Express Pharma January 1-15, 2013

I N D I A’ S F O R E M O S T P H A R M A & B I OT E C H P U B L I C AT I O N January 1-15, 2013 ` 40

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FORTNIGHTLY INSIGHT FOR PHARMA PROFESSIONALS

VOL 8 | NO. 5 | PAGES 78

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Pharma VOL 8. NO. 5 JANUARY 1-15, 2013

Chairman of the Board Viveck Goenka

CONTENTS

Editor Viveka Roychowdhury*

RESEARCH

BUREAUS

Merck, GE to collaborate on Alzheimer’s drug development PAGE 47 GlaxoSmithKline wins US approval for new flu vaccine PAGE 48

Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das Bangalore Neelam M Kachhap Delhi Shalini Gupta MARKETING Deputy General Manager Harit Mohanty

PHARMA ALLY

Senior Manager Rajesh Bhatkal

'We are committed to discovering new approaches for drug delivery' PAGE 49 'Both academia and industry drive the growth for the Indian market' PAGE 50 SPDS officially launched at 64th Indian Pharmaceutical Congress PAGE 52 VSEP-A revolutionary effluent recycle technology PAGE 53

PRODUCTION General Manager B R Tipnis Production Manager Bhadresh Valia Asst. Manager - Scheduling & Coordination Arvind Mane Asst. Art Director Surajit Patro Chief Designer Pravin Temble Senior Graphic Designer Rushikesh Konka Photo Editor Sandeep Patil

PHARMA LIFE

Layout Rakesh Sharma

'Community pharmacist slowly transforming from a trader to a professional' PAGE 73 Dr Rabinder Buttar, CEO, ClinTec International wins Scottish Asian Business Women of the Year Award 2012 PAGE 75

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

January 1-15, 2013

PAGE 44

MARKET State drug regulators equally responsible for clinical trial activities: DCGI PAGE 36 iPHEX 2013 to showcase Indian pharma exports; R&D capabilities ‘Envisioning affordable healthcare for all’ PAGE 41

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EDITOR’S NOTE

2013: A year of short-term pain, for long-term gain?

With 2013 all set to be a watershed year in the life sciences sector in India, we present some ‘Predictions from Pharma Pundits’ to kickstart the year. One theme that promises to lend colour to the years ahead is the increasing role of the patientconsumer. Tapan Ray, Director General, OPPI focusses on how ‘empowered patients’ will change the dynamics of the sector, as they are expected to play an important role in their healthcare decision making process.

The vocal role of NGO networks like the All India Drug Action Network (AIDAN) is a case in point. Its petition to the Supreme Court (SC) of India on rational drug use delayed the drafting of the National Pharmaceuticals Pricing Policy, 2012 and could still change its contours, with the SC due to hear further contentions based on the PIL in the second week of January. The SC is also set to decide on Novartis’ plea on the Glivec patent, another case which could have long-term repercussions. Thus as Milind Sathe, Deputy General Manager-Projects, Unichem Laboratories predicts, IPR issues will mark 2013.

Adding to this theme, is Ankit Suri, Vice President, Tecnova India who says companies will have to be quick to spot changes and trends in consumption patterns and then adapt accordingly.

The adapt and adopt policy is most starkly seen among MNC pharma who have implemented Indiafocussed strategies in the last year, taking on domestic pharma with a new aggression. For example, Hitesh Sharma, Partner & National Leader – Life Sciences, Ernst & Young points out that both

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MNC pharma and their domestic counterparts are today chasing growth in the the country's Tier II and rural markets, even as they collaborate on other fronts.

Anjan Sen, Director, Deloitte Touche Tohmatsu India too stresses the attractiveness of the Indian pharma story in the long term, provided they focus on internal improvements in their business models in the face of relative lack of clarity on policy issues.

Clinical research and trials have been in the news for the wrong reasons in 2012 and the CRO industry seems to gearing up to set the record right in 2013. Dr Kiran Marthak, Vice Chairman, Medical Sub Committee- IDMA and Head Global Clinical Development, Lambda Therapeutic Research, stresses that improved awareness will lead to better business while Hemant Rehani, Vice President & Head - Clinical Development Services, India & Sri Lanka, Quintiles calls for self regulation within the industry. Increasing expectations of sponsors, investigators and patients will also pressurise CROs to turn to technology for solutions, predicts Ted Gastineau, President, ICON Clinical Research.

With impending regulatory reform and the depressed global economy set to be the leitmotif for the year ahead, 2013 could see some short-term pain (new regulations), in the interest of long-term gains (better efficiencies, more transparency). Will the industry be able to walk the talk?

Viveka Roychowdhury viveka.r@expressindia.com

January 1-15, 2013

QUALITY AND HEALTH FOR ALL

SanjeevGupta,MD,KusumIndia

RajeevGupta,MD,KusumUkraine

KusumHealthcarehasemergedasone of the leading pharmaceutical companies in the CIS countries, specifically Ukraine.Whatstrategieshadthemanagement devised to achieve this remarkablefeat?

Kusum group of companies owe their existence to the team of two brothers, elder brother Sanjeev Gupta based in India and younger brother Rajeev Gupta based in Ukraine. It was Rajeev Gupta who went to Ukraine to study engineering and spotted theopportunityandpotentialforpharmaceuticalformulationbusinessintheearly 1990s. Starting point for the business in CIS was Gladpharm Ltd., which began its operations in early 1990s as Distribution Company in Ukraine. Today Gladpharm the distribution company is a captive distribution setup and ranks among top 10 distributors in terms of business and has warehouses and delivery facilities with ownsalesteamsformerchandising.Gladpharmisoneof theonlythreedistribution companies in Ukraine with GDP (Good DistributionPractice)certificationasper PIC/snorms.

In 2002 KHPL began marketing of own products by registering own brands and promoting them to doctors through dedicated field force in Ukraine. Currently Kusum is at 1st position among all Indian companies in Ukraine. In 2006 Kusum group of companies went on to establish two manufacturing units one each in Bhiwadi-IndiaandSumy-Ukraine.

All this has been achieved because of our singular focus on quality. When we speakof qualityitisnotonlyqualityof finished products but it encompasses every

aspect of business and all stake holders.

To ensure the quality of our formulations,whenwestartedbuildingourmanufacturing facilities they were designed to meet current and future regulatory requirements of all important markets worldwide. Building world class facilities is one aspect but even more important is puttingsystemsinplacetoensurequality by design, not by accident. As a result our Indian facilities have been audited and certified three times by Ukraine and Ukrainianfacilitiestwice.Apartfromthis Indian facilities are audited and certified byKazakhstanandMoldova.Wewelcome audits as they help us to push ourselves several notches higher on the quality ladder. Kusum India Facilities are approved after the Ukraine audit as PIC/S compliant facilities and Ukrainian facilities too qualifyforthePIC/Scompliancebyvirtue of it being certified by Ukrainian MOH. Our motto is “Quality and Health for all” and we constantly strive to ensure it.

WhenwestartedKusumUkraineplantwe added a line stating “In Ukraine for Ukrainians” because we believe that like treeswhichderivenutritionfromsoiland give it back to the soil in their lifecycle; we toohavederivedourgrowthfromUkraine and we give it back to the country which providedusthebaseandopportunitytobe wherewearetoday.

Weneversparedanyeffortsinensuring thatwehaveallfunctionsoperatingasper the recommended SOPs such as Pharmacovigilancetomonitorthepostmarketing efficacyandsafetyof ourproducts.

We expanded operations to other CIS countries like Kazakhstan, Uzbekistan and Moldova where also thanks to excellentteamandleadershipweareamongtop threeIndiancompanies.

Worldwide now there is requirement of dossiers in CTD formats and looking in to our current requirements and futuretoowehaveafullyfunctionalteamof specialist in the Regulatory cell to meet the exacting regulatory requirements of differentcountries.

Your plant is PIC/S certified. How significantisthisachievementforKusum Healthcare, what are its benefits? Will this help you in the Indian market too?

To understand this we should know what exactlyPIC/Sis.

The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (jointly referred to as PIC/S) are two international instruments between countries and pharmaceutical inspection authorities, which provide together an active and constructiveco-operationinthefieldof GMP. PIC/S’ mission is "to lead the international development, implementation and maintenanceof harmonisedGoodManufacturing Practice (GMP) standards and quality systems of inspectorates in the fieldof medicinalproducts”.

There are currently 41 Participating Authorities inPIC/S As per the convention, products manufactured in manufacturing facilities in anyof the41participatingcountriesneed not undergo quality certification for every batch release when exported to anotherPIC/smembercountry.

Further,if manufacturingfacilitiesare locatedinacountrylikeIndiawhichisnot participant country, it needs to be audited by competent authority of the importing country if that country happens to be PIC/S participant. Once the facilities are audited and certified by any of the 41 participating country the products from these facilities can be exported to other PIC/S participating country without repeat audit. Of course marketing authorisation has to be obtained from the importing countries MOH or designated authority.

Because Kusum Bhiwadi facilities andSumyfacilitiesareauditedbyPIC/S member country Ukraine these facilitiesdonotneedauditof otherremaining PIC/s participating countries for export. Now there is a trend in many places that manufacturing facilities need to be audited even before you apply for marketing authorisation in a country. We do nothavetoundergothisauditof individual country before applying for marketingauthorisation.

With regards to India the benefit is that we will provide them medicines of international quality at Indian prices. Now everyonerecognisesthebenefitof quality medicines in terms of efficacy and safety for the end users, so that should help us in marketingourproductsinIndiatoo.

WheredoyouseeKusumHealthcarein

thecomingfiveyearsgloballyandhow isitplanningtoreachthisaim?

Answer to this has to be in two parts first concerninginternationalmarketandsecond part with regards to Indian market.

On the International side we are working on getting marketing authorizations for four Southeast Asian markets namely the Philippines, Malaysia, Vietnam and Myanmar. We have a number of authorisationsineachof thecountriesandactivitiestoexpandtheproductportfolioaswell assettingupfull-fledgedoperationsthere.

Apartfromthiswearelookingatmoreopportunities and markets in the same region. We are also considering putting up manufacturing facilities in other countriesinfuture.

Marketing operations in India are still at a nascent stage. We just started in the first quarter of 2012 with four states and soon would like to double it in 2013 beginning, and have all-India operations by 2015. Once we have established our presence all over India we will expand and enterintospecialtysegments.

Can you share with us the level of investmentandeffortsinR&D? Withregardstoformulationdevelopment we have a multipronged approach. We used to collaborate with reputed institutions such as well-known UICT Mumbai professors. We have now fully equipped formulation R&D facilities operational at Bhiwadi where our manufacturing facilities are located for quite some time. A full teamof developmentandanalyticalscientist is in place which we would be expanding further. Still we do collaborate with institutions such as UICT to expedite the development of a large number of products and drug delivery systems and new therapeuticareas.

Is the company planning to enter into JVagreementswithothercompanies?

Currently we are working with Takeda/NycomedinUkraine.

We do get more offers and we are workingactivelyonmarketingoralanti-diabetic products still under patent under licencefromtheinnovators.Wealsogetoffersfromotherstomarketourproductsin markets where we do not have a presence as yet. We keep our options open and are willingtocollaborate.

Celebrating20yearsofdiplomaticrelationshipbetweenIndia&Ukraine WelcometoIndiaHEMr.ViktorYanukovych,ThePresidentofUkraine ADVERTORIAL

MARKET

W H AT ’ S INSIDE

THE BUSINESS OF PHARMACEUTICALS

Empowered Patients’: A changing dynamic PG 14 Growth intact amid current headwinds faced by industry PG 16 Adapting to the evolving consumer landscape PG 18 Indian pharmaceuticals: A long-term story PG 19 Improved awareness will lead to better business PG 21 Indian clinical research: A call to self regulate PG 22 Indian pharma: Emerging as global power in R&D PG 24 Tech solutions to improve management PG 26 IPR trends in 2013: An alloy of problems and solutions PG 27 Transformational change in 2013 PG 30 Modest progress in fiscal and public sector reforms expected PG 32

MANAGEMENT 44 RESEARCH 47 PHARMA ALLY 49 PHARMA LIFE 73 January 1-15, 2013

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‘Empowered Patients’: A changing dynamic ‘Empowered Patients’ are expected to play an important role in the healthcare decision making process, opines Tapan J Ray, Director General, Organisation of Pharmaceutical Producers of India n the good old days, when someone used to fall sick in the family, a friendly local medical practitioner, known as a ‘family doctor’, used to be called for treatment.

Unfortunately, they are a vanishing breed of caring doctors in today’s world.

Thorough knowledge of patient’s medical history gained over a period of time used to come handy to these ‘family doctors’ while treating patients. Their smiling or at times even an admonishing look for falling sick due to avoidable reasons, a caring approach and willingness to patiently answer all questions even beyond sickness, used to instill a strong confidence and hope to the patients for a quick recovery.

Today’s perspective is very different. The concept of a ‘family doctor’, by and large, does no longer exist, even in the urban families of India. Though the elite groups belonging to the upper echelon of the society still talk in terms of ‘my dentist’ - ‘my cardiologist’ - ‘my physician’, common patients, on the contrary, have already started experiencing that their healthcare needs are being greatly compromised.

The good news is that in future, one can still expect to

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Tapan J Ray Director General Organisation of Pharmaceutical Producers of India (OPPI)

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call a doctor home for treatment, which may not cost a bomb, as it happens today.

However, they may not exactly be of the same ilk as the 'family doctors’ of the yesteryears. For instance, a media report in early January this year talked about how an IIM-A student decided to drop out of the course and set up a business where he promises to deliver both doctors and medicines at the consumer’s/ patient’s doorstep over a phone call.

That said, the doctor–patient relationship has also undergone a vast change over a period of time.

The healthcare environment of this era in India, more often than not, smacks of commercial ‘gain and loss’ of the private service providers, just as the public health system has been failing to deliver.

In a situation like this, the civil society also has a critical role to play. Like, many other countries of the world, in India too, the society should encourage individual ‘Patient Empowerment’ by making him/her understand how the healthcare system is currently working on the ground.

Make people aware, who and what are the key obstacles in getting a reasonably decent healthcare support.

At the same time, there is a need to carefully explore how effectively those issues can be addressed in the democratic framework of the country.

To achieve this goal, the

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movement of ‘Patient Empowerment’ started in the US in 1970’s, which asserts that for truly healthy living, one should get engaged in transforming the social situation and environment affecting one’s life, demanding a greater say in their respective treatment process by observing the following tenets: ● Patients’ choice and lifestyle cannot be dictated by others ● ‘Patient empowerment’ is necessary even for preventive medicines to be effective ● Patients, just like any other consumers, have the right to make their own choices Thus, the ‘Empowered Patients’ should always play the role of participating partners in the healthcare process.

‘Natural Health Perspective’ highlighted 'Patient Empowerment' as follows: ● Health, as an attitude, can be defined as being successful in coping with pain, sickness, and death ● Successful coping always requires being in control of one’s own life ● Health belongs to the individual and the individuals have the prime responsibility for their own health ● An individual's capacity for growth and self-determination is paramount. ● Healthcare professionals cannot empower people only people can empower

themselves In today’s world, as said earlier, the distrust of patients on the overall healthcare system is growing all over the world. This situation makes an ‘Empowered Patient’ resolve to actively participate in his/her medical treatment process.

In a scenario like this, other stakeholders in healthcare will also require to align themselves with a ‘PatientCentric’ approach, which has already started happening in many parts of the world. In India, as ‘out-ofpocket’ healthcare expenses are skyrocketing in the absence of a comprehensive and affordable Universal Health Coverage (UHC), ‘Empowered Patients’ will increasingly demand to know more of available treatment choices and medicine prescription options.

As a proactive measure to this emerging trend, many global companies have already started taking new initiatives to open up channels of direct communication with their primary and secondary customers to know more about them in order to satisfy them better.

In future, with growing ‘Patient Empowerment’ the basic sales and marketing models of the pharma companies are also expected to undergo a metamorphosis.

There could probably be a switch from ‘hard-selling’ to a new process of achieving business excellence through constant endeavour to satisfy both the expressed and

January 1-15, 2013

the un-expressed needs of the patients, not just with innovative products, but more importantly with innovative and caring services.

In the years ahead, more and more ‘Empowered Patients’ are expected to play an important role in their healthcare decision making process, initially in the urban India, ensuring further improvement not just in the public and private healthcare system, but also in engaging the pharma industry to be a part of that changing process.

In the book titled, The Empowered Patient: How to Get the Right Diagnosis, Buy the Cheapest Drugs, Beat Your Insurance Company, and Get the Best Medical Care Every Time, Elizabeth Cohen articulated as follows: “The facts are alarming.

Medical errors kill more people each year than AIDS, breast cancer or car accidents. A doctor’s relationship with pharma companies may influence his choice of drugs

January 1-15, 2013

for you. The wrong key word on an insurance claim can deny you coverage.”

‘USA Today’ dated August 31, 2010 in an article titled, “More empowered patients question doctors' orders,” reported: ‘In the past, most patients placed their entire trust in the hands of their physician.

Your doctor said you needed a certain medical test, you got it. Not so much anymore.’

Unfortunately in India, the situation has not changed much just as yet.

Reinhard Angelmar, the Salmon and Rameau Fellow in Healthcare Management and Professor of Marketing at INSEAD, was quoted saying that 'Empowered Patients' can make an impact even before the drug is available to them. He cited instances of how the empowered breast cancer patients in the US played a crucial role not only in diverting funds from the Department of Defense to breast cancer

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research, but also in expediting the market authorisation and improving market access of various other drugs.

Angelmar also highlighted that ‘Empowered Patients’ of the UK were instrumental in getting NICE, their watchdog for cost-effectiveness of medicines, to change its position on the Age-related Macular Degeneration (AMD) drug and approve it for wider use than originally contemplated by them.

To respond to the challenge posed by the ‘Empowered Patients’, pharma companies especially in the US are in the process of developing innovative approaches for a more direct relationship with the patients and patient groups. Creation of ‘Patient Empowered’ social networks may help addressing this issue effectively.

For example, to respond to this challenge of change companies like, Novo Nordisk has reportedly developed a vibrant patient community named ‘Juvenation’,

which is a peer-to-peer social group of individuals suffering from Type 1 diabetes. The report also says that this programme was launched by the company in November 2008 and now the community has over 16,000 members, as available in its ‘Facebook’ page.

To cite another example, Becton, Dickinson and Co. reportedly created a webbased patient-engagement initiative called 'Diabetes Learning Center' for the patients, not just to describe the causes of diabetes, but also to explain its symptoms and complications. From the website a patient can also learn how to inject insulin, along with detailed information about blood-glucose monitoring. They can even participate in interactive quizzes, download educational literature and learn through animated demonstrations about diabetes-care skills.

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Indian pharmaceutical industry— growth intact amid current headwinds faced by industry Pharma MNCs have adopted India-focused strategies to tap the growing potential of the country’s pharma market, says Hitesh Sharma, Partner & National Leader – Life Sciences, Ernst & Young midst the increasing patent cliffs, declining R&D productivity, and increasing regulatory and price containment pressures; the global pharmaceutical market continues its focus toward emerging markets.

The contribution of emerging markets is expected to double by 2016, as compared to 2006. The growth in emerging markets is expected to be led by China and India in the near future (China with a CAGR of 15 per cent–18 per cent during 2012–2016 and India with a CAGR 14 per cent–17 per cent during 2012–2016).1 This augurs well for all the constituents of the Indian pharma industry – Indian companies and global pharma companies along with all ancillary supporting players like CRAMS, CROs. The Indian pharma industry is expected to be among the top 10 global markets in value terms by 2020, bolstered by increasing domestic demand. The Indian pharma (formulations) industry stood at ` 629.0 billion in FY12, registering a y-o-y growth of 16 per cent2 and expected to reach around ` 55 billion by 2020.

Essentially the domestic market growth has been driven by increased affordability (middle class growing by 67 per cent from 160 million in 2011 to 267 million), access to healthcare (Increasing penetration of private health insurance—CAGR of more than 30 per cent) and change in the disease profile from acute to chronic.

The growth of the market was largely driven by sales of drugs for chronic diseases such as diabetes and cardiovascular ailments, which grew by nearly 21 per cent yo-y in FY12.

Global pharma majors continue their strategy of inorganic growth, differential pricing strategy and rural initiatives to increase their market presence in India.

Also with the Indian Government’s focus on Indian healthcare growth with coverage of the masses through the National Rural Health Scheme, even with

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Hitesh Sharma Partner & National Leader Life Sciences, Ernst & Young

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the economic conditions, the Indian pharma industry is expected to continue.

strategies to tap the growing potential of the country’s pharma market.

Global pharma companies India to remain as a key market

Increased patented drug launched in India

India continues to remain a focus market for pharma MNCs. Currently, the Indian market is regarded by MNCs as one of the faster growing market globally, primarily driven by a large population, evolving patient demographics, increasing health care expenditure, growing urbanisation, rising life expectancy, and active private-sector participation.

They have increased investments in the domestic market over the past few years and are now comfortably placed to capture a sub-

The advent of the product patent regime in 2005 instilled confidence in the country’s IP regime. With renewed confidence, large pharma MNCs are now looking to launch their patented drugs in India and such product launches are expected to increase further in future.

Adopting inorganic route to enhance presence Pharma MNCs have been considering acquisitions of domestic players to gain sizeable share in the domestic market. These acquisitions have also enabled pharma

put some bumps for the MNCs. On the other hand, licensing agreements with Indian companies have helped pharma MNCs access a ready basket of generic products.

Going forward, these deals are likely to accelerate the launch of products in various emerging markets while offering MNCs the advantage of cost-effective manufacturing. Furthermore, pharma MNCs consider India as a preferred strategic outsourcing partner with services ranging from Contract Research Manufacturing (CRO) and clinical research services to sales and marketing, information technology, finance and accounting, and customer-relationship management.

Graph 1: Indian pharmacetical market

Source: Domestic Pharma monthly review- April 2012, Edelweiss Securities and OPPI

Graph 2: Growth trend of acute vs chronic segment (%)

Source: Domestic Pharma monthly review- April 2012, Edelweiss Securities stantial share of the domestic market. MNCs have outperformed the growth rate of domestic players in 1H FY13.

Evidently, pharma MNCs are projected to capture a 35 per cent market share of the market by 2017, compared with 28 per cent in 20095. Over the years, pharma MNCs have adopted India-focused www.expresspharmaonline.com

MNCs to access the infrastructure, distribution networks, and management capabilities of domestic players, thereby strengthening their business operations in the country. However, valuations and the current debate by the Indian Government on Foreign Direct Investment guidelines for the sector have

Differential pricing strategy to strengthen market reach In a bid to compete with domestic generic players, pharma MNCs are launching patent-protected drugs in India at relatively low price points than those in developed markets.

Simultaneously, a differential pricing strategy is helping January 1-15, 2013

these MNCs to enhance their market reach by addressing affordability issues. Drugs such as Diovan (Novartis), Januvia (Merck Sharp & Dohme), and Galvus (Novartis) are being sold at discounts of up to 80 per cent on global prices.

ket opportunity for the future.

While exports continue to be a large driver of margins for the larger Indian companies, given the regulatory environments in the regulated markets, the margins will continue to be under focus going forward. Also the

adherence to the regulated standards will be an area that most of the Indian companies tapping global markets would have to differentially focus on.

The Indian companies have also continued to focus on the Indian market. While launches of new products in

the Indian markets has come down (as a result of the IP regime), the focus has turned towards reach and therefore growth in Tier-II and rural markets. Also the focus is more on more effective marketing and distribution strategies. Alliances with MNCs as part of co-marketing/distri-

bution arrangements are further strengthening this learning for the industry.

CRAMs players had at the start of the year felt a lot of pressure and in some case seen a de-growth.

But the industry seems to be Continued on Pg 23

Rural-centric initiatives to enhance market access Robust consumption in the rural economy is expected to be a key growth driver.

Rural India accounts for more than 70 per cent of all Indian households and close to 40 per cent of the total consumption pie. Henceforth, a large number of companies are organising their efforts to derive a major portion of their overall sales from this untapped market.

Additionally, pharma MNCs are looking to implement new and effective business models in India and improve the health of patients. Delivering patient health outcomes implies getting involved in the cycle of care, rather than just delivering drugs to a health care system.

The Government’s regulatory and pricing policy is likely to have a larger impact on the MNCs. Also the IP litigation does create a few bumps for the MNCs. However, overall the India story still remains positive for MNCs.

Domestic pharma players Indian pharma manufacturers are known globally for their low-cost approach, which is backwards-integrated and has the scale to challenge patents and be the first to launch on their expiry.

With $76 billion worth of patented drugs likely to go off patent in the US between 2012 and 2015, India is poised to capture its share of the global generics market Plavix, Seroquel, Singulair and Lexapro went off patent in 2012. Consequently, the share of global generics (including biosimilars) is expected to increase from 25.3 per cent in 2011 to 35.2 per cent by 2016. This rise in the demand for generics is likely to drive the growth of bulk drug export of off-patent drugs.3 In addition, super generics, the incrementally modified generics drugs (IMDs), are currently at a nascent stage of their development in India, but offer a huge marJanuary 1-15, 2013

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Adapting to the evolving consumer landscape Ankit Suri, Vice President, Tecnova India, predicts that both MNCs and Indian pharma companies will adopt new tools and business models to adapt to the evolving market and consumer landscape iven its traditional resourcefulness and determination, it is beyond doubt that India is a key driving force for the current global pharmaceutical industry. In recent years, healthcare demands among the region’s populations have increased and its low operating costs continue to attract pharma companies.

