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Is Aamir A New Messiah Of Deprived India?Is Aamir A New Messiah Of Deprived India?

Obamacare BackfiresMay Lose His Dream Second Term

Obamacare BackfiresMay Lose His Dream Second Term

Drug Patents Expiry To Give Generic Pharma Market Shot In Arm

Drug Patents Expiry To Give Generic Pharma Market Shot In Arm

Superstar Aamir Khan Raises

Pushes for

Against

Branded Formulations

Revolt

Generics Medicines

Exclusive

5th Annual Pharmaceutical

Leadership Summit & Business

Leadership Awards 2012

Coming Back from Challenge and Heading towards Super-power Status

BRAND INDIA : BEYOND GENERICSLeading With Resilience.Leading With Resilience.

BRAND INDIA : BEYOND GENERICS

5th Annual

Pharmaceutical

Leadership Summit

& Business Leadership

Awards 2012Honouring Excellence In Pharmaceuticals Since 1999Honouring Excellence In Pharmaceuticals Since 1999

Exclusive

w w w . p h a r m a l e a d e r s . c o . i n

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I N S I D E

Publisher & Editor-in-ChiefSatya Brahma*Deputy EditorAbhinav SharmaEditor - Special ReportsAlok VermaEditor, NewsAkshay GuptaEditor-InvestigationsAbdull KhanSenior EditorDebashish MishraAssociate EditorRajiv BatraAssistant EditorsSnehal LambaDamodar ParekhSpecial CorrespondentsPrakash JhaRehena RafiquePrincipal CorrespondentsParveen TajSuresh JadavSenior CorrespondentsHrishikeshCorrespondentAnoop YadavAsst Copy EditorHarshvardhanEditor-In-Chief's OfficeSanjeev KaurDesign HeadKaushik PradhanArt EditorAbdul BariDesign TeamV G R ManeMahalakshmi CreationsDeputy Photo EditorSubrat RoyPhotographesNalini, Sharada, RizwanSenior Photo CoordinatorSupriya KamatkarWeb EditorAshish AgarwalSoftware DeveloperSuhasini KhatriManager-ProductionSynthia VazPublished,Printed & Editedby Satya Brahma on behalf ofPharma Leaders AcademyFOUNDER GROUPPharma Leaders AcademyNetwork 7 Media GroupChief Operating OfficerGaurav VermaVP MarketingDeepak KapoorVP-CirculationSonam SinhaFinance ManagerSteve Rozer

Aamir Raises Revolt Against Branded Formulations, Pushes for Generics Medicines!IS AAMIR KHAN A NEW MESSIAH OF DEPRIVED INDIA?

Can India Operate on a Chttorgarh Model?

Aamir Raises Revolt Against Branded Formulations, Pushes for Generics Medicines!IS AAMIR KHAN A NEW MESSIAH OF DEPRIVED INDIA?

Can India Operate on a Chttorgarh Model?

Unethical Drug Trials, But Health Activists Say

That Is Not Enough.

Unethical Drug Trials, But Health Activists Say

That Is Not Enough.

Who Will Pay for Prescription Drugs in 2021?

Who Will Pay for Prescription Drugs in 2021?

PRICE CONTROL MECHANISM

The author is CEO , Natco Pharma. The views expressed are personal.

PRICE CONTROL MECHANISM

Pharmaceutical Industry & Technology Transfer agencies in India

Pharmaceutical Industry & Technology Transfer agencies in India

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he Theme of this that place their interests over the interests of the Nation. Corruption is the year 's Summit is root causes of India's backwardness. The damage caused by corruption T“ I n d i a n P h a r m a on the country's economy and progress is unimaginable.

Brand : The Emerging Super power”. India is The last decade has seen India emerge stronger on the world map, poised to be the worlds next especially during the global financial meltdown when the country superpower with sound and weathered the crisis much to the admiration of the world. India today transparent financial system, stands poised at the threshold of change. India, today, has emerged as flourishing IT industry and a one of the decisive nations shaping the contours of the world economy. well-regulated stock market Consistently charting a growth path over the last few years, Brand India .It has been active politically is an idea whose time has truly arrived. Today, the triumph of Brand India and economically in the past is visible in almost all fields. With some aggressive cross-border decade as well. Its core acquisitions, India has been rewriting the global business equations; i n s t i t u t i o n s f r o m India has established its leadership in IT and knowledge-based independent judiciary and industries globally and has the fastest growing population of workers and free press to military are consumers. With huge investments in infrastructure development on the secured by its more than half anvil, India today is a preferred investment destination. It has one of the century old roots. India is on world's most rapidly growing markets, and today, Indian products and the verge of becoming a services are recognised for their quality all over the world. (1.22 billion) permanent member of the people is the second most populous country in the world, while China is

United Nations Security Council. Its scientists are planning to launch a on the top with over 1,350,044,605 (1.35 billion) people. The figures moon probe. By putting all theses aspects together, one may be amazed show that India represents almost 17.31% of the world's population, that India is already in the race for becoming the next super power. which means one out of six people on this planet live in India. India is

predicted to have more than 1.53 billion people by the end of 2030. More The question that come to my mind as I interact with people is that of a than 50% of India's current population is below the age of 25 and over mixed reactions, which to some extent, cant be underestimated. 65% below the age of 35. This means the youth will form a majority chunk

in decision making.Is India a Poor Country or Emerging Superpower?

The Indian economy has continuously recorded high growth rates and India, along with China, is the fastest emerging economy in the world. It is has become an attractive destination for investments. Today India is the fourth largest global economy looking from the purchasing power among the most attractive destinations globally, for investments and parity angle and its large domestic market kept it insulated from the business and FDI had increased over the last few years. India's recent depression in Western economies. Few years ago, Goldman economic growth is expected to remain robust in 2012 and 2013, despite Sachs predicted that India's GDP would overtake France and Italy by likely headwind of double-dip recessions in Europe and the US, 2020, Germany, UK and Russia by 2025 and Japan by 2035, making it according to a United Nations' annual economic report - World Economic the third largest economy of the world, behind the US and China. Most Situation and Prospects 2012. The Indian economy is expected to grow economists see India as an emerging economic superpower and between 7.7 per cent and 7.9 per cent this year, as per the report.expected it to play a major role in the global economy in the 21st century. Being an economic power makes a country a global power. But Indians

India is the second most preferred destination for foreign investors, The should keep one thing in mind, and that is that India has to compete with wealth of high net worth individuals (HNIs) in India, is set to grow by a China and from the looks of it now China is deemed to be the winner. But compounded annual growth rate (CAGR) of 23 per cent over the next India can move ahead. It has to develop its infrastructure and create an four years and will touch a staggering Rs 249 trillion (US$ 5.05 trillion). efficient and transparent administration. Communal distrust should be India's Private Sector accounts for 75 percent of its GDP. Private sector eliminated and so should be right wing parties which encourage it. If investment has responded vigorously to the Government policy of these problems can be taken into account and solved then India can promoting competition, removing policy distortions and hurdles, and definitely join the global power elite. improving access to factors of production such as technology and capital. With domestic industry developing an increasingly global focus, My main concern is how India will construct a sustainable and the Indian corporate sector has expanded capacity and upgraded distinct identity that reflects the country's great diversity. I hope technology. Simultaneously, it has been clocking higher sales and India will follow its own road and not simply create a facade resembling profits. The regulatory framework India has made sweeping reforms in Western modernity. Throughout history, India has managed to absorb policies relating to virtually every sector of the economy-trade, industry, foreign elements into its culture and express them in its own language; I foreign investment, finance, taxation and public sector. These reforms hope it will not lose this fantastic ability. I am concerned about India's have succeeded in large ways in achieving macro economic future. The greatest problem in India is corruption and not population. stabilization. The economy is now clearly on the path of global The political field has become a real mafia. Political leaders, except a integration, accelerated growth, improved productivity, innovation and very few, think about accumulating wealth for themselves and their international competitiveness.families. Bribing is a commonplace here and very little is being done to

check it. When India glories in its "shining" it does not take into account the vast majority of the villagers who live in absolute misery, Remember

Happy reading 72 % of population of India lives in rural areas; Satya Brahma,

The evils that we see in India today like corruption, public sector Editor-In-Chief, Pharmaleaders Groupinefficiency, religious tensions, lack of development, poverty, illiteracy, poor infrastructure, and shortages are caused by corrupt leaderships

Eidtorial

Indian Pharma Brand : The Emerging Super powerIndian Pharma Brand : The Emerging Super power

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harma-biotech partnerships: creative approaches to doing the Dr Robert Kilpatrick is founder and partner of TVG, which runs the dealBioPartnering Europe is just one of the many regular BioPartnering conference. He says that because biotechnology is now a global conferences which bring pharma and biotech together to promote industry, partnering needs to take place in a variety of ways - between large and themselves and discuss possible deals small companies; Western and non-Western; established and new; and virtual P and bricks and mortar. “Openness to new thinking is combined with access to

new markets and novel deal structures, so what is taking place is now termed 'creative partnering',” he says.Research and development partnerships between big pharma and the biotech

sector are now a vital component in bringing new medicines to the market - so “TVG launched BioPartnering Europe in 1993 as one of the first life science much so that securing the best molecules for the best price has become a core partnering conferences. This year we have held high profile events in three competency for big pharma companies.emerging markets - BioPartnering India in Bangalore, BioPartnering Latin America in Rio de Janeiro and BioPartnering China in Shanghai.The relationship between pharma and 'biotech' (i.e. small, start up drug

discovery companies) is now mature, and mutually dependent. Declining “Partnering is just being adopted in these markets and there is a learning curve productivity from in-house R&D operations means big pharma is becoming involved. TVG has also learned a lot about partnering around the world because more and more reliant on external alliances to produce the medicines of we have worked with over 5,000 companies over a 20 year period,” he tomorrow. Conversely, small pharma and biotech companies with limited cash explained.reserves need to find big pharma partners to help them develop and bring their This year's BioPartnering Europe event brought together more than 450 drug to market.companies from 30 countries, including many biotech companies eager to talk to pharma licensing executives and persuade them that their molecule or Around $25 billion was spent by big pharma in licensing deals and other R&D technology was worth investing in.alliances in 2010, a figure which looks set to continue growing over the long

term.One company was Swiss firm Telormedix, a biopharmaceutical company focused on targeted immunity in the treatment of cancer. Their lead product The dynamics are clear when pharma and biotech start to negotiate on TMX-101 is moving towards clinical trials in bladder cancer and the company licensing; big pharma won't have to pay as much if it buys into a molecule at is now looking for partners. Johanna Holldeck, Ph.D., chief executive, who has phase I or earlier, and will face less competition from other big pharma worked with many big pharma companies, including Roche, Aventis, Schering companies looking to do a deal. But the chances of the molecule being a failure and Johnson & Johnson, said: “For biotech companies, it is important to have are high.core operations in place for licensing. Investors need external validation and if big pharma is interested, then the investor will be too. Co-operation with big The alternative is to sign a deal only once a drug has shown proof of concept in pharma also allows access to their expertise and know-how,' she added.phase II or later - but prices are higher, and competition for the deal is greater.

Even then, its success is far from guaranteed.Innovative molecules, innovative deals

Figures suggest that the trend for pharma is for a greater proportion of deals to Partnering deals between biotech and pharma come in all shapes and sizes. be done in phase III. Statistics compiled by Deloitte in 2009 showed 35% of Damian Marron, Ph.D., chief executive at Marseille-based Trophos described deals were done in late stages, though early stage deals were still more common, an interesting deal it struck with Swiss specialist pharma firm Actelion earlier accounting for 41 per cent.this year.

Meetings and moleculesTrophos is developing a number of therapies in neurology and cardiology. Its lead compound TRO19622, a novel oxime, is in phase III for amyotrophic Partnering conferences are one of the prime means for pharma and biotech to lateral sclerosis. Actelion's Tracleer, is licensed for the treatment of pulmonary meet and exchange information, TVG's recent BioPartnering Europe being one arterial hypertension, a life-threatening disorder and a $1.3 billion market.of them.

Trophos needed to refinance and to maintain its clinical programme. Under the Speaking at the event, Dr Chris Brown, director of International and Primary agreement, Actelion has paid €10 million for an option to acquire Trophos for Care, Pfizer, explained how his company goes about finding partners.€125 million plus two milestones for a further €70 million - US approval of its drug and progress on other programmes. The two companies have set-up a “Our collaborations span every area of development. We recognise that some of research collaboration in which Actelion compounds are screened in the the most exciting science happens outside the walls of Pfizer.”Trophos screening programme.

Dr Brown says Pfizer uses a number of means to identify promising molecules - “This deal buys Actelion a new approach to neurology research,” Marron by attending partnering conferences, using pipeline databases, venture capital pointed out. “It is a good fit for both companies. This deal is not unique, but intelligence and company visits. Promising ideas go through an initial screening there are very few like it and they are mainly in the US,” says Marron, citing a (answering the basic question of whether or not it aligns with the company's deal between Novartis and Cephalon as an example. “This is a win-win deal strategy) followed by analysis and due diligence, with assessment from the which brings us the support of a much bigger organisation, but one that knows science, manufacturing, commercial and finance side of Pfizer. Then the what it is like to be a small company.”company's business development committee will follow through negotiations

with the various deal structure options on the table.Immutep (Orsay, France) specialises in targeted protein-based immunotherapeutics and has recently announced encouraging phase I/II Pfizer is interested in local, regional and global opportunities to partner. “We clinical trial (one of seven trials) results for IMP321 combined with paclitaxel are looking for late stage compounds with a broad geographical scope. A deal in metastatic breast cancer. Dr Frédéric Triebel, scientific and medical with Pfizer can provide a company with sales and marketing know-how,” director, says that the immunostimulation with first line chemotherapy is a new Brown says.approach in oncology. “We are hoping to get a partner because clinical trials are very expensive and take a long time,” he said.

Biotech Research

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Biotech Research

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interest. But scientific meetings were held between the two companies and Another company with an innovative product on offer is Genticel (formerly BT when ElexoPharm published a milestone paper in the Journal of Medicinal Pharma, Labège-Innopole, France). Their cervical cancer vaccine, ProCervix, Chemistry, the deal was completed in April 2010. This deal covers development can be offered to women already infected with HPV and has recently been and commercialisation of drug candidates targeting aldosterone synthase, a approved for phase I clinical trials. Dr Benedikt Timmerman, Genticel's chief novel target, in cardiovascular disease.executive explained: “We want to cure the infection before cancer sets in. Our product compliments the prophylactic vaccines currently on the market.” Dr Jeroen Tonnaer, the Merck scout in Benelux, Israel and South Africa said Genticel hopes that their 'first in class' platform will attract a pharma partner. they always look to see how opportunities in the outside world might fit with the “We have the capability to bring this therapeutic vaccine to market on a global Merck development pipeline. “We are looking for drug candidates in unmet and regional basis. It is going to be a market of similar value and size as medical need, for novel validated targets which are first in class or best in class, Gardasil so we need a big partner. The type of deal we are interested in would and solid IP on the target.”involve licensing with co-development or purchasing the whole HPV franchise. We are very open to different types of deal.” They are also interested in new synthetic routes and polymorphs of drug

compounds. A biomarker strategy is a plus because it offers the possibility of Each major pharma company applies their own unique approach to partnering. companion diagnostics. The company is also interested in any technology that Dr Axel Maibuecher, head of Search and Evaluation for Integrated Hospital helps do things faster, better and cheaper. “More significantly, any technology Care at Novartis, says his company has a 'three-dimensional' pathway involving that will help us identify or validate novel targets is very welcome,” Tonnaer stage of development, deal stage, and therapeutic area which “ensures that an added.opportunity gets the right expertise”.

Another interest area is formulation and delivery technologies, as well as Novartis has several different franchises and business units, including improved manufacturing approaches and new therapeutics modalities like cardiovascular and metabolism, neurology and ophthalmology, respiratory and RNAi.oncology. Novartis is therefore looking for opportunities in type II diabetes, obesity, dyslipidemia and antihypertensives. “Emerging markets are an important part of our strategy,” added Tonnaer,

listing Turkey, Brazil, India, Russia, China and Korea as examples. They are Neurodegeneration is another strategic focus and Novartis also has an also interested in Asia Pacific, Latin America, Eastern Europe, the Middle 'opportunistic eye open' in old age psychiatry and mood and anxiety drugs with a East, and Africa.new mode of action. In ophthalmology, they are interested in wet AMD, from the strategic perspective, and in dry eye from the opportunistic side. Novartis has a Kilpatrick concludes by saying there is a definite skillset required in deal long track record in transplantation drugs and is interested in biomarkers in making, whichever side of the fence you are on.this area. “We are very flexible in the type of deal we will do,” said Maibuecher. So these will include mergers and acquisitions, research collaborations and “It requires persistence, patience, clarity, communication, access to the right licensing. people - and a little bit of luck.”

MERCK SHARP & DOHME SIGNING THE DEAL

Meanwhile, Merck relies heavily on the activities of its scientific scouts in The importance of the legal agreement between firms means that lawyers play partnering, said Dr Barbara Yanni, VP and chief licensing officer. a vital role in the process, usually representing biotech firms.

In 2009, the company signed 51 licensing and partnership deals. “Merck led John Wilkinson, partner at London law firm Reed Smith says setting up a the field in biotech partnering between 2005 and 2009,” she said. partnership is a painstaking process which typically takes six to nine months. First, the company with the asset will decide on a deal structure, then start “We expect to do a lot of deal making in the future. The scouts operate looking for a partner, making partnering events like BPE extremely important. worldwide, each taking responsibility for their own area. Also presenting at the When a certain level of interest is generated, the details of the deal will be conference was Dr Margaret Beer, senior director for external scientific affairs, crystallised in order to define the Net Present Value of the asset. worldwide licensing at Merck Sharp & Dohme. She said: “This is simply the best job in the world.” There are 17 scouts in Merck's worldwide network, all of The next stage is to generate a Term Sheet, a non-binding agreement which sets them senior scientists. “Scouting and licensing and the science are so important out the draft terms of the deal. This is where firms like Reed Smith often get that we will take scientists from the bench to do it,” Beer added. involved, acting for biotech companies and typically negotiating with a pharma company's in-house legal department.Merck is interested in all stages of the drug development process. The scouts build close relationships with the local science community including companies, “We help our clients draft a detailed agreement with specific definitions VCs and academics, and they look in all therapeutic areas. “The most important tailored for agreement,” said Wilkinson, adding that it is important to be part of my job is relationship building.” aware of the very specialised language of life science at this stage.

Beer adds: “We are as much dependent on our partners as they are on us, however small the company. I like to think of myself as the friendly face of Merck in the region.”

