OPPI in Media

OPPI IN MEDIA 2010-12

Strong Medicine on procuring drugs to be distributed through government-
run hospitals and clinics by 2017. Currently, India spends
July 14, 2012, The Times of India, The Crest about 60 billion rupees ($1.1 billion), or 0.1% of GDP, on
Edition this......

The Rs 28, 000-crore plan to make essential medicines ........Most government hospitals in India are
freely available at government-run hospitals and clinics is overcrowded, understaffed and lack medicines and
laudable. But it should be rolled out only after an supplies. “Significant shortages in the number of doctors,
overhaul of the healthcare system and measures to plug nurses, paramedics and hospital beds per 1,000
the leaks in the flawed public distribution system. It's population in India pose a great challenge for speedier
being billed as a game changer in Indian healthcare. The implementation of universal healthcare in the country,”
government's multi-crore plan to ensure the supply of said Tapan Ray, director general of the Organisation of
free essential medicines at government hospitals and Pharmaceutical Producers of India, or OPPI, a lobby
clinics is remarkably bold and ambitious because it covers group for multinational drugmakers in the country.
the entire gamut of therapies such as anti-infectives,
pain-killers, cancer, HIV, cardiovascular, antiplatelet and
anti-ulcer.
India To Give Free Medicine To
Hundreds Of Millions
Given the corruption and leakages that plague India's July 5, 2012, Deccan Herald
public distribution system, this skepticism may not be India has put in place a $5.4 billion policy to provide free
misplaced. Even if the procurement of low-priced quality medicine to its people, a decision that could change the
medicines is somehow achieved, efficient delivery will be lives of hundreds of millions, but a ban on branded drugs
a huge stumbling block. Agrees Tapan Ray director stands to cut Big Pharma out of the windfall. From city
general, Organisation of Pharmaceutical Producers of hospitals to tiny rural clinics, India's public doctors will
India (OPPI): "The huge shortages in the number doctors, soon be able to prescribe free generic drugs to all
nurses, paramedics and hospital beds-per-1000 population comers, vastly expanding access to medicine in a country
will pose a great challenge in the speedy implementation where public spending on health was just $4.50 per
of this project. India should respond to its healthcare person last year. The plan was quietly adopted last year
infrastructure developmental needs much faster now to but not publicised. Initial funding has been allocated in
achieve its objective of providing healthcare to all. " recent weeks, officials said.

India’s Plan To Distribute Free The Organisation of Pharmaceutical Producers of India
(OPPI), a lobby group for multinational drugmakers in the
Medicines Raises Questions country, argues that the price of drugs is just one factor
July 6, 2012, Wall Street Journal in access to healthcare and that the scheme need not be
detrimental to manufacturers of branded drugs. "I think
India is proposing an ambitious plan to substantially raise this will hasten overall growth of the pharmaceutical
spending on providing free drugs for India’s 1.2 billion industry, as poor patients who could not afford will now
population. But there are doubts over the plan’s have access to essential medicines," said Tapan Ray,
implementation. India wants to spend up to 300 billion director general of OPPI.
rupees ($5.4 billion), or 0.5% of gross domestic product,

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War On Bad Medicine A growing number of countries are adopting India's
intellectual property regulations, which give enough
July 5, 2012, The Times of India flexibility to local companies to produce generic versions
of popular drugs to safeguard public health. Although
When you buy a drug over the counter, there is no way to multinational companies have criticised India for being
determine if it is substandard or spurious. From lax in enforcing intellectual property (IP) laws, countries
September 2009 till now, the Gujarat Food and Drugs such as China, Argentina and the Philippines are adopting
control administration (FDCA) recalled 615 batches of similar provisions...........
tablets, injections, and capsules that did not meet
pharmacological standards. Considering this problem, and .........However, MNCs disagree that India could have
following an Allahabad High Court ruling in October 2010, been a trigger for China's move. Tapan Ray, director-
a special task force headed by Gujarat was formed for general of OPPI, the representative body of global
implementing the unique 'track-and-trace' system for drugmakers in India, said, "Amendment of a law is the
every strip or bottle of medicine you buy off the counter prerogative of the country concerned, and it is specific to
anywhere in the country. the country's requirement." India and China, which
together account for about a third of the world's
Drug manufacturers' organizations like the Confederation population, form a critical market for MNCs. IP laws
of Indian Pharmaceutical Industry (CIPI), Federation of favourable to MNCs enable them to increase sales in
Pharma Entrepreneurs (FOPE), Indian Drugs Manufacturers developing countries.
Associations (IDMA), and Organization of Pharmaceutical
Producers in India (OPPI) had opposed the tracking
system. They claimed that it will be a huge burden to OPPI Organises Seminar On Cold Chain
small and medium enterprises. The associations in the Management In Pharma Industry
report said that an SME with exports of around Rs15-20 May 30, 2012, Express Pharma
crore would need to invest Rs 2 crore on barcode
machines (one for each blister machine and one each for Organisation of Pharmaceutical Producers of India
syrups and injections). (OPPI) had recently organised a seminar on 'Stakeholders
Engagement—Improving Cold Chain Management in
Pharma Cos Stay Mum As Govt Seeks Pharmaceutical Industry'. Held in Mumbai, the seminar
Details Of Overcharging was attended by stakeholders in large numbers. During
the seminar many do’s and dont's related to cold chain
June 24, 2012, Hindustan Times management in the pharma industry were discussed.
Pharma companies in India are giving a cold shoulder to Tapan Ray, Director General, OPPI said, “With the
charges of overpricing. Literally. Even after four months growth of biological products across the world and with
of receiving overcharging notices from the department of increasing demand for products like vaccines, hormones
pharmaceuticals (DoP), not even one of the 500-odd and insulin among others, it is becoming imperative that
pharma companies have responded to the charges. The a careful consideration is given by the authorities and
DoP had sent the notices to the companies through the stakeholders for enhancing cold chain capability of India.
Indian Drug Manufacturers’ Association (IDMA), the The increasing number of heat sensitive pharma products
industry body of Indian companies, and the Organisation prompts the relevance of having in place a robust pharma
of Pharmaceutical Producers of India (OPPI), which cold chain in the country.”
represents global pharma companies in India.