And, it is emerging as a powerhouse of pharma Research & Development (R&D) facilitated by the availability of a vast patient population, quality data, lower costs and skilled manpower.

The Indian pharma industry is growing at about 12 to 13 per cent annually and is expected to grow to $45 billion by 2020. Along with the change in the growth momentum, the industry is deliberating over how Indian market can scale up to an even higher growth trajectory. Seeing the aggressive growth of this sector the Government of India also aims to position the country among the top five pharma innovation hubs by 2020, with one out of every five to 10 drugs discovered worldwide originating from the country, by 2020. The drivers of growth have proliferated and become more nuanced.

Key growth driver factors such as an increased patient pool, increasing accessibility to drugs due to a rise in investment in medical infrastructure, greater acceptance of new medicines and higher affordability will be the drivers of growth in this sector.

G

Ankit Suri Vice President Tecnova India

people will have health insurance by 2020. While private insurance will grow by 15 per cent by 2020, the majority of people will be provided insurance through government-sponsored schemes which focus on the ‘bottom of the pyramid’ segment of society.

Increased chronic diseases Treatment for chronic diseases such as asthma, cancer, diabetes, heart ailments, osteoporosis and kidney problems will likely to constitute more than half of India’s pharma market by 2020. According to estimates, cardio vascular diseases (CVDs) and diabetes will surge the most, rising to six times by 2020.

Preventive care The acceptance of biologics and preventive medicine is rising and companies are aligning their focus from treatment to prevention in healthcare.

The market expects an increase in the usage of preventive medicines like vaccines. Vaccines

Affordability will result in half of the forecasted growth, with rising incomes and increasing insurance coverage lowering the cost of drugs. Increases in income will result in an additional 73 million people in middle and upper class segments, while 650 million

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Corporate moves (2013-2020) The market dynamics are pointing towards new tools that companies are adopting that will see a widespread acceptance by 2020. The pharma companies are moving away from traditional blockbuster sales model to a more sophisticated direct-to-consumer distribution channels that will diminish the role of whole-

THE MARKET DYNAMICS ARE POINTING TOWARDS NEW TOOLS THAT COMPANIES ARE ADOPTING THAT WILL SEE A WIDESPREAD ACCEPTANCE BY 2020.THE PHARMA COMPANIES ARE MOVING AWAY FROM TRADITIONAL BLOCKBUSTER SALES MODEL TO A MORE SOPHISTICATED DIRECT-TO-CONSUMER DISTRIBUTION CHANNELS THAT WILL DIMINISH THE ROLE OF WHOLESALERS can grow at over 20 per cent over the next decade. The biologics market will also grow rapidly to become a $3 billion segment by 2020.

Challenges A greater acceptance of new medicines and greater affordability

consumption patterns and trends will be of utmost importance for pharma companies to adapt suitably to the changing environment.

There will be a heightened emphasis on building of large brands through brand portfolio managements. A shift away from traditional business models is also suggested, with companies being advised to import talent from outside the industry and encouraging more risk-taking.

The government will also have to take an active role to ensure the potential of the industry is realised.

To compete with domestic generic players, pharma MNCs are launching patentprotected drugs in India at relatively low price points than those in developed markets. Simultaneously, a differential pricing strategy is helping these MNCs to enhance their market reach by addressing affordability issues.

Identifying changes in www.expresspharmaonline.com

salers. Companies will provide total health care packages.

All companies, including MNCs, will be increasing their field force in the coming years as they are looking at tapping a larger chunk of the Indian population in the rural markets by enhancing presence. On one hand, Indian companies are entering into strategic tie-ups with MNCs to strengthen their product portfolio while on the other hand even MNCs are actively looking at acquisitions to gain a quick foothold in the fastest growing pharma market.

Between 2010 and 2015 patent drugs worth $171 billion are estimated to go offpatent leading to a huge surge in generic products. In fact, Indian companies file the highest number of ANDA’s with US FDA leading to greater chances of approvals and thereby increasing export to regulated markets especially the US. There are a number of pharma SEZ in India which provides various opportunities for the manufacturers.

Future focus: Research Indian pharma companies are investing on the R&D front to tap opportunities in the domestic and global markets. To encourage the same, the weighted deduction on R&D expenditure to 200 per cent (inhouse research) has been extended for a further period of five years.

R&D process will improve our understanding of the underlying biology of the human body and its diseases, allowing researchers to better predict the effects of new drug candidates before they enter human beings. It discusses the fact that these changes could enable the shortening of the R&D process by up to two thirds, a dramatic reduction in attrition rates and a substantial reduction in the costs of clinical trials. It is estimated that this decade innovators will launch at least 25 per cent of their patented products in India, patent products will be launched in four therapies metabolics, neuro psychiatry, oncology and antiinfectives.

Conclusion India is a high growth centre for the pharma sector and MNCs are actively looking at capturing a higher share in the market through innovative products, campaigns and reaching out to new regions earlier than the competition. Indian companies will have to be on their toes to be ahead of their foreign counterparts, and to keep their advantage of an early footprint as well as the regional connect through stronger product portfolio and quick strategies to adapt to the evolving market and consumer landscape.

January 1-15, 2013

Indian pharmaceuticals: A long-term story Inspite of attracive long term growth prospects, Anjan Sen, Director, Deloitte Touche Tohmatsu India, opines that field force effectiveness, institutional access and key account management, and innovative marketing practices are three focus areas which could impact growth and revenue in 2013

impact only the big industry players; while smaller regional Indian pharma companies continue with ‘business as usual’.

The Indian Government has also stated that there will be new guide-

lines announced for the pricing of patented products.

In such a scenario, it will be prudent for pharma organisations to be cautious while designing strategies. A ‘wait and watch’ principle towards

33-year history of partnership with leading pharma companies

Anjan Sen Director Deloitte Touche Tohmatsu India he Indian pharmaceutical sector has grown at a double digit rate and is expected to reach ~$ 55 billion in sales by 2020, nearly five times that of the 2009 level, as per the IBEF Report, August 2012. The same report ranks India currently at third position in terms of volume and tenth in terms of value.

2012 saw a multitude of changes happening on the regulatory front which have severely impacted the outlook for the industry in the near term. The announcement of Pharmaceutical Pricing Policy, disallowing expense deduction for tax purpose on promotional expenses that are in violation of the uniform marketing code, court rulings invalidating patents granted earlier, allowing compulsory licensing to local companies for manufacturing patented drugs and clarification on the process to be followed for brownfield investments, etc. have raised many questions about the future direction of the industry. These seem to be issues pertaining to a general lack of clarity on some directives from the Government.

Some industry experts fear that the government is taking a stance which favours local players while others feel that India does not truly respect IP rights of innovator companies.

There are also concerns with respect to implementation of the uniform marketing code and how it would potentially

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January 1-15, 2013

TELMISARTAN TELMISART AN GREEN Non-Infringing Process

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

Antimalarial Artesunate Arteether Artemether# * Dihydroartemisinin Lumefantrine# * Piperaquine

Macrolides

Antihypertensive

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

Irbesartan # Losartan potassium Telmisartan Valsartan

Antihistaminic

Alendronate sodium Zoledronic acid

Sedative, Hypnotic Zopiclone

#

Antifungal Flucytosine

#

Cetirizine dihydrochloride # Hydroxyzine diydrochlorid + Meclizine diydrochlorid

Antiosteoporotic

#

Antiepileptic Valproic acid

Antidepressant Venlafaxine hydrochloride

Under Development Antiretroviral

Antidiabetic

Hypnotic

Antithrombotic

Ganciclovir Valaciclovir Valganciclovir Maraviroc

Linagliptin Vildagliptin

Eszopiclone

Clopidogrel bisulphate

* WHO APIMF

CEP / COS

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

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

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

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

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the external environment may make more sense considering the relative lack of clarity on certain key issues. However, these are very short-term trends. In the long run, India, as a pharma market, is still lucrative and is expected to provide enough opportunities for organisations to create and realise value. Government’s focus on healthcare inclusion, growing incidences of chronic and lifestyle diseases, better healthcare infrastructure, increasing health awareness, and deeper penetration of government sponsored and private health insurance schemes is expected to drive the Indian healthcare sector forward.

Considering these factors, pharma companies need to innovate business models to adapt to the changing scenario. They can leverage learning from the changing commercial model in the developed world, coupled with innovations used in the emerging markets to create a customised strategy for India.

Three immediate areas of focus, impacting growth and revenue in 2013 that could be considered are Field Force Effectiveness, Institutional Access and Key Account Management (KAM), and Innovative Marketing Practices. These areas are outlined below in greater detail.

Sales force effectiveness Effective sales force strategy is crucial for organisations to maximise coverage, improve sales, and optimise costs. Pharma companies are facing major field force related challenges due to high attrition rates, declining productivity, and limited attention span of customers. It is important to have an orchestrated approach to managing the sales force in order to increase return on investment (RoI). Below are the components of an effective sales force strategy.

Training and development Regular training modules along with coordinated onthe-field training programmes can improve overall performance levels of field force members. Courses on motivation, self-development and leadership along with roadmap for career progression can be effective in increasing sales force productivity and help improve loyalty for the organisation.

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Optimised coverage Optimal territory coverage with limited investments is one of the growing needs for pharma companies. An optimal strategy for territory coverage depends on factors like the company’s product portfolio, potential of the territory, presence of customer specialties, access, healthcare infrastructure, etc. With intense competition and increasing pressure on margins, pharma organisations are in need for effective coverage planning that can deliver the desired RoI.

Performance review It is important to use MIS tools/ platforms to optimise sales force performance through tracking of key parameters like doctor call records, details of pharmacists met, customer conversions, performance in training programmes and activation programmes launched etc. Such tools can be effectively used to understand the causal factors responsible for good/ bad performance in a particular territory which can be helpful for the organisation in improving its performance.

Differentiation It is becoming increasingly necessary for pharma organisations to differentiate members of their sales force in a cluttered market like India.

Limited attention span of doctors is creating severe challenges for players.

Organisations need to effectively work towards differentiating their sales force members through innovative detailing techniques, usage of different mediums of detailing, improving confidence levels of members of the sales force etc.

Institutional access and KAM Growth of corporate hospital chains and increasing government spend and consolidated buying through healthcare institutions have made organisations focus on the need to create dedicated institutional sales teams.

Institutional access strategy is becoming crucial as corporate and government hospitals have operational dynamics that require different approaches. Contrary to popular belief, they do not all operate on an ‘L1’ or lowest bidder pricing model.

The institutional segment is becoming more important www.expresspharmaonline.com

because of increase in proportion of inpatient spend; proliferation of large number of tertiary/ specialty care hospitals and entry and expansion of large organised players ; increased health awareness and better diagnostic facilities resulting in early diagnosis and higher hospital care utilisation; growing public healthcare spend through various government sponsored programmes, and deeper penetration of public and private health insurance schemes This segment requires dedicated approach and strategy because of its complex procurement machinery and purchasing process. Multiple stakeholders form a part of the purchase process at various stages from drug introduction to demand sustenance. Each institute is different and requires an organic approach.

Organisations need to take cognizance of the same while designing their institutional teams. Institutional strategies of pharma organisations typically depend on the product portfolio. The target set of key hospitals may vary from one product portfolio to another. It is also crucial for an organisation to understand the purchase process as it involves multiple layers of stakeholders in the decision making process. Strategies should include development of targeted sales and communication programmes at different levels of interaction and at different stages of the purchase process.

Institutional teams should also build standardised modules and SOPs to improve system performance including KPIs, MIS etc.

Additionally, KAM is an evolving strategy being used by pharma organisations to deal with changing requirements of large corporate hospitals/ institutions. Many pharma and medical devices companies have started employing key account managers to take care of the special needs of that segment.

KAM is different from a typical sales model in the sense that it partners with key customers and delivers solutions based on their business goals/ needs. Organisations will need a different set of skills and internal capabilities to effectively implement the KAM strategy.

Innovative marketing practices The Indian pharma indus-

try is highly cluttered. In such a stiffly competitive market that favours branded generics, it is difficult for organisations to create adequate brand recall. Key customers and institutions have also started putting restrictions on time/ slots for meeting company sales representatives. Thus, organisations need to break away from traditional modes of detailing to create an indelible brand image in the minds of customers.

Key opinion leaders (KOLs) are typically hard pressed for time. Additionally, launch of ‘uniform marketing codes’ by the government warrants for changes in the approach of pharma companies. Transparency and ethical practices will form the cornerstones of neo-marketing tactics.

Although the physician is still the decision maker, modern day patients are becoming more aware of their disease states and prescribed medications. Organisations are finding ways of connecting directly with them, albeit within boundaries of the regulatory landscape to spread awareness and improve outcomes through disease management programmes. besides pamphlets, companies have used social media tools like Twitter and Facebook to connect with patients by making them aware of the need for medications. Some organisations have used tele-counselling to improve compliance levels of patients on chronic medications. Rise of corporate hospital chains and institutions have led to dedicated and focused marketing activities aimed at increasing product awareness. Retailers play a critical role in brand choice and organisations need to include them as target audience while allocating marketing spends. Organisations will have to devise customised marketing strategies for doctors, patients, retailers and hospitals.

In conclusion, changes in the regulatory scenario in India are beyond the control of pharma companies. However, while companies wait for those regulations to take concrete shape, they should focus on internal improvements in their business and commercial models, in order to be on a stronger position to take advantage of the long term growth prospects.

January 1-15, 2013

Improved awareness will lead to better business Dr Kiran Marthak, Vice Chairman, Medical Sub Committee- IDMA and Head Global Clinical Development, Lambda Therapeutic Research, reveals his wish list for the clinical research industry still recollect early 2000 when Mckinsey Report was out indicating that clinical research would be a boom and would touch the market size of a billion dollar by year 201012. In India !!!! How unpredictable the market could be as we all know what is the market size at present. Hence the picture in a crystal ball will always be hazy. But there could be some improvements as I am always optimistic.

I would crystal gaze not on the finance part but on the processes and on expected improvement which would automatically lead to better business.

I will divide it into regulatory authorities, Ethics Committees/ IRB/ IEC, CROs/ SMOs, institutes and investi-

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Dr Kiran Marthak Vice Chairman Medical Sub Committee (IDMA) and Head Global Clinical Development – Lambda

January 1-15, 2013

gators and miscellaneous Regulatory authorities The whole industry at at present suffering from recession due to erratic approval timelines. I do wish that they would realise the importance of it and would place various timelines on the website and would adhere to it.

I strongly recommend to have a separate director for clinical research activities, separate director for marketing authorisation, and separate director for manufacturing activities in Drugs Controller General of India (DCGI) office.

Each director will be master in their own field. This will resolve many issues including timelines.

There should be a decentralisation of certain activities e.g. T-License, inspection of the CRO sites as well as institutes, NOC for BE studies – Local/ export etc. should be managed by Regional Deputy DCGIs. This will reduce a lot

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of general work load in Delhi office.

Revamp the New Drug Advisory Committee (NDAC) – Give them a target number of protocols to be reviewed within a stipulated time period, make them accountable and also if they do not attend regularly, even replace them.

Only certain discreet protocols only should be referred to the NDAC. The fees for the experts should be attractive.

Reconstitute IND committee in a fashion similar to NDAC. Knowledgeable practical staff right from technical officers upwards. The knowledge should not only be on clinical research but also on time management, finance and International Regulatory Guidelines.

Allow Phase-I studies – F.I.M. even if the molecule is discovered out of India.

Severe penalty clauses in the Schedule-Y and in consti-

tution for those who violate the laws and those do not conform to ICH- GCP Guidelines recommended by ICMR in India.

Online applications for all different NOCs required from health authorities.

KRAs for various positions in DCGI office should reflect the outcome.

Constant dialogue between DCGI and regulatory authorities of developed countries and under developed countries.

Acceptance of the data between the regulatory bodies would hasten the process of launch of the products in many countries simultaneously.

Ethics Committee (EC) Ethics Committees plays a major role for the subject’s safety and also for his well being in the study.

Continued on Pg 31

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Indian clinical research: A call to self regulate The Indian clinical research industry is at the crossroads. If 2012 was a year of regulatory discussion and debate, 2013 will see the implementation and roll out of several initiatives. The call to action is self regulation, says Hemant Rehani, Vice President and Head—Clinical Development Services, India and Sri Lanka, Quintiles he clinical research ecosystem in India is changing at a fast pace.

In its 15 year history, clinical research in the country has evolved from being a totally naive industry to a maturing one that is moving from just doing drug development to also contributing to drug discovery. Increasingly, global pharmaceutical companies are looking at leveraging the talent and resources in India to focus on innovation rather than myopically viewing India as just another low-cost destination.

The regulatory environment in India has been very active in 2012 and focused on strengthening regulation, increasing controls and governance and setting policies for the future stability of innovative clinical research in the country. We have welcomed the consultative approach taken by the Ministry of Health and Family Welfare on several issues impacting the industry and are hopeful that whatever is developed will be in the best interests of all stakeholders, most importantly patients. By no means is the job of the Government in improving regulation an easy task given mounting media pressure and allegations, public interest litigations and so on.

Allegations have also been levelled that the sea of regulatory changes being planned by the DCGI has been more of a knee jerk reaction to external pressures than part of a longterm strategic plan to develop the industry while protecting the interest of patients and meeting our country’s health objectives. While this is true in some instances, it is also true that much time has been spent by the government in explaining its rationale and decisions to various stakeholders which has hindered quick implementation and progress.

Irrespective of intent and direction of regulation, we cannot ignore the fact that our country is moving towards an

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Hemant Rehani Vice President & Head - Clinical Development Services India & Sri Lanka Quintiles

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exciting era of innovation in drug discovery and development where various stakeholders, be they pharma companies, CROs, investigators or ethics committees, all have a significant and critical role to play. The call to action is self regulation.

In psychological terms, self-regulation refers to the self-altering of one’s own responses or inner states. For example, when otherwise quite different people go to the movie theatre, they tend to behave in similar ways. Most self-regulate themselves.

There are many examples of how self-regulation has helped businesses in changing public perceptions and creating confidence amongst stakeholders. The most prominent example is the advertising industry which has done an excellent job of self-regulation, both in India and overseas.

The Advertising Standards Council of India (ASCI) has adopted a Code for SelfRegulation in Advertising. It is a commitment to honest advertising and to fair competition in the market-place. It stands for the protection of the legitimate interests of consumers and all concerned with advertising with an overarching goal of maintaining and enhancing the public's confidence in advertising. Perhaps the clinical research industry in India would do well to adopt a similar approach even as regulators strengthen policies. Self regulation applies to all stakeholders within the industry, including Ethics Committees (ECs) and investigators. In 2012, we witnessed a lot of discussion over the role of ECs with a call for them to take a more active role in policing investigators.

However, the big question remains whether all ECs in India have the resources, both in terms of manpower and time, to do this sort of policing. Investigators have also been at the centre of much controversy and debate in 2012. The investigators-patient relationship is where rubber meets the road in clinical research which is why selfregulation by investigators will be extremely beneficial in curbing incidences that malign the industry and lead to negative reportage.

Self-regulation does not and should not replace govwww.expresspharmaonline.com

ernment regulation. Rather, it complements an existing framework of law and provides a double layer of protection to consumers. To work well and to win the confidence and assurance of the public, it needs to include stringent sanctions for participant stakeholders who are in breach of code of conduct. Such self regulation would work well for all stakeholders concerned. It would free up time for regulators to work on and develop a more strategic framework for the development of the industry, it would help the industry in some ways to determine and shape its own destiny, it would ensure consensus building and collaboration and finally through transparency and openness, ensure goodwill and buy in from the public at large. While biopharma companies and CROs in India will continue to innovate and reinvent their ways of working to bring safer and more affordable products to the Indian population, there is also a big need in this part of the world for better equipped clinicians willing to change gears to be more active researchers/investigators and equal partners in the drug discovery and drug development process. India has a strong base of quality researchers. However, that number needs to increase to meet the growing need to bring products to market faster. Given India’s growing economy and increasing healthcare spend (both public and private), the standard of care will continue to improve in 2013. We will also see increasing spends on insurance-based medical care.

However, the rising demand for quality healthcare cannot be fulfilled by health insurance alone. There is a need for affordable products that are safe and efficacious.

Biosimilars are a solution to meet these realities of our market. The guidelines on similar biologics released by the Government of India have provided the much required fillip to boost the growth of the industry and encourage local biopharma companies who have both, local and global aspirations. In 2012, we saw several companies in Asia announce their forays into biosimilars. In 2013, I believe we will see more R&D in biosimilars, specifically target-

ed at the Indian market, gaining momentum. As this segment evolves, CROs will develop more mature models to help Indian biopharma companies navigate the complexities of biosimilars development and take their products to market faster. We will see the emergence of models that are customised, competitively priced, globally aligned and more consultative in approach. The biopharma industry needs a robust regulatory environment to foster a culture of innovation and R&D industry in the country. If 2012 was a year of regulatory discussion and debate, 2013 will see the implementation and roll out of several initiatives which will augur well for the industry. The proposed regulatory recommendations will introduce a whole new dynamic to the already complex clinical research scenario in India. We will see the emergence of companies whose focus is on the place where all the real action is that is clinical trial sites. These services could include provision of trained study coordinators, providing technologies that help automate and manage site processes, providing video/audio equipment for informed consent administration, providing site accreditation services and many other sites related services that will help contribute to auditable, systematic, high-quality research at sites. Another emerging opportunity for countries like India to extend their capabilities in clinical research is tapping into neighbouring countries like Sri Lanka and Bangladesh. These countries have similar disease burdens with improving health care delivery systems.

Sri Lanka has taken great strides forward in defining a regulatory framework and creating an approved EC network at a national level. Pharma, CROs and investigators from India can play a positive role in helping define and shape the clinical research environment in these countries.

I believe that the dynamics of increased regulation with the growth that we envisage in the domestic sector and biosimilars and opportunities in neighbouring countries will make 2013 an interesting and exciting one for the industry.

January 1-15, 2013

Continued from Pg 17 stabilising and with many MNCs wanting to deleverage their over reliance on China, this industry seems to be back on growth path. But global economic conditions can have an impact both on growth and margins for this

ther strengthened the Indian pharma industry. Moreover, the GoI is providing incentives to encourage investment in the pharma sector.

In August 2010, the GoI announced its plans to set up a $639.56-million venture capital (VC) fund to give impetus to drug discovery and strengthen

Graph 3: Rise of lifestyle-related chronic diseases in india

Source: Fortis Healthcare (India) Limited, December 2011 industry.

India was touted as fast emerging global hub in the clinical trials and research space (driven by cost-effectiveness, a huge patient pool, a genetically diverse population and trained clinical investigators are some of the factors driving the country’s clinical trials industry). The size of the market was around $400 million (` 23.1 billion) in 20114.

India’s share of this market is expected to increase from 2.1 per cent in 2011 to 2.9 per cent in 2015 and reach almost $1 billion (` 43.9 billion)5. There are more than 120 clinical trial organisations in the country.

The Government is also tightening its regulatory norms related to informed consent and provision of compensation to victims of clinical trial.

However, India is facing stiff competition from countries such as China, due to which the number of new trials registered in the country declined from 365 in 2010 to 230 in 20116.

Adequate government support to further boost the domestic market In the last 10 years, the Government of India (GoI) has aggressively adopted prudent strategies to boost the country’s healthcare industry. From granting 100 per cent Foreign Direct Investment (FDI) in the drugs and pharma sector to establishing various pharma SEZs across the country, a range of initiatives have furJanuary 1-15, 2013

the country’s pharma infrastructure. Both domestic and MNC pharma players are

ered worldwide by 2020 originating from the country.

The GoI’s long-term vision is to provide quality and affordable health care services to all classes of Indian society. Consequently, the GoI plans to cover at least 50 per cent of the country’s population under health insurance by 2020, compared with the current average of 15 per cent.

Expanding health care infrastructure and changing demographics to supplement growth The Indian healthcare sector is forecast to reach $280 billion by 2020, contributing expected GDP expenditure of eight per cent by 2012, compared with 4.2 per cent in 2009, according to a report by an industry body. Over the past two decades, India’s thriving economy has driven the need for urbanisation, thereby creating an expanding middle class with increased disposable income to spend on healthcare. Other key

growth path. In conclusion, as emerging markets become increasingly important and India’s role among these becomes progressively significant, both domestic and pharma MNCs will need to adapt their business models, organisations and processes and create customised strategies. Overall, active participation from domestic and international pharma companies, increased investments and strategic initiatives will likely underpin future growth and enable the Indian pharma market to break into the global top tier in the present decade.

References 1. “The global use of medicines: outlook through 2016,” IMS Health website, http://www.imshealth.com/d eployedfiles/ims/Global/Cont ent/Insights/IMS%20Institute %20for%20Healthcare%20In formatics/Global%20Use%20 of%20Meds%202011/Medicin es_Outlook_Through_2016_R

Graph 4: US patent expiries: 2006-15

Source: Indian Pharmaceuticals Outlook 2012: bracing for absolute performance year, January 2012, Morgan Stanley expected to leverage these initiatives to expand their operations in the country.