What is Merck looking for? The company's areas of interest are published twice a year, and they are interested mainly in phase III and beyond in all therapeutic areas. Dr Manfred Horst is the Merck scout for France and Germany. He gave the example the development of their deal with ElexoPharm, which is a spin-off from Saarland University in southern Germany. ElexoPharm's synthase inhibitors were on Merck's list but were originally too early stage to be of real

Generic Drug

India is also in a position to supply cheap and quality generic drugs to the ealth economist and advisor to the High-Level Expert Group on

world. Most Indian generic drugs are extremely happy with this decision and Universal Health Care, S Selvaraj says that tackling lack of doctors

are likely to benefit from the scheme. The real ultimate beneficiary, however, Hin India will take time to sort out, but providing free drugs can be would be patients.Several industrialised countries are moving towards generic

done immediately: What will be the most important component of the universal drugs. These are substituting branded medicines across the world. The US is no

health care (UHC) package that the 12th Plan is likely to unfold?. Of all the exception. Recently, Spain had announced a substantial cost savings plan from

components of UHC, strengthening public health system in the country is the generic substitution.

most significant. The pacing and phasing of reforms are critical and, therefore, According to recent estimates, Spain is expected to save about $1 billion while

free distribution of drugs is likely to be taken up immediately. This is expected to the US had saved about $1 trillion in the last 10 years from generic

provide significant financial risk protection to households. The High-Level substitution. Thailand and China, which are approaching 100 per cent

Expert Group (HLEG) on UHC has asked for distribution of free drugs as the universal coverage, are moving substantially towards generics.Free drugs is

way forward. But, why did free drug distribution decline from 18 per cent in the only a part of the grand package recommended by HLEG. Besides, drugs would

1980s to just four per cent in the first place?put pressure on doctors to be present there. Getting doctors will take time,

while this can be done immediately. So, this is a beginning. Bihar spends Rs 93 Globally, only seven countries are behind India in terms of public health

per capita on health with pathetic results, while Kerala spends Rs 287 — giving spending. Both the Central and the state governments had to cut down public

it the best health indicator in the country. What is the portion they spend on expenditure 1990 onwards. The under-resourced public health facilities were

doctors and drugs?forced to prescribe medicines, which saw patients buying drugs from the open

market in large scale. Gradually, this has led to a situation where a household's On an average, salaries and other compensation account for 40 per cent of the

70 per cent of health care expenditure is on buying medicines. The health government's public health spending, while medicines account for 10 per cent.

ministry, as I believe, is putting in place a mechanism that would tie in financial However, the state governments spending on medicine varies considerably from

allocation to a host of reforms, expected to improve governance and as high as 13-14 per cent in Tamil Nadu and Kerala to five per cent or less in

accountability in the medicine supply system in the country. The proposed Punjab, Uttar Pradesh and Bihar. The Central government at present spends

system is on the lines of Tamil Nadu Medical Service Corporation, the time-10-12 per cent of its overall expenditure on drugs. With additional funds for

tested and successful model based on the principles of 'centralised procurement medicine procurement, the Centre may end up spending 14-15 per cent, but a

and decentralised distribution'. Since the state governments do not have the substantial share would go to the statesWhile monopsony and economies of

fiscal width currently to implement the same, the Central government is scale will help government to procure quality drugs at a cheaper rate, the states

expected to contribute 75 per cent of the additional funds.are expected to move towards an accountable system. One of the ways to make

the system transparent is enactment of Transparency in Tender Act, as in Tamil According to the current estimates, the additional funds are expected to be Rs

Nadu.4,000-5,000 crore (Rs 40-50 billion) a year. This proposal already has the

backing of the Prime Minister's Office and the Planning Commission.The How will the government finance the programme to raise health spending from

additional funding likely to be allocated by the Centre for the scheme will help 1.2 per cent of the GDP to 2.5 per cent in the next five years, as envisaged by

the states to shore up their fiscal position to procure medicines and distribute HLEG?. A reallocation in the Budget is called for.There are two ways by which

these freely to patients. Are there enough generic drug companies to fulfil the drugs can be delivered. The free medicine scheme is one such initiative. By

demand of the government health sector? Which are the existing players? In strengthening the procurement and distribution system, and with additional

case of these companies falling short, is there a way to generate more supplies?funding from the Central/state governments, free drugs can be delivered partly.

Well, India has a large number of generic drug companies, close to 10,000. The additional funds, as envisaged in HLEG's recommendation, is expected to be Rs 12,000-15,000 crore (Rs 120-150 billion) annually. In addition, another Nearly 250 of them are large and medium industries, while the rest are small-Rs 10,000 crore (Rs 100 billion) is required every year, in order to deliver

scale players. We not only have an adequate number of generic companies; publicly procured drugs but delivered through private chemists. In total, the

4

Can India sustain the 'free for all' generic drugs plan?

The pros and cons of free generic drugs

Can India sustain the 'free for all' generic drugs plan?

The pros and cons of free generic drugs

country will need Rs 25,000-30,000 crore (Rs 250-300 billion) a year to follows on from state-level initiatives in Rajasthan and Andhra Pradesh and is deliver drugs to people.Currently, the public health system in India spends Rs modelled on Tamil Nadu's successful free drugs programme, which has been in 6,000 crore (Rs 60 billion) annually, of which the states together account for operation since 1995.nearly 2/3rd, while the rest is contributed by the Central government. On the other hand, the private consumption of drugs is Rs 60,000 crore (Rs 600 Tamil Nadu set up an autonomous corporation for the bulk procurement of billion) a year. News of the government's proposal that free generic medicines generic drugs directly from manufacturers through a transparent bidding be made available through the public health system can be read in two ways. On process, for allocation to primary health centres and hospitals -- through a the one hand, it is a much-needed step forward – possibly a game-changing one demand-driven pass-book system rather than the normal supply-based – in improving affordability and accessibility in public health. On the other distribution procedures.Though corrupt practices have not been altogether hand, its efficacy will depend on whether simultaneous measures are taken to eliminated by this system, they have reportedly been curbed to a large extent.In improve healthcare service delivery, which is in a shambles in most Indian expanding the programme nationwide, mechanisms to minimise leakages or states. The Planning Commission's working group on drugs and food for the recycling of publicly procured medicines must, of course, be adopted. However, 12th Five-Year Plan estimated that the country's public health sector caters to a vital prerequisite for the success of the free medicines programme is the only 22 per cent of the population.Out-of-pocket expenses on health can have strengthening of the existing catastrophic effects on households. On an average, 78 per cent of health expenditure is paid by patients themselves, of which 72 per cent goes on buying drugs. Unsurprisingly, therefore, about 30 per cent of India's rural population and 20 per cent of its urban population have to endure common ailments without, for financial reasons, any treatment.

Worse still, close to half of all hospitalisation cases in rural areas are financed through loans or the sale of assets.As a result, medical treatment has emerged as the second most common cause of rural indebtedness. Equally disquietingly, some 39 million people are pushed into poverty every year because of illness. The new scheme, therefore, does seem capable – in theory– of addressing the dysfunctional economics of Indian healthcare. The Union health ministry expects this programme to reach over 50 per cent of India's population by the end of the 12th Plan.Should this happen, it would be a notable achievement. Indeed, in spite of the recent growth of India's private sector health network, public spending on health is insufficient to meet requirements.

The Centre and states together spend merely 1.1 per cent of gross domestic product (GDP) on public health; some indices rank India eighth last in the world on public health spending. The Prime Minister's Office, unsurprisingly, directed the Planning Commission in February to increase healthcare provision to 2.5 per cent of GDP in the 12th Plan.Like many other such ideas, the new scheme

healthcare system which has, over the years, tended to expand without consolidation. Most of the country's vast network of 640 district hospitals, 23,000 primary health centres and 5,000 community health centres is understaffed and ill-equipped.

And, of course, there's the question of funding: where will the Rs 27,000 crore (Rs 270 billion) to be spent on medicines come from? Is this the best time for a cash-strapped government to expand entitlements?. Who is a poor Indian? One who earns below Rs 35 a day? Or one whose salary is in four figures? While the debate rages, the Bombay Parsi Punchayet, the organisation that governs the affairs of the Zoroastrian community in Bombay, has said that any Parsi who earns less than Rs 90,000 a month (or Rs 10.8 lakh a year) is poor and therefore eligible for its help in finding a house. This "poverty line", drawn way above the national per capita income of Rs 68,491 (in 2011-12), was bound to raise eyebrows. The Punchayet perhaps felt that this was drawing unnecessary attention to the community's prosperity and hence quickly denied it in its monthly magazine, The BPP Review.The definition of a poor Parsi, according to Dinshaw Mehta, the Punchayet's chairman, is anybody whose family income is below Rs 10,000 a month. The poverty line of Rs 90,000 a month was drawn only for the allotment of 46 flats owned by the Punchayet in Andheri.

These flats, each of which would cost at least Rs 70 lakh in the market, are being given to Parsis for Rs 20 lakh. A loan of this amount, the Punchayet

Generic Drug

5

Generics Medicines

Seema, who was operated on “without permission” appears to have been presented in haste and without checking the facts. For example, according to a rejoinder by the Indian Medical Association, in this case, “informed consent” was taken and was examined by an independent agency, the Karnataka Medical Council, which reportedly found no negligence on the part of the doctors. These facts were apparently not divulged by the husband. If the counterclaims are accurate, there is a major lapse on the part of the research team of the show, and labelling the doctors responsible for Seema's care “ m a u t k e s a u d a g a r ” a n d “dhokebaaz” is uncalled for and probably defamatory.

It is true that issues such as the mushrooming of private medical colleges and paucity of government-funded medical colleges and in particular, major gaps in primary healthcare in remote areas, need strong regulatory measures and calculated, would result in monthly installments of at least Rs 25,000. To pay

consistent follow-up actions. But there are many more government medical this money, the family income ought to be Rs 90,000 a month. "One has to view colleges than Khan mentioned on his show. It was stated that since 2001, the the 'poor' in the context of owning a Rs 20-lakh flat, and not 'poor' in isolation," government has opened 31 medical colleges and 106 private institutes; says Mehta.however, a total of 181 private and 152 government medical colleges exist in India. To take up these issues in a progressive manner, multilevel action, political will, administrative firmness, regulatory action on corruption, grassroots efforts and crusaders in the middle (not those appearing for one show or writing one article, but consistently devoted to the cause) are required. atyamev Jayate' has dangerously over-simplified the generic versus These issues need more thoughtful discussion, rather than emphasising branded drugs debatecapitation fees in private medical colleges.SKhan's article initiates debate on the issue of generic drugs admirably, but does When a prominent person makes statements in the media, there are usually two not finish it smoothly. Treatment by generic drugs is an excellent way of results: people take those statements to be gospel truths (even if the subject decreasing the cost of medical therapy, provided these generic drugs, matter is outside the area of expertise of the person making them), and it starts sometimes made by firms with dubious records, have the same bioavailability a debate.and quality as drugs made by major pharmaceutical companies. Glimepiride is not a frontline drug for diabetes, domperidone is not a drug for diarrhoea and Any complex issue with innumerable variables needs careful scrutiny, not cetirizine is often not needed for a self-limiting common cold, all of which were judgements passed on the basis of quickly assembled pieces of information. stated as examples of expensive drugs in the article. These mistakes Consider an episode of Aamir Khan's show Satyamev Jayate, as well as a notwithstanding, if quality-controlled generic drugs are available, doctors newspaper article written by him that discussed medical malpractice and the would welcome it. However, if I had a heart attack, and have the choice of being issue of generic versus branded drugs.given the generic streptokinase — another example cited in the article — or the same drug made by a pharma company with strict quality controls, I would This is not a claim based on hard evidence, but based on 30 years of experience choose the latter.at AIIMS and then five years in a corporate setup, I can assert that doctors do

not want to harm patients. If patients come in harm's way due to an operation or Corruption in medical practice is a worthy subject for discussion, and the show other medical intervention, it is attributable to chance. On the show, the case of was able to initiate this successfully. Discussions of corrupt practices in the

6

Aamir Raises Revolt Against Branded Formulations, Pushes for Generics Medicines!

IS AAMIR KHAN A NEW MESSIAH OF DEPRIVED INDIA?

Can India Operate on a Chttorgarh Model?

Aamir Raises Revolt Against Branded Formulations, Pushes for Generics Medicines!

IS AAMIR KHAN A NEW MESSIAH OF DEPRIVED INDIA?

Can India Operate on a Chttorgarh Model?

medical profession are often avoided within medical circles, signifying a refusal temperature, pressure and humidity at which it is packed or the foil used for to deal with these important issues head on. The scams, the nexus with Big that or even the weight of the molecule contributes to the efficacy of the drug.”Pharma and other incorrect practices do, indeed, exist. Nobody should pardon such unsavoury practices, but many of them emerge from weak supervision, Dr Anoop Kohli, consultant neurologist at Indraprastha Apollo Hospital, says little regulation, lack of cohesion, an absence of hard administrative action and in reality most common brands are in effect generic because the molecule is not a lack of firm political will. These factors must be addressed to contain patented by the company selling it. “The only drug that was researched in India corruption in medical services. was LSD and about 50% of the Indian drug market is of generics — meaning

these are molecules whose patent period has expired and companies who are I agree that there is little point in achieving high GDP growth if, as a society, we not originators of the drug are selling it. Beyond that it is a issue of quality remain unhealthy. But health is determined by several factors: genes, individual control because a brand always carries a certain authenticity which doctors habits, environment, regulations and medical care. Thus, it is not the sole would not like to compromise on.”responsibility of the government or doctors, both of which Khan's show and article targeted, but also society at large. Given that many people will follow Doctors, however, agree that if generic drugs is indeed taken up at a policy level celebrities “blindly” on all issues, how about doing a couple of shows on regular — provided a system of certification for unbranded medicines is evolved — it exercise, diet and healthy habits, and health education? Such shows, not could be the way forward but the initiative in that case would have to come from highlighting the negative but intending to build on the positive, would help all of the government rather than individual doctors. States like Rajasthan and Tamil us to become healthier. Nadu with their respective medical supplies corporations have set a trend.

The writer is executive director of the Fortis-CDOC Centre of Excellence for Using generics is a philosophy and principle that is pro-people and anti-Big Diabetes, Metabolic Diseases and Endocrinology, New Delhi Pharma. It makes medicines affordable and accessible to tens of millions of

people in India, who otherwise will have to buy the same drug from the original innovator company at a price several times higher. Without them, most of us Aamir Khan's generic prescription shocks medical expertswill simply perish for want of medicines and the country will be gripped by waves of epidemics that will kill people by the thousands. The best recent It was the actor's suggestion of genericdrugs as a key to affordable healthcare example of the miracle that generics could bring about, in driving down the for India's poor — as advocated in his weekly show Satyamev Jayate on May 27 prices and averting mass-scale deaths, was the way they addressed the HIV and subsequently in his column in some newspapers — that got him the call epidemic.from the panel.

When Big Pharma invented anti-retroviral drugs, which almost made the Experts, however, have said his idea of prescribing generic drugs is “overly illness a chronic manageable condition, they were priced at thousands of simplistic” and “potentially dangerous”.dollars for a year's dose. Even in the beginning of 2000, they were only the preserve of the rich in the West, and the rich in countries such as India. Health Doctors quote WHO figures of 20-45 per cent spurious drugs in India to counter economists from World Bank and national public health establishments Aamir's contention that they are taking patients for a ride. In a follow-up (including India), mostly borrowing their argument from multi national column to his television show, the actor had urged doctors to mandatorily add pharmaceutical companies, were certain that it was impossible to make the generic names in the prescription and let patients choose the brand so as not anti-retrovirals accessible to people until Dr Jim Yong Kim, the present World become victims of doctors' “vested interests”.Bank President and then the head of the HIV unit in WHO, audaciously declared that he would put three million people on treatment by 2005.For one, as some doctors point out, the recipe could make patients susceptible to

the chemist's business interests as opposed to the doctor's who at least has the He betted big time on generics and succeeded. Now, generics have become the training to balance his “business interests” with what is called in management mainstay of AIDS-treatment all over the developing world. People with AIDS parlance as “information bias”. And it is a proposition that is defunct when it in poor countries get their drugs either free or buy at prices less than that of comes to patented anti-cancer and other drugs.diabetes. The story is similar for multi drug resistant TB (MDR TB) as well. Even when WHO had more or less given up on MDR TB, given the steep cost of “The World Health Organisation says 40% of drugs in India are fake. In case of drugs, the Boston based Partners In Health (PIH), took to treating people first genericmedicines there is little guarantee of their efficacy or even safety. What using the expensive branded drugs, followed by pursuing the generic route.if it is a fake? There is no way to determine that. A fake medicine will not allay

symptoms, but that is the lesser evil. What if it creates a side-effect for which Interestingly, the WHO apparently was not even aware that some of the drugs the patient needs 10 more medicines. Does that really make it a cost effective for MDR TB had outlived their patent periods and anybody could have made the treatment option?”asks Dr Anoop Misra, former professor of medicine at the generic versions. But somebody had to compel them and there had to be a All India Institute of Medical Sciences and chairman Fortis Centre of market for sufficient supplies. PIH took up that role. The point here is, without Excellence for Diabetes, Metabolic Diseases and Endocrinology.the demand and compulsion and a championing voice, we won't get the cheap copies of the expensive originals to stay alive. We cannot expect our politicians Dr D R Rai, secretary general of the Indian Medical Association, says the issue to do that. Aamir, by repeating the call for using generics, is contributing to this of authenticity of the drugs is one among a host of concerns. “There is no campaign. There should be a thousand more voices for such unfashionable effective mechanism for regulation of drug pricing. A chemist will often give causes.you a drug at half the marked price. If the government cannot even ensure that

registered drug companies charge just price, how will it regulate either the Much before Aamir, the Tamil Nadu Medical Services Corporation (TNMSC), pricing or the quality of generic drugs which is a far less structured industry? had made a highly successful working model of a state-wide drug procurement There is need for a price regulator and DCGI needs to be more proactive in and distribution system in the 1990s based on generic drugs. Through several quality control.”iterations, the TNMSC has perfected a process to weed out poor quality and ensure reliable supply. Its bulk procurement offered to buy sufficient quantities Speaking on conditions of anonymity, a senior doctor at a government hospital that made business sense to suppliers. This is in fact the same technique that said: “Every day I have rickshaw pullers and MCD sweepers coming in to say Clinton Foundation and other international NGOs would use in future – bulk or doctor saab write the best medicine for my child I will buy it from outside. They pooled procurement.do not know but we know that a medicine is just not a chemical...the

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offices, etc.) to see how easy it was for disabled people to move around. Sadly at The TNMSC is now replicated in many other states such as Karnataka, Andhra most places it was almost impossible.Pradesh, Rajasthan and Kerala. On Wednesday, the Kerala chief minister The next guest was Krishnakant Mane who prefers to be called KK. He lost Oomen Chandy used the same “generic” word in the state assembly when he sight when he was three but never lost his way. He does everything a normal answered a question on free supply of some medicines. So Aamir is perfectly person does including trekking and is a top-grade software engineer whilst right in campaigning for generic drugs. But then in India, the same generics doing research work as well. He explained how technology has helped him and come in different brands and that is where he wanted the people and not the felt people should remember two important things 1) Don't think you're disabled doctor to choose the brand – his second point. Here, he is as simplistic on a 2) Stop expecting the world is there for you; it'll be cruel and kind to you in complex issue as team anna is on corruption is. His intent is clear — the doctor equal measure. He said it's wrong to blame the government and society had a doesn't take a call on the drug because he/she is heavily induced by drug role to play in allaying the problems of the disabled. The show then went on to companies; but who does the patient go to with the prescription? The highlight how hard it is for people with disabilities to get admissions in regular pharmacist, who cannot be any better than the doctor. And the pharmaceutical schools. One principal in the audience blamed it on other parents who refused to companies will simply shift the goal post. Instead, what Aamir could do to take let their 'normal' children mix with children with disabilities. The show then his generic argument forward is to argue for a prescription method in which the pondered if it indeed was a challenge to admit disabled children in regular doctor writes both the generic and branded names of the drug. And the patient, schools. Amar Jyoti School in New Delhi showed it wasn't and that only some who wants to buy the generic version, then goes to a fair price drug shop run by changes need to be made to provide an environment where everyone can be the government or a cooperative across the state. given an equal education. There is a general consensus among people that

disabled people are being 'punished' for their sins from a past life. Aamir pointed out the very successful polio eradication campaign and lauded the Fair price drug shops like the PDS?country's effort in eradicating the disease, pointing out that past sins had nothing to do with disabilities. Yes, Kerala is now planning one in every district. Chandigarh has a few. The

government drug corporations (eg TNMSC) can set up such shops in district Then the show focussed on various people who've fought their disabilities and and Taluk headquarters and extend it to even PHCs. Of course, there were what can be done to improve their lives.exceptions such as the one in Mohali that got into a nexus with the drug

mafia.Some media reports carried stories expressing shock at Aamir's One example was a young girl called Nisha who suffered from a rare genetic statement while a Parliamentary panel wanted to hear him out. Here is a line disorder called Lamellar ichthyosis that affects 1 in 6 lakh people. In this that Aamir might do well in telling the panel – this one straight from the WHO: condition the skin fails to grow alongwith the body which results in a host of “competition between drug companies and generic producers has been more problems. Ketan Kothari of Sight Savers said people needed to change their effective than negotiations with drug companies in reducing the cost of drugs.” stereotypical attitude about people with disabilities. He said the term Let the drug companies and their crony doctors be shocked, but Aamir should 'differently abled' was insulting and there was nothing wrong with calling pursue his statement with action. For once, he is not treading on unknown someone disabled.terrains. Dr Kim, Bill Clinton, and many Indian states had successfully

traversed this path. Less popular issues such as this need ambassadors like Javed Abidi, the director of the National Centre for Promotion of Employment Aamir. After all, 75 percent of our health expenses are from our own pocket and for Disabled People (NCPEDP) in India, and the founder of the Disability there is considerable push for universal access to health in the 12th plan. Rights Group said there were 6 crore disabled people in the country though the Without generics, we wont reach anywhere.government refuses to acknowledge that the numbers are that high. Till 2001, none of the censuses even accounted for disabled people and though the 2001 Aamir Khan is an ignoramus.

