I am small molecule entities?

Biologics clearly offer sure most Indian companies November 1-15, 2012

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several advantages over small molecules in treating various ailments. But since so many of them are patented, not many companies ventured into this space, which is likely to change in this decade due to patent cliff. This could increase the players in this space driving sales volume which in turn is expected to bring down price making it cost effective. Indian government also ensures that “evergreening” of patents are kept at bay to shield cost escalation of life saving products.

Measures also include a price control system and including certain products in the national essential medicines category.

With regard to biologics, Indian companies are expected not just to make “similar biologics” but also “super biologics” that outsmart existing product lines opening up new markets. In fact this space could offer loads of innovation potential for both process innovation and product innovation.

in India. As mentioned, it is important that we look at creative ways to make VCs look at the biotech industry as the first choice of investment rather than the last which is the current trend.

Initiatives to fund clean energy and cutting edge technologies should be adequately incentivised. We have to create the micro and macro environment. Like we need roads and infrastructure, the

essentials of growing biotech in our country also needs to be addressed. If we fail to take a leap of faith for the next decade, we could end up ruing that we did not do now. No country which

aspires to be a super power can lag behind in cutting edge technologies. India has to watch out and ensure we are ahead of most other emerging powers. ep.editorial@expressindia.com

The country has tasted success with biogenerics thanks to the process patent law. What are your views on the Draft Biotech policy unveiled by DBT in June this year? Will these regulations help India to become the hub for similar biologics (biosimilars)?

The draft biotech policy covers the major areas that need to be covered. This is a good first step in the right direction. The real challenges in my view are the ways in which implementation of the policy is carried out in our country. Our past record shows that our implementation is poor with too much of paper work, lack of transparency and red tapism. As a developing country we should overcome these internal challenges with a lot of courage and fortitude. We should have a visionary regulatory set up and path breaking trends which are unique and customised to our requirement.

Are venture capitalists showing an interest in the biotech industry, more specifically Indian companies?

There are unfortunately too little VC funds available November 1-15, 2012

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THE PRICE OF INNOVATION: WHICH WAY PHARMA? Are the high prices set by pharmaceutical companies for their products justifiable, asks Adefemi Adenuga, GlobalData's analyst covering healthcare industry dynamics. We can’t afford to kill the golden goose, he says, believing that somewhere out there is a line of compromise for all stakeholders in the global pharma business, all we have to do is walk across it together

ADEFEMI ADENUGA GlobalData's analyst covering healthcare industry dynamics

roduct launches are usually characterised with high expectations and excitement, more so if the product is a therapeutic aimed at the prevention (as is the case with vaccines) or cure of a potentially lifethreatening disease with significant unmet clinical need.

However, behind all the buzz and hype looms an underlining factor with the capability to single-handedly determine the fate of the product – pricing. No matter how you look at it, pricing has always been and continues to remain a crucial determinant of a product’s success or failure.

Its significance is further highlighted by the dependence of healthcare reimbursement and the out-ofpocket costs borne by patients on the price of a therapy.

Due to the current fiscal crises sweeping across the globe, especially in Europe, there has been an increasing tightening of healthcare spending by governments.

Countries including the US, China, Russia, and Japan are implementing policies aimed at reducing the negative contributions of healthcare costs to their worsening financial situations. In most cases, the accusing finger is quickly pointed at pharmaceutical companies for charging exorbitant prices for their drugs and vaccines, many of which are essential to improve the quality of life of patients and in many cases, save lives.

Studies by the US Congressional Budget Office (CBO) indicate that the aver-

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age prices of new drug products have been rising much faster than the rate of inflation. Consequently, drug companies have recently been receiving demands from various quarters, including governments and patient advocacy groups, to reduce the prices of their lifesaving therapies through discounts and other methods.

However, pharma companies are usually quick to respond with an explanation of the risky and expensive drug discovery and development process. This suggests that high drug prices are as a result of the passage of innovation costs from drug makers to the consumers.

Innovation drives the global pharma industry, but unfortunately its fading presence in the industry is a cause for concern. Going back to as far as the 1970’s, innovation has always yielded substantial results to pharma companies, healthcare payers, and patients.

The blockbuster model, upon which many pharma companies were built and have carved a niche for themselves over time, is a readily-available case study of the contribution of innovation to healthcare. From 1977 when Tagamet (cimetidine), which earned GlaxoSmithKline (GSK) over $1 billion in its first year, was approved by the US Food and Drug Administration (FDA) as an ulcer medication, pharma companies have been engaged in a race for blockbuster drugs – new innovative and efficacious therapies

that cater to large unmet areas such as genomics and medical needs. Indeed, many molecular biology have yet companies have succeeded to impact the bottom line of companies. in doing this and drugs such pharma as Prozac (fluoxetine), the Consequently, there has been first selective serotonin reup- a decline in the number of take inhibitor, Mevacor blockbuster drugs launched (lovastatin), the first statin, per year, which is why the and Lipitor (atorvastatin) patent cliff is a much-dreadhave historically been the ed but inevitable occurrence largest contributors to the for many drug companies annual revenues of their including large multinationrespective companies – Eli als such as GSK, Johnson & Johnson (J&J), and Pfizer.

Lilly, Merck, and Pfizer.

Recent events have Many blockbusters that were shown that things are not as launched in the 1990’s have either lost market excluthey used to be with the sivity or are on the pharma industry, verge of doing so, which is curgiving drug rently witnessmakers many ing a decline Innovation drives a sleepless in R&D prothe global pharma night.

For d u c t i v i t y. industry, but unfortuinstance, Ac c o rd i n g nately its fading presthese are to the FDA, ence in the industry is worrisome a total R&D a cause for concern times at GSK spending of as the compaover $51 bilny braces up for lion by pharma a decline in revcompanies yieldenue due to the immied 21 new molecular nent patent expiry of its entities (NMEs) in 2005, a asthma and chronic obstrucsharp decline from about 35 pulmonary disease NMEs from a R&D spending tive of about $34m in 2000. Also, (COPD) combination drug, the number of new drugs Advair (fluticasone/salmeapproved by the US FDA per terol) in 2013. The compabillion US dollars (inflation- ny’s executives and shareadjusted) spent on R&D has holders have a genuine cause halved roughly every nine to be worried, especially as years. Furthermore, total the drug in question accountnew drug application (NDA) ed for 34 per cent of the comand biological license appli- pany’s revenues in 2011.

Apart from a decrease in cation (BLA) approvals by the FDA reduced by 15.5 per innovation, pharma compacent from 123 in 2009 to 104 nies have also had to cope in 2011, despite efforts by the with increasing development FDA to reduce the approval costs. Currently, the average times for new drugs and bio- cost of developing an innovalogics in response to its being tive drug is about $1 billion. regarded as a bottleneck to Sunk costs and opportunity the availability of life-saving costs have increased subtherapies. The traditional stantially as a result of the vertical model of innovation high failure rates of molecreation and commercialisa- cules in development. This is tion is not as productive as it the primary reason why used to be, and recent scien- many drug makers now seem tific advances in various to shy away from some highwww.expresspharmaonline.com

risk, high-reward drug candidates and would rather invest in making incremental improvements to existing drugs, which have less risky profiles but less attractive market potential. In other words, focusing on lowhanging fruit is becoming a more reasonable alternative than the quest for blockbusters. In addition, the demand for larger, longer, and consequently, more expensive clinical trials by regulatory bodies to ascertain safety and efficacy have further driven up developmental costs.

The question is: Are the high prices set by pharma companies for their products justifiable? To some extent, they are. These companies encounter pressure from generics manufacturers, governments, patient advocacy groups, investors, physicians and even other pharma or biotechnology firms. Generic manufacturers make and market very cheap versions of drugs that have lost market exclusivity, thereby reducing the market share and revenues of pharma companies; governments require huge discounts and enforce stringent regulations to make drug makers invest substantially in the local economy before they can market their drugs; patient advocacy groups clamor for price cuts; investors require significant return on their investment; physicians want more options to enable them make better-informed treatment decisions; in addition to fierce competition with other drug makers.

Quite often, we find pharma companies being pushed up against the wall by these different stakeholders. Clearly, drug makers have to walk a fine line while November 1-15, 2012

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attempting to please both million– 300m ($262m investors and the public – $393m) a year as a result of healthcare two parties with contrasting governments’ expectations and demands. spending cuts. This is an Novartis is currently example of some of the burembroiled in a lawsuit with dens being borne by drug the Indian courts over the makers. Other pharma comprices of Gleevec (imatinib), panies are also experiencing where the company asserts increasing difficulty in shortthat most patients that par- ening the length of time they ticipated in the trial did not need to wait to receive payhave to pay out of pocket for ment for drugs supplied to the pricey drug treatment. the governments of some Gilead, a leader in HIV thera- European countries, thus peutics, has been pushed putting a strain on their cash into a corner by health advo- spending. Therefore, the cacy groups and other lobby- European situation is making ists to provide therapies at many pharma companies huge discount to patients in haemorrhage money.

Clearly, something differcountries with a low annual gross domestic product ent has to be done by drug (GDP). Gilead, potentially makers to at least reduce coerced into responding to some of the pressures they these claims, has succumbed face from pricing. Despite to these external pressures the efforts of companies like Gilead and Roche runand agreed to participate ning “access” proin the transfer of grams, which technology to are targeted at promote the making their distribution of Pharma compad r u g s its drugs as nies should not be a f f o rd a b l e generics. In maligned for choosing by developAugust 2012, to focus on the needs ing counthe company of their main staketries, the signed deals holder - the investors public still with Mylan, or shareholders cringes at the Strides Arcolab, mammoth profand Ranbaxy to its announced by manufacture lowthese drug makers cost generic versions of quarterly. Of course how its HIV drug, Emtriva people feel about drug pric(emtricitabine). For now, the deals would appear to pla- ing largely depends on what cate these advocacy groups, side of the fence they are – but history reminds us that patients want them cheaper patient advocacy groups will while investors want higher view this development as a return on investment (ROI). scalp taken off a drug-mak- In all fairness, pharma coming giant and with the savour panies have been trying to the innovation of victory fresh on their lips, tackle return time and time again drought through various means, one of which is for more.