The Department of Pharmaceuticals has prepared ‘Pharma Vision 2020,’ aimed at making India one of the leading destinations for end-to-end drug discovery and innovation. It envisages meeting this objective by building top-notch infrastructure for talent and research, encouraging public-private partnership (PPP) models, offering financial incentives to encourage and incubate innovation and shaping a favourable regulatory environment2. GoI also aims to position India among the top five pharma innovation hubs by 2020, with one out of every five to 10 drug discovwww.expresspharmaonline.com

growth drivers for this sector include a growing population, the opening of new hospitals, growing lifestyle related health issues, less expensive treatment costs, the growth of medical tourism, improving health insurance penetration, government initiatives and enhanced focus on PPP models.

The overall growth of the Indian healthcare sector is likely to create a sizeable demand for quality and affordable medicines, thereby providing significant growth opportunities for both domestic and pharma MNCs.

In summary…

India’s pharma market has evolved and shifted gears to set foot on an accelerated

eport.pdf, accessed 10 August 2012.

2. “Health check – Indian Pharmaceuticals market,” ICICI Securities Ltd., April 2012, via ThomsonONE.com 3. “Indian Pharmaceuticals Outlook 2012: bracing for absolute performance year,” Morgan Stanley, January 2012, via ThomsonONE.com 4. “India losing out on clinical trial biz pie,” Financial Express, 9 July 2012 via Factiva, ©2012 Indian Express Online Media Pvt. Ltd. 5. Clinical trials market India,” Netscribe Pvt. Ltd., April 2012, via ISI Emerging Markets 6. “Clinical trials market India,” Netscribe Pvt. Ltd., April 2012, via ISI Emerging Markets EXPRESS PHARMA

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Indian pharma: Emerging as global power in R&D DK Aggarwal, CMD, SMC Investments and Advisors, says that collaboration between the Government and industry holds the key to achieving India’s potential he Indian pharmaceutical market is highly fragmented with 300 large and 18,000 mid-sized and small companies. It is a successful, high-technologybased industry that has witnessed consistent growth over the past three decades.

The Indian pharma industry (IPM) accounts for about 1.4 per cent of the world's pharma industry in value terms and 10 per cent in volume terms. The pharma industry across the world is likely to get boost owing to increased urbanisation and change in lifestyle patterns. According to rating agency Fitch, the Indian healthcare sector is expected to reach $100 billion by 2015 from the current $ 65 billion, growing at around 20 per cent a year.

The sector, which was opened to 100 per cent FDI in 2001, encountered a series of takeovers between 2006 and 2010, Ranbaxy by Daiichi, Shanta Biotech’s by Sanofi Aventis, and more recently Piramal Healthcare

by Abbott Laboratories. In future also, India will see the largest number of mergers and acquisitions (M&As) in the pharma and healthcare sector and the foreign acquisitions of Indian companies will enable the domestic companies to gain a foothold in the western regulated markets, to diversify their portfolios, acquire recognised brands, and gain R&D capabilities, which is indispensable for the Indian phar-

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DK Aggarwal CMD SMC Investments and Advisors

Company Sun Pharma.Inds.

Cipla Dr Reddy's Labs Lupin Ranbaxy Labs.

GlaxoSmithKline Pharma Cadila Health.

Glenmark Pharma.

Piramal Enterp.

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ma companies. The multinational pharma companies are now becoming aggressive in the Indian market to focus on emerging markets.

Apart from acquisitions, they have also been targeting growth opportunities through in-licensing deals with domestic generic players both for domestic as well other emerging markets.

Pricing of drugs continues to be one of the most important issues in the pharma world, as affordable healthcare remains a priority for governments worldwide.

The pharma sector is one such where the products are seldom purchased by choice, therefore market forces do not impact prices except for generic drugs. The rising cost of R&D for new molecules, as well as spiralling healthcare budgets and mounting governmental pressure to reduce drug prices have inspired companies to ramp up their generic business. India tops the world in exporting generic medicines worth $11 billion.

Currently, the Indian pharma industry is one of the world's largest and most developed industries.

Pharma companies across the world have got 36 Abbreviated New Drug Application (ANDA) approvals and 11 tentative approvals from US Food and Drug Administration (US FDA) in October 2012. Out of 36 ANDA, India received 11 approvals and six tentative approvals from US FDA out of 11.

Government initiatives in the public health sector have recorded some noteworthy

Investment in R&D made by some key Indian pharmaceutical players in 2011-2012.

(Rs in Crore)

Indian pharma market is predominantly a branded generic market

successes over time with focus on investments related to better medical infrastructure, rural health facilities etc. Industry leaders in pharma are of the opinion that the recent pricing policy introduce by government is negative for the sector as 40 per cent of the pharma market will come under the price control. Also 21 per cent of the Indian pharma industry will be covered under drug pricing from current 4.5 per cent and the government's suggestion of market-based pricing control based on 1 per cent market share formula is expected to be negative for most of the pharma companies.

According to the Performance of key players as on 12.12.12.

I n d i a n Market Latest EPS Face Value Latest P/E Latest Close Pharmaceutical Cap[Latest] -Unit Curr.

Ratio(BSE) P/BV(BSE) Price[Latest] Alliance (IPA) and Organisation of the 75049.93 28.92 1 25.06 6.17 724.7 Pharmaceutical Producers of India 33352.47 14.28 2 29.08 4.37 415.4 (OPPI), “the new 31827.66 94.16 5 19.9 6.38 1874.2 drug policy would also adversely impact 27141.52 21.49 2 28.23 6.76 606.65 profitability of Indian 21205.38 40.17 5 12.5 7.41 501.95 pharmaceutical companies.”

17308.87 61.73 10 33.1 8.94 2043.55 For most of the Indian pharma companies, the domestic 17304.62 29.79 5 28.37 6.72 845.2 business contributes 12162.55 15.89 1 28.27 5.06 449.3 20-50 per cent of the overall revenue.

9793.08 0 2 0 0.87 567.55 While US business www.expresspharmaonline.com

contribution stands at 20-30 per cent and remaining comes from the RoW markets.

Research and development is the key to the future of pharma industry. The tough increasing competition has emphasised India’s Pharma companies to invest in Research and Development (R&D); India ranks globally eighth position, spending $30 billion. If compared, the US, the largest R&D spender nation, spends $427.2 billion and India too has moved up in the pecking order which includes leading innovators like China, Japan, Germany and South Korea. The average R&D expenditure by Indian pharma companies is close to 6 per cent. Further, investments in biotechnology, clinical trials and contract research activities will play key role in future growth. Money spent by Indian pharma companies on R&D, basically goes for generic product development and ANDA filings.

The R&D expenditure of 30 companies, with R&D spending above Rs 20 crore, has increased by 19.6 per cent to Rs 4,678 crore during the year ended March 2012 from Rs 3,911 crore in the previous year March January 1-15, 2013

2011. This spending worked out to 7 per cent of their net sales. India has got more and more filings and approvals from various regulatory authorities on the back of higher investment and increasing standard in R&D. The Indian companies also have set up subsidiaries in the US, Europe and Japan to focus on approvals.

Inaugurating the 64th Indian Pharmaceutical Congress (IPC) at SRM University at Kattankulathur in Tamil Nadu, the former President appreciated the recent introduction of the anti-malarial drug ‘Synriam’

by Ranbaxy in collaboration with Department of Science & Technology. He also opined that all the industrial pharmacists and researchers must follow the step taken

by Ranbaxy as a model and concentrate on inventing new drugs.

Generics to dominate with share of patented products rising to a sizeable 10

January 1-15, 2013

per cent by 2015. Factors such as growing middle class population, rapid urbanisation, increase in lifestylerelated diseases and acceptance of health insurance are likely to boost growth of Indian pharma. In near-term factors like, currency appreciation and approval-based FDI in brownfield pharma projects may be the negative triggers but in long term the impact will not be significant enough to hamper the prospects of the sector. We expect an impressive growth in the Indian pharma industry because of the strong growth in chronic segment in the domestic market, patent expires in US driving generic imports to the country and increasing footprints of domestic companies in other emerging markets.

India ranks top in the world in exporting generic medicines worth $11 billion and the same market is expected to grow at a CAGR of around 17 per cent

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between 2010-11 and 201213. However, over the next few years patent law will provide impetus to the launch of patent-protected products which have the potential to capture up to a 10 per cent share of the market by 2015, implying the market size of $2 billion.

Riding on back of the generic opportunity, Indian companies have capitalised on the growth prospects to emerge as formidable players in the US generics markets as blockbuster drugs worth $100 billion are set to go off patent over next five years in US and this will drive the growth for the overall Contract Research and Manufacturing Services (CRAMS) segment which is foreseeing the future generic market buoyancy.

The on-going critical market situations in Europe and pricing pressures have slowed the enthusiasm of the Indian pharma companies. However, the European

markets remain an important part of Indian companies’ long-term growth strategy; most of the India pharma companies have been ramping up their presence across markets by steadily enhancing product portfolio, investing in developing marketing and distribution strengths. Moreover, the Japanese market also offers potential to drive significant growth in the medium term for the Indian pharma companies. Apart from the developed markets, the Indian pharma companies have also been eyeing growth opportunities in some of the other fast-growing emerging markets such Russia, South Africa and some of the countries in Latin America (Brazil, Mexico) and SouthEast Asia. The true fact is that the continuous, liberal, and collaboration by the Government and pharma industry hold the key to achieving India’s full potential.

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Tech solutions to improve management of drug development programmes Ted Gastineau, President, ICON Clinical Research explains how the increased use of technology is likely to lead to changes within the CRO industry, all geared to meet evolving expectations of sponsors, investigators and patients he pharmaceutical industry and contract research organisations (CROs) are increasingly adopting the use of technology to improve the process of clinical research. The drive to develop and adopt eClinical technologies is due to a number of factors, such as the pressure to increase drug research productivity while also reducing costs and the need for improved data quality. eClinical technologies, such as Electronic Data Capture (EDC), Interactive Voice or Web Response (IVR/IWR) Systems, Electronic Patient-Reported Outcomes (ePROs) and Electronic Imaging, provide a range of solutions to address the need for greater efficiency and productivity in the drug development process.

Despite providing a range of benefits, eClinical technologies also pose a number of challenges that need to be addressed before these benefits can be fully realised. A major challenge for CROs is to establish an efficient and effective information technology (IT) infrastructure together with appropriate user support. Once the infrastructure is in place, paper-based processes must be automated and different systems must be integrated and standardised to ensure compatibility. In addition, it is essential to ensure that the system complies with regulatory agency requirements. The increasing use of technology is likely to lead to a number of changes within the CRO industry, such as the way in which individual CROs adapt to and use new technologies and the types of technology led services they can provide to sponsors.

T

Clinical trial technology Technology has undergone a revolution in functionality, cost and popularity over the past decade, driven by the widespread availability of the

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Internet and personal computers. CROs now have to provide sophisticated solutions to meet the evolving expectations of the sponsor, the investigator and the patient, with increasing expectations for real-time access to data and information.

These expectations include the optimisation of patient enrolment, reduction of screening failures, minimisation of monitoring costs, adjudication of data in real time for endpoints, assessment of safety data for trends and outliers in real-time and the optimisation of transparency and data access. CROs need to meet these expectations to be able to show real value added benefit.

increased data collection requirements. For example, the growth in targeted therapies has increased the use of wet and imaging biomarkers to identify patients who might benefit from new target receptor molecules or to demonstrate a drug's effects. These data may originate from various sources, e.g., clinical trial management software (CTMS), EDC, laboratory, bioanalytic, medical imaging and interactive technologies. This can lead to problems with data comparability and compatibility when different methods and standards of data capture and storage are used.

Clinical practice

The use of technology is continually advancing in the pharma industry. A decade ago, pharma companies were making their own internal investments in technology and systems. However, the proliferation of multiple systems has led to issues with compatibility. Now, the onus is on CROs to develop technology solutions that can be used across companies and trials. This requirement has been aided by the widespread use of the Internet and global telecommunications. Strategic relationships and personalised medicine have resulted in a desire by sponsors for better value for money, increased efficiency and improved visibility of real-time CRO performance. Additional needs are for real-time visibility of safety data and the provision of internet-based investigator training and communications.

Data standardisation and data handling technology solutions provided by CROs are becoming increasingly important for sponsors. At present, multiple data standards, platforms and databases, often located with different vendors, must be used to access all the available information on a clinical trial. This can lead to problems with data sharing and comparability of trial results, e.g., imaging data – knowing which version of the data is the latest and which database holds the latest version. An integrated

The use of technology in clinical research mirrors the changes occurring in clinical practice, with the increasing and widespread use of electronic medical/health records (EMRs/EHRs). The use of EMRs has several benefits for CROs conducting trials: it can greatly accelerate the process of patient recruitment, reach patient groups not previously well represented in studies and make screening for potential subjects faster and more methodical.

In addition, EMRs can facilitate access to data from other doctors involved in the patient's care.

The use of EMRs has the additional benefit of making investigators more comfortable working in an electronic environment for data entry and communication, potentially reducing data entry errors in EDC and other systems.

Increasing complexity of clinical research data 'Designer' drugs targeted at particular populations and particular subtypes of disease are becoming more popular and this type of development philosophy characterises 'personalised' drug development.

Personalised drugs are popular with sponsors as they are more likely to be effective, although the potential for safety issues remains. Clinical trials may involve fewer patients but tend to have more complex designs with www.expresspharmaonline.com

Technology needs of the sponsor

technology solution that could provide a single information source would solve such problems. Such a solution would manage and standardise all the study data emanating from multiple sources, including EDC, patient diaries, central laboratories and imaging.

Potential benefits include data traceability and quicker access to safety and efficacy data. It could also help to reduce trial costs, in particular by removing the need for reaggregation of data at the end of a study

ICONIK – ICON’s integrated information platform ICONIK is ICON’s powerful integrated information platform that consolidates, standardises and visualises operational and clinical data from multiple sources (including CTMS, EDC, IVRS, laboratories, imaging and ePRO) to provide a single holistic view, via a web-based portal, of all study information, from study start-up to database lock.

ICONIK can analyse a blend of operational, quality, efficacy and clinical safety data across multiple studies and different therapeutic areas, making it the most effective tool in the industry for the proactive management of a clinical trial.

ICONIK optimises the management and aggregation of clinical trial data in near real time, allowing data to be maintained in a single standardised format, with appropriate controls, providing an auditable chain of custody and the ability to create customised performance metrics.

It provides one place to go for all teams for any study-related questions. ICON is the first CRO to incorporate Oracle’s Life Sciences Data Hub in its platform, which provides a fully integrated clinical data environment, with strict version control and full traceability of data processing. ICONIK enables risk based monitoring and adaptive trial design based on the availability of near real-time data collected while the trial is ongoing. In addition, it can have a positive impact on facilitating audit trails, data mining and combating malpractice.

January 1-15, 2013

IPR trends in 2013: An alloy of problems and solutions Trends in IPR in 2013 will be an alloy of problems and solutions based in the performance of TRIPs IPR frame, International Organisations (IO), International Agreements (IA), their interpretation and extent of international interference in domestic processes. Milind Sathe, Deputy General Manager-Projects, Unichem Laboratories expresses his views

creating IP, protecting it to invade and rule the markets, e.g. Data, voice, and communication technology, voice, data and robotics, planar waveguide technology, light wave circuits and systems-on-

the chip; photonic integrated circuit design, technology and applications; theory, modelling and numerical simulation of waveguide and integrated photonic devices and circuits.

4. Increased international

An Investment in Drug Protection

Milind Sathe Deputy General Manager-Projects Unichem Laboratories he problems primarily amount to shrinkage of sovereign domains, unwarranted international interference due to lopsided interpretation of IPR and misinterpretation of IA, arrested industrial growth, failure of developing countries (DCs) and least developing countries (LDCs) to increase contribution in global trade and failure to expand the product list beyond conventional products, free flow of Traditional Knowledge (TK) outside and payment of heavy royalties on products derived from that TK, acceptance of imports for local working of patent resulting into centralisation of production activities in some remote corner of the globe, failure to boost exports over increased imports, exodus of national wealth, increased fragile nature of economy and threatened political stability.

These problems of the knowledge economy will mark 2013.

Trends in 2013 will be dominated by following factors: 1. Monopolisation of sectors of vital importance in DCs and LDCs by foreign entities.

2. Exploiting IPR on domestic front to guard domestic markets and on international front to promote national industry houses and businesses to gain competitiveness and progress.

3. Convergence between diverse technology sectors,

T

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insistence on protecting technical, personal data.

5. Pressures to adopt stringent IPR standards independent of their economic stage, industrial capabilities of the nation.

6. Adoption of stringent IPR standards to augment patenting and not innovation.

7. Learning and experience gained by DCs and LDCs for over 1.5 decade and their abilities to counter the IPR based invasion on their economy.

From a to z trends listed below, some trends will be visible in 2013 a) Some nations will change policies to encourage and maintain adequate IPR protection and enforcement; to then align with IAs, to protect economy, to give inventors the confidence to invest in the production, to license out without allowing the IPR holder to insist on his insane demands, giving fair indication that his failure will disallow him to label sovereign action as misappropriation or theft of his IP. Invasive interpretations and international interferences troubling 'indigenous inventive ingenuity and its commercialisation' will be more resisted than in past. IAs shall be interpreted in sane manner to suit national priorities to arrest invasive, lopsided interpretations of IPR and curb tendency to blame national legislations. b) DCs and LDCs will adopt policies to protect domestic business and industry to meet the needs of consumers and society. They will aggressively protect their IP overseas; to promote the competitiveness and growth of domestic business and industry houses, globally, by close interaction with trading partners expecting others to respect their national identities and priorities. This will, give a new perspective to IPR, its interpretations and enforcement. Policy statements describing what is abuse and misuse of IPR and steps to be taken to eliminate its impact will emerge.

Maiden precedents will be established and these may displease few nations. Some nations will begin the activity of identifying economic indices and correlating IP enforcement with them, to eliminate abuse and misuse of IP for economic progress.

Harmonised coherent

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approaches to protect domestic markets shall be adopted in more countries by coordinating customs, judiciary, enforcement departments and industry where imports or intransit goods are involved.

New strategies will emerge to install and commission effective mechanisms for identification, tracking and isolation of IPR infringing goods. New guidelines will emerge to help judiciary to construe the meaning, the intension of apex institute to facilitate enforcement.

Complicated laws for digital and internet governance will suffocate DCs and LDCs. c) Actions alleged as infringements of IPR causing financial losses to IPR holder, shall be briskly debated within and on international platforms questioning national priorities and sovereign domain powers although allowed by TRIPs and other IAs. What is a legitimate right and legitimate business within a nation will be on the anvil. d) Innovation and creativity shall be evaluated against its availability, accessibility and affordability to do away with pernicious interpretation. e) International interference and insistence for Data protection, protection from unfair commercial use, policies to protect IPR in internet related business primarily from copyright piracy and their enforcement shall be very brisk. f) Superiority of Compulsory Licenses (CL) over patent pools will be realised. Continued abuse and misuse of IPR will expand the list of countries granting CL. These events may soften the rigid stance of patentees and encourage voluntary licensing or licensing on mutually agreed terms. It will advance innovation, public policy goals, improve accessibility to and affordability of IPR protected goods. CL may be granted for non medicine products. g) Industry associations will improvise their stance by insisting IP wings to publish the list of non-worked patents, will liaise with apex institute to put in place a mechanism to force IP wings to identify, notify and publish non-worked patents open for CL. This new development shall reduce the durations of litigations, eliminate wasteful www.expresspharmaonline.com

expenditure and lead to quicker CL decisions. h) CL awareness will rise.

More people will know that developed nations have used CL very frequently. India and many other nations will voice that CL provisions in their laws are far better, transparent and more predictable than similar provisions in IP laws and other documents of few other nations. i) Awareness about reverse settlements springing from IPR litigation preventing entry of generics into markets of some countries will rise.

How these settlements prevent an efficient operation of IP system, how these disable nation’s ability to spur innovation and bring new services and products to the marketplace faster, will be realised by larger subject population.

This will raise public pressure to stop these settlements in future. j) Complications in global trade by enforcement of border measures and debates about what are and what are not counterfeit goods will continue. Some major brands will be sued by local brands registered earlier. Territorial nature of brands will be globally questioned. k) DCs and LDCs will face resource crunch to install IPR enforcement mechanisms, leading to more compromises.

Extreme dangers arising from lack of precedents, lack of knowledge of IPR laws to judiciary, government employees, IPR practitioners and enforcement officials, inappropriate interpretations of IPR laws and policy directives may lead to some turbulent decisions prejudicial to national priorities, public interest. It will harm domestic industry, national economy, lead to political instability and will disturb social tranquility.

Balance of interests, pure territorial interests, national priorities, capacity building and sustainable development shall govern interpretation and enforcement of IPR being the only solution to prevent IPR driven catastrophe. l) Acute shortage of well read and well led staff driven by national values, identity and striving to achieve national goals will continue in LDCs and DCs. National priorities will continue to be at risk where Law, Trade, Industry, Commerce and finance portfolios are guided by IPR ignorant individuals. Across the

globe educating employees and individuals in IP wings and profession, judiciary and in enforcement departments on IPR matters will assume importance. There will be new job openings in Govt. departments, IP/legal wings and in IP profession. IP education imparted by foreign nation will trigger identity diffusion leading to identity crisis because such training is unfit for the situation in DCs and LDCs, because it is heterogeneous to local requirements imposed by local economy, industry, public interest, sovereign identity.

Establishment of heterogeneous unworthy precedents, leading to faster shrinkage of sovereign domains by foreign trained force may augment political instability, harm social tranquility. Internally, national leaderships will be in a precarious situation and will be seen as voiceless, remotely controlled robots, externally.

Intelligent apex institutes would depute their subjects to foreign IP training to understand how national interests will be invaded by lopsided interpretations of IPR laws, policies and how to design and install domestic IPR frame to safeguard national priorities and sovereign identity. Developed nations will also need the education to avoid recurrence of international trade complexities by their actions. 2013 may witness some more events where developed world enforcement agencies will contradict IAs, leading to loss of lives and property due to inadequate knowledge of IPR. Party suffering from such action will seek damages or manage undisclosed political compromise.

IPR may be included in study subjects at school level. m) Lopsided interpretations of IPR, failure of TRIPs to increase contribution of DCs and LDCs in global trade and in expanding their traditional product lists, frustrated objectives of DCs and LDCs and their exposure to economic and financial crises more than ever will create large scale displeasure. It will increase awareness of origin, development and history (ODH) of patents and patent system. More people will understand that IPR is to ensure more employment opportunities and to ensure January 1-15, 2013

balance of private and public interests. Absence of “nonworking of patent” as patentee’s right in TRIPs Article 28 will be known to more people. This trend will proliferate and gain strong hold for the betterment of signatories.

DCs and LDCs will orient to interpret IPR to stabilise domestic industry, to increase exports, create more employment opportunities and to question nonworking of patents. IPR enforcement shall be correlated to national economy more than ever. n) Old legal concepts shall be revisited to redefine terms viz. “enemy”, locus standi”, “multiple litigations”, “admissibility of new evidence”. Few nations will submit to patent linkages, others will not. Few nations may force patentee to declare the patents protecting the product on label. Doctrine of exhaustion may receive new dimensions across the globe to protect domestic interests. Influential nations will continue to insist other nations to adopt certain definitions of legal terms. o) Controls on global industrial activity will continue to centralise. Employment opportunities in DCs and LDCs in manufacturing sectors will continue shrink.

SMEs and age old domestic players will continue to vanish. Thanks to substitution of imports for the local working of the patent, requirement.

Nations may realign or begin to polarise into new groups primarily driven by balanced interpretation and enforcement of IPR. The noise to replace some existing IO with other IO which will say what it will do and will do what it will say will rise. p) IPR driven trade frame will expose the gap between IMF and WTO necessitating an alternative means for transacting global trade. q) Global understanding that IPR does not drive economy but economy drives IPR and that IPR is not an end but is means to an end, will rise, so will rise the awareness about ODH, utility of IPR and responsibility of IPR holder.

People will understand that IPR is for the benefit of the nation. Identification and isolation of subjects voicing IPR version prejudicial to national and public interest will start to label them as enemy of the nation. Compromising national interest and patriotism for lopsided IPR version will be January 1-15, 2013

condemned. Idea of mechanism for global rights will surface again, with renewed force and vigor. r) Futilities and risks to domestic industry by alleged trans-border or cross border reputation of non-registered marks will be recognised.

Global hatred towards non-

registered marks will rise. s) Generic players will have to overcome multiple IPR barriers such as marks, trade dress, allegations of deceptive appearance and counterfeit products. Forcible rendezvous of IPR with regulatory bodies will complicate the drug approvals in many countries,

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create artificial scarcity facilitating MNCs. Regulatory norms will be more complicated favouring IPR generation by financially strong and politically influential entities. t) Generation of IP in IT, communication, biopharmaceuticals, liquid crystals, biotechnology, pharmaceuti-

cals, agrochemicals, seeds, fuel and energy, and alleged environment protective technologies will continue unabated. Throttling of technology transfer opportunities to DCs and LDCs will continue.

Continued on Pg 35

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Transformational change in 2013 Pharma leaders need tp proactively transform themselves in 2013 in order to face the challenges ahead, reasons Dr RB Smarta, Founder and Managing Director, Interlink Marketing Consultancy ost of us would like to live in a more caring, socially just, economically-dynamic, affordable and environmentally responsible country.

The challenge is to close the gap between our aspirations and the trajectory of trends on which current status thinking, and action of the industry places us.

As we are placed in India, key developments are expected out of the current regulatory, social and political environment for pharma’s and lifescience’s status along with its impact. What I can foresee for 2013, can be described in two directional moves. But to do this, we need to think afresh about industry context, social, political and regulatory issues and understand how it might impact the industry!

