Express Pharma April 1-15, 2013

VOL .8 NO.11 PAGES 68

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Research Thinking beyond BCG Management EU Falsified Medicines Directive: Industry proposes, regulator disposes?

Pharma Life A decent appraisal 1-15 APRIL, 2013, `40

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V O L 8 . N O . 1 1 A PR I L 1 - 1 5 , 2 0 1 3

CONTENTS

Chairman of the Board Viveck Goenka

MANAGEMENT

Editor Viveka Roychowdhury*

Strategies for generic asthma inhalers: Copy

BUREAUS

or create?

Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das

PAGE 31

Digital Dose – Exploring real time in Indian pharma

Bangalore Neelam M Kachhap

PAGE 33

RESEARCH

Delhi Shalini Gupta

Thinking beyond BCG

MARKETING

PAGE 37

Pentavalent vaccine: Doing more harm than

Deputy General Manager Harit Mohanty

good?

Senior Manager Rajesh Bhatkal

PAGE 39

PHARMA ALLY

PRODUCTION

Treatment of water PAGE 41

General Manager B R Tipnis

BIS recognises SCHOTT’s expertise in

Production Manager Bhadresh Valia

pharmaceutical glass manufacturing

Asst. Manager - Scheduling & Coordination Arvind Mane

PHARMA LIFE

Asst. Art Director Surajit Patro

A decent appraisal PAGE 62

Chief Designer Pravin Temble

MSF Access Campaign names

PAGE 42

Rohit Malpani as new Director of

Senior Graphic Designer Rushikesh Konka

Policy and Analysis

PAGE 65

Photo Editor Sandeep Patil Layout Rakesh Sharma

lopment

C I R C U L AT I O N Circulation Team Mohan Varadkar

R

Express Pharma Reg. No.MH/MR/SOUTH-77/2013-15 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.

April1-15, 2013

cartons pharma flexibles plastic films corrugation packaging development testing services

MARKET Free trade or trade off?

enquiry@ansapack.com

PAGE 15

‘Regulatory process should have separate pathways for biologics and biosimilars’

PAGE 18

Indian pharma growth outpaces rivals: Cambridge Consultants Heal Wellness ties up with US-based Metagenics

PAGE 20

PAGE 21

Venus Remedies’ Meropenem receives market authorisation in Mexico

PAGE 22

IPM grows at 7.4 per cent in February 2013 PAGE 23 ABLE celebrates its 10th anniversary PAGE 26 8th Nutra India Summit concludes on a healthy note PAGE 27

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EDITOR’S NOTE

‘Copiers’ but saviours nonetheless …

In early March, BDR Pharmaceuticals International, a Mumbai-based company dealing in generic APIs and formulations, became the second company after Hyderabad’s Natco Pharma, to apply for a compulsory license (CL) for Bristol-Myers Squibb's Sprycel (dasatinib), a blood cancer drug. This was the second bold move on BDR Pharma’s part, the first being its announcement that it would soon launch its generic version of Pfizer’s Sutent (sunitinib), a renal cancer drug.

Given that BDR Pharma is just under a decade old, it would be fair to say that the Davids of the pharma world are getting set to push the envelope as far as intellectual property (IP) rights of pharmaceuticals are concerned. BDR Pharma seems to have taken its cue from the decision of the IPAB to uphold Natco’s CL on Bayer's kidney cancer drug Nexavar (sorafenib).

On cue, MNC pharma hit back with Pfizer’s Chief IP counsel Roy Waldron criticising India’s ‘protectionist’ IP regime in a March 13 US congressional hearing. Calling pharma companies like Natco Pharma and BDR Pharma "copiers” who want to obtain a “free ride or use the technology at a much-reduced cost", he accused India of abusing the CL system.

Indeed, MNC pharma is leaning on governments to put pressure on their counterparts in developing countries via trade agreements. A case in point is the generalised system of preferences (GSP) between the US and India which is up for renewal in July.

Médecins Sans Frontières (MSF) has also called attention to aggressive IP measures proposed by the US in the Trans-Pacific Partnership (TPP) Agreement negotiations with developing countries.

One proposed TPP provision, according to the

MSF release, would require governments to grant new 20-year patents for modifications of existing medicines, such as a new forms, uses or methods, even without improvement of therapeutic efficacy for patients. Another provision would make it more expensive and cumbersome to challenge undeserved or invalid patents; and yet another would add additional years to a patent term to compensate for administrative processes.

As our market cover story analyses, such trade agreements could arm-twist governments of developing countries and could be the death knell for generics ('Free trade or trade off?', see page 15 in this issue).

Besides IP, patient safety is ironically the reason being cited for proposed regulations like the EU Falsified Medicines Directive. Our Management cover story, “Industry proposes, regulator disposes?” (see page 28) highlights the plight of API exporters who say that this Directive calls for repeat inspections for export consignments to the EU. Hence they are urging the Indian regulator to stand its ground and ask that the GMP certifications issued by India be considered equal to those of the EU. Given the hue and cry, one has to consider the possibility that such excessive regulations, under the guise of patient safety, are actually meant to stem the flow of affordable APIs from countries like India.

The IPAB’s backing of Natco Pharma’s CL has shown the way forward. Let us hope that other sections of the Indian regulatory mechanism also display the same steely resolve. For today, it is the ‘copiers’ who are the clear winners and saviours.

Dear Ma’m,

Dear Ma’m,

eferring to the latest Express Pharma issue (March 1-15, 2013: International Women’s Day special), it’s a proud feeling to read interviews of women in pharma or any woman-issues related articles. All the best wishes to continue to do such work in future.

Regards, Neeta Sawant, Manager – Quality Control, Blue Cross Laboratories

ust saw the Express Pharma March 1631, 2013 World TB Day special issue online – looks wonderful!! Congrats!

Great job with the entire issue Regards,

Viveka Roychowdhury viveka.r@expressindia.com

Corrigendum

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12 EXPRESS PHARMA

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Dr Madhukar Pai, MD, PhD Associate Professor Dept of Epidemiology & Biostatistics McGill University, Canada

www.expresspharmaonline.com

The article titled 'Quality in APIs' in February 16-28, 2013 Express Pharma issue by Dr BV Sivakumar had the designation missing. The designation of Dr BV Sivakumar is Chief Scientific Officer, Enaltec Labs. The error is regretted.

April 1-15, 2013

MARKET

W H AT ’ S INSIDE

THE BUSINESS OF PHARMACEUTICALS

‘Regulatory process should have separate pathways for biologics and biosimilars’ PG 18 Indian pharma growth outpaces rivals: Cambridge Consultants PG 20 Venus Remedies’ Meropenem receives market authorisation in Mexico PG 22 IPM grows at 7.4 per cent in February 2013 PG 23 ABLE celebrates its 10th anniversary PG 26 8th Nutra India Summit concludes on a healthy note PG 27

MANAGEMENT 28 RESEARCH 37 PHARMA ALLY 41 PHARMA LIFE 62 April 1-15, 2013

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As chief negotiators from India and EU meet in Brussels to fast track the Bilateral Trade and Investment Agreement (BTIA) that started in June 2007, the atmosphere is rife with speculations on what would this mean for India’s pharmaceutical sector. The agreement might have far reaching implications given the intellectual right provisions that it supposedly aims to ratify. The talks have been shrouded in secrecy ever since they began with vague responses from both sides.

Civil rights and public health activists are closely watching the events unfold amidst reports that EU aims to go aggressive on IPR, in the light of the fact that its first ever Free Trade Agreement (FTA) with an Asian country, South Korea, signed last year, had several TRIPS plus provisions. Over the past year, the Supreme Court in India has hardened its stance on protecting public interest when it comes to health by issuing the country’s first ever compulsory license in March 2012, not to mention revoking patents when necessary.

While these moves have come under sharp criticism from pharma MNCs, analysts believe that India is well within its powers to protect the right to public health, even as much hue and cry is being raised. It remains to be seen if the country will be able to take a strong stand even as pressure mounts on it to comply with standards other than its own.

A TRIPS plus deal FTA between two countries or amongst a group of countries aim to provide both parties economic benefits through the removal or reduction of barriers to trade. With the Doha round of negotiations still going on, bilateral

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and regional FTAs have become the norm to take trade liberalisation forward.

All WTO Members are obliged to provide patent protection to pharma companies under the WTO Agreement on Trade-related Aspects of Intellectual Property Rights, known as the TRIPS Agreement, signed in 1994.

However, TRIPS offers flexibility to determine the grounds for issuing compulsory licenses and ordering government use of the licensed products; allowing various forms of parallel imports and apply general exceptions, such as early working to facilitate generic entry of pharma and agrochemical products upon expiry of a patented product or experimental use exceptions.

FTAs often include intellectual property protection stronger than that required by World Trade Organization (WTO), known as ‘TRIPSplus’ protection.

This includes measures such as broadening patentability, restricting patent opposition, extending patent duration, introducing test data exclusivity and last but not the least other IP enforcements as well.

Explaining the implications of a TRIPS plus deal for India Rai S Mittal, Partner Titus and Co, Advocates, based in Delhi, says, “Several health safeguards included by the Indian Parliament in patent law would be at risk of being overturned or undermined if the demands of the EU are accepted. These include demand for a longer patent term extending the monopoly period enjoyed by the patent holder thus delaying the entry of generic medicines. Data exclusivity would require generic manufacturers to conduct their own clinical trials to get marketing approval or wait till a specified exclusivity period is over (five to 11 years) before a generic product is approved.

This measure would create exclusivity over medicines separate from patents and applies even to medicines www.expresspharmaonline.com

RAI S MITTAL

LEENA MENGHANEY

Titus & Co, Advocates

Manager for MSF’s Access Campaign in India

“Several health safeguards included by the Indian Parliament in patent law would be at risk of being overturned or undermined if the demands of the EU are accepted.

Patent holders might also be empowered to get court orders to stop generic medicines from reaching the market before even having proven that their patents are being infringed”

“After the rejection of the ACTA by the European parliament, there is a renewed effort to stamp out generic manufacturers through intimidation, and FTA seems to be a move in that direction. The EU's proposed enforcement measures include, but are not limited to, a stricter injunction system, third party liability regime and strong border measures”

that are off-patent or where a compulsory license has been issued. Patent holders might also be empowered to get court orders to stop generic medicines from reaching the market before even having proven that their patents are being infringed.”

All these are areas of concern that could adversely impact India's generic production capacity and, consequently, the ability of patients in India and across the developing world to access safe, effective and affordable generic medicines from India.

While the EU has dropped its demand for patent term extension and data exclusivity, the pressure on India to harmonise its drug regulatory standards may ultimately squeeze generic companies out of production, since it is quite obvious that such standards are designed to be met by well-resourced companies.

This might signal a setback to the country’s thriving generic industry.

body of evidence that such TRIPS-plus provisions may adversely impact medicine prices and consequently, access to treatment. A study estimated that such provisions in the US-Colombia Trade Promotion Agreement would increase expenditure on medicines in Columbia by $ 919 million by 2020 or, alternatively, reduce medicine consumption drastically by as much as 40 per cent. India and Brazil are testament to the fact that a flexible IP law can facilitate a thriving generic pharma industry. Not only this, competition from Indian pharma is responsible for a dramatic reduction in the prices of WHO pre-qualified first-line antiretroviral medicines from over $ 10,000 per person per year to as little as $ 116 for in less than a decade. The price reductions further fuelled scaling up of the international response to HIV with more than 6.6 million on treatment by the end of 2010 from a meagre 300,000 in 2002.

Apprehensions on removing barriers to trade, which would in turn create barriers to access to medicine, are growing.

Death knell for generics?

As per a brief by the UNAIDS on the impact of FTAs on public health issued last year, there is growing

April 1-15, 2013

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Medicines Sans Frontiers (MSF) which has been closely monitoring the negotiations since their inception, in a letter to the Prime Minister of India dated March 14 has raised serious concerns on IP enforcement provisions which could further hamper production and dissemination of generic medicines. A mere claim of infringement by pharma MNCs could then lead to seizure or halting production of the competitors generic drug. The effects are far reaching beyond, the ambit of countries who sign the FTA and could even implicate third parties such as suppliers of APIs, retailers and stockists of generic drugs including treatment providers like MSF itself.

Pitches in Leena Menghaney, Manager for MSF’s Access Campaign in India, “After the rejection of the ACTA by the European parliament, there is a renewed effort to stamp out generic manufacturers through intimidation, and FTA seems to be a move in that direction. The EU's pro-

April 1-15, 2013

posed enforcement measures include, but are not limited to, a stricter injunction system, third party liability regime and strong border measures.”

WTO TRIPS agreement has already reduced the freedom of operation for Indian generic manufacturers in the area of news medicines for HIV, cancer etc, she adds.

states. Under this, “foreign corporations would have the power to sue companies if national laws, domestic policies or courts decisions or anything else threatens the enjoyment of their investment” even if the former measures are in public interest or in accordance with the law. In the light of India having taken a firm stand to pro-

APPREHENSIONS ON REMOVING BARRIERS TO TRADE,WHICH WOULD IN TURN CREATE BARRIERS TO ACCESS TO MEDICINE, ARE GROWING MSF has to switch more and more people in Mumbai to new HIV drugs like raltegravir; but high prices ($1,775 per person) for just one patented drug in the cocktail of three that people need are a major deterrent.

The inclusion of investor state dispute mechanism in the broader definition of investment, could be the most detrimental, the letter

www.expresspharmaonline.com

tect public health by issuing compulsory licenses, free medicines, revamping its pricing policy and other such measures, it is strongly felt that it would be in our larger interests not to cave in to such demands. India is keen to wrap up negotiations by April this year and would need to keep this in mind.

Amidst all the speculation, Mittal is positive that India

might not sign such a deal.

“India is already facing a great challenge to strike the right balance between rewarding innovators and promoting public access from the standpoint of public health objectives, industrial development, food security and education.

Promotion of public access will remain the crucial consideration in time to come.

Commitments within such trade deals might also risk sanctions for non-compliance, which are usually not available under WIPO treaties, due to which India may not sign such as IPR regime till the time there is complete unanimity on the issue.” Menghaney offers a caveat informing that even after the deal, a sub committee on IP that would include representatives from both India and EU might continue to push for exclusivity, but not in public domain.

However, given the closed door nature of the deals, we’ll have to wait and watch. shalini.g@expressindia.com

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‘Regulatory process should have separate pathways for biologics and biosimilars’ Member companies from Biotechnology Industry Organization (BIO) have indicated their reluctance to partner with Indian companies this year, opines Lila Feisee, Vice President, International Affairs, Biotechnology Industry Organization (BIO). In a chat with Shalini Gupta, she explains how India needs to create an environment to attract investment and foster innovation What is the theme for the BIO conference to be held in April this year?

The theme this year is partner, connect, innovate. We are having a BRIC day wherein on the first day, there would be two parallel tracks with a focus on China and Russia in the morning and India and Brazil in the evening. Our theme for India this year is “Can India be a leader in biotech innovation?” That is the big question and we have half a day dedicated to exploring that. Biotech innovation means cutting edge research and development, coming up with novel products, not generics. So we would discuss if Indian companies can actually be innovators, i.e come up with the first product that someone else can copy. We think that the potential for India to do that exists, because there are institutions, scientists, researchers and the entrepreneurial spirit. The tendency to innovate is there, what is keeping India back, is the policies the Indian government has put into place. This is holding not only western companies but Indian industry back as well. The latter are finding the gaps and trying to fill them in, by doing contract research, but that is not helping them meet their full potential.

Collaboration is a key to fostering innovation. How do you think India has fared in this respect?

On the collaboration front, India has made a lot of effort in trying to develop a strategy for biotech under the leadership of Dr MK Bhan, Past Secretary, Department of Biotechnology (DBT). This included proposals to look at how to translate some of the research that is being done, to find collaborators and then to develop products, essentially the technology transfer part of it. The larger issue is how is

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INTERVIEW

that actually managed, is it too bureaucratic, are there too many hurdles. If there are too many requirements, that hinders such collaborations and one cannot go to the next level. There is a need to foster collaborations between foreign universities and Indian universities, Indian companies partnering with each of them or both or even western companies doing that. So the opportunity exists, but the question is how is that facilitated. The concept for building funding institutions is there, but translating the research into products is the missing link and needs to be pondered upon.

Many MNCs have come in the line of fire in the recent past owing to India’s IP laws.

Has that made investors wary of the Indian market?

Biotech is a very IP intensive industry. It requires a lot of investment of money, time, human capital and intellectual capital to make biotech products. For a country that wants to build an innovative sector, building IP is important. Not only IP, but strong IP, and not only strong IP but predictable IP. As is evident, one can't make quick money in biotech, it takes a decade or two decades to get returns on the investment trickling in. This needs to be conveyed to the investors, even as they keep pooling in money. Of course, knowing that once you have the patent, you can enforce it, helps. But with compulsory licenses and patents being revoked, there’s no protection, leading to uncertainty. Its hard enough to invest in biotech in the best possible situation, because one needs to watch and wait and see if your www.expresspharmaonline.com

investment bears fruit. Even Indian investors face the same constraints with less capital to boot.

the one thing that they can add is data protection, that is not part of the regulatory system as of now.

What are your views on the regulatory environment in India?

A significant regulatory process that is transparent, science based and indicates clearly what is needed to comply helps. However, the data that is submitted needs to be protected, data exclusivity should be there. Regulatory process should have two pathways: one for the innovatorbiologic to come into the market, which requires a full data package with clinical trials and preclinical and PKPD in a robust manner. However, it shouldn’t be so onerous that you can’t get something approved, at the same time one should have enough information to get the product to the patient safely. A second pathway for biosimilarsbecause once the biologic is on the market and they are past the time taken to recoup their investment, then there should be an abbreviated pathway for biosimilars, not the same as the biologics, but at the same time not compromising on patient safety. So with those two pathways, you can bring the cost of medicines down, have a thriving biotech sector with both innovators and biosimilars coexisting side by side.