Pharma companies through mergers and acquisishould not be maligned for tions (M&As) of smaller, choosing to focus on the nimbler biotech companies. needs of their main stake- Biotechs have recorded relaholder - the investors or tively better performance in shareholders. As the time- innovation than larger pharframe of exclusivity shortens ma companies, primarily due and the regulatory require- to their limited bureaucracy ments increase, these compa- and increased focus on cutnies are faced with declining ting-edge research and develprofits and decreasing brand opment. Consequently, they cache, especially in emerging have recently emerged as markets. Furthermore, they M&A targets of multinational have to deal with reference companies including Pfizer, pricing and the stringent GSK, and Roche, which are healthcare cost controls seemingly trying to buy innobeing set up by governments, vation. Generally, M&As are because the particularly in Europe. expensive According to Sanofi’s CEO, acquirer often has to pay a Chris Viehbacher, the finan- premium on the acquiree’s cial situation in Europe has market capitalisation to seal been costing Sanofi 200 a deal. For instance, GSK’s November 1-15, 2012

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$3.6 billion acquisition of Human Genome Sciences (HGS) in July 2012 was at a 98.7 per cent premium on HGS’s share price of $7.17 each on April 18, 2012. In addition, high integration costs associated with M&As drive up the overall acquisition costs, making them a relatively risky and expensive way of driving innovation.

Pharma companies are also engaging in strategic collaborations and partnerships with academic institutions for access to innovative compounds and research. In August 2012, Novartis signed a research and licensing agreement with the University of Pennsylvania aimed at the development and commercialisation of an experimental cancer treatment. Some similar drug discovery research collaborations established over the past two years include partnerships between Pfizer and the University of California at San Diego in a deal worth more than $50m over five years, Gilead Sciences and the Yale School of Medicine, Sanofi-Aventis and Columbia University Medical Center, and the University of Pennsylvania and AstraZeneca. Although these partnerships are significantly cheaper than M&As, drug makers will still have to

grapple with the high risks discovery of treatments and a and costs associated with cure for amyotrophic lateral sclerosis (ALS), to launch early-stage R&D. However, the $1million ALS academic institutions biomarker prize, have been known Pharma a challenge to churn out companies are designed to innovation also engaging in find a bioafter innovastrategic collaboramarker to tion, so drug tions and partnerships measure makers may with academic instituthe pronot mind tions for access to gression of waiting for innovative comALS ( also their pay-day. pounds and known as Some drug research Lou Gehrig’s makers have disease) in embraced an openpatients. After about innovation model for five years, in February solving their innovation 2011, the $1million prize drought by using innovationwas awarded to Dr. Seward focused platforms, which are expected to provide a rela- Rutkove for his creation and tively cheaper method of validation of a clinically obtaining solutions to crucial viable biomarker. Open innoprocess and product develop- vation suggests that valuable ment problems. This is based ideas come from both interon the premise that the verti- nal and external sources. cal model of R&D is associat- Therefore, by embracing this ed with very expensive and model, companies such as Eli limited resources. In 2005, Eli Lilly seek to access a wider Lilly spun out InnoCentive, range of human resources an open-innovation company and motivate them with that accepts R&D problems in incentives to provide solua broad range of domains tions to problems. However, including life sciences, chem- this model isn’t without its istry, and mathematics, pit-falls, as these companies frames them as "challenge have to pay extra attention problems" for anyone to and detail to intellectual solve them, and gives cash property and control of awards for the best solutions domain knowledge.

Pharma companies to solvers who meet the challenge criteria. A year later, arguably have enough probInnoCentive partnered with lems of their own. It is Prize4Life, a non-profit understandable that patients, organisation dedicated to the physicians, and governments

demand cheaper therapeutics, but we can’t afford to kill the golden goose.

Without the R&D efforts of pharma companies, we would be lacking many of the life-saving treatments we currently have access to.

Bearing in mind the pressures drug makers have to bear from advocacy groups and governments’ health ministries, the strict regulations they have to abide by, fierce competition by brand and generics makers, and high investor demands, it is unsurprising that it is not a business for the faint-hearted. Advocacy groups need to be more considerate and reasonable in their demands for price cuts, and governments should learn to compromise with drug makers, especially if such therapeutics are for life-threatening conditions.

On the other hand, pharma companies should price their drugs so that they are still affordable by consumers while being able to give reasonable returns to their investors. Somewhere out there is a line of compromise for all stakeholders in the global pharma business, all we have to do is walk across it together, bearing in mind that health is wealth after all.

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‘COLLABORATIVE COMMERCIALISATION OF INCREMENTAL INNOVATION COULD HELP BRING AFFORDABLE NEW DRUGS’ lchemy, a medieval chemical science and a speculative philosophy aiming at achieving transmutation of the base metals into gold searching for a universal cure for disease and indefinitely prolonging life, though not considered a science by many, gradually became the basis for the development of chemistry into the 17th cen-

A TAPAN RAY Director General OPPI

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tury. However, perceivable impact of chemistry on humanity, through its smaller incremental innovation, started being felt only in the second half of the 19th century.

Experts in this field often opine that the current form of human civilization has been made possible, to a great extent, through significant advancement of incre-

mental innovation in chemistry and its role in modern technology. Chemistry is therefore considered by many as an interface between the physical world on the one hand and the humanity on the other.

While deliberating on this issue, a close similarity between the development of pharmaceutical chemistry and information technology November 1-15, 2012

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(IT) comes at the top of mind. In both these areas incremental innovation has been playing a decisive role across the world since long, immensely benefiting the humanity.

Today, one finds a striking similarity between small and inexpensive incremental innovation in IT and the same in the pharma chemistry. Both are creative as well as inventive and belong to the knowledge economy of the 21st century.

Scientists in both these communities need to be encouraged and rewarded for generating such innovative ideas, which can lead to their effective commercialisation for the benefit of general population of the country. Unfortunately current ecosystem for fostering innovation in the country does not seem to encourage this process.

That said, there are still some questions, which will need to be effectively answered. The nature of the commercialisation process of these two sciences, as we

know, though seemingly similar in terms of innovativeness, is indeed quite different on the ground. In the IT community, two people can implement an idea with minimal resource requirement and could end up with a profitable commercialised product, without much difficulty. In contrast, two chemists may come up with a brilliant idea, which in many cases, may require significant investment of resources much before to even think to get the initial product commercialised.

Subsequent steps of scaling up will be a separate issue altogether, with more resource commitment.

Usually, the process of commercialisation of incremental innovation in chemistry takes a much longer time scale, as these are not usually spare time projects, unlike IT. The cost involved in testing out and implementing a new idea in chemistry is very high and may not even be possible without any robust institutional backing or funding

arrangements.

Thus, there is a greater need to target inexpensive smaller incremental innovation in pharma chemistry for consumers’ interest, if encouraged by the government through appropriate policy measures.

Some illustrative examples of such smaller incremental innovation in pharma chemistry are as follows: 1. Development of pharmaceutical co-crystals 2. Merger of pharmaceutical chemistry of traditional and modern medicines for enhancing efficacy and safety of a drug substance.

3. Chemical technology switch: Taking technology of one field and transferring it to a different field to get a new drug substance 4. Application of polymorphic chemistry in the drug discovery process.

This process has already begun not just globally, but locally, as well. It now needs to be fostered with utmost care for the benefit of the nation.

Some of the examples

are as follows: Global experience: The chemistry department of Oxford University, UK, which is incidentally the biggest chemistry department of the western world, has reportedly made significant advances in commercialising incremental innovation in chemistry. Among many, they created and commercialised the following three entities through such incremental innovation: Medisense, Oxford Molecular and Oxford Asymmetry.

Indian experience: In India, despite all challenges, the commercialisation process of smaller incremental innovation in chemistry has also begun.

The Chemistry Department of the University of Delhi has reportedly developed 11 patentable technologies for improved drug delivery system using nano-particles.

One such technology was development of ‘smart’ hydrogel nano-particles for

encapsulating water-soluble drugs. This technology was reportedly sold to Dabur Research Foundation in 1999.

Another nano-particle drug delivery technology in opthalmogy area was also commercialised by transferring it to Chandigarh-based Panacea Biotech.

Creation of an appropriate ecosystem to help this process gaining momentum is the need of the hour, especially, to make affordable new drugs available to the patients, contributing significantly to the progress of the healthcare sector of the nation.

Thus, collaborative commercialisation of smaller and inexpensive incremental innovation in pharma chemistry, I reckon, could play a key role in providing affordable modern medicines or even a New Drug Delivery System (NDDS) to a vast majority of the ailing population of the nation, as India transforms itself into a knowledge superpower.

‘THE NEED OF THE HOUR IS PRODUCT INNOVATION’

ANJAN SEN Director, Deloitte Touche Tohmatsu India he healthcare market in India reflects a strange paradox. On one hand, it provides superior healthcare delivery, which has made India one of the sought after destinations for medical

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tourism, while on the other hand a large part of the population lacks quality, accessible and affordable healthcare services, owing to inadequate infrastructure (especially in smaller towns and rural areas)

and low availability of qualified medical professionals.

While a better infrastructure and availability of qualified physicians will help alleviate the situation, it is only a part of the solution. One of the important elements that need to be addressed is inculcation of innovative medical technology in the prevailing system.

However, availability of affordable and reliable medical devices still poses a significant challenge as currently, 85 per cent of the medical equipment demand is met by imports, primarily from US. Domestic manufacturers target the low end segments wherein competition is intense. Paucity of adequate regulatory control www.expresspharmaonline.com

has sometimes led to production of equipment that lack consistent quality.

Manufacturers in this segment are also attracted to the better price realisation of the semiregulated markets and a large part of their production is exported.

However, the need of the hour is product innovation to target requirements of the Indian consumers, economy at a reliable quality and advancements to cater to the changing disease profile. Interestingly, most stakeholders including the government, public and private healthcare providers believe that penetration of technology in the healthcare sector could lead to preventa-

tive care, early diagnosis, better clinical outcomes, a proficient healthcare delivery chain, and hence they acknowledge the potential of product innovation.

Concerns The industry continues to face the following challenges that need to be overcome before it can experience maximum growth potential.

Demographic and socio-economic factors: The per capita spend on medical expenses is still significantly lower than most other economies.