A generic drug is a drug out of patent. All drugs in India are generics!They are 'branded' generics because they carry the brands of the companies that manufacture the generic drug.The Brand is necessary, because this helps differentiate the genuine drug companies (many with US FDA approved plants) from fly by night operations that make drugs in garages and rented Galas. Yet, fake falsely labeled branded generics are the bane of the industry and the patients who suffer consequently from drugs with low bioavailability and effectiveness. India has a fragmented drug market with top 3 companies having 3% - 7% of the market. This results in fierce competition that result in the lowest prices in the world. The Drug Price Control Order already controls the prices of essential drugs and is now due to expand and cover ~67% of the drugs available. The real problem is not price but ACCESS. Today 60% of Indians have no access to pharmacies and prescription drugs

Satyamev Jayate's sixth episode highlighted the trials and tribulations of people who are disabled (the politically correct 'differently-abled' is considered an insult by many). It highlighted the various problems people with disabilities face and how easily it can be overcome only if society were a little more considerate and aware of their needs. The first guest was a Sai Prasad Vishwanathan who recalled how he was never treated differently by his parents and encouraged to attend normal schools though this was made difficult by the authorities. He said that the biggest problem people with disabilities face are the lack of adequate infrastructure to move around. He explained how different things were in the USA where his university had provided adequate infrastructure for him to move around with any problems. To check the facilities available for the disabled the Satyamev Jayate team checked various public locations (bus stops, government

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did take note none of the measures had been implemented. He added that it was fundamental right that was being snatched away and it was a paramount We've covered the rights. But what's equally important is patients understand importance in a democracy that everyone should be treated equally. The policies their responsibilities as well:and tax structure pertaining to disabilities needed to reworked as he pointed out it used to cheaper to bring back gold from a foreign country rather than a The patient should undergo the treatment as prescribed by the doctor wheelchair which had a customs duty of around 30-40%. He said the only way faithfully and follow his/her instructions diligently.to ensure disabled children were included in regular schools was for the If the doctor has prescribed certain preventive measures in case of University Grants Commision (UGC) to give a notice to all schools and infections, the patient should follow the same.universities to include disabled children in their courses or become The patients need to be punctual for the treatments and follow-ups.unrecognized by the UGC. Patients should maintain all the medical records and prescriptions.

If the patient wants to take a second opinion, consult with your doctor He also pointed out the bad employment scenario for disabled people with only about the same.0.4% of them employed in private companies and 0.5% employed by public Patients should pay for their treatment as applicable to the doctors and sector ones. It was simply foolish he added to keep disabled people grounded hospitals promptlyand not let them contribute to the country's economy.

Excerpts from the Interview : Dr Rajendra Joher of the Family of Disabled also highlighted the work he was doing to empower the disabled. Incidentally Dr Joher was deemed bed-ridden Satyamev Jayate's fourth episode made the term generic drugs popular. for life but he got past his own disability and is now helping others deal with Generic drugs have been around for ages. In fact India's the global leader in the theirs. Aamir Khan went on to talk to Captain Kamaljeet Brar whose company generic market with Indian drugs popular in Africa and other emerging Designmate employed over 70% disabled people. It's an e-learning company markets. Some Indian pharmaceuticals have even made headway in the USA that employed over 270 disabled employees and was doing very well market.highlighting the fact that disabled people can make a major contribution to soceity. The last guest on the show was Joginder Singh Saluja, a disabled So what are generic drugs?bodybuilder and weight lifting champ who started a gym for the disabled because regular gyms denied him entry. The show wrapped up with Aamir They are drugs which have the same chemical composition as branded drugs asking the audience to write in and support the motion that will force all schools are and sold under their chemical name. For example Paracetamol , a and colleges to become inclusive failing which their UGC status would be painkiller, is the generic name for branded drugs like Crocin and Calpol. The revoked.In the end, Ability Unlimited a group of disabled performers moved drug market situation is a little different in India than the USA or other everyone with their astounding moves. All in all it was another great episode of developed nations. In the USA, when a new drug is launched only the company Satyamev Jayate focussing on an issue we seldom dwell upon. that holds the FDA patent are legally allowed to sell the drug , thus giving them

market monopoly. In India however there were no patent laws till 2005 which The fourth episode of Satyamev Jayate brought to light several cases of medical meant that anyone could replicate any drug in India without legal malpractice. Most patients in India treat their doctors like Gods and have an ramifications. This led to the trend of branded generic drugs which has 99.5% unquestioning trust in them. However, in recent times, there have been cases of of the country's generic drug sharemedical negligence and/or malpractice due to which the patients have suffered physically, mentally, financially and emotionally. In 1995, the Supreme Court Where are they available?brought the medical profession under the Consumer protection act and medical treatments were labelled 'services'. As per the Consumer Guidance Society of

Generic drugs are sold everywhere including your local chemist. To buy them India, the patient's rights as a consumer are the following:

one simply has to ask for generic version of a branded drug though they don't have them for all medicines. The department of pharmaceuticals of the

Patients have the right to be told about their illness; to have their medical government is responsible for promoting generic drugs but they haven't done a

records explained.very good job. To promote cheap drugs in 2008, the government had set up a

Patients should be explained about whatever treatment/medicines are scheme called Jan Ausadhi whose purpose was to set up generic drugstores

prescribed to them. They should be made aware of the risks and side around the country. Their initial plan was to set up 3000 stores but four years

effects, if any. They have the right to ask questions and clarify their doubts later only 300 of them exist. Here's a list of all Jan Aushadhi stores in the

about the treatment.country.

Patients have the right to know a doctor's qualifications.

What is the price difference between generic drugs and popular branded drugs?Patients have the right to be handled with consideration and due regard for their modesty when being physically examined by the doctor.

Note: All prices are taken from the 2010 comparative price listPatients have the right to maintain confidentiality regarding their illness We can clearly see that in some drugs the price difference is significant.and can expect the same from the doctors.

Patients have the right to a second opinion if they are doubtful about the Note: The list compares prices of generic vs braded drugs from 2010. As we can medicines or treatment suggested.see except for the anti-TB drug there's a huge price difference.Patients have the right to know what a suggested operation/surgery is for

and the possible risks involved. If he/she is unconscious or unable to make Is there a difference in quality between generic drugs and branded ones?the decision due to other reasons, informed consent needs to be taken from This is a question which is hard to answer and polarises the entire medical their nearest relatives.fraternity – doctors, chemists, pharmaceutical reps, etc. Some of them say that Patients have the right to get their medical records/case papers on request they are as good as branded ones while others feel that they are of poorer from the doctor/hospital.quality. Doctors and chemists have the impression that they are less effective. If the patient needs to be moved to another hospital, he/she has the right to In fact some doctors avoid prescribing generic drugs as far as possible and even know the reason for it and also has the right to make their own choice in go to the extent of handing out free samples of branded drugs to patients who consultation with the doctor.can't afford branded medicines. Doctors also aren't aware about their Patients have the right to get details of the bills they have paid for.

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availability due to lack of advertising and marketing. On the other hand a examples of positive work by doctors like Dr. Devi Shetty and Dr. Shamit pharma rep we talked to was of the opinion that there is no difference in quality Sharma,” Aamir told IANS.and a generic drug was as good as a branded one.

He denied the accusation that he insulted the medical profession. ”I have not insulted the medical profession at all. I have the highest regard for the medical Why aren't generic drugs more popular?profession. In fact what is insulting to the medical profession is those doctors who are indulging in unethical practices. They have insulted the medical There are various reasons for their unpopularity. There is a distinct lack of profession, not me,” he said. However, he is happy with the positive response awareness about them. Before the Satyamev Jayate episode only a handful of from the medical community as well as youths who aspire to be in the people knew them. Also since they are cheap, people who can afford branded profession.drugs don't buy them believing them to be of inferior quality. Chemists have to

hand out exactly what's written on the prescription and most doctors except in “A lot of doctors have written to me and said, 'Your work is fantastic and we are government hospitals don't hand out generic drugs.thank you for what you have done'. Dr. K.K.Talwar, head of the Medical Council of India, was on our show and after the show was aired, he wrote to me saying: 'I An insider felt that private doctors would never hand out generic drugs because thought what you did on the show was very good.' ”He said that 'I am aware that there are no kickbacks or incentives involved from pharma companies. a small section of doctors is upset with you, but I want you to know that what According to a highly placed source in the MCI, the body has very little say in you are doing is very important and I want you to know that MCI and I will do the doctor-pharma relationship. Most guidelines are blatantly ignored. The everything we can in our control and power to set things right'. Now that is such government or specifically the government's Department of Pharmaceuticals is an important and encouraging response. “Young medical students have written also to blame for the lack of awareness. The DoP has failed to do a good enough to me that this is a profession we are about to enter and we are so inspired by job of promoting generic drugs and the aforementioned failure to implement the your show to do the right thing when we enter the profession,” he added.Jan Ausadhi scheme reinforces that.

“I want to thank these doctors and young medical students whose messages and How to promote generic drugsletters have been most encouraging” he said. Aamir says his conviction in the concept and aim of the show have left him fearless of negative reactions. ”I feel Generic drugs are the answer to better healthcare for all. India has one the what I have set out to do is extremely important and what I support is important highest out-of-pocket healthcare expenditure in the world and despite providing for me and very important for society and our country. I have absolutely no very cheap services (compared to rates of the countries like USA and UK) it's hesitation in doing what I feel is right for the country. So in that, if there is a still inaccessible to many due to poor purchasing power. The only way to small group of people who are getting upset, it is sad, but so be it. In fact, I promote generic drugs is to curb illicit medical practices. Though the MCI would request those people who are getting upset to look inward.guidelines dictate that doctors should prescribe generic medicines as far as

possible, very few private practitioners actually do it. There's a need to “I believe we are trying to make a sincere effort in first understanding issues strengthen the Jan Ausadhi scheme and break down the doctor-big pharma and then shedding light on them, and we are committed to that attempt,” said nexus. Moreover the MCI needs to provide more practical guidelines rather the 47-year-old trailblazing cinema personality.than an archaic set of rules which simply can't be followed in the real world.

People trust medical practitioners, believing that they are equipped with the Pats and brickbats – Aamir Khan was prepared for it all when he set out to knowledge and skills to safeguard their health. But when this knowledge is discuss burning issues in his debut TV show “Satyamev Jayate”. Fearless and misused to exploit this trust, medical care becomes a nightmare. The convinced about the aim of the show, the actor-filmmaker says he is totally profession is riddled with unscrupulous doctors and hospitals out to make big unapologetic about raising the issue of malpractices in the medical profession, bucks at the cost of patients, but there are still medical practitioners who stand thereby upsetting an umbrella body of 21 medical institutions.“I have up for the Hippocratic Oath, and those who want to clean up the profession. absolutely no intentions of apologising because I have not done anything

wrong,” Aamir told IANS in an exclusive interview over phone from Mumbai. Medical NightmareAfter raising concerns over female foeticide, dowry andchild abuse, Aamir took

it upon himself to shake up viewers and awaken them to the existence of It is generally believed that health is wealth; one can tackle any of life's irregularities in the country's healthcare system. He brought issues like cut problems if one is in good health. But when one is not in good health, whom does practices, unethical medical practices, and commission demands to the fore and one go to for help? A doctor, of course. In this episode, in the audience there are presented live examples of people who could have been cured with simple many young medical students. Asked why they want to become doctors, the medicines but were advised by doctors to undergo surgeries, robbing them of general response is, to help people. When our future and wellbeing is in the precious money. This 'exposure' has landed Aamir in the bad books of the Indian hands of medical professionals, it is pertinent to examine issues related to Medical Association (IMA). But he does not fret!medicine and doctors. The episode begins by examining the relationship between a doctor and a patient. We see the stories of two people, V S Venkatesh “We were aware that since these are issues that are core to all of us and and Arvind Kumar. Venkatesh had a swelling on his foot and when he went to affecting every Indian, obviously there are some people who are part of the the doctor he was told that if he did not go to hospital he would lose his foot. problem, and they are not going to be happy with us because these are the ones Venkatesh got admitted and was treated, but an infection developed in his foot who don't want a solution to be there. ”In fact, I would have been surprised if we the next day. He was told that a toe needed to be amputated. After that, he was would not have earned brickbats. The people who are getting troubled are very told that the doctor who had performed the surgery had left some bone inside. likely the ones who are part of the problems,” said Aamir, adding that he hasn't One after the other, four operations were carried out – and eventually received any physical threats so far.Venkatesh learnt that none of this had been necessary, and that he could have been treated with antibiotics and other medication. Venkatesh is seething at the He protests against the allegation that he only highlighted the negative aspects loss of his toe, the loss of more than Rs 2 lakh towards treatment, and the sheer of the medical profession on his show, to which was invited K.K. Talwar, trauma that he was made to undergo.chairman, board of governors, Medical Council of India (MCI).”I don't know

whether they have seen the show because a number of times we brought out that It was a similar story with Arvind. Troubled by persistent vomiting, Arvind there are many doctors who are doing great work. We gave such strong went to hospital for a checkup and was admitted to the intensive care unit for

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three days, to undergo several expensive tests. He was then told that his being given as normal, because the doctor knows that there is nothing really appendix had ruptured and would have to be removed, otherwise he would die in wrong with the patient. Dr Pichad says that it was a personal tragedy which three hours. But Arvind did not believe the doctor, and went to another hospital brought him to his senses. He realized that what goes round comes round, and for a second opinion. There, more tests were carried out and he was told that he felt that he should make amends for his bad practices. He stopped giving there was nothing wrong with his appendix. He ended up spending Rs 1,40,000 commissions, and reduced his rates. He found that as a result, he lost his doctor between the two hospitals, for no reason. Now, he says, he is afraid to go to a friends, he stopped getting referrals, and often his reports would be rejected by doctor. Venkatesh remarks that people practically worship doctors, but in the doctors. He says that after explaining to his patients that nothing had reality they play quite a different role. When Daya Suryavanshi's father was changed in his lab except the pricing, and after he made it known that he was feeling uneasy one night some years ago, he went to hospital, where he was refusing to pay commission, word of mouth spread and his business began to admitted to the ICU for tests. After two days of tests he was told that his pick up. He has also displayed a board at the reception area which says that his condition was serious, and that he needed a liver transplant otherwise he would lab does not operate on a commission basis. With patients gaining confidence not survive beyond two or three weeks. Worried, he sought a second opinion in him, his business is now doing well without him having to pay off any doctors.from a doctor referred by the hospital itself. This doctor echoed the first opinion, and Daya's father then went to the family doctor. The family doctor diagnosed But the system of commissions and payoffs is rampant, and sickening. Cancer gastroenteritis and said there was absolutely no need for a liver transplant. surgeon Dr. Amol Pandit of Wales explains via 3G link that when he came back Daya's family spent some Rs 25,000, not counting the ICU charges, on all this – to India to practice, he learnt from his colleagues that they expected a “cut” of but if they had agreed to the liver transplant, it would have cost them some Rs 30 to 50 per cent for referring patients to him. In big hospitals, he says, he was 36 lakh. expected to give patients medical opinions that would scare them into agreeing

to surgery at the hospitals, at cost to them and profit to the hospital. Refusing to For retired army Major Pankaj Rai and his daughter Abha, the cost was much, go along with these schemes, Dr. Pandit returned to the UK, disheartened and much greater. Maj Rai's wife Seema developed kidney disease, and had to disillusioned with his native land.undergo regular dialysis. Seema could well have continued for many years with dialysis but on the urging of the doctors, though she was apprehensive of the Unscrupulous doctors are to be found everywhere, even operating among the outcome, Seema went in for a kidney transplant when a donor became poorest sections. In Andhra Pradesh, poor women had hysterectomies available. One day before the surgery Maj Rai was told that his wife would also performed on them under the threat of losing their lives if the operation was not need a pancreas transplant. He did not agree, but he was asked to speak to a performed. Many of them took loans, or sold their land, to pay for the cardiologist before making up his mind. The day of the surgery, at about 5am, a operations, and in some cases, after the women realized they could not have nurse told Abha that her mother was to be taken for a checkup, and asked her to children, their husbands left them to remarry. In reality, as Dr Puneet Bedi sign a form; before Abha knew it Seema had been wheeled away into the explains, leaving aside the case of cancer, a hysterectomy is rarely required – operating theatre. By the time Maj Rai arrived at the hospital, he was told that perhaps one patient in every four to six months. He says it is impossible that so surgery had begun and it could not be stopped, despite his protests that many women in the same area would need a hysterectomy. Who can curb this permission had not been given for it. The Rais were then told to arrange for rampant abuse of the medical profession? The Medical Council of India is the replacement blood, and Maj Rai says that eventually they ended up giving regulatory body that is supposed to keep a watch on medical malpractices and Seema a total of 7 litres of blood – even more than is contained in the human give recognition to medical colleges. In 2001, MCI chief Dr. Ketan Desai was body! Maj Rai says that neither was a cardiologist consulted before the charged with corruption and Maj Gen (Retd) Som Jhingon was appointed operation, nor was the transplant surgeon qualified for a pancreas transplant. administrator of the MCI. But the den of corruption, as Maj Gen Jhingon terms Also, the hospital did not have a license to carry out pancreas transplants. it, was too much of a battle even for the war-hardened army veteran. Stymied at Seema was on the operating table for 17 hours and was in critical condition for every turn by the corrupt practices kept going by Dr. Desai's regime and two days after that. Maj Rai says that he met her one evening, and she told him supporters, he resigned, and Dr. Desai was back in the MCI. But only till 2010, that he and Abha should look after themselves. She passed away that night. when he was nabbed on a bribery charge by the Central Bureau of Abha says that they were not even informed about this, until she asked one of the Investigation. This time, the MCI was handed over to Dr. K K Talwar to run.staff how her mother was. That was when she was told she was no more. The Rais spent Rs 8.25 lakh, and Maj Rai feels that the hospital took a gamble on the Dr. Talwar admits that the malpractices which are now coming to public pancreas transplant, hoping that if it went well the institution would gain a attention are bad, and that change is required. Granted that all of the name, and if it did not go well it was no big loss – only the loss of a patient's life. approximately 8 lakh doctors in India swear to abide by the code of medical Maj Rai says Seema had told the nephrologist that she had complete faith in him ethics, Dr. Talwar says it is difficult to say how many doctors actually abide by it and while she may even ignore what her husband told her, she trusted and and how many break this code. Aamir Khan points out that as per a Right to believed the doctor. It is a faith that doctors play upon. Aamir Khan explains Information application, it is learnt that not even one doctor's licence has been that while doctors may make mistakes just like any other human being, the cancelled since 2008. In contrast, in England, in 2010 73 doctors lost their episode is focusing not on mistakes but on intentions, on doctors who licences, 68 in 2009, and 42 in 2008. Dr. Talwar says that there are good deliberately mislead and exploit patients. doctors and bad doctors, and a solution to the malpractice problem needs to be

found. He assures Aamir Khan that action will be taken in the Andhra Pradesh hysterectomies cases, and promises to make a serious effort to clean up the The percentage gamesystem. Asked how much capitation fee is charged by private colleges, the medical students in the audience say it is about Rs 60 lakh. This is all black Even when the situation is not as serious as to require hospitalization, in regular money, paid in cash, and there is no record or account of it. Dr. Talwar admits treatment too, patients are often advised to have blood, urine and other tests that some of these institutions and the hospitals attached to them are not up to done. Dr. Anil Pichad explains the business of running a pathology lab. He says standard, and says that this is a long-standing issue which needs to be that when he started his pathology lab, he did not get patients for a couple of remedied. He promises that action will be taken in the cases of erring doctors months, then he realized that he would have to go and meet doctors to let them and institutions. know about his lab and services. He found that doctors would straightaway ask

him for a percentage, of about 40 to 50 per cent, in return for referring patients to his lab for tests. This naturally resulted in the cost of the tests being raised for Rays Of Hopethe lab to be able to make a profit. Moreover, says Dr. Pichad, doctors often prescribe more tests than are required. In fact, one such test is called a “basin Just as there are people who are part of the problem, there are people who are test”, and involves the blood sample being thrown into the basin, with reports part of the solution. Dr. C M Gulhati is one of those who has long been