What are some of the challenges to get biosimilars to the market?

The European Medicine agency (EMA) and Food and Drug Administration (FDA) have separate requirements, so there is no uniformity across both which might be a barrier for Indian companies planning to sell their products in these markets. They would need two sets of data packages to meet both requirements.

From an innovators perspective, we’d also want convergence there. In the US, biosimilar law has gone into effect and we have three sets of guidance. In the US, if you can prove interchangeability, the law allows for it. The question is how do you prove that the biosimilar is interchangeable with the actual product. We think that there should be a rigorous assessment of that because the clinical outcome has to be the same for both.

India and US are in the same boat since both have just come out with their biosimilar guidelines, companies are yet to see how those guidelines are yet to be implemented.

How do you look at the Indian biosimilar guidelines?

The biosimilar guidelines are relatively in line with WHO and EMA, have a combination of both, But how does (a company) demonstrate safety and efficacy and how much data does one need to put in, that is where the debate and discussion lies.

The data doesn’t need to be loaded so much that it is similar to the innovator, but at the same time it can’t be so relaxed, so striking the right balance on data in the interest of patient safety is crucial for biosimilars. Both the US and India seem to be in agreement to the fact that it is essential to get biosimilars that are safe to the patient. There need to be clinical trials, but how much that is the moot point. From our perspective, India is moving in the right direction, but

How would you compare the funding for R&D in the US and India?

We recently got new data saying that investment has gone down in biotech, but its slowly coming up in the US. The problem for a lot of our companies is that their research is in earlier stages, but it is not in that zone where it has attracted the big investors. We call this the valley of death, which is dry with funding, its all about crossing to the other side. What has happened in the US is that there are several different mechanisms- angel investors who focus on specific or niche areas, patient organisations such as Alzheimers foundations, and then the larger companies are also creating other funding sources. As BIO, is that we do a lot of partnering, with countries such as China, who wants to do a lot in R&D including countries in the Middle East who want to fund R&D in the US. shalini.g@expressindia.com April 1-15, 2013

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COMPANY WATCH Indian pharma growth outpaces rivals: Cambridge Consultants Workshop reveals innovation and technology as key differentiators anking among the top five globally by production volume, the Indian pharmaceutical market today accounts for over 10 per cent of global drug production. It continues to be one of India’s biggest employers – with more than 340,000 Indian employees dedicated to an industry that is worth in excess of $22 billion. But senior delegates at the Cambridge Consultants Mumbai pharma workshop said Indian pharma companies must embrace innovation and adopt technology if they are to stay competitive at both a domestic and global level. In an industry that is extremely competitive – with more than 20,000 pharma companies – delegates agreed these were the two main driving forces defining the future landscape of the Indian pharmaceutical industry.

The Cambridge Consultants workshop, attended by a cross–section of senior personnel from a variety of functions within leading Indian and multinational companies, explored the question of whether India would become one of the world’s leading pharma countries by 2030. Recent reports suggest India’s domestic pharma sector will grow to $55 billion by 2020. As a significant exporter of high-quality generic drugs, India is expected to see the value of its drug exports double to $25 billion by the end of 2014, according to the country’s Minister of Health.

Delegate feedback revealed that the Indian pharma industry still has significant growth opportunities, and major local companies could have the potential to compete with multinational pharma companies. Amongst them, the greatest impact in world markets will come from those Indian pharma companies which adopt technology innovations to differentiate

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their products and make them more competitive both domestically and globally.

This trend for differentiation is particularly important as Indian pharma companies have fewer new generic opportunities. This is because the number of New Chemical Entity (NCE) filings to the US Food and Drug Administration has declined over recent years and the number of innovator drug patents reaching their expiry date has peaked. Similarly, at a global level there are more generic pharma developers from other emerging nations, including China, which will offer low-cost competition for India, as well as the ongoing global threat of counterfeit drugs.

Dr Cyrus Karkaria, President of the Biotech Division, Lupin Pharma, said, “The Indian pharma market is really at a very exciting yet challenging point, where it can become an even greater contributor to the Indian economy. Indian pharma companies must remain competitive and look to innovate and adopt technologies that can complement and accelerate the uptake of drugs for better health management.”

Andrew Barrett, Director of medical technology in India, Cambridge Consultants, said, “In order to drive faster growth, and capitalise on their existing success, Indian pharma companies must now aim to create true added-value offerings with ‘super-generics’, which can deliver additional benefit to patients. Innovation and technology are key, and the required investments can be recouped because medical products have long lifecycles.

Technology has a great role in drug delivery to extend these lifecycles, add value and, importantly, allow product differentiation in a crowded market space.

Technology can play a pivotal role in the Indian pharma industry as success will be driven by combining drugs with devices and delivwww.expresspharmaonline.com

ery systems – rather than by drugs alone. In addition, Indian pharma companies could benefit from the following technologies: Injectable technology: A growing number of Indian companies are moving into biologics (including biosimilars and biobetters) where injectable therapies necessarily predominate due to the greater difficulty of formulating these drugs for oral administration.

Injection technologies, such as autoinjectors and patch pumps, can provide easier and less painful drug administration.

Inhalation products: Inhaled products are already common place in the Indian market through major local and multinational products, targeting respiratory disease markets such as asthma and chronic obstructive pulmonary disease. Indian companies with this pre-existing specialist knowledge are well placed to develop valueadded products using the pulmonary route to deliver systemic drugs.

Medical devices: Indian pharma companies are unlikely to build significant expertise purely in this area.

Instead, they could use experienced device design and development consultants to support their significant formulation/chemistry expertise. Indian companies have the opportunity to change manufacturing and production methods to support the further adoption of drug delivery device technologies.

Connected health: Against the background of rising healthcare costs, Indian pharma companies can use technology to harvest and beneficially use data to bring benefits to healthcare providers and consumers alike. Given India’s dominance in IT and software in places like Bangalore, it isn’t beyond belief that a connection could be made between one industry and the other, placing India in a strong position to become a global player in connected health markets.

EP News Bureau – Mumbai

Claris Lifesciences receives ANDA approvals Ondensetron injection will help in the treatment of nausea and vomiting laris Lifesciences has received two Abbreviated New Drug Application (ANDA) approvals for Ondensetron injection in the US. Ondensetron injection is indicated for prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high-dose cisplatin, and for prevention of postoperative nausea and/or vomiting.

The company plans to launch Ondensetron in two variants of 2 mg/mI in 2 ml single dosage vials and 20 ml multi dosage vials.

The total addressable market size of the product is estimated at $49 million in the US. Claris had recently received the long awaited US-FDA approval for its manufacturing facility.

The company now has nine ANDAs approved in its name across four molecules. The company has a total filing of 30 ANDAs across 20 products.

EP News Bureau – Mumbai

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Heal Wellness ties up with US-based Metagenics To launch nutrigenomic products in India erala-based healthcare company Heal Wellness will launch the nutrigenomics-based functional medicines of USbased Metagenics in the country, delivering truly nutrigenomic medical foods and nutraceuticals that offer a higher degree of safety, effectiveness, and reliability in natural approaches.

Metagenics will be launched during the 8th Nutra India Summit, which will be held in Mumbai from March 13-16, 2013.

The three-pronged strategy of Heal Wellness is to establish a network of functional medicine centres /clin-

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ics offering chronic disease care through functional medicine, facilitate a network of functional medicine practitioners in India through imparting functional medicine education, and finally,

establishing a distribution network of hypoallergenic professional nutritional supplements.

Mohammed Saheer Siraj, Chairman, Heal Wellness Solutions (I) said, “We welcome Metagenics to our global line up of nutritional sup-

plement partners including Thorne Research, Pure Encapsulations, Metabolic Maintenance, and Wellness Pharmacy. The nutraceuticals of these trusted international brands will be made available in India through our Nutrimart pharmacy chain.

We have also established tieups with Metametrix/ Genova Diagnostics Labs for functional medicine testing in India. Heal Wellness aims to operate 25 functional medicine clinics in India by the year 2014.”

EP News Bureau – Mumbai

Lupin receives US FDA approval Will help in treatment of otitis media, acute exacerbation of chronic bronchitis upin has received approval for SUPRAX (Cefixime) for oral suspension, 500 mg/5mL from the United States Food and Drugs Administration.

Lupin expects to commence shipping the product in the near future.

The approval will expand Lupin’s range of SUPRAX dosage forms available to treat approved indications in appropriate patients. SUPRAX is currently available as 100 mg/5ml and 200 mg/5ml suspensions; 400 mg tablets as well as chewable tablets 100 & 200 mg. This new drug application provides for a new strength, 500mg/5mL, of SUPRAX (cefixime) for oral suspension for the treatment of otitis media, acute exacerbation of chronic bronchitis, uncomplicated urinary tract infections, uncomplicated gonorrhea (cervical/urethral) and pharyngitis/ tonsillitis.

Vinita Gupta, Group President, Lupin and CEO, Lupin Pharmaceutical said, “The new dosage form will add to our growing SUPRAX franchise and will give healthcare providers and patients a new formulation to treat the indicated infections.”

EP News Bureau – Mumbai

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Venus Remedies’ Meropenem receives market authorisation in Mexico Plans to launch its first product in the market within the first quarter of fiscal year 2014 enus Remedies has received grant of market authorisation from COFEPRIS the Drug Regulatory Authority of Mexico, for its Meropenem 500 mg and Meropenem 1000 mg in Mexico. This grant from COFEPRIS (La Comisión Federal para la Protección contra Riesgos Sanitarios) the Latin America’s most stringent regulatory authority, is further endorsement to Venus Remedies’ R&D capabilities and its expertise in developing world class products.

The company has also accord exclusive marketing rights for its novel antibiotic product – Potentox to South Africa’s pharmaceutical giant Adcock in a deal.

Market authorisation for Meropenem will enable Venus Remedies to launch its first product in Mexico and will strengthen its position in Latin America where Venus is currently exporting to various countries of LAC such as Columbia, Peru, Guatemala, Dominican Republic, Jamaica, Bahamas and the Caribbean.

Commenting on this

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achievement, Dheeraj Aggarwal, Chief Financial Officer, Venus Remedies said, “Grant of market authorisation at this point of time when the innovator’s product has already gone off patent is going to be an advantage for us. We are hopeful of capturing 10 per cent of the market share within the first three years of our product launch.”

At present, Meropenem sales account for $16.3 million in Mexico, of which, major share of 80 per cent is with innovator’s product ‘Merrem’ and rest with other local companies.

Venus Remedies with its dedicated penems EU GMP certified manufacturing facility in Baddi, India, is all set to expand its footprints across

the globe. It already has 73 marketing authorisations for Meropenem across the world while product registrations from 13 countries are under process and are expected within this year only.

The company is planning to launch the product in Mexico within the first quarter of fiscal year 2013-2014.

EP News Bureau – Mumbai

Glenmark confirms patent challenge for its generic version of FINACEA Filed an ANDA for Azelaic Acid, Gel 15 per cent Topical, with US FDA lenmark Generics has filed an Abbreviated New Drug Application (ANDA) for Azelaic Acid, Gel 15 per cent Topical, with the US Food and Drug Administration (FDA) with a Paragraph IV Certification for the Orange-Book listed patent. Glenmark’s ANDA product is a generic version of FINACEA, which is indicated for the topical treatment of inflammatory papules and pustules of mild to moderate rosacea.

Intendis, Intraserv, Bayer Healthcare Pharmaceuticals filed suit against Glenmark Generics and Glenmark Generics on March 14, 2013, in the US District Court for the District of Delaware, seeking to prevent Glenmark from commercialising its ANDA

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product prior to the expiration of US Patent No. 6,534,070.

This lawsuit was filed under the provisions of the Hatch-Waxman Act, which triggers a stay of final FDA approval of Glenmark’s ANDA product for up to 30 months or until final resolution of the matter before the Court, whichever occurs sooner.

Based on available information, Glenmark believes it may be a 'first applicant' to file an ANDA for the generic version of FINACEA and may be entitled to 180 days of generic market exclusivity. According to the IMS health data for the 12 months ending September 30, 2012, FINACEA had total US sales of approximately $95 million.

EP News Bureau – Mumbai

PRE EVENT SPDS to conduct Disso India 2013 Event to be held in Mumbai on May 3-4, 2013

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ociety for Pharmaceutical Dissolution Science (SPDS) will be conducting its 1st Annual International Convention Disso India 2013 on May 3 and 4, 2013 in Mumbai. The event will promote introduction of new technology, innovation and would have deliberations on various issues faced related to dissolution. Disso India 2013 event shall witness eminent professionals from the pharma industry.

The event will be organised under the Chairmanship of Dr Vinay G Nayak, President-Technical of Alembic Pharmaceuticals and

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the Organising Secretary, Dr L Ramaswamy, Managing Director, Sotax India. The scientific sessions are programmed and executed under the chairmanship of Dr Mangal Nagarsenker, HOD and Professor of Pharmaceutics, Bombay College of Pharmacy, Mumbai.

The event will have plenary lecture, poster session, panel discussion and exhibits.

Dr Diane J Burgess, Professor of Pharmaceutics, University of Connecticut, US; Dr Umesh Banakar, President, Banakar Consulting Services, US; Dr Vinod Shah, Ex US FDA, www.expresspharmaonline.com

Pharmaceutical Consultant, US; Vijay Kshirsagar, Executive Vice PresidentCorporate QA & Regulatory Affairs, Unichem Lab, Mumbai; Dr Jean Michelle Cardot, Professor and Head of the Department of Biopharmaceutics and Pharmaceutical Technology from the Universite d’Auvergne, France; Samir Haddouchi, Managing Director, SPS Pharma Services, France; Vatsala Nageshwaran, Associate Director, Scientific Operations, Absorption Systems, US; Kailas Thakker, Co-Founder and President, Tergus

Pharma; Arvind K Bansal, Professor and Head, Dept. of Pharmaceutics, National Institute of Pharmaceutical Education and Research (NIPER), Punjab; Dr Vinay Nayak, President-Technical Operations, Alembic Pharmaceuticals, Vadodara will take part in the event.

Disso India has been specifically designed for all the professionals from R&D, QA and QC as well as the Academia. Around 250-300 delegates are expected to participate in this event, which would be first mega event focussing on dissolution.

EP News Bureau - Mumbai April 1-15, 2013

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GROWTH TRACKER IPM grows at 7.4 per cent in February 2013 MAT value crosses ` 70000 crore With Bonus Units at Full Value Val in Crs CORPORATE

Rank MAT

MAT Feb -13 MTH

IPM

Feb-13

Val (Cr)

MS%

GR%

Val (Cr)

MS%

GR%

70287

100.00

13.0

5569

100.00

7.4

Abbott + Abbott HC + Novo

1

1

4736

6.74

8.6

376

6.75

1.6

Cipla

2

2

3531

5.02

8.7

303

5.43

6.3

Sun Pharma

3

3

3436

4.89

20.9

282

5.06

15.0

Glaxo

4

5

3258

4.64

14.3

239

4.30

0.5

Zydus + Biochem

5

4

3066

4.36

19.4

266

4.78

24.3

Ranbaxy

6

6

2942

4.19

9.3

224

4.02

6.0

Mankind

7

7

2549

3.63

24.9

201

3.60

13.8

Alkem + Cachet + Indchemie

8

8

2378

3.38

13.1

184

3.31

7.8

Pfizer + Wyeth

9

10

2231

3.17

14.6

168

3.02

1.4

Lupin

10

9

2137

3.04

13.9

175

3.14

11.3

Macleods

11

12

1806

2.57

23.7

140

2.52

11.4

Intas

12

11

1712

2.44

18.7

152

2.72

22.8

Aristo

13

15

1625

2.31

11.7

115

2.07

2.3

Emcure + Zuventus

14

13

1619

2.30

14.5

133

2.39

12.5

Sanofi-Aventis + Universal

15

14

1566

2.23

11.6

122

2.18

0.4

Glenmark

16

16

1383

1.97

21.4

113

2.03

10.3

Dr. Reddys

17

17

1369

1.95

8.6

108

1.94

1.2

Micro + Bal

18

19

1315

1.87

12.4

104

1.86

4.1

Ipca

19

22

1249

1.78

16.9

93

1.67

13.8

USV

20

18

1235

1.76

23.0

105

1.88

20.7

Val in Crs Super Group

MAT Feb 13

GR%

Mth Feb 13

GR%

IPM

70287

13.0

5569

7.4

ANTI-INFECTIVES

12492

11.0

945

5.1

CARDIAC

8636

15.9

707

8.2

GASTRO INTESTINAL

8036

14.5

613

7.5

VITAMINS / MINERALS / NUTRIENTS

6203

14.2

467

5.3

RESPIRATORY

5344

9.1

476

7.0

PAIN / ANALGESICS

5217

10.0

400

5.9

GYNAECOLOGICAL

4608

10.0

387

10.8

ANTI DIABETIC

4562

18.1

372

9.5

NEURO / CNS

4274

12.6

351

8.0

DERMA

3705

13.8

289

5.4

OPHTHAL / OTOLOGICALS

1257

13.9

98

10.7

HORMONES

1205

18.1

96

12.9

OTHERS

971

18.5

87

29.0

BLOOD RELATED

873

12.9

66

9.6

VACCINES

863

8.5

71

-4.6

ANTI-NEOPLASTICS

682

13.0

54

16.8

ANTI MALARIALS

648

17.2

30

4.1

SEX STIMULANTS / REJUVENATORS

397

19.1

34

11.3

STOMATOLOGICALS

314

13.4

25

5.0

April 1-15, 2013

www.expresspharmaonline.com

he Indian Pharma Market (IPM) is valued at ` 5569 crores in February 2013. It has grown at 7.4 per cent in the same month. MAT value has crossed ` 70000 crores.