“After that, we also issued a public notice asking the Supply Chain Visibility And Control Must
companies to submit the details within 30 days but not For Cold Chain Transport Say Experts
even a single firm has replied,” Raja Sekhar Vundru, May 28 – June 4, 2012, Aviation Cargo Express
joint secretary of DoP, told Hindustan Times. The DoP
now is mulling to crack the whip on these companies The Organisation of Pharmaceutical Producers of India
with the help of the National Pharmaceutical Pricing (OPPI) organised a day long seminar on ‘Improving Cold
Authority (NPPA). “We are contemplating to ask the Chain Management in Pharmaceutical Industry’ on May 7,
NPPA to take charge of the matter,” said Vundru. 2012. Attended by pharma manufacturers, logistics
service providers and freight forwarders as well as cargo
More Nations Adopting Indian custodians like Mumbai International Airport, the seminar
Intellectual Property Regulations For featured key industry experts who imparted vital
information on effective temperature sensitive logistics .
Drug Manufacturing
June 22, 2012, The Economic Times Commencing the days proceedings, Tapan Ray, DG, OPPI
said that the new generation of vaccines and bio
technology required appropriate environment of cold

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chain to reach its destination in good shape. ........ top-three brands by sales (originally suggested in the
.........Speaking about challenges in cold chain draft National Pharma Pricing Policy, NPPP). Second
transportation from the pharma manufacturers preference:1) Average the prices of all drug brands which
perspective Ranjit Shahani, President OPPI and Vice command a market share of over 1% in the concerned
Chairman & MD, Novartis unequivocally stated, "A therapy in volume terms. 2) Allow a price increase of 10%
temperature-abused product is counterfeit. Constant on an annual basis. 3) Restrict price control to National
power cuts make the task of maintaining an unbroken List of Essential Medicines (NLEM), 2011. 4) Spare the
cold chain challenging in the Indian context. Failure to strengths, combinations not listed in NLEM. Strengths of
maintain the cold chain affects the product, patient as second preference:
well as the organisation.
FIPB May Be Allowed To Clear Foreign
OPPI Highlights Key Issues In Cold Chain Buys In Pharma Companies
Transport Of Pharma Goods May 16, 2012, The Economic Times
May 28 – June 4, 2012, Aviation Cargo Express
The Department of Pharmaceuticals has mooted a
Insulins and vaccines sector in India growing at 25% per proposal to allow the country's foreign investment
annum, While India’s manufacturing infrastructure is at approving body to continue clearing stake purchases by
par with the best in the world, distribution infrastructure foreign firms in Indian drug companies, as it seeks to end
lags behind, Cold chain infrastructure in India even at the uncertainty that has stalled the investment plans of
metros was in need of overhaul. A casual approach and MNCs and foreign investors in the sector........
untrained manpower was hindering growth of pharma
exports. .............. The unnamed government official quoted
above said the inter-ministerial group's decision was not
The 12th edition of the Perishable Cargo Regulations has legally binding and there would no problems if FIPB
introduced new mandatory requirements for the continued to approve pharma M&A deals for some more
transportation logistics of healthcare products such as the time, till new rules are put in place. "Otherwise pending
mandatory use of the time and temperature sensitive applications will pile up," the official said. The
label as of July 1st, 2012. These changes are the result of Organisation of Pharmaceutical Producers of India
the collaboration by carriers with pharmaceutical (OPPI), the industry body that represents foreign
companies and associations as well as other stakeholders drugmakers in the country, said there appeared to be
in the supply chain, including but not limited to shippers, some issues that were making it difficult to route
freight forwarders, terminal operators, ULD brownfield investments through CCI even after six
manufacturers, packaging & tracking and tracing months.
companies.
Drugs Cos Open To Milder Pricing
Alternatives Before GoM On Pharma Formula
Pricing May 16, 2012, Economic Times
May 19, 2012, Financial Express
Foreign drug makers and small local pharma companies
The draft National Pharma Pricing Policy 2011 have told the panel of ministers, tasked with the mandate
recommended fixing the ceiling price of an essential drug of finalising the country’s drug pricing policy, that they
by taking the Weighted Average Price of top-three brands are willing to accept a toned-down alternative pricing
by sales in a particular therapy segment. While the mechanism. This will help allay government’s fears of a
formula found full support in the industry which calls it spiralling of medicine prices if a marketbased model,
transparent, reasonable and verifiable by all, it was originally sought by the pharma companies, is adopted.
fiercely opposed by public health groups, ministry of
health and lately by the department of pharmaceuticals, The Organisation of Pharmaceutical Producers of India
who maintained that top-selling brands are also the (OPPI) — the industry body of foreign drug makers in India
priciest ones. Health groups claim capping prices at — told the Group of Ministers (GoM) led by agriculture
prevailing rates would encourage those selling cheaper minister Sharad Pawar, on Monday, that the MRP of
brands to jack up prices, thus making the average prices essential drugs can be fixed at the average of all brands
of essential drugs dearer. in a segment, having more than 1% volume share.

Following are the views of some of the stakeholders on
the pricing issue... (A) Organisation of Pharmaceutical
Producers of India (An industry association comprising
foreign pharma multinationals) First preference:
Benchmark ceiling price to Weighted Average Price of

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Different Formulae Emerge For Drug companies. The OPPI, however, suggested that medicines
with volumes more than one per cent be capped at their
Pricing At GoM average price. This would cover over 90 per cent of the
May 16, 2012, Business Line market, the OPPI said.

However, this suggestion was not acceptable to the Drug Pricing Policy: IPA Agrees To
Organisation of Pharmaceutical Producers of India
(OPPI), a platform for largely overseas companies. About PMEAC's Hybrid Formula
60 per cent of the multinational companies would be May 15, 2012, Economic Times
under this non-transparent cost-based net, the OPPI
pointed out, compared with 40 per cent Indian An industry body representing the country's top drug
companies. makers has told the panel of ministers, tasked with the
mandate of finalising the country's drug pricing policy,
The OPPI, however, suggested that medicines with that it is ready to accept the hybrid drug pricing
volumes more than one per cent be capped at their mechanism suggested by the PM's economic advisory
average price. This would cover over 90 per cent of the council (PMEAC).
market, the OPPI said.
But OPPI, the industry body that represents foreign drug
companies in India, is still sticking to its demand that the
Pharma Companies Open To Milder Department of Pharmaceuticals' proposal of fixing the cap
Alternative Pricing Mechanism on the average of top three selling brands be
May 16, 2012, The Economic Times implemented...........In addition to the OPPI, Zydus
Cadila Managing Director Pankaj Patel, Dr Reddy's
Foreign drug makers and small local pharma companies Laboratories Managing Director & COO Satish Reddy, and
have told the panel of ministers, tasked with the mandate Torrent Pharma's chairman Sudhir Mehta argued the
of finalising the country's drug pricing policy, that they industry's case for a market-based pricing policy.
are willing to accept a toned-down alternative pricing
mechanism. This will help allay government's fears of a GoM On Pharma Pricing To Gather More
spiraling of medicine prices if a market-based model, Feedback
originally sought by the pharma companies, is adopted.
May 15, 2012, Business Standard
The industry body of foreign drug makers in India,
Organisation of Pharmaceutical Producers of India The group of ministers (GoM) on the National
(OPPI), told the Group of Ministers led by agriculture Pharmaceutical Pricing Policy, which met on Monday to
minister Sharad Pawar, on Monday that the MRP of seek feedback from various industry associations, is likely
essential drugs can be fixed at the average of all brands to meet again on Friday to listen to more stakeholders,
in a segment, having more than 1% volume share. A before finalising a mechanism to cap the prices of
person who attended the GoM briefing told ET that this essential medicines.....
will cover a wide representation of the market - about
91% - and dispel fears of some stakeholders that the MRP On Friday, two non-government organisations and
was being fixed at the average price of costly drugs. member of Parliament Jyoti Mirdha would put their
presentations before the GoM. Five industry
organisations, including the Organisation of
Different Formulae Emerge For Drug Pharmaceutical Producers of India, the Indian
Pricing At GoM Pharmaceutical Association and an association of chemists
May 15, 2012, Hindu Business Line and druggists gave their inputs to the high-level
ministerial panel on Monday.
There still is no single pill to address the pricing concerns
involving the pharmaceutical industry. However, different Pharma Inc-GoM Meet To Tackle
formulae to tackle the pricing of medicines have emerged ‘Thorny’ Pricing
from the half-a-dozen presentations made to the Group of
Ministers by the drug industry and distributor
May 14, 2012, Financial Express
organisations.......
As key stakeholders in the pharma industry — associations
........However, this suggestion was not acceptable to the of drug makers, drug retailers and civil society groups —
Organisation of Pharmaceutical Producers of India meet the group of ministers (GoM) led by agriculture
(OPPI), a platform for largely overseas companies. About minister Sharad Pawar on pharma pricing in New Delhi on
60 per cent of the multinational companies would be Monday, two issues will be hotly debated: The span of
under this non-transparent cost-based net, the OPPI control and the method of price fixation......
pointed out, compared with 40 per cent Indian