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concerned about medical ethics. He says that the basic question is, whether we Dr. Sharma says that medicines are overpriced because of the brands they are give medical services priority or not. He says that while medical care should be sold under. Generic medicines are unbranded and therefore cost less, though No 1 priority, it has actually been pushed to the very bottom. The reason for this they contain the same basic salt that is used for the treatment. He gives the is the privatization of medical colleges, where students have to pay enormous example of a medicine for diabetes, which costs Rs 117 for a branded version, fees to get admission. When they have paid so much, he reasons, they expect to but only Rs 1.95 per 10 tablets for the generic. A cancer drug that costs Rs get the same kind of returns from the profession. He says it would be a better 1.25 lakh can be had in generic form for Rs 6,500 to Rs 10,200. In fact, India option to invest that money instead of spending it on a medical education. Dr. exports some Rs 45,000 crore worth of generic drugs every year. Gulhati says that the solution is to have more government hospitals, because at the moment the number of government hospitals is not enough to serve the Dr. Sharma says that the movement he has started in Rajasthan for the use of population, and people have to either wait long hours or come away untreated. generic medicines has attracted a lot of opposition especially from the Another ill of the profession is the practice of pharmaceutical companies pharmaceutical company mafias, who end up losing their hefty profit margins. encouraging doctors to prescribe their products, with incentives. Dr. Gulhati But he says the movement has the support of doctors, not all of who are bad. says that this incentive again is in the form of a commission of 30 per cent paid There are 50 to 60 per cent of doctors who genuinely want to help people, and to the doctor. Pharmaceutical companies, he says, spend Rs 1,31,000 per often shell out of their pockets, or bring samples of medicines to give the poor. doctor per year for these commissions. Dr Gulhati says that while taking a bribe He says that when he was away once, his domestic helper's son died because she is an offence, the pharmaceutical companies do not come under any sort of could not afford the medicine which cost Rs 400, but which was actually liability. He says that health care is neglected because it affects mainly the poor, available for Rs 1.25. It is criminal that this happens, he says, and even worse is and he recommends that it should be equally accessible to all. He cites the the fact that it is not difficult to change this. example of Belgium where a percentage of salary is automatically credited to a medical insurance company, so that good medical care is available to all. He Aamir Khan says that if any NGO wants to set up a medical store selling generic says that of India's Gross Domestic Product, only 1.4 per cent is spent on health medicines, the Department of Chemicals and Fertilisers offers a grant of Rs care, and it will never improve until this figure reaches 6 per cent. In the midst 50,000 for this purpose. The SMS question is: Should every state government of this bleak scenario, a ray of hope comes from people such as Dr. Devi Shetty. follow the example of Rajasthan and open generic medicine stores throughout Founder of the Narayan Hridayalay in Bangalore, Dr. Shetty instituted the their state so that all citizens get medicines at the lowest possible price?Yashaswini scheme for farmers nine years ago where the farmers each pay Rs 10 per month, which the government matches with Rs 30 per year, and this What can be done?makes the best medical care at Dr. Shetty's hospital available to everyone. Dr. Shetty says that any type of operation is possible under this scheme. Poor people The SMS question for the episode. And, Aamir salutes doctors who are working living in isolation are weak, but together they are very strong, says Dr. Shetty. selflessly and tirelessly in the genuine spirit of their profession – helping people He explains that while the so-called rack rate for a heart operation, for and being healers – and appeals to medical students to hold such doctors as example, is Rs 1,40,000, his hospital does it for Rs 60,000 for patients under their ideal.the scheme. He says this is possible due to the turnover, as his hospital carries out the largest number of heart surgeries in the world – about 35 in a single day. Does Healthcare Need Healing?Health care is sensitive to economies of scale, says Dr. Shetty, so the fact that his hospital group performs 12 per cent of the heart surgeries done in India gives him the advantage of being able to lower costs. He says that this is possible The practice of medicine has long been seen as a noble one. The doctor is looked anywhere, and in fact a similar scheme was started in Andhra Pradesh about upon as healer, guardian of our well-being, and someone we trust with our lives. four years after Yashaswini, and another one has been started in Tamil Nadu. If Literally. In India, with privatization and globalization having brought in the government can be convinced that there are 750 million Indians who are modern medical equipment and techniques, no longer are the choices limited spending Rs 150 per month just to talk on their cell phones, and if Rs 10 can be when it comes to finding a doctor. Now, the question is which doctor at which collected from each of them, we can have the most robust health insurance hospital or clinic to choose. In the midst of this bounty, it is heart-breaking that scheme. more than 16.8 lakh children under five died in 2010 – of diseases such as

pneumonia and diarrhoea, diseases that are easily curable if treated with the Dr. Shetty says that charging less does not mean that the doctors in his group right medicine. *are earning less. Everyone is doing very well, he says, and exhorts medical students and doctors to do what their heart tells them. Those who indulge in But the reality is that health care, and specifically the cost of medicines, itself malpractices are also always afraid of being caught, he says, and they cannot drains the average pocket so much, that large numbers of people are often sleep easy as their conscience is not clear. He tells the audience, “Nobody can forced to go without appropriate treatment. Adding to this are factors that do come in the way of people wanting to do something good for society. You all can not help the medical industry, such as some corrupt practices, patients being be heroes in real life. This is a fantastic profession.” overcharged, and prescribed treatment and surgery they did not need. Why is

the simple act of giving and receiving medical care so fraught? It begins, The Cost Of Medicine perhaps, with the very notion of studying medicine. Once considered a rarefied

and glorious stream of study, medicine slowly came to acquire a cachet of A major part of health care is the pharmaceutical profession. And the cost of prestige. Parents pressurized children into it, eager to boast that their child was branded medicines can be astronomical, as can the difference between these a medical student. Students, egged on by peer pressure, applied for medical and generic medicines. Showing by example that one does not need to pay overly college and, bizarrely, opted for the “alternate” stream of Engineering if they high prices for medicine is Dr Samit Sharma, former collector and now did not get into medical college.Managing Director, Rajasthan Medical Services Corporation. He says that the daily tragedy of India is that medicines are sold at up to 50 per cent more than With globalization came a wave of knowledge, awareness of alternative they should actually cost. When there are more than 40 crore people in India streams of work and jobs that, under socialist India, had been looked upon as who cannot even make ends meet, how will they be able to afford such “loser” choices. But medicine was still the shiny option. Nevertheless, it is still medicines, he asks. According to the World Health Organization, he says, 65 not a cheap option. Besides the actual study and other fees, the practice of per cent of the population of India lacks access to essential medicines – 65 years capitation fees in private colleges, which had become popular in the late 1970s after Independence. and 1980s, has taken firm hold in the world of medical education. Over and

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above other fees, a student may be expected to pay anything from Rs 50 lakh private entity should discuss the issue, evolve a consensus, take doctors and upwards as “donation” towards the college, in cash. This is a sizeable amount staff into confidence and adopt a resolution to provide low-cost drugs to the which many doctors are under pressure to recover as quickly as possible when citizens. Take from the doctors the list of drugs which are commonly prescribed they qualify and begin practicing. by their generic/salt name (start with 100-200 drugs which are not available in

hospital supply). Let doctors also decide the name of 15-20 companies which The plethora of private medical insurance schemes available help the educated they consider as “good”. Invite open tender by generic name or take drug lists and privileged to cover medical costs – but for the vast majority of India's poor of reputed drug companies (which doctors have indicated) from the authorised and lower-lower middle class, medical insurance is unviable. The only ray of local stockists (the wholesalers) of these companies. Apart from the offer price hope for the less privileged comes from micro-insurance schemes implemented the stockist lists usually also shows MRP which may be 5 to 10 times the offer by state governments – a facility available only in a handful of states. For those price. To avoid misbranded or spurious drugs always get these from a stockist with access to medical insurance, access to health care became easier to pay for, authorised by the company. Also insist for the authorisation certificate, a valid but this did not guarantee the quality of that health care. Moreover, it still left a bill/cash memo and certificate of analysis (test report) for every batch of each gap in the numbers. At last count, India had more than 6 lakh allopathic drug. This will ensure quality standards. Compare the prices of different medical practitioners – but this means only one doctor for every 2000 people.* companies and prepare a comparative statement. Choose the L1 (best buy) and Even 24 hours in a day would not suffice to treat this number. This also means purchase these generic drugs. A fair price generic drug store can be opened in that doctors are still “in demand”. The Medical Council of India itself says, in any suitable vacant room near/in the hospital. A registered pharmacist is its chairman's note, “The large gaps in health care accessibility in rural parts of required to run the store. The licence for the shop is to be obtained from the the country, the need for enhanced clinical competence and limited office of the local drug control authority, for a licence fee of about Rs 3,000 opportunities for post-graduate training are our major concerns.”* (one time for 5 years). The generic drugs received from the authorised suppliers

can be sold at 10-20% profit margin which is charged at the purchase price, Even when doctors are available, and are affordable, the basic problem is that which will help to meet day-to-day expenses and the remuneration of the the medicines they prescribe are not always within the budget of the average pharmacist, and no external financial help is required. A computerised list of person. On the whole, the cost of medicines itself makes up a major part of our the available generic drugs may be displayed prominently outside the shop. health care expenditure, and the tragic reality is that this does not have to be so. Preferably the list should show the rate at which the drug is actually sold The medicines available in the market are sold at prices which can be anywhere (CP+10%). You may also compare the selling price with the MRP printed on from 10 to a thousand times more than the actual cost of the medicine. A 2010 the drug, which will educate the patients about drug prices. Parliamentary standing committee report on generic medicines, for example noted that a seven-day pneumonia treatment costs Rs 1,136 when actually the Similarly, surgical items like IV sets, blood transfusion sets, needles, canulas, medicine, when purchased at a cooperative generic medicine store, cost only Rs suture items etc can be sold. Orthopaedic implants, eye lenses, cardiac stents 139.51.* etc can be sold at about one-fourth of the prevalent market prices. The mere

availability of low-cost drugs will not help, until the doctors can be persuaded Some state governments – including Rajasthan, Tamil Nadu and Bihar – have to prescribe either the generic (salt) name of the drugs or at least prescribe started cooperative and other stores selling medicines in their generic, non- those brands which are of low cost and are available at the store. Then the branded form, at a fraction of the branded cost.* If this movement can be taken patient must be properly guided and counselled to purchase drugs from the low-across the country, to every state and every town and village, it will give every cost generic drug store. In Rajasthan about 72 fair price generic medicine Indian access to affordable medicine – a vital component of making health care shops are operational in medical college hospitals, district, sub-district and available to all. satellite hospitals by the name of “Life Line Drug Stores” and are operated by

Rajasthan Medicare Relief Societies, which are in fact the “Rogi Kalyan A dream worth dreaming. Samiti” that is the local hospital management committees. If the state By Dr Samit Sharma government or local body or charitable trust is ready to bear the cost (which is

very low, about Rs 10 per OPD patient), then these generic drugs can be given The cost of production of most of the drugs is many times less than the retail to poor/all patients free of cost as is being done by the Government of price (MRP) printed on it. Generic medicines are not new types of medicines, Rajasthan, through 15,000 free drug distribution Centres, right from medical these are abundantly available everywhere in India. These are drugs which have college hospital to PHCs and sub-centres. About 400 types of commonly used come out of the patent duration of 20 years and now, apart from the original essential generic drugs, surgical and sutures are given free of cost in innovator company, any other pharmaceutical manufacturer can produce this government hospitals in Rajasthan.salt after getting due permission from the drug control authorities. In fact, 97% of the drugs in the Indian market are generics (or branded generics). But even The above steps are merely indicative and general guidelines, and they should these are sold at high prices, because they are prescribed by doctors and be modified according to the circumstances in the field..supplied by manufacturers under brand names. Branding limits the choice for the patient, kills competition and creates artificial monopoly, and enables the Dr. Samit Sharma, MD (Paediatrics), I.A.S., is Managing Director of the manufacturers to charge a very high MRP. Rajasthan Medical Services Corporation, Gandhi Block, Swasthya Bhawan, The doctor plays a key role not only in prescribing drugs by generic name but Tilak Marg, C-Scheme, Jaipur (Rajasthan) 302 005also in convincing the patients that these drugs are 100% identical to commonly used brands in quality, ie, they have the same identity, purity, I am a bit of a dreamer. And that's one of the reasons I am able to do this show. I strength, bioequivalence and effectiveness, provided the doctor himself is dream that one day we will be living in a country where things will be different. I convinced of these facts. Even when you open a low-cost generic drug shop the dream that one day, in our country, the rich and the poor will both get the same patient won't get the price benefit unless the doctor is inclined to help him.The good quality health care. To many it may seem like a totally impractical, and an patient must also be made to understand that although he is getting a particular unachievable dream… but it's a dream worth dreaming… and one that has drug at a very low price compared to the printed MRP or his doctor's favourite every reason to come true!. Irrespective of whether you are rich or poor, when brand, it is in no way different or inferior. It will have the same effect. you lose a loved one, the pain is the same. To watch my child suffer and die while

I am unable to do anything because of an incurable disease is truly sad. But, if Steps To Open & Operate A Fair Price Generic Medicine Shop there is treatment available which can save my child, but I am unable to save

my child because I can't afford it… and can only helplessly sit by and watch my The hospital management or the local self-government or NGO or any other

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child die… that is unimaginably tragic… that is used to treat resistant malaria is available at, as little as, Rs 25/- for a pack of 3 injections, however the branded versions of the same injection costs Rs 300/- to Rs 400/-. In cases of diaorrhea, another big killer of children in What is stopping us from having a great public healthcare system?India, the vomiting that causes dehydration can be stopped with a medicine whose salt name is 'domperidone', which is available at Rs. 1.25 paisa for a A number of us pay our taxes. Some of us don't. And most of us don't earn strip of 10 tabs, the same medicine in its branded version Domstal sells at Rs. enough to be required to pay direct taxes. Then, there are indirect taxes. A host 33/-of indirect taxes are also collected by each State. Each time we buy

something… salt, sugar, tea, anything… we pay some or the other tax. So, it turns out, that the poor are after all paying for public health care too! Only they How can our poor, or for that matter even our middle class, afford medication?don't get proper healthcare services in return. Less than 2% of our GDP (Gross Generic medicines is the answer.Domestic Product), - 1.4% to be precise, - is allotted to public healthcare!.

And in this regard we have to applaud the efforts of the Rajasthan Government. Why?!!!The Rajasthan Government has set up shops selling generic medicines across the state in an effort to make good quality medicines available to people at the Dr Gulati, one of the guests on our show, and someone who has been working in lowest possible rates. Roughly 25% of all the ailments go untreated in India this space for years, said, that it should be at least 6% for a very basic level of because of financial reasons… THINK OF THE DIFFERENCE GENERIC public health facilities… I am neither an economist nor a doctor, but I would MEDICINES CAN MAKE TO EVERY INDIAN!. If the Rajasthan prefer to err on the safer side and say 8 to 10% is what it should be. What is the Government can do it why can't other State Governments do the same?. One point of having a great GDP if as a society we are not healthy? Economic interesting piece of information… the Ministry of Chemicals and Fertilizers strength will come only if first we are healthy, and it will be of some use only if offers Rs50,000/- to anyone wanting to open a shop selling generic medicines, we are healthy enough to enjoy it. Importantly, health is also a State issue and and at their discretion they also sometimes offer space to open such a shop!!!. each State collects ONLY indirect taxes. Why isn't more of our money spent on Looks like my dream of good quality public healthcare being available to rich making more PUBLIC HOSPITALS, and more importantly, on PUBLIC and poor alike may be possible after all… MEDICAL COLLEGES? Why are there not enough public medical colleges

with attached public hospitals across each state?. With a vibrant young How Chittorgarh Did Itpopulation more public medical colleges is the need of the hour. But it seems the

government at the centre, and all the various state governments, are concentrating less on opening government medical colleges, and therefore, the Orders passed saying doctors in government hospitals must prescribe great need of young students wanting to become doctors is getting filled by… generic medicines onlyyou guessed right… PRIVATE medical colleges… many of who I am told Strict checks to ensure only generic drugs are prescribed unless charge 50 to 60 lakhs as unofficial donation!!! absolutely necessary; ad campaign too

Cooperative asked to procure generic medicines and supply them through In most cases private medical colleges are basically springing up as businesses.

a network of 16 storesMany of them don't even have proper running hospitals attached to them, which

Tenders invited by the cooperative, most bids far lower than currently is mandatory. I sometimes wonder how competent would the doctors be who are retailing. Pre-selected companies allowed to bid.coming out of many of these private medical colleges?. We need to insist to our Despite a long history of battles and a still-intact fort, dusty, small-town state governments, and the central government, that we want more public Chittorgarh doesn't quite look like a place where revolutions still happen. hospitals with attached public medical colleges. Private hospitals are most But thanks to a project that started last July, this hilly district in south welcome, but let's concentrate on our public healthcare system and make it so Rajasthan has quietly overthrown the prevailing regime of high-priced strong that private hospitals have to work harder to compete, and therefore, we medicines—a key failure of India's healthcare system. In its stead, it has as a society get better healthcare services. When a student sits for his/her introduced another that dramatically lowers the cost of drugs, making MBBS exams and is asked what is the name of the drug that is to be prescribed access to healthcare easier for even the very poor. The usual 'medical for a patient suffering from diabetes he might write 'glimeperide'. This is the salt shops' that sell at maximum retail price still exist, but in 16 stores run by commonly used to treat diabetes. When that same student becomes a doctor and the Central Cooperative Bank essential medicines are being supplied as a patient suffering from diabetes comes to him for treatment he might write the part of a 'Generic Drugs Initiative'—prices here are 40-50, sometimes 90 medicine name as Amaryl. So, is that young doctor giving the wrong per cent lower.Chittorgarh is among the 50 worst performing districts on medication? No. Amaryl happens to be one of the brand names by which the salt the human development index, with poverty widespread and access to 'glimeperide' is sold. So what is the difference between the two… apart from the social services dismal at best. It's in this milieu that the cooperative stores names? Well, a strip of 10 tablets of Amaryl costs around Rs 125/-, and a strip have come forward to sell generic versions of hundreds (564 to be of 10 tablets of the salt 'glimeperide' costs Rs 2/-. Both are essentially the same precise) of drugs. The stores have opened near hospitals and, no surprises, thing. We pay approximately Rs 123/- more for the brand name.patients are flocking to them. So much so, the administration now believes there's room for a further drop in prices.Here are some more examples:

Another round of price cuts may sound far-fetched—the popular stress relief The common cold is one of the most prevalent illnesses. The salt name of the medicine Diazepam, for instance, already sells at the cooperative store for Rs medicine used to tackle the common cold is cetrizine. Now, the manufacturing, 2.48 per injection instead of the usual Rs 21. Similarly, the price of a two-day packaging, transportation costs of this generic medicine, including a decent supply of the blood pressure-regulating drug, Simvastatin, has gone down from margin, is Rs. 1.20 paise for 10 tablets.But the branded version of the same Rs 120 to less than Rs 35. The cooperatives manage the price cuts because they medicine, for example Cetzine, costs over Rs 35/- for 10 tabs. A common sell only generic versions—copies of drugs whose patents have expired. The law injection used to treat blockages that cause heart attacks is 'streptokinase' or says once the patent expires on a medicine, any drug company can manufacture 'urokinase', these injections cost Rs 1000/-, however in their branded form they it. Without the associated R&D, marketing and advertising costs, generics can cost over Rs. 5000/- in the market.retail at far lower prices.