Inequitable distribution of healthcare for rural population remains a major concern.

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Regulatory hardships and deficiencies: The lack of an independent regulatory body to oversee industry specific requirements has resulted in inadequate regulations/policies and their enforcement.

Weak IPR protection dissuading MNC investments, inferior quality leading to low reliability are some of the many key concerns.

Poor adoption: Demand for medical devices is significantly low in Tier-II/III cities and rural areas. As identified in the WHO Priority Medical Devices Project, poor adoption is a result of four 'A' Barriers Affordability, Accessibility, Appropriateness, and Awareness.

Optimism Most of the impediments are expected to be overcome in the medium to long term as the market matures and the inherent dynamics change.

Success of the medical devices industry is closely linked to demand drivers such as improvements in the demographic and socio-economic condition of the population, and supply side enablers such as affordability, reliability and accessibility of quality healthcare. Some of the key factors are as follows: Increasing awareness and income base: Rising income

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base, growing health awareness and reduced accessibility barriers are aiding market growth. Moreover, ageing population, with number of people in the 60-plus age group expected to go up from 89 million in 2009 to 316 million by 2050 is also a major demand driver.

Changing disease profile: Alarming increase of lifestyle and non-communicable diseases like cardiovascular diseases, obesity and diabetes, has resulted in a significant public health problem.

Increased awareness has driven the usage of devices for effective screening and long term disease management

Manufacturing and resource prudent innovation: A large number of Indian scientists and entrepreneurs are developing products that are cost effective and suited for the unique market needs.

Realising the high growth potential, MNCs also continue to invest in innovative solutions Foreign investment: The total FDI investments made in the medical and surgical appliances in India have amounted to $115.3 million between August 1991 and April 2007. FDI is expected to spur R&D and manufacturing innovations, in turn increasing the efficiency and effec-

tiveness devices

of

the

medical

Emerging trends: Growth in medical tourism, increased wellness and prevention, improved infrastructure, developments in outpatient care and telemedicine, are some of the other factors which have increased interest and consumption levels of medical devices.

Despite the challenges, companies are shifting their focus towards developing innovative products to cater to the unmet needs of Indian domestic market. In addition to their emphasis on localised innovation, they are building and retaining their

customer base by offering efficient post sales services.

Some examples of innovative low-cost customised products in the market are given in the table.

In spite of the challenges, the future of Indian medical devices industry looks promising. Some such indicators are as follows: ◆ Convergence of drugs, devices, and diagnostics is expected to introduce new technologies and products that could eventually replace traditional medical methods ◆ Demand for health care products which can be self-administered or administered with limited assistance in a home setup ◆ Emergence of R&D practices with focus on disease specific research ◆ Evolution of technology leading to reduced detection time ◆ Innovation commitments to meet market demand by delivering quality products at affordable price ranges ◆ Initiatives from the government to alleviate the condition with regulatory norms that increase capital inflow, protect IPR, incentivise manufacturers and, increase health education/awareness of the masses.

'NON-WORKING OF PATENT A BLOT ON KNOWLEDGE ECONOMY' on-working of patents is a turbulent issue. It is made turbulent because some nations want to force their unique version of IPR on signatories of TRIPs albeit other versions of IPR and patent system are TRIPs compliant. For the purpose of this article non use also includes refusal to license or not licensing the patent. Let us have a quick review of some perspectives of non-working of patents.

N MILIND SATHE Deputy General Manager – Projects, Unichem Laboratories November 1-15, 2012

www.expresspharmaonline.com

Study of evolution of Crown monopoly privileges, British patents and patent system clearly and convincingly substantiate privilege and patent system to ensure working within the realm so as to increase exports, reduce imports, provide employment to native apprentices, dissemination of new technologies and to provide products at cheaper price. Statute of monopolies which is interpreted as political and policy com-

promise for some reasons is alleged to have shifted focus from the local working requirement. Despite this interpretation, British Patent law has always retained compulsory licensing provisions which would have same impact.

Paris convention Article 5 which is internalised by TRIPs indicates the corrective measures to be taken in case of failure of local working of the patent. It also prescribes the EXPRESS PHARMA

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period within which patent has to be worked in the country and is within three years after the grant of the patent.

The Patents Act of India which is TRIPs compliant has internalised all these features of international agreements. It also stipulates the conditions of grant. Like India, many nations treat non-working of patent as an act that contradicts the law of the land. This is a perfect interpretation within the legal frame prevailing in these nations. The law in these nations suggests Compulsory Licensing (CL) to neutralise the bad effects resulting from non-working of patents. CL necessitates prior efforts and dialogue with patentee for licensing. However the US blames India and other countries in their 301 reports for alleged loose IP protections and for presence of CL provisions. It does not want India and other nations to invoke CL provisions.

The patent system is alleged to have been internalised by the US to promote the progress of science and useful arts. Early days in the US witnessed litigations where working of patent was adjudged an essential attribute of patent system1. Patents were privilege 'conditioned by a public purpose. After Continental Paper Bag Co. v.

Eastern Paper Bag Co., 210 U.S. 405, 28 S.Ct. 748, 52 L.Ed. 1122, a change in focus

was observed that prioritised interest of the patentee over the public purpose of the grant.

Non-working of patents, also known as nonuse of patents, is litigated under competition laws in the US, which has a legal provision called 28USC1498 which allows the State to use the patents even without prior negotiation with patentee.

The US has invoked this provision several times so far.

The most detrimental impact of non-working of patents is suppression of technologies, processes and products (TPP), elimination of opportunities to make versatile applications of TPP. How is this related to the objective of promoting progress of science and useful arts?

Commonly sited reasons for non-working of patents Non-working is closely associated with the TPP protected by patent.

Competitive disadvantage, lack of market demand, and apprehension that the technology is obsolete, threat to hierarchical tiers within the company or in organogram, apprehension of impact in the market position/share/reputation of company in case of failures, threat of existing labour and machines becoming idle, threat of loss of jobs, inability to grasp and master new skills, cost of investment in internalising new TPP, high

investment required albeit the growth of economy.

Non-working of patent new technology may be better in the long run, pace of has disadvantages such as change in the given type of the subject population is TPP/industry, to block com- denied the use of the invenpetitor (the strategy used by tion and entrepreneurial or companies working in the industry members are prefield of energy, pesticides, vented from developing add agrochemicals), huge switch- on or incremental innovation ing costs, to eliminate new which can result in superior competitor from establishing technology and better more user friendly, more effective himself in the market. products. Thus nonNon-working of use of one patentpatents serves pured technology poses which conor patent protradict national tected prodinterests and uct has a sovereign priNon-working of cascading orities. It crepatents serves purpose f f e c t ates dependes which contradict which stops ency, ensures national interests and f u r t h e r exodus of sovereign priorities inventions n a t i o n a l and arrests w e a l t h . social, technoCompetitors canlogical, industrial not access effective comfort. It kills the TPP. Patentee is able to inventive ingenuity which continue its rule over the marthe patent and patent sysket. Patents of inferior TPP are also not worked to prevent tem is preached to be providintroduction of cost competi- ing the incentive. Diffusion of tive TPP and to avoid potent knowledge is incomplete if possibilities of price war the TPP protected by patent which in most probability is not available for consumpwould impinge upon bottom tion. Description in the patent and its quality can be lines of patentee.

Non-working contradicts understood only by those public justification2, shrinks who know the game of sovereign domains and pro- patent drafting. Nonworking motes anti- commons3. Anti- prevents optimum use of commons prejudicially affects resources. Nonworking conconsumer comfort, interrupts tradicts the spirit and purindustrial progress, and exerts pose of promoting progress of detrimental impact on sectors science and useful arts. contradicts of vital importance and arrests Nonworking

public interest, denies social welfare, threatens political stability. Non-practicing patentees dent the economy of the nation, puncture entire legal system, raise level of inconvenience, create legal and administrative crises4.

How to prevent nonworking of patents 1) Publish the information collected under FORM 27 or non-worked inventions.

2) Declare non-worked patents open for CL. This will also save lot of time, social and public cost incurred in establishing Section 83, 84.

3) Treat nonworking of patents as anti-public interest activity and should be condemned professionally, socially, politically, economically, individually and collectively.

Non-working of patent is blot on knowledge economy All explanations given to justify and tolerate non-working of patents, such as “hindsight” should be effectively eliminated and patent system be made to deliver its objective of “promoting progress of science and useful arts” “dissemination of essential technologies” to ensure that WTO and TRIPs does not fail hereafter in achieving its objectives5 and preamble.

(The author wishes to state that the views expressed in this article are his personal views.)

CAN INDIAN SMES ADDRESS HEALTHCARE SOLUTIONS?

KANNAN VIJAYARAGHAVAN Chairman, Sathguru Management Consultants

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Can Indian SMEs pursue passion and profit to address healthcare solutions? While emerging enterprises may lack access to deep pockets to fund resources to engage in discovery level research, Kannan Vijayaraghavan, Chairman, Sathguru Management Consultants believes that small and medium biotech enterprises in India do possess the ability to actively engage in the discovery led commercialisation process

www.expresspharmaonline.com

he rapidly growing world population has become more and more prone to communicable diseases. As humans move across the world, they carry disease vectors to regions that were hitherto insulated from major incidences of communicable diseases. Human movement, zoonotic disease spread and travelers from different parts of the world converging in

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busy airports has resulted in a situation where the threat of epidemics is no longer limited to the southern, less developed regions of the world.

Enterprises in India have come a long way from manufacturing traditional plasma derived vaccines to producing multivalent recombinant vaccines, therapeutic streptokinase and other biotechnology derived products for preventive and curative health care.

While large enterprises generally limit themselves globally to products with lucrative revenue opportunities, emerging enterprises have a significant opportunity to seize growing markets for an array of vaccine products and therapeutic applications. However, these emerging enterprises lack access to deep pockets to fund resources to engage in discovery level research.

Discovery level research requires comprehensive inter-disciplinary skill sets within the enterprise level and it is hard to create comprehensive inter-disciplinary capacity in any small enterprise when very few multinational companies themselves possess such strong inter-disciplinary competency. However, the emerging enterprises in India possess the ability to apply discovery led solutions for the development of affordable products by engaging in product development, translational validation and clinical regulation related research, development and commercialisation efforts.