For the month of February 2013, amongst the top 10, Zydus has seen a growth at 24.3 per cent, Sun Pharma at 15 per cent, Mankind has seen a growth of 13.8 per cent and Lupin at 11.3 per cent. 21 corporates have crossed the growth of IPM for the month of February 2013.

Without bonus Sun Pharma is ranked at second for the month and MAT for February 2013 amongst corporates.

Amongst the top 50 corporates, Merck has the highest growth of 43.7 per cent followed by Franco Indian at 30.5 per cent.

Amongst the 11-20 ranked companies, Intas has shown high growth at 22.8 per cent followed by USV at 20.7 per cent and Ipca at 13.8 per cent.

Fourrts has moved up one rank over last time to be the 49th biggest corporate in February 2013.

Amongst upcoming corporates Corona Remedies has grown at 103 per cent and have crossed ` 150 crores, Akumentis at 37.4 per cent and Gland Pharma at 24.2 per cent.

From a therapy perspective, 11 therapies have outgrown the IPM growth. The anti-infective market has a growth of 5.1 per cent whereas respiratory market has seen a growth of seven per cent. The antidiabetic market has grown at 9.5 per cent and cardiac at 8.2 per cent in chronic business. Amongst the top 10 therapies, the gynaecological market shows highest growth at 10.8 per cent.

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About PharmaTrac PharmaTrac is a the secondary sales data audit conducted by AIOCD Pharmasofttech AWACS, a pharmaceutical market research company formed by All Indian Origin Chemists & Distributors (AIOCD ) in a joint venture with Trikaal Mediinfotech.

AWACS in AIOCD AWACS stands for Advanced Working, Action & Correction System – reflecting the underlying philosophy behind AIOCD AWACS' research tools to reduce time to information by 50 per cent or more and to significantly improve on accuracy of information. Accurate and faster information flows from the market will help clients grow topline and bottomline.

Terminologies used MAT – Moving Annual TotalMTH – MonthVal (Cr) – Value in CroresMS per cent – Market Share in PercentageGR per cent – Growth in percentage For more information, visit http://www.aiocd.net

EXPRESS PHARMA

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EVENT BRIEF DIA India's 6th Regulatory Conference Date: April 5-6, 2013 Venue: Ahmedabad, Gujarat Summary: India’s initiatives to encourage the enforcement of regulations will be discussed by prominent industry experts at DIA India’s 6th Regulatory Conference. The two-day event will bring together local and multinational pharmaceutical companies, clinical research professionals, academicians, regulators, and key stakeholders in health authorities to share the knowledge they’ve gained from decades of experience and note-worthy contributions to the development of the Indian pharma industry.

The conference will feature Rajiv Gulati, President Global Pharmaceuticals Business, Ranbaxy Laboratories, speaking on the theme ‘India, the Upcoming Economy: Encouraging Enforcement of Regulations.’ Dr GN Singh from the Drug Controller General of India (DCGI) will also participate.

Contact details: Laura Hollis Tel: +1-215-442-6154 Email: Laura.Hollis@diahome.org

iPHEX 2013 Date: April 24-26, 2013 Venue: Bombay Exhibition Centre Summary: Pharmaceuticals Export Promotion Council of India (Pharmexcil), has announced the launch of iPHEX 2013, India’s own pharmaceutical show under the support of Ministry of Commerce and Industry, Department of Commerce, and Government of India.

Over 400 leading Indian companies are expected to showcase the best of pharma products at the event.

The organisers claim that iPHEX 2013 will see the presence of 5,000 business visitors including overseas buyers and drug regulators.

Huge business opportunities are expected to emerge dur-

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ing the event. Further, the presence of large number of drug regulators from overseas market is expected to help Pharmexcil and its members to promote the quality and affordability aspect as envisaged in ‘Brand India’ pharma campaign. The campaign has been initiated by Ministry of Commerce and executed by Pharmexcil in association with IBEF. Contact details: Sanika Patil ProjectManager – IPHEX 2013 Tel: 91.11.23324288 M: 91.9582758812 E-mail: sanika@falconmail.com

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.

best practice strategies to implement project management from the leaders of the industry who have successfully handled complex projects themselves.

This distinctive conference has received a lot of interest and has already confirmed industry leaders to present including Sanjit Singh Lamba, Managing Director India, President, Global Brands Business Unit Eisai Knowledge Centre; Swaminathan Srinivasan, Director Project Management, Dr Reddy’s Laboratories (UK); Sanjay Bhanushali, Director International Operations, Cipla; Mohan Pandey, Director R&D operations, Bristol-Myers Squibb; Dr Varada Bapat, Head-Project Management, Wockhardt and many more.

The event will feature indepth discussions on streamlining end-to-end product life cycle management, minimising project risk management, overcoming application challenges in R&D, clinical research, engineering, SCM and manufacturing. It will also help in understanding application of theory of constraints specific to complex pharma projects, best strategies for critical path identification and innovative strategies for effective time management.

Contact details: Paresh Jhurmurwala GPE EXPO Global, Opp. Priyadarshini Tower, Near Judges’ Bungalows, Bodakdev, Ahmedabad 380015, Gujarat Tel: +91 79-2687 1390 +91 79-4000 8253 +91 79-4000 8233 Email: contact@pharmapropack.com

Contact details: Tel: (022) 61727001 Email: conferencesindia@ubm.com (Promo Code: EXP-DISC10) Website: http://www.pharmaprojectmanagement.com?utm_campaign=MEDIAPARTNER &utm_medium=EVENTLISTING&utm_source=EXPRESS PHARMA

Pharma Project Management conference

Drug Delivery & Complex Generics Conference

Date: May 8-10, 2013

Date: May 28-30, 2013

Venue: Mumbai

Venue: Mumbai

Summary: CPhI in association with PMI India will hold Pharma Project Management conference, customised specifically for pharmaceutical industry’s high end project needs around cost, quality and time. This strategic conference aims on discussing

Summary: With the patent cliff reaching its peak, complex generics and innovations in drug delivery present huge opportunities for the pharmaceutical industry to gain the first mover advantage.

Visitors will be able to delve deeper into innovative formu-

www.expresspharmaonline.com

lation and manufacturing techniques and latest drug delivery systems orals, injectibles, nasal, transdermal and opthalmics by attending the conference. Latest case studies on controlled release formulations, HME and spray drying techniques, depot injections, nanoparticle technology will be discussed. A workshop will be held on how to ensure smooth scale-up of complex generics that will address all critical scale-up issues - from concept to commercialisation.

Contact details: Tel: (022) 61727001 Email: Conferencesindia@ubm.com Website url: http://www.drugdelivery-complexgenerics.com?utm_campaign=MEDIAPARTNER&ut m_medium=EVENTLISTING&utm_source=EXPRESS PHARMA

Pharma Quality by Design Date: June 12-14, 2013 Venue: Mumbai Summary: The 2nd Annual Pharm QbD Forum will have case study sessions on various dosage forms (pulsatile drugs, solid oral dosage, lyophilised products), on API synthesis and scale up, on various analytical sciences and development. Workshop on DOE covering all the basic statistical approach all supported with different case studies will be held. Speakers who have been implementing and working on the QbD principles for their respective organisations like Dr Reddys Laboratory, Emcure, Lupin, Jubilant Life science, Teva Pharmaceuticals, Bristol-Myers Squibb, Orchid Pharmaceuticals will attend the event.

Contact details: Tel: (022) 61727001 Email: Conferencesindia@ubm.com Website url: http://pharmaqbd.com/?utm_campaign=ME DIAPARTNER&utm_medium=EVENTLISTING&utm_so urce=EXPRESSPHARMA

April 1-15, 2013

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POST EVENT ABLE celebrates its 10th anniversary Charts biotech industry’s road map for the next decade by addressing the challenges and concerns.

Shalini Gupta reports ndian biotech industry has made its mark on the world map exhibiting a phenomenal growth from $500 million to $8 billion from 2003 to 2012. With a view to further its development and chart the roadmap ahead, the Association for Biotechnology Led Enterprises (ABLE), to commemmorate its 10th anniversary, organised BIOINVEST – a series of panel discussions between members of the industry and the government to discuss the key issues and challenges plaguing the sector recently and brainstorming their way to solutions forward. The event was held in Delhi over March 11 and 12, 2013.

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Building on India’s strength Pointing out the need for creating an innovative and enabling environment for all stakeholders and a pressing need for policy implementation, Kiran Mazumdar Shaw, Chairman and Managing Director, Biocon said, “Biotechnology is going to have a huge impact on nutritional security, healthcare environment, sustainability and energy. As we try to build this bioeconomy, we need to address regulatory challenges.

If we can deliver in an effective way we can bring products quickly to the market.”

She cited challenges in terms of investment and funding that need to be overcome, with the biotechnology sector presenting a long gestation period for the investor, the upside being a long-term return, which is exponential.

Conveying this to the investors, along with building the right talent pool is important, she added. She also mulled on creating a manufacturing sector in biotechnology given that it has been neglected for long, emphasising that India has to focus on its natural advantages to create focused strategic investments that make it stand apart.

“We can build a global scale in generics, BioIT is a huge opportunity for India.

Are we prepared to invest in

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genomics? While agriculture creates 50 per cent of jobs, it contributes only 15 per cent to the GDP. Services on the other hand contribute 65 per cent to the GDP but only create 30 per cent jobs. Fermentation-based manufacturing can be done.

Can we do this in biologics?

Can we look at going beyond generic vaccines to DNA vaccines?” said Shaw.

Dr Vijay Raghavan, Secretary DBT took the discussion a notch further by pointing that India needs to establish itself from being a vendor of biotechnology to being a leader of quality biotechnology given that the centres of innovation lie elsewhere and the country also faces the challenge of grappling with a host of diseases. This coupled with a nascent biotech industry, not so huge resources, competition in a global market, along with regulatory issues, makes the challenges formidable but they can be overcome. He called for combined efforts across all departments be it health or agriculture also underlining the collaborations that DBT is charting with nascent start ups.

Investment in chemistrybiology interface, drug interface and screening is the way to go. Raghavan said, “We need to create a high level sequencing centre, analyse data, work in big data in genomics, learning from the mistakes and success of the Genomics Institute. In the next two years this could help us www.expresspharmaonline.com

hit the IT and genomics space.

Growth can be exponential in these areas, but will only provide us with temporary respite unless we can come up with other innovative ideas,” he said. He also outlined the role of training scientists and engineers, as well as the management to negotiate the pipeline.

Learnings from countries such as Singapore, South China and Korea who have also been facing the same issues need to be applied.

He added that DBT is investing in a platform technology centre between industry and academia. Industry utilise the current global economic situation to their advantage by enlisting talented people form start ups to join their innovation team.

Talking about the recent news on clinical trials and revised guidelines, he said that the civil society harbours a fear of technology, which is okay if it is there in the early days, but needs to be addressed nonetheless, as evidence mounts, they lessen, he added. “People tend to confuse the probability of having a disaster and the impact of a disaster,” he pointed.

Regulation is the key K Desiraju, Special Secretary, Ministry of Health and Family welfare opined that constant dialogue between science, industry and healthcare needs to continue since each player has a crucial role to play. Regulation has

been a talking point in the past year and he enumerated two very big reasons why the government sees the need for an efficient regulatory system.

“Affordability is important from our point of view. We need to define universal healthcare. It involves ready and easy availability of drugs and medicines. In the 12th chapter of the 12th Plan, affordability, access and quality have been cited as the three basic principles on which we need to have healthcare globally. Affordability is crucial, administration is equally important,” he said.

He lamented the fact that regulatory institutions such as DCGI are under-resourced, and not well equipped to handle the huge body of work allotted to them, however for now, those are the resources one has to operate in, given the realities of the recent budget.

“Regulatory mechanisms in healthcare have always been flawed, it’s a vicious circle. “With everyone quick to blame the government for everything that goes wrong, one cannot also leave everything to individual good sense, the probability of misuse in such a case is 100 per cent,” he added. Nor can a system work if the entire responsibility lies with the regulator. He stressed on introspection to come up with the right answers. Citing that courts have to intervene in matters of dispute which would not arise April 1-15, 2013

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in the first place if everyone takes up their individual responsibility seriously, he said.

“The Supreme Court is now holding the Health Ministry responsible for every clinical trial. The buck should not stop here. Government tends to over regulate because everything tends to go wrong otherwise. Let us not dispute the role of regulation,” Desiraju said. With new guidelines for clinical trials laid down recently the Ministry of Health and Family Welfare is also looking at reforms within Central Drugs Standard Control Organization, he informed.

Shaw brought out industry concerns by highlighting that a cumbersome regulatory process coupled with a trust deficit between the government and those being regulated needs to be worked upon.

With regulation being a big enabler, the longer a regulatory pathway, the more expensive a product entering the market, she added.

“Is it possible to put the data on clinical trials conducted by companies publicly where the information on the sites where they are being conducted along with other relevant data is made available. Also, can we can encourage expenses as an adjunct by

getting industry to pay for it, with a pool of experts who can use user fees to raise the standards?” she questioned.

Raghavan made a good point by suggesting that not just getting experts but amping up the resources would help, otherwise only those with deep pockets will have access to regulatory pipelines.”

Finally, Raghavan gave a clear direction to the industry by charting its future road map. “What is needed is to harness out collective strength in chemistry and engineering and bring it into biologics.

Drug discovery appears to be a formidable challenge but it can be tackled, “ he concluded.

Desiraju stressed on the availability of drugs and diagnostics at all public health centres so that people should not die for want of a drug that is well known but not available. Long-term efforts include the integration of non-physician clinicians including nurse practitioners, Ayush staff and public health professionals into the workforce, he added further. The day-long summit saw more than 250 participants from industry with a keynote address by Steven Burrill, Chief Executive Officer, Burrill and company US and Narayan Vaghul, Chairman ICICI Bank. shalini.g@expressindia.com

8th Nutra India Summit concludes on a healthy note Attended by over 500 delegates

April 1-15, 2013

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he 8 Nutra India Summit recently culminated where the who’s who of global Nutraceutical, Functional Foods and Dietary Supplement industry participated.

The summit held in Mumbai was inaugurated by Satej Dnyandeo Patil, State for Home, Rural and Food & Drug Administration (FDA), Maharashtra. He was also the Chief Patron of the 8th Nutra India Summit.

The summit was organised by the Council of Scientific & Industrial Research (CSIR), The International Society for Nutraceuticals, Naturals and Nutritionals (ISNNaN) and MM Activ Sci-Tech Communications.

The theme of the summit is 'Health & Wellness through Nutraceuticals, Nutritionals and Naturals.' The event had sessions addressed by 65 speakers and attended by 500 plus delegates. The event observed participation from 20 countries including China, Japan, Singapore, Brazil, Canada, the US, New Zealand, Germany, Switzerland, France, Poland, Netherlands from 300 plus organisations.

Dignitaries who were present for the inauguration include Samir K. Brahmachari, Secretary, Department of Scientific & Industrial Research (DSIR), Government of India; Director General of the Council of Scientific & Industrial Research (CSIR); ISN Prasad, Principal Secretary to Government, Department of Information Technology, Biotechnology and Science & Technology, Government of Karnataka; K Chandramouli, Chairperson,

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Food Safety & Standards Authority of India (FSSAI); Dr Krishan Lal, President, Indian National Science Academy; Dr Pingfan Rao,| President, International Union of Food Science & Technology (IUFoST); Vice President, Chinese Institute of Food Science and Technology, China, Professor & Director, Institute of Biotechnology, Fuzhou University, Fujian, China; John Ruff, President, Institute of Food Technologists (IFT), US; Dr V Prakash, Chairman, Nutra India Summit; Distinguished Scientist of CSIR - India; Council Member, IUNS , IUFoST & GHI and Fellow IFT and Jagdish Patankar, Organising Secretary, Nutra www.expresspharmaonline.com

India Summit; Managing Director, MM Activ Sci-Tech Communications.

Expression of Interest was signed between Brazilian Society of Food Science & Technology, International Society for Nutraceuticals, Nutritionals and Naturals (ISNNaN) & Nutra India Summit.

Nutra Excellence Awards recognised contribution of immense personalities and organisations. Amway, awarded for its 'Outstanding contribution to industry growth in the sector of Nutraceuticals & Nutritionals and Dietary Supplements'; Sami Labs, for 'Its role in promoting the sectors of Herbal Products, Nutraceuticals & Dietary

Supplements, to connect with the Global Marketplace'; British Biologicals, for 'Its role in its Outstanding Contribution for Industry Growth in the sector of Nutritionals'. Internationally also Institute of Food Technologists, USA was awarded for its 'Outstanding contribution in Promoting Industry, Professionals and Student interface in the area of Food Science & Technology in the areas of Nutraceuticals & Nutritionals' and Dr Pingfan Rao, for his 'Outstanding contribution in promoting the sectors of Understanding of Science of Nutraceuticals and connect Research with the Global Marketplace.'

EP News Bureau-Mumbai EXPRESS PHARMA

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W H AT ’ S INSIDE

MANAGEMENT INSIGHT FOR MANAGING PHARMA

Strategies for generic asthma inhalers: copy or create? PG 31 Digital Dose – Exploring real time in Indian pharma PG 33 International technology transfer, FDI and development PG 35

RESEARCH 37 PHARMA ALLY 41 PHARMA LIFE 62 28

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April 1-15, 2013

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Entire re-process leads to delay in export consignment

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N R MUNJAL Vice Chairman cum Managing Director, Ind Swift Laboratories

he European Union has recently notified Switzerland as a country which is equivalent in the implementation of GMP requirements to that of EU GMP. The requests of other countries like Brazil, Israel, Australia and Singapore are under examination by EU for equivalence assessment. Our industry is also of the view that, inspecting/Indian GMP being followed/enforced for APIs under the provisions of Schedule M of Drugs & Cosmetics Act is also equivalent to EU CGMP. We strongly feel that hassles of issuing written confirmations (certificates) to each company exporting the APIs can be avoided, if DCGI takes up the matter with European Union

towards accepting Indian GMP as equivalent to EU CGMP. Then there will be no need to be inspected again.