Malaria is a big killer in India especially among children. A critical injection N.C. Saxena, who assists on UNICEF health and access projects, says that

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“unlike the rest of the country where regulating drug prices has become a very tends to prescribe more generic drugs.difficult task, the Chittorgarh model shows how much a government can achieve if it decides to make cheaper medicines accessible”. But it's not always about According to experts, the fear of fake drugs, and of generic medicines not being prices, for many patients have doubts about the efficacy of generics. At the same effective enough, must go. For most generics have such low manufacturing time, for Indians 80 per cent of healthcare spends come out of their own pocket, costs that it's rarely profitable to fake them. In Chittorgarh, a technical panel of and most of this goes for medicines. For Dr Samit Sharma, Chittorgarh district doctors has pre-selected 22 drug companies (now being expanded to 57) who collector since July 2008, it was imperative that change happened in both are welcome to participate in the tenders. “Surprise checks” on the areas. cooperative's medicines show they have “the same results as branded drugs”.

“Except, I believe, in the case of cancer drugs, you'll get the same treatment “The Chittorgarh model shows how much a government can achieve if it makes and results with generics,” says Ranjit Roy Chaudhury, who runs the Delhi cheaper medicines accessible.” Society for Promotion of Rational Use of Drugs, an ngo that led a similar

project in the late '90s in Delhi's government hospitals. Chaudhury's project did not encourage generics—it was too premature for that, he says. But when —N.C. Saxena, Consultant, UNICEFprocurement was centralised and tendering cleaned up, he found 50 per cent of supplies had shifted, with little effort, to generics, from almost none earlier. First, he tightened the grip on government-run hospitals and its doctors. They “Seriously, it's difficult to imagine low medical costs in India without generic were disallowed from prescribing medicines by brand names; doctors can now drugs,” says Kumar Bikram, a UNICEF official in Chittorgarh who has been only prescribe a “salt” name—the final choice of drug to be bought, generic or working closely with the administration on social sector projects. Other states branded, remains with the patient. Sharma then launched a campaign to have tried making drug access easier on the pocket—such as Tamil Nadu—but promote generics: every third street corner in Chittorgarh and the government-on bigger budgets, while no concerted effort has been made to supply low-cost run community health centre in nearby village Bassi have signs drugs countrywide. Sharma has indeed made a start in Rajasthan. What emblazoned—'Buy generic drugs: They cost less' or 'Ask your doctor for generic happens to this model when he is posted elsewhere is anybody's guess.medicines: They are just as effective.' The messages were placed on

prescriptions as well. Needless to add, doctor's prescriptions are also being As a medical doctor who practised in different Rajasthan hospitals for nearly monitored. The results were encouraging. Doctors in the town—which has two five years before he took the IAS exam, Chittorgarh district collector Dr Samit large hospitals and about 50 private doctors' practices—report that patient Sharma, 38, knows how the system works. Excerpts from an interview:numbers have increased by 15-40 per cent, a sign that people are now more

confident that they can afford medical care. The state's medical bill for This is a time of letting market forces work. Who will appreciate your idea of pensioners and others (who access the government health system) has also controlling prices?declined for the first time, by about Rs 4 crore, mostly because people are

spending less on medicines.It's strange. India is the biggest bulk and generics drugs manufacturer, has among the lowest cost of healthcare in the world, but still out-of-pocket Sharma, who was a doctor in Jaipur before he sat for the ias, is now a household expenses on medicines are the highest in the world here. Without the name—even rickshaw drivers will tell you about him. “If the government is government intervening, there's no way to cut prices.serious about reducing healthcare costs, it will have to take some cost-related

measures—either price controls or ensuring that doctors prescribe generics,” How did you bring doctors around?says Sharma. In fact, similar orders have been passed all over the country (by

the Medical Council of India in 2002) but no one has seen about Doctors spend five years in medical school, but are never taught about generics. implementation.They learn about generics from medical representatives, who have an interest in promoting branded drugs. Sometimes doctors will have to compromise on But when it's tackled, medicines seem to be one field where the trickledown their lifestyle, often funded by benefits from branded drug makers! But all theory has worked. Lower-priced drugs in government-run stores have put doctors are not bad...many of them are simply ignorant about the efficacy of pressure on private practitioners to follow suit. Private medical stores, who generic medicines and come around pretty quickly.have started to lose business to sarkari stores, are cutting prices. Central

Cooperative Bank MD Pradeep Sahay says the impact is spreading to other In your previous posting in Jhalawar, you tried to create access to low-cost parts of Rajasthan too. Nine districts including Jaipur, Bhilwara, Jalore and medicines. What happened when you left?Sirohi are now procuring drugs from the Chittorgarh cooperatives. In fact, in It did lose steam once I moved to Chittor, but I also realised that for such a districts such as Jhalawar and Bundi, drugs must now be procured at venture to succeed, more than one person is needed. So Chittor's doctors, “Chittorgarh rates”. “In some cases, just by removing the middleman there is patients, medicine suppliers and manufacturers, even the state machinery, are sometimes as much as a 700 per cent reduction in prices,” says Ram Singh all working together. I learned that you cannot have a stick method alone for Sankhla, general manager with the bank.such a cause—you need both carrot and stick.

Six months on, even individual patients from adjoining districts have now Pharma brands: Old is goldstarted rushing to Chittorgarh for medical supplies. At any given time, orders

worth Rs 2-3 crore are waiting to be shipped to nearby districts by the As many as 260 out of the top 300 brands are pre-2005 vintagecooperative. The medical store at the district hospital for women is in a perpetual state of flux because of the demand. This is where the government's At a time when pharmaceutical companies are investing billions of dollars to 'godown' for generic drugs is. Letters exchanged with Pali district show an order develop new and path-breaking medicines, it is the old and heritage brands that worth over Rs 5.7 lakh. Another from Kota is a demand for Rs 1 crore worth of continue to dominate the market. Sales in 2011 show that the average age of (generic) cetrizine. Each order is placed in cardboard boxes and loaded on to the top 10 pharma brands is 19.3 years, and some of them are as old as 25 buses. years. For instance, Novartis' painkiller Voveran, which was launched in 1986,

ranks third, whereas Ranbaxy's much popular health supplement Revital and Meawhile, private-practice doctors like B.S. Kothari, whose clinic is in a row of Himalaya's Liv-52, both 22-years old, rank sixth and 10th respectively.houses next to the cooperative drugstores, look on. “I've come around to the view that one should try generic medicines—they are very good, particularly According to a study conducted by IDFC Securities on pharmaceutical brands, ones manufactured by established companies,” he says. Kothari says he now

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out of the top-100 brands, 93 are pre-2005 vintage. Among the top 300 brands, building these limited launches into big brands. This bodes well for future as it's as many as 260. While most of these brands are painkillers, vitamins and MNCs seek to broaden their portfolio through branded generics and patented cough syrups, even drugs to treat diabetes and those treating gynaecology products,” the study said.problems figure among the vintage brands.

Abbott, which leads the top-300 list, now has 28 brands in that bracket aided by its acquisition of Piramal Healthcare. However, some of the Indian Matter of Trust companies are also gearing up to create a meaningful place for themselves. “Brand building is a matter of trust, high degree of recall and consistency,” According to analysts, Mankind has emerged as the biggest brand creator in says Sujay Shetty, Partner, PricewaterhouseCoopers. “A brand is built with a the pharma space in the last few years. Says R C Juneja, Chairman and Chief lot of investment and it has to be reinforced every year. So ultimately, it is Executive Officer of Mankind Pharma, “brand is like a lifeline for pharma several crore over several decades”. Novartis India Vice Chairman and companies. More brands not only mean more profit, it also means that your Managing Director Ranjit Shahani agrees. “Brand is a promise and reputation company is becoming more popular and this is very important for drug is the delivery of that promise over and over again. Successful brands are built makers.” Since 2000, the company has built 12 brands in the top-300 list – on innovation while block buster brands are built on game-changing highest in the domestic market and surpassing even the largest players. Of innovation,” Shahani said. Dominating sales Mankind's 12 brands, 11 are in the acute segment including five anti-infectives Analyst say mature brands not only dominate rankings but sales are also brands. According to Juneja, brand building is a challenge and companies have growing at a strong double-digit clip year-on-year. Despite ageing, top-100 to formulate product specific strategies to position their brands well in the brands, with an average age of 15.8 years, have shown nearly 16 per cent market. “The field force also plays an important role here,” he points out. growth over 2007-2011. Similarly, the top-50 brands, with an average age of Other domestic players like Cipla, Cadila and Elder Pharma also have 17.3 years, have recorded more than 16 per cent growth. “Importantly, despite successful brands in the pharma market.their vintage, the top 10 brands continue to grow steadily with a revenue CAGR

of 14.2 per cent over 2007-2011 – signifying high brand stickiness,” the study said. “Rising on a strong brand recall and increasing sales from rural and untapped markets, these brands are huge money spinners. Some of them clocked annual sales of over Rs 200 crore last year,” said the brand manager of a leading pharmaceutical company.

According to a study conducted by IDFC Securities, Abbott's anti-diabetic drug Human Mixtard, which was launched in 1992 and currently occupies the top-slot of best-selling brands, garnered revenue of around Rs 219 crore last year. Similarly, Pfizer's cough medication Corex, launched a year later in 1993, clocked annual sales of Rs 215 crore in 2011. Even older brands like Voveran and Revital clocked significant sales. While Voveran earned Rs 194 crore for Novartis, Revital contributed Rs 182 crore towards Ranbaxy's sales last year. Other heritage brands enriching the cash registers of various pharmaceutical companies include popular medicines like Combiflam (anti-inflammatory and painkiller), Benadryl (cough syrup), Calpol (paracetamol), Mox (antibiotic), Liv-52 (for liver ailments) and Shelcal (calcium and Vitamin D3).

Branding requirements Most of these best-selling brands in India are off-patent, unlike in the developed countries where the average age of top brands is typically 12-15 years, depending on the length of patent protection. “One of the reasons could be because in India, painkillers, cough and cold medication and antibiotics are initially prescribed by general practitioners and over the years they adopt characteristics of over-the-counter products. How many of us really go to a doctor for a Combiflam, a Benadryl or a Calpol? We go straight to the chemist,” Shetty said. But analysts suggest that brand building skills are critical and there is clearly a challenge in creating newer brands. Experts say, though a successful brand building is a continuous process and takes decades, a new product needs minimum of six months to develop a market. “India is mainly a branded generics market and life cycle management can carry brands through their leadership cycle for more than 25 years. Classic examples are Voveran, a nonsteroidal anti-inflammatory drug (NSAID) for osteoarthritic conditions and Calcium Sandoz for strong bones and Otrivin a nasal decongestant,” says Shahani. Novartis had launched Voveran as a tablet, which was followed by a gel formulation and later a thermagel. The idea was to capture an additional market segment at each stage.

MNCs Vs domestic firms Multinational companies (MNCs) have excelled in the act with better brand building capabilities, notwithstanding their relatively limited market share. Foreign players such as Abbott, GlaxoSmithKline, Novartis and Pfizer account for five of the top-10 brands. “Given their historic strategic constraint in terms of fewer product launches compared to local players, MNCs have focused on

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iven the uncertainty, analysts say there is more room for an upside also poised to shift from developed to emerging markets such as India, China, despite steep valuations. Brazil, Russia, Turkey and South Korea, as huge potential still remains G untapped in these countries, the analysis said.

Economic and political developments across the globe have kept the markets, The research finds that the markets earned revenues of USD 123.85 billion in including ours, on the edge in the June quarter. Given the uncertainty, investors 2010 which are likely to touch USD 231 bn in 2017 at a compound annual have shunned high-beta names for safer and trusted defensive bets to ride out of growth rate (CAGR) of 9.29 percent from 2011 to 2018. Regions covered in the storm. Stocks from the fast-moving consumer goods (FMCG) and the research include the United States, Europe (Germany, the United Kingdom, pharmaceutical companies continued their upward march for the third quarter France, Spain and Italy) and Asia (India and China). "The patent expiry of in a row despite steep valuations. The rising investor interest for these so-called several major blockbuster drugs between 2010 and 2017 will fuel the growth “safe havens” took the BSE FMCG (up 11 per cent) and Healthcare indices (up of the global generic pharmaceuticals market," said a Frost & Sullivan 4 per cent) close to their lifetime highs in the June quarter, vastly outperforming research analyst. "The trend is shifting towards less competitive, yet the Sensex which remained flat in the same period. commercially attractive segments such as difficult-to-produce generics,

speciality generics and biosimilars," he said. Leading global generic Both the indices had surged more than 11 per cent each in the March quarter, pharmaceutical manufacturers have been proactive in forging strategic while they gained between one-three per cent in the December quarter. alliances with branded pharmaceutical companies for marketing rights and Investors flocked to defensive stocks as most of the interest rate-sensitive stocks exclusivity in producing generic versions of blockbuster drugs such as Lipitor, have been hammered due to poor financial performance and growth concerns, Cozaar and Crestor, among others. Market such as Teva, Sandoz and Mylan are analysts say. Typically, defensive stocks hold up in hard times because demand increasingly focused on biosimilars, as this segment provides a competitive does not decrease as dramatically as it may in other sectors, they suggest. edge and presents huge profit margins, the report said.“Generally, large investors seek refuge in FMCG stocks as defensive bets, since While these are positive signs for market participants, a potential dampener is it's difficult to hold cash in balance sheet due to accountability to the the progressively stringent regulations and price control measures being stakeholders,” said Kishor Ostwal, chairman and managing director, CNI imposed by some governments. These have tended to squeeze profit margins for Research Ltd. generic manufacturers, Frost & Sullivan said. As competition intensifies,

generic drug manufacturers will have to make careful choices about the ITC, Godrej Consumer Products and Emami from the FMCG pack and Strides product segments that they wish to compete in and the appropriate time of Arcolab, Wockhardt and Ajanta Pharma from the pharmaceuticals space have entry into the market, it said. "Large multinational generic firms need to adopt rallied more than 10 per cent in past two consecutive quarters on the back of a differentiated approach by opting for products with technologically robust financial performances. (See table: Up, up and away). According to challenging formulations and products that require significant regulatory rating agency ICRA, Indian generic players are likely to benefit from patent support, and products with limited availability of active pharmaceutical expires in 2012; the domestic formulation business is likely to maintain healthy ingredients (APIs)," the research analyst added.volume growth as emerging markets are expected to offer strong growth opportunity. “The Indian pharma sector will continue to outperform in the near future, despite stocks being reprised with risks to the global economy and Indian Pharma Brandsuncertainty that may drive markets for some time. Indian growth prospects in In an age where billions of dollars are being spent on research for new domestic and export markets remain strong relative outperformance,” says a molecules and drugs, it appears that old is still gold in the Indian pharma analyst with a local brokerage. However, most analysts feel defensive pharmaceutical market. The 20 to 25-year-old heritage brands of painkillers, stocks have run up ahead of fundamentals. The BSE Healthcare Index currently vitamins and cough syrups continue to dominate the domestic pharma space trades at 45.33 times average P/E (price-to-earnings) ratio, while the BSE and are still the money spinners. Riding on a strong brand recall and increasing FMCG Index is hovering at 35.64 times. This is as compared to the benchmark sales from rural and untapped markets, these drugs - including painkiller Sensex, which trades at 17.02 times. “FMCG stocks are trading at extremely Voveran, health supplement Revital, and cough medication Corex - clocked high valuations. However, considering the current market conditions and lack annual sales of nearly Rs 200 crore each last year, and are growing at a strong of investment opportunities, the investors are continuously chasing FMCG double-digit clip year-on-year. Others heritage brands which are making the stocks,” said Jagannadham Thunuguntla, strategist and head of research at cash registers ring include popular medicines like Combiflam (anti-SMC Global Securities. inflammatory and painkiller), Mox (antibiotic), Liv-52 (for liver ailments),

Benadryl (cough syrup), Calpol (paracetamol) and Shelcal (calcium and Even though gross margins were adversely impacted due to incessant increase Vitamin D3). in input costs, FMCG players have taken judicious price increases without losing market shares and major slowdown in volume growth, which is vital. “If The average age of all the best selling drugs is 19.3 years, with the oldest being the current bearish market conditions remain, these stocks can rally further 25-year-old Voveran, manufactured by Novartis, and the youngest, Abbott's from the current levels,” added Thunuguntla. 15-year-old Phensedyl Cough, reveals an IDFC Securities analysis of the top 10

largest-selling drugs (see table). Right on top of the list is Abbott's anti-diabetic Drug Patents Expiry To Give Generic Pharma Market Shot In Arm drug (insulin) with sales of Rs 220 crore. The brand was launched in 1992 and

has registered a 18% CAGR over CY07-11. Significantly, despite their The patent expiry of several major 'blockbuster' drugs, coupled with other vintage, the top 10 brands continue to grow steadily with a revenue CAGR of factors, will fuel growth of global generic pharmaceuticals market by 2017, 14.2% over CY07-11, signifying a high brand stickiness. This is quite unlike research firm Frost & Sullivan said. the developed countries where the average age of top brands is typically 12-15 "Imminent patent expiry of key blockbuster drugs is expected to benefit years, depending on the length of patent protection, analysts TOI spoke to said. generics manufacturers. The global generic pharmaceuticals market is likely to One of the reasons why old brands are still popular here is because painkillers, witness strong growth in the next few years owing to the patent expiration of key cough and cold medication and antibiotics are mostly prescribed by general blockbuster drugs, and the judicious cost containment efforts of governments practitioners (GPs). Smaller cities and towns continue to have GPs who and healthcare service providers worldwide," a global analysis research report prescribe these medicines routinely to people suffering from acute illnesses.from Frost & Sullivan said. The healthcare expenditure and sales revenue are Certain medicines enjoy a strong brand legacy built over a long time, and over