4


.........During Monday’s meeting, the first ever involving pharmaceutical market is the fourth largest in the world
all stakeholders since an unsuccessful, earlier one when in terms of volume, according to the Organisation of
Ram Vilas Paswan was minister for chemicals and Pharmaceutical Producers of India (OPPI). It generates
fertilisers, top pharma manufacturers bodies including $12 billion in sales every year.
the Indian Drug Manufacturers’ Association (IDMA), the
Organisation of Pharmaceutical Producers of India Indian Drug Regulator Accused Of
(OPPI) and the Indian Pharmaceutical Alliance (IPA) will
be unanimous in putting across evidence to prove why the Malpractice
earlier method of cost-based pricing was flawed, and May 9, 2012, Financial Times
stress on the need to move to a market-based pricing
mechanism. IDMA represents domestic pharma India’s drug regulator colluded with global
companies, while OPPI is the body for international drug pharmaceutical companies to expedite the approval of
companies operating in India. drugs, according to a parliamentary report whose findings
were swiftly challenged by manufacturers. The results of
Health Panel Rap To Drug Regulator, a year long investigation by parliament’s health
committee concluded that the Central Drugs Standard
Boost For Consumers Control Organisation, which oversees clinical trials,
May 10, 2012, Hindu Business Line licensing and marketing of drugs in India, committed
serious regulatory violations that could jeopardise the
On an average DCGI is approving one drug every month lives of millions of people.
without trials. This cannot be in public interest by any
stretch of imagination,” says a parliamentary panel Tapan Ray, director-general of the Organisation of
report on health, hugely critical on how medicines are Pharmaceutical Producers of India, said all his members
approved for sale in the country. In a massive shot in the complied with domestic regulations. “The issue now
arm for consumers and public health, the report opens a appears to be in their appropriate implementation by the
can of worms on the “invisible hands” of drug-makers in regulatory authorities.” GSK said its cited drug
getting favourable opinions from experts on medicines ambrisentan to treat pulmonary arterial hypertension had
seeking marketing approvals. been approved in India after trials in other countries and
in accordance with local regulations allowing a waiver to
“The issue now appears to be in their appropriate meet “a clear unmet medical need”.
implementation by the regulatory authorities due to many
factors as specified in the ‘Parliamentary Committee' Unclear Rules Stop FDI In Pharma
report,” Mr Tapan J. Ray, Director General of the
Organisation of Pharmaceutical Producers of India Companies
(OPPI) told Business Line. A platform for foreign drug- May 8, 2012, The Economic Times
makers, the OPPI added that its members were
“committed to sponsoring clinical trials that fully comply The government has recently stopped giving permission to
with all legal and regulatory requirements in India.” foreign companies and overseas investors to buy into
Responses from individual drug companies are still Indian drugmakers till clear guidelines regarding foreign
awaited. direct investment in the sector are finalised. The Foreign
Investment Promotion Board (FIPB), the nodal agency that
Probe Finds Collusion Between Drug approves investments in India, deferred four proposals at
its March 30 meeting on the grounds that specific
Regulator, Pharma Firms conditions for considering cases of brownfield foreign
May 9, 2012, Deccan Herald investment in the pharma sector were under formulation.

Officials of India's drug regulator have been colluding with There have been no restrictions on foreign investments in
pharmaceutical firms to speed up approval procedures, pharma for the past decade, but a series of high-profile
allowing some drugs that are not permitted in other acquisitions in the sector has prompted the government
countries to go on sale, according to an 18-month to tinker with the approval process, resulting in delays.
investigation by MPs. The parliamentary panel's 78-page "Foreign direct investment (FDI) of 100% through the
report names a number of major international drug automatic route in the pharma sector was opened just a
companies and Indian firms. The report may fuel concerns decade back...and there was no tangible reason to revisit
over lax supervision of the global industry in emerging it so soon. It is unfortunate that recent policy changes,
markets, where Western drug manufacturers are primarily based on unfounded apprehensions, are causing
increasingly focusing their sales effort.......... avoidable delays in FDI approvals," said Tapan Ray,
director-general of industry body Organisation of
.............. Thirteen drugs scrutinised by the panel are Pharmaceutical Producers of India.
not allowed to be sold in the United States, Canada,
Britain, European Union and Australia, it said. The Indian

5


DoP Says Competition Doesn't Always industry associations in the country have urged the
Department of Pharmaceuticals (DoP) not to deviate from
Lead To Cheaper Drugs; Raises Concern its proposal in the draft policy on the method of price
Among Industry fixation and the span of the price control.
April 30, 2012, The Economic Times
Expressing concern over the final recommendations of the
The Department of Pharmaceuticals has told a group of DoP on the draft pharma policy, major pharma industry
ministers that competition does not necessarily lead to associations like Indian Pharmaceutical Alliance (IPA),
reduction in medicine prices, raising concern among the Indian Drug Manufacturers Association (IDMA) and
industry that the department is moving away from its Organisation of Pharmaceutical Producers in India
stance on pricing of essential medicines. "In a drug (OPPI) in a joint representation to union minister for
market, competition does not lead to lowering of prices. chemicals and fertilisers MK Alagiri said that the two key
In majority of cases, it has been observed that the brand issues affecting the industry immediately and availability
leader is also the price leader," the department said in a of medicines in the long run are span of price control and
presentation to the group of ministers last week...... method of price fixation.