For all practical purpose, WHO GMP inspection takes approximately six months from the application to receipt of certificate. And cost is negligible and not the criteria. The entire re-process leads to delay in export consignment, if the time bound procedure is not implemented, it will for sure result in delays of export consignments.

To issue certificate to all licensed API exporters for their use with each exported consignment.

In case India cannot get listed on the EU’s list of countries, DCGI may give a certificate to all the licensed

The DCGI can delegate the certification process to local FDA

ADITI KARE PANANDIKAR Managing Director, Indoco Remedies

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he approval of COPP is being granted, with a validity of two years, based on facility inspection by WHO authorities. Also, the manufacturer shall be committed and abide by the Schedule M regulations for GMP compliance. So repeat inspection is not necessary. The inspection can be considered, if any new API is intended for export to Europe, which is not covered in the list of granted COPPs. Also for firms not having COPP, inspections may apply. The DCGI shall rely on their own grant of COPP and shall consider other regulatory approvals like US FDA, TGA etc. The DCGI can also utilise April 1-15, 2013

this as a tool for improvising the confidence of European countries on Indian manufacturers. The written certification shall be a one time grant having a reasonable validity of two years. This certification shall be product wise and need not be applied to every batch or consignment.

The current COPP approval or renewal process takes approximately six months, including inspections.

It is subjected to nature of observations and relevant compliance. As the EU Directive 2011/62/EU is a new initiative, the DCGI has not arrived at any specific time lines. However, the DCGI has to speed up the process as the effective date of EU directive is approaching fast. As the inspections are not felt necessary to initiate this process, specific timelines may not be applicable. The cost involvement may be only the respective fees, if any assigned by the DCGI. If the DCGI decides to inspect the facility prior to giving the written certificate, then it will definitely cause delay.

Considering the number of API manufacturers and exporters across India, DCGI

may find it practically difficult for inspections within the set timeline.

The DCGI can delegate the certification process to local FDA. One more reason for this delegation is every DCGI inspection is a joint inspection of DCGI and local FDA. The local FDA has periodic and more frequent checks on the companies. This can minimise the load on DCGI. The local FDA is more approachable for companies in suburban industrial areas.

This will also be beneficial to the companies whenever a new API is identified for European export. Hence, the certification process will move fast and boost the export business of the companies.

There should be a particular time frame for approval.

Timely approval facilitates the export of APIs in a timely manner and leads towards customer satisfaction. Also this will benefit the companies to continue the business in Europe and minimise the competition from other countries.

Obviously the approval process shall be completed before 02/07/2013, as the EU directive has given enough lead time. www.expresspharmaonline.com

units in India confirming that our units confirm to the following: i) The standards of Good Manufacturing Practice (GMP) applicable to the plant manufacturing the exported active substance are at least equivalent to those laid down by the Union pursuant to the third paragraph of Article 47; ii) The manufacturing plant concerned is subject to regular, strict and transparent controls and to the effective enforcement of good manufacturing practice, including repeated and unannounced inspections, so as to ensure a protection of public health at least equivalent to that in the Union; and iii) In the event of findings relating to non-compli-

ance, information on such findings is supplied by the exporting third country to the union without any delay.

A certificate of the above nature can be used by the manufacturing units in India exporting APIs to the European Union by enclosing a copy of such certificate with each of the consignment, which could be acceptable to the EU Authorities.

There should be a time bound inspection certification programme initiated after a consultative committee comprising of DCGI representative, pharmaceutical associations representatives and Ministry of Commerce representative to take the decision regarding the time frame and procedure to be followed.

There is not enough time and manpower

DAARA B PATEL Secretary, Indian Drug Manufacturers Association (IDMA)

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ny facility that has any of the international approvals such as WHO GMP or US FDA, EDQM, UK MHRA, etc. need not be inspected again as these units are being inspected regularly. Whatever time it takes to inspect one unit, there is not enough time and manpower to implement procedures of inspection of all API units in India who exports to EU countries, not to mention the huge documentation that would be required.

If the CDSCO goes by the letter of the rule and not the spirit behind it, it will delay almost all consign-

ments, as the inspections will need to be completed now, since the companies take up manufacturing activities for fulfilling orders two to three months in advance.

We have requested the DCG(I) to consider an automatic route for units holding WHO-GMP or any of the universally recognised international regulatory approvals as mentioned earlier.

The DCG(I) could, for example, certify that the unit meets with the requirements of EU standards, based on the most recent inspection by any of these regulatory authority as above.

If DCG(I) decides to follow the automatic route, then the whole process is eased to a large extent as certification should not take too much time. Almost all the manufacturers without exception exporting to EU would have WHO-GMP and any of the other international approvals. Our government has to ensure that exports of APIs to EU do not suffer and continue without delay.

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It is a waste of time for regulators as well as for manufacturers

B R SIKRI Co Chairman FOPE, Vice Chairman, CIPI, Vice President, BDMA, Secretary, IDMA Board of Himachal and Uttarakhand

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nce a manufacturer wants to start export projects, his first and foremost duty is to have GMP compliance as per WHO guidelines. Prior to this compliance, the company or manufacturer has to have Schedule M compliance. By the above two methods his unit is validated and qualified by auditors of Government i.e.

Central Drugs Standard Control Organization (CDSCO) and State licensing authorities. The products being manufactured, whether for domestic need or for export, have to be a quality product as per rules and regulations under Drugs and Cosmetic Act. Once the above exercise is done by the Government regulators, why should they accept the recommendations of EU draft guidelines? It is not only a duplication of the work done earlier, rather it is a waste of

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time for regulators and manufacturers. This will lead to delay of the consignment and people will get discouraged to export to various countries.

Today, India is a proud country since we are the largest exporters of pharma products as we are third in volume, 10 per cent of global share and 14th largest by value. The day is not far off when India will be the second largest bulk drug manufacturer world wide by overtaking Italy. But if these hindrances are created by the Government or by outside agencies, it will certainly have a negative impact on the growing pharma industry.

India is losing its competitive advantage, becoming dependent on China. Almost every Indian DMF is filed considering the Chinese intermediate supplier as alternate source. If duplication of work starts taking place by inspecting the Indian units, China will become more aggressive and will try to take undue advantage of the situation.

China is already working on macro strategy with the result that slowly and gradually intemediate industry is moving out of India. Satran, prazols, microlytes are classic examples of intermediate sourcing.

Taking Schedule M compliance clearance, taking WHO GMP certificate itself is a big exercise because it is quite an expensive exercise and by adding another audit or inspection by DCGI, this

will add fuel to the fire.

While granting the WHO GMP certificate, the requirement of EU guidelines can be strictly adhered too instead of duplication. Instead of wasting time, Government should come forward to build infrastructure in the areas of innovation, sophisticated testing labs. There is a need for promoting incubation centres to realise the ideas with first generation entrepreneurs.

We appreciate that nowadays a specific time frame is being followed by CDSCO in inspecting the units for WHO GMP certification and delays are being avoided, but adding this duplication of inspection will be a futile exercise on the part of the Government, particularly when they have limited manpower and in many other areas due to which there is a delay in clearing industry applications. The impact of such duplication will be more painful to SMEs as the small players continue to run out of steam in the battle for survival while big players are growing from strength to strength.

Therefore, it is high time the Government avoids such an exercise because it is the same CDSCO who wants to inspect our facility, emphasising on quality parameters and will provide approval for a particular batch or consignment and the same officer/auditors/inspectors, would have audited the plant at the time of GMP certification.

www.expresspharmaonline.com

Directive will promote more of EU industries

BHAVIN MEHTA Director, Kilitch Drugs

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feel if the facility has WHO approval then it need not be visited since regulations specified by WHO are similar to the EU regulation but DCGI is the competent authority and it shall decide what is best

has taken very proactive steps in order to ensure this does not happen and Dr PV Appaji, Director General, Pharmexcil has requested DCGI, and DCGI has also assured to look into the matter and it is conveyed that there are no delays in clearance of export consignments. Since, Ministry of Health (MOH) has officially deputed DCGI and EU directive also specifies for competent authority, we need to follow the guideline.

In order to promote API sourcing within EU, this directive will promote more of EU industries than outsourcing to be done from world over and hence Pharmexcil is keen to ensure India implements the same and exports are not affected.

Pharmexcil along with

THE INSPECTION SHALL TAKE ONE TO FIVE DAYS DEPENDING ON THE SIZE OF THE PLANT AND NUMBER OF THE MOLECULES ARE INVOLVED FOR THE EXPORT CONSIGNMENTS in the interest of the EU directive.

The inspection shall take one to five days depending on the size of the plant and number of the molecules are involved for the export consignments.

I believe that Pharmexcil

DCGI is working on the same, since export orders are based on letter of credit (LC) vendors will have to ensure that this is done before their expiry. Usually vendors get LC's in the range of 30-90 days and it needs to be taken care of within this period.

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INSIGHT Strategies for generic asthma inhalers: Copy or create?

Pharma companies around the world are looking for ways to address the global pulmonary drug delivery market and capitalise on long established therapies which are now off-patent. David Harris, Head of Respiratory Drug Delivery, Team Consulting gives an insight

CC research claims that the global pulmonary drug delivery market will be worth a staggering $44 billion by 2016.1 With key drugs and delivery devices soon to come off-patent, the race is on to take a share of this highly profitable market - but should pharmaceutical companies copy successful products or create something new?

Unfortunately for the world’s population, inhaler use continues to grow.

Rapid industrialisation (especially in BRIC countries) together with better access to healthcare has led to a continuous rise in asthma diagnoses and resulted in a global market currently worth over $26 billion a year.

Pharma companies around the world, especially those in India, are looking for ways to address this market, and one route is to capitalise on long established therapies which are now off-patent.

This is certainly the case for the DPI (dry powder inhaler), a sector currently dominated by GSK’s Advair Diskus - often used by patients who find it difficult to use a pMDI device (pressurised metered dose inhaler).

Although more expensive – and therefore less frequently prescribed than the pMDI – Advair has become the therapy of choice for millions of patients around the world, generating a staggering $7 billion of revenue in 2009 for GSK. Key patents relating to Advair have started to expire,

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opening the market to a host of new competitors. Not surprisingly, many of these have been waiting for this moment for many years, with device replication a common response strategy. Given the investment GSK made in developing Advair, and the proven success of the product, replication seems the most obvious way to quickly enter a highly profitable market, but one which is also driven almost exclusively by price. If the copy is the same in every aspect except cost, then market share is virtually guaranteed.

But some competitors have chosen not to replicate but to innovate instead. By comparison, innovation – higher risk and higher cost – seems almost inappropriate, given that most users are happy with what they already have. But some companies are innovating, and innovating successfully, challenging the almost automatic assumption that replication is the best route forward.

Replication for fast market share Replicating off-patent therapies to create cheaper, ‘own’ or ‘no brand’ alternatives has a long and well-established history. In the Indian domestic market alone there are at least 12 variants of the original Miat capsule DPI, for example.

Although studies showi that a recognised brand can improve therapeutic effect, there is still a large market share to be had when patient choice is driven primarily by price, especially in sectors such as tablet-based analgesics.

The relative ease with which many generic drugs have entered specific markets has perhaps developed a false assumption that all generic equivalents are ‘simple’ to create, especially when formulations are well documented, and off-the-shelf packaging systems ready to buy. But recreating a www.expresspharmaonline.com

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device as complex as a DPI requires much greater and wider ranging expertise, and it is becoming clear that R&D teams can underestimate the challenge involved.

In particular, many companies fail to appreciate the importance of the delivery device, seeing it as just another form of ‘packaging’. The replication of a DPI, however, requires an understanding of the complex interactions between device and formulation, and of areas such as fluid dynamics and aerosol science, often beyond the scope of many inhouse R&D teams.

DPI design tolerances are critical, given the nature of its operation and its small size; poorly designed copies can exhibit undetected faults such as air leaks or poor powder aerosolisation characteristics, significantly affecting efficacy and success in the clinic. Price may be a driving factor, but the device still has to work just as well as the branded equivalent. In addition, the regulators now require evidence that devices are safe to use: this means that it cannot be assured that a device based on outmoded functionality will meet current regulatory requirements.

The important interaction between the DPI powder formulation and the delivery device is also frequently misunderstood. DPI formulations typically comprise active pharmaceutical ingredients (APIs) and lactose carrier particles in a mixture which has to remain homogenous when stored or transported, as any vibration can cause preferential segregation, compromising dose content uniformity throughout the life of the inhaler. For Advair, GSK developed a highly sophisticated packaging system which loads and seals single doses of the compound in a specially designed foil sealed blister pack. The packaging process is so precise that even though no headspace exists within each compartment, the compound is not compacted simply held securely. This prevents movement, and therefore minimises segregation, but also means that when the Diskus device removes the foil seal, the compound is moved only by the inhaled breath and at the minimum flow rate to ensure an efficient dose. If packed too tightly, the compound may form a solid lump, too loosely and the active compound may separate from the lactose carrier. In both cases, the dose would be

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delivered incorrectly and given that each dose is already only 25 – 30 per cent efficient, getting this right is crucial.

This attention to detail by GSK is one of the many reasons why Advair has been so successful – and why generic alternatives may fail to replicate the performance.

A final hurdle for a replicated product is to show that it is ‘substitutable’ - that the instructions given for the original device can be used with the new. In the case of Advair - with elements of the Diskus still protected by design rights - achieving this level of reproduction is, again, a serious challenge. Not impossible, but rarely achievable without some expert input across the R&D process.

Innovating for future growth When successful, copying is undoubtedly a much quicker route to market. Clinical trials are shorter, saving significant time and money, and market success is guaranteed if the product operates correctly and is priced aggressively.

However, any product chosen purely on price is always vulnerable to competition from alternatives developed in just the same way. Replication can certainly generate short-term profits, but is perhaps a less appealing longer-term strategy.

An alternative was demonstrated in 2010, when one of the leading Indian pharma companies, Sun Pharma, announced the imminent launch of a brand new DPI design, developed to work with a generic version of the Advair formulation.

Sun worked with external design houses to create a device www.expresspharmaonline.com

which may not be cheaper than a Diskus copy, but which offers much better value for money. Sun’s strategy was to offer an improvement over the market-leading Diskus inhaler, both in terms of clinical performance and features.

Overall, the device is sleeker, simpler and more intuitive to use – and it even glows in the dark.

Undoubtedly, Sun’s decision was not without risk. The process to develop a new DPI is expensive and must take place in a highly competitive space; around 400 patents have been filed in the last year related to DPI technologies, indicating the level of activity in this area. In addition, we would approximate, based on data that we have seen and anecdotal evidence, that currently, the accepted success rate for new inhaler devices reaching the market is only around 10 per cent, further underlining the challenges inherent in this sector.

But a crucial feature of the Sun device – and a compelling argument in favour of innovation - is that it is specifically designed to adapt to both current and future formulations which could be developed by Sun. This means that users familiar with the Sun device can stay with the same technology as drugs improve. This future-proofing also addresses a number of regulatory issues associated with DPI design.

For example, many current devices would not meet regulatory approval if they were designed today. By starting from scratch, Sun has created a device which meets and exceeds current standards and guidelines, is better for patients, and which should

also generate a bigger, and more sustainable return on the original investment required to innovate. However, it must also be said that the Sun device still leaves room for further, more radical innovation.

Deciding on a future strategy The response to off-patent DPI therapies is teaching the industry many useful – and possibly uncomfortable – lessons, and one of the most important is never to underestimate the complexity of an established design. Effective replication requires an understanding of all the many reasons why the therapy has proved so successful, and access to the full range of skills and technologies needed to create a viable product is essential.

Replication, however, is certainly one of the best strategies for short-term income generation. For many companies it will still make better economic sense to invest in getting a copy right, thereby securing their share of such a huge market, than to create a brand new device which carries with it a much higher level of risk.

But Sun Pharma’s experience shows that innovation is not as unrealistic as may first seem, and in fact offers many opportunities for better product design, enhanced performance, greater clinician and patient support, and – crucially - future potential.

References 1. Branthwaite A, Analgesic effects of branding in treatments of headaches, British Medical Journal, 16 May, 1981 April 1-15, 2013

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DIGITAL DOSE Digital Dose – Exploring real time in Indian pharma Dinesh Chindarkar, Co-founder, MediaMedic Communications kicks of series of articles titled ‘The Digital Dose for Indian Pharma’. In this episode he discusses the ‘emerging media & digital technology’ and how it is affecting the pharma ecosystem in general. The series will cover topics ranging from technology to mobile health, i-pad detailing to patient behaviour, social media opportunities within pharma and the changing health eco-system and its implications on pharma marketing echnological advancement in the last decade has brought an exponential change in the way people are communicating and connecting with each other. This is mainly because of the ‘rise and rise’ in the digital and social media space. Further, bringing it an inch closer to people is the newer drivers of communication that has flooded the digital market and spoiled people for different choices. From the initial days of desktop computers to the more tech savvy tablets, people have surplus

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options to choose their hitech device.

Taking advantage of this, the FMCG industry has been quite effective in striking a cord with their consumers to successfully communicate with them, resulting in larger spends on emerging media including digital and social. But where does the Indian pharma industry stand as on date when it comes to online spends? The numbers are nowhere close when it comes to matching with the traditional marketing spends.

Today, the world has

acknowledged the fact that healthcare is in the process of real time change. This thought has also triggered changes in Indian healthcare practitioners (HCP’s) outlook and attitude towards their practice. On the personal front, due to time restrictions, doctors are known to spend highly on online shopping and doing online banking transactions etc. Those who are on a high learning curve have also started to evolve over time, and adapting themselves well. Those who belong to the young breed of doctors are already high on digital knowledge and are largely using it in their dayto-day practice to get and share medical information.