Several factors contribute to the accomplishment of this amazing feat by small and medium biotech enterprises in India.

There are a couple of key factors that are important in this discovery led commercialisation process with the active engagement of Indian SMEs.

DNA sequence data has provided a better understanding of biological function and genotyping and phenotyping technologies and complex algorithm driven predictive

models have provided innumerable leads to develop new medicines. However, these discovery outcomes are patented by leading global academic bodies or

large companies. Prior to the creation of a WTO compliant patent regime, Indian SMEs access to global biomaterials and technologies were greatly limited. With the elimina-

tion of such constraints, Indian ventures have the potential to be responsible recipients of discovery outcomes to validate the applicability of such discoveries

Gaining access to biomaterials and contemporary technologies: The fundamental research in life sciences is carried out in an academic environment with OECD countries committing large resources for accelerating discovery pathways.

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for the development of preventive and curative products. The model is akin to the spread of chip technology in the realm of information technology. As successful companies like Intel develop faster and cost effective chip technologies, other innovators adopt these technologies for their own product applications.

Intel technologies are licensed to various end users depending upon the nature of the products that they innovate for the markets. A gene of interest or a biological strain with known functional applications is accessible through this licensing process.

Sathguru’s efforts in the recent decade to provide such access to innovators has resulted in a number of discovery led biotechnology products reaching the markets. However, the pace of innovation in competing countries such as China, Taiwan, Korea and even Vietnam is catching up and therefore, the demand for such biomaterials and technologies are constantly on the rise. Nations that are effectively accelerating innovation have the potential to access similar biomaterials and technologies and over a period of time, they themselves will become generators of such technologies.

Technology access has connotations for the end product application and its public good relevance. There are a number of instances where Sathguru has facilitated pro bono access to contemporary technologies if there is considerable public good relevance for such technologies. The dream of every inventor in the world is that his or her technology should reach the billions of people around the world, and India can make that dream a reality. The speed of innovation drives the innovators to downstream technology application in partnership with the private sector in order to ensure that the innovations do not turn obsolete.

Access to external research capacity: Indian SMEs now have wider access to research capacity both within and outside the country.

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The creation of large inter- becoming increasingly diffi- centers of major global playdisciplinary infrastructure cult for any enterprise to ers have contributed enorwithin Indian public carry out all the activities in mously to the acceleration research systems, accelerat- the product development of global discovery pathed investment by third party pathway all by themselves. ways to such companies in service providers within Development connectivity addition to providing local India, entry of global service accelerates the development resources with the ability to providers for third party process and brings innova- integrate with the global services and the ability of tion to markets in an accel- advancements in research.

Indian ventures to access erated manner. The connec- When the global research global infrastructure have all tivity may be created by centers explore indigenous technologies without contributed to Indian SMEs wider geographical violating the in with limited internal footprint national biodiof research capacity, augment- regions versity laws ing their research capacity i n n o v a t i o n Emerging enterand other manifold by accessing such for the same prises have a signifirestrictions infrastructure. There are a entity or by cant opportunity to that are number of Indian ventures connecting seize growing markets imposed in that have accessed the inter- or partnerfor an array of vaccine accessing national incubation infra- ing with difproducts and theraindigenous structure available at uni- ferent entipeutic applicaknowledge, versities such as Cornell and ties in differtions there is accelerregions. have gained from accelerat- ent ated competition developed research results. In India, The for enterprises to large infrastructure estab- ment connectivity turn them into globally lishments such as the also triggers resource marketable products. The Faridabad Biotechnology pooling from intended partCluster built by the ners, as they perceive the SMEs perceive a threat to Department of accelerated gains from prod- their indigenous markets Biotechnology, the C-CAMP uct delivery in needy and therefore are forced to in Bangalore and their inter- regions. When we succeed innovate faster to retain national linkages will go a with five candidates in the their current markets. long way in supporting area of prevention of compartnerships SMEs to accelerate their municable diseases, we are Technology product development efforts contemplating an invest- for joint product developbased on effective biomater- ment of $ 60 to 70 million ment: Joint venture partnerial discoveries and contem- per candidate and pooling ships have occurred in the porary technologies. such resource will be a past significantly in the pharmaceutical seamless process, if such chemical Licensed technologies come Global biotech product develop- sector. with enormous stewment partner- majors are no exception for ardship responsiships are sys- adopting this strategy. And bilities and the t e m a t i c a l l y globally, Sathguru has been Indian SMEs The SMEs perpursued. I associated with creating and are in the ceive a threat to perceive a nurturing a number of partprocess of their indigenous marc o m b i n a - nerships for biotech majors learning to kets and therefore are tion of with local SMEs and in all comply with forced to innovate approaches such joint initiatives that t h e s e . faster to retain their b r i n g i n g have been formed with an Globally there current markets a c c e l e ra t e d innovative structure that are also ceninnovation to result in a win-win-situation ters for validatboth Indian and through the emergence of ing the devices global markets. successful products from that are indigenously partnerships.

Some of these approach- such developed so that they can Considerable efforts go into es are: be assessed for their design structuring such partnerefficiency, product reliabiliflow to ships to determine the backty, delivery efficiency, cost Technology reduction factor and regula- research centers created by ground intellectual property, in emerging investment milestones, and tory compliances. There are ventures centers of excellence in lead- regions: While multination- human resource pooling confidentiality ing universities such as al companies have advan- needs, Cornell, which have part- tages in bringing currently covenants and usage rights nered with enterprises in de-regulated products from of research results. It is necperfecting the device tech- other regions to countries essary for any Indian SME to nologies and delivery con- such as India, they also look determine these terms in sistencies. Over a period of forward to accelerating their advance, so as to avoid lostime, I do perceive India to current pipeline by estab- ing out on lucrative opportucreate such a center duly lishing their own entities in nities.

While there are certainly triggered by major public India. Our experience in investment in creating such such multinational compa- contract research developnies indicates the contribu- ment opportunities, they are a center. tion such centers are making distinct from the two Development connectivity: to their global research pro- approaches detailed above. contract research In the current context it is gramme. Indian research The www.expresspharmaonline.com

approach does not provide access to IP and the service provider gains a fraction of the stream of values that is likely to be created resulting from commercialisation by the primary developing entity. Indian SMEs are bound to increasingly opt for cocreating innovation rather than remaining third party service providers. The innovation funding platforms such as Biotechnology Industry Partnership Programme (BIPP) and the Small Business Innovation and Research Initiative (SBIRI) of the Department of Biotechnology will encourage Indian SMEs to take the journey through the innovation pathway. When the SMEs co-create innovation over a decade, working with global corporations, they secure the ability to move to the next layer of the innovation journey to lead the innovation pathway on their own. In our experience in the area of biomedical research, we believe that over 100 Indian ventures will have potential to drive this co-creation opportunity and about 10 of them will graduate to sole innovators in a span of five years or so. Their dreams will call for larger investment to take their products to the last mile delivery and there will be enlarged interest for development partners as well as strategic investors to take stakes in such ventures to make these dreams a reality for these ventures. These strategies will help SMEs to pursue the profits and the passion for finding affordable solutions for communicable and other diseases and place them among the global innovators. An exciting time indeed for Indian ventures and the global partners.

Kannan Vijayaraghavan is also the Regional Coordinator for the Cornell University – Sathguru led life science initiatives in the region and recently coauthored a World Bank publication titled “Biotechnology innovation for inclusive growth” with Dr Mark Dutz of World Bank.

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‘INDIAN INNOVATION – STAY THE COURSE’

NICK MITCHELL Phenomenex India

were attending schools like Harvard, he 21st century is Oxford, India’s to own when it Cambridge, Stanford, and comes to the develop- MIT, in cities like Paris in ment of new technologies. France, Manchester and From its roots in innovation London in the United in the IT sector now more Kingdom, and Boston and than 20 years strong, to San Francisco in the US, to today’s developments across name a few. These expatriall of the high technology ates were learning so platforms in pharmaceuti- much more than what cals and biotechnology, the coursework providIndia is proving that when it ed as their foundation comes to science and tech- for becoming a steward of innovation. When nology it’s leading the way.

Let India forget not those not studying or attendthat have helped along the ing classes, your fellow journey to reach this impres- Indians abroad were sive milestone. Do so not exploring these great only with fond recollection, cities and these great but with a call to action to nations and learning take responsibility as an about proper infraorganised aggregate whole to become structure, the world’s next largest systems, and economic innovator nation.

The development assisted world’s multinational phar- by local, state, and federal governments. ma and biotech firms such They were as Astra-Zeneca, exposed to Sanofi-Aventis, This urban phiNovartis, proud nation lanthropy at Pfizer, and that continuously its finest, plenty of celebrates its individand many others have uality must also contindidn’t just given the ue to learn new ways observe global playto join forces with its from the ers of today international brothers sidelines, a roadmap and sisters on the they became to follow and world stage involved. the owner’s Many of these manual for the expatriates are vehicles that are returning home to India ready to drive innovation today. And, as they are to an entire new level.

How many accomplished returning, they are discoverresearchers and business ing that India was not fast professionals alike reading asleep while they were this article spent time gone, au contraire, India has abroad in the west to obtain gone through many more a world class education in changes in the time the the 1980’s, the 1990’s, and NRI’s and PIO’s were the first decade of the 21st abroad. These changes have century? Indian expatriates been brought about by fel-

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low countrymen and women that have been at home engaging in India’s progressive development in concert with their expatriate brothers and sisters. They have been nurturing the tremendously growing Indian population and preparing them for this exact moment in history where greatness is possible!

And to look outside of this wonderful nation, only for a moment to glance at the “brothers and sisters” of our global family that are also growing, we have to give strong consideration to our relations labeled so closely to us as our “BRIC” relatives. Each of these nations; Brazil, Russia, and China, are making incredi-

ble strides in their own right. China continues to modernise its modern urban centers, Russia continues to educate its scientists and engineers with vigour at home, and Brazil enjoys the abundance of its natural resources similar to India, but with the compliment of large amounts of fossil fuels at its disposal as well.

The best celebrations are those that are based on incredible accomplishments.