Pharma Stocks Are Favourites, Will Grow FastPharma Stocks Are Favourites, Will Grow Fast

generations. "Old molecules still have a strong play in a cluttered, me-too market in India as they command a high level of perception built over decades. Apart from the above, over the counter (OTC) drugs sold without prescriptions Also, the disease categories here are growing, and with more people in rural need to have their own brands since they are based upon the consumer areas and small towns getting access to treatment, these drugs register a strong perception. On an average, a pharma company spends roughly 10-12 percent of volume growth as well," says Sujay Shetty, Partner PwC India. Globally, some its revenues on sales and marketing activities. The current pharma sales and blockbuster medicines have made very successful switches to the over-the- marketing model is under tremendous pressure. It is estimated that leading counter segment after losing patent protection, and continue to clock high pharma companies will lose between 14 percent and 41 percent of their sales. A lot of these top-selling brands here are available over the counter, like existing revenues as a result of patent expiries. The spate of lay-offs, re-cough and fever medications. "People are confident about which pill to pop as organisations and growth in outsourcing announcements across companies are they trust the company, and also because of loyalty to a particular brand. They a testament to the fact that the industry is trying to reconfigure itself and adapt continue to do so each time they are unwell, particularly so in cough and cold to a new reality.illnesses, fever, pain and for wellness," explains Kewal Handa managing director of Pfizer India, which owns heritage brands like Corex (cough syrup), Dipta Chaudhury, Programme Manager, South Asia and Middle East, Pharma Becosules (vitamins), Gelusil (antacid) and Folvite (folic acid). and Biotech Practice, Frost & Sullivan, explains the global scenario, “In highly

regulated markets like North America, Western Europe and Japan, brands are Pharma companies, meanwhile, are happy to leverage the brand equity enjoyed usually developed for novel innovator molecules and branded generics are few by these mature established brands, and reap the benefits for a long time. Says in number. The market still has a number of pharma brands, including products Ranjit Shahani, VC and MD of Novartis India, which owns painkiller Voveran for many of which patents have expired, and yet the branded drug is sold. Most and Calcium Sandoz in its portfolio, "With fewer new chemical entities being of these medicines are innovative products developed after extensive research. launched, pharma companies are trying to see how they can extend many of There are very few Indian brands available in highly regulated markets, mainly these strong brands as many of these still account for a large chunk of the available in the US market. This is because branded generics in these markets company's bottomline". In the analysis, domestic players dominate the rankings have a very limited scope, while requiring a lot of marketing push.”with a 65% share by owning 196 brands in the top-300 list. However, despite a Indian pharma companies reportedly spend as much as 1/6th to 1/5th of their limited presence in India (20% of the total domestic sales), MNCs have turnover on promotional activity. Dr Kamal K Sharma, Managing Director, demonstrated better brand building capabilities and have created 92 of the top- Lupin, explains the need of a branding exercise, "A product branding of pharma 300 brands, and five of top 10 brands sold in the country. For instance, in a bid product is more complex as compared to other sectors as it also involves a high to build the brand in untapped areas, MNCs like Novartis are running degree of compliance to regulatory frameworks and laws, depending on the healthcare initiatives like Arogya Parivar to create awareness, accessibility and nature of the market you exist in. “affordability, where small packs of their blockbuster medicines are sold in villages. There are multiple legislative and ethical guidelines that are in place in India

regarding pharma marketing practices. The major legislation for pharma Globally, pharmaceutical companies have always allocated adequate resources regulation is the Drugs and Cosmetics Act, 1940 (DCA). Related to that there towards brand building of their respective products, and this is expected to are also the Drugs and Cosmetics Rules, 1945 (DCR), Drug Prices Control continue, especially for branded product markets. For lesser regulated markets Order (DPCO), 1995, Drugs (Magic Remedies) Objectionable Advertisement like India, Brazil, China and Russia, there are branded versions of every Act, 1954 and The Pharmacy Act, 1948. These are whole-legislations that patented drug, known as branded generics, which result in the same molecule apply to the entire country and all drugs that are sold, whether home-produced having multiple brands for each company selling the product. Some of the or imported. Also, the Organization of Pharmaceutical Producers of India leading brands are Lipitor (Pfizer), Plavix (Sanofi-Aventis), Enbrel (Pfizer, (OPPI) has developed a code practice, based on the International Federation of Takeda), Advair (GSK), Remicade (Johnson and Johnson, Merck). In other less Pharmaceutical Manufacturers and Association (IFPMA) code of ethical regulated markets like Africa, South-East Asia, Brazil etc, Indian companies guidelines for pharma marketing.have developrd their own brands. Some of the other brands developed by Indian companies in highly regulated markets are Desquam-X, Exelderm, Eurax, Chaudhury explains the marketing ethics of pharma products, “Marketing of Ultravate, Halog, Kenalog by Ranbaxy, Synalgos, Elixophyllin, by Caraco (Sun pharma products are under strict supervision. Since usages of these products Pharma), etc. are dependant upon a number of factors, like patient health, predispositions,

possible interaction with other medication, etc, it is strictly promoted only to According to IMS Health, the global pharma sales in the year 2009 crossed physicians who can prescribe them. Promotion of prescription medicines to $820 billion, growing at four to five percent. As expected, 87 percent of sales patients or the common public is prohibited. Similarly, there are other came from US, Europe and Japan with US alone clocking over $300 billion. marketing restrictions which do not allow pharma companies to give incentives While there are over 106 blockbusters (sales exceeding $1 billion each) , the to doctors for prescribing their products to the patients, or for pharma mother of all brands continues to be Pfizer`s cholesterol lowering drug Lipitor companies to provide unlimited free samples of their products, etc, which are in (atorvastatin ) which clocked in sales of $11.4 billion with a degrowth of eight place to ensure ethical nature of the pharma industry remains intact.” Sharma percent. What is interesting is that the so-called 'pharmerging' markets (Brazil, emphasises the core need of marketing initiative by pharma companies, “The India, China, Russia, Korea, Mexicoand Turkey) exceeded sales of $110 billion goal is to make your brand distinguishable against products that are becoming with a growth of 14–15 percent. Clearly, this market will continue to dominate increasingly similar in the doctors mind. Doctors and patients tend to recall the in the next decade. For any successful brand, sales and marketing are the key corporate brand and then drug name. A decade ago, the product brand used to vehicles that drive companies to get their products to their target audience. be the strongest point of recall but we do observe a gradual move towards Manish Gupta, Director, Indegene Lifesystems says, “What is important to association with the corporate brand name. Lupin, as a strategy has also note, though, is that the traditional means of reaching out to physicians and always aimed to achieve a sizeable share of it revenues from branded and patients may not work. With 20 percent of US and British physicians now proprietary products globally.”refusing to see any sales representatives, companies are finding innovative ways of engagement. Pharma companies have also realised the value of ensuring For MNC's whose product are still under patent, up to 70 percent of the cost of patient adherence, since patients are more informed now. While there are drug is spent on marketing activities. These activities help in establishing and significant changes witnessed in the behaviour of traditional stakeholders, promoting the brand. A global growth partnership company in India, products there is an emergence of a newer group that includes nurse practitioners, are mostly generics and are therefore not innovative, which means they do not physician assistants and patient caregivers.” need to educate physicians about an absolutely new product. This enables the

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companies to have a lower spend on marketing activities. quality affordable generic drugs, branding has been the best marketing strategy that has added value to the drugs and distinguished them as 'branded

Gupta provides the fact that specialty areas such as oncology, neurology, generics' in the market. This is especially important for the Indian pharma cardiology and diabetology, owing to their continued developments, require companies with over 57,000 brands competing for attention, for greater amount of sales rep training. “In our experience, 75 percent of the sales differentiating the product from competition and also to establish a positive training budget is allocated to these areas,” he says. Chaudhury compares a image of the brand and the company in the crowded market.” He continues, “A pharma company's expenditure on sales and marketing with research and recent trend seems to point towards the growth of the OTC market in India. development on an year basis. “While sales and marketing expense is a variable Globally, the Indian pharma industry ranks third in terms of volume and 13th dependant upon the product, R&D expenses are at the discretion of the company in terms of value. Currently, India ranks 11th in terms of the OTC market size and can vary from six percent of revenues to higher or lower amounts, with an estimated OTC market of $1,793 million with an annual growth rate of depending upon the stress the company lays on R&D,” she says.Dr Ajit Dangi, 23 percent. OTC or non-prescription medicines in India seem to be growing President and Chief Executive Officer, Danssen Consulting, says, faster than the global average of approximately five percent despite being “Pharmaceutical marketing in India is quite a challenge due to highly perceived as less effective than prescription drugs.” Chaudhury explains the fragmented nature of the market, with over 60, 000 brands battling for a share surge of sales and marketing expenditure with a n OTC and prescription drugs. of about $9 billion domestic market. With the result, even the industry leader “OTC drugs are sold over the counter at any pharmacy or other shop. They can has just about six percent of the market share. The lack of product patent be bought by a customer without a prescription. Hence, these can be marketed protection until 2005 resulted in market getting flooded with me too brands for through conventional media like TV and print. As a result the sales and the same molecule, sometimes even 20-100 brands of a single molecule marketing expense of these drugs are more similar to FMCG goods. competing for the same indication.” Table 1 shows top five brands in India Prescription drugs on the other hand have more expense in training of medical indicating that no brand has crossed even Rs 500 crore annual sales revenue. reps and their travel to personally meet and educate doctors on the product

range. The expense is of a different nature than OTC drugs and depends upon The top 10 Indian pharma companies spend a significant amount of their the complexity of the product portfolio. For drugs like oncology the expense is earnings on sales promotion, training of medical reps and brand building. This higher than oral pain relief medication,” she avers. However, Shetty remarks definitely helps them position their products better in the crowded market and that the need of such expenditures is not necessarily directly related. Factors ensure higher brand recall among doctors, which in turn spurs sales and helps like the equity of the brand and therapeutic category, competition, price control the company boost its top line. Chaudhury emphasises,”Products which require will help determine the marketing budgets.a lot of knowledge and understanding to ensure knowledge flow to doctors require their sales reps to be well trained. Some such products are oncology Higher sales and marketing spends may yield greater revenues, it is unreal for a drugs, biologics, drugs used in intensive care situations, etc. Such medical company to do this at the cost of its bottom line. What is important is for a representatives are few in number, and spend a much longer time with their company to identify an optimum sales and marketing mix, to yield desired physicians as they detail the effect of the drug on patients apart from just results. Promotion spends certainly exceed R&D spends. A study conducted by creating awareness of the products. Sales and marketing expenses can be Marc-André Gagnon and Joel Lexchin in 2006 suggests that pharma broadly broken into product promotion through sales reps, med rep trainings, companies spend almost twice as much on promotion as they do on R&D. product promotion through limited number of free samples to encourage usage Pharma companies spend on a variety of activities that can be grouped under and discuss the feedback of the drug, and educational events where product can sales and marketing expenditure. Break up of sales and marketing expenditure be discussed by key opinion leaders or thought leaders. Dangi give an example, are 14-15 percent sales, six to seven percent sampling and six to seven percent “Building an OTC brand is equally difficult due to high cost of advertising marketing tools (brochures, scientific input etc). ”Pharma companies are not particularly in electronic media. Because of multilingual advertising to get pan only seeing clear savings but are also seeing the possibility of driving multiple India presence the media budget often gets fragmented, reducing its impact. innovative marketing ideas and programmes due to the low cost of innovation Detailing through medical reps therefore is often more cost effective. and also the fact that really high quality resources can be leveraged,” Distribution also plays an important role in promoting an OTC brand. India does concludes Gupta.not have a well defined OTC policy. Drugs which are not covered by schedule 'G' or 'H' of the Drugs Act, by default become OTC. Inspite of these challenges, companies like P&G, Paras etc have built powerful brands like Vicks (P&G), Move/Krack/Itchguard (Paras). Dr Mom, (JB Chemicals) a herbal cough syrup is the number one OTC brand in Russia and is a classic example of effective brand building.”

Since most prescription drugs in India are available without prescription, they become part of the deemed OTC category eg pain killers like ibuprofen, diclofenac etc and even cough syrups containing codeine. Pricing also plays an important part in brand building. “Most MNCs have now realised that aggressive pricing in emerging markets does not always succeed and only delays the market penetration. More and more companies are therefore adopting country specific pricing keeping the affordability factor in mind due to lack of adequate health insurance coverage,” Dangi adds.

Sujay Shetty, Director, Pharma Life Sciences Leader, PwC, explains, “Sales and marketing expenditure goes in holding continuing medical education's (CME's) to educate the doctors about their existing products new launches with the necessary clinical data, along with developing a connect with the product. This helps to capture a share of his mind by getting the doctors to prefer one brand over other, given the multitude of choices at his end.” Daara B Patel, Secretary General, Indian Drug Manufacturers' Association (IDMA) says, “As Indian pharma industry concentrates and promotes the manufacture and sale of

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“Many Indian pharma majors already have agreements with pharma stimated size of the generic drugs market in Mexico: $4 billion (out of a multinationals to share markets. Indian pharma companies have entrusted the total market size of $11.5 billion). Margins are high too. The responsibility of tapping emerging markets to their foreign partners. So, at Eregulatory regime is known for relatively quick approval of new least in the immediate future, the presence of Indian companies in Mexico molecules.would be through these tie-ups and not directly,” said a CEO of a pharma research major. He cited agreements of Dr Reddy's with GSK and Aurobindo There's more. Unlike in some European markets where insurers determine with Pfizer as examples. Dr Reddy's, for instance, has not registered any which drugmaker's products are covered for claims, Mexican consumers pay for revenues from its API facility in Mexico. their drugs out of their pockets, hence are free to use any drugs. Apart from

drugs for critical illnesses, products relating to the central nervous system (CNS), oral contraceptives and biosimilars have a big market in Mexico. And India to mount sector-specific delegations to Iranso, Indian pharmaceutical companies, who excel in making generics, can hardly Seeking to expand its trade relationship with Iran and make inroads into this wait to check if Mexico, the second largest market in Latin America after lucrative market, India has decided to send sector specific trade delegations to Brazil, could be their new Eldorado. Although only a few Indian firms are explore opportunities to enhance economic engagement including that in tapping Mexico as of now, analysts are convinced all that will change shortly. pharmaceutical, automobiles and oil and gas sectors.“Like Brazil, Mexico encourages a lot of branded generics over branded biosimilars. This market is currently growing at a rate of around 11-12%. In addition to this, the business chambers and export organisations have been Hence, Mexico holds promise for Indian companies, given the scope to focus on asked to prepare along with the Commerce Ministry for hosting a ``India generics,” said an analyst. Show'' in Iran during next year to showcase India's economic might and what all

it could offer to Iran and vis-à-vis. The Commerce and Industry Ministry has For instance, Ranbaxy, Torrent, Glenmark and Sun Pharma already have a asked the Gems and jewellery Export Promotion Council (GJEPC) to mount a presence in Mexico. Cadila is keen to expand into Brazil and Mexico. Dr Reddy's delegation to Iran to explore opportunities and areas of cooperation and trade (DRL) has an active pharma ingredient (API) manufacturing plant in Mexico in order to expand the footprints of Indian gems and diamond trade. ̀ `the old (it does not sell any products though). Lupin set up its subsidiary Lupin Mexico Silk route could form the basis for initiating a new direction to the intra-14 months ago and has started filing branded and generic products. It wants to regional trade. The GJEPC had recently taken a delegation to Pakistan and focus on therapy segments like CNS, oral contraceptives and biosimilars. signed a seven-point agenda programme for promoting and expanding gems Bhavika Thakker, research analyst at IIFL, said, “As medicine, healthcare and and diamond trade ties with its Pakistani counterparts. ̀ `Iran presents a huge related costs head northwards in Western countries, markets like Mexico opportunity for us and we should grab it. We have to adopt a sector specific certainly offer immense opportunity for drugs companies in emerging approach. Now that the rupee payment mechanism has been resolved, the speed economies like India. For, they already have proven capabilities in making high- of trade would increase tremendously. We have urged the exporters to also get quality, standard-compliant products at a fraction of the cost in developed aggressive on trade with Tehran,'' a senior Commerce Ministry official markets.” remarked.

In developed markets, drug regulatory issues bordering on protectionism have The Federation of Indian Exporters Organisation (FIEO) is spearheading the been thwarting Indian pharmaceutical companies. In this context, Mexico's initiative for expanding trading activity with Iran. Apart from this, India would recent measures to reduce regulatory hurdles hold much attraction. “What also be sending a delegation with specific interest in automobiles and makes Mexico attractive is that the government is taking proactive steps to automotive components. "Tata Motors is already holding talks with local encourage foreign participation and putting in place guidelines that could help companies for possible joint venture. There is a huge opportunity in the expand the market," said Vinod Dhawan, group president, business automobile sector especially the automotive components that could be cashed development, Lupin. According to analysts, Mexican drugs regulator Cofepris upon by the Indian companies. We are working on sending a delegation in this is aggressively working toward approving pending applications. As against 150 connection also,'' the senior official remarked. India is also very keen on forging in 2010, the regulator approved 9,225 applications last year, thanks to select strong ties with Tehran in the pharmaceutical sector especially in supply of third-party agencies that preview applications and weed out incomplete ones, generic drugs. reducing processing time. Foreign companies don't have to set up a manufacturing plant in Mexico to sell drugs. However, exporters need to have There are certain standard specification and tariff issues that need to be their own distribution, storage and legal representatives. Mexico's objective is resolved with Iran before this sector gets a fillip. "India has one of the best to increase supply of medicines in the country. “This opens way for Indian firms laboratories for testing of pharma drugs, something even US acknowledges. to supply to Mexico from Indian facilities,” wrote Anubhav Aggarwal, research There should not be any quality standard issues. We are engaged with Iran on analyst with Credit Suisse, in a report. Companies such as Lupin have already pharma sector and are hopeful of a breakthrough very soon,'' the official said.started filing products from India. According to Lupin sources, Mexico's approval process is quite similar to that of the US and Brazilian. “It doesn't India firm shakes up cancer drug market with price cutstake a lot of time, is quite liberal and it is the standard time (16-22 months) that companies can expect for any regulatory pathway to action their filings,” said a Indian pharmaceutical tycoon Yusuf Hamied revolutionised AIDS treatment Lupin official. Even in terms of realisation, analysts said, Mexico offers very more than a decade ago by supplying cut-price drugs to the world's poor -- and good prospects. “There is no doubt Indian companies will invest in marketing now he wants to do the same for cancer. Hamied, chairman of generic drugs and distribution set-ups. Once they acquire a critical mass, a large part of giant Cipla, last month slashed the cost of three medicines to fight brain, kidney incremental revenue will flow down to their bottomline. That's why, markets like and lung cancer in India, making the drugs up to more than four times cheaper. Mexico are highly profitable,” said an analyst. Since Cofepris recognizes good "I hope we'll cut prices of many more cancer drugs," he told AFP, adding that he manufacturing practice (GMP) certificates issued by regulators in the US, wants to supply the cheaper drugs to Africa and elsewhere. "Reducing the price Canada, Japan, Australia and Brazil to foreign drugmakers, many Indian of cancer drugs is a humanitarian move."companies are expected to benefit as they already have such GMP certificates. But not in the immediate future though, say industry veterans. Hamied, 76, was pilloried by Western drug giants 11 years ago when he broke