Especially with 50 per cent population below the age of 30 years, the new breed of doctors that are emerging are ‘native’ users, unlike

their senior counterparts who have been ‘migrants’.

The psychology and behaviour of the younger breed is completely different and will lead to an accelerated change within healthcare.

Patients on the other hand have also started to look forward to Internet and social media platforms for getting additional information on the drugs that have been prescribed to them.

The rise of this e-patient is in turn forcing doctors to adapt to changes and be more careful in the transaction and relationship building with the patient. Health as a subject is highly ‘searched’ in India on various conditions. Increasing life-span is forcing people to discuss health topics openly unlike the traditional olden days. They are not just seeking information but sharing information as well. This is

Industry insights rnst & Young famously predicted in 2009 that the pharmaceutical industry had entered “Pharma 3.0”, or the era of health outcomes.

This model required that pharma should embrace alternate media to communicate with stakeholders that is both digital and interactive.

Spiralling costs made the traditional business model unsustainable.

However, as it turned out from 2009 to date, the widespread adoption, by pharma, of the digital medium in general and social media in particular, was marred by the lack of formal regulation, perceived as a big stumbling block for an industry that is tightly regulated. Social media is posing a challenge for pharma – on the one hand, it offers possibilities such as targeted messaging and the ability to monitor online conversations, while on the negative side, its interactive features can prove an obstacle for such a highlyregulated industry. As a result, pharma has been slow to integrate social media into its marketing strategies.

Among the benefits of digital media are that it helps build disease/brand awareness; facilitates eCME for HCPs; provides real-time interactions; crosses geographical boundaries; and certain chronic diseases, in particular, those that require frequent monitoring, lend themselves to this medium. Among the challenges, are lack of regulatory framework; ADR (adverse drug reaction) reporting; who is responsible for UGC (User Generated Content); lack of trust in pharma; and the fact that it can be labour intensive. Balancing

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the free-form messaging of social media, with the control, consistency and mass reach of traditional media, can offer the best of both worlds.

Digital technology includes concepts such as Cloud Computing, or using multiple server computers via a digital network, as though they were one computer, the use of distribution tools such as iPads and other tablets and mHealth (mobile health care). These technologies help to cut costs in terms of information storage and sharing, while offering the potential for more effective communication. Fear of this hitherto unexplored medium should not be a reason to sit on the sidelines. Despite the lack of in-depth experience and guidelines, there are low-risk digital media tactics in which pharma should engage.

Trust in pharma is at an all-time low - HCPs and patients prefer to liaise with their respective groups within ‘closed-loop’ settings, as opposed to accessing healthcare information via pharma.

However, pharma can alter this perception, by producing accurate and transparent information and focusing on what these groups want, which is, disease-focused, with added collaborative capabilities. CEOs of the industry need to be brave enough to have their own voice on Twitter, to have their following, and share what is happening at a corporate level, especially in times of crises. Unfortunately, the industry considers sharing information to be slightly less significant than ‘monitoring’. In the short- to mid-term future, the most prudent approach might be to integrate social media into the marketing mix,

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Salil Kallianpur using it in a complementary way with traditional marketing.

In the prevailing global economic environment and the backlash that it created, pharma companies will either succeed or fail, based on how well their market offering improve health outcomes. As India moves towards an increased role of government in health care delivery, reimbursement to pharma companies for their products will be based on outcomes such as disease management, patient satisfaction and building the corporate brand. With the possibility of metrics measurement, digital technology will therefore become an integral component of this outcomes-driven healthcare environment.

The author is Commercial Head – Classic Brands, GSK

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giving rise to discussions, opinions and in turn is creating a pool of online data for people to refer.

Experiences of people shared online is shaping up opinions and is greatly influencing patients behaviour.

All this completely serves as a wakeup call for the pharma industry. The pharma industry, known for its traditional approach, though initially reluctant, has now started responding and adapting to these changes.

With over 120 million of the population actively using the Internet and 900 plus million mobile phone users, the pharma industry has a plethora of opportunities to explore. It has now started to sense the newer avenues to engage with its customers – the doctors and consumers – the patients.

This has led to an increase in the acceptance of mHealth or Mobile Health

by Pharma professionals and has thrown up some wonderful opportunities for marketers.

Worldwide, mHealth has helped healthcare professionals (HCPs) and patients

alike to gain healthcare information, as well as real time monitoring of health status, and subsequently understanding the medical care that needs to be taken.

Moreover, a new health app is introduced almost every day in the digital world so much so that people have leaped into a pool of healthcare information.

Keeping these benefits in mind, the future of digital

INCREASING LIFE-SPAN IS FORCING PEOPLE TO DISCUSS HEALTH TOPICS OPENLY UNLIKE THE TRADITIONAL OLDEN DAYS.THEY ARE NOT JUST SEEKING INFORMATION BUT SHARING INFORMATION AS WELL healthcare looks very promising in India.

If the emerging tools and media are used strategically, the industry can very well leverage its integrated marketing efforts.

Doctor communication

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Marketing (MCM) and Closed Loop Marketing (CLM) have caught up with the western world and will also change the way India pharma marketing operates.

Unfortunately, both the depth and the context of this

2231 8879 / 80 Fax: +91-33-22138582 Cell: 09830130965 / 09831182580 Email: prasenjit.basu@expressindia.com ajanta.sengupta@expressindia.com KOCHI Dr Raghu Pillai Business Publications Division, The Indian Express Limited, Sankoorikal Building, 36/2248, Kaloor,Kadavanthara Road, Opp. Kaloor Private Bus Stand, Kaloor - 682 017 Tel: (0484) 2343152, 2343328 Fax: 2343153 E-mail: Kochi.bpd@expressindia.com raghu.pillai@expressindia.com COIMBATORE The Indian Express Limited, Business Publications Division, 1st Floor, 731, Avinashi Road, Opp. PRS Grounds, Coimbatore-641 018 Tel: 2212157/2216718/2216732 E-mail: bpdcbe@vsnl.in

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can be taken to a newer level by the pharma industry as digital can help leverage a plethora of opportunities in terms of interactivity.

Unfortunately the print visual communication has been ‘digitised’ on an i-pad or a tablet and has gone nowhere.

The pharma sector needs to adapt to a complete new and a fresh outlook on this.

Also Multi-Channel

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have not been understood by pharma marketers completely.

CLM basically measures the results of marketing and communication initiatives by monitoring and tracking the response of the targeted groups. The evaluation of the results, such as interaction, surveys, perception towards a new drug, safety profile etc. helps to improve future marketing decisions.

Proposed promotional campaigns can then continuously adapt to the customers' wants and desires, creating a true relationship.

With doctors getting technologically savvy and patients increasingly searching for health information on the Internet, can the pharma industry leverage newer tools and media as a key differentiator?

Can it look beyond traditional methods of communication? Will pharma be able to stick its neck out and start interacting with patient communities?

Will the mindset change from being a mere ‘drug manufacturer’ to partnering for ‘healthy outcomes’ ever happen?

(To be continued)

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LEGAL EAGLE International technology transfer, FDI and development Kamal Saggi, Professor of Economics, Vanderbilt University, gives an outlook about the strengths of Foreign Direct Investment, which can generate substantial benefits for both consumers and local companies in developing countries ince most developing countries lack the resources to invest heavily in research and development (R&D), a technology gap separates them from the developed world.

International transfer of technology helps close this gap and, along with investments in human and physical capital, is likely our best hope for raising living standards across the developing world. Such technology transfer makes eminent economic sense: it keeps poorer countries from spending their already scarce resources on ‘reinventing the wheel’.

Economists regard knowledge (and its application in the form of technology) as a ‘non-rival good’, meaning that knowledge can be simultaneously accessed by more than one person.

However, the non-rival nature of knowledge does not imply that it can be acquired or transferred free of cost. Rather, all it means is that if two parties are willing to pay the cost of adopting a new idea or a technology, they can do so without interfering with each other's decisions. Indeed, substantial empirical evidence indicates that international technology transfer does not come cheap and economic policies should aim to lower its costs rather than increasing it.

While the allocation of R&D across the world is changing continually, most of the world’s R&D still takes place in industrialised countries and is carried out by multinational corporations. The results of this R&D are transmitted globally through many channels.

Perhaps the most important such channel is Foreign Direct Investment (FDI) –

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investment projects whose ownership and control lie in the hands of overseas investors. For example, if a US automobile company such as Ford sets up a factory in India, the investment counts as FDI. By contrast, the purchase of a small amount of stock in an Indian company by an individual foreign investor does not.

FDI flows to developing countries have increased substantially during recent decades, with China being the stand-out performer.

Today, roughly one third of the global stock of FDI is in developing countries. While this is an impressive figure, it is not as large as it should be since FDI, particularly in services, is often subject to major policy restrictions. For example, India has been hostile to FDI during much of its existence as an independent country and has only recently begun to take on the difficult but important task of liberalising its FDI policies in the retail sector.

Restrictions on inward FDI hamper a country’s ability to update its production technologies, organisational structures, and management techniques. Of course, FDI is not the sole channel of achieving these objectives: private sector channels such as technology licensing and www.expresspharmaonline.com

joint ventures between foreign and local companies can substitute for FDI to some degree. Furthermore, technology transfer does and can occur without any participation from those that originally created the technologies: imitation or ‘reverse engineering’ allows local entrepreneurs and companies to replicate foreign products and technologies without paying any royalties or fees to creators.

However, if one is constrained to pick among those channels of technology transfer that involve willing exchanges between market participants on both sides of the market for technology, there really is nothing to talk about. The game pretty much begins and ends with FDI: over 80 per cent of fees and royalties paid in a given year for licensing of technology are intra-firm in nature, i.e., involve exchanges between parent firms and their overseas subsidiaries.

Reverse engineering of foreign technologies and products has played an important role in the industrial development of India, particularly in its thriving pharmaceutical industry.

But, looking ahead, reverse engineering is not a sustainable strategy for several reasons. First, developed countries have started to increasingly demand stronger enforcement of intellectual property rights across the world, as is indicated by the ratification of a multilateral agreement on intellectual property rights by the World Trade Organization in 1995.

Second, to continually raise living standards, at some point a country must make the leap from imitation to innovation. A case can be made that India is ready to do so in several major industries and local policy must adjust to meet this new reality.

From the perspective of economic development, one of the great strengths of FDI is that it can generate sub-

stantial benefits for both consumers and local companies in developing countries.

Benefits to consumers include access to higherquality goods or completely new goods that are simply not produced locally due to technological constraints.

Benefits to local companies include what is known as the ‘demonstration effect’, in which local firms adopt a technology from overseas after observing its successful introduction by a multinational. Similarly, people trained or previously employed by multinational firms can provide added benefit to local business by helping with technology transfer when they change jobs or start new firms. Last but not the least, multinationals often willingly transfer technology to firms that either supply them with necessary intermediates or buy their finished products. An example can be found in Mexico’s automobile industry.

After the North American Free Trade Agreement (NAFTA) was ratified in 1992, US car companies set up manufacturing plants in Mexico. Within five years this had led to hundreds of domestic producers of car parts and accessories springing up. US and other multinational corporations transferred technology to these Mexican suppliers who, as a direct result, gained expertise in industry best practices and quality control.

All this is not to say that the multinational firms are charitable institutions whose goal is to encourage economic development in host countries. It goes without saying that multinationals engage in FDI to maximise their own profits. If transferring a technology strengthens a company’s local rivals, it should be expected to thwart the process of technology diffusion to some degree. For example, a multinational worried about losing a technological innovation to local EXPRESS PHARMA

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rivals may choose not to invest locally, and may simply export the product from its home market or may only transfer tangential technologies. But such trade-offs do not always exist, particularly when one considers relationships between multinationals and their local suppliers. Furthermore, multinationals compete vigorously with each other and have an incentive to use their best available technologies globally.

FDI brings tangible benefits to host countries even when the scope for technology spillovers to local firms is limited. Indeed, in today’s world economy, FDI just might be the best way of integrating local suppliers into the global production chain thereby enhancing their quality and export prospects. Not to mention the direct employment that is created by large scale projects undertaken by multinational firms. Indeed, multinationals typically pay higher wages than their

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local competitors.

In today’s world of rapid international capital flows, another attractive feature of FDI from the viewpoint of host countries is that it is relatively less reversible than other forms of foreign investment.

Such irreversibility lowers uncertainty for local workers and suppliers engaged in economic relationships with multinationals producing locally.

Despite its many benefits, historically FDI has often met with resistance in many host countries. For example, in several Asian countries, technologies in the private sector were transferred frequently through technology licensing between independent firms rather than internally through multinational firms since local policy restricted inward FDI. This may have allowed some countries such as Japan and South Korea to obtain foreign technologies at relatively low prices. To some extent, China too has been able to

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leverage its large domestic market to force foreign firms to share their technologies as a precondition for access.

While such policies are not necessarily the most desirable ones in the long run, they are surely preferable to an excessive focus on self-reliance, a slogan that defies the logic of comparative advantage and makes little sense in today’s integrated global economy.

Chasing self-reliance led India to pursue a policy regime that protected local industries from foreign competition. Such protection encouraged investments in local technologies that were invariably far below the global state of the art and forced domestic consumers to endure goods that fell short of international quality standards. India’s youth, raised in the age of Facebook and Google, cannot appreciate the extent to which foreign manufactured goods were sought after by previous generations: not only were such goods far

superior in quality to their domestic counterparts, they were essentially unavailable locally due to severe trade and investment restrictions imposed by the Indian government.

Developing countries such as India are likely to maximise the benefits of FDI and technology transfer by investing more in local education and infrastructure development while giving multinational firms relatively unrestricted access to their markets. Protectionist attitudes may have been a legitimate response to colonialism during the first three to four decades of independence but modern India can ill afford them today. Like colonialism, they too must become a thing of the past.

India must continue on the path of increased integration with the global economy if it is to take its rightful place in the world order and fulfill its promise as a great modern nation. Its citizens should settle for nothing less.

April 1-15, 2013

RESEARCH

W H AT ’ S INSIDE

EXPERTISE FOR DRUG DEVELOPMENT

Pentavalent vaccine: Doing more harm than good? PG 39

PHARMA ALLY 41 PHARMA LIFE 62 April 1-15, 2013

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For many decades Bacillus Calmette–Guérin (BCG) vaccine has served as a weapon for India to tackle the TB menace. However, recent rise in TB cases across India has sparked a debate over the reliability and limitations of this vaccine. The form and mode of action of Mycobacterium tuberculosis has remarkably changed over the years and so has its nuisance value. However, on the other hand, a developing country like India is still heavily relying on age old vaccines like BCG. So, perhaps the time has come to look beyond BCG. Is there no alternative?

According to Soumya Swaminathan, Director, National Institute for Research in Tuberculosis, Chennai, there is no better alternative to BCG vaccine at present. BCG protects against serious forms of TB

SOUMYA SWAMINATHAN Director, National Institute for Research in Tuberculosis, Chennai

in young children like meningitis and disseminated TB. So, till a better vaccine is found, we should continue using it.

Even the Indian Government is aware of the fact that BCG has its own limitations and a more potent remedy needs to be introduced. India's revised national TB control programme is the largest TB control programme in the world, placing more than 100,000 patients on treatment every month.

However, it seems, even such mammoth efforts are not enough to stop TB's aggression and hence more advanced vaccines are the need of the hour.

Dr Pradip Shah, Senior Consultant Physician and DNB Teacher, Fortis, Mumbai, opines, “Tuberculosis is one of the most deadly infectious diseases in India. The situation is worsening because of coinfection with HIV and increased occurrence of

DR PRADIP SHAH Senior Consultant Physician and DNB Teacher, Fortis, Mumbai

There is no better alternative to BCG vaccine at present.

BCG protects against serious forms of TB in young children like meningitis and disseminated TB. So, till a better vaccine is found, we should continue using it.

Tuberculosis is one of the most deadly infectious diseases in India.

The situation is worsening because of co-infection with HIV and increased occurrence of drug resistance

drug resistance. It is accepted that BCG vaccine protects young children (age, <5 years) against more dangerous extra-pulmonary forms of TB and, thus, is given as a routine vaccination.

However, the efficacy of BCG vaccine against pulmonary TB is doubtful. This combination of ineffectiveness and risks of adverse

events demands that better vaccines be developed to protect everyone. As of now, we are not ready with an alternative yet.”

Research on TB vaccines Globally, there are various TB vaccine candidates that are in different stages of development. However, till today there is no conclusive

TB Vaccine Pipeline Recombinant BCG vaccines: The first new recombinant BCG TB vaccine to be tested in humans was rBCG30 (developed by Dr. Horowitz's group at University of California, Los Angeles).

The next recombinant BCG vaccine to be tested was VPM1002 (developed by Dr. Kaufman's group at the Max Planck Institute, Berlin, Germany).

Many other recombinant BCG vaccines and recombinant nonreplicating and attenuated TB organisms are in preclinical development.

Booster vaccines for BCG- or recombinant BCG-primed infants and for adolescents and adults: Two recombinant proteins combined with advanced adjuvants have been tested in phase I trials in Europe and are currently being tested in studies in Africa. The GSK M72 Aerassponsored vaccine is a recombinant fusion protein that has induced protection in long-term nonhuman primate challenge studies and high levels of CD4 T cells in BCGprimed individuals, including HIV-infected individuals with CD4 T cell counts as low as 200 cells/mm3. This vaccine is scheduled for phase IIb efficacy studies in 2010.

Two recombinant fusion proteins developed by the

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Statens Serum Institut, Hybrid-1 and HYVAC4/AERAS-404 (with Sanofi-Pasteur), induce protection in mice and guinea pigs and also induce antigen-specific CD4 T cell responses in humans.