When we think of the Olympic Summer Games that were held in London earlier this year, we see a nation that acts like a proud parent, dare I suggest a proud “grandparent” to the www.expresspharmaonline.com

global community. During to learn new ways to join the 1940’s and 50’s this forces with its international great nation was the west’s brothers and sisters on the strongest and proudest par- world stage.

I personally have had the ent nation, and the US took pleasure of being charge as one of its mentored over the evolving descenlast 15 years by dants to grow a gentleman up not in their India comes to that has shadow, but the global stage with lived his life in their legaan incredible developon the cy. Today, it ment of its own over a world stage. is time for far longer time span Born in Iran India to do than both of the years ago, the same. Of nations it now takes F a s h a course, India the baton from Mahjoor in his comes to the early teenage global stage with years had the an incredible developportunity to immiopment of its own over a grate to England and far longer time span than both of the nations it now attend secondary school and takes the baton from to run university in this wonderful the next leg of the race. It is nation just a decade or two this beautiful inte- after it had passed the baton gration of the to the US to become the patiently developing world’s largest economic land of the Sun with superpower. After completthe high-paced ing his formative years of nations of the west education and development that will surely offer in England, Fasha moved to India the challenge the West Coast of the US of further under- and settled in the city of Los Angeles, standing your angels, responsibility as California. Over the last 15 India become a years, I have watched Fasha strong and proud continue to understand the parental role model global community better for new rising than most and three to four nations like Egypt, years ago when he decided Nigeria, Ethiopia, to concentrate his efforts on and many others India, I knew once again he throughout Africa was making another great that will possibly decision.

Phenomenex India is take the baton from honoured to be a part of the India in centuries ahead.

There are many nations life sciences landscape here coming to agreement every- in Hyderabad, India and we day on how to work with look forward to many years one another to promote the of watching India’s long progress of innovation. term success. Best wishes in Foreign direct investment your journey and it is a across the high technology pleasure to be here with sectors, open immigration you. Assume your position policies and a concerted graciously, and continue to effort to infuse the thought- stay the course. leaders and international Nick Mitchell is part of scholars with those here in the management team of India to create incredible Phenomenex India. He has global achievements within been travelling to India on the academic community behalf of Phenomenex for are all ways in which India almost 10 years, and is now can collaborate at the same is settled with his family in time it strives to compete.

Hyderabad, India to further This proud nation that condevelop Indian operations tinuously celebrates its indifor the US-based MNC viduality must also continue November 1-15, 2012

PHARMA ALLY

W H AT ’ S INSIDE

EXPERTISE FOR DRUG DEVELOPMENT

‘An important part of our growth strategy is to increase our presence in Asia Pacific and emerging markets’

Novasep to build chromatography plant, invests 30 million euro PG51 Rolta extends global relationship with Oracle PG52

During a regularly scheduled trip to India to connect with employees and customers, Marc Casper, President & CEO, Thermo Fisher Scientific Inc spoke to Viveka Roychowdhury on the company’s significant investments in India and how it is helping Indian pharma customers grow rapidly and compete on a global scale Thermo Fisher Scientific clocked strong revenue and earnings growth for the second quarter ended June 30, 2012. What is the contribution of the various regions (North America, Europe, APAC, ROW)?

As of the end of our second quarter this year, (trailing 12 months through Q2’12) approximately 20 per cent of our revenues came from APAC and ROW. Europe accounted for 26 per cent, whereas North America comprised the remaining for 54 per cent.

Of the company’s three business segments, i.e.

Analytical Technologies, Specialty Diagnostics and the Laboratory Products and Services, which is the fastest growing product/service segment?

We have a track record of growth and innovation in each of these segments. Our Lab Products and Services segment represents just under half of our revenues and is expected to grow steadily. This segment has an addressable market of about $29 billion, growing at 2- 4 per cent annually.

Our annual (trailing 12 months through Q1’12) revenues of around $6 billion came from a balanced mix November 1-15, 2012

of everyday lab equipment, consumables and services.

Our Analytical Technologies segment is a third of our revenues and is where the bulk of our product innovation occurs. This segment addresses a market of approximately $31 billion, growing between 4 and 6 per cent. Our annual (trailing 12 months through Q1’12) revenues of $ 4.1 billion came from our range of Chromatography and Mass Spectrometry Equipment & Consumables, Chemical Analysis Instruments, Environmental & Process Instruments and Biosciences portfolios.

The Speciality Diagnostics segment is just over 20 per cent of our revenue, and covers a broad spectrum of products such as Clinical Assays, Immunodiagnostics, Microbiology, Anatomical Pathology and our healthcare channel – all adding to annual (trailing 12 months through Q1’12) revenues of about $ 2.8 billion*. The addressable market for us is about $ 19 billion, growing at between 4 and 6 per cent annually.

Our recent acquisitions of Dionex, Phadia and One Lambda give us added capabilities in growing markets within the analyti-

cal and specialty diagnostics segments, adding to the unique value proposition we can bring to our customers.

What are the region-wise trends in these segments?

In Analytical Technologies, APAC and ROW contributed almost 32 per cent of our revenues, with North America representing 39 per cent and Europe 29 per cent. (trailing 12 months through Q1’12) In Specialty Diagnostics, a high majoriwww.expresspharmaonline.com

ty of revenue (trailing 12 months through Q1’12) (about 59 per cent) comes from North America.

Europe represents 29 per cent of our revenue in this segment, whereas APAC and ROW total about 12 per cent. In Laboratory Products & Services, North America contributes 66 per cent of revenues, followed by Europe (21 per cent) and APAC & ROW (13 per cent). (trailing 12 months through Q1’12).

Analysts predict that since around two-thirds of

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INDIA IS ONE OF THE LEADING COUNTRIES OF THE WORLD IN THE AREA OF BIOTECHNOLOGY DEVELOPMENT AND MANUFACTURING. COMPANIES SUCH AS BIOCON, DR REDDY’S, SHANTHA BIOTECHNICS (NOW A PART OF SANOFI) ARE INTRODUCING WORLD-CLASS VACCINES AND DRUGS NOT JUST FOR THE INDIA BUT ALSO FOCUSING ON SOME OF THE SOUTH ASIAN AND SOUTHEAST ASIAN COUNTRIES revenue is generated from the sale of consumables and services, the company is insulated to some degree from the cyclic nature of the manufacturing industry. Is this observation bearing out?

Yes – it is correct that from a product mix perspective, about two-thirds of our revenue is from the sales of consumables and services.

This ensures that many of our 13,000-strong customerfacing team interact with our customers every day. This puts us in a position to have a unique mindshare in this industry.

What are the other strategies put in place by Thermo Fisher Scientific to maintain strong growth?

Looking at the end markets, we are indeed very balanced as nearly a quarter of our revenues come from each of our major market segments – Pharmaceuticals & Biotechnology, Healthcare & Diagnostics, Industrial & Applied and Academic & Government. This, combined with our unique product mix spanning Instruments, Equipment, Consumables, Reagents & Chemicals, Software & Services gives us an industry-leading position in most markets that we serve.

An important part of our growth strategy is to increase our presence in Asia Pacific and Emerging Markets. At the time of our merger in 2006 that created Thermo Fisher Scientific, only 10 per cent of our revenue came from Asia Pacific and emerg-

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ing markets. Today it is 20 per cent and in five years we expect it to be at least 25 per cent. Our tremendous success in China, India and other parts of these exciting markets has shown that we have a proven strategy.

How did the India market perform during this period?

For us, India is an approx $2.2 billion addressable market and we are very excited about the opportunities that exist in areas such as pharmaceuticals, healthcare, food safety and environment.

India is one of the leading countries of the world in the area of biotechnology development and manufacturing. Companies such as Biocon, Dr Reddy’s, Shantha Biotechnics (now a part of Sanofi) are introducing world-class vaccines and drugs not just for the India but also focusing on some of the South Asian and Southeast Asian countries.

We also see that the Indian government is showing more commitment to investing in innovation, science and technology. We understand that there will be some significant investments in infrastructure and food safety labs all across the country.

During the time of our merger, we had revenues of about $50 million from India and we have been averaging double-digit growth since then.

We have made significant investments in India since 2006, such as four acquisitions and augmenting the sales, service and supply

chain infrastructure. We have set up a green-field, state-ofthe-art clinical service facility at Ahmedabad.

What are the consumer trends driving the pharma and biotech markets which impact (in terms of evolving regulatory imperatives, financial constraints impacting companies, etc)?

The world is becoming a much more regulated space, which means more requirements for measurement, detection and monitoring.

We are observing increased scrutiny by the FDA on new drug applications which may have arisen from studies on adverse drug reactions.

Hence, we see a trend that major pharma companies are implementing companion diagnostics programmes as a part of their formal R & D process.

We have had customers approaching us in the late stages of product development and have worked together in record time to launch the drugs, introduce them hospital-by-hospital and monitor the diagnostic results in the lab.

The convergence of life sciences and diagnostics is a natural area for us to focus on, since we have the widest technology base in these applications, as well as support of our biopharma services.

For the pharma and biotech end markets, what is the focus of the company in the APAC region and India specifically, in terms of product focus areas, etc?

Many of our global customers are also investing in APAC regions, and specifically India. Our aim is to be there with them anywhere in the world, to offer them the same level of technology and application expertise for them to achieve their business objectives. There is a large generic pharma manufacturing sector in India that is also adopting global standards, SOPs and quality procedures. We have enjoyed helping our Indian pharma customers grow rapidly and compete on a global scale in Europe and North America.

With several pharmaceuticals going off patent in these coming years, we are very www.expresspharmaonline.com

optimistic about the investments planned by our customers in India.

Last year, we established an APAC Chromatography Center of Excellence here in Ahmedabad to support customers in India and APAC on method development and to provide faster solutions for their complex R&D and QC problems. Our demo centre in Mumbai and training center at Nasik are also accessed by our customers to help them chose the right technology.

For Biopharma product development, we focus on offering tailor-made solutions such as customised media to help our customers speed up their product development and also support them to scale-up from R&D to pilot and finally to bulk manufacturing. Our singleuse technologies are also helping our customers reduce their time-to-market.

Our hand-held raw material analysers are proving to be a huge productivity improver for pharma operations. They support our customers to achieve 100 percent scanning of all incoming raw materials.