.............. "If this is true, then the department is Pharma Majors Block Better Deal For
contradicting what it has proposed publicly - to do away Victims
with the cost-based mechanism," said Tapan Ray, director
general, Organisation of Pharmaceutical Producers of
April 10, 2012, The Pioneer
India. "This is an utter confusion and lack of
transparency." But one person close to the development Victims of clinical trials in India will continue to be given
said the department's presentation was a mere briefing to a raw deal, as drug companies are calling the shots in the
the group of ministers about the character of the pharma panel set up by the Government to decide on the
market and it did not represent the department's views. payment of compensation to such victims. In what seems
to be a clear case of conflict of interest, of the 17
stakeholders who participated at a meeting called by the
GoM May Decide Drug Pricing Policy On Drug Controller General of India (DCGI) on March 18 to
Wednesday deliberate on the guidelines for payment of compensation
April 25, 2012, The Economic Times to the victims of clinical trials, as many as 10 represented
drug manufacturing firms...........
A panel of ministers will meet on Wednesday to decide
the formula to cap the retail prices of 348 essential drugs ..........At the meeting chaired by YK Gupta, Professor
and their combinations that seek to make medicines and Head of Pharmacology Department, AIIMS, in many
affordable without hampering the growth of the industry. cases the drug manufacturers were represented twice.
The group of ministers (GoM), headed by agriculture Glenmark Pharmaceuticals participated even though
minister Sharad Pawar, will look into several pricing Indian Drugs Manufacturers Association (IDMA) of which it
models suggested by stakeholders. is member, had two other participants. Similarly,
GlaxoSmithkline participated as a drug firm despite being
According to few government and industry officials represented by the Organisation of Pharmaceutical
familiar with the development, the GoM would discuss Producers of India (OPPI), of which it is a member.
the issue and proposals, but is unlikely to take a call.
Meanwhile, in a rare camaraderie, three industry bodies All Drug Bodies For Market-Based
that are at loggerheads on several drug policy matters -- Pricing
OPPI the lobby body of foreign drug makers in India and
IPA and IDMA representatives of local companies -- have
April 7, 2012, The Times of India
jointly demanded the government to stick to its draft
policy to fix maximum retail price of drugs based on It's rare to find three industry associations, each holding
market-based model. divergent views, to come together on a controversial
issue. But for the first time probably in years, three
Industry Urges Dop Not To Deviate pharma associations - Indian Pharmaceutical Alliance
From Method Of Price Fixation, Span Of (IPA), Indian Drug Manufacturers' Association (IDMA) and
Control As In Draft Policy (OPPI) have rallied and submitted a uniform proposal to
April 24, 2012, Pharmabiz, Ramesh Shankar the government, suggesting a market-based pricing model
for essential medicines.
Even as the Group of Ministers (GoM) on national pharma
policy led by union agriculture minister Sharad Pawar is Interestingly, IPA represents the interests of the domestic
scheduled to hold its first meeting on April 25 to decide home-grown industry, while OPPI fights for issues
on national pharma pricing policy (NPPP), major pharma concerning multinationals. The development comes at a

6


time when the Group of Ministers (GoM) is slated to innovation to flourish. The Indian economy on the whole
finalize the model for fixing retail prices of essential is on a growth trajectory which means there is plenty of
medicines, and when certain health groups and ministries opportunity out there in the marketplace. It is therefore
are opposing the suggested pricing model in the national not uncommon for people to switch jobs and careers
pharma policy. more frequently than previously.”

‘Drug Prices Need To Be Monitored, Not Shahani anticipates, “The last three years have seen
salary hikes in the pharma industry that have been among
Controlled’ the highest across sectors, in the range of 13-14 per cent.
April 7, 2012, Indian Express Since most companies in the sector have ambitious plans
for the next few years, we expect the talent war to
Multinational pharma companies operating in India are continue. However, such aggressive salary hikes, coupled
“disappointed” with some recent developments in the with a number of business and HR initiatives will
healthcare sector. Ranjit Shahani, vice-chairman and MD contribute to making the sector more attractive and will
of Novartis India and president of the Organisation of help in getting more good talent into the sector. We
Pharmaceutical Producers of India (OPPI), the clearly see that we are moving in the right direction.”
representative body of MNC pharma firms, spoke to (both Paragraphs appeared in following news)
George Mathew on the issue of intellectual property
rights and public health. Excerpts: Debate: A Sweet Or Bitter Pill?
What’s your opinion on the recent order on compulsory
March 22, 2012, Financial Express
licencing to Natco Pharma? Do you see more Indian By Mr. Ranjit Shahani, president of the Organisation of
companies using this route for generic version of patented Pharmaceutical Producers of India and Ms. Leena
drugs? We believe compulsory licences should be used Menghaney, project manager for MSF’s Access
only in exceptional circumstances, such as in times of a Campaign in India
national health crises. If used arbitrarily, they will serve http://www.financialexpress.com/news/a-sweet-or-
to undermine the innovative pharmaceutical industry and bitter-pill/926728/0
will be to the long term detriment of the patient. The
poor in developing countries will suffer needlessly until a It’s been seven years since the pharmaceutical industry
wide variety of issues such as lack of diagnosis, welcomed the re-introduction of product patent laws in
healthcare infrastructure and distribution are solved. India. Seven years on, we continue to give mixed signals
regarding the implementation of intellectual property
rights.
Not Given Adequate Attention
April 1-15, 2012, Express Pharma Early last week, the controller general of patents, on his
Tapan Ray, Director General, Organisation of last day in office, chose to award the first compulsory
Pharmaceutical Producers of India licence for a pharmaceutical product in India. In our
endeavour to be seen as the guardians of the poor and to
Overall, there is nothing significant in this budget for the making medicines available,…. we are actually doing a
healthcare sector, as such. However, we appreciate the disservice to the long-term interests of patients and the
announcements for the healthcare as well as for the challenge of tackling unmet medical needs.
pharma sector of the Finance Minister in his budget
speech with reference to the following areas: HR Issues Could Trip Pharmaceutical
Infrastructure Building: Existing vaccine units to be Sector In India
modernised and new integrated vaccine unit to be set up March 16-31, Express Pharma
in Chennai. Improving access to medicines: Scope of http://www.expresspharmaonline.com/20120331/pharma
‘Accredited Social Health Activist’ – ‘ASHA’ is being life01.shtml
enlarged. This will also enhance their remuneration.
Reduction in transaction costs: Cancer and HIV patients Indian Institute of Health Management Research (IIHMR)
get a breather this budget with the Finance Minister recently conducted national conclave on ‘Human
announcing a cut in medicine prices for these deadly Resource Management in Pharmaceutical Industry:
diseases. Challenges and Future Directions’ in Mumbai. The
Talent Hunt : The Race Intensifies (OPPI), the umbrella body representing mostly MNC
pharma companies, actively supported this initiative to
April 1-15, Express Pharma analyse the importance of human resources (HR) in a
Ranjit Shahani, President, OPPI and Vice Chairman and start-up, budding or a well-established pharma company.
Managing Director, Novartis India analyses the situation
and comments, “India became a product patent country
in 2005 but is yet to provide the right ecosystem for