Two recombinant nonreplicating viral-vectored TB vaccines have undergone extensive clinical studies and have entered phase IIb proof-of-principle safety and efficacy studies. One of these vaccines, MVA8A/AERAS-485 (Emergent Biosolutions), was developed by Dr. McShane's group at Oxford University (London, United Kingdom). .On 15 July 2009, a girl became the first infant to receive a new TB vaccine being studied for efficacy in >80 years. In total, 2800 infants in the trial will receive the BCG vaccine at or near birth and a booster at 14–16 weeks of age with eitherMVA85A/ AERAS-485 or placebo. This study has 90 per cent power to detect a 60 per cent decrease in the incidence of clinical TB, compared with placebo. The same vaccine is scheduled to be tested for efficacy in HIV-infected adults with CD4 T cell counts >350 cells/mm3 in 2010.

Source--Dr Pradip Shah

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outcome from this research.

Swaminathan provides details regarding TB vaccine development. She informs, “There are about 12-14 candidates at different stages of vaccine trial around the globe. So far, results have been disappointing among those that have reached phase 2b. In India, no indigenous TB vaccine candidate has progressed to the stage of human clinical trial, though there is one that is promising in early stage development.”

According to Shah, in India, the only currently licensed vaccine against TB is BCG vaccine, of which >100 million doses are given each year. He stresses that although the BCG vaccine has been in use for 90 years, protection is insufficient; new vaccine candidates are therefore needed.

“In abroad, 12 potential vaccines have gone into clinical trials. Ten are aimed at prevention of TB and, of these, seven are subunit vaccines either as adjuvant or viral-vectored antigens.

These vaccines would be boosters of BCG-prime vaccination. Three vaccines are recombinant BCG con-

structs-possible replacements for BCG. Additional vaccine candidates will enter clinical trials in the near future, including postexposure vaccines for individuals with latent infection. Although research has focused on injectable vaccines, aerosolised vaccines that are delivered to the deep lung and mimic the natural route of Mycobacterium tuberculosis infection are also being developed, as are oral vaccines (S Rao, K Song, DL Bolton, RL Wilson, JJ Mattapallil, C Andrews, J Sadoff, J Goudsmit, MG Pau, R Seder, PA Kozlowski, GJ Nabel, M Roederer, unpublished data). Both approaches would have the advantage of being inexpensive and easily administered,” says Shah.

Role of hospitals and pharma companies Recent findings of MDRTB cases in the metro cities like Mumbai have made hospitals rework their strategies to handle such cases.

Not just hospitals but even pharma companies have to fix their responsibilities as they are the

ones who supply medicines/injectibles to hospitals.

“The most important thing is to prevent more MDR-TB from developing by following scientific and rational diagnostic and treatment strategies. All doctors who treat TB should follow standard regimens and recommendations. Pharma companies should not manufacture and market drug combinations that are not recommended.

Bioavailability and quality assurance of drugs must be ensured,” says Swaminathan.

While adding to Swaminathan's suggestions, Shah provides more details on do's and dont's for the hospitals and pharma companies. He says, “Of the estimated global total of TB disease cases, an estimated 4.9 per cent cases involve MDRTB. A vaccine will also help against the spread of drug resistant TB. The new generation of vaccines being developed will protect against drug-resistant forms of the disease, because they are directed against antigens that are not modified by resistance to antibiotics.”

Shah adds, “Hospitals should implement policies towards early diagnosis and ethical treatment of MDR cases. There should be proper isolation of such cases and only trained staff and doctors should be involved in treatment. Rational use of antibiotics, low threshold for suspicion and new methods for fast TB cultures and sensitivity patterns should be available at labs. Pharma companies should conduct post market surveillance to know compliance of patients towards and aim at improving it. Single separate drug is better than combination tablets which should be promoted and should be available at reasonable cost.”

Diseases like HIV and TB are difficult to treat.

However, due to years of efforts, scientists have managed to make an HIV patient's life more bearable.

In the same manner, though today cases like MDR-TB look deadly, it is to be hoped that scientists across the globe would soon be able to bring TB-related complications under check in the coming years. sachin.jagdale@expressindia.com

INSIGHT Pentavalent vaccine: Doing more harm than good?

Jacob Puliyel, Head of Pediatrics, St Stephens Hospital Delhi, questions whether the time has come to stop using Pentavalent vaccine for immunisation mmunisation with the new Pentavalent vaccine resulted in the recent death of two babies in Kerala. This combination vaccine was to replace the trivalent DPT (against diphtheria, whooping cough, tetanus vaccine) and additionally protects against Haemophilus influenzae type b and Hepatitis B. The post mortem certificate in both babies stated: “Based on the findings in the autopsy, preliminary reports of microbiological and histopathological findings, no definite opinion as to the cause of death can be furnished. Death due to natural disease, injury and aspiration pneumonia are ruled out. However, death as a result of post vaccination

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sequelae could not be ruled out.”1 Vaccines are administered to a large number of healthy children to protect against illness and death.

The autopsy reports suggest that the vaccine was the most likely cause for the deaths but stopped short of saying the vaccine definitely caused the deaths.

All drugs have side effects, it has to be decided if the adverse effects are unacceptable. As children die from other reasons, unrelated to the vaccine there it is possible that coincidentally children may die of other disease on the day they were immunised. However for children noted as dying after pentavalent vaccine no ‘alternate and sufficient cause’ was found to explain the death in spite of diligent investigations. Even if no alternate cause of death is www.expresspharmaonline.com

established the possibility of ‘Sudden Infant Deaths Syndrome’ (SIDS) exists where deaths happen without explanation.

Deaths in several countries where the vaccine is used The two deaths whose autopsy reports are discussed above are not the only deaths associated with this vaccine. This vaccine is used mostly in developing countries. There were eight deaths in Bhutan.2 There were 25 instances of serious adverse events in Sri Lanka including five deaths.3 There were three deaths in Pakistan.4 There were 10 children who suffered serious adverse events of whom seven died in Vietnam.5 There were at least 15 deaths in Kerala6 and two in Tamil Nadu7 and one in Haryana8 making the total 18 deaths in India. These deaths, in dif-

ferent countries using vaccine from varied manufacturers, rules out defects in some specific batch of the vaccine, and also indicate that they are unlikely to be because of incorrect administration of the vaccine. The WHO considers two deaths due to vaccination as a cluster9 that mandates rapid evaluation of the risk to public safety.10 That there are 41 deaths are a matter of serious concern. Should the programme be now suspended?

Infant mortality rate and coincidental death on day of immunisation Information obtained under the right to information suggests that in the first six months, when the vaccine was administered to 40,000 children in Kerala, five children died. If this is extrapolated and the 25 million babies in India born EXPRESS PHARMA

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each year are vaccinated we can expect 3125 deaths.

These deaths from the vaccine would seem to outweigh any benefit that immunisation can yield. In Kerala 14 babies die before their first birthday per 1000 live births. This is called the infant mortality rate (IMR).

Half of these deaths occur in the first month of life. The other seven deaths per 1000 occur in the remaining 11 months. Pentavalent vaccine is administered after six weeks of age, and so it is administered to babies who have survived the first month of life. Four out of five deaths occurred with the first dose of the vaccine and on the day or the next day of vaccination. The death of babies in the first day after vaccination works out to be four times higher than the expected number.

The vaccine meant to save lives seems to be increasing mortality rather than reducing it.

Deaths from SIDS Pentavalent vaccine is given to healthy babies.

Mothers in Kerala donâ&#x20AC;&#x2122;t ordinarily bring very sick babies for immunisation.

Each baby is examined by healthcare personnel before vaccination. So sick babies are unlikely to receive vaccination. Babies who die are usually severely ill. The deaths in these vaccinated babies are deaths in apparently healthy babies who no one anticipates will die in the next few hours. Another possibility is the rare SIDS, the death of an apparently healthy baby without explanation. SIDS may be the explanation for a very small number of deaths. Here the â&#x20AC;&#x2DC;unexplained deathsâ&#x20AC;&#x2122; following immunisation, are four times the number that usually die after the first month of life. SIDS is very unlikely to be the explanation for these deaths following Pentavalent vaccination.

Furthermore, the SIDS rate in the third month of life is higher than that in the second month, and if these deaths were merely coincidental with the Pentavalent vaccine there should be more deaths after the second dose rather than the first. However, four of the five deaths in the first six months in Kerala, were after the first dose. This also argues against all these deaths being SIDS deaths.

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Lives lost to adverse events against lives saved by vaccination One method to decide on continuing the programme would be to see if more harm is done than the benefits (reducing disease deaths in the community) by vaccination.

Pentavalent vaccine provides protection against Hib disease. Evidence from the World Health Organization studies in India suggests that seven children in 100,000 get Hib meningitis of which 10 per cent die. If the 25 million babies born each year are immunised it will prevent 8750 cases of Hib meningitis and 875 deaths over the next five years. Vaccination also protects children against pneumonia: more children get Hib pneumonia but few die of it. If we double the estimated deaths about 1750 children in the country die each year from HIb disease and these can be saved by immunisation. We cannot estimate the lives saved by Hepatitis B immunisation as they do not happen in childhood. The deaths from the vaccine (3125) seem to outweigh the benefits (1750 lives saved).

The parallels with Rotavirus vaccine withdrawal In 1999 the newly introduced Rotavirus vaccine in the West was suspected of increasing 'intussusceptions' (a surgical condition of the small intestine). Ordinarily one in 10,000 children would get intussusception. This went upto 2/10,000 in the two weeks after the first dose of Rotavirus vaccine was administered. When 15 extra cases of intussusceptions were noticed (and when not even one baby had died) the vaccine was withdrawn.11 Product liability rules are so stringent in the West that the manufacturers voluntarily removed the vaccines before they were asked to.

Noel Narayanan Commission and underestimation of adverse events Before starting the programme in Kerala the Government set up theNoel Narayanan Committee12. It recommended the Government collect data on each child immunised with the vaccine, for 48 hours after immunisation. A government affidavit to the www.expresspharmaonline.com

Delhi High Court suggests this was not done in a systematic way but reporting of adverse events was left to voluntary ASHA workers13.

They are given incentives depending on the number of children receiving Pentavalent vaccine in their area. This could be a disincentive for reporting adverse events as, such reports could reduce vaccine uptake and her earnings.

There are the Government Standard Operating Procedure (SOP) for adverse events following immunisation (AEFI)14. The numbers reported suggest severe under-reporting: while over 100 serious adverse reactions of various types would be expected with the standard DPT (triple antigen) vaccine in six months, only two were reported with Pentavalent vaccine that incorporates the DPT. In addition it appears there was an attempt to blame the parents of the first child who died following immunisation in Kerala. The press reported that the baby did not die of vaccine reaction but was smothered15 to death and later a spokesperson for the Health Department claimed the mother's breast-milk feeding killed the child.16 It took the post-mortem report to clear the parents of these accusations. Given these circumstances it is clear that adverse events are likely to be under-reported and we can anticipate that the 15 deaths reported from Kerala, is an underestimation.

Post-marketing surveillance and concluding remarks Notwithstanding any deficiency in the Government reporting system, the vaccine manufacturer is obliged to provide the Drug Controller with a listing of all side effects in the first few years of marketing a newly licensed drug.

The Drug Controller is the regulatory authority which has to ensure such reporting is made available.

Most of the information presented here pertains to the first six months of the programme in Kerala for which information was made available under the RTI. The public must insist that data for the 14 months the vaccine has been in use in Kerala and Tamil Nadu is carefully evaluated in a

transparent manner before decisions are made for the health and safety of our children.

(Disclosure: In December 2009 a former Union Health Secretary Professor KB Saxena and eight others filed a public interest petition in the Delhi High Court to ask the Government of India to formulate an evidence-based rational vaccine policy for introducing new vaccines and to ensure that the basic EPI vaccines are provided to every child without discrimination or constraints of funds. The author is one of the petitioners. Since August 2010, he is a member of the National Advisory Group on Immunization. (NTAGI)).

The opinions expressed in this article are those of the author.

References 1. http://articles.timesofindia.indiatimes.com/2013-02-25/thiruvananthapuram/37288777_1_pentavalentvaccine-infant-deaths-mortem 2. http://bhutannews.blogspot.in /2010/07/pentavalent-killer-isback.html 3. http://www.bmj.com/rapidresponse/2011/11/02/sri-lankandeaths-following-pentavalent-vaccineacceptable-collateral-dama 4. http://www.bmj.com/rapidresponse/2011/11/02/sudden-deathsafter-pentavalent-vaccination-vaccine-really-safe 5. http://www.thanhniennews.com /2010/pages/20130117-7-deaths-intwo-months-who-deems-vaccine-invietnam-safe.aspx 6. http://articles.timesofindia.indiatimes.com/2013-02-05/thiruvananthapuram/36764202_1_pentavalentvaccine-immunization 7. http://articles.timesofindia.indiatimes.com/2012-07-13/chennai/32662981_1_pentavalent-vaccine-immunization-programme-aefi 8. http://articles.timesofindia.indiatimes.com/2013-01-12/chandigarh/36295667_1_pentavalent-vaccine-vaccination-programmejhajjar#inbox 9. www.rho.org/HPV-vaccine-implementation.htm 10. http://www.who.int/bulletin /archives/78%282%29170.pdf 11. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm4843a5.htm 12. http://jacob.puliyel.com /edit.php?id=264 13. http://jacob.puliyel.com /edit.php?id=278 14. http://jacob.puliyel.com/ edit.php?id=258 15. http://archive.asianage.com /india/kerala-infant-died-smothering510 16. http://articles.timesofindia.indiatimes.com/2011-12-21/thiruvananthapuram/30542007_1_pentavalentautopsy-report-expert-team April 1-15, 2013

PHARMA ALLY Treatment of water Kishor Datar, Chief Technical Officer, Technolutions Projects, gives an insight on the myriad applications of water, understanding pharmaceutical water systems and its treatment methods to enable its usage in the pharma industry rom the earlier chapters we know that, with the difference in types and degree of contaminants present in water, different types of water required for different process, it is essential to have water treated so as to take care of these variations and assuring “Consistency in quality of water produced” It is clear that consistency in quality of water produced is the key criteria for pharmaceutical water treatment. Probably the word ‘consistency’ is forgotten many a times and users get carried away by few high tech systems described by consultants like us or vendors, irrespective of the source water and the requirement. People forget to ask questions like whether this high tech system is required and can it be maintained etc. and ultimately the users runs in to problem.

Let us try and understand some of the treatments used currently. I will be presenting few things in subsequent articles which are guidance-oriented and not specific. However, I am sure that the information will help users a lot in understanding and mainly

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avoiding getting carried away by consultants or vendors.

We will go through the types of treatments we discussed earlier. We will just run through them quickly to have summarised information regarding these types of treatments used in the industry.

However, the details of each system will be discussed in the subsequent articles.

The system in any pharma industry is always considered as vulnerable and people continue making statement that the “system is bad.”

However, I am sure that after going through this entire series of articles, which will start from defining properly what is the source of water and what I need, the view of the users will change.

Let us differentiate between ‘want’ and ‘wish’.

Wants are must to be addressed, wishes can follow if everything permits.

Most of the time I have seen that wishes take over wants and put the operating staff in difficulties.

Physical treatments The treatment process using physical parameters

Reverse osmosis and ultra filtration

of contaminants to isolate it from water. Thus these type of processes will use physical properties of contaminants like size, shape, weight etc. to remove them from the water.

With this basic concept, it is clear that these treatments will have many physical aspects which will need to be maintained / monitored.

Major process used today that fall under this type of treatment are:

Filters Normally these are depth filters. The filter media will have porosity of designated size. Water is forced through this medium using pressure to isolate particles bigger in size of porosity.

Treatment

Type of contaminants handled

Filters

Suspended solids, dirt, dust

RO

Dissolved Ions, Bacteria

UF

Bacteria, Colloidals

Softener

To exchange Na/K for Ca/Mg

DM/DI

Ionic / Dissolved solids

Chlorination / Ozonation

Microbial control

EDI/CDI

Dissolved solids/Ions-Polishing

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This also is a process of filtration, but normally using cross flow. The porosity of this type of filtration, normally referred as membrane filters, ranges between 20 and 100000 molecular weight cut-off (MWCO). This makes it clear that higher pressure is essential to be applied to ensure that water is forced through these membranes and at the same time a flow is maintained on other side to reject the concentrate.

At the same time, it is clear that since the porosity is ultra low, these filters are not meant for suspended particles, but to remove micro and macro molecules, which includes dissolved ions as well as bacteria.

W H AT ’ S INSIDE

BIS recognises SCHOTT’s expertise in pharma glass manufacturing PG 42 LANXESS solutions for disinfection and antimicrobial protection PG 43 Cognex launches In-Sight 7000 Series of vision systems PG 44

Distillation Distillation is a process of converting the phase of water as follows: Liquid ➜ Vapours ➜Liquid.

Since water boils at 1000C, when water is converted to vapour form, most of the dissolved contaminants don't get converted into vapour phase and hence when these vapours are converted to liquid phase, contaminants gets isolated.

Chemical treatments The treatment process using chemical parameters of contaminants to isolate them from water. Thus this type of processes will use chemical properties of contaminants like charge, affinity, reactivity, etc. to isolate it from water.

It is clear from above concept that these type of treatments will use chemicals to complete the process or to enhance the process.

Major process used today that fall under these type of treatments are:

Softener As the name suggests, this is a process of softening the water. It is a known fact that salts of ions like Ca and Mg, form very hard

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scaling / deposition. These scales are difficult to remove. Hence these ions are referred as hardness building ions. The chemical process of replacing these ions is referred to as softening and the unit that does this is called a softener.

Demineralisation / Deionisation (DM/DI) The process of removing minerals / ions from water using chemical method is referred as demineralisation/deionization. As we know minerals /ions present in water have +ve and -ve charges. For e.g, calcium, magnesium, manganese, iron, zinc are +ve ions, chlorides, sulphates, are –ve ions. In the process of DM/DI, the particles are charged with H/OH ions, the H being +ve charged will attract –ve charged ions and OH being –ve charged will attract +ve charged ions.

Thus this process will

remove the ions with chemical treatment.