What are the channels used to service this clientèle?

While we collaborate very closely with our key pharma and biotech accounts here, India is a diverse market and customers are spread all across the country. To ensure accessibility to our customers, we operate through a combination of our own market channel and other business partners. These third-party partners offer various valueadded services from installation, commissioning and after sales services for our instruments and equipment to offering quick deliveries of our chemicals and reagents.

Our Indian operations regularly invest in our channel partners capabilities through extensive training on our products.

The company has acquired specialty chemicals channel Doe & Ingalls this FY. What was the rationale behind this move?

Doe & Ingalls is a leading channel for the production environment. This acquisition creates significant cross-

selling opportunities for our existing customer base and to move from a historically research laboratory environment to production environment for our biopharma customers.

Is the company mulling further acquisitions? In which areas?

Thermo Fisher looks at organic as well as inorganic routes to growth. We have been investing in acquisitions that help us to enhance our offering to our customers and increase our access to growing markets worldwide.

The company has acquired a fair number of smaller technology-focussed companies in the recent years.

How has the integration process been, given the global depressed economic scenario?

Since 2009, we have deployed about $7 billion (closer to $8B with One Lambda) in acquisitions, including the larger Dionex, Phadia and One Lambda deals. Acquisitions and integrations are among our core competencies, regardless of the economic environment.

Just to cite an example, we have successfully managed the Dionex integration, delivering operating income from revenue synergies, cost synergies and tax efficiencies.

Some of the other acquisitions we have successfully completed in the recent past are Ahura Scientific, Fermentas, Finnzymes, BRAHMS, TREK Diagnostics and Doe & Ingalls. Each of these has also brought on board some great talent and have transformed our competitive position.

What is the guidance for this financial year for the pharma and biotech segment?

We do not give formal guidance by end market but we do expect the biopharma segment, worldwide, will continue to grow well above company average, which is approximately 3 per cent. *All Revenue figures, addressable market sizes, regional shares based on LTM as of Q1 2012 and before inter-company eliminations viveka.r@expressindia.com November 1-15, 2012

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VENDOR NEWS Cognex Corporation wins 2012 Control Design Readers’ Choice Award Wins award in the category of Machine Vision System ognex Corporation has won the Control Design Readers’ Choice Award in the category of Machine Vision System by a margin of 43 per cent over the second place finisher. Control Design surveyed the machine builders and system integrators among its readership and of the approximately 1,000 that responded 52 per cent answered that Cognex machine vision systems delivered the best value compared to 9 per cent for the second place finisher.

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The 2012 survey went to about 15,000 subscribers with buying influence or buying authorisation for industrial automation and control products. Vendors were not eligible to vote. The ballot was unaided which means the respondents had to provide their own names of suppliers rather than picking from a list.

"We are proud to win the Control Design Readers’ Choice Award for 2012. This award validates our strategy of continual investment into

the R&D of our products. The overall result is continued best-in-class products that help our customers improve the quality and traceability of their products while at the same time reducing manufacturing and distribution costs," said Ron Pulicari, Marketing Manager, Cognex.

Cognex has won a Control Design Readers’ Choice Award in the machine vision category every year since 2001 with seven first place wins and four second place finishes.

EP News Bureau

Thermo Fisher Scientific, Immundiagnostik to develop MS-based tools hermo Fisher Scientific and Immundiagnostik AG announced a collaboration to develop novel mass spectrometry-based assays for qualitative and quantitative analysis of proteins and peptides. The goal is development of commercial assays to be widely applicable in research and routine clinical analysis.

The collaboration will focus on advancing biomarker research by combining Immundiagnostik’s ImmunoTube antibody technology with Thermo Fisher’s new liquid chromatographytriple quadrupole mass spectrometry (LC-MS/MS) analytics to create new assays for the diagnosis of cardiovascular diseases and bone metabolism disorders.

The goal is to develop a sensitive, reliable, qualitative and quantitative assay of complex samples, using Immundiagnostik’s antibody capabilities to optimise sample preparation and to efficiently isolate low level analytes in complex mixtures.

Thermo Fisher’s proprietary,

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high-throughput Mass Spectrometric Immunoassay (MSIA) technology will also be applied, as well as the Thermo Scientific TSQ Vantage Triple Quadrupole Mass Spectrometer for quantitative analysis of small

THE GOAL IS TO DEVELOP A SENSITIVE, RELIABLE, QUALITATIVE AND QUANTITATIVE ASSAY OF COMPLEX SAMPLES peptides, and Thermo Scientific Orbitrap Elite highresolution accurate mass mass spectrometer to measure post-translational modifications. The goal is to develop assays that will achieve extremely selective identification of all molecular variations of peptides and proteins.

“We are impressed with

Immundiagnostik’s antibody expertise, and are confident that the immunoaffinitypurification of proteins will take quantitative LC-MS/MS protein analysis to the next level,” said Jeff Zonderman, Director of Clinical and Toxicology LC/MS, Thermo Fisher.

Dr Franz Paul Armbruster, CEO, Immundiagnostik, “This type of work demands precise analytical tools.

Thermo Fisher, with its recognized excellence in accurate mass and high resolution measurement, is the ideal partner for the advancement of our LC-MS/MS product line of assays.”

As part of the collaboration, Immundiagnostik will provide a venue for demonstrating various Thermo Fisher technology applications.

In addition, Immundiagnostik will utilize its academic and clinical network to identify diagnostic parameters, validate novel LC-MS/MS products and develop new assays for commercial distribution. . .

EP News Bureau www.expresspharmaonline.com

Novasep to build chromatography plant, invests 30 million euro New plant on its Mourenx, France site to produce a large volume commercial API ovasep, a leading provider of purificationbased manufacturing solutions for life science molecules, has invested 30 million euro to build a chromatography plant used for the production of a large volume commercial active pharmaceutical ingredients (APIs).

The plant will be built on Novasep's existing Mourenx site in France and will be operational and validated within 18 months. Both the development of an advanced purification process and the plant expansion within the challenging timescale are results of the sharp increase in the projected demand for a large volume, highly purified API. The 30 million euro investment follows two other significant global investments in 2012. The first is the opening of a new 2,000 m2 facility in Shanghai, China and the second is a 3 million euro investment to expand the Highly Potent API (HPAPI) manufacturing capabilities at the facility in Le Mans, France.

Novasep has pioneered continuous chromatography for pharma manufacturing for more than 20 years. Its SMB and Varicol continuous chromatography technologies are currently used for commercial scale production of several chiral APIs. The new plant, designed by a Novasep in-house engineering team, will include Varicol systems with 1,200 mm diameter columns operated at up to 70 bars, the largest ever built in the pharma industry. The plant will enable the production of a highly purified API from a complex mixture. The systems will also integrate sophisticated solvent recovery systems for the recycling of 99.9 per cent of solvents, resulting in both a very costeffective and environmentally friendly process.

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"Demand for Novasep's advanced, purification-based manufacturing capabilities in the life science industries continues to increase as drugs in development and reaching the market become more complex and specific.

This necessitates our third, and largest global plant expansion in 2012. This successful project, the world's largest chromatography plant in the pharma industry, demonstrates the validity of the Novasep strategy which is based on the combination of synthesis, biosynthesis and purification. We thank our institutional partners for

THE PLANT WILL BE BUILT ON NOVASEP’S EXISTING MOURENX SITE IN FRANCE AND WILL BE OPERATIONAL AND VALIDATED WITHIN 18 MONTHS their active support and our shareholders for their strong involvement to enable this transforming project," said Patrick Glaser, President and CEO, Novasep.

Beyond Novasep's commitment, the EUR 30 million investment has been made possible through financial and/or logistic support from partners like the association of local authorities of Lacq, the General Council of Pyrénées Atlantiques, the Regional Council of Aquitaine, the Economic Development Bureau, DIRECCTE Aquitaine, the Prefecture of Pyrénées Atlantiques, the Total Group, and OSEO, France's innovation partner. The plant will leverage the SOBEGI platform's utility supply.

EP News Bureau EXPRESS PHARMA

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Trophos gets 1 mn euro for multiple sclerosis project Agence Nationale de la Recherche awards second grant to Trophos led consortium for Phase Ib/IIa clinical study rophos SA, a clinical stage pharmaceutical company developing innovative therapeutics from discovery to clinical validation for indications with under-served needs in neurology and cardiology, has received an 1 million euro grant to support the Translate-MS-Repair project.

The French 'Agence Nationale de la Recherche' (ANR) awarded the second successive grant to Trophos to target Multiple Sclerosis (MS) with olesoxime. The funding will be provided under the Recherches Partenariales et Innovation Biomedicale 2012 programme.

Translate-MSRepair will be a 24-month project and will include a

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Phase Ib/IIa clinical study of olesoxime, Trophos' lead compound, to target neurodegeneration that underlies long-term progressive disability in multiple sclerosis.

The project will be operated by a consortium spearheaded by Trophos including leading experts in Marseille (AP-HM/CNRS and CEMEREM-CRMBM), Rennes (CHU de Rennes and INRIA VISAGES) and Reims (CHU de Reims).

The clinical trial, which will be performed in three centres in France, will be led

by Dr Jean Pelletier APHM/CNRS-CEMEREM. The clinical trial is designed to demonstrate the compatibility of olesoxime as a co-med-

ication with existing treatments, the most frequent being beta interferon. The study will also assess the feasibility of non-conventional magnetic resonance imaging procedures in a multicenter trial. The clinical trial is designed to result in future large-scale clinical trials to assess efficacy of olesoxime to prevent progressive disability in MS patients.

Rebecca Pruss, CSO, Trophos, “MS is the first cause of non-traumatic disability in young adults.

While there are a number of effective treatments to control the relapsing inflammatory episodes, they have little effect on progressive disability in MS patients.

EP News Bureau

Rolta extends global relationship with Oracle Rolta OneView is an innovative BI solution with field-proven benefits for plant operators of process industries olta, a Platinum level member of Oracle PartnerNetwork, announced that it has agreed with Oracle Technologies for bundling their software components with its flagship Rolta OneView Enterprise Suite, for delivery to customers worldwide. Frost & Sullivan, in a white paper for Oil & Gas Information Technology, titled ‘Enabling Operational Excellence’ stated that solutions such as Rolta OneView will play a critical role in transforming plant management and drive growth.