7


Talent acquisition, employee retention and management Amit Sengupta and Ranjit Shahani
are some of the important topics which experts at the
conclave discussed in the context of what more can be The decision by the Indian Patent Office to issue a
done to improve the organisation. compulsory licence (CL) to Natco for Bayer's anti-cancer
drug Sorafenib means the drug will now be available at Rs
Pharma Industry Disappointed 8,800 per month, a 97 % reduction from Bayer's Rs 2.8
lakh. Globally, people working on public health and
March 17, 2012, Hindu Business Line access to medicines have welcomed the decision.....
http://www.thehindubusinessline.com/industry-and-
economy/economy/article3003140.ece It was with great anticipation that the innovative
pharmaceutical industry welcomed the introduction of
The Pharmaceutical and healthcare industry said it was product patent laws in 2005. Intellectual property rights
disappointed with the Budget as it did not have any are the driving forces behind the pharmaceutical industry
significant proposals for the sector. “In our view, the without which the world would have no new medicines to
healthcare concerns of the country have not been given meet unmet medical needs of today and tomorrow.....
adequate importance in the Union Budget proposals to
help improving the healthcare needs of the nation,” said
the Organisation of Pharmaceutical Producers of India. Pharma, Healthcare Sectors Hoping For
Impetus From Union Budget
The Finance Minister has only tweaked the duty structure March 14, 2012, Pharmabiz, Joseph
on some life saving medicines for cancer and HIV
patients. There is also a proposal to extend concessional
Alexander
basic customs duty of 5 per cent with full exemption from http://pharmabiz.com/NewsDetails.aspx?aid=67989&sid=1
excise duty/CVD to 6 specified life saving drugs/vaccines.
As the countdown has started for the Union Budget
presentation on March 16, the pharmaceutical and
Natco Ruling Is A Watershed healthcare sectors are waiting with bated breath
March 15, 2012, Hindu Business Line announcement of some encouraging budget proposals
http://www.thehindubusinessline.com/opinion/article29 ensuring necessary impetus to these sectors. A check on
95239.ece the cross-section of various segments of these two
industries on the eve of the budget reveals that the
The day of the nation-wide trade union strike, few people leaders are harbouring high hopes from the Union Finance
are on the roads and in offices in Mumbai. But on the Minister Pranab Mukherjee........
second floor of the Patent Controller's office, a handful of
people sit around a horse-shoe-shaped table, in a post- ........Benefits for such units can be provided via
lunch session. They are listening to final arguments on deduction from profits linked to investments, which
pharmaceutical company Natco's application, seeking a includes permitting research tax credits to offset future
compulsory licence on Bayer's Nexavar, an advanced tax liability,” a spokesman of the Organisation of
kidney cancer medicine. It is also the last hearing of Mr P. Pharmaceutical Producers of India (OPPI) said.
H. Kurian, as Patent Controller General.
Natco Gets India’s First Compulsory
........But the Organisation of Pharmaceutical Producers
of India (OPPI), a platform largely for foreign companies, Licence
is disappointed with the CL judgment. “Compulsory March 13, 2012, Livemint
licences should be used only in exceptional http://www.livemint.com/2012/03/12225420/Natco-
circumstances, such as in times of a national health crisis. gets-India8217s-first.html?atype=tp
If used arbitrarily, compulsory licences will serve to
undermine the innovative pharmaceutical industry and In a landmark decision, India’s intellectual property office
will be to the long-term detriment of the patient,” says on Monday allowed Hyderabad-based Natco Pharma Ltd to
Mr Ranjit Shahani, OPPI President, and the India-head of make and sell a copycat version of German drug maker
Novartis. For better access, you need improved Bayer AG’s patented cancer treatment Nexavar. It’s the
healthcare infrastructure and distribution, he points out. first time that an Indian company has been granted the
so-called compulsory licence to market a generic version
Should Compulsory Licensing Be of a patented drug.

Allowed? .....The foreign drug makers’ lobby, the Organisation of
March 14, 2012, The Times of India Pharmaceutical Producers of India, echoed its
By Amit Sengupta who is with the All India People's disappointment. “Today’s announcement to issue a
Science Network & compulsory licence is disappointing, as such measures
By Ranjit Shahani who is Novartis India V-C & MD and cannot be the permanent solution of improving access to
also heads OPPI innovative medicines in India, while creating an

8


appropriate ecosystem to foster innovation in the Natco's baby step may pave the way for a giant leap of
country,” said Tapan Ray, director general of the group. sorts, where many more drug patents are subjected to
this “stick” to help bring down highly excessive prices for
Natco Pharma Bags Licence To Sell a country like India, says Mr Shamnad Basheer, an
intellectual property expert.
Bayer's Cancer Drug Nexavar
March 13, 2012, The Economic Times ......But expressing disappointment with the judgement,
http://m.economictimes.com/PDAET/articleshow/122401 Mr Ranjit Shahani, President of the Organisation of
00.cms Pharmaceutical Producers of India, said that the issue of
compulsory licenses should be used only in exceptional
The government has allowed a local drugmaker to make circumstances. “The poor in developing countries like
and sell a patented cancer drug at a fraction of the price India will suffer needlessly until a wide variety of issues
charged by Germany's Bayer AG, setting a precedent for such as lack of diagnosis, healthcare infrastructure and
more such efforts by Indian firms and heightening the distribution are solved. Existence of trained healthcare
global pharmaceutical industry's anxiety over the use of staff and infrastructure, cultural acceptability of
the controversial compulsory licensing provision. treatment, accessibility of healthcare facilities and
quality of care all play a role in making medicines
.......While healthcare activists were quick to welcome available,” he added. The OPPI is a platform largely for
the order and said it would discourage innovator foreign drug makers.
companies from selling medicines at exorbitant prices,
Bayer and OPPI, the body that represents foreign drug Path Breaking Financial Reform
companies in India, expressed their disappointment at the
development. "The solution to helping patients with Process, But Caught In A Political
innovative medicines does not lie in breaking patents," Quagmire
said OPPI Director-General Tapan Ray. March 1-5, 2012, Express Pharma
http://www.expresspharmaonline.com/20120315/manag
Budget Expectations: Pharma Producers ement01.shtml
Body Calls For Infra Status To
Tapan J Ray, Director General, Organisation of
Healthcare Pharmaceutical Producers of India (OPPI).
March 13, 2012, Moneycontrol.com Implementation of Goods and Services Tax (GST), first
The writer is President, Organisation of Pharmaceutical proposed in 2005, will be a path breaking financial reform
Producers of India and Vice-Chairman, MD, Novartis process in India, which has generated great expectations
India in and outside the country.
http://www.moneycontrol.com/news/business/budget-
expectations-pharma-producers-body-calls-for-infra- Unfortunately, the process has got caught in a political
status-to-healthcare_679049.html quagmire and has already missed two deadlines, the first
being April 2010. The proposed GST is expected to
As 16 March draws close, Indian healthcare is once again subsume most of the existing Central and State taxes
at the crossroads waiting with bated breath for the Union including the Excise Duty and VAT. Under the present tax
Budget in the hope that it will provide the necessary system, the pharma industry faces Excise Duty on the
impetus to the pharmaceutical industry. Announcing manufacture and VAT on the sale of pharmaceutical
Infrastructure status for Healthcare would be just what products.
the doctor ordered.
IIHMR Organises Conclave On Human
The reality is that rural and semi-urban India lacks even
the most basic healthcare infrastructure. Since setting up Resource Strategy In Pharma Sector
facilities in such areas involves substantial investments February 27, 2012, Pharmabiz
with long gestation periods, tax incentives are http://pharmabiz.com/NewsDetails.aspx?aid=67726&sid=2
imperative. A weighted deduction for expenditure
incurred in rural/semi-urban areas is therefore required. Indian Institute of Health Management Research (IIHMR),
Jaipur has organised the national conclave on ‘Human
Health Groups Hail Verdict, Pharma Resource Management in Pharmaceutical Industry:
Challenges and Future Directions’ at Hotel Grand Hyatt in
Body Disappointed Mumbai today. The conclave, supported by Organization
March 13, 2012, Hindu Business Line of Pharmaceutical Producers of India (OPPI) – the
http://www.thehindubusinessline.com/companies/article umbrella body representing mostly MNC pharma
2988316.ece companies, analysed the importance of human resources
in a start-up, budding or a well-established
pharmaceutical company.