Mexico – goldmine for Indian pharma cosMexico – goldmine for Indian pharma cos

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Country Report

their monopoly by offering to supply life-saving triple therapy AIDS drug magazine Forbes puts Hamied's personal fortune at $1.75 billion. But Hamied cocktails for under $1 a day -- one-thirtieth the price of the multinationals. The said poverty-racked India "can't afford to divide people into those who can firms branded him an intellectual property thief while he accused them of being afford life-saving drugs and those who can't". "It needs a pragmatic policy," he "global serial killers" whose high prices were costing the lives of AIDS patients. said. He believes the pharma giants should let emerging market drugmakers "What he did was path-breaking. It has been very important in saving lives, and make copycat medicines in exchange for small royalties. Some 95 percent of what he is doing with cancer drugs is the same," said Leena Menghaney, a Western firms' profits come from regulated developed markets like Japan, lawyer with humanitarian group Medecins sans Frontieres ( Doctors Without Europe, America, so the pharmaceutical giants "really won't lose out", he said. Borders). In 1972, India made only the process for making drugs patentable, Even with the reduced price of generic drugs, such medicines are still beyond not the drugs themselves. This meant firms could "reverse-engineer" or change the reach of many of the world's poorest, conceded Hamied, who confesses he methods used to make medicines and sell them at up to one-fiftieth of US prices. has his eye on his legacy. "I want it to be said when I leave this world that 'he was The legislation gave a huge leg-up to India's generics industry and gave the not just a money-making machine,'" he said.nation the nickname "the pharmacy to the Third World". But in 2005, India brought its law in line with World Trade Organization (WTO) rules recognising India's diabetes drugs market grew 22% at $700 million in FY1220-year patents, pushing up the prices of newly launched drugs. Cipla, India's In an indicator of the growing prevalence of diabetes in India, the domestic fourth largest pharmaceutical company by sales, has been pressing the diabetes drugs market for FY 12 grew 22 per cent at $ 700 million, according government to allow widespread use of "compulsory licences", which are to a Credit Suisse report. Estimates suggest that India is set to become the permitted under WTO rules. The licences allow companies to make existing life- 'diabetes capital of the world' with the number of people with diabetes is likely saving drugs to sell in countries where they are otherwise priced out of reach. to swell to 70 million from present 40 million. India's first such licence was granted in March to Natco Pharma to produce a generic version of Bayer's blockbuster kidney cancer drug Nexavar, cutting the "The diabetes, ophthalmic and derma have the higher mix of fastest-growing price from 28,000 rupees ($500) for a monthly dose to 6,840 rupees. molecules in FY 12. The therapy split of molecules grew by 30 per cent, of

which diabetes molecule grew 22 per cent at $ 700 million," Credit Suisse Ranjit Shahani, who heads the Organisation of Pharmaceutical Producers of research analyst Anubhav Aggarwal told PTI here. The overall diabetes drugs India, says widespread compulsory licensing will jeopardise investment in market grew by $ 500 million and insulin by $ 200 million in the fiscal bygone, innovative pharmaceuticals. whereas the pharmaceutical industry is witnessing 25 per cent growth in

overall diabetes and 15 per cent in insulin segment, Aggarwal said. Bayer has said it will launch a legal challenge to the compulsory licence, and global drugmakers have vowed to oppose the spread of such legislation. Hamied Among other therapy molecules, cardiac grew by 20 per cent, pain and anti-denied that his latest move was simply an attempt to boost his share in the invective 7 per cent, resp-acute 5 per cent, and oncology and gastro 3 per cent oncology drugs market, insisting business must be linked to "social each. The Credit Suisse report on speciality pharmaceuticals said Sun Pharma, responsibility". But he said like any other business his company, which has 23 Glenmark and Lupin have the best overall portfolios in India. "Glenmark gets cancer drugs, also wants higher sales. "I owe it to my shareholders to be only one-fourth of its sales from chronic therapies and despite that it has the pragmatic," he said. Born in Lithuania to an Indian Muslim father and a highest exposure in the fastest-growing molecules. Sun Pharma too has strong Lithuanian Jewish mother, Hamied was two months old when his parents fled exposure to high-growth molecules and consistently gained market share Europe in the 1930s under the threat of Nazi Germany. He was raised in across the segments. Lupin and Glenmark also continued to gain market shares Mumbai and studied for a doctorate in chemistry at Cambridge University in in the highest growth segment, the report said. Among other leading pharma Britain before joining Cipla, which was founded by his father. "My father never players, Dr Reddy's, Cadila and Cipla have high exposure to slow-growing forced me but chemistry was my best subject," said Hamied, who became molecules, it said. According to the report, Dr Reddy's, Cipla and Cadila have chairman of the company in 1989. almost 60 per cent of sales coming from molecules growing less than 15 per

cent, which explains weak India sales growth for these firms, while leaders like His bold step in offering cheap AIDS drugs turned out to be a smart business Dr Reddy's and Ranbaxy slipped on growth trajectory in last two years due to move. Cipla is now the world's largest AIDS antiretroviral drugs supplier and market share loss.the publicly-listed company is valued at nearly $5 billion, while business

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he 59th report of the department-related Parliamentary Standing compensation ranged from a minimum of Rs.1.08 lakh to a maximum of Rs.20 Committee on Health and Family Welfare, especially its suggestion for a lakh. The average rate was, however, Rs.1.5 lakh. In one single case, the Tseparate report on clinical trials given the unprecedented growth in drug amount had been enhanced to Rs.20 lakh following the recommendation of the

trial markets, was well received by various health groups. The report, which was Ethics Committee. In Section 3 of Appendix XI of the Rules (Data elements for tabled in Parliament on May 8, essentially dealt with the functioning of the reporting SAEs occurring during a clinical trial), under the sub-section on Central Drugs Standard Control Organisation (CDSCO). details of suspected adverse drug reactions, it is clearly specified that the

setting – for instance, hospital, out-patient clinic, home or nursing home – has Responding to a query in Parliament in March, the Minister for Health and to be mentioned. Following reports early this year about clinical trials being Family Welfare informed that as per the information given in the Clinical Trials conducted on mentally ill persons in Indore by psychiatrists attached to the Registry maintained by the Indian Council of Medical Research (ICMR), the Mahatma Gandhi Medical College and Mental Hospital ( Frontline, February target Indian sample size in clinical trials had shown an upward trend in 2009 10, 2012), the CDSCO found after an investigation that the subjects had been and 2010 but had declined in 2011. The number of clinical trials permitted by enrolled as per inclusion and exclusion criteria of approved protocol and were the Drugs Controller General of India (DCGI), in the past three years were 453 found to be mentally sound. The psychiatrists had conducted 11 clinical trials (2009), 505 (2010) and 271 (2011). The number of serious adverse events between January 2008 and October 2010 in their private clinics. Only in one (SAE) of deaths in all clinical trials in the past three years stood at 637, 668 case, the investigator did not have the original consent form at the site.and 438 respectively. He also informed that two clinical trials had been conducted without the DCGI's permission in the past two years. But as no It may be recalled that of the 78 doctors who were found conducting these adverse event of death was reported, no compensation was paid. trials, the State government penalised only 12, with a fine of Rs.5,000 each.

While replying to a question in Parliament about these trials, the Health While there is little doubt that clinical trials are necessary for the advancement Minister said that while Schedule Y of the rules and Good Clinical Practice of medicine and for the approval and testing of new drugs, in recent times there (GCP) guidelines recognised that mentally challenged and mentally differently have been several instances of conflict of interest as well as violation of the abled persons, who were incapable of personally giving consent, were ethical guidelines pertaining to informed consent of trial subjects. A national considered vulnerable subjects, there was no prohibition under the said rules consultation on the regulation of drug trials in September last year organised by and guidelines that clinical trials could not be conducted on such patients. For Sama, a resource group for Women and Health, underscored the need for better enrolling such patients, informed consent was required from a legally infrastructure for regulation, review of ethical practices and monitoring to acceptable representative of the patient. The Minister did not specify whether regulate clinical trials, especially in the context of pharmaceutical companies this was done in all the cases or that whether economic compulsions were outsourcing drug trials to Contract Research Organisations. behind the cases of informed consent. In any event, this was a loophole that

needed to be corrected.The problem is rather deep-rooted and, as the status report points out, may need a completely new report. The 59th report does not cover the whole gamut of On June 12, Anand Rai again wrote to the Central Information Commission unethical drug trials but has touched upon some important aspects. The extent stating that clinical trial was a sensitive issue and that 2,031 deaths had of the problem can be gauged from an illustration. When Dr Anand Rai, the occurred since 2008 and that there were thousands of SAEs while Indore-based health activist who filed a public interest petition in the Supreme compensation had been paid only in 22 cases. Representing the Swasthya Sewa Court on clinical trials, sought information through a Right to Information Samarpan Samity, Anand Rai and Kalpana Mehta, of the Madhya Pradesh application about data (such as trial site code and hospital names) on trial sites Mahila Manch, said that the parliamentary committee report mirrored their from the Directorate-General of Health Services, the DGHS' office wrote back experience as health activists. “Truly, in this era of globalisation Indian to him saying that it had not maintained composite data of such reports in citizens are being squeezed from both ends. They feature only in cost-cutting respect of trial sites. exercises. On the one hand they are being subjected to unnecessary trials to cut

the cost of pre-approval global trials of multinational drug companies, while Anand Rai told Frontline that as per Schedule 'Y' of the Drugs and Cosmetics the trials that would give them safe and effective drugs are being waived off,” a Rules, any unexpected SAE occurring during a clinical trial should be statement issued by them said.communicated within 14 days by the sponsor to the licensing authority and to other investigators participating in the study. In Appendix XI of the Rules, he The committee, they observed, had done a long-overdue review of the CDSCO said, the sponsor and the investigator were both required to submit details of the and hoped that the action taken would match the inquiry and remove the gross SAE and the investigator was required to give an undertaking to inform all anomalies to make drug control responsive to the needs of the people. The SAEs to the sponsor and the ethics committee. On March 23, Anand Rai activists said that the worst fears that the DCGI was acting in favour of the received a reply from the DGHS office giving details of the number of SAE pharmaceutical companies was confirmed by the mission statement of the deaths in clinical trials in 2008, 2009, 2010 and 2011, which were 288, 637, CDSCO, which was about meeting the aspirations, demands and requirements 668 and 438 respectively. On the query about data on the trial sites (hospital of the pharmaceutical industry. Even market-oriented economies ran their names), and the States where they were conducted, the office held that such respective departments in the interest of public health.data were not maintained by the Directorate. “Where are the data then about where the trials have been conducted?” asked Anand Rai. He was informed that “We are happy that the committee has stated that '(it) is of the firm opinion that “as per available data, there were 22 cases of death related to clinical trials in most of the ills besetting the system of drugs regulation in India are mainly due 2010 and as per information received by the sponsor/Contract Research to the skewed priorities and perceptions of CDSCO. For decades together it has Organisations, compensation was paid in all 22 cases of deaths related to been according primacy to the propagation and facilitation of the drugs clinical trials.” industry, due to which, unfortunately, the interest of the biggest stakeholder,

i.e. the consumer, has never been ensured',” the statement said. It expressed It was interesting that at least 10 major multinational pharmaceutical concern over the committee's findings that “overworked and under-qualified companies featured in the list prepared by the DGHS and the rate of staff of the CDSCO arbitrarily waives off trials and allows the companies to

The Parliamentary Committee's Report Touches Upon Some Important Aspects

Of Unethical Drug Trials, But Health Activists Say That Is Not Enough.

The Parliamentary Committee's Report Touches Upon Some Important Aspects

Of Unethical Drug Trials, But Health Activists Say That Is Not Enough.

default on regulatory requirements...” changes in the 2006 guidelines would take the form of a draft Bill. The experiences of the human papilloma virus (HPV) vaccine projects in Andhra Pradesh and Gujarat had brought to light a number of issues and problems Welcome moverelating to the execution of clinical trials. Despite common ICMR guidelines, Other health activists and organisations, too, have welcomed the committee's he said, there were differences in the performance of projects across different recommendations, which they felt had been arrived at after a rigorous States. He also posed the question whether the same institute making the investigation into the flawed system of drug regulation. “The committee also guidelines could also play the role of a regulatory body or act as a partner. “At makes a case for unambiguous and clear guidelines for a range of issues related the same time, if it does indeed become a partner, how can it then monitor the to clinical research particularly related to approval of new drugs and the performance?” he asked.selection processes of 'outside experts' for this purpose; highlighting the

importance of identification of all possible biases and potential conflicts of Replying to a question in the Rajya Sabha on a stringent piece of legislation to interest,” read a statement jointly issued by the Jan Swasthya Abhiyaan, Sama, curb unethical clinical trials, the Union Minister for Health and Family LOCOST Therapeutics, the Delhi Science Forum, the Centre for Trade and Welfare informed that proposals had been approved by the Drug Testing Development, Prayas (a non-governmental organisation in Chittorgarh), the Advisory Board (DTAB) to carry out amendments to the Drugs and Cosmetics Drug Action Forum, the All India People's Science Network and several Rules. This included the enhancement of the responsibilities of the ethics individuals. They said the committee had rightly questioned the approval of new committees, sponsor and investigator in order to ensure that financial drugs without the mandatory Phase 3 clinical trials under the guise of public compensation and medical care were provided to trial subjects who suffered interest and called for an urgent scrutiny of the arena of clinical trials as a trial-related injury or deaths.separate issue. “This is a welcome move; with the increasing scale and scope of

the clinical trial industry in India, there is an urgent need for further But the Minister was silent on the composition of the ethics committees independent inquiry into this area,” the statement read.wherein there have been cases of conflict of interest. He said that an amendment to the format for obtaining informed consent of trial subjects with “We are encouraged that the committee has concluded that there is an urgent details of address, occupation, annual income, and so on to get information on need to increase the minimum number of subjects in Phase III pre-approval their socio-economic status would be made.clinical trials. The committee has recommended that while approving Phase III

clinical trials, the DCGI should ensure that such trials are spread across the If any amendments are to be made to the Drugs and Cosmetics Rules or the country so as to ensure a truly representative sample. Besides, trials should be ambit of the GCP guidelines is to be widened, it has to be done after broad conducted in well-equipped medical colleges and large hospitals with round-consultations with all the stakeholders and not just with the pharmaceutical the-clock emergency services to handle unexpected serious side-effects and with companies. As of now, health activists have demanded that the Ministry take expertise in research and not in private clinics,” Anand Rai and Kalpana Mehta action on the recommendations of the department-related report instead of said in their statement.constituting new committees to look into the inquiries that have already been conducted.Interestingly, at the consultation organised by Sama and others last September,

V.M. Katoch, Secretary and Director-General of the ICMR, observed that there was an urgent need to strengthen the regulatory mechanisms in the area of clinical trials and that there was a need to revise the guidelines. He said that the

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exchanges' drug spending share using the CMS' health insurance enrollment data. I assume that per-capita drug spending will be similar between people ere are four key insights about the 2021 drug market, assuming that with employer-sponsored private and those with private insurance from an the Patient Protection and Affordable Care Act (ACA) remains in exchange.Hplace: Public funds, primarily Medicare and Medicaid, will pay for

44% of all drug spending. Insurance purchased via exchanges will be 5% of drug spending. The employer-sponsored insurance market will keep shrinking. THE OUTLOOKOut-of-pocket spending by consumers will account for an even-smaller part of drug spending. Read on for a look at the past, present, and future of payers. Assuming that the ACA remains in place, here's what will happen:Pharmaceutical manufacturers need to consider how contracting will change as Public funds, primarily Medicare and Medicaid, will pay for 44% of all drug traditional private insurance declines. Meanwhile, PBMs will be gearing up as spending. This level is actually below the government share of overall health more people get coverage, although the business will shift to health plans at the care expenditures. By 2021, federal, state, and local government health care expense of self-insured employers. spending is projected to account for nearly 50 percent of national health

spending. Exchanges will be 5% of drug spending. The exchanges will be used THE DATA primarily by the uninsured. However, some employers will stop offering health

insurance and shift employees to the exchange plans. Some policy analysts expect only limited erosion in individual coverage via ESI, while others project I once again rely on forecast data from the National Health Expenditure Data 20% or more declines. Click here for a useful summary from Avalere Health. Projections page. The economists at CMS graciously provided me with certain The employer-sponsored insurance market will keep shrinking. In addition to unpublished data to compute the sources of payment if the ACA does not go into the shift to exchanges, 2018 will see an excise tax on high-cost insurance plans. effect. Note that I also estimated for drug spending via private insurance This will likely trigger a shift to lower-cost plans with tighter utilization purchased via exchanges. The PPACA's growth in coverage is projected to come management, narrower networks, or higher cost-sharing requirements. via state-run Health Insurance Exchanges (HIE), which are mandated to be a Consumers will pay even less. Consumers' out-of-pocket expenses—cash-pay state-established governmental agency or nonprofit entity. CMS classifies prescriptions plus copayments and coinsurance—shrank from 87% of total coverage via HIE as "private insurance." I find this classification to be a bit U.S. retail prescription drug expenditures in 1970 to 2010's record-low 19%. misleading about the sources of payment because a large portion of so-called In 2010, consumer's out-of-pocket drug spending dropped by $2 billion (-private insurance coverage will actually be paid for by the government through 4.1%) in 2010, due primarily to the health care reform legislation. See subsidies. According to the CBO, 81% of individuals purchasing their own Healthcare Reform Hits U.S. Drug Spending in 2010. By 2021, the consumer's coverage through the Exchanges will receive federal subsidies that reduce the share will drop to a super-low 14% of spending, due to the subsidized exchange cost of purchasing health insurance coverage. Therefore, I have estimated coverage and expanded Medicaid coverage. So much for skin in the game!

Prescription Drugs

Who Will Pay for Prescription Drugs in 2021?Who Will Pay for Prescription Drugs in 2021?

PERSONAL OPINION COMPETITION PANEL'S ROLE

t would soon be time for the government to review its 2011 policy decision The Competition Commission of India (CCI) is required to approve mergers on foreign direct investment in the pharma sector. The occasion is ripe to above a threshold limit. It is also empowered to deal with cases of cartelisation, Iconsider perceptions on the impact of FDI on the industry.The FDI policy and cases impeding competition in the market.The fears that acquisitions

for the pharma sector was revised on November 8, 2011, essentially shifting the would result in price increases are ill-founded. In fact, competition has been so FDI(in relation to the brownfield investments) from the automatic to approval fierce that prices have actually been coming down. Even if one were to consider route. FDI in the sector is permitted up to 100 per cent.The decision was a that the shift in FDI policy as a temporary phenomenon, subject to a review, the sequel to the acquisition spree by multinational corporations — notably Matrix focus seems to be on using the CCI as a gateway for scrutinising acquisition by Mylan (2006), Ranbaxy by Dai-ichi Sankyo (2008), Shanta Biotechnics by proposals. The Maira committee appointed by the Cabinet did recommend Sanofi Aventis (2009), Orchid Chemicals by Hospira (2009), and Piramal lowering of merger control threshold limits and the CCI to be better equipped. Healthcare by Abbott Laboratories (2010). Some of the factors that would play a significant role in approving a brownfield

investment — or a possible merger activity — would be creation of jobs, more research and development activity, increase in manufacturing facilities, EXAGGERATED FEARSassurances on continued supplies, guarantees on no upward price revisions and balanced product portfolios.While these acquisitions at seemingly high values have spelt a bonanza for the

owners of the acquired companies, they did sound warning bells — in the Ever since the shift in the policy, at least eight proposals have been approved by Government — of alleged concentration in the hands of MNCs, with a possibly the FIPB. Though this has gone to nullify fears that the shift would drastically negative effect on the price and availability of medicines.It is not that affect FDI inflows in to the Rs. 62,000 crore-plus sector, the real test would acquisitions did not occur prior to 2006. One must not ignore that these MNCs, come when a major proposal comes up before the FIPB. The proposals so far like other corporates, were clamouring for growth.cleared are small value transactions. Industry would live with FIPB perhaps, so long as the approvals are accorded within a reasonable time-frame, and are With its vast market, cost-competitiveness and quality manufacturing transparent. The four proposals that were cleared relate to acquisition of stakes facilities, it certainly makes economic sense for MNCs to pay a slightly higher in Aptuit Laurus Private Limited, Edict Pharma Private Limited, price for a running business. To presume that every acquisition is done with an Pharmaceuticals Ingredients, and Formulations India Private Limited.ulterior motive of controlling prices and markets, can perhaps be termed as an

over-reaction.In the same vein, what would one say about Indian acquisitions abroad — such as those made by the erstwhile Matrix Laboratories or Ranbaxy or Dr. Reddy's? We cannot attribute ulterior motives to these acquisitions. Since the government viewed these acquisitions as invasions by the MNCs, it wished to have a closer look. Therefore, it put them through the Foreign Investment Promotion Board scanner.