Responding to increasing demographic dividend, social mobility and the need for this industry to stay competitive in this turbulent and disrupt age, industry leaders need to find out their own collective as well as individual ways. These are complex issues as multiple stakeholders are involved for its impact in the foreseeable future.

Today, country considered as export destinations are facing uncertain economic conditions.

The domestic situation has become complex from pricing to ethics of marketing and selling. Bigger challenges lie ahead and the leadership needs a complete 360 degrees change to transform itself and others.

These two directional moves, can be summarised as immediately impacting moves and transformational moves in a domestic market.

Immediately impacting moves:

M

Dr RB Smarta Founder and Managing Director Interlink Marketing Consultancy

Moves of immediate impact Affordable pricing move Looking at the trajectory of revoking patents, compulsory licensing for Indian players, encompassing 384

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drugs under price control and forthcoming NPPA effects, there is definitely a move towards an affordable pricing for patients. This move will immediately impact the industry as well as patients.

Generics & biosimilars Social impact which has accelerated after Satyamev Jayate hosted by Amir Khan coupled with affordable pricing which is a key issue for political agenda is paving the way for generics and biosimilars. It has been further accelerated by the start of Swasthya bhandars.

This generic move will make everybody inclusive of international, multi-nationals, national companies to launch generics in India. It will increase the competitive intensity. Similarly, purchase of medicines by Indian government in the health sector would be increased by manifold in the 12th plan, which will result in increased hospital purchases of generics.

Food and nutrition move: Move on FBO foods business operators: Licensing has evoked a very encouraging response with deadlines

industry would cling to preemptive, proactive and preventive medicines as well as dietary supplements to move towards profitability.

This move towards increasing profitability along with increasing volume through generics will balance the industry in its future.

Diagnostic move Due to higher education and health consciousness, medical practitioners would use more diagnostics. The move towards diagnostics, medical products and other allied health products would come up in the market with high income group population.

Technology move Indian retailed sector is poised to adapt greater technology which will improve efficiency and also give rise to organised retailing. This move will also lead to the birth of pharmacists which is a requirement in Indian conditions for patients.

International move On international fronts, emerging markets as well as developed markets are looking at generics substitutes and new launches. India has

move against the stream in domestic as well as international markets.

Marketing ethical codes move As the environment amongst prescribers is being monitored through codes, ethics would bring back transformation in branding strategies in this industry.

Branding move Branding could be for corporates as well as for individual products although the importance of existing Customer Relationship Management (CRM) would not be fully affected.

Promotional move With the advent of social media being very popular, promotional stance as well as transformation in media is likely to take place through social media, specialized carved out media, mobiles, e-detailing, e-sampling etc.

Integrated medicines move As there is a lot happening on the front of Ayush for ayurvedic, Ayurceuticals and homeopathic medicines, chances of getting a transformation in treatment is

KEY DEVELOPMENTS ARE EXPECTED OUT OF THE CURRENT REGULATORY, SOCIAL AND POLITICAL ENVIRONMENT FOR PHARMA’S AND LIFESCIENCE’S STATUS ALONG WITH ITS IMPACT. RESPONDING TO INCREASING DEMOGRAPHIC DIVIDEND, SOCIAL MOBILITY AND THE NEED FOR THIS INDUSTRY TO STAY COMPETITIVE IN THIS TURBULENT AND DISRUPT AGE, INDUSTRY LEADERS NEED TO FIND OUT THEIR OWN COLLECTIVE AS WELL AS INDIVIDUAL WAYS given by Food Safety and Standards Authority of India (FSSAI) all over India. It makes a nutritional transition in the Indian context.

Nutraceuticals, functional foods, medical purpose foods, sports medicines etc. would be encouraging and form a significant part of the market to start with.

Profitability move In absence of new patents coming in, the www.expresspharmaonline.com

tremendous scope for generics all over the world.

Transformational moves NDDS & Indian Patents move As many patents are expiring over time and more generic line up for the future, transformation of national companies providing, NDDS products as well as patents along with newer vaccines made in India would form a very different

likely. It may lead towards integrated medicines which would be for not only managing the disease but also ensuring that the patient is healed in holistic ways.

Both these moves will urge all the players in the Pharma Industry and those who are proactive and ready to invest in strategy and people to really make their mark in the next three years.

January 1-15, 2013

Improved awareness will lead to better...

Continued from Pg 21 The guidelines now have placed more responsibilities on the shoulders of ECs. Each EC should be registered with the government organisation. They should be inspected and accredited.

Regular inspection/ audit of ECs will make the members realise that they have to be up to date in their knowledge and record keeping. If found non- compliance EC should be de-listed and for major fraud there should be penalty for the members too.

CROs/ SMOs: SMOs will flourish as there would be more and more systematic approach for patient’s identification, investigators commitment would be required. This would be done through an excellent database of patients, as well as for the investigators.

Compensation to healthy subjects for BE study will increase as the subjects will be more professionals.

Compensation for serious adverse event in a study will be much more and there would be even lawyers looking out for serious adverse events in a subject and to make some quick money out of it. (I see nothing wrong in it).

More and more CROs would go for Pharmacovigillance, Central Lab particularly for ECGs, radilogy, X-Rays, CT Scan, MRI, colour doppler, data management, medical writing, quality assurance, etc. since it does not require any approvals from regulatory authorities and the profit margins are higher.

More use of end –points related to biomarkers. This will provide independent opinion on efficacy and safety of the trial subjects. More and better software related to CTs would be in the market leading to consistency in analysis and minimal chance of fraudulent cases. More practical and acceptable study design will provide better clues about efficacy and safety of the molecules.

Use of robots in Bioanalytical Lab and Central Lab to speed up the process and will have less errors.Patients Group will play a major role in protocol design, compensation, and enrollment in the study. More clinical trials related to medical devices would take place as there would be great demand for the same for various activities in the life and to improve quality of life.

Severe punishment for non- compliance to CROs and SMOs.

Institutions and investigators Institution charges for conduct of CTs would increase as they are now becoming more and more aware about it. Each institute will have a separate clinical research department under taking CTs. The trained staff will take care of it. It would be the duty of the chief of the institution to see that the CTs are performed as per ICH-GCP guidelines. Each institute will have EC too.

Investigators will be specially trained to conduct CTs. However, the investigator fees would be much higher (more than 100 per cent increase compared to present structure) as they would be in demand. Each investigator will conduct the CTs in their super specialised therapeutic areas.

Frequent audits of the institutes and the conduct of the study by the investigators would be a must. Any fraud by institution or by the investigator should be considered as criminal activity and penalty should be the outcome of it. In such cases both can be debarred from undertaking clinical trials for a certain period.

Miscellaneous There would be more manufacturing units for the formulations related to CTs, packaging, quality control, quality assurance, etc. will mushroom. Courier services work would reduce as there would be more online services. Mobiles would be used more in getting the patients feedback. It will reduce their visits to the sites. Media would be more educated and hence there will be less unnecessary noise in the media

Conclusion All these can happen if there is a good awareness about clinical research in every partner. Every individual will have to do their best to achieve it. Regulatory agencies will have to be more sharp and understand the reality of the business and science.

Even the pharmaceutical, biotech and medical device industries will have to pitch in. Quality will always remain to the top requirement in every aspect. The CTs will become more expensive and there would be less number of new molecules.

January 1-15, 2013

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Modest progress in fiscal and public sector reforms expected Policy makers should be upbeat in implementing the policy reforms to get the economy back on the track, Abhishek Goenka, Founder and CEO, India Forex Advisors, gives an outlook 012 has been a very volatile year for the global as well as the local markets. With major events like prolonged concern over Euro crisis, FED QE3, US Presidential Election and many more had made the markets witnessed volatile moves.

Talking about India, the year started with a big bang as the government and RBI policy to lure the investors fetched about USD The Indian economy has witnessed record inflow from the FII’s. The sum total of flows into the equity and debt markets surpassed almost $26 billion till 11th December 2012. With a couple of weeks left for the new year, the markets are seen getting huge flows largely driven by the liquidity exercises by various central banks across the globe.

Looking at the history of the Indian rupee, from 1973 until 2012 the USD INR exchange averaged 30.65 reaching an historical high of 57.33 in June 2012 and a record low of 7.19 in March of 1973. The poor macro economic fundamental, rising fiscal deficit and current account deficit, which is highest among the Asian countries, are the factors responsible for the havoc created in the local currency market. The international factors cannot be blamed completely for the deteriorating rupee; it’s been the lack of management of the deficit that had been accumulated over the years, which is resulting in slowing economy growth.

The Indian rupee has weakened 2.6 per cent from the year start on account of the poor macroeconomic fundamentals. The story of twin account deficit continues to exert pressure on the local currency. The rupee was seen reaching the record low of 57.33 levels against the dollar on the back of poor fundamentals and uncertainties in the global markets.

The policy makers can't blame international develop-

2

Abhishek Goenka Founder and CEO India Forex Advisors

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ments for all the ills. The ignorant behaviour is the primary reason for the macro-economic conditions deteriorated over the years be it the current account deficit, or the fiscal deficit.

It was taken for granted that overseas investors will forever be pouring money into India, irrespective of its macro-economic conditions.

The slowing industrial production and sticky inflation have also paved the way for rupee weakness.

The Indian economy has held current account deficit since a long time and this is considered as one of the primary reasons for the rupee weakness.

Instead of praying for the international economic situation to improve, currency policy makers should be upbeat in implementing the policy reforms to get the economy back on the track.

The rupee has been the worst performer among emerging market peers in Asia. After recovering from new lows in December 2011 and early January 2012, the rupee started recovering against the dollar. The local currency appreciated from 54 levels to 48.60 levels, a close to seven per cent appreciation.

This was largely because foreign portfolio investors started pouring in huge funds. The global Indians too invested in NRI deposits offered by Indian banks as the central bank liberalised the interest rates offered on these deposits, which were nearly five times more than what the western world was paying.

However, the rupee’s gains started reversing from late February, touching new lows visa-vis the US dollar in the last few days. This is largely because on the one hand, foreign portfolio investors have started going slow on investments into the country - in the month of April, they pulled out close to $1 billion from the Indian markets - on the other hand, the country's import bill too has risen due to higher crude and commodity prices amid a slower growth in exports. The trade deficit has widened also because exports did not manage to keep pace with imports as developed marwww.expresspharmaonline.com

kets are yet to fully come out of recession.

The trend in the rupee is also reflective of India's huge fiscal deficit as well as the current account deficit among emerging Asian peers. India's combined fiscal deficit, including that of state government, has risen sharply.

The wide fiscal deficit and a heavy debt burden are the most "significant rating constraints" to the country's sovereign rating according to the rating agency Standard & Poor's.

Repeating its warning that India faces a one-in-three chance of being downgraded to junk over the next 24 months. India has a BBBrating from S&P, the lowest investment grade among the BRIC economies.

With the up-coming elections in March 2014 and the current political gridlock, we expect only modest progress in fiscal and public sector reforms.

A rating downgrade is likely if India's economic growth continues to underperform its external position deteriorates, its political climateworsens, or fiscal reforms slow.

India, Asia's third largest economy grew at its slowest pace in three years at 5.3 per cent in the September quarter and is on track to post its weakest growth in a decade.

Talking about the reforms, the government managed to secure majority votes in both the houses, increasing the market expectation of further more reforms to be passed on banking, Insurance and pension sector. As said earlier, with just a year left for the central election and economy growth slowing down, the Foreign direct investors will refrain from pumping in huge flows in the nation till the economy shows signs of bottoming out.

Looking at the global factors, which also impact on the movement of the local currency are seen stable. But the concern has not ended with no concrete solution made over Euro debt and the concern continue over US fiscal cliff.

The "fiscal cliff" impasse is raising the odds that Congress will fail to meet a year-end deadline to

avert steep tax hikes and budget cuts that could push the nation into another recession.

With talks between President Barack Obama and House of at an apparent standstill it is likely that the leaders won't be able to reach a deal before January 1, 2013.

The resulting $600 billion hit could push the economy back into recession, but the full effect likely would not be felt for months - giving legislators some time after the New Year to resolve the situation. Even though the economy would likely not take an immediate hit if lawmakers miss the deadline, failure to reach a deal could spook financial markets, which have been relatively calm in recent weeks.

So we could see a volatile market in the new year.

Many economists believe that the economy could withstand a brief slip over the cliff because the impact of tax increases would be felt gradually.

However psychologically the consequences may be severe especially if stocks fall sharply.

With just over two weeks to go before the end of the year, each day that passes without a deal could mean more pressure for currencies and equities. More stimulus from the Federal Reserve failed to boost the investors sentiments.

The US central bank committed to monthly purchases of $45 billion in Treasuries along with the $40 billion per month in mortgage-backed bonds it started buying in September.

Bringing their total monthly purchases to $85 billion.

The investors are focused on the Fed's new approach of linking its policy to a drop in jobless rates, fearing that the Fed might withdraw its economic stimulus if the job market improved dramatically in the months to come.

The chances are higher of monetary policy reversal as the unemployment is seen reducing in the last few months. The US companies added 146k jobs in the month of November, exceeding the estimates. Between Hurricane Sandy and fiscal cliff concerns, the market was looking for an addition Continued on Pg 35 January 1-15, 2013

M|A|R|K|E|T

GROWTH TRACKER IPM grows 4.1 per cent, valued at ` 5939 crore in November ‘12

Pfizer + Wyeth

9

9

2202

3.18

18.5

195

3.28

3.8

Lupin

10

10

2083

3.01

14.9

181

3.05

9.8

Macleods

11

11

1751

2.53

29.8

150

2.53

12.8

Intas

12

12

1640

2.37

19.0

143

2.41

9.8

he Indian pharmaceutical market clocked a value of ` 5939 crore in November 2012, growing at 4.1 per cent.

As per the monthly secondary sales data audit conducted by AIOCD-AWACS' PharmaTrac, from a therapy perspective, sex stimulants/rejuvenators clocked a 25 per cent growth.

The anti-diabetic market recorded the second highest growth at 15.6 per cent, resulting in Novo Nordisk, with its large insulin portfolio, showing the highest growth (32.5 per cent) among the top 50 corporates.

The cardiac segment followed with 8.0 per cent in chronic business. The anti-infective market had a growth of 3.3 per cent whereas respiratory market was little better at 3.9 pre cent growth.

The gastro and vitamins/minerals/ nutrients segments showed negligible growth whereas pain and analgesics market showed a degrowth of -0.9 per cent in November.

Among the top performing companies, in the top 10, Mankind had the highest growth of 16.6 per cent , followed

by Zydus (including Biochem) at 15.3 per cent, Sun Pharma at 14.9 per cent, Ranbaxy at 11.8 per cent and Lupin at fifth place at 9.8 per cent.

Two companies crossed ` 300 crore sales in November, the first being the combined entity of Abbott, Abbott Healthcare and Solvay (` 317 crore) folllowed by Sun Pharma, at ` 301 crore.

Without bonus units, Sun Pharma ranked second for the month and MAT for November. Corona Remedies, currently ranked 57, registered a growth of 102 per cent.

More inventory, less retail sales than October

Abbott, Sun Pharma cross ` 300 crore in monthly sales With bonus units at full value Rank Corporate

MAT

MAT Nov -12

MTH

IPM

34

Nov -12

Val (cr)

MS%

GR%

Val (cr)

MS%

GR%

69296

100

15.4

5939

100

4.1

Abbott + Abbott HC + Solvay

1

1

3886

5.61

9.83886

323

5.44

-5.8

Cipla

2

3

3494

5.04

11.8

292

4.91

-0.5

Sun Pharma

3

2

3299

4.76

22.8

304

5.13

14.9

Glaxo

4

5

3233

4.67

18.2

276

4.64

1.6

Zydus + Biochem

5

6

3012

4.35

16.2

276

4.64

15.3

Ranbaxy

6

4

2925

4.22

10.8

279

4.70

11.8

Mankind

7

7

2470

3.56

26.3

210

3.53

16.6

Alkem + Cachet + Indchemie

8

8

2350

3.39

16.9

205

3.45

3.2

Aristo

13

13

1620

2.34

15.5

137

2.31

5.6

Sanofi-Aventis + Universal

14

14

1549

2.24

15.2

131

2.21

4.2

Emcure + Zuventus

15

15

1456

2.10

14.3

122

2.05

3.4

Dr Reddys

16

17

1358

1.96

10.5

116

1.96

4.9

Glenmark

17

16

1345

1.94

27.1

117

1.96

10.9

Micro + Bal

18

18

1315

1.90

21.1

107

1.80

-7.9

Ipca

19

19

1224

1.77

19.6

105

1.77

-3.7

Wockhardt

20

22

1211

1.75

11.8

99

1.67

-7.2

Super Group

MAT Nov - 12

GR%

Nov - 12

GR%

IPM

69296

15.4

5939

4.1

ANTI-INFECTIVES

12502

13.5

1099

3.3

CARDIAC

8427

18.1

730

8.0

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AIOCD-AWACS' PharmaTrac estimates that November recorded extra primary growth compared to secondary growth, as sales/demand at retail level (which are audited

by PharmaTrac) were lower than in the previous month (possibly due to public holidays like Divali in November).

This anomaly has resulted in more than normal levels of stocks in the market and corresponding lower recorded sales. Specifically, closing stock days (without in-transit) for November went up to 22.3 days as compared to 19.8 days in the previous month, resulting in 2.5 days of additional inventory in the market. AIOCD-AWACS' PharmaTrac estimates that the 2.5 days of additional inventory would have resulted in 8 per cent extra primary growth in November compared to secondary growth.

Almost all companies show increase in closing stock over the previous month, most notably Macleods (3.8 days), Ranbaxy (2.9 days), and Cipla (2.6 days). Sun Pharma had the least closing stock days, showing an increase of just 1.3 days over October. PharmaTrac estimates that this anomaly should balance out in December.

GASTRO INTESTINAL

7856

15.5

615

0.2

VITAMINS / MINERALS / NUTRIENTS

6075

16.9

486

0.2

RESPIRATORY

5295

12.1

516

3.9

About PharmaTrac

PAIN / ANALGESICS

5156

11.2

436

-0.9

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 bottom-line.

ANTI DIABETIC

4557

26.0

400

15.6

GYNAECOLOGICAL

4555

11.7

366

-0.4

NEURO / CNS

4180

14.0

361

4.5

DERMA

3666

17.3

318

4.1

HORMONES

1175

20.1

105

7.7

OPHTHAL / OTOLOGICALS

1152

14.8

94

-0.2

OTHERS

955

19.7

95

32.8

VACCINES

877

11.0

71

3.6

BLOOD RELATED

858

16.0

69

2.5

ANTI-NEOPLASTICS

670

9.6

63

23.0

ANTI MALARIALS

651

19.9

55

-11.8

SEX STIMULANTS / REJUVENATORS

384

20.9

37

25.0

STOMATOLOGICALS

305

14.4

25

4.0

EXPRESS PHARMA

www.expresspharmaonline.com

Terminologies used MAT – Moving Annual Total MTH – Month Val (Cr) – Value in Crs MS per cent - Market Share in Percentage GR per cent - Growth in percentage For more information, visit http://www.aiocd.net January 1-15, 2013

‘Empowered Patients’: A changing ...

Continued from Pg 15 Some other global pharma companies, who are reportedly in the process of engaging with the customers through social media like Twitter, are Pfizer, Johnson & Johnson, Novartis, Boehringer Ingelheim, AstraZeneca,

Bayer, GlaxoSmithKline, Sanofi, Roche and Merck.

Thus, many pharma companies, over so many years, have been increasingly trying to be more and more ‘Patient-Centric’ in their endeavour to satisfy the demands of the new generation healthcare con-

sumers – ‘The Empowered Patients’.

In today’s era, increasing general awareness, rapid access to information on diseases, products and costeffective treatment through the cyberspace, together with instant communication between the patients and also the patient groups

through social media like, 'Twitter' and 'Facebook', I reckon, would hasten the process of ‘Patient Empowerment’ in India too.

This trend, in turn, will have its own inherent potential to change the overall dynamics of healthcare in the country significantly.

‘IPR trends in 2013: An alloy...

Continued from Pg 29 MNCs will continue to resist requests for submission of information for regulatory approval by calling it confidential. International interference in government functioning will rise and IPR based business interests of many MNCs will be protected. Apex institution will be challenged and will be taken to dispute settlement bodies of IOs. u) DCs will voice that their IP laws are TRIPs compliant and will find out means to circumvent TRIPs+ provisions in alleged free trade (?) agreement. To fulfill their trade interests, developed world will increase pressure on LDCs to accept TRIPs+ conditions and LDCs will succumb to it, albeit DCs, BRICS and pharmerging economies may be able to resist some

extent. v) DCs and LDCs will realize that i) lopsided interpretation of IPR will extinguish identity of their nation ii) each country has to fight its own war as most of TRIPs members are docile. iii) it is imperative to study and ensure that IPR clauses in IAs are consistent with their needs and policies. iv) IPR is the only tool in knowledge economy to protect domestic markets and to penetrate foreign markets. w) Dissatisfaction about complicated DOHA CL provisions will grow and realistic and workable alternative may be visible. x) DCs and LDCs will be forced to divert resources from more important sectors like agriculture, defense and public health to reinvigorate IP wings to impart more

transparency in accessing prosecution details, online form filling, online file inspection, accessibility to prosecution history, use of emails and virtual interaction or interaction by audiovisual media rendering physical human presence exceptional and for e-renewals.

Developed countries will raise fees for prosecution, grant and maintenance of IPR. DCs and LDCs will learn to disapprove patent claims not substantiated by illustrations or examples and claiming thousands of compounds in claim will be difficult in. Patent application backlogs will continue to rise across the globe.

Capabilities of IP offices will be challenged. There will be opportunities for collaborative actions between IP offices of different countries.

y) LDCs and DCs will continue to share their TK with developed world free of cost and will pay huge royalties for the patent protected products derived from that TK. Wise DCs and LDCs will identify internal barriers to growth of IP by self assessment without the help of external input. z) Seed producing companies will further tighten their grip over global food production, assert their IP, challenge sovereign of DCs and LDCs and will expose abilities of the national leaderships to serve public interest.

Quality and quantity of trends in 2013 will be product of the extent to which IPR and their ODH are understood.

(Views expressed in this article are personal)

Modest progress in fiscal and public...

Continued from Pg 32 of only 85k jobs. The unemployment rate dropped to 7.7 per cent, its lowest level since December 2008. The closely watched US underemployment rate also fell to 14.4 per cent from 14.6 per cent.

The European Central Bank (ECB) in its final press conference for the year 2012, downgraded their 2012 and 2013 growth forecasts along with next year's inflation estimates and warned that the risks are to the downside.

Coming back to the Indian rupee, we continue to hold our bullish view on USD INR. The US dollar Index seems to have bottomed in 2011 near 73 levels and could rise to 90 levels.

January 1-15, 2013

High risk aversion and positive economic numbers compared with its peers countries may push the US economy to stronger levels. The dollar index going above 85 levels could add to the woes and push rupee close to 5859 levels again.

Checking out the impact of a weak rupee on pharma ceutical industry, recovery of sales in the US and in the global pharma business and the rupee's decline have enabled pharma companies in India to come out with a strong performance in the March quarter, one of the best in recent times. The rupee depreciation further will continue to benefit the sector as between 60 to 80 per cent of its revenues come from exports. www.expresspharmaonline.com

We expect the pharma sector to remain in focus on account of Obama back in power, benefits of Patient Protection and Affordable Care Act which will be a reality without any hassle, the benefits of which will directly flow down to leading generic players.

The pharma stocks have also outperformed the broader market over the past several months on the back of the rupee depreciation and several companies announcing FDA approvals and drug launches in the US. The government’s recent decision that all foreign investments in existing domestic pharma firms should be allowed only after clearance by the FIPB, amid mounting concerns

over availability of affordable essential drugs in the wake of multinationals acquiring local companies.

After a series of criticism over the government's decision the Prime Minister Manmohan Singh said that the government is trying to bring greater clarity on allowing foreign capital inflows in the domestic pharma sector.

It is largely argued that the India is already FDI-starved, any policy which restricts freedom of trade and investment will further restrict capital flows in the sector.

Still, rupee depreciating to 57-58 levels by mid 2013 would surely help the sector and the boost the overall performance, on one condition: if they maintain a proper risk management policy.

EXPRESS PHARMA

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COMPANY WATCH State drug regulators equally responsible for clinical trial activities: DCGI In a watchdog role, state regulators now mandated to accompany CDSCO officers on clinical trial site inspections Usha Sharma Mumbai he Drug Controller General (India), in a recent order, seems to be expecting all State and Union Territory Drugs Control Authorities, to play a more vigilant role when it comes to approving clinical trial protocols and monitoring ongoing clinical trials in their jurisdiction.

All state regulators will be expected to accompany CDSCO officers on their regular activities related to monitoring clinical activities in their respective states, taking on a watchdog role.

Commenting on the CDSCO order dated December 12, Dr GN Singh, Drugs Controller General of India said, “Our mission is to protect human health safety and we are constantly working towards this goal. The order

T

letter dated December 12 aims to ensure that clinical trials are conducted in accordance with the provision of Schedule Y of the Drugs and Cosmetic Rules. As we have issued copies of this letter to State and Union Territory Drugs Control Authorities as well, it is equally their responsibility to keep an eye on clinical trial activities in their territories.”