9


It has been predicted that by the year 2015, the Indian reforms and put in place transfer pricing norms
Pharmaceutical industry would be the third largest all immediately. To deepen rural health infrastructure, the
over the world with an output of US$ 20 billion. Research association has asked for weighted deduction for
& Development is the core function of pharmaceutical expenditure incurred in rural or semi-urban areas. It also
companies and to deliver the required high-skilled felt that companies investing in the rural and semi-urban
employees. The focus of product patent era in India has markets have long gestation period.
shifted to ‘Research & Development’ for the
pharmaceutical companies to survive in the global The Indian Pharmaceutical Industry: A
market. In pharma industry no one can rely on generic
drugs and innovation is the need of the hour. India falls Time Of Growth And Change (Part 2)
short of highly qualified individuals suited to perform February 17, 2012, Pharmaphotum
these functions.
http://www.pharmaphorum.com/2012/02/17/indian-
IPC, USP Symposium Stresses On pharmaceutical-industry-time-growth-change-part-2/

Strengthening Collaboration In The Rebecca Aris interviews Tapan Ray
Field Of Biologics Organisation of Pharmaceutical Producers of India
February 23, 2012, Pharmabiz
http://pharmabiz.com/NewsDetails.aspx?aid=67673&sid=2 Concluding his thoughts on Indian pharma, Tapan Ray
shares his views on social media adoption by the industry
Indian Pharmacopoeia Commission (IPC) and the US and what he thinks the future of pharmaceuticals in India
Pharmacopoeial Convention (USP) stressed on looks like.
strengthening its collaboration in the field of biologics to
develop biological standards and references substance Interview summary
that will enable the companies to manufacture quality RA: What are your thoughts on the Department of
medicines for people across the world. There was a Pharmaceutical’s recently introduced draft code on
general consensus among the organisers, regulators and pharma marketing practices?
the industry representatives to take strategic decisions in
this matter so that it will help India to churn out its own TR: OPPI appreciates the initiative taken by Department
reference substances for biologics. of Pharmaceuticals (DoP) of the Government of India in
this regard and is confident that the Code will provide
........The symposium was co-sponsored by the uniform guidance for the pharmaceutical industry in its
Association of Biotechnology Led Enterprises (ABLE), the interaction with Healthcare Professionals. The document
Bulk Drug Manufacturers Association (BDMA), the Indian is well written, balanced and fair. The DoP should,
Drug Manufacturers Association (IDMA), the Indian indeed, be commended on the great work that they have
Pharmaceutical Association (IPA), and the Organisation of done in putting all details of pharmaceutical marketing
Pharmaceutical Producers of India (OPPI). practices together in this document in a very
comprehensive manner.
OPPI is happy to notice that the Department has taken
Pharma Industry's Pre Budget note of various suggestions put forth by OPPI in the draft
Memorandum Seeks Duty Cuts, Uniform Code of Pharmaceutical Marketing Practices
submitted by OPPI along with other Industry Associations
Incentives From FM to the Department of Pharmaceuticals in November 2009.
February 22, 2012, Pharmabiz, Joseph
Alexander Mumbai To Host IPC-USP Science &
http://pharmabiz.com/NewsDetails.aspx?aid=67637&sid=1
Standards Symposium On Feb 22-23
With another Union Budget is round the corner, February 14, 2012, BioSpectrum Asia
expectations and apprehensions are building up in the http://www.biospectrumasia.com/content/140212IND182
pharmaceutical industry which has already submitted the 39.asp
wish-lists to the Finance Minister who will table the
budget on March 16. Tax reforms, sops for promoting India’s role as a leading figure in global pharmaceutical
research and development, special support to boost manufacturing is bringing together regulators,
active pharmaceutical ingredients, and cut on taxes on manufacturers and other stakeholders in global public
life-saving drugs in view of the GST that is set to be rolled health at the 11th IPC-USP Science & Standards
out are among the wish-list by the industry, even as it is Symposium on February 22–23 in Mumbai. Hosted by the
too early to get feelers from the Finance Ministry. Indian Pharmacopoeia Commission (IPC) and the US
Pharmacopeial Convention (USP), the nearly 400 expected
Organisation of Pharmaceutical Producers of India attendees will explore ways in which science and quality
(OPPI) has asked the government to go ahead with tax

10


standards can help ensure good quality medicines in India policy, the Supreme Court has asked the Union ministry of
and throughout the world..... health and Department of Pharmaceuticals (DoP) to
immediately review and come up with their views to
..... Symposium co-sponsors are the Association of make the essential medicines affordable to the poor
Biotechnology Led Enterprises, the Bulk Drug people of the country. Come up with your view on the
Manufacturers Association, the Indian Drug Manufacturers policy by February 9, or else the Court will give its
Association, the Indian Pharmaceutical Association, and direction on the issue, the Supreme Court said...........
the Organization of Pharmaceutical Producers of
India..... The two-member SC bench also posed a question to the
The Indian Pharmaceutical Industry: A (OPPI), an organisation of multinational pharma
companies in India, who was also made a party in the
Time Of Growth And Change (Part 1) case. The SC bench asked its counsel U Lalit, why you
February 13, 2012, Pharmaphotum cannot reduce the prices of essential medicines to make
http://www.pharmaphorum.com/2012/02/13/6845/ it affordable to the poor people of this country.