With this agreement customers worldwide will now be able to get Rolta OneView alongwith full Oracle Business Intelligence Enterprise Edition Suite and Oracle Database Enterprise Edition as a complete package, including sup-

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port and services. Bundling of Oracle’s industry leading business intelligence platform with Rolta OneView provides competitive advantage over proprietary BI solutions, allowing customers to benefit from the continuous R&D investments and technology refreshes. Rolta expects to consolidate Rolta OneView position in large enterprises as well as penetrate medium and small enterprises.

Rolta OneView is an innovative BI solution with fieldproven benefits for plant operators of process industries, including utilities transmission and distribution, power generation, oil and gas, petrochemicals, and chemicals, to significantly improve operational efficiencies and plant reliability.

EP News Bureau

PRODUCT WATCH Thermo Fisher Scientific launches Detector-Agnostic Software hermo Fisher Scientific has launched Thermo Scientific TraceFinder software version 2.1 for routine, high analytical throughput analysis of gas and liquid chromatography data. The software now supports Thermo Scientific non-mass spectrometry detectors, and this detector-agnostic package is designed for the quantitative and qualitative review of data for routine analyses.

Major applications include clinical research, forensic toxicology, food safety and environmental analysis. TraceFinderTM software version 2.1 is designed to eliminate the need for multiple software packages when moving between most gas and liquid chromatographic techniques. This can provide more flexibility in the labora-

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tory and reduce the need to learn new software packages.

TraceFinder software is designed to make routine GC, GC-MS, HPLC, and LC-MS quantitation and targeted analysis simple, fast and productive. The software offers a simple workflow-driven method setup and automated data acquisition, data processing and reporting capabilities. Methods developed with TraceFinder software can be shared between instruments and between laboratories. This sharing ability allows users to make methods readily available on new instruments.

When using triple quadrupole GC-MS and LCMS systems, the Compound Data Store (CDS) provides an extensive list of selected reaction monitoring (SRM) exper-

iments in environmental testing, food safety residue analysis, clinical research and forensic toxicology applications. Data review is customisable and assigns multiple flags to aid with quick identification of problem areas within a data set. To protect the integrity of analytical data, the software also includes a rights-based secure user login system.

Contact details: Stuart Matlow Public Relations Manager Chromatography and Mass Spectrometry Thermo Fisher Scientific, Inc. 355 River Oaks Parkway San Jose, CA 95134 (408) 965-6408 office (415) 407-5474 mobile email: stu.matlow@thermofisher.com www.expresspharmaonline.com

Sanofi launches re-usable insulin pen anofi India has launched AllStar, its first indigenously manufactured reusable insulin pen.

Developed especially for Indian patients by Sanofi’s Medical Device Development team at Frankfurt AllStar is indicat-

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ed for use of insulinised patients using Sanofi’s insulin portfolio. The AllStar re-usable insulin pen conforms to ISO (International Organisation for Standardisation) standards and is equipped with stateof-the-art, unparalleled 10in-1 features. AllStar will help improve both insulin initiation and compliance; and bring ease and reassur-

ance to the lives of Indian patients, giving them the convenience of international standards at an affordable price.

Contact details: Nikita Merchant Assistant Manager Marketing Communications Tel: +91 9819071300 Email: nikita.merchant@ sanofi.com November 1-15, 2012

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Express Pharma Business Avenues “ The 1st Indian Silicone Rubber Product Mfg. co, certified with Clean Room of class 10000” SILICONE RUBBER PRODUCT G Silicone Transparent Tubing's (USP / FDA Grade) G Silicone Transparent Braided Hose (USP / FDA Grade) G FBD Inflatable Gaskets in Silicone Transparent G Rubber and also in Food Grade Neoprene Rubber

Silicone Transparent Tubing & Braided Hose Conforms to USP Class VI Requirement & FDA 21 CFR 177.2600 (AVAILABLE IN PLATINUM & PEROXIDE CURED)

Silicone & Viton Rubber O Rings

G Platinum Cured Silicone Transparent Tubes G Platinum Cured Silicone Transparent Braided Hose G Platinum Cured Silicone T/c Gaskets G Silicone Extruded Door Gaskets (Autoclavable)

FBD Inflatable Gasket Conformd to FDA 21 CFR 177.2600

Silicone Extruded Door Gasket

G Silicone Stripss, Cords &sponge Gaskets ISO 14644-1 Certified Clean Room

G Rubber Expansion Joint/Bellows G Viton O-Rings, Cords & Strips G O-Rings (Viton & Silicone) G Tri Clover Gasket G Silicone & Viton Sheets

Quality Management System

Environmental Management System Occupational Health Safety m Assessment System

Ami Polymer Pvt. Ltd. (The Sealing Expert in Silicone Rubber)An ISO : 2008 Certified Co.) 15 & 303, Mahesh Industrial Estate,Opp.Silver Park, Mira Bhayandar Rd.,Mira Road (E), Dist. Thane, Mumbai-401 104 Tel.: 91-22-28555107/ 28555631/ 28555914 Fax : 91-22-28555378 Email :amipolymer@vsnl.com Url : www. amipolymer.com BRANCHES

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HYDERABAD

BADDI (H.P)

BANGALURU

ROORKEE

MAHARASHTRA

GOA

INDORE

09246502943/42 hybd@amipolymer.com

09218595103 / 09218595011 Baddi@amipolymer.com

09916072800/ 08691013931 bngl@amipolymer.com

09219691095/ 09219521095 roorkee@amipolymer.com

09223290933/ 09223290933 amipolymer@vsnl.com

09223290935 goa@amipolymer.com

07869267791/ 09816595011

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November 1-15, 2012

Express Pharma Business Avenues www.airtechsys.in

An ISO 9001: 2008 Certified Company

The art of air management

the leading air management solution provider...

Airtech is a customized air solutions provider. Since its inception in 1992, Airtech has cultivated an in-depth understanding and expertise of executing turnkey HVAC & Clean Room Projects.

Airtech undertakes complete project management comprising of design, supply, installation & commissioning and validation of HVAC and Clean Room Systems.

Airtech's Clean Room system provides an ultra-clean environment ranging from Class 100 to Class 100000 with effective control of Air flow, Pressure, temperature, Relative humidity and Filteration suitable for Clean room applications.

Modular Clean Room PUF / EPS WALL / CEILING Partitions -Thickness Range: 50-200 mm.

HVAC System

Clean Room

CLEAN ROOM EQUIPMENT AND ACCESSORIES

Reverse Laminar Air Flow (Dispensing & Sampling Booth)

Horizontal LAF Unit

Air Showers

Static Pass Box

Dynamic Pass Box

Garment Cubicle

EXPERTS IN HVAC & CLEAN ROOM SOLUTIONS Airtech offers Validation services which comply with DQ, IQ, OQ & PQ protocols conforming to following WHO cGMP US FDA UK MHRA AUS TGA International Standards ( Green Field Projects ): South Africa MCC

AIRTECH

CORPORATE OFFICE: (Mumbai) B-110, Hind Saurashtra Estate, Marol Naka, Andheri (East), Mumbai - 400 059.

Tel: +91 9322218023 /+91 9324644630 /+91 9699626434 /+91 22 28592275 E-mail: sales@airtechsys.in, sunil.airtech@gmail.com • Website: www.airtechsys.in

DEALERS November 1-15, 2012

ENQUIRY www.expresspharmaonline.com

VISIT OUR STALL AT P-MEC-2012 21-23 NOV. HALL No.6 STALL No. B-64

SOLICITED EXPRESS PHARMA

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KLEPTOSE速 HPB KLEPTOSE速 HPB and HP comprise a range of accessible hydroxypropyl cyclodextrins used increasingly as formulation aids to solve difficulties with aqueous solubility, stability or taste. KLEPTOSE速 HPB and HP are available as compliant cGMP grades that are particularly useful for parenteral solutions, syrups and oral suspensions, as well as for dry formulations.

We deliver!

ROQUETTE, through its production units (in Europe, in Asia and in the United States) and its international distribution network, will assure a constant quality of products and services throughout the whole world.

www.roquettepharma.com For your local contact : Roquette India Pvt Ltd Email : pharmabiz.india@roquette.com - Tel : +91 22 2570 6775 Our local Distributor : Signet Chemical Corp. Pvt Ltd - Email : sales@signetchem.com

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Express Pharma Business Avenues HPTLC CAMAG TLC / HPTLC – MS Interface

O O O O O O

Analyze TLC plates using Mass Spectrometry Extraction directly from the plate using a suitable solvent.

Online transfer into MS (any model).

Automatic cleaning.

Advantages of TLC as well as MS !

Samples can be collected for IR / NMR also For demonstration with your samples, please contact Mr. Akshay Charegaonkar

e-mail :akshay.charegaonkar@anchrom.in

Cell No. 9619482710

Enterprises (I) Pvt. Ltd. 101, Shree Aniket Apt. Navghar Road, Mulund (E) Mumbai – 400081.

Tel. 022 21639928 – 31 Fax : 022 21639927 Email : hptlc@anchrom.in Web : www.anchrom.in Exclusive Distributors since 1978 CAMAG (Switzerland) : TLC/ HPTLC Systems.

TECHNOLOGISTS, NOT TRADERS !

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Express Pharma Business Avenues

FLC – filling and closing machine For vials and infusion bottles

 Short delivery times due to

Versatile Solutions for medium

Filling Systems

output range

Depending on the product character-

The FCL is extremely flexible and

istics, five different filling systems are

reliable, meeting the highest techni-

available: rotary slide valve pumps,

cal standards with an excellent price/

a time-pressure filling system, rolling

benefit ratio. The continuous motion

diaphragm pumps, Bosch Peristaltic

machine provides a processing range

Pumps and a filling station with mass

with filling volumes of 0.5–500 ml.

flow metering. Furthermore, a

A “V-cleat” conveyor system offers

combination filling station is optional.

modular machine structure.  Flexible processing, ranging from 0.5 to 500 ml.  Integrated LF infeed turnable with large central opening.  “V-cleat” conveyor system with automatic container size changeover (optional feature).  Size components can be used for

advantages in ease of size changeover. An innovative control system

Fully automatic in-process weight

provides ease of use, high reliability

control (IPC)

 Carrying container transport.

and reproducible production settings.