Chlorine / Ozone dosing Chlorine/ozone are highly oxidising agents. These chemicals oxidise the compound.

The oxidation process, oxidises vital compounds in the cells, thus bacteria, and other microbes get killed. This process is also used to oxidise and remove the iron contaminants from water. In case of chlorine, either Cl2 gas is dosed directly or by dosing the chemical which will release Cl2.

In case of ozone, it is generated using the same water and dosed directly.

This is the general principle used to control microbial contamination in water used in the pharma industry.

In the past few years ClO2 dosing has found its way in treatment of water.

This is more lethal when it comes to pathogens and hence is more popular in this subcontinent as the surface water used will normally

have a very high contamination of pathogens and they vary as the seasons change.

You will find them highest just before and after first few showers of monsoons.

Electrical treatments The treatment process using chemical parameters of contaminants along with use of electricale energy to accelerate/improve efficiency of the process of isolation of contaminants or improving the efficiency of removal of contamination.

Major process used today which fall under this type of treatment are:

Electro-Deionisation (Continuous Deionisation) As the name indicates, it is a process of de-mineralisation / deionisation using electrical power. As understood in previous slides, the DM/DI process has +ve / ve charged H/OH ions, which attract the –ve / +ve charged ions from water.

When an electric field is

applied across this process, the +ve and -ve poles impart additional force to remove the ions from water.

From the information gathered about the types of treatments, we understand the importance of each such treatment. Also it indicates the treatment type and what type of contaminants it can handle. The chart given summarises the treatments and the contaminants an individual treatment can handle The major issues of the users are: ● How to select the type of treatment? ● For the given requirement, flow, source water analysis, economical considerations, which methodology is suitable?

All these can be answered, provided the salient features of each type of treatment and its advantages/disadvantages are known. These will be discussed in subsequent articles.

VENDOR NEWS BIS recognises SCHOTT’s expertise in pharma glass manufacturing Rewards company’s strong commitment to international Good Manufacturing Practice standard CHOTT has been appointed to India’s national standards body. As a new Bureau of Indian Standards (BIS) member, the company will advise CHD-10, a subcommittee of the Chemicals Department, on specifications and guidelines for various kinds of glass manufacturing in India – mainly for pharmaceutical tubing but also for other applications such as fire-safe glass, household appliances, and fibre optics. This allows BIS to tap into SCHOTT’s vast experience in the areas of speciality glasses, materials and advanced technologies.

“It is a tremendous privilege to support BIS in improving glass manufacturing standards in India,” says Sundeep Prabhu, Vice President Marketing and

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Sales for Pharmaceutical Tubing at SCHOTT Glass India. “This milestone is another illustration of the outstanding standardisation of product quality and manufacturing processes SCHOTT has achieved in India.

Together with BIS, our efforts will benefit Indian con-

BIS’ decision underlines SCHOTT’s position as a global leader in high quality glass manufacturing.

Working closely with India’s national standards body, SCHOTT will share its decades of expertise with the aim of enhancing production and testing standards of

WILL ADVISE CHD-10, A SUBCOMMITTEE OF THE CHEMICALS DEPARTMENT, ON SPECIFICATIONS AND GUIDELINES FOR VARIOUS KINDS OF GLASS MANUFACTURING IN INDIA – MAINLY FOR PHARMACEUTICAL TUBING sumers, as well as industry by ensuring that glass products are safe, reliable and of highest quality.” www.expresspharmaonline.com

India’s glass manufacturing industry.

For more than 125 years, SCHOTT has constantly

improved its quality standards to accommodate evolving market demands and deliver maximum benefits to its customers. A key global success factor for SCHOTT has been its strong focus on maintaining the highest quality standards. Company data released recently proves that SCHOTT managed to maintain stringent quality standards in the area of pharma tubing consistently over the last 25 years.

“At SCHOTT, we have been setting standards for manufacturing glass tubing with our technical terms of supply. This means we are committed to constantly improve our production process and offer our customers the highest possible transparency and quality assurance,” says Jürgen Achatz, Global Sales Director for Pharmaceutical Tubing at SCHOTT. EP News Bureau-Mumbai April 1-15, 2013

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PRODUCTS LANXESS solutions for disinfection and antimicrobial protection L ANXESS, the global specialty chemicals company manufactures a spectrum of active molecules which have a wide range of applications in institutional disinfection segment. For the formulation and production of specialised disinfectants to all-purpose disinfectants for use in hospitals, surgeries, the business material protection products from LANXESS offers a wide range of active ingredients – phenolic derivatives, aldehydes, and quaternary ammonium compounds. The active molecules are made available as readyto-use concentrates for application in household, industry, public institutions and animal husbandry.

The LANXESS active molecules are applicable for many personal care and healthcare products that are used daily and generally come into contact with the skin. Therefore, it complies with regulations related to quality, health and safety requirements for use in cosmetics, pharmaceuticals, antiseptics and skin disinfectants. The LANXESS actives for personal care disinfection help to keep pathogenic micro-organisms in check, break infection chains and maintain good health wherever in use.

In hospitals and similar institutions, where disinfection is indispensable, antimicrobials are needed to ensure a safe environment, prevention of further spread of pathogenic micro-organisms and implementation of an effective health care management.

Aqueous pharmaceutical formulations need reliable and safe in-can preservation.

LANXESS in-can preservatives and antimicrobials for these

purposes are highly effective, safe in use and cost effective.

For example, they can be used for cleaning surgical equipment, glass surfaces, floors, toilets and other sanitary cleaning etc.

Products Preventol CD601 is a ready formulated disinfectant concentrate with cleaning power, highly effective in combating and eliminating a broad spectrum of microbial activity arising from bacteria, viruses, fungi and spores. This formulation combines the benefits of new generation phenolic active ingredients and stabilised aldehyde-based active ingredient to create a synergistic combination. It is proven to be effective where there is a high combination of blood and/or protein and against naked viruses. It is perfectly suited for surface disinfection in hospitals, clinics, nursing homes, commercial establishments, manufacturing areas and animal houses. It is also ideal for protecting medical devices and instruments.

The range of phenolics from the stable of LANXESS Material Protection products includes Preventol CMK, OEXtra and ONExtra. These are used for the formulation of disinfectants of all-purpose disinfectants and liquid soaps, for use in hospitals, surgeries, industry, institutions, stables and sheds.

Preventol CMK, when used in combination with other phenolic active ingredients such as Preventol Oextra, ON extra and/or Preventol BP, is highly effective against lipophilic, enveloped viruses such as Herpes simplex, Hepatitis B or HIV viruses. It is

recommended for use in formulation of aqueous alkaline solutions for strong dirt dissolving power and good miscibility with water and is preferable for heavy duty disinfection.

Preventol Oextra and ONextra: The AOX-free grade Preventol Oextra distinguished by its low acute toxicity, good biodegrability and as a nonsensitising active ingredient with only a slight odour. The halogen free grades Prevenol O extra and Preventol ON extra have a broad and balanced spectrum of activity against bacteria, yeats and mould fungi. Preventol Oextra can be succesfully combined with a very small amount of Preventol GDA 50 in order to achieve a fully virucidal effect.

Preventol SB is an active ingredient for antimicrobial deodorant soaps, washing products, medicated cleansing products and other cosmetic deodorant products. It can also be used in toothpaste, bar soaps, shower gels, hygienic disinfection of fabrics and antibacterial finishing of plastics and fibres. This ready-touse formulation is at least as effective as equivalent liquid soaps containing Triclosan/Triclocarban (TCC).

TCC is highly effective against skin resident microflora and works well at low temperatures. It works continuously ensuring maximum antibacterial protection, long after application. It is insoluble in water so is not removed by rinsing once applied to the skin. It can be used for light or white colored products as it does not discolor.

Preventol BP has a broad spectrum of activity against bacteria (especially gram-posi-

Eppendorf extends detection product portfolio W ith the addition of the new BioSpectrometer fluorescence and the new BioPhotometer D30, Eppendorf has extended its family of detection instruments. The new instruments offer additional measurement capabilities and features to the wide range of Eppendorf´s easy-to-use instruments that combine effective hardware with powerful and innovative software solutions. The detec-

April 1-15, 2013

tion instrument portfolio of Eppendorf is supported by accessories and consumables, such as the UVette, a UV-transparent disposable cuvette, and the new semi-micro and macro Vis Cuvettes.

Additional accessories that include reference filter sets and a microvolume measurement cell, the µCuvette G1.0, to measure sample volumes of only 1.5µL, are available.

The Eppendorf detection www.expresspharmaonline.com

family is used in a broad range of life science applications, including kinetic and fluorescence measurements as well as microvolume measurements. The combination of Eppendorf instruments, accessories and consumables enable users to perform many different applications, with variable sample volumes and concentrations in a flexible way. Equipment can be selected and combined to

tive cocci), yeast and mold fungi. When used in other phenolic active ingredients (those mentioned above) have high effectiveness against cocci and lipophilic, enveloped viruses such as Hepatitis B or HIV viruses.

As with other groups of active ingredients, the microbicidal effectiveness of Preventol BP can be affected by the formulating components of the disinfectant, the pH of the ready-to-use dilutions, the degree of contamination/germ count, the amount of dirt/protein, the hardness of water and the temperature.

Another interesting product range from this business unit is DGH (Dodecylguanidinium Hydrochloride) which is a broad spectrum microbiocide for paper, paper board, industrial process watertreatment, and oil and gas applications. It is non-corrosive, completely water soluble, has broad pH stability and is very effective against Sulphate reducing bacterias. LANXESS offers this product further to the acquisition of Verichem in 2011.

Contact details: Rhituparna Mitra Manager – Public Relations LANXESS India, LANXESS House Plot no A-162, A-163, A-164 Road No 27, Wagle Estate Opp. ITI College MIDC, Thane (west) – 400604 Phone: +91 22 2587 1000 (B) Phone: +91 22 2587 1553 (D) Telefax: +91 22 25826742 Mobile : +91 9619171456 Email: rhituparna.mitra @lanxess.com Website: http://www.lanxess.in

match the specific requirements of the work taking place, while achieving highest reliability.

Contact details: Anthoni Jai Kumar Eppendorf India Chennai Tel: 44 421 11 314 Fax: +91 44 421 87 405 Email: anthoni.ik @eppendorf.co.in website:www.eppendorf.co.in EXPRESS PHARMA

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Cognex launches In-Sight 7000 Series of vision systems he In-Sight 7000 series of vision systems features powerful vision tools, autofocus, faster image capture, integrated lighting and lens and the capability to power and control a range of external lighting—all in a compact, industrial IP67 package that makes the system ideal for more applications than ever before.

Users can simply set and save the optimal focus values associated with the inspection of specific parts, making InSight 7000 the ideal choice for production situations requiring regular part changes or projects that require the vision system to be placed in hard-toreach spaces.

In-Sight 7000 offers integrated, field-replaceable lighting with five different colour options, giving users total flexibility to support any vision application. In addition, integrated field-replaceable lenses allow users to further customise the vision system for specific applications.

In-Sight 7000 users can rely on proven In-Sight measurement, location and inspection vision tools and the flexible EasyBuilder environment to make all inspection, defect detection, guidance, alignment and measurement applications easy to set up and deploy. New tools include OCRMax for optical character reading and verification appli-

the capability to power and control specialised lighting directly, which eliminates the need for external power supplies. Cognex Connect offers the widest range of built-in communication protocols that interface directly with the vision system. The compact In-Sight 7000 features built-in Ethernet, RS-232 serial and multiple discrete I/Os. The system can communicate directly to virtually any PLC or robot controller and manage multiple smart cameras remotely from a networked PC or HMI, simplifying implementation and reducing costs. ● Set and save optimal focus values of specific parts ● Helps in part changes or projects that require the system to be placed in hard to reach spaces ● Field replaceable lighting with five different colour options ● Allows users to further customise for specific applications

T

cations. OCRMax gives InSight the power to achieve the highest read rates. OCRMax is fast, easy to set up and simple to use across all platforms.

The In-Sight 7000 delivers

the highest acquisition speeds available with In-Sight with a maximum of over 100 image captures per second. The high acquisition rate provides users reliable inspection of products on even the fastest bottling and pharmaceutical production lines. Unlike most vision systems, the In-Sight 7000 has

Contact details: Sunil Vaggu Marketing Specialist Cognex Sensors India Level 6 - Pentagon Towers P II, Magarpatta City, Hadapsar, Pune - 411028 Mob+91 9881466003 Tel: +9120 40147840 Email: vaggu.sunil @cognex.com

PharMed BPT Tubing - An ideal solution for biotech applications ole-Parmer offers PharMed BPT tubing formulation - ideal tubing for use in cell culture, tissue culture work, medical diagnostic product manufacturing, fermentation systems and purification applications.

PharMed BPT is manufactured according to GMP, is FDA-compliant (21 CFR 177.2600) and meets USP Class VI, European Pharmacopoeia and NSF (Standard 51) requirements.

It is ideal for use in clean-inplace (CIP) and steam-inplace (SIP) cleaning systems and can be sterilised by autoclave, ethylene oxide, or gamma irradiation.

This tubing is nontoxic nonhemolytic with extremely low permeability. It resists acids, alkalies, oxidising agents, and animal and vegetable oils. PharMed BPT is heat-resealable, bondable and formable, making it ideal

temperatures between -59°C to 135°C. PharMed BPT formulation is less permeable to gases and vapours than silicone tubing and has a superior flex life which reduces the production downtime when used in peristaltic pumps. Cole-Parmer offers an extensive range of tubing formulations including PharMed BPT. Contact ColeParmer’s Application Specialist to discuss your fluid handling needs at:'

C

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choice in bioreactors and single use applications. It is opaque beige in appearance www.expresspharmaonline.com

and is useful in applications involving light-sensitive samples. It operates optimally in

Contact details: Rajashri Lele Marketing Analyst Cole-Parmer India 403-404, B-Wing, Delphi, Hiranandani Business Park, Powai Mumbai - 400 076, India Tel: +91-22-67162209 / 2222 Fax: +91-22-67162211 Email id: response@coleparmer.in www.coleparmer.in April 1-15, 2013

Express Pharma Business Avenues

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Express Pharma Business Avenues We care for your family . . .

Anti-Inflammatory Enzymes Serratiopeptidase Peptizyme (enteric coated serratiopeptidase granules) Trypsin Chymotrypsin mix ( 6:1)

Probiotics Saccharomyces boulardii Lactic acid basillus sporogenous

Circulatory Health Nattokinase

Bio Catalysts Immobilized Cal B

Digestive Aids Alpha amylase / fungal diastase / fungal amylase Alpha galactosidase Bacterial alpha amylase Bromelain Hemicellulase Lactase Lipase Ox bile

Papain Pepsin Pancreatin Protease ( acid / alkali)

Advanced Enzyme Technologies Limited Sun Magnetica, 'A' wing, 5th Floor, Accolade Galaxy, LIC Service Road, Louiswadi, Thane(W) - 400604, India Tel: +91 22 41703200, Fax: +91 22 25835159 • E-mail : info@enzymeindia.com • Website: www.enzymeindia.com

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Non-GMO ISO CERTIFICATION

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Products

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Express Pharma Business Avenues ONE STOP SOLUTION FOR PHARMACEUTICAL RESEARCH

Innovation is our culture…

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I%)9)6%'(9 ;'$%J%$< 3 K( (#! (: BD(.$"+ LMNOP: 2<+)6"# A"/$%#6 3BD(.$"+ LONOP: I('$"+%(9 C#!)$)H%#/ 3BD(.$"+ LMNP: 1$"+%9%$< A"/$%#6 3BD(.$"+ LQOP: E"$D)! R(9%!($%)# (/ ."+ BG ;EC1 A"/$ (/ ."+ SCB4 TQO 2+"/"+J($%J" C&&%'('< A"/$ 3BD(.$"+LNOP: I%)9)6%'(9 @"('$%J%$< &)+ 2('U%#6 E($"+%(9 (/ ."+ 3BD(.$"+LMQP7LMMP:

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

4($( E(#(6","#$ .+('$%'"/ %# 1 2@; V;I1 (+" !"/%6#"! $) "#/=+" $)$(9 %#$"6+%$<7 /"'=+%$< (#! &(/$"/$ +"$+%"J(9 )& !($(W

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

Tel: 040-23802000, Fax: 040-23802005 Email:sipra@sipralabs.com web: www.sipralabs.com April 1-15, 2013

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Express Pharma Business Avenues WE DESIGN AND ENGINEER EASY TO VALIDATE USP PURIFIED WATER SYSTEMS

Me a su 10 m ring ra n ic r o n s t g e fr o m o 12 5m m

Our installations speak of the robustness of our design, our validation expertise and our service standards

Over the last 10 years, we have been engineering & delivering systems for Purified Water Storage & Distribution with Loop piping. Repeat orders are the hall mark of our consistency in design, project execution and service standards

Meet us at Stall C-11, Hall 6, April 24-26 Goregaon, Mumbai

SPACEAGE

www.spaceageaqua.com

pure science – no fiction

WE HAVE BEEN DOING SO, FOR MORE THAN 10 YEARS.

Widest range of sieve shakers RETSCH’s line of sieving machines not only covers a wide measuring range from 10 microns to 125 mm. Thanks to various sieving motions and sieve sizes it is possible to select the ideal instrument for practically any sieving application. The instruments provide exact and reproducible results and are easy to operate. The sieve shakers of the "control" series comply with the requirements for the test materials monitoring according to DIN EN ISO 9000 ff.