Commenting on this latest development, Dr Bharatesh Jagashetty, Drug Controller, Karnataka state said, “So far, we have not received any official communication from the DCGI’s office regarding this matter but if it is true, then we welcome this move as we were trying to do this for a long time.”

He also added, “We should be allowed to get involved in all matters related to clinical trials like inspecting investigator sites, granting approval (to conduct the trial) etc.”

In the order dated December 12, the DCGI has reiterated the responsibilites

of Ethics Committees (ECs) under Schedule Y of the Drugs and Cosmetic Rules, and concludes with a reminder that sites of sponsors/clinical research organisations (CROs) as well as ECs need to remain open for inspection by inspectors/officials of CDSCO to ensure that the clinical trials are conducted strictly in accordance with Schedule Y. The DCGI has indicated that representative officials of state regulators will be expected to accompany CDSCO officers on these inspections and other regular activities related to monitoring clinical activities in their respective states.

This order seems to be a follow up to the points discussed at the 44th meeting of the Drugs Consultative Committee (DCC) held on July 20. In the inaugural deliberations, Sanjay Prasad, Director, Ministry of Health and Family Welfare had stated that the drug regulatory frame work both at the Centre and the States is an important part of health care system.

He had opined that the large number of Court cases and RTI applications show that there is awareness in the public about the Drugs Control Departments and therefore the regulatory agencies are required to be transparent and accountable, with both the Centre as well as States required to work in tandem to ensure that there is strict control over the quality of drugs in the country.On the subject of Centre and State authorities working together, the minutes of the same DCC meeting go on to quote Dr V M Katoch, Secretary, Dept Of Health Research & Director General, ICMR, New Delhi, saying that the regulatory environment in the country is changing and as there are lot of expectations from the drug regulatory authorities, he opined that the system which is working with the nucleus organisations at Centre as well as State level is required to be made broad based to ensure that responsibilities are discharged more effectively. u.sharma@expressindia.com

Claris in JV with Otsuka, Mitsui for injectables Deal gives Otsuka entry into IV solution/clinical nutrition business in India, emerging markets laris Lifesciences recently executed joint venture (JV) agreements with Japanbased pharmaceutical company Otsuka Pharmaceutical Factory (OPF) and Mitsui & Co for its infusion business in India and emerging markets, subject to shareholders’ and regulatory approvals and other closing formalities.

Arjun Handa will be the Chairman and Claris will appoint the CEO of ClarisOtsuka.

OPF’s global expertise in the infusions business and Claris’ India advantage to be a huge advantage to ClarisOtsuka. Commenting on the deal, Arjun Handa, MD and CEO said, “We welcome Otsuka and Mitsui to India and to our infusions business.

We are very happy with this

C

36

EXPRESS PHARMA

partnership as both Otsuka; with its global expertise in the Infusions business and their speciality products; and Mitsui; with its global trading and financial expertise; will add significant value to the JV.” He continued further, “The infusions business is growing very well in India and the emerging markets. This business needs a broad product portfolio and a commitment towards long term capital investments in addition to technical and global expertise, which are clearly achieved by Otsuka and Mitsui’s entry. It is my belief that this partnership synergises the strength of all three partners. This partnership enables Claris to focus and intensify its efforts to build out its speciality injectables business globally.

Globally injectable products are in shortage as pure-play injectables companies are a rarity. The company has www.expresspharmaonline.com

always had a niche positioning within the injectables domain and this transaction will help us to further build on this advantage by intensifying our new product development pipeline with several large and complex injectable products.”

Ichiro Otsuka, President, OPF said, “We are pleased to have entered into a partnership with Claris and Mitsui for the full-fledged entry into the IV solution/clinical nutrition business in India. Mitsui, on the other hand, has a long history on conducting business in India. Mitsui, with its comprehensive expertise, will contribute to the smooth operation of the new company from a business and financial standpoint. Otsuka, based on its experience from developing business in Japan and other Asian nations, is committed to being the best partner of both patients and healthcare professionals in the field of clinical

nutrition, and together with Claris and Mitsui will contribute to the betterment of medical care in India.”

Satoshi Tanaka, Managing Officer and COO, Mitsui said, “The medical and healthcare field is a key area of business for Mitsui. Mitsui’s mediumterm management plan calls for efforts to reinforce initiatives in emerging countries in anticipation of expanding demand for pharma products, and the BRICs have been identified as priority markets.

Mitsui aims to strengthen its relationships with Claris and Otsuka, which it regards as important partners. It will make India, which is achieving rapid economic growth, the platform for its efforts to meet the expanding demand for infusion products in other emerging countries.”

Barclays was the sole advisor for Claris.

EP News Bureau- Mumbai January 1-15, 2013

M|A|R|K|E|T

PRE EVENTS iPHEX 2013 to showcase Indian pharma exports; R&D capabilities Over 400 international buyers and regulators expected at iPHEX 2013 he 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. iPHEX 2013 shall be held in Mumbai from April 2426, 2013 and 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 during 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. Elaborating on the strengths of the Indian pharma industry, Dr PV Appaji, Director General, Pharmexcil says, “India is the third largest player in the world with 500 different APIs and ranks fourth globally in terms of production volumes; and 13th globally in domestic consumption value. The country is the largest exporter globally of generic formulations in volume. It exports vaccines to 150 countries and produces 40-70 per cent of the WHO demand for DPT and BCG and 90 per cent of measles vaccines.”

Besides domestic companies are accredited with 851 CEPs, 845 TGA and 513 manufacturing sites, registered with US FDA. They have been granted 90 per cent of APIs approvals for ARVs, anti-tubercular and anti-malarial. India also ranks highest with 35 per cent share in filings of DMF filed with US FDA and it sells 15 per cent of generics by volume in US.” iPHEX 2013 aims to be a complete value chain show and Pharmexcil is creating a sustainable pharma industry

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January 1-15, 2013

platform with a special focus on exports market development. “The exports growth story is one to be proud of,” says Appaji. “Total exports during the last five years have grown by 16 per cent CAGR, growth during the last financial year, 2011-12 was 23.34

They also inform that Indian pharma industry today is ranked world class, in terms of technology, quality and range of medicines manufactured.

From simple headache pills to sophisticated antibiotics and complex cardiac compounds, almost every type of medicine

(L-R) Dr PV Appaji, Director General at Pharmexcil India and Bhavin Mehta, CoA Member Pharmexcil and Committee Chief of iPHEX per cent in USD terms. North America continues to be our best destination with a CAGR of 25 per cent and 33 per cent growth during 2011-12.

Exports to EU has grown exceptionally well during 201112 with 28 per cent considering the fact that a single digit CAGR was recorded during the last four years. Exports to Oceania have also grown well with a growth of 43 per cent but the overall turnover is small and considering the fact that Australia and New Zealand are not yet fully tapped, higher growth rates can be expected,” he mentioned.

With increasing R&D spends, Indian pharma sector has become a cost-effective centre for world class research as also for contract R&D. Indian companies in recent years have produced many cost-effective drugs that are affordable to the masses, said Ashutosh Gupta, Vice Chairman of Pharmaexcil.

“We are making concerted efforts to promote India’s status as the manufacturing hub of the world,” added Gupta.

Pharmaexcil informs that India is a favoured pharma hub since it is technologically strong and totally self-reliant, has low costs of production, low R&D costs, innovative scientific manpower, strength of national laboratories and an increasing balance of trade. www.expresspharmaonline.com

is now made indigenously.

The industry today can boast of producing the entire range of pharma formulations, i.e., medicines ready for consumption by patients and about 350 bulk drugs, i.e., chemicals having therapeutic value and used for production of pharma formulations.

Pharmexcil also highlights that more and more Indian companies are investing in research and development (R&D). They are working overtime to improve the overall quality of their existing product and services lines.

India has steadily emerged as a major global R&D hub despite starting late. The country with a spending of $30 billion globally ranks eighth.

India has moved up in the pecking order which includes leading innovators like China, Japan, Germany and South Korea. The average R&D expenditure by Indian pharma companies is close to six per cent.

The Government has prepared a ‘Pharma Vision 2020’ document for making India one of the leading destinations for end-to-end drug discovery and innovation. Through this, the government provides support by way of world class infrastructure, internationally competitive scientific manpower for pharma R&D and venture fund for research in the public and private domain.

The Government is also embarking on a major multibillion dollar initiative with 50 per cent public funding through a public-private partnership (PPP) model to harness India’s innovation capability. The vision is to catapult India into one of the top five pharma innovation hubs by 2020, targeting to achieve a global niche with one out of every five to ten drugs discovered worldwide by 2020 originating from India.

“The Government has also been taking various policy initiatives for the pharma sector.

These include tax-breaks to the pharma sector and weighted tax deduction at 150 per cent for the R&D expenditure incurred. Steps have also been taken to streamline procedures covering development of new drug molecules, clinical research etc.

Indian Government has launched two schemes—New Millennium Indian Technology Leadership Initiative and the Drugs and Pharmaceuticals Research Programme—specially targeted at drugs and pharma research,” says Appaji. “iPHEX 2013 will be the biggest industry exposition in India showcasing the diverse range of products and will include formulations, APIs, Ayush, nutraceuticals, health services, biotechnology and biotechnology products, R&D services etc,” informed Bhavin Mehta Committee Chief of iPHEX and CoA member, Pharmexcil.

In addition to a world class exhibition and meeting place for Indian companies and global buyers, Pharmexcil plans to organise several thematic seminars and conferences on the sidelines as well.

“These shall include pharma sector investments, R&D and innovation, overseas market entry strategies etc,” mentioned Mehta. The Ministry of Commerce, has launched a series of initiatives to promote Brand India Pharma and iPHEX 2013 is expected to offer a perfect opportunity for international buyers and regulators to come to India and evaluate how well structured and regulated the Indian pharma industry is.

Visit www.pharmexcil.com for more details.

EP News Bureau-Mumbai EXPRESS PHARMA

37

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BioAsia and BioRx to host workshop on private equity To be held on January 28 on the sidelines of BioAsia-2013 ioAsia and BioRx will conduct a workshop on Private Equity (PE) and and Venture Capital (VC) in Lifesciences sector, a perspective changing interactive event. The workshop will be held on the sidelines of BioAsia-2013. It will take place at HICC, Hyderabad on January 28, 2013.

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The target audience will be CEOs, CFOs, corporate treasurers and board members of life sciences companies, private bankers and wealth managers, investment bankers and security analysts, corporate lawyers, risk managers and structured financial professionals.

The workshop will provide an update on Indian VC and PE market; Due diligence-key imperatives, The Art of valuation: How does

VC/PE value a company; Legal aspect of PE/VC and exit strategies.

BioAsia 2013 to be held at Genome Valley, Hyderabad from January 28 to 30, 2013, will seek to enhance, enrich and encourage newer innovations, pathbreaking discoveries and effective solutions in the industry by offering a vibrant global platform for convergence of the key stakeholders—biotech and

biopharma companies, research institutions, investors, service providers, policy makers, regulators and analysts.

With an objective of optimising the immense business potential of biotech, BioAsia enables an effective environment for fostering collaborations, joint ventures, M&As that has increasingly become an integral part of industry growth agenda.

EP News Bureau- Mumbai

Nominations invited for Healthcare & Pharma HR of The Year, HarNeedi TREE Awards 2012 Instituted to honour HR professionals in the healthcare and pharma fraternity, HR of the Year, HarNeedi TREE Awards 2012 are the vision of HarNeedi.com, with Padmashree Dr DY Patil University as Knowledge Partners and Express Healthcare and Express Pharma as exclusive media partners xpress Healthcare, Express Pharma and Padmashree Dr DY Patil University along with HarNeedi.com have teamed up to honour the HR professionals who have contributed relentlessly and continue to propel Indian healthcare and pharma industries on a growth path.

As India’s number one jobsite for healthcare and pharma professionals, HarNeedi.com is an offering from Makro Group launched in 2007 to address crucial manpower solutions to these two industries.

Through keen observation of recruitment trends over the years, HarNeedi.com has acknowledged the immense challenges and contributions of HR professionals and therefore instituted the HR of The Year HarNeedi TREE Awards 2012.

Explaining the thought process behind the awards, Mahesh Malneedi, Chief Executive Officer, HarNeedi.com said, “Today HR plays a dynamic role to hunt, recruit, manage and retain human resources for an organisation. In fact HR is like a tree, supporting

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thousands of professionals who dwell and grow along and get introduced, impacted, mentored and climb on the ladder of success.” Dr Sanjay Oak, Vice Chancellor, Padmashree Dr DY Patil University opine, “HR plays a silent and vital role in both healthcare and pharma industries. Such events will

judges explained the crunch, “Talent attraction, retention and development are key challenges in healthcare today and it would be exciting to see and analyse how the HR managers successfully manage.”

The panel of judges comprises Dr Sanjay Oak, Gaurav Malhotra, Viveka Roychowdhury, Editor, Express Healthcare and Express Pharma and Sudhir Bahl, Co- Founder and CEO, Irene Healthcare, Kawaljeet Oberoi, Chief Nursing Officer, Gleneagles

HARNEEDI.COM HAS ACKNOWLEDGED THE IMMENSE CHALLENGES AND CONTRIBUTIONS OF HR PROFESSIONALS AND THEREFORE INSTITUTED THE HR OF THE YEAR HARNEEDI TREE AWARDS 2012.THE NOMINATIONS WILL BE PUT THROUGH A STRINGENT PROCEDURE WHERE THEY WILL BE SCREENED ON VARIOUS PARAMETERS BY THE PANEL OF JUDGES not only boost the HR leaders but also provide an excellent platform to discuss current and future HR problems and solutions. Gaurav Malhotra, Managing Director and Chief Executive Officer, Patni Healthcare, also a member of panel of www.expresspharmaonline.com

Khubchandani Hospitals, Biblob B Banerjee, GM HR, GSK, with more confirmations in the pipeline.

Nominations are invited from the pharma and healthcare fraternity nationally for various categories.

The nominations will be put

through a stringent procedure where they will be screened on various parameters by the panel of judges.

“The entire healthcare and pharma community is invited to nominate HR professionals. Here I see an opportunity for industry to display its solidarity by honouring our HR professionals.

We hope the HarNeedi TREE Awards 2012 will serve as an appreciation and salutation to help our HR colleagues shine and grow into a much bigger tree to accommodate more and more talent,” mentioned Richard D’silva, Senior Marketing Manager, HarNeedi.com explaining the process and procedure followed for these awards.

“Being associated as knowledge partners with HarNeedi TREE Awards 2012, we stand to applause the selfless work being performed by HR personnel in both the sectors,” stated Dr Nitin Sippy, Asst Professor and Course Incharge - MBA Health and Hospital Management, DY Patil University. The awards will be announced and given away during the conference focussing on HR issues prevalent in the healthcare and pharma sectors. Dates and venue will be announced shortly.

For nominations and more details visit: http://www.harneedi.com/i ndex.php/hr-awards EP News Bureau- Mumbai January 1-15, 2013

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EVENT BRIEF platform for convergence of the key stakeholders - Biotech & Biopharma companies, research institutions, investors, service providers, policy makers, regulators and analysts.

Vibrant Gujarat 2013 Summit Date: January 11-13, 2013 Venue: Mahatma Mandir, Gandhinagar, Gujarat Summary: The Vibrant Gujarat 2013 Summit is going to be transformational and revolutionary – both in its coverage and scale. It will provide a platform for various states of India and other countries to cooperate and explore attractive business opportunities. One of the focus sectors to be covered will be pharmaceuticals and biotechnology.

Contact details: Industrial Extension Bureau (A Govt of Gujarat Organisation) Phone : +91-79-2325 6009, +91-79-2325 0492 / 93

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

first commercially successful molecule.

Designed under the guidance of the strategic advisory members, this three-day strategic meet will be a platform to understand practical solutions to minimise the risks associated with the highest spend areas of the biosimilars development cycle. Don’t miss this exclusive chance of engaging with the top biosimilars experts in India and across the globe!

Contact details: Tel: +91 (0)22 40461466 email: conferences-india@ubm.com Website: http://www.biosimilarsindia.com/?utm_campaign=MEDIAPARTNER&utm_medium=EVENTLISTING&utm _source=EXPRESSPHARMA

Bangalore INDIA BIO 2013 Date: February 6-8, 2013

Global Pharma Regulatory Summit

Venue: Bangalore, India Date: March 11-15, 2013

High Potent Drugs 2013 Date: January 23-25, 2013 Venue: Holiday Inn Mumbai International Airport Summary: CPhI’s unique High Potent Drugs 2013 conference, is the only event in India bringing heads of high potent drug manufacturing and R&D together. It will cover complexities at each level of high potent drug R&D and manufacturing and will focus on latest technologies in handling potent drugs, waste disposal and state-ofthe-art facility design with practical case study insights. Safebridge, Affygility Solutions, LAT Pharma, Cadila, Famy Care, Rephine and many more will join this conference. Discussions will be held on most successful strategies to develop and manufacture high potent drugs.

Contact details: Tel: +91 (0)22 40461466 Email: conferences-india@ubm.com Website: http://www.highpotentdrugs.com/?utm_campaign=MEDIAPARTNER&utm_medium=E VENTLISTING&utm_source=EXPRESSPH ARMA

Summary: Bangalore INDIA BIO is an annual event organised by Department of Science & Technology Government of Karnataka, under the guidance of Vision Group of Biotechnology. Since 2001, Bangalore INDIA BIO has been promoting the Indian biotech industry to the outside world and is one of the biggest event on life sciences.

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

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

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

BioAsia 2013 4th Annual Biosimilars

Date: January 28-30, 2013

Venue: Mumbai Summary: 2nd Annual Global Pharma Regulatory Summit will focus on the recent regulatory amendments for 2013.The conference agenda includes a pre-conference summit on GDUFA, US focused day, EU focused day, ROW focused day and a workshop on eCTD Lifecycle management. Some of the confirmed speakers for this summit include Ashish Kohli - Pfizer UK, Naveen Kumar Jain - Dr Reddy’s, Dr Rajkiran Jain Zydus Cadila, Dr Hoss Dowlat - PharmaBio Consulting, Germany, Jasbir Chohan - PEC, UK and many more.

Contact details: Tel: +91 (0)22 40461466 e-mail: conferences-india@ubm.com Website: http://www.pharmaregulationindia.com/?utm_campaign=MEDIAPARTNER&utm_medium=EVENTLISTING&utm _source=EXPRESSPHARMA

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.

Venue: Hyderabad Date: March 6-8, 2013 Summary: Biotechnology being an emerging industry, game-changing strategies and relevant application of the knowledge-intelligence resource pool, drive the process of growth. BioAsia seeks to enhance, enrich and encourage newer innovations, pathbreaking discoveries and effective solutions in the industry by offering a vibrant global January 1-15, 2013

Venue: Mumbai, India Summary: With over 100 attendees in 2012, the 4th Annual Biosimilars is all set to be bigger and better with exclusive focus on process development and analytics to suggest best strategies for developing the

www.expresspharmaonline.com

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 EXPRESS PHARMA

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Pharma-2012 conference focuses on regulatory affairs The two-day conference had four parallel scientific sessions with about 150 lectures and 300 poster presentations Sachin Jagdale Hyderabad he 2nd International Conference of Pharmaceutical Regulatory Affairs (Pharma-2012) concluded recently at Hyderabad International Convention Center (HICC). The two-day conference was organised by OMICS Group, which was attended by industry stalwarts and students from all across the country. There were participants from overseas countries as well.

Dr Srinubabu Gedela, Founding Director, OMICS Group, US said, “The main objective to organise Pharma2012 was to provide a platform for domestic and international players to share and discuss contemporary issues related to the pharma industry with an aim to standardise quality guidelines and

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safety regulations.”

Dr Jayaprakash Narayan, President, Lok Satta Party and Member of Legislative Assembly, Andhra Pradesh, shared his views on regulations in the pharma industry.

Being a student of biology, he blended his past experiences to overcome the challenges in future. Narayan said, “A century ago we had very little knowledge to share about the budding technologies of that period such as vaccines, recombination etc. But today history has left us with valuable experiences where a technology can be a pro or a con.”

Narayan focused on the need for efficacy, safety and cost effectiveness in the field of pharma. He adds, “Careful intervention and regulatory thought process is required to accept a novel technique today. Companies are carrying a great hope along with an intense fear in the process of drug discovery and it proved that a failure at any step can be a huge set back

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Dr Shivanand Puthli receives 'Distinguished Scientist Award' from Dr Srinubabu Gedela not only for the drug but in the economic status of an organisation. Higher cost does not bring higher benefits.”

Following the speech of Narayan, other guests, D Prakash Nagara Katti, President-Research, University of South Carolina, US; Prof Patrick Leoni, Euromed Management, France, Prof Jagat R Kanwar, Director-Research Council, Deakin University, Australia and Dr Michael Alexender, Director-MIDI, US also discussed the importance of regulatory affairs in the pharma industry.

Pharma-2012 conference was designed to help gaining a new vision of current and emerging regulatory prospects and new ideas to build regulatory systems. The two-day conference had four parallel scientific sessions

with about 150 lectures and 300 poster presentations.

“With more than 700 delegates from 25 countries participation, Pharma-2012 promised to be the door to opportunities of a dynamic mix of high profile industry thought leaders, policy makers and other key stakeholders of the industry and academia,” said Dr Ravi Kumar Dasari, Head – OMICS Group Conferences.

According to the participants, the main highlights of the conference were discussions on regulatory affairs for healthcare products, safety and quality regulation, law enforcement and education.

Speakers also spoke about biomedical intellectual property management and novel strategies for growth in the pharma and regulatory environment.

Sachin.jagdale@expressindia.com

January 1-15, 2013

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‘Envisioning affordable healthcare for all’ The Omidyar Network and the Delhi branch of The Indus Entrepreneurs (TiE) organised a conference to bring eminent panelists from the healthcare sector under one roof for a discussion on ways and means to achieve the goal of healthcare for all.

Shalini Gupta reports ven as Obamacare rings in ‘affordable healthcare’ as a buzzword worldwide, it has been doing the rounds in India for quite some time, with the Indian government having constituted a high level expert group to put together the plan for universal health coverage. Private sector efforts along with public private partnerships, entrepreneurs and NGOs have pushed the cause a notch further.

However, there are lessons to be learnt, including going back to the drawing board, brainstorming ideas and coming up with unique solutions that address the equally challenging needs that a country such as India presents. It was with this in mind that the Omidyar Network and The Indus Entrepreneurs (TiE) organised the ‘Affordable Healthcare Summit’ in New Delhi that brought together various stakeholders from the industry, academia, entrepreneurs and Government to ponder, rethink, debate and share their opinions and learnings.

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The Government’s role Opening the session, Sanjeev Bhikchandani, Founder and Vice Chairman Naukri.com and President of the Delhi chapter of TiE, revealed that TiE no longer represents only IT entrepreneurs, healthcare is an emerging domain. He lauded Omidyar for its model of being a for profit and doing social good, a role traditionally left to non-profits. “My personal belief is to really build a scalable model, you have to be a for-profit, otherwise you are constantly seeking funds from outside,” he added. Jayant Sinha, Partner, Omidyar

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Network, then gave the audience a background of the networks activities and its inception. An initiative of eBay founder Pierre Omidyar, the network has invested $600 million in the last eight years since its inception across both for profits and not-for-profits out of which $100 million have been so far invested in India. He stressed on a sectorbased approach and how it can be used to take healthcare to a completely new trajectory.

Following this, Arun Maira, Member, Planning Commission cited healthcare as a next big opportunity where innovation and new solutions could change the game altogether. Health is a fundamental right that even the poor should have access to and hence the need to find solutions specific to the needs of the country, is imperative, he stressed. Talking about the government’s role in healthcare, he added that innovations are needed on the process side to have efficient healthcare delivery mechanisms that ensure both healthcare providers and provisions being accessible, new medicines and devices on the product side and also newer ways of providing insurance to people. While advocating the role of regulations in the medical devices, Maira was optimistic about the sector, which has a huge potential for growth. He urged for ‘People Public Private’ solutions and models that bring together the government, industry and civil societies keeping the needs of the common man in mind. “So let’s work together to see what each of our roles is in devising the process of continuing to learn together, because we won’t get the innovation right the first time,” he concluded.

Representing the Medtech industry, Ajay Pitre, Managing Director, Sushrut Surgicals, stressed the need for the right regulations, citing them as fundamental for those in the industry.

However, there needs to be prioritisation and

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then sensitisation to these along with an influx of investment and adequate technology, he added. “The industry needs to put in a huge input in terms of training and development which requires an all rounded approach from all stakeholders, some of whom currently undermine the relevance of the sector,” he opined. This in turn would help enhance medtech outcomes and directly benefit the end user. Talking about Department of Biotechnology’s innovative schemes, which although help develop IP, do not fund it, he praised DBT’s open-mindedness to suggestions to improve the same. Pitre outlined the role of the Indian medical device sector when he said, “Medtech is about contribution and not about profit.”