The Government has appointed a committee headed by Planning Commission Member, Mr Arun Maira, for examining the impact of these acquisition activities. This Cabinet-appointed committee did not find any evidence of distortion in competition, price or availability. Therefore, was there lobbying by certain industry organisations, before a policy shift was effected?

PRICE CONTROL MECHANISM

Those advocating controls over investments into the sector (in existing companies) were talking of MNCs creating a market in which just a few companies would determine the prices of medicines. There is, of course, no doubt that acquisitions have become an easy entry point for MNCs into India's generic market. It is perceived that such acquisitions result in aggressive price increases, diversion of drugs to more remunerative global markets, and adverse effects on the availability of drugs in local markets. Moreover, the absence of any shift in the FDI policy would be seen as an endorsement of takeovers by the Government. However, they never considered the fact that a shift in policy could convey a wrong signal to foreign investors. If the governments are serious about drug prices, they can control prices and availability. For example, South Korea has negotiated with Novartis for reducing the price of their Glivec before granting approval. India has the Drug Price Control Order in its armoury (already being revamped to make it workable); its latest exercise (2009) in the matter of controlling the price and availability of medicine for swine flu is another good example. In addition, the Competition Commission of India (CCI) can oversee unfair trade practices. The Damocles' sword of compulsory licensing is, of course, always available. Therefore, relying on an FDI policy shift to achieve the same is unnecessary. It could only put off foreign investors.

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Personal Opinion

The author is CEO , Natco Pharma. The views expressed are personal.

Pharma Technology

26

Pharmaceutical Industry and Technology Transfer agencies in India

Industry and Technology Transfer agencies in India

Pharmaceutical Industry and Technology Transfer agencies in India

Industry and Technology Transfer agencies in Indiathrough clinical studies, scale-up, manufacturing, production and launch, to

1the post-approval phase”.Sulogna Mehta*

It is one means by which low and middle income countries can accelerate the n violation of the Hippocratic Oath taken by medical practitioners, the acquisition of knowledge, experience and equipment related to advanced, nexus between doctors and pharmaceutical companies continues innovative industrial products and processes. It has been credited with the Iunabashedly, with doctors prescribing branded medicines based on a potential to help improve health; increase the reliability of supply and decrease

higher rate of commission instead of taking into account the quality of reliance on imports; raise the competence of the local workforce; and reverse medicines. Doctors are not supposed to prescribe anything but generic names of the “brain drain” from low and middle income countries, by increasing local

2, 3drugs. They keep experimenting with drugs on a trial-and-error basis making “high-tech” employment opportunities.guinea pigs out of patients.

Critical factors of technology transfer Dr E. Sai Prasad, former honorary secretary general of Indian Medical · A viable and accessible local market; Association said, “In the absence of any check on the nexus between · Political stability, good economic governance; pharmaceutical companies and doctors, such practices exist widely and lot of · Clear development priorities; lacunae prevail. However, doctors aren't supposed to prescribe any branded · Effective regulation; drugs to patients, but prescribe generic names only. When for a greater · Availability of skilled workers; commission, they prescribe drugs from a lesser known company, chances are · Adequate capital markets; high that quality may be compromised. Again, repeatedly changing drugs if one · Strong intellectual property rights (IPR) and effective enforcement; set of medicines fails to work rapidly can be detrimental to patients, who can · Quality of the relationship between industry and government, and develop resistance to the antibiotics.” the extent they are able to work together effectively for long periods of

time.Dr C. Hemanth, senior general physician, Yashoda Hospital added, “One of the reasons for doctors prescribing branded drugs is the non-availability of generic National Research Development Corporation (NRDC)drugs on wider scale. Compared to thousands of drug stores in cities, there are It is a premier Knowledge Transfer Organisation (KTO) in India. It is a Section hardly one or two generic drug stores or Jeevandhara stores.” 25 Company established in December 1953 under the Ministry of Science and

Technology with a mandate to commercialise, to develop and promote Abstract: The article attempts to discuss the technology transfer agencies in indigenously developed technologies from universities, individual inventors, India which are helpful to Pharmaceutical industry. Although technology national R & D Institutions, etc. It has been playing a very significant role in transfer has received substantial attention among government, enterprise and providing a vital link between research network and industry in the country. universities in recent days, there does not appear to be a comprehensive strategy During the past five decade of its operations, the Corporation has forged strong and holistic approach to deal with this issue. The article will first define the role links with various R & D organisations in the country as well as from abroad. and agencies of technology transfer agencies in India. Afterwards, the article The Corporation is now recognised as a large repository of wide range of will focus on how different agencies will work tougher to develop a goal of technologies spread over almost all areas of industries, viz. Chemicals technology transfer. Technology plays a central role in the economic and social including Pesticides, Drugs and Pharmaceuticals, Bio-Technology, Metallurgy, transformation of countries. The wide use of technology in an economy tends to Electrical & Electronics, Instrumentation, Building Materials, Mechanical, lead to improvement in the quality of production, generation of new knowledge, Agriculture and Food, etc. improvement in living standards and productivity or efficiency of exports. The technology transfer process results in investment in the production of food, Responsibilities and Functions of NRDCmedicines, steel, cars, electronics as one party gains access to a second party's A Viable Responsibilitiestechnology, successfully learning and absorbing it, and implementing it in

Development and Commercialization of Technologiesproduction. · Participation in equity of early stage ventures. · Consultancy to R&D Institutes and Corporate for Intellectual Property Keywords: Technology transfer, NRDC, TIFAC, TBSE, SIDBI, BCIL, APCTT

Rights (IPR).· Licensing of technologies to companies and end user organizations.

Introduction · Providing grants for development of Technologies to R&D laboratories for setting up pilot plants to validate or scale-up laboratory processes

The area of pharmaceutical industry, investments in innovation show a well-prior to commercialization.

known increase as a consequence of a suitable financial situation that becomes · Export of Indian technologies / know-how and services.apparent in an important economic growth and a larger willpower to seize the · Execution of turnkey projects abroad based on indigenous opportunities offered by a globalized market, Therefore companies must be able

technologies.to evolve. Evolving means continuous change that is based on innovation and

· Technical evaluation of the technology.the assurance of competitiveness which only can be achieved when all the company's activities are carried out in the best possible way and showing a

B Promotional Taskparticular interest in its daily and continuous improvement in R&D and I) Promotion and Commercialization of Inventionsmanufacturing strategies. By this the company is enabled to leadership in its · Awarding meritorious inventionsbusiness areas, dedicating itself to carry out those activities where it disposes of · Assisting inventors in patenting and commercializing their inventions.a high degree of excellence “Transfer of processes to an alternative site occur at · Popularization of science highlighting inventions by bringing out some stage in the life-cycle of most products, from preclinical development

Doctor-pharma firm nexus hits drug quality

magazines · Assess the technology trajectories, and support technology innovation by “Invention Intelligence” (bi-monthly) in English and “Awishkar” network actions in select technology areas of national importance(monthly) in Hindi. · To set up specialized sub-groups for examining and evaluating the

II) Promotion & Development of Household & Rural Technology existing state of art of technology · To identify, prove and demonstrate selected rural & household · To prepare Technology Impact Statements with newly emerging

technologies. technologies upon society and their short-term and long-term · Assisting in commercialization of selected rural & household implications.

technologies. · To facilitate linkages of developed products and innovative technologies III) Promotion of Export of Technology with the market Technology Refinement and Marketing Programme

(TREMAP)· Projecting India as a source of technology.· Providing Patent Protection to promote export of major Indian products &

How TIFAC facilitate technology transfer with funding agencies?technologies by filing patents abroad.The collaborative programme of TIFAC & SIDBI launched on 2010, aims at · Participation in international exhibitions, workshops, seminars, facilitating development, demonstration and scaling-up (commercialization) symposia.of technology.· To prepare catalogues, brochures, multimedia CDs of the technologies

suitable for export Goals of TIFAC· Carry out Knowledge Management System (KMS), wherein a group of · Agriculture & Agro Food Processing – Increasing Agricultural experts evaluate the technologies and suggests further modifications for

production (Total systems approach, Green-house cultivation, etc.) and value-addition to technologies in order to make them more competitive in Food Processing (Milk, Fruits & Vegetables, Cereals) 10 Projects the domestic / international market.Launched.

To prepare feasibility reports and basic engineering design packages for the · Road Construction & Transportation Equipment – Upgrading existing 4 strength of manufacturing capability in the sectors and provide facilitation of licensees.

technology support. 5 Projects Launched

· Textile Machinery Up gradation – Aimed at technology up gradation of Goals of NRDCselected textile machines. 6 Projects Launched.

· Up gradation of Science & Engineering Colleges (Mission REACH) – NRDC has set for itself a portfolio of corporate goals. The Goals that its Aims to create about 100 Centers of Relevance and Excellence in team of professionals helps to achieve by giving of their best. NRDC team Achieving new heights in selected departments at par with national / has a singular purpose that is to identify and satisfy the potential investor in world's best. 8 Centers of Relevance & Excellence (CORE) Setup.the use of innovative, reliable and competitive technologies co-developed or

Licensed by the Corporation. · Health Care Services – Technology Development for medical equipment & Optimization of Process for Herbal & Natural Products.

To this purpose, NRDC harnesses its human resources to: · Targetted Programmes in other Important Areas – Electric Power, Rural · Promote, through flexible funding schemes, the development of Connectivity, up gradation of Pharma SMEs, Alternate Energy Sources

6,7marketable technologies in close association with industry and like – Hydrogen, Energy Towers, Garbage to power etc.National R&D institutions. Technology Bureau for Small Enterprises (TBSE)

· Evaluate the technological merits and commercial potential of incipient The Technology Bureau for Small Enterprises (TBSE) provides a platform or mature technologies by conducting techno-economic surveys; where small enterprises can tap opportunities at the global level for technology and business forecasts and investment appraisals. acquisition of technology or establish business collaboration. Resulting

· Pre-emptively protect intellectual property rights worldwide. from the joint initiative of the United Nations' Asian and Pacific Centre · Design and engineer manufacturing plants of commercial scale. for Transfer of Technology (APCTT) and Small Industries Development

Bank of India (SIDBI) it represents, under one roof, synergy of · Shape and manage technology contracts that are fair and equitable.technology and finance. TBSE also receives partial funding from the · Test - market products.

8Office of DC (SSI), Government of India.· Assist in obtaining certifications for products and their quality, where Responsibilities and Functionsthese are prerequisites for entering commerce.· Offers a professionally managed system for technology and

collaboration search. Technology Information, Forecasting and Assessment Council (TIFAC)· Helps in building up confidence between prospective partners.TIFAC is an autonomous organization set up in 1988 under the Department of

Science & Technology to look ahead in technologies, assess the technology · Lends a friendly hand in the intricate task of negotiations and trajectories, and support technology innovation by network actions in select matching of perceptions.technology areas of national importance. In 1993, TIFAC embarked upon the · Provides a gateway to global technology market through networking.major task of formulating a Technology Vision for the country in various · Unique mechanism for arranging technology and finance.emerging technology areas. TIFAC continues to strive for technology · Takes up project appraisal and preparation of business plan.development of the country by leveraging technology innovation through sustained and concerted programmes in close association with academia and

5industry. Goals of TBSE

Responsibilities and Functions Technology Information:· Undertake techno-market, technology assessment /forecasting studies in The Bureau has a large computerised data base on technology options available

key sectors of national economy, from different countries. It gives the user updated information on sources of · Technology watches on global trends and formulation of preferred options technologies and means of accessing them. Also background information on

for India, technology-seeking enterprises is maintained and made available to interested · Establish a nationally accessible technology information system, technology suppliers and collaborators.

Promotion of key technologies.

Pharma Technology

27

11banks and financial institutions.Match Making:It identifies business partners willing to collaborate, brings them face to face and extends support to tie up financial assistance and other requirements for Responsibilities and Functionstransfer of technology and joint ventures. Collaborating partners are further assisted in drafting agreements, obtaining various approvals and preparation of The services of BCIL are aimed at facilitating accelerated business plans. commercialization of biotechnology by establishing linkages among the

various stake holders including industry , R&D institutions, Government, Finance Syndication: financial institutions and international agencies and providing access to Depending on the cost of project, nature and quantum of assistance required, technologies ; creating awareness about business opportunities, IPR the Bureau undertakes financial syndication through SIDBI covering term protection, regulatory and biosafety requirements; preparing feasibility and loans, foreign currency, venture capital, lines of credit, equity assistance and on detailed project reports; arranging financial support and manpower training selective basis interest-free loan to meet initial expenditure in the pre- and placement .technology absorption stage.

Keeping these in view, the company is engaged in the following services:Business Collaboration:The Bureau offers support to small enterprises for the export of technologies and the products manufactured by them through business tie-ups as a part of the · Technology transferpackage. To promote international cooperation amongst SMEs the Bureau · Project consultancyorganises overseas visits of business delegations. · Certification services

· Information servicesSupport Services: · BiosafetyIt arranges consultancy services, visits of overseas experts for in-plant · Biotech Industrial Training Programmecounselling: coordinates buyer-seller meets for specific product process · Project managementtechnologies and represents the business interests of small enterprises in

8international events.

BCIL's Unique StrengthsAsian and Pacific Centre for Transfer of Technology (APCTT)

· Promoted by (DBT) Department of Biotechnology for facilitating The Asian and Pacific Centre for Transfer of Technology established on 16 July

commercialization of biotechnology. 1977 pursuant to Economic and Social Commission for Asia and the Pacific

· Extensive experience and expertise in technology evaluation, packaging resolutions of 6 March 1975 and of 31 March 1976 shall continue in existence and transfer. under the terms of the present statute. APCTT has the status of a subsidiary

9 · Strong in-house subject expertise. body of Economic and Social Commission for Asia and the Pacific (ESCAP). · Valuable resource base of subject specific experts from industry and

academia. Responsibilities and Functions

· Human Resource Development · To develop and manage national innovation systems; develop, transfer, · Information Services adapt and apply technology; improve the terms of transfer of technology; · Project Managementand identify and promote the development and transfer of technologies

relevant to the region.Small Industries Development Bank of India (SIDBI)Research and analysis of trends, conditions and opportunities;Small industries development bank of India was set up on April 02, 1990 under Advisory services;an Act of the Parliament, functions as the Principal Financial Institution for Dissemination of information and good practices;the promotion, financing and development of the micro, small and medium Networking and partnership with international organizations and key Enterprise (MSME). SIDBI started as refinancing institution, has emerged as stakeholders;a complete financial solution institution meeting all the financial and capacity Training of national personnel, particularly national scientists and policy building needs of MSME sector. SIDBI gives increasing emphasis on analysts.promotional activities in clusters to foster sustainable development of Indian MSMEs Biotech Consortium India Limited (BCIL)

BCIL was incorporated as public limited company in 1990 under the Indian They also require different non-credit facilities to gain the extra mile in their Companies Act 1956. It is promoted by the Department of Biotechnology, endeavour to attain international competitiveness. Such requirements are Government of India and financed by the All India Financial Institutions equity capital, credit rating, technology transfer and up gradation, etc. SIDBI including IDBI, ICICI, IFCI, UTI and IFCI Venture Capital Funds Limited has been constantly working on building various institutional mechanisms to (formely RCTC) and the corporate sector including Ranbaxy Laboratories, cater to the emerging needs of the MSME sector and has set-up various Glaxo India, Cadila Laboratories, Lupin Laboratories, Kothari Sugars and subsidiaries / associates viz. Chemicals, Rallis India, SPIC, Madras Refineries, Zuari Agro, and Excel

Industries.· SIDBI Venture Capital Ltd. (SVCL), a subsidiary of SIDBI set up in

July,1999, is an asset management company, presently managing two BCIL has been actively involved in technology transfer, project consultancy, venture capital funds;fund syndication, information dissemination, and manpower training &

placement related to biotechnology over the last decade and half. It has assisted · Credit Guarantee Fund Trust for Micro and Small Enterprises hundreds of clients including scientists, technologies, research institutions,

(CGTMSE) in July 2000 by Government of India and SIDBI, to provide universities, first entrepreneurs, the corporate sector, national and credit guarantee support to collateral free / third-party guarantee free international organizations, central government, various state governments,

Pharma Technology

28

Pharma Technology

loans extended by banks and lending institutions for micro and small 2009 (09)enterprises (MSEs);

4. MSME, (Micro, small and medium enterprises in India an overview) Ministry of micro, small and medium enterprises(MSME), Nirman · SME Rating Agency of India Ltd. (SMERA) in September 2005, as an Bhavan, New Delhi, (2007). www.smallindustryindia.comMSME dedicated third-party rating agency to provide comprehensive,

transparent and reliable ratings and risk profiling5. UNITED NATIONS ECONOMICAND SOCIAL COUNCIL, Economic

And Social Commission For Asia And The Pacific, 2009.· India SME Technology Services Limited (ISTSL), set up in November 2005, provides a platform for MSMEs to tap opportunities at the global

6. Purnima Sharma, An overview key element of an effective grant, level for acquisition of modern technologies2011.

· India SME Asset Reconstruction Company ltd (ISARC) is the country's 7. Allan, M.F. “A Review of Best Practices in University Technology first MSME focused Asset Reconstruction Company striving for speedier

Licensing Offices.” Journal of the Association of University Technology resolution of non-performing assets (NPA) by unlocking the idle NPAs for Managers. 2001.productive purposes which would facilitate greater and easier flow of

13credit from the banking sector to the MSMEs. 8. Berman, B. “From Ideas to Assets: Investing Wisely in Intellectual

Property”. 2002.

Authors : 9. Green, S. and Warren, P. Technology Transfer in Practice. Sue

Horwood Publishing Limited, West Sussex, UK. 2002.VIVEK DAVE, Assistant Professor, Department of Pharmacy, Banasthali

University, ASHUTOSH PAREEK, Assistant Professor, Department of 10. P. Burrall ,McKinsey & Co. In: Managing Product Creation: A

Pharmacy, Banasthali University, SACHDEV YADAV, Assistant Professor, Management Overview, The Design Council for the UK Department of

Department of Pharmacy, Banasthali University, Dr. SARVESH PALIWAL, Trade and Industry,. London. 1991

Associate Professor, Department of Pharmacy, Banasthali University. For

correspondence: E-mail: vivekdave1984@gmail.com 11. Tucker, D. The World Health Market: The Future of the Pharmaceutical Industry. Euromonitor Publications Ltd, Germany. 1984.

References 12. www.nrdcindia.com (Accessed on 16 April 2012)

1. Eduardo Pisani, Technology Transfer: A Collaborative Approach to 13. http://www.tifac.org.in (Accessed on 16 April 2012)Improve Global Health the Research-Based Pharmaceutical Industry Experience. 2011 (www.ifpma.org/ClinicalTrials), 14. http://www.dst.gov.in (Accessed on 18April 2012)(www.ifpma.org/EthicalPromotion) (www.ifpma.org/HealthPartnerships) 15. http://www.angelfire.com/ny/tbse/ (Accessed on 18 April 2012)

2. YUE Feifei, Research on Technology Transfer in the Pharmaceutical 16. http://www.apctt.org/ (Accessed on 21 April 2012)Industry. Available from: 2010. (http://www.2010cygchy01a3.pdf)

17. http://www.bcil.nic.in/(Accessed on 21 April 2012)3. HUA Ying, Technology Transfer: the Conundrum in the Enterprise

Technology Innovation Science of Science and Management of S.& T., 18. http://www.sidbi.com/(Accessed on 21 April 2012)

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