Rebecca Aris interviews Tapan Ray Pharma: High Demand For Skilled
Manpower In The Industry
The pharma industry in India continues to grow rapidly Tapan Ray, Director General, Organisation of
and as it does the regulatory environment continues to Pharmaceutical Producers of India, shares his
shift. With over thirty years experience in pharma Tapan views on challenges faced by pharma and
Ray has a broad overview of how Indian pharma currently healthcare sector, hiring trends, need for skilled
looks, compared with other parts of the world, and how it professionals, growth opportunities, etc.
is set to evolve. In a written interview Tapan shares his
January 6, 2012, Shine.com
thoughts with us.
http://info.shine.com/Article/Industry-Buzz/Pharma-
Interview summary
High-demand-for-skilled-manpower-in-the-
industry/5588/cid819.aspx
RA: Could you please start by telling me about your
background and your current role?
What are the key traits, according to you, to be a good
manager?
TR: I have over thirty years of national and international
experience in the Pharmaceutical and Healthcare Industry
In my view, following are the key traits to be a good
based in India and the U.K. I currently hold the position of
manager:
Director General of the Organisation of Pharmaceutical
Producers of India (OPPI).  Performance orientation
 Interpersonal relationship
In the past I have held various senior positions, such as
 People management skills
International Marketing Strategy Manager, Glaxo plc.
U.K.; Director in the Board of Glaxo India Ltd; Non-  Ability to develop subordinates
Executive Director of Biddle Sawyer India Ltd.; Managing  ‘Right first time’ Decision making
Director of Abbott Laboratories India Ltd.; Managing  Crisis management
Director of Kopran Limited, India; CEO and Director of
Sami Labs. Ltd., India, Chairman of the Board of Shasun What, according to you, will be the major areas of
Pharma Solutions Ltd., Northumberland, England, U.K. concern for pharma and healthcare companies in 2012?
and Non-Executive Director in the Board of Shasun
Chemicals and Drugs Ltd. In my opinion, following could be the major areas for
manpower related concern in 2012:
SC Pulls Up Central Govt For Delay In  Attracting and retaining talent
Framing Pharma Policy To Make  Simultaneous top line and bottom line focus
Essential Drugs Affordable To Poor  Ability to leverage technology
People  Effective product life-cycle management
February 4, 2012, Pharmabiz, Ramesh  Ethical business conducts and value standards,
Shankar  Compliance to regulatory standards
http://pharmabiz.com/NewsDetails.aspx?aid=67362&sid=1

In what can virtually be termed as an indictment of their
dilly-dallying tactics on the issue of framing a pharma

11


Drug Firms’ Petition Dismissed price of the top three brands in the respective segments.
Sales of these drugs form three-fifths of the country's
January 2, 2012, Business Standard 60,000-crore pharmaceutical market................
http://wap.business-
standard.com/storypage.php?id=0&autono=460392 The Organisation of Pharmaceutical Producers of India
(OPPI), the lobby group of global drugmakers, has asked
A division bench of the Bombay High Court has dismissed the government to fix ceiling prices separately for
the petitions of Indian Drug Manufacturers Association imported formulations because making the same drugs
and the Organisation of Pharmaceutical Producers of outside the country is more costly.
India challenging the show cause notices to their
members, who produce bulk drugs, about their liability
under paragraph 7 (2) of the Drugs Prices Control Order OPPI Urges Govt To Reconsider Decision
(DPCO) 1979. To Exclude APIs From Price Control In
The authorities had also asked them to furnish
NPPP-2011
information regarding prices between 1979 and 1987. December 17, 2011, PharmaBiz
Their reply was that the department of chemicals had no http://www.pharmabiz.com/NewsDetails.aspx?aid=66592
power or authority to issue such notices. According to &sid=1
them, on a true interpretation of the DPCO, 1979 read
with the DPCO, 1987 and DPCO, 1995,.......... The Organisation of Pharmaceutical Producers of India
(OPPI), representing a group of multinational pharma
companies, has urged the department of pharmaceuticals
Bulk Drugs Should Remain Under Price (DoP) to reconsider its decision to bring bulk drugs and
Control, Say Pharma MNCs intermediates out of the purview of price control in the
December 19, 2011, Financial Express National Pharmaceutical Pricing Policy 2011 (NPPP 2011).
http://www.financialexpress.com/news/bulk-drugs-
should-remain-under-price-control-say-pharma- In its comments on the draft NPPP-2011, OPPI said, “OPPI
mncs/888806/0 strongly urges the reconsideration of para 4(2)
recommendation that price regulation would not apply to
In a surprising turn of events, the pharma multinationals any upstream products such as bulk drugs and
have sought that government should not do away with intermediates. We have a strong apprehension that there
price control on bulk drugs if it must regulate the prices will be a significant increase in prices of bulk drugs/APIs
of formulations. Many of the heads of MNCs had after their price controls are lifted. Moreover, there will
previously lauded the government’s proposal to make the be a time lag between increase in cost of bulk drugs/APIs
transition to regulating formulation following their first used as inputs for finished formulations and the price
instincts. Multinationals have expressed fear that once neutralization of input costs can only be taken at the end
decontrolled, bulk drug players may increase prices of the financial year based on price index. OPPI,
manifold rendering the inputs of medicine therefore, recommends the same treatment for price
dearer.............. increase for 348 bulk drugs as done in case of
formulations viz. the same per cent rise as given for
Hence, there is no scope for any price review in case of formulations”.
an increase in the bulk drug prices in the proposed
policy,” said Tapan J Ray, DG, OPPI, an industry Help In The Hour Of Need
association of multinational drug firms. November 16-30, 2011, Express Pharma
http://www.expresspharmaonline.com/20111130/retrosp
New Drug Policy Draft Faces Public ective04.shtml
Heat
"Though this is a patent law-related issue, unfortunately
December 19, 2011, India Today it has been hyped up as a ‘major victory for public health
http://economictimes.indiatimes.com/news/news-by- and access to affordable treatment." Tapan Ray, Director
industry/healthcare/biotech/pharmaceuticals/new-drug- General, Organisation of Pharmaceutical Producers of
policy-draft-faces-public-heat/articleshow/11162212.cms India.
The government's new drug pricing policy draft is facing Tapan Ray, Director General, Organisation of
stiff all-round opposition over fears that it will increase Pharmaceutical Producers of India (OPPI) emphasised,
prices of medicines, though manufacturers have “Recently two key HIV/AIDS medicines namely,
welcomed it albeit with some changes. The draft National lopinavir/ritonavir and atazanavir bisulphate were not
Pharmaceuticals Pricing Policy 2011, circulated in granted patents by the Indian Patent Office with the
October for feedback, plans to cap prices of all 348 reason cited that they 'lacked inventive ingenuity'.
essential drugs and their combinations at the average Though, this is a patent law-related issue, unfortunately