Nachiket Mor, Chairman of the Boards of Directors, Sughavazhvu Health Care, on an optimistic note for the role of the private sector, said, “Unlike other sectors, the government is a small player in healthcare and therein lies an opportunity for us.” He stressed the need to find out ways the Government can mobilise funds currently being utilised in secondary and tertiary centres, towards primary healthcare centres. This needs to be followed with evidencebased screening alongwith guidelines and protocols behind it, he added. Drawing from his experience at Sughavazhvu Health Care which is trying to make healthcare accessible to the rural poor in Tanjore, Tamil Nadu, Mor added that the Government should commis-

sion a group giving them a set of problems and then direct them to solutions. “There is a need for clarity for vision. For instance, what do we need to do at primary healthcare level, build capacity there to deal with emergencies then and there.” Even the Governmentrun Rashtriya Swasthya Bima Yojana (RSBY) scheme has its challenges, he said, facing them and learning from them is the road ahead. “If we do not address the disease burden it will show up sooner or later, thus also increasing the utilisation of resources at the ground level vis-a-vis the projected figures. Hence, the Government needs to give the vision and leave the execution to the private sector,” he concluded.

Rethinking access This session had an interesting mix of panelists, sharing their experiences on how to make healthcare accessible to the populace. Zeena Johar, President, IKP Centre for Technologies in Public Health (ICTPH), the research arm behind Tamil Nadu-based Sughavazhvu Health Care expressed the excitement and challenges of starting the venture six years back. “Initially we started out thinking that if we systemise the supply side, we will be able to create a good business model.

However, during the course of time, we learnt that demand side generation is even more important.” A systematic understanding of the community they operate in, its requirements and sustained efforts to make a difference in the lives of these people were

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some of the driving factors behind Sughavazhvu which has a user fee driven model till now.

Rajat Goyal, Co Founder, and CEO EyeQ, a chain of eye care hospitals in Tier-II and III cities, echoed Johar’s thoughts restating that it takes initial years to breakdown the problem, understand it and then automate the process. He talked about the opportunities that lie for secondary models to be created in rural areas.

Building the patients trust, understanding their needs while taking care of infrastructure, training and manpower were some of his learnings.

The impact of the company can be gauged by the fact that 40 per cent of EyeQ’s patients come from households with income less than R`s 10,000 per annum and 30 per cent of the total surgeries performed are done for less than ` 5000.

Sheena Chabbra Chief of the Health Systems Division, USAID, pointed out that the limited role donor agencies can play given that less than one per cent of the funding in healthcare comes from them.

A total market approach then is the best way, she suggested.

Commenting on the role of NGOs, Alkesh Wadhwani, Deputy Director, Avahan, an initiative from the Bill and Melinda Gates Foundation, highlighted that scalability is a challenge for non-profits as they drive towards self-sustenance. Most of the large agencies in the field will continue to be foreign civil society NGOs. The panelists agreed on use of technology to increasing access. To this effect, android-based platforms, open source technologies and aggregation of such solutions and deploying them to the end user was suggested.

Ruchi Dass, CEO, Healthcursor Consulting Group emphasised on funding more models centered around mHealth commending India for being the best adopter as

per a PriceWaterhouseCoopers (PwC) report. Asif Saleh, D i re c t o r - S t ra t e g y, Communications & Capacity Division , BRAC, an organisation in Bangladesh that started 50 years ago with a vision of providing ‘low tech, high touch’ care talked about using information, communication and technology to change people’s behaviour so that they are aware enough to protect themselves. Citing the fact that the country was able to increase its immunisation rate from two per cent to a current high of 85 per cent. He said that the process innovation is then the key. Talking about the challenge of relocating doctors to rural areas, Goyal from his experience suggested that providing amenities such as schools, residential facilities etc helps physicians to consider working in such areas.

Debunking a few myths on innovation Pitre of Sushrut Surgicals of set the tone by suggesting that the methodology for innovation needs to be repetitive and it needs to move from an art to a science. “We need to ask if a cost-effect relationship can be established.

When this inadequacy is treated as a learning, only then can innovation be unearthed,” he added.

A patient-centric approach when designing a product was of consensus across the panel.

Bhaskar Bhatt, Coordinator (Product Design), National Institute of Design, (NID) Ahmedabad put it in words when he said, “Design is about humanising technology.”

Nish Chashmawala, CoFounder, Managing Director and Chief Executive Officer, Consure Medical, a start up that focuses on focal incontinence stressed how difficult it is to commercialise a simple product. Sudhakar Mairpadi, Director, Quality & Regulatory (Health Care Sector), Philips Electronics India noted that although the patent act does

not support incremental innovation, Ministry of Health and the Department of Science and Technology are now realising the capability of the medical electronics industry through the new manufacturing policy.

The lack of mentorship in the industry as a gap that needs to be addressed was also mulled upon.

Closing session The concluding session saw Dr AK Shiva Kumar, Member, National Advisory Council, concerned with growing scepticism in the Government about the private sector, urging it to get its act right and become more transparent and accountable since it needs to join hands with the Government as per the Universal Health Care (UHC) plan. He emphasised the need for affordable care at primary, secondary and tertiary level that reaches the interiors of the country while also pointing out the demand for 5 million to 10 million health workers who need to be trained as paramedics and technicians to make this a reality.

“Lack of capacity in the Government to deal with training and certification requires healthcare professionals to take up the mantle,” he said. Payment through insurance and pre-payment thus reducing out of pocket expenditure at the point of service and integrating primary and secondary healthcare, were pointed out as the two pivotal points of a well performing healthsystem, by Mor. Stating that we can have affordable healthcare at $30 per capita, he stressed the need for greater Government funding and initiatives by the public sector in this regard.

Sinha of Omidyar added to the above saying that the market and the state need to work in harmony to ensure equitable distribution. Dr Kumar further elaborated that the emphasis is to provide univer-

sal primary care, and most of secondary care in order to reduce the expenditure of those who cannot afford it, so that tertiary care is only needed when required.” The Government is open to experimentation, innovation and piloting. The scope for public private partnerships is huge,” he enthused. The caveat is that there has to be genuine interest from the private sector, only then can they be given the task of contracting the services. The discussion then veered to the role of state vs the centre with health not being a priority subject in political circles and a tussle of funds between the state and the centre. While the centre lacks the political will and has the funds, the constitution mandates that health is a state subject. This coupled with state governments having a better understanding of their respective situations, the future would see more autonomy to the states. And hence what we need is more than just high end insurance schemes, we need a people’s movement that pushes for primary care, universal immunisation, lowering maternal births, thus demanding greater accountability from the healthcare system, concluded Dr Kumar.

The day-long event saw huge participation from close to 190 participants from the healthcare domain, including eminent panelists who helped delve into pressing issues that need to be addressed at the earliest to ensure that the millions of people at the base of the pyramid get the benefits that are overdue. While answers to all questions cannot be readily found, the day saw some tough questions being asked and equally tough answers given. Although we are still far away from the reality of affordable healthcare, such dialogue is a beginning in the right direction.

Shalini.g@expressindia.com

CII organises Life Science Conclave in Delhi Sees participation from industry stalwarts, academia and other stakeholders in the lifesciences industry II recently organised a two-day Life Science Conclave in Delhi that saw participation from industry stalwarts, academia and other stakeholders in the lifesciences industry. The opening session moderated by Dr Rajesh Jain, Joint Managing

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Director, Panacea Biotec, saw an eminent panel comprising Nata Menabde, WHO Representative to India; Arun Sawhney, CEO, Ranbaxy, YK Gupta, Head, Department of Pharmacology, AIIMS; Steven Smith, Health Attache, US Embassy and Nitya Anand, Chairman, Ranbaxy Research Foundation and former director Central Drug Research www.expresspharmaonline.com

Institute. In his inaugural address, Anand emphasised on the need to focus on infectious diseases, while advocating affordability of drugs for tuberculosis (TB) and a better distribution to enable greater reach. He also stressed on the need to promote repositioning of generic drugs and setting up a council on the lines of the National Institutes of Health

(NIH), UK to research and find newer uses of existing drugs, citing Aspirin as an example.

Gupta pointed out that universities worldwide have been the hub of innovation and the industry should take greater advantage of academic institutions and government labs. He has been instrumental in getting the Medical Council of India (MCI) to January 1-15, 2013

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introduce pharmacovigilance as an essential part of MBBS curriculum.

Jain summed up the discussion by saying that India needs to focus on innovation to ensure healthcare outcomes are brought to people who need them. Public private partnerships can play a huge role in this regard, he added.

The session on central and state government initiatives driving policy for the industry saw an interesting mix of speakers from Department of Science and Technology(DST), Department of Biotechnology (DBT), National Skill Development Corporation and representatives from different states sharing statistics and information on new projects and developments.

Elucidating that more than 95 per cent of all skill building

happens in Government institutions, Basab Banerjee from National Skill Development Corporation, said that there is a pressing need to address the quality paradigm of the workforce by setting up standards of certification and assessment. Representatives from TICEL Biopark, Chennai announced that it is slated to be the biggest biopark in Asia

by April 2013.

The impact of a strong IPR on biopharma innovation was also touched upon. Talking about the same, Praful Naik, Chief Scientific Officer and Executive Director, Bilcare said that statistics don’t point out to a strong innovation culture in India. He was referring to the number of patents filed in India vis-a-vis those globally. Emphasising that innovations need to be commeri-

cialised while also ensuring that we have a strong regulation, he said, “We need a shift from innovative to an innovation pathway.” Pricing of drugs has been a topic that touches many chords.

Sundeep Kumar, Head Corporate and Public Affairs, Novartis, made an interesting presentation validating the fact that price control of drugs only helps to subsidise the rich while compromising the ability of a company to invest in R&D and its inability to launch patient programmes.

Giving people the power to purchase medicines, instead of free or cheap medicines was strongly advocated.

Partnerships are increasingly becoming the norm in pharma industry, but its the value companies bring to it that matters echoed Dr

Rashmi Barbhaiya, Chief Executive Officer and Managing Director, Advinus Therapeutics. The company joined hands with Takeda Pharmaceuticals in drug discovery collaboration in October this year. Risk sharing, clarity of purpose and investment in capability building were cited as some of the drivers that make partnerships work in the pharma space by Rahul Guha, Principal, Boston Consulting Group (BCG).

The second day of the conclave saw discussions on viable business models to counter drying drug pipelines and future course of action, building hubs of innovation centered around universities and academia and strategies to augment the growth of pharma ecosystem.

EP News Bureau-Mumbai

5th edition of Bangalore Nano sees record participation Discussions, lectures and presentations were held on Nanoscience and Nanotechnology he 5th edition of Bangalore Nano, organised by The Department of IT, BT and S&T, Government of Karnataka under the guidance of Vision Group on Nanotechnology, concluded on a high note, which showcased a plethora of discussions, lectures and presentations on Nanoscience and Nanotechnology. The trade show featured 43 exhibitors from across the globe. Cumulatively, organisations from 12 countries like France, Germany, the US, the UK, Japan Italy, Ireland, Czech Republic, Saudi Arabia etc, participated in the 5th Bangalore Nano. The Nano Mission pavilion showcased 13 companies.

Prof CNR Rao, National Research Professor; Linus Pauling Research Professor; President, JNCASR, said, “The overwhelming response to Bangalore Nano reiterates the deep penetration that Nano Science and Nano technology have made in India and

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Bangalore. India is in the top five destinations for Nanoscience and Technology.

There’s a sharp rise is the number of scientists, research scholars and technocrats pursuing Nanoscience and Nanotechnology.”

He said, “The Nano Mission (Department of Science and Technology, Govt. of India) has played a significant role in giving a boost to nanotechnology. Both the Central Government and the Government of Karnataka have been very proactive in supporting and funding science and especially nanotechnology.”

Prof Sir Richard Friend Cavendish Professor of Physics, Cavendish Laboratory, Cambridge, UK, said, “Bangalore Nano is a prized and valued event for the nano-community and the event has grown from strength to strength over the years.”

ISN Prasad, IAS - Principal Secretary to Government, Department of IT, BT and S&T, Government of Karnataka, said, “Bangalore Nano is now acknowledged as the top platwww.expresspharmaonline.com

form to deliberate on Nanoscience and on Nanotechnology. The sheer number of participants in the 5th Bangalore Nano reflects the popularity of the event across academia and industry.

This has by far been the most successful Bangalore Nano with largest participation of delegates, exhibitors, students, poster entries – the event recorded 700 Delegates.

Bangalore Nano is now become a ‘must attend’ event for the Nano Community.”

In the opening plenary, Rao and Dr K Kasturirangan conferred the Bangalore Nano National Award 2012 on Prof GU Kulkarni, Chemistry & Physics of Materials Unit and DST Unit on Nanoscience, JNCASR. Speaking on Bangalore Nano, Kasturirangan, said, “We don’t have another such event in the country and it draws the best of the talent from all over globe. Bangalore Nano not only symbolises but is really the way forward in taking advantage of Nano technology.”

The India Nanotech

Innovation Award was presented to Prof T Pradeep, Professor, Department of Chemistry, IIT, Madras, Award Discovery: Discovery of noble metal, nanoparticle-based drinking water purification methods.

The ‘Malhotra Weikfield Foundation Bangalore Nano Young Scientist Award’ were given to six budding scientists from leading institutions in India.

Young Scientists and Researchers from 60 institutions like IISc, JNCASR, IITs, NCBS and international Universities showcased several new concepts and ideas in the Poster Session. Overall 120 posters were displayed by the researchers. The first place was bagged by Kasinath Ojha from IIT Delhi, second place

by Sakshath Sadashivaiah, from IISc Bangalore and the third place were bagged by R Srinivasa, National Bureau of Agriculturally Important Insects, K Gopalakrishnan from JNCASR and Sreerekha PR from Amrita Centre for Nanosciences and Molecular Medicine.

EP News Bureau-Mumbai EXPRESS PHARMA

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The procurement process is always considered as one of the most critical activities in any industry. The procurement function in the pharmaceutical industry involves purchase of many sensitive solvents, as well as ingredients that are used to manufacture different kinds of drugs. As with other industries, adoption of best procurement practices helped pharma companies to sustain their cost advantage and improve productivity.

Unfortunately, may be due to the lack of proper mechanisms, the procurement process provided enough scope for fraudulent activities as well. Though such frauds are common across all industries, fraud in the procurement of pharma related products could result in life threatening incidences at the patient’s end.

Ways of doing fraud According to KPMG India’s recently released ‘India Fraud Survey 2012’, procurement, sales and distribution are the top most vulnerable processes to fraud risks in the pharma sector.

Rohit Mahajan, Partner and Co-Head, Forensic Services, KPMG India, gives more details, saying that in case of the pharma sector this is more prevalent in the procurement of basic raw materials and other additives like solvents etc, which constitute large parts of routine procurement.

“While the basic risk of a potential kickback payment in the procurement process exists in every sector/ industry/ company, there may be slight differences in the manner in which such fraud is perpetrated in sectors,” says Mahajan. He adds, “In the pharma industry, it is extremely important to procure materials of the right specifications as it may lead to significant non-compliance on regulatory matters.

Another level of fraud occurs at the sales end of the pharma supply chain. For example, says Mahajan, a majority of Indian hospitals are public hospitals and January 1-15, 2013

these are a significant revenue source for drug companies. Procurement teams at these hospitals can manipulate prices in return for kickbacks from pharma manufacturers.”

According to Mahajan, such kickbacks, as described in the example above, are quite common and such practices additionally constitute unethical practices by the sales and distribution divisions of the company.

Chithur Devraj, Former Head Global Procurement and Supply chain – Pfizer, and currently the Professor in Supply Chain Management at Somaiya Institute of Management and Research, reiterates the issues discussed by Mahajan. Adding a few more points to the discussion as well, he informs, “As in other procurement processes, forms of corruption in drug procurement include collusion among bidders leading to higher prices for purchased medicines, kickbacks from suppliers and bribes to public officials overseeing the bidding and contract implementation processes. There are many other opportunities for fraud in procurement processes.

Due to the lack of management and monitoring capacity, substandard, expired, counterfeit or harmful drugs can be delivered, partially delivered or not delivered at all. Intellectual property fraud is also another common type of fraud in the pharma industry.”

The Indian pharma sector is even more prone to procurement related frauds because companies around the globe source raw and finished pharma products from India, attracted by the country’s comparatively low labour costs.

“According to a 2011 Global Fraud Survey, 20 per cent of Indian companies are affected by vendor, supplier, or procurement fraud. Apart from vendor kickbacks, the most common procurementrelated fraud, which these Indian pharma companies have been subjected to, involved conflicts of interest of the senior management. www.expresspharmaonline.com

ROHIT MAHAJAN

CHITHUR DEVRAJ

Partner and Co-Head Forensic Services KPMG India

Former Head Global Procurement and Supply chain—Pfizer, and currently the Professor in Supply Chain ManagementSomaiya Institute of Management and Research

While the basic risk of a potential kickback payment in procurement process exists in every sector/ industry/ company, there may be slight differences in the manner in which such fraud is perpetrated in the sector

Leveraging technology also pertains to introducing e-payment to suppliers and service providers of drugs and pharma. The intention is to bring economy and efficiency, while at the same time, reducing corruption

They obtain favourable rates and terms with manufacturers for their own self-run companies,” says Devraj.

He adds, “In turn, these personal businesses are often suppliers for other local companies, as well as to the competition. They might employ family members and friends in the purchasing organisation who will help conceal the conflicts.” Devraj highlights that procurement fraud is a large risk in hospitals, as virtually all capital spending involves procurement, and medicines and supplies are often the next largest recurrent expenditure item after salaries.

Procurement agents may seek bribes or kickbacks from supply companies, or contractors may engage in collusion or offer bribes to hospital officials in order to win contracts.

According to Devraj, drug manufacturers or their agents try to bribe officials to ensure that their medicine or formulation appears on the hospital’s pre-approved drugs list. There is diversion/stealing of hospital medicines for personal use

or use in private practice or re-sale.

The bigger picture India’s annual budget presentation is always criticised for ignoring the Indian pharma industry. The funds allocated out of the total budget for the healthcare sector as a whole is also very negligible. While the odds are already piling up, fraud/corruption could further erode the frail Indian healthcare system. This would in turn affect the country's economy as well, because the funds allocated would not be reaching its actual destination.

Mahajan explains the scenario.

He says, “Malpractices in the procurement process in any company/ sector lead to overall value erosion for the company/ sector and hence may reduce the attractiveness of that company/ sector for investors/ other stakeholders. However, in the case of pharma companies, if malpractices in procurement results in non-compliance to pharma regulations, it may additionally lead to enforceEXPRESS PHARMA

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ment actions by regulators.

This in turn can lead to loss of reputation and disruption in business for extended periods of time and heavy fines.”

Devraj opines, “Several studies highlight the fact that corruption in the health sector impacts the poor the most heavily, given their limited access to resources.

A study by Amnesty International found that one of the primary causes of deaths of thousands of pregnant women annually (including during childbirth) is due to corruption by health professionals.

He also pointed to further evidence from International Monetary Fund (IMF) shows that corruption has a significant, negative effect on health indicators such as infant and child mortality, even after adjusting for income, female education, health spending, and level of urbanisation.

Corruption lowers the immunisation rate of children and discourages the use of public health clinics. In many countries, its pervasiveness impedes improvement in health outcomes and therefore is a serious barrier to the achievement of the country’s economic development.”

He adds, “Ten to 25 per cent of public procurement spending (including on pharma) is lost to corrupt practices.

In developed countries, fraud and abuse in healthcare has been estimated to cost individual governments as much as $23 billion per year. Countries with a higher incidence of corruption have higher child mortality rates.”

Technology as a watchdog?

Recently, the Indian Government has decided to directly deposit subsidised money for the LPG cylinder in the LPG holders bank account. This initiative will leave very little chance for fraud during LPG cylinder distribution. In the same manner, if technology comes into play during the pharma procurement process a lot of irregularities could be avoided.

“Use of technology for monitoring transactions through the use of pro-active data analytics can help in significantly reducing the instances of fraud in any organisation. Data analytics

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is gradually evolving and being accepted/ adopted by organisations. These tools can be used to highlight potential red flags such as duplicate payments, inefficient invoice processing, multiple instances of the same vendor within the master data, inconsistent vendor payment terms across the organisation etc.,” opines Mahajan.

“Advances in information technology offer promising opportunities to increase the transparency and accountability of the drug procurement process,” says Devraj.

He points out that an electronic bidding system has been introduced for drug procurement that uses the internet for publishing the lists of supplies offered in tenders with the view to providing public access to prices, products and quantities as well as bidding results. Devraj feels that procurement firms in both private and public sectors and also in hospitals can save

around five to seven per cent by using this electronic bidding system. Such an approach also allows transparency at all stages of the procurement process.

“It has been the experience of a large number of organisations worldwide, both in the public and private sectors that e-procurement can bring in economy and efficiency in the procurement of pharma goods, works and services. Apart from these benefits, the process also brings in greater transparency, thus reducing opportunities for corruption.

Leveraging technology also pertains to introducing epayment to suppliers and service providers of drugs and pharma. The intention is to bring economy and efficiency, while at the same time, reducing corruption,” explains Devraj. According to him, pharma procurement fraud controls also include, audits of ERP system (SAP/Oracle) and forensic fraud control techniques to

Procurement frauds well known example of corruption in public procurement was when the India controversy began with a 2005 World Bank report on pharmaceutical drug procurement as part of the Bank's Reproductive and Child Health I Project. This was reported in the Wall Street Journal in 2007. In 2010, the World Bank debarred three Indian companies from participating in its projects, stating that they indulged in fraudulent practices while doing business with it in the country.

Pharma firm Ambalal Sarabhai Enterprises, Mumbaibased Chemito Technologies, New Delhi-based Global Spin Weave, were been banned from participating in any World Bank-financed or executed projects. The World Bank Report said that Ambalal Sarabhai Enterprises and Chemito, which were mainly involved in purification solutions, have been debarred for engaging in fraudulent practices related to food and drugs capacity building project.

Global Spin Weave was found to have indulged in fraudulent practices related to three World Bank-financed initiatives -First Reproductive and Child Health project, Second National HIV/AIDS Control project and Malaria Control project.

Some major non-pharma companies banned by the World Bank. In January 2010, World Bank banned conglomerate Videocon Industries from doing any business with multilateral lender for violating "procurement guidelines", for a period of three years. Further, two Kolkata-based firms BR & Sons and Hemant Tibrewal, and three Delhi-based entities—Om Prakash Jindal Steel & Power Ltd (BSE:532286), Upasana Jindal and S M Scientific Instruments—were also debarred by the World Bank.

In January 2009, the World Bank disclosed that it had banned three Indian firms — Satyam Computer Services, Wipro Technologies and Megasoft Consultants — from receiving direct contracts from the Bank group under its corporate procurement programme. Several major European chemical firms also face possible debarment by the World Bank following allegations that they colluded to overcharge a bank—funded anti-malaria programme in India.

Source: Prof. Chithur Devraj

A

ensure appropriate internal controls are established.

‘Law’gical remedies Finding procurement related fraud would call for immediate action from the company management.

However, there are provisions in the law as well to book the culprit.

Termination of the guilty may end the issue for the company. The company may not pursue the matter in the court to prevent any brand damage. However, public sector related procurement frauds are more likely to get heard in the court.

Devraj says, “In India, all procurement frauds are covered under the Prevention of Corruption Act 1988. The normal penal code provisions are applicable, which are inadequate for dealing with complex procurement matters. Typically, in the private sector any procurement fraud is dealt with transfer or sacking of employee or gets charged under the prevention of corruption act, depending on the severity of the charge. In April 2012, Indian Government approved the Public Procurement Bill 2011 that seeks to regulate government purchases of above ` 50 lakh through a transparent bidding process. The bill provides for a jail term ranging from six months to five years for public servants found guilty of demanding and accepting bribes from bidders of government contracts.”

Giving the US scenario, Devraj informs, “The US Foreign Corrupt Practices Act (FCPA) provisions prohibit corruptly offering, making, or authorising a payment of anything of value to any person, to obtain or retain business. All US pharrma firms in India follow FCPA. Even doctors who are government employees are covered.”

The Indian healthcare sector of which pharma products form a major part, is one of the largest in the world. With an increased influx of the pharma companies in the Indian market, procurement related frauds are going to become more prominent in the future.

Instead of having a common law to handle such frauds, it will be wise to formulate a separate law to look into them. sachin.jagdale@expressindia.com

www.expresspharmaonline.com

January 1-15, 2013

RESEARCH

W H AT ’ S INSIDE

EXPERTISE FOR DRUG DEVELOPMENT

UPDATE Merck, GE to collaborate on Alzheimer’s drug development GE Healthcare will supply Flutemetamol, an investigational imaging agent, to Merck erck & Co and General Electric Co’s healthcare unit have agreed to collaborate on an experimental drug for Alzheimer's disease, the companies said.

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GE Healthcare will supply Flutemetamol, an investigational imaging agent, to Merck for use with its experimental Alzheimer’s disease drug MK-8931. The companies hope GE’s imag-

ing agent will help identify patients who might benefit from a therapy such as Merck’s, which targets beta amyloid, a protein that can clump together and form plaques in the brain. Such plaques have been found in the brains of patients with Alzheimer’s disease.

MK-8931 is Merck’s lead

GlaxoSmithKline wins US approval for new flu vaccine PG 48

Alzheimer’s drug candidate and is designed to modify progression of the disease as well as improve symptoms. Alzheimer’s robs patients of their memory and can cause other cognitive disturbances. Based on promising results from an early-stage clinical trial of MK-8931, Merck plans to move forward with a larger trial, called EPOCH, at multiple sites around the world.

Flutemetamol is a positron emission tomography (PET) imaging agent that has been able, in clinical trials, to detect beta amyloid in the brain. GE Healthcare will supply Flutemetamol to help select patients for clinical trials and evaluate the agent as a companion diagnostic tool.