■ ■ ■ ■ ■

www.retsch.com/sieving RETSCH INDIA PVT LTD, 1-2-45/1, 2nd Floor, Street No: 2, Kakatiya Nagar Colony, Habsiguda, 500 007 Hyderabad, India Phone: +91 40 2717 2431, Fax: +91 40 2715 4686 E-mail: info@retsch.co.in, Web: www.retsch.co.in

HEAD OFFICE: Flat No. G 1, Sri Sai Residency, Karkhana, Secunderabad – 500 0015 A.P. Tel : +91 40 32500704, +91 9848129507, 9848597481 ; MUMBAI OFF: Apollo Ind. 30-G, Gr. Flr. Apollo Ind. Estate, Opp. MIDC , Andheri –[E]

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Vibratory Sieve Shakers with 3D movement Horizontal Sieve Shakers Tap Sieve Shakers Air Jet Sieving Machine High-Quality Test Sieves

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World's smallest Roll Compactor with an output of 1 kg/hr Excellent scalability upto 3400kg/hr Feedscrews with designs to handle low BD and heavy powders

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Optional gap-feedback control and accumulators to give excellent flake uniformity minimal fines.

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* The pictures shown in this add is for reference only, actual product may vary.

Bombay Exhibition Center, Goregaon (E)

PARLE GLOBAL TECHNOLOGIES PVT. LTD.

ep@parleglobal.com

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Express Pharma Business Avenues Advertise in

Business Avenues Please Contact: ■ Mumbai: Rajesh Bhatkal 09821313017 ■ Delhi: Ambuj Kumar 09999070900 ■ Chennai: Vijay Kulkarni 09940047667 ■ Bangalore: Khaja Ali 09741100008 ■ Hyderabad: A K Shukla 09849297724 ■ Kolkata: Ajanta / Prasenjit Basu 09831182580 / 09830130965 ■ Ahmedabad: Rajesh Bhatkal 09821313017

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Business Avenues Please Contact: ■ Mumbai: Rajesh Bhatkal 09821313017 ■ Delhi: Ambuj Kumar 09999070900 ■ Chennai: Vijay Kulkarni 09940047667 ■ Bangalore: Khaja Ali 09741100008 ■ Hyderabad: A K Shukla 09849297724 ■ Kolkata: Ajanta / Prasenjit Basu 09831182580 / 09830130965 ■ Ahmedabad: Rajesh Bhatkal 09821313017

April 1-15, 2013

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B

By 2016, many blockbuster drugs of various pharmaceutical giants, which are currently generating around $100 billion sales, will go off patent. In 2013 itself 15 branded drugs are set to go off patent and these numbers are likely to increase in the coming years. This will open a huge market for the Indian pharma companies as India exports generic medicines worth $11 billion.

Dheeraj Aggarwal, Chief Financial Officer, Venus Remedies informs, “The list of drugs going off patent by 2016 includes Sanofi and Bristol-Myers' Plavix, Takeda's Actos, Abbott's Tricor, GlaxoSimthKline's asthma drug Advair and many more. Patent expiration of these big sellers will invite generic competition and put the sales of the blockbuster drugs at risk of being undercut by cheaper, duplicate versions.”

The biggest setback to the branded drugs happened when Pfizer's most popular drug Lipitor lost its patent exclusivity in November 2011. Soon after this, there were another couple of drugs which went off patent and opened the market access to the generic pharma companies. It has opened the competitive market to the generic drug companies and allowed physicians to choose best generics and relieved patients from the healthcare burden.

Ravi Sitaraman, Assistant General Manager – HR, Inventia Healthcare says, ”The generic pharma industry is looking lucrative at this moment with a host of blockbuster drugs ranging from those in pain management to gastroesophageal reflux disease (GERD), from those in asthma to high cholesterol to psychosis going off patent in the current ‘patent cliff’ leading up to 2016. All these small molecule drugs approximately April 1-15, 2013

DHEERAJ AGGARWAL account for $133.0 billion in the US alone that shall be facing generic competition.

As per estimates, roughly 7075 per cent of prescriptions are from generics.”

Chief Financial Officer, Venus Remedies

RAVI SITARAMAN Assistant General Manager – HR, Inventia Healthcare

Planning strategically Competing with each other and keeping pace with the growing needs of a healthy business environment is a must for individual pharma companies hoping to tap the patent cliff opportunity to its hilt. Besides investing in research and development, technology, etc. companies also need to invest in their people/staff in order to retain a stable employee base to execute the company's strategies to tap this opportunity.

Sitaraman agrees with this and avers, “We strongly and truly believe in investing in our talent pool by creating the right atmosphere where employees spend more than a third of their day. The company is well placed technically to conform to noninfringing processes. It is also prudent to be focusing on the ‘large molecule drugs’ which are also expected to account for more than 40 per cent of the US sales by 2016.

We see the coming years to be very exciting and unfold new vistas. Our business is extremely focused on novel drug delivery systems (NDDS) and accordingly we have prepared the road map for the future by carefully shortlisting the therapies and the potential drugs based on its suitability to our business model.”

He continues, “Our deeply entrenched family values form the perfect binder to keep this framework together. By ensuring a conducive work atmosphere we aim at striking the right base notes towards gainful employee engagement. Secondly, the focus and demand for constant innovation is inherent of our business model. This in itself creates an invigorating learning experience for the thinkers and doers alike, resulting in huge job satisfaction. Thirdly, we have encouraging reward and recognition programmes to recognise innovation and stretched contributions.”

Ajay Bhatt, Regional Human Resources Director, www.expresspharmaonline.com

We are one of the very few companies dealing in injectables with complex molecules. We are specialised in oncology, carbapenems, and anti-infective. Therefore, the patent cliff would definitely offer huge opportunities for us

We strongly and truly believe in investing in our talent pool by creating the right atmosphere where employees spend more than a third of their day

Abbott India emphasises, “Building a performance culture and developing the next generation of leaders are critical to Abbott’s success.

Learning and development and continuing employee education are priorities because we believe that it is only through our people that we can achieve our business goals. At Abbott, we help employees realise their full potential with training, mentoring, growth planning and leadership development programmes. We provide a wide range of courses to help employees develop their skills, and build and advance their careers.”

Ravi C Dasgupta, Group Head, HR, Biocon shares his company's strategies and says, “At Biocon we believe in driving a performance culture and our performance management system is designed towards identifying top performers. As a part of this process, we look to provide them with opportunities to grow within the company.

Our strategy for retaining top performers is to keep them challenged, engaged, and motivated to reach significant career milestones.”

Bhatt reveals, “At Abbott, our robust HR programmes and talent management process are geared to meet the changes in the market.

Abbott recognises the value of offering employees both,

an extensive benefits programme that is market competitive, as well as a significant investment in their professional development.”

Retention “Retention strategies are never sporadic, rather a process evolved over time.

Hence, our strategies for retention are woven around several dimensions.

Appraisal process is therefore just one of the tools in the basket and over-reliance on the outcome of this process alone may not necessarily yield the right dividends. We have invested in automating our performance management system for effective tracking and encouraging key stakeholders to invest quality time in the entire process – be it goal setting or review,” adds Sitaraman.

Recognition High potential and top performing employees are key to growth and success.

Acknowleding this fact, Aggarwal shares, “At Venus, we organise and celebrate our Annual Raising Day in March where we appreciate and acknowledge the efforts and performances of our employees for their dedicated work in the best interest of the company. Besides this, we engage our employees in various activities within the EXPRESS PHARMA

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company's premises, which include employee stock option plans (ESOPs), halfyearly increments, stability increments linked with performance and long stay in the company, tutor and training programmes, voting for best departments on quarterly basis and committee system wherein various committees are involved in value addition activities apart from the employees' specific job profile.”

Venus also provides additional perks to its top performers and promising new comers every year on their Annual Raising Day. “We firmly believe that word of appreciation and accolades are the best way to boost the morale of your employees.

Apart from this, our employees are also provided with various facilities which includes allotment of cars to senior employees, twowheelers to other employees, bus facility for pick and drop from Baddi unit and so on,” informs Aggarwal.

However, Inventia Healthcare is still at its policy framing stage. Sitaraman briefs, “Over and above our existing reward and recognition framework, we would explore more innovative ways of incentivising superior performance; modalities of which are at a nascent stage.”

Spur to growth The Indian pharma market is both cluttered and fragmented. In order to make an impact in such an environment, one needs quality products, good marketing strategies and a competent sales force. So, is the industry able to attract fresh talent to join its ever expanding sales force? Or is the regulated nature of the pharma industry acting as a deterrent?

Dasgupta shows his concern over regulatory interference commenting, “Doctors prescribe drugs based on their confidence that the drug will work and cure their patients quickly, with little or no side effects. Thus, the recent changes which regulators have introduced as new rules and regulations for the pharma industry would not adversely affect companies with good products and strong brand. That being the case, the inflow of fresh talent should not dry up.”

Another point of view is that this challenge can be overcome, provided the edu-

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AJAY BHATT

RAVI C DASGUPTA

Regional Human Resources Director, Abbott India

Group Head, HR, Biocon

We believe that it is only through our people that we can achieve our business goals

This year the projected increment is 12.5 per cent for the pharma industry

cation system trains these new recruits. “Regulations over the years have always become more stringent. In one way it helps us to be more competitive in the global market and thereby attract quality talent which is critical for the organisation’s success. But I do not foresee this as an impediment in attracting fresh talent. The industry will always require fresh infusion of talent at the base of the pyramid. The only concern is the alignment of the curriculum to the industry needs which makes the transition from being ‘student’ to that of a ‘professional’ that much more easy.

This fortunately has been happening in the last few years,” remarks Sitaraman.

However, Aggarwal senses, “We don't think increasing stringency would hamper the process of attracting fresh talent into the industry as rules and regulations are in the best interest of the industry. The pharma industry (in India) is evolving from generic contract manufacturing to a research driven industry. With new innovations and inventions coming, it is required to have strict laws to minimise the chances of duplicacy and maintains exclusivity. This dynamic change in the industry would rather allure more fresh talent into the industry.”

dicted at 13.3 per cent) which is again impressive considering the industry average of 10.3 per cent which in turn is a tad lower as compared to last year.

India is seen at the fifth spot in the top five global list of payouts. The survey has also pointed out continuation of the trend that has been set over the last three years or so – around three per cent on an average higher payout for the top talent.

The life sciences sector is also slated to witness high increment of around 13.1 per cent. All these are still impressive figures, given that corporate houses across sectors have not been able to record improved performances early on in the review year due to global and domestic economic uncertainties. This also speaks a lot on the tremendous pressure that companies face in carrying out the ‘balancing act’ to retain their key talent and at the same time not be over adventurous with their overheads.

In this context, sustainability will largely depend on how successful companies are in optimising their resources and processes.

Innovation shall be the key differentiator, according to the Aon Hewitt Survey.

Aggarwal anticipates, “It is speculated that the Indian pharma industry will offer its employees an increment of around 10 per cent for the year 2013. As far as sustainability is concerned, it will be sustainable as the pharma industry in India is very promising and is poised to grow at a great pace. In 2012, the industry witnessed a growth of 25 per

Forward looking As per the recently released Aon Hewitt 17th Annual Salary Increase Survey 2013, the predictive figures for the pharma sector this year is pegged at 13.5 per cent (last year it was prewww.expresspharmaonline.com

cent in exports, 17-18 per cent in domestic sales and so on.”

In the pharma industry, salary increases are usually in the 10 per cent to 15 per cent range. Companies need to provide such increases as the job market is volatile and many opportunities exist for job seekers.

Dasgupta predicts and informs, “This year the projected increment is 12.5 per cent for the pharma industry. As long as talent is in short supply and you have multiple organisations vying for the same pool of talent, organisations have to continue to pay such increments.

Having said that, in the last few years the differentials between salaries in India and more developed countries are shrinking. For many roles, salaries in India are 40-70 per cent of markets such as the US. As there is also considerable difference between the prices you can command in India vs. abroad, such increases may not be sustainable beyond a few years and organisations have to let talented people go and look at grooming fresh talent.”

Agarwals reveals, “Being a research-driven company, we are very optimistic about our research products. We have a bi-annual appraisal system in Venus Remedies.

In 2012, the companies have given approximately 10-11 per cent of salary hike to its employees despite the rising cost and slow growth rate of pharma industry. On an average, we offer 10 per cent salary hike to our employees.”

On the other hand, Inventia Healthcare follows the industry benchmark and it will continue for the current year too.

So far, the reading is that this year and the coming year too have some big opportunities. But the candidates need to match their talent with the companies’ capabilities.

As we have seen in 2012, percentage of increments in the pharma industry was 12.5 per cent; in 2011 it stood at 12.3 per cent, and in 2010 it was 11.7 per cent which reflects a continuous growth curve. Here’s hoping that the ascending opportunities match with the expectations of the industry, employers and employees in the coming years. u.sharma@expressindia.com April 1-15, 2013

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APPOINTMENT MSF Access Campaign names Rohit Malpani as new Director of Policy and Analysis Will take up his position mid-April ohit Malpani will take up his new role as the Director of Policy and Analysis at Médecins Sans Frontières’ (MSF). Malpani will succeed Michelle Childs, who has stood down from her position as Director of Policy Advocacy, after four

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and a half years at MSF Access Campaign. Malpani will be based in Geneva.

Malpani joins MSF from Oxfam, where he is currently Special Advisor, Policy and Campaigns Unit for Oxfam Hong Kong. He has also worked for Oxfam America, the International Federation of the Red Cross,

and various UN agencies in Geneva, India, and the Maldives. He holds a Juris Doctorate from New York University’s School of Law and a Bachelor of Arts in Political Science and Biology from Rice University in Texas.

Dr Manica Balasegaram, Executive Director of the

Access Campaign said, “I am excited to welcome Rohit to the Campaign; his strategic insight, technical knowledge and his experience in campaigning on access to medicines issues are highly valued and I know he’ll make a positive impact in the areas where we work.”

EP News Bureau-Mumbai

of professionals at KPMG in India. I am very optimistic about our combined ability to grow both the businesses in this environment. We seek to capitalise on these positive fundamentals through further deepening our sector skills, while expanding the spectrum of deal services to add value to our clients.”

Richard Rekhy, Chief Executive Officer, KPMG in India said, “We are delighted to welcome Palnitkar into the

KPMG family. An industry veteran, Palnitkar has a vast experience across life sciences, business advisory, government, real estate and infrastructure advisory.

Several of the practices he led were market leaders amongst the Big Four. I am confident that under his able leadership, the transactions and restructuring business will see exponential growth in the coming phase.”

EP News Bureau-Mumbai

Utkarsh Palnitkar joins KPMG Will be the Partner and National Head of Transactions & Restructuring practice and for the Life sciences practice PMG has announced the appointment of Utkarsh Palnitkar as Partner & National Head of Transactions & Restructuring practice and for the Life sciences practice. Palnitkar has joined KPMG in India from Centrum Capital, a large financial services company,

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where he was an Executive Director. Prior to this, he was associated with Ernst & Young (E&Y) for 15 years.

During this period he was office managing partner of E&Y’s Hyderabad practice, leader of the advisory practice and led the Life sciences practice.

Speaking on his appointment, Palnitkar said, “I am honoured to be given the opportunity to lead this tremendously talented group

OBITUARY Dr K Anji Reddy, Founder and Chairman, DRL, passes away he Founder and Chairman of Dr Reddy’s Laboratories (DRL), Dr K Anji Reddy, passed away recently in Hyderabad. With his demise, a golden chapter of Indian pharmaceutical industry has come to an end.

Reddy was fighting cancer for a long time. He is always considered as one of the pharma

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entrepreneurs who redefined the growth of the Indian pharma industry.

Reddy graduated from Bombay University in B.Sc. (Tech) with specialisation in Pharmaceutical Science and Fine Chemicals and obtained his Ph.D in Chemical Engineering from National Chemical Laboratory, Pune.

He founded DRL in 1984.

Under his leadership, DRL has been a pioneer and trendsetter in the Indian Pharmaceutical industry.

Reddy’s leadership made DRL earn many prestigious recognitions. He knew the importance of research oriented growth and his passion for research led DRL taking up

drug discovery research in 1993. Reddy set up in 1998 the “Naandi Foundation” as a Public Charitable Trust. The Government of India in April 2011, awarded Reddy a “Padma Bhushan” in recognition of his distinguished service of high order in the field of Trade and Industry.

EP News Bureau-Mumbai

Ion Exchange mourns Founder GS Ranganathan’s demise on Exchange (India) lost its Founder and Chairman with the passing away of G Shankar Ranganathan on March 18, 2013.

Ion Exchange was formed in 1964 as a subsidiary of British Permutit on Rangnathan’s initiative and recommendation. In 1984 when Permutit divested their holding, he advocated and set up employee welfare trusts, a pioneering concept

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April 1-15, 2013

for India. He expanded the company’s technology base through R&D, joint ventures, licensing and representative agreements.

This enabled the company to offer total and integrated solutions for all sectors - industry communities and homes, urban and rural. He also built up an impressive countrywide infrastructure of factories, sales offices, dealers and www.expresspharmaonline.com

and service network. Under his visionary leadership, the company attained its pre-eminent position in water and environment in India and globally.

Constantly scanning the environment and quick to opportunities, very early on Ranganathan took Ion Exchange into new market avenues such as desalination, water conservation and recycle, rural water

treatment, services and exports.

He was convinced that people are an organisation’s greatest asset and had a unique ability to empower and build up people and inspire lasting loyalty. He laid a strong foundation for the company through R&D, training, and development, systems and quality standards.

EP News Bureau-Mumbai EXPRESS PHARMA

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JOB TRENDS Pharma sector witnesses four months of consecutive upswing in hiring Hiring activity moves up by five per cent in February 2013 There is some good news coming on the way of job seekers as hiring activity for the pharma sector moved up by five per cent in

2012 is eight per cent more than the same time a year before. The index value at 1381 is the highest value in the last one year.

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The Naukri job speak index for the Pharma sector is a monthly report that indicates hiring trends across industry sectors, geographies and functional areas February 2013 when compared to January 2013. This upward movement in the Naukri Job Speak index has been witnessed consecutively for the past four months. Also, what is interesting to note that hiring activity for the sector in January

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April 1-15, 2013

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