The IPC system (optional feature)

 Gentle motion of the container

removes the containers in batches

transport through filling and

Transport system – flexibility via

from the conveyor system for tare

stoppering ensured by continuous

ease of size changeover

and gross weighing and then feeds

mode of operation.

The new linear conveyor system runs

them back into the system. If a

horizontally in continuous motion.

deviation in filling weight is detected,

(IPC) with automatic adjustment

The containers are guided by inter-

it is corrected by fully automated

of the individual filling heads

changeable size components

adjustment of the filling point.

(optional feature).

a range of container diameters.

 Fully automatic in-process control

 Batchwise removal of containers

attached to the carrier system.

Horizontal adjustment of the

FLC – the secure investment for

conveyor system allows containers

medium output range

with various diameters within a

Key features

Feed” delivery of stoppers to

specified range of sizes to be

 Easily accessible, compact

minimize the risk of particle

processed without changing the size components. All sizeparts can be exchanged without tools.

structure.

for tare and gross weighing.  Stoppering station with “Clean

contamination.

 Outstanding price/performance ratio.

 Integrated control panel (touchscreen).  FLC with closed RABS execution.

Bosch Limited Packaging Technology Division NEW DELHI: Mr. Priya Ranjan Kumar Singh Mobile: +91 987 1728832; priyaranjan.kumar.singh@in.bosch.com MUMBAI: Mr. Suhas Rai Mobile: +91 982 0421660; suhas.rai@in.bosch.com FLC filling and closing machine

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Express Pharma Business Avenues ONE STOP SOLUTION FOR PHARMACEUTICAL RESEARCH

Innovation is our culture…

Quality in our genes…

Identification and quantification of Organic process impurities by LC-MS/MS – GCMS/MS. Inorganic impurities by ICP-MS and A.A.S with Graphite furnace, IC Solvent impurities by GC-MS/MS and GC head space with MS.

Genotoxic impurity quantification Genotoxic Studies.

1. Sub chronic oral Toxicity 2. Bacterial Mutation Assay.

3. Micro Nucleus test 4. Bone marrow chromosome aberration test.

Qualification of Impurities.

Degradation products Method Validations as per ICH Guidelines Extractable and Leachable studies INVITRO safety STUDIES Polymorphic studies by XRPD. Protein impurities by capillary Electrophoresis.

TECHNOLOGIES FOR IMPURITY PROFILE STUDIES

ACCREDITATIONS

SERVICES Formulation Development Microbiological Studies Biological Studies Pre Clinical Studies Analytical Research Bio-equivalence Studies Clinical Trials Dossier Preparation Preclinical Pharmacopoeial Services

USFDA registered cGMP control testing laboratory DSIR approved R & D Centre Drugs Controller General of India (DCGI) NABL accreditation for Chemical, Biological Medical Testing, Bioanalytical & Mechanical Recognized by Bureau of Indian Standards Drugs Control Administration (A.P) Department of Biotechnology approved Institutional Bio-Safety Committee (IBSC)

Data Management practices in SIPRA LABS are designed to ensure total integrity, security and fastest retrieval.

SIPRA LABS LIMITED Industrial Estate, Sanathnagar, Hyderabad – 500 018.

Tel: 040-23802000, Fax: 040-23802005, Email:sipra@sipralabs.com web: www.sipralabs.com November 1-15, 2012

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Hikal wins award for ‘Best Responsible Care Committed Company 2011’ AWARDS ikal has won an award for the ‘Best Responsible Care Committed Company for 2011’ at the Annual Indian Chemical Council Awards function held recently in Mumbai. The award was presented to Hikal by the ICC in the presence of the International Council of Chemical Association (ICCA), Responsible Care Leadership Group.

Speaking on the occasion, Jai Hiremath, Chairman and Managing Director, Hikal said; “The ICC Aditya Birla Award is a testament of Hikal’s commitment to continuous improvement in performance when it comes to environment protection, health and safety and commitment to sustainability through the development of innovative technologies. Our goal is to continuously improve the environmental, health and safety knowledge of people and those of the surroundings, using

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(L-R) HC Karangale – ICC, Parthasarathy - President ICC, A Moza – EHS Head Hikal, Dr A Ganguly Member of Indian Parliament, Y Kothari VP ICC, Jai Hiremath – Chairman and MD Hikal, Daniel Roczniak – Senior Director IC resources wisely and minimising waste and to foster the responsible management of chemicals in our development and manufacturing processes along the value

chain. For us, being a Responsible Care company goes beyond the mandatory regulatory compliance and enables us to positively contribute to the sustainable

development of local communities and society as a whole.”

The Indian Chemical Council was established in 1938 to promote the Indian

chemical industry. Its vast membership includes both Indian companies with a global presence as well as subsidiaries of multinationals. ICC holds its annual awards to encourage achievements of excellence in various fields.

Nominations received for this award were scrutinised by a committee consisting of experts from the industry and academia.

Hikal, established in 1988 is a manufacturer of active ingredients, intermediates, regulatory starting materials and a provider of research support services to the Pharmaceutical, Crop Protection and Specialty Chemicals industry. Hikal provides its services from its five manufacturing facilities and two state-of-the-art R&D facilities located in India. Its manufacturing facilities are certified by the US FDA, TGA (Australia), and are ISO 9001, ISO 14001, OHSAS 18001 certified. Company facilities have been audited by global innovator, generic and biotech companies.

EP News Bureau

McGill University Montreal, Canada to conduct course on TB diagnostic research NEW COURSE

Around 40 participants with prior TB diagnostic research experience will be eligible for the course n intensive, high-level course on TB diagnostic research methods, will be conducted at McGill University Montreal, Canada, from July 8-12, 2013. A max-

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imum of 40 participants with prior TB diagnostic research experience or advanced training will be eligible to participate.

The advanced course will cover the principles behind diagnostic research, diagnostic study designs, sources of bias, and value chain for TB diagnostics development.

Also, conventional and advanced methods for systematic reviews (meta-analyses) of diagnostic tests will be presented, along with the

GRADE approach to diagnostic policies.

The course will introduce multi-variable approaches to diagnostic research, and cover alternative designs which evaluate patient outcomes, including the diagnostic RCT, and implementation research. The course will also cover latent class analysis, mathematical modelling, costing and cost-effectiveness studies. Panel discussions will cover topics such as market analyses, market dynamwww.expresspharmaonline.com

ics, regulatory issues, target product profiles, and industry engagement in TB diagnostics development.

Participants will be able to get an idea about the the value chain for TB diagnostics development, current pipeline of diagnostics, market dynamics, WHO policies on new diagnostics, and challenges for scale-up; Principles of multi-variable approaches to diagnostic research, and adjustment for imperfect reference stan-

dards; Principles of metaanalyses of diagnostic accuracy studies and GRADE approach to diagnostic policies; Principles of alternative designs to evaluate impact of new tests on clinical decision-making, therapeutic choices, and patient-important outcomes; Principles of implementation research, collecting evidence for scaleup, cost-effectiveness analyses and modeling studies in TB diagnostics.

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Cipla Palliative Care Centre celebrates World Palliative Care Day INITIATIVE

Organises a walk in Pune where more than 500 people participate une-based Cipla Palliative Care and Training Centre concluded its World Palliative Care Day celebrations by organising a walk in Pune. More than 500 people consisting of doctors and nurses, members of different clubs & NGO’s, volunteers, patients and their families and students from schools, and college institutions practicing in the field of Palliative Care, took part in it.

Observing the theme of World Palliative Care Day – 'Living Life to the End, Palliative Care for the Ageing Population; the Cipla

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Palliative Care Centre felicitated several non-profit organisations like Aasra Foundation, Samavedana, Centre for Special Education,

Bhagini Nivedita Pratishthan and Aapla Ghar for their tremendous contribution in building a better society and improving the quality of life

for several underprivileged children and elderly people.

Dr Priyadarshini Kulkarni, Medical Director, Cipla Palliative Care and Training

Centre said, “It is heartening to see the increasing response to our walk every year. This year the theme of World Palliative Care Day is caring for the elderly. Cipla Centre conducts regular workshops for caregivers to help them take better care of patients at home. Recently, we organised a workshop for people who are caring for those affected

by Alzheimer’s disease.”

Speaking at the conclusion of the walk at Shaniwarwada, SV Iyer, Managing Trustee of Cipla Foundation informed that Cipla Centre was celebrating its 15th year and had cared for more than 8000 patients. “I am very happy to see the number of school children who are with us today and the society will benefit immensely, if we succeed in creating awareness about palliative care at an young age.”

EP News Bureau

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Express Pharma,

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The Indian Express Limited,

74

EXPRESS PHARMA

www.expresspharmaonline.com

November 1-15, 2012

REGD.WITH RNI NO.MAHENG/2005/21398 REGD.NO.MH/MR/SOUTH-77/2010-12, PUBLISHED ON 5TH & 20TH EVERY FORTNIGHLY & POSTED 6-7-8 & 21-22-23 OF EVERY FORTNIGHLY. AT IND.EXP.PSO. From the makers of:

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Ready to use Expert System For Extended Release Instamodel has been developed to fulfill requirements of quick ER formulations launch.

The processes is simple involving blending, granulation (dry or wet) and conventional tablet manufacturing.

Complete compliance to pharmacopeial dissolution requirements.

Appearance and in vitro drug release profile comparable to the brand leader and innovator products.

Presently available for – Diclofenac ER tablets 100 mg, Metformin HCl ER Tablets 500 & 1000 mg, Metorprolol succinate ER Tablets 25, 50, 100 and 200 mg, Acetaminophen ER Tablets 650 mg, Carbamazepine 200 mg, Trimetazidine Hydrochloride 35 mg, Aceclofenac 200 mg, many more in the pipeline.

Complete technical support available for manufacturing of initial batch.

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A 223-229, Virwani Industrial Estate, Western Express Highway, Goregaon (East), Mumbai - 400 063 , India Tel: +91-22-42688700 Fax: +91-22-42688713 E-mail: info@idealcures.co.in Website: www.idealcures.co.in