Financial and other terms of the agreement between the companies were not disclosed.

Reuters

Vanda’s drug for rare disorder meets main trial goal The main goal of the trial was to reset the rhythm of the hormone melatonin anda Pharmaceuticals said a late-stage trial of its drug to treat a rare disorder affecting blind people met the main goal of showing improvement over a placebo.

The drug tasimelteon is being tested for non-24-hour disorder, a rare and chronic circadian rhythm disorder for which there is no approved treatment, Vanda said. The disorder, in which a person’s body clock does not automatically set to the 24-hour

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January 1-15, 2013

day thereby affecting sleep cycles, affects a majority of blind people.

The main goal of the trial was to reset the rhythm of the hormone melatonin, which controls sleep and wake cycles, to a 24-hour day-night cycle. The goal also included measuring patients’ clinical response to the drug compared with a placebo. The study, which enrolled 84 patients, was the first of four studies that form Vanda’s late-stage pro-

gramme for the drug. The drug was well tolerated in the study.

Vanda said it expects results from the second study in the first quarter of 2013, and plans to submit a marketing approval application to the US health regulator in mid 2013.

Tasimelteon received orphan drug status from the US Food and Drug Administration in 2010 and from the European Commission in 2011. The FDA grants orphan drug status to drugs or biologics that treat a condition affecting less than 200,000 Americans, www.expresspharmaonline.com

giving the drugmaker marketing exclusivity for seven years in the US. In Europe, the status is granted to drugs treating a condition affecting no more than five in 10,000 people in the European Union, and carries a 10-year marketing exclusivity.

Tasimelteon is also being developed as a treatment for Major Depressive Disorder.

Vanda’s schizophrenia drug Fanapt, which is marketed and sold in the US by Novartis AG, received a negative opinion earlier this month from the European Medicines Agency.

Reuters

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GlaxoSmithKline wins US approval for new flu vaccine It is the first intramuscular vaccine to protect against four influenza strains S health regulators have approved a new four-strain seasonal influenza vaccine made by GlaxoSmithKline, the company said. The US Food and Drug Administration (FDA) has approved Fluarix Quadrivalent to immunise children age three and older and adults against flu virus subtypes A and B contained in the vaccine. It is the first intramuscular vaccine to protect against four influenza

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strains. Three-strain flu vaccines currently administered help protect against the two most common A virus strains and the B strain expected to be predominant in a given year, the company said.

Since 2000, however, two B virus strains have circulated to varying degrees each season, meaning patients infected with the B virus not contained in the vaccine were not immunized.

Fluarix Quadrivalent helps protect against the two A strains and adds coverage against a sec-

ond B strain, the company said.

“Three-strain vaccines have helped protect millions of people against flu, but in six of the last 11 flu seasons, the predominant circulating influenza B strain was not the strain that public health authorities selected," said Dr Leonard Friedland, Head of Clinical Development and Medical Affairs for Glaxo's North American vaccines programme. “Fluarix Quadrivalent will help protect individuals against both B

strains and from a publichealth standpoint, can help decrease the burden of disease.”

Glaxo said it will make the vaccine available in time for the 2013-14 flu season and plans to fulfill orders for its trivalent, or three-strain, vaccines. Healthcare providers traditionally order flu vaccines about a year in advance of each flu season. Fluarix Quadrivalent is not currently approved or licensed in any country outside of the US. Reuters

Ariad gets early FDA approval for leukaemia drug The drug, given the brand name Iclusig, was approved three months ahead he US Food and Drug Administration (FDA) granted earlier-than-expected approval to Ariad Pharmaceuticals’ drug for two rares types of leukaemia, but is requiring that patients be warned of potential side effects. The drug, given the brand name Iclusig, was approved three months ahead of time under the FDA’s accelerated programme for earlier access to promis-

T

ing new drugs.

The FDA is requiring a socalled ‘blackbox’ on the drug’s label warning of the potential for arterial thrombotic events and liver toxicity, according to Ariad.

“While the blackbox warning may impact the pace of adoption initially in the community setting, we expect high volume academic centers to quickly look past the warning,” said Jim Birchenough, BMO Capital Markets analyst in a research note. The

approval covers use of the drug, also known as ponatinib, to treat chronic myeloid leukemia and Philadelphia chromosome positive acute lymphoblastic leukemia, two types of rare blood and bone marrow cancers, in patients who had been treated with older drugs.

“We would be buyers of Ariad into the 2013 Iclusig launch,” Guggenheim analyst Bret Holley said.

He forecast a relatively rapid uptake of the drug in

earlier treatment of CML and a good possibility of positive results from an ongoing trial of the drug as an initial treatment for the targeted diseases. Ponatinib was granted orphan product status for drugs that treat rare diseases.

The status grants the drugmaker marketing exclusivity for seven years in the US. Iclusig is designed to block an abnormal protein that stimulates the development of the two rare types of leukemia.

Reuters

Lilly stops rheumatoid arthritis trial for lack of efficacy It would suspend enrollment of new patients in the rheumatoid arthritis programme li Lilly and Co said it will stop one of three latestage trials of its rheumatoid arthritis drug tabalumab after an analysis showed that the trial was unlikely to be successful. The trial was testing the drug in patients with moderate-to-severe rheumatoid arthritis who were not responding adequately to methotrexate therapy, which is a standard rheumatoid arthritis treatment. The decision was not based on safety concerns, and patients currently enrolled in other tabalumab rheumatoid arthritis studies will continue treatment, Lilly said.

However, the company said it would suspend enroll-

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ment of new patients in the rheumatoid arthritis programme until additional analysis from other ongoing rheumatoid arthritis studies is completed in early 2013.

“The results of this study were unexpected given the data generated in earlier Phase II clinical studies of tabalumab,” Lilly's Vice President of autoimmune product development, Eiry Roberts, said.

The discontinuation of the study is expected to result in an after-tax charge of about 2 cents per share in the fourth quarter. Late-stage trials testing the drug in lupus, an autoimmune disorder, will continue to enroll new patients, the company said.

ISI Group analyst Mark Schoenebaum said the drug’s www.expresspharmaonline.com

sales were estimated at around $250 million in 2018, noting that rheumatoid arthritis was a competitive market and expectations for the lupus market were low as well.

“If we wipe out all (tabalumab) sales from our model, our discounted cash flow drops about 50 cents, so the impact is small," Schoenebaum added.

Lilly is working on another rheumatoid arthritis drug called baricitinib, which is being far more closely watched by the industry given its potential. The drug is also getting tested for psoriasis and diabetic nephropathy. Baricitinib, currently in late-stage development, belongs to a new class of oral medicines called Jak

inhibitors that aim to compete with the injected rheumatoid arthritis drugs that currently dominate the market with billions in sales.

Rheumatoid arthritis is an autoimmune disorder that leads to inflammation of the joints and surrounding tissues. Jak inhibitors block enzymes believed to be involved in the inflammatory process. Pfizer was the first company to bring one of these new drugs to market with the US approval of tofacitinib, which will be sold under the brand name Xeljanz. It was launched last month. Another autoimmune disorder drug in Lilly's pipeline is ixekizumab — being tested for psoriasis and psoriatic arthritis.

Reuters January 1-15, 2013

PHARMA ALLY

W H AT ’ S INSIDE

'We are committed to discovering new approaches for drug delivery'

'Both academia and industry drive the growth for the Indian market' PG 50

Global leading material sciences company Dow Chemical has worldwide presence including India and continuously it is expanding it. Also being a active member of IPEC it is playing important role in standardising regulation for excipients. Dago Caceres, Global Pharmaceutical Marketing Leader Dow Chemical Company shares the company's role in IPEC and its Asia pacific plans with Usha Sharma

SPDS officially launched at 64th IPC PG 52

Tell us about Dow Chemicals' journey and experience in India?

Dow Chemical International is (Dow India) leading material sciences company that connects science with innovation to create sustainable solutions for human progress. Headquartered in Mumbai, Dow India has four manufacturing units and two established Centres of Excellence and sales offices across the country. Dow India is committed to consistent growth through its expertise as a science and technology leader and its experience as a leading chemical company exploring sustainable solutions in areas of health and nutrition, infrastructure, transportation, energy, and consumerism. To mention about our journey in India’s pharma formulation market, Dow Wolff Cellulosic’s Pharma focus is to provide Indian pharma producers’ sustainable and innovative solutions for their formulation needs in the generic and complex generic Indian pharma market. Solutions which bring meaningful advancement to the industry and ultimately contribute to improving patient health; be this through novel drug delivery systems that minimise health risks of patients, or by lowering cost to make medicines more widely accessible.

Our customers seek new technologies and designer solutions for a competitive edge. We at Dow are committed to delivering these kinds of tailored solutions to our customers. Methocel Premium VLV is one such solution. It helps to reduce the costs associated with tablet coating, drug layerJanuary 1-15, 2013

INTERVIEW

ing, and fluid bed granulation during the drug product manufacturing process, without compromising on quality, as per the feedback we have received from the market.

What are the company's corporate plans for Asia Pacific?

As the generic pharma industry competitive climate becomes more complex, formulation scientists are faced with an everincreasing challenge to develop solid dosage formulations properly and quickly. Particularly in India, formulation scientists are faced with the formulation strategy problems of Para III and IV drugs; an issue which can be solved by different approaches during pharma product development working with Dow. Our local, scientificallyadvanced customer application development centre at Mumbai, supports our customers in the areas of

controlled release and immediate release technology. Our three main objectives are customer intimacy ability to respond to customer unmet needs faster with meaningful solutions, support our product offering by closely working with customers on their key projects and align our resources/ expertise with a fast growing economy that has significant expertise in the pharma area. We are committed to discovering new approaches for drug delivery in the region that help our customers create high-value products which brings people healthier lives.

What is Dow Chemicals' role as a member in the The International Pharmaceutical Excipients Council (IPEC) Federation?

Dow Chemical is a member of IPEC as are many other excipient makers and users. As all other members, our role is to www.expresspharmaonline.com

develop, implement, and promote voluntary guidance and other programmes for the pharma companys' that are designed to ensure excipients and related components in finished drug products meet only the highest appropriate standards for quality, safety, and functionality throughout their manufacturing process.

GPS Synchronized Clock working principle PG 52 VSEP-A revolutionary effluent recycle technology PG 53

What are the global issues that IPEC has identified and how will they be tackled by the federation in the future?

IPEC is the premier trade association focused on excipient quality and safety.

The IPEC Federation brings together representation from all geographic IPEC groups to determine priorities on which to focus. Some current key areas of focus include metal impurities, atypical visible particles, quality by design, significant change guides and validation.

These and other topics like them are tackled through the collaborative effort of committees of excipient makers and users in the development of science and riskbased guidance for the industry.

There was a plan to set up an Indian Chapter of IPEC. Could you please share some details on this development?

India has a presence of both excipient makers and users. Any world geography with such a presence can and should charter an IPEC chapter to enable global visibility of geographic issues where these arise but most importantly Continued on Pg 51 EXPRESS PHARMA

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‘Both academia and industry drive the growth for the Indian market’ AB SCIEX, a global leader in providing mass spectrometry solutions to companies worldwide, opened its central application support and training centre in Gurgaon, a first of its kind in India, with an investment of $3 million. Shalini Gupta finds out more about the company's plans in India and the opportunity the country poses, in an interview with Rainer Blair, President, AB SCIEX What are the major markets for the company?

Where all do you have a presence in APAC, any new markets you entered this year (2012)?

As a global leader in mass spectrometry technologies, AB SCIEX is in more than 70 countries around the world. In addition to China and India, AB SCIEX has a presence in several APAC countries, including Singapore, Thailand, Vietnam, Malaysia, Indonesia, Korea, Hong Kong, Taiwan and Japan. We have been in these countries for years but we continue to expand. By revenue growth opportunities, China and India are our top priorities.

In countries where we don’t have a direct presence, we work through dealers. In 2012, we expanded our presence not only in India, but also in China and Southeast Asia.

The company had a presence in the Indian market through LABINDIA before it acquired the latter. What is the India strategy like and how has it changed over the years? How has the integration of LABINDIA been since the acquisition?

Our strategy for India is to deliver high-value analytical solutions that meet the evolving needs of the Indian scientific communities that conduct complex and routine analysis of compounds, proteins and contaminants. The pharmaceutical market, the food and environmental market and the clinical research market are major opportunities for us in India going forward, so we continue to make our solutions more efficient to put the power of mass spectrometry into the hands of an increas-

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INTERVIEW

ing number of scientists and lab technicians.

We understand that every geography will have their own specific challenges and needs and, therefore, we are also customising the solutions for the Indian market, for instance developing and offering Methods for pesticides analyses specific to Indian regulatory requirements. On the routine testing front, there is a move to faster, more accurate answers. On the more advanced scientific front there is a move to more comprehensive analysis, which requires more advanced tools like our TripleTOF systems. We are evolving our technologies to stay one step ahead and provide solutions to cater to these various needs of different labs.

The integration of Labindia’s mass spectrometry business into AB SCIEX has gone phenomenally well.

As far as Indian customers were concerned, the transition was seamless. We have seen a double-digit growth in India since the acquisition.

We have great traction in India because the market for mass spectrometry systems sees the value of AB SCIEX solutions.

Taking a cue from the question above, just as pharma companies are looking at emerging markets, are supplier companies also exploring and foraying into www.expresspharmaonline.com

these markets, if yes, what are some of these markets for AB and how different is the strategy, challenges encountered etc?

AB SCIEX is absolutely focused on emerging markets. We refer to them as high-growth markets now.

Not long ago India was considered an 'emerging market' from a global perspective.

Globally, we are looking at the Middle East, Russia, Brazil and Thailand.

Because there is a much smaller existing market for mass spectrometry, we are working to better understand how these markets can expand by more laboratories switching to LC/MS technologies. We need to educate the markets better before we see an accelerated adoption of these technologies.

Which product segments have been the growth drivers for AB in the past year by revenues?

Food testing and clinical research are ahead of the curve, driving growth.

Recent passage of the Food Safety law in India for domestic food consumption has called for more advanced technologies to be used for contaminant testing in food products. In clinical research we see a need in the market to reduce false positives from other technologies. We also seen a significant growth in academia and basic research driven by the Indian government’s mandate to increase the focus on research in India.

How have the needs of the pharma industry evolved in the mass spectrometry segment and how are you better placed to address them?

Are there any unmet needs where MS has an application that need to addressed?

The pharma industry, especially in India, is moving increasingly into biologics and biosimilars. We have tailored our solutions and have a special focused programme as well as latest hardware and software solutions to meet the need for this type of drug development. Mass spectrometry will play a major role in biologics for

years to come, but there is a need for better education of the market and we are customising or training offerings to cater to this need of the industry. Even though the majority of drug development is still small molecule, the pharma market as a whole is shifting toward biopharmaceuticals (large molecule analysis). The industry is looking long term and there is a tremendous opportunity here.

What new products did the company launch this year?

We have launched 11 new products in 2012, all of which were launched in India. These include new mass spectrometry systems, including the QTRAP and TripleQuad 6500 systems, TripleTOF 5600+ system, TripleTOF 4600 system and QTRAP and TripleQuad 4500 systems. We also launched new Eksigent LC systems for liquid chromatography as part of a complete LC/MS workflow solution.

Customers are expecting more value for the money they invest in capital equipment for scientific analysis.

Many of our new systems meet this need for better value. The marketing strategy for India is focused on a value sell, but what really makes a difference is the service and support in India.

We make sure it is world-class.

What opportunities does the food safety law pose for your business?

While in the past, food testing was being done primarily for exports from India, with the passage of this law in 2011, there is an increased focus on food testing for domestic consumption as well. This obviously implies a huge increase in infrastructure, including setup of new labs for food testing and augmenting the capabilities of existing labs.

There are several initiatives from the government to support the setup of these new labs and implement the revised regulations. This, in turn, means a significant business opportunity for a company like AB SCIEX, January 1-15, 2013

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which is one of the leading suppliers of LC-MS technology widely used in these labs for food contaminant testing.

We are collaborating with research institutes by offering unique solutions for their food testing research, helping promote awareness in government referral and commercial labs engaged in food testing. We are also offering practical hands on workshops in the new Centre of Excellence where labs thinking of expanding in this area can see for themselves the power of MS technology.

With governments all over looking at affordable healthcare, pushing for generics and also with drug pipelines drying up, what does this imply for companies such as yours?

The push for generics as well as drive to affordable healthcare is very good for us because not only our solutions are perfect for use in the development of generics, but they also help the biomedical community find better remedies for patients.

Although the drug pipelines may be 'drying up,' our systems are used in new drug discovery, and there is a huge opportunity in biologics, which is large molecule analysis. We see ourselves as partners in all aspects of drug discovery and development, whether it is for NCEs (new chemical entities) or biologics or for generics and biosimilars.

How do regulations

government enable and

Continued from Pg 49 to work with makers, users and geographic regulatory entities to globally harmonise requirements for excipient makers and users whenever possible.

Besides the US, which are the other countries where IPEC has its presence?

As far as I know, IPEC has presence in Europe, Japan and China and is working with industry and regulatory entities in emerging geographies such as Brazil and India.

What are the prerequisites for becoming a member of Indian IPEC? Anyone who has an interest in excipients quality and safety can be a candidate of January 1-15, 2013

empower you?

Food testing in India started almost a decade ago, but it was predominantly done for export market, where the products were tested to comply with the regulatory guidelines of the ultimate country of destination of these products. The testing for domestic food consumption was at a bare minimum only for premium products. But with the passage of Food Safety law in 2011, mandating the testing of food products for domestic consumption as well, this market has started growing exponentially. The need for these tests is directly linked to the adaption of new technologies and thereby means setup of many new labs / expansion of existing infrastructure which results in mutual growth for the labs as well as technology providers like us. Discovery of new contaminants and inclusion in the regulatory guidelines also drives organisations like ours to invest in R&D for development of technologies and workflows for newer tests.

What are the trends in new drug discovery of the future and how are you gearing up to tap them?

Proteins are the ultimate targets for drug discovery.

There is considerable amount of research going on in India in proteomics as well as a shift from chemical entities to large molecules as drug targets. We do not see this as a niche movement but a strategic approach to new

IPEC member. Excipient makers, users, consultants who work closely with either makers or users, academia, etc. are all members of IPEC organisations around the world.

Do you have any plans for collaboration with Indian regulatory bodies?

Dow works with our customers to assist and provide solutions where possible. Our close involvement with IPEC has increased our ability to assist customers navigate through some regulatory processes. The IPEC trade association would likely collaborate with the Indian regulatory bodies in much the same way as in other countries/geographies which is to highlight issues and seek science and risk-based solutions www.expresspharmaonline.com

drug discovery. This is also the key to development of biosimilars and, therefore, we see this as a huge potential for future. Besides our traditional products, we are developing new products in line with this requirement of industry, as well as academia, which is a strong partner with the industry in this area of research. The Indian market in 2012 was driven equally by industry, as well as academia research which contributed to over 40 per cent of the total market, so it is a significant size of market for us.

What was the rationale behind opening up a one of its kind application and training centre in India?

How many training centres does AB have in APAC? Indian customers highly value world-class service and support, as well as on-going training. The centre is a perfect area for us to furnish these needs and collaborate with them on an on-going basis, using state-of-the-art technology. Although we have have field staff and work with local customers to meet the needs of our client base in other parts of India, the $3 million centre in Gurgaon is the central application support and training centre that will take service and support to the next level.

We also have a similar centre in Shanghai, China, as well as several smaller centres around APAC. How much staff does the new application centre

with patient safety as the underlying principle.

Indian regulators are making the existing regulations even more stringent. What are your views on this issue?

The ultimate goal of any regulatory authority, excipient maker or user should be to develop science and riskbased industry guidance with the goal of protecting patient safety. However, the ultimate goal of protecting patient safety becomes increasingly difficult when each country or geography develops their own unique regulations. Wherever possible, we should be seeking to harmonise requirements on a global basis and only look to develop local regulatory differences when the glob-

have? How many people do you hope to train in the next year? What facilities does it offer?

The centre has over 45 associates with over 20 dedicated to after sales support of our client base. It has the capacity to train well over 300 scientists annually. This number can change as per the needs of the industry and our client base. Equipped with all the latest technologies from AB SCIEX, it will offer workflow-based training right from sample processing to MS analyses and final data processing specific to area of interest to the customers. Besides this, handson workshops for scientists to see the technology in action in real-time would be a big plus point. It will also support customers in method development of challenging molecules and any molecules that are of national priority, such as newly discovered contaminants in food, for example.

What is future outlook for India?

AB SCIEX is fully committed to India. It is a growth market for us and we expect a continued growth. As new products are launched globally, we will bring them online in India to ensure easy access for Indian customers to the latest advancements in LC/MS technologies. We plan to grow the business locally, which means more job opportunities.

We are very positive about our future outlook of India heading into 2013. shalini.g@expressindia.com

ally harmonised approach would not protect patient safety.

Who are your competitors in the domestic market?

Dow participates in the pharma market with multiple areas of solutions; depending on the specific segment we are talking about we have different competitors. In the case of cellulosic derived products, we have both multinational competitors as well as regional ones. We believe that science-driven innovation will give us the edge to continue to be the leader in the markets we compete in. Hence all polymers competing in our addressable market we consider them as our competitor. u.sharma@expressindia.com EXPRESS PHARMA

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EVENT UPDATE SPDS officially launched at 64th IPC SPDS will impart by organising a number of high-quality, value added workshops and seminars

ociety for Pharmaceutical Dissolution Science (SPDS) was formally inaugurated at 64th IPC congress at Chennai. Dr B Suresh, the past president of IPA and the Vice Chancellor of JSS Deemed University, Mysore together with the Chairman of the Congress Veeramani inaugurated SPDS. SPDS has three functional committees namely the Executive Committee, the Scientific Committee and the OrganiSing Committee. They released the first announce-

S

ment of the International Annual Symposium to be held at Mumbai in May 2013.

The initiative has been supported by Sotax India, an 100 per cent fully-owned subsidiary of Sotax AG Switzerland, a global organisation that has pioneered in Dissolution Science. The effort to establish the Society for Pharmaceutical Science began on July 16, 2012 with an objective of bringing professionals and expertise in Dissolution Science under one roof.

SPDS will impart by organising a number of highquality, value added workshops and seminars that will help pharma industry professionals and academia to improve their knowledge and skill sets.

This will result in much better on-job performance and efficiency. It will work in close tandem with colleges, universities, other professional and regulatory bodies related to the pharma industry in an effort to update PhD scholars, post-graduates and phar-

macy students through training and workshops to provide a better understanding of the sophisticated modern dissolution systems, equipment and software.

Plans are also underway at SPDS to make a web-portal www.spds.in. This interactive website acts as a source of knowledge. One can post their queries or issues in the arena of dissolution, methods, developments and more. A panel of experts will address all inquiries and offer solutions to the same.

The society is also planning a comprehensive e-journal that will feature articles from society members as well as industry professionals from around the world.

To gain membership in the society one can enroll oneself under one of the following categories: Individual membership, life, academia, international and students. pharma companies, analytical instruments manufacturing companies, CRO’s, CMO’s and others can be a part of the corporate membership in the

society.

Disso India 2013 will be an annual international convention to be first held in Mumbai in May 2013. This event will be organised under the Chairmanship of Dr Vinay G Nayak, the PresidentTechnical of Alembic Pharmaceuticals and the Organising Secretary, Dr L Ramaswamy, the Managing Director of Sotax India The scientific programmes shall be designed and executed by the Scientific Committee Chairman.

The executive members of the Society for Pharmaceutical Dissolution Science are industry experts and professionals who have best of industry knowledge and also Dissolution Testing Processes to their name.

The society is looking forward to work closely with universities, regulatory bodies, industry professionals on a global level to gain best-inclass knowledge and expertise to ensure the success of the cause.

EP News Bureau-Mumbai

Appropriate and accurate entries called as 'time stamps' should be made / recorded at every stage. These records are liable to be audited by FDA inspectors. After each stage is completed there is a pause for the next process to commence.

The product is analysed during this 'pause' phase. It is important to note that each of these processes is carried out in different facilities in the same campus.

There exists a clock in each facility to record the time.

If these clocks are not calibrated or not in sync with each other, one process might start before the other has actually ended or it might start during the 'analysis' period. As per USFDA norms section 483, this situation is a serious violation leading to an observation, which is a non-conformity. The entire batch is liable to be recalled or cancelled there-

by leading to significant loss of expensive raw material, loss of working hours along with loss of customer confidence and credibility.

Essae GPS Clocks with synchronised time displays renders the whole process error free. GPS process time stamps are extremely accurate and fully comply with FDA audit guidelines. Several leading pharma manufacturers in India like Strides Arcolab, Ranbaxy, Dr Reddys, Alkem Labs etc are already using the GPS clocks as a source of time stamp in all their manufacturing facilities in India.

PRODUCTS GPS Synchronized Clock working principle he Global Positioning System (GPS) is a network of 24 satellites in circular orbits around the earth. Each satellite carries a highly accurate atomic clock (along with several backup clocks) and emits timed signals that include a code detailing its location. By analysing a combination of signals from at least four of these satellites, a GPS receiver on the surface of the earth with a built-in microprocessor can receive the accurate time information along with location of the receiver (latitude, longitude and altitude).

The GPS satellites transmit UTC (Universal Co-ordinated Time) information to a GPS receiver in the Master installed in the facility. Based on this reference, the RF Transmitter in the Master re-transmits the local time information via a radio frequency signal

T

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@866Mhz to wireless digital clock (s) in the facility.

Distance coverage is about 400 Meter Line of sight from Master to Clock, but depends on actual site conditions and layout.

As a result, all wireless clock(s) in the system are precisely synchronised to Master and therefore to atomic time.

Essae’s GPS synchronised clocks systems consist of master (s) and as many clock(s) as may be required.

Why Essae GPS clocks in pharmaceutical manufacturing process?

There are various stages involved in the manufacturing of pharmaceutical drugs. For example, consider three vital stages: granulation, compression and coating. Granulation is subdivided into two process stages: -mixing and drying.

Each stage is time bound. www.expresspharmaonline.com

Contact details Essae -Teraoka Limited Bangalore Website : www.essae.com/ http:// www.essae.com/gpssynchronized-clock.html For more details write to info@essae.com January 1-15, 2013

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VALUE ADD VSEP-A revolutionary effluent recycle technology Bhushan Zarapkar, Business Head, Wastewater Solutions, Clean Technology Group, ATE Enterprises and Dr Jaideep Dudhbhate, General ManagerApplication and Services, Wastewater Solutions, Clean Technology Group, ATE Enterprises give an outlook about VSEP, a revolutionary membranebased system for Evaporator Volume Reduction (EVR) in zero liquid discharge systems any waste water processing units use spiral wound membrane-based RO systems for recycle of treated effluent.

The RO treatment process produces a small, but two to three times more concentrated reject stream (approximately 20-30 per cent of the treated water volume). For plants which are zero liquid discharge (ZLD) this reject needs further treatment.

Usually this stream is sent for further volume reduction using evaporators like MEE (multiple effect evaporator) or MVR (mechanical vapour recompression) followed by spray dryers or solar ponds.

All these post RO processes are energy intensive depending on fuel costs. The operating costs should be anywhere between Rs 300 to Rs 600 per 1000 litres of effluent.

Is there a better solution?

We believe there is. ATE offers 'VSEP' (Vibratory Shear Enhanced Processing), a patented membrane-based patented technology from New Logic Research Inc, USA to the Indian market. The final treated effluent (and RO reject) volume going to the evaporator (MEE /MVR) may be further reduced by about 30 per cent to 70 per cent, thereby reducing the cost of evaporation both in terms of Capex and Opex. VSEP has also been used as a single stage unit so as to eliminate the high cost of three stages of RO while obtaining the same efficiency. The VSEP system also generates permeate of a quality suitable for recycling.

In the VSEP process, a shear is introduced at the membrane surface whereby the separation through membrane becomes very effective without any fouling at the

M

January 1-15, 2013

required.

VSEP finds application in difficult to handle waste streams from textile, pharmaceutical, chemical, distillery, dairy, food processing, electronics, pulp and paper, dyes and other manufacturing units.

Application Note: Bhushan Zarapkar, Business Head, Wastewater Solutions, Clean Technology Group, ATE Enterprises

Dr Jaideep Dudhbhate, General Manager- Application and Services, Wastewater Solutions, Clean Technology Group, ATE Enterprises

membrane surface. This results in several advantages of VSEP over any conventional membrane-based filtration system.

1. It is fouling resistant.

2. Virtually no pretreatment necessary (in comparison to conventional systems) 3. Low chemical consumption.

4. Low reject volume going to MEE, thus reducing

capital cost for a new MEE 5. Higher recovery resulting in more volume being recycled. This results in reducing the requirement of raw water.

6. Low foot print.

7. Fully automatic with minimum manual intervention.

8. Facility of remote monitoring.

9.

No foundation

The following application note will elaborate on the EVR application of VSEP in effluent treatment processes.

Objective of going in for VSEP: The objective was to reduce the volume sent for evaporation in a ZLD system so that the total cost of ownership of the evaporation system is reduced drastically.

Following are the major advantages seen with the use of a VSEP system for EVR. 1) Virtually no pre-treatment and low chemical consumption during CIP. 2) Low reject volume going to MEE, This has helped in drastically reducing the total costs of evaporation.

Typical membrane-based RO systems

Typical membrane system RO system along with VSEP

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Photograph of effluent samples from VSEP plant:

Sr. No. VSEP specification 1.0

Parameters

1.1

Application

Reduction of feed volume going to evaporator

1.2

Design feed flow rate

600 m3/day (Of RO reject feed)

1.3

% Recovery (40%)

240 m3/day

2.0

Present feed quality

2.1

Feed water quality.

3.0

Pre-treatment

3.1

Pre treatment

4.0

Plant operation and maintenance

4.1

Plant operation

Fully automatic

4.2

Pressure

32 bar

4.3

Cartridge filter replacement

Not applicable

5.6

Membrane replacement

Expected once in two years

5.0

Cleaning in place (CIP)

5.1

Frequency of cleaning

COD: 1000 ppm TDS: 17000 to 20000 ppm

Only Micro screen 100 micron

Typical VSEP-EVR installations-

48-72 hours and requires max two hours.

Approximate payback Calculations for VSEP MEE (100%)

1

Operating flow rate

600

600

2

Recovery VSEP

40

0

3

Recovery of secondary MEE

95

95

4

Approximate cost of VSEP units

60000000

0

5

Approximate cost of MEE

7000000

15000000

6

Total capex

67000000

15000000

7

Increase in capex due to incorporation of VSEP

52000000

8

Steam consumption for MEE @ 0.34 ton steam/ m3 water evaporated

116

194

9

Power consumption of MEE @ 10 kW / m3 water evaporated

3600

6000

10

Operating cost on account of steam consumption of MEE (cost of steam Rs. 1200 / ton)

139000

233000

Operating cost on account of power consumption of MEE (cost of power Rs 6 / kWh

21600

11

54

VSEP + MEE (50%)

36000

12

Operating cost of MEE (CIP, tube replacement etc. approx. Rs. 55 / m3 of water evaporated)

19800

33000

13

Approximate cost of operating VSEP including CIP, replacement cost of membrane, power etc. approx. Rs. 80 / m3 of water treated

48000

0

14

Operating cost of MEE / year

6,58,46,000

11,02,30,000

15

Operating cost of VSEP / year

1,75,20,000

0

16

Total operating cost

8,33,66,000

11,02,30,000

Saving in operating cost due to incorporation of VSEP

2,68,64,000

Simple payback period

2.23

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This resulted in a very attractive payback of less than two years for EVR.

VSEP payback viz-a-viz MEE: Basis – a) Reduces volumetric load on MEE. b) Reduces volumetric load on MEE thus resulting in lowering of operating costs of MEE Note: It can be seen that the reject from VSEP is highly concentrated.

Conclusions: It is seen from the sample above that VSEP can easily help units which have a ZLD requirement with evaporation

as final stage to save operational expenses drastically.

Also it has several advantages over any conventional membrane-based filtration system.

1. Very low pay back period making VSEP system very attractive as a part of ZLD system.

2. Virtually no pretreatment necessary (in comparison to conventional systems) 3. Low chemical consumption 4. Low reject volume going to MEE, thus reducing capital cost for a new MEE 5. Higher recovery resulting in more volume being recycled. This results in lowering requirement of raw water.

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January 1-15, 2013

‘Community pharmacist slowly transforming from a trader to a professional’ As everyone knows professionals involved in the healthcare delivery system will never cry over recession as community pharmacy is a lucrative career and is a very well developed and well respected setting. However, the true community pharmacy concept has yet to develop in India. Manjiri Gharat, Vice-President and Chairperson, Indian Pharmaceutical Association-Community Pharmacy Division (IPA CPD) speaks about the reforms needed and the positive happenings in the Indian community pharmacy system with Usha Sharma INTERVIEW

January 1-15, 2013

Recently you were elected as the Vice-President and Chairperson, Indian P h a r m a c e u t i c a l Association-Community Pharmacy Division (IPA CPD) and also as the Executive Committee Member of Community Pharmacy Section of International Pharmaceutical Federation (FIP).

What are your responsibilities?

At IPA CPD, we have been working as a team and our focus is to work towards improving the professional standards of the retail (community) pharmacy practice and encourage the realisation of the social aims of the pharmacy profession as a contribution to public health. We strongly believe that collaborative working can yield a lot of results. We work with chemist associations, academia, corporate sector, government authorities and other organisations.

As the chairperson of IPA CPD, I lead IPA’s community pharmacy and public health activities and try to have a spread across the country.

Reaching out to maximum pharmacists from different corners of the country and educating them, sensitising them for their healthcare professional role is one of the main agenda. I must say that IPA provides an excellent platform for working at local, national as well as international level. Being a pharmacy academician, it provides me with a unique opportunity to work with budding as well as practicing pharmacists.

Let me describe some of

the major activities and achievements of CPD. At IPA CPD we already had several unique initiatives. For the first time we have developed countryspecific Good Pharmacy Practices Guidelines based on FIP guidelines 2002 and followed it up with a GPP training manual (in collaboration with WHO India Country Office and CDSCO) 2005. CPD’s immediate past chairman Raj Vaidya has been the leader for our GPP Project. We continue to conduct GPP training programmes across the country.

We also had a pilot project on accreditation of retail pharmacies, again a first of its kind initiative. Engaging pharmacists in Revised National TB Control Programme (RNTCP) is another innovative work of IPA CPD. This Public Private Partnership (PPP) is well established now in Mumbai.

This project of IPA CPD is in collaboration with RNTCP, MSCDA, SEARPharm Forum and is supported by Lilly MDR TB Partnership. We followed up with Central TB Division (CTD), Ministry of Health, Government of India (GoI) for national expansion of this initiative and in April, 2012 CTD has signed a MoU with IPA, AIOCD, SEARPharm Forum and PCI for inclusion of pharmacies in RNTCP at a national level.

IPA’s work and advocacy for pharmacist’s role acted as an agent of change and contributed to the policy change. It is a historic development for the pharmacy profession and marks the first time entry of www.expresspharmaonline.com

pharmacists in a National Health Programme. This pharmacist PPP model is also recognised by WHO. High TB burden countries are consulting IPA CPD, visiting Mumbai to learn the model for replication in their countries. Vietnam MoH delegates visited us this July and delegates from the US, Tanzania and Pakistan are coming in March, 2013. So it is a matter of pride for pharmacy profession in India that our pharmacies have become model internationally in public health work. I have been leading this initiative with our team and we are in the process of spreading this model in other parts of the country, as well as are helping the international spread of it. At CPD, we strongly wish and encourage pharmacists to attend national congresses and FIP congresses to take the global experience. Attending international conference such as FIP Congress and learning the global pharmacy practices, meeting people from 100 plus countries itself is a great inspiration and learning. I am glad to inform that at least a handful of pharmacists from Maharashtara have attended last two FIP Congresses and are even presenting papers.

Maharashtra State Chemist and Druggist Association (MSCDA) is very supportive to the pharmacists for this activity. This is a new trend setting which will further contribute to professionalise pharmacies. Medicine literacy in the community is essential and CPD works hard for consumer education. Myself and my colleagues regularly write consumer educative articles related to medicines and health in local papers and magazines. We also conduct exhibitions on “Safe Use of Medicines”. We have also begun a campaign “Aushadh Saakharata” since last few years.

I have been associated with FIP for attending congresses, as symposium speaker or for paper presentations, for FIP surveys/projects etc. It is always a great pleasure to work with FIP in any capacity. As regards to CPS Ex Co, I am a new entrant and learning the systematic functioning of CPS. This is a four-year term. I need to attend two ExCo meetings every year and one of the meetings is during Annual FIP Congress and the other one in mid-of year.

There is a lot to learn from FIP CPS experts. To make FIP more visible among community pharmacists in this part of the world, not only India but also in SEAR countries, will be one of the major responsibilities. Also contributing to FIP Congress programme and projects is another responsibility. We already work closely with SEARPharm Forum (WHOFIP Forum in SEAR Countries) and now with FIP ExCO, it is a great opportunity to contribute to global pharmacy practice development through FIP and which also brings opportunities for Indian pharmacists.

Being a part of FIP, what changes would you like to recommend in India and how are you going to proceed?

As part of FIP we will get more support from FIP in our work, FIP has a lot of expertise and initiatives for taking the pharmacy profession to its pinnacle, across the globe. I will draw ideas from there and adapt them to our country, and try to introduce them one by one, with guidance and support from FIP – by this I hope we will be able to build in the much needed respect and recognition amongst the pharmacists in the country.

Do you think the Indian pharmacy community is EXPRESS PHARMA

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Globally, the role of the pharmacists have expanded and they are considered as healthcare professionals and serves as a link between the doctor and the patient.

Pharmacists offer all sorts of patient care services from patient counselling to even immunisation. Prescription audits, monitoring ADRs, de-addiction services, health promotion, use of drug information resources for patient consultation, as well as for advice to medical professionals, home medication reviews by visiting patient’s home and so on. Good pharmacy practices are followed by pharmacists. National standards, scope of pharmacy practice etc are well defined. Pharmacist gets the relevant knowledge, skills and confidence through pharmacy education. Also, continuing education through classroom training or web based is common and mandatory in many countries. Now, there is a trend of specialist pharmacists, i e a pharmacists who will be specialised in a particular therapeutic area.

Remuneration and working conditions/set up are quite conducive. Of course, in the recent times, pharmacists do feel pressure of litigation etc but overall community pharmacy is a lucrative career and is a very well developed and well respected setting. In several public opinion polls, pharmacists have been rated by the society as the most trusted professional, above doctors, teachers etc.

When you look into our country, things are totally different. Honestly it is very disturbing. More or less, with very few exceptions, pharmacies are the drug selling shops and not yet healthcare settings. We do have the true community pharmacy concept developed yet. There are multiple reasons for this situation. In the pharma industry we have made huge strides but unfortunately not in the practice sector. We can't recognise who is a pharmacist in our pharmacy shops.

Sometimes, we don't find pharmacists in many shops especially in some states.

Then where the question of professional patient care service arises? And does our pharmacy education - either D Pharm or B Pharm oriented, give adequate knowledge to the budding phar-

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macists? A diploma holder or most university graduates will come out of college without much concept and confidence of patient care services. When they start practicing, they face a plethora of problems from lack of hands on knowledge and professionalism, cut throat competition, thousands of formulations, many issues such as strip cutting, doctors dispensing, shortage of staff etc. The list is endless. Overall, the setup is not very lucrative and we need to do a lot to change this situation.

Why did this situation come about?

There have been multiple reasons including lack of required policies for pharmacy practice, lack of patient riented education, no compulsory continuing education, weak enforcement of laws. No recognition of pharmacists in Government/public/other stakeholders, lack of public awareness about role of pharmacist. We are a huge country, with more than six lakh pharmacies, complex socio-economic conditions and that complicates the situation further.

But in recent years, there have been many positive happenings and a wave of upliftment of professionalism has set in.

In Maharashtra, a one-week Patient Counseling Course (PCC) by MSCDA and MSPC has been a unique effort of educating pharmacists intensely for their counselor role. We can slowly see some positive changes in few pharmacies and can see that professional services have been initiated, including educating patients on dosage, use of devices such as inhaler techniques, measurement of height-weightBI, blood pressure, blood sugar checks. There have been improvements in computerisation and infrastructure with growth in patient counselling areas. Patient leaflets and stickers for counselling have also been developed. Pharmacists are starting to make themselves and their expertise visible with signs about the availability of counselling in the local language.

So these new generation pharmacies and pharmacists are the ray of hope for us. I appreciate their efforts and encourage to take the step to change. www.expresspharmaonline.com

What changes would you like to recommend on an immediate basis to overcome the current unstable picture of the Indian pharmacy community?

India is a huge country and any change requires long time. It is very challenging .

As I said earlier, the efforts have started by different stakeholders and it is showing some positive results. As per WHO, It is clear that the pharmacy has an important role to play in the health sector’s reform process. To do so, however, the role of pharmacists need to be redefined and re-oriented. This is where we need to act upon immediately. All stakeholders need to be at one table to develop a white paper/vision statement regarding community pharmacy practice. IPA CPD will make strong effort to initiate this process. We need to clearly say what is the role of the pharmacist and scope of pharmacy practice. Accordingly, reorient, revamp the education, develop/modify legislation/s, ensure law enforcement, sensitise consumers and medical professionals.

FIP CPS has recently developed Vision 2020 for community pharmacy and will soon be on the FIP website.

It will be a guiding document for us. Also, there is an urgent requirement to bring GPP under a legal framework and that’s CPD’s immediate agenda too. So overall it is a very challenging situation, where ground realities are quite complex.

What other new initiatives has IPA planned on its 'To Do' list and how soon will it be implemented?

IPA has started a bimonthly E-bulletin (the second issue is already out) to increase the outreach and to update pharmacists with relevant knowledge and information. It has got excellent response and will serve as a connect for us to the entire country. It is also reaching across the globe thanks to the FIP CPS newsletter carries a link to this bulletin. In the CPD team, we have members from different parts of the country.

Through them we try to organise training programmes and regional conventions. Recently, we had a convention in Farmagudi, Goa and GPP training programmes at Anantpur, as well as at Nagpur and

Chandrapur. We wish to continue working closely with chemist associations at all levels for GPP training programmes. We wish to conduct ToT (training of trainers) programmes to develop a larger pool of faculty for training of pharmacists. Many pharma giants are approaching IPA CPD and wish to utilise IPA’s experience and expertise for training of pharmacists, this is a very welcoming development and we are in dialogue with the pharma industry and we hope soon some of the partnerships may develop soon.

Can Indian pharmacists prescribe medicines? What are their other responsibilities?

In India, we are still far away from prescribing medicines. We can best limit ourselves to recommend OTC medicines for simple ailments and giving advice. We have a lot things to do – providing patient instructions to the prescribed medications, counselling on the prescribed medicines and illness, follow-ups, etc.

What is your outlook about the Indian pharmacist community in a broader sense?

Indian pharmacists are hard working and they work for more than 12 hours, catering to the medicinal needs of the society day and night.

Positive change towards professionalism has begun and the Indian pharmacist is slowly transforming from a trader to a professional. Indian pharmacists have a great opportunity to play an active role in public health and you can see that the pharmacists are already working for TB care and control. Similarly, pharmacists can be part of several other national health programmes. With illiteracy and poverty in our country, pharmacists have all the more responsibility to educate consumers about medicines and health issues and I am sure that in the years to come, we will see our pharmacists as a health care professional advancing patient care. Of course it won’t be a revolution but rather an evolution. I am hopeful that with all the stakeholders joining hands, the day is not far when Indian pharmacists will be at par with their global counterparts. u.sharma@expressindia.com January 1-15, 2013

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Dr Rabinder Buttar, CEO, ClinTec International wins Scottish Asian Business Women of the Year Award 2012 Buttar, founded the company in 1997 and has in the last 15 years grown the company’s operations across more than 40 countries worldwide AWARDS

r Rabinder Buttar, Chairperson and Chief Executive Officer, ClinTec International, has received the Scottish Asian Business women of the year award.

The Scottish Asian Business Awards honour the achievements, determination and hard work of Scottish Asian Entrepreneurs who have been the leaders and drivers of growth in their industry.

Buttar commented, “I am delighted to receive this award. It demonstrates the progress that ClinTec International has made since 2009 when opening its headquarters in Glasgow growing in emerging economies and developing our CRO services portfolio.

This progress is down to innovation and the commit-

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(L to R) Donna Kerr Roscoe, Senior Manager Business Development Bank of Scotland presents the award to Dr Rabinder Buttar, President and CEO, ClinTec International ment of our diligent employees. The accolade highlights the significant contribution

Asian women are making to business in Scotland and overseas.”

Buttar, founded the company in 1997 and has in the last 15 years grown the company’s operations across more than 40 countries worldwide. Buttar’s business acumen has helped her identify opportunities in emerging markets, where ClinTec International has developed clinical trial capabilities of local stakeholders.

ClinTec International has attracted huge support from the Scottish Government, the Scottish business sector and the wider community.

This support has provided a strong foundation for the robust growth ClinTec International has seen and continues to attain. The award is the latest accolade for Buttar and ClinTec International having previously won the Queen’s Award for Enterprise and the Ernst and Young Scottish entrepreneur of the year award.

EP News Bureau-Mumbai

Sinhagad College of Pharmacy organises pharma rally to commemorate 51st NPW CAMPUS BEAT

he Pune branch of Indian Pharmaceutical Association along with pharmacy institutes from Pune had organised various competitions and events to

T

motive of the rally was to create awareness about safe utilisation of the medicine and contribution of the pharmacist towards healthy life.

Sinhgad road area.

Dr KN Gujar, Principal, SCOP, said that the rally evoked a good response by the local residents.

The college also organ-

different colleges took part in the competition representing their colleges. The competition was planned

by Dr KN Gujar, Principal Sinhgad college of Pharmacy

interview skill competition Students at the pharma rally celebrate 51st National Pharmacy Week (NPW).

On this occasion Sinhagad College of Pharmacy organised Pharma Rally to initiate the celebration of 51st NPW 2012. The January 1-15, 2013

Over 500 students from Sinhagad College of Pharmacy and staff members participated in the rally. Students distributed informative handbills to the residents of Vadgaon and www.expresspharmaonline.com

ised interview skill competition as a part of NPW celebration.

Priti Jog, HR Consultant and Anurag Shrivastav, Executive Future Generali health insurance were the judges for the competition.

Around 50 Students from

to groom the students for the challenging selection process for any opportunity for professional development.

SK Mandlik Coordinater of NPW at SCOP conducted the event.

EP News Bureau-Mumbai EXPRESS PHARMA

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JOB TRENDS Hiring activity for pharma sector has not been impacted in 2012 February and June saw maximum hiring s 2012 ends and 2013 begins, there is good news for job seekers in the pharmaceutical sector, because amidst the background of economic downturn hiring levels for the sector has been stable. There have been seasonal dips in hiring levels but the overall job scenario of the sector has been indicating signs of movement. A look at the movement of the Naukri Job Speak Index which tracks job movement across sectors month on month shows that the index in January 2012 was 1,185 and in November 2012 was 1,233.

February and June were the months which saw maximum hiring. The index crossed the 1,300 mark. This means that hiring activity for the sector in June 2012 was almost 11 per cent higher than January 2012. Although the second quarter of the year did see some dips in new jobs, but this could be owing to the cautious hiring approach adopted by recruiters. Thus among the top cities of India, Hyderabad which is the considered as the pharma hub has seen positive hiring trends over the last one year.

The overall sentiment is positive and much better than all the other top industry sectors.

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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

About Naukri.com Naukri.com, India’s number 1 job site and the flagship brand of Info Edge revolutionized the concept of recruitment in India. Since its inception in 1997, Naukri.com has seen continued growth while outperforming its competitors in every sphere. Info Edge was the first internet Company to list in India.

The site enjoys a traffic share of around 61 per cent as per the Sept Comscore data.

Naukri.com is a recruitment platform that provides hiring-related services to corporates/

recruiters, placement agencies and to job seekers in India and overseas. It offers multiple products like Resume Database Access, and Response Management tools and its services include Job Postings, and recruiter branding solutions on the site. The site has a database of over 29 million resumes and has serviced over 46000 clients in FY2012. The company has over 2000 people operating through 48 offices in 31 cities in India and overseas offices in Dubai, Abu Dhabi, Riyadh and Bahrain.

Jobs from Naukri.com Regional Sales Manager Company: Exp: Location: Job Id:

Wanger Huber Pharma Pvt Ltd 10-15 Guwahati 031212000658

Product Specialist - Critical Care Company: Exp: Location: Job Id:

Biocon Ltd 0-4 Jaipur 031212000512

Exp: Location: Job Id:

Company: Exp: Location: Job Id:

Synkrom Healthcare Pvt Ltd 1-4 Chandigarh 041112000404

Product Manager Company: Exp: Location: Job Id:

Alkem Laboratories Ltd 3-8 Mumbai 031212000166

Sr Officer QA Company:

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Claris Lifesciences Ltd

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Company: Exp: Location: Job Id:

Aanjaneya Lifecare Ltd 5-7 Pune 021212000128

Exp: Location: Job Id:

Mac-Chem Products Pvt Ltd 2-4 Mumbai Suburbs 060812002807

Principal Investigator - Clinical Company: Exp: Location: Job Id:

Piramal Enterprises Ltd 4-6 Mumbai 081012002703

Manager- QA- Formulations Company: Exp: Location:

Aurobindo Pharma Ltd 10-15 Hyderabad / Secunderabad

www.expresspharmaonline.com

Stedman Pharmaceuticals Pvt. Ltd 5-8 Aurangabad 210610000261

Pharma Franchisee

Navision Technical Consultant Company:

011212002206

Regional Sales Manager

Executive Excise

Business Development Manager Company: Exp: Location: Job Id:

Job Id:

2-3 Ahmedabad 031212000104

(India)

Company: Exp: Location: Job Id:

Nippon Seiyaku Pvt. Ltd 5-10 Noida 011212001556

Sale Executive Company: Exp: Location: Job Id:

AXA Parenterals Ltd. 1-4 Bathinda 011212001359

Administration Assistant Company: Exp: Location: Job Id:

BioGenomics Ltd. 2-3 Pondicherry 011212001341

January 1-15, 2013

REGD.WITH RNI NO.MAHENG/2005/21398 REGD.NO.MH/MR/SOUTH-77/2013-15, PUBLISHED ON 5TH & 20TH EVERY FORTNIGHLY & POSTED 6-7-8 & 21-22-23 OF EVERY FORTNIGHLY. AT IND.EXP.PSO.