12


it has been hyped up as a ‘major victory for public health In what could be a shot in the arm for government, the
and access to affordable treatment’.” domestic pharma industry has endorsed price regulation
model as suggested in the draft policy, subject to certain
Rs.3,000 Crore Loss To Industry If Draft exemptions for indigenous research drugs. Recently, the
department of pharmaceuticals had proposed price
Drug Policy Implemented control on all 348 essential medicines (National list of
December 6, 2011, Livemint essential medicines) through a market-based pricing
http://www.livemint.com/2011/12/05222308/3000- mechanism. Though initially reports suggested the
crore-loss-to-industry.html?atype=tp industry was unhappy with the scope of price control
being extended from the existing 74 drugs, it may not
India’s pharmaceuticals industry could lose Rs.3,000 crore oppose it now. However, the MNC-led body OPPI has
in local profits if the government implements a proposed already made its concerns public by intervening in the
drug pricing policy, an industry lobby said on Monday. ongoing drug pricing issue in the Supreme Court. The
“The aggregate profit before tax of the pharmaceutical government will finalise the policy after receiving
industry will reduce sharply by 22.4% under the proposed comments of all stakeholders.
policy,” said the Indian Pharmaceutical Alliance (IPA),
which represents domestic drug makers. It will mainly Apex body, Indian Pharmaceutical Alliance (IPA), which
impact top local firms, the group said, which will represents the domestic industry, has said in a note to
translate into a loss of profit before tax of Rs.3,000 crore. the government, the 12th Plan allocation for medicines
will provide a growth opportunity , which will to some
.............“The more significant loss will be on trade, extent , minimize the losses due to the policy impact.
which is estimated at Rs.2,500 crore, as they (traders) The IPA estimates that price reduction alone will result in
will see a 6% loss on products that were non-price control a revenue loss of around Rs 3,000 crore to the industry).
products,” said Ranjith Kapadia, pharma analyst at The IPA expects government procurement of medicines
Centrum Broking Pvt. Ltd. The Organisation of which is done at discounted rates, to go up by six to
Pharmaceutical Producers of India, which counts foreign seven times in the 12th Plan. This will provide a huge
drug makers as its members, also expressed its concerns incremental growth to the industry , IPA secretary-
on the proposed pricing policy. general DG Shah told TOI.

Drug Companies Object To Draft Policy Packing Of Counterfeits
December 6, 2011, The Economic Times November 16-30, 2011, Express Pharma
(epaper page 15) http://www.expresspharmaonline.com/20111130/retrosp
http://lite.epaper.timesofindia.com/getpage.aspx?pagei ective04.shtml
d=15&pagesize=&edid=ET&edlabel=ETM&mydateHid=06-
12-2011&pubname=Economic+Times+- Though this is a patent law-related issue, unfortunately it
+Mumbai&edname=Mumbai&publabel=ET has been hyped up as a ‘major victory for public health
and access to affordable treatment." Tapan Ray, Director
Drug companies have asked the Department of General, Organisation of Pharmaceutical Producers of
Pharmaceuticals to modify the present draft drug policy India. There is also increased effort on the part of
as it doesnt achieve the purpose of ensuring essential voluntary organisations such as Clinton Foundation, Bill
medicines at affordable prices or encourage innovation and Melinda Gates Foundation, Médecins Sans Frontières
and investment in the industry. (MSF), UNITAID, PEPFAR etc to increase the accessibility
to HIV drugs in countries with a higher percentage of low-
The Indian Pharmaceutical Alliance and the Organization and mid-income groups. This can only be done with
of Pharmaceutical Producers of India, two lobby groups generic medicines.
representing domestic and foreign companies, have
objected to 75% of drugs coming under price control and Tapan Ray, Director General, Organisation of
asked the government not to change the List of Essential Pharmaceutical Producers of India (OPPI) emphasised,
Medicines. “Recently two key HIV/AIDS medicines namely, lopinavir
/ ritonavir and atazanavir bisulphate were not granted
patents by the Indian Patent Office with the reason cited
Indian Pharma Firms Back Price that they 'lacked inventive ingenuity'.
Regulation
December 6, 2011, The Times of India
http://timesofindia.indiatimes.com/business/india-
business/Indian-pharma-firms-back-price-
regulation/articleshow/11001287.cms

13


MNCs Move SC Over Drug Price Control stakeholders to improve access to quality health care.
Further efforts to bring over 60 per cent of the Indian
November 23, 2011, The Times of India pharmaceutical market under price control will only
http://timesofindia.indiatimes.com/business/india- impede the industry’s growth and development, with a
business/MNCs-move-SC-over-drug-price- long-term negative impact on the nations’ health care
control/articleshow/10836944.cms goals.
Till now, pharma companies, opposing price control, have
been trying to make their voices heard in the corridors of Setting New Standards
power. With the courts recently stepping in to bring November 1-15, Express Pharma
essential medicines under a price control regime, http://www.expresspharmaonline.com/20111115/manag
multinational-led industry body OPPI (Organization of ement01.shtml
Pharmaceutical Producers of India) has moved the
Supreme Court seeking to be heard on the drug pricing "The main challenge of the DoP would be to ensure that
issue. OPPI through an application seeking "impleadment" all companies across the pharma industry follow the same
in the ongoing public interest litigation on the drug standards in their marketing practices and interactions
pricing issue in the Supreme Court, wants to be a formal with the healthcare practitioners" Tapan Ray, Director
party in the case. Sources said that the OPPI filed the General, The Organisation of Pharmaceutical Producers
application to engage with the government "more of India. Reactions to the Department of Pharmaceutical's
actively'', and wanted to ensure that its case is heard. recently introduced draft code on pharma marketing
practices range from resigned acceptance, uncertainity
The PIL was filed by health groups led by All India Drug on its clauses, cynicism that it will only increase
Action Network, seeking essential drugs to be regulated corruption in the system to a call for a Jan Lokpal for the
under a price control regime in 2003. The "impleadment" pharma industry. More discussion and debate on the draft
application was filed on November 12, and later admitted code will be required to find a win-win solution for all
by the court. "The OPPI moved the Supreme Court to get stakeholders, writes Viveka Roychowdhury......
impleaded as a party in the ongoing PIL because the drug
pricing issue affects our industry's ability to sustainably ....Indeed, India is now globally the third largest market
provide medicines-both innovative and generic-to the in terms of volume of production and not having such a
population in India, and, hence will have an effect on regulation in place could spell disaster. In India the
public health and access to medicines, as well as the Organization of Pharmaceutical Producers of India (OPPI)
economic development of the pharma industry," OPPI issued a Code of Pharmaceutical Marketing Practices 2010
president Ranjit Shahani told TOI. (called the “OPPI Code”), based on the IFPMA Code. The
Indian Drug Manufacturers' Association (IDMA) also
Q&A: Ranjit Shahani, President, OPPI released another set of guidelines for its members. Tapan
Ray, director general, OPPI points out that the decision of
November 11, 2011, Business Standard the Government is the culmination of a series of events,
http://business-standard.com/india/news/qa-ranjit- covered widely by the various sections of the media, at
shahani-president-oppi/455085/ least since 2004. He quotes from the January–March, 2004
issue of The Indian Journal of Medical Ethics (IJME) which
Eight years after the national pharmaceutical policy was in context of marketing practices for ethical pharma
struck down by the judiciary, the Department of products in India had commented: “If the one who
Pharmaceuticals, under the chemicals and fertilisers decides, does not pay and the one who pays, does not
ministry, has attempted to re-frame a pricing policy for decide and if the one who decides is ‘paid’, will truth
medicines sold in the country. The new policy draft stand any chance?”
attempts to suggest a model that brings in all essential
medicines under price control, as the Supreme Court
suggested. There are differing views on the efficacy of Industry Bodies To Jointly Examine
this attempt too. Ranjit Shahani, chief of the Indian Merits Of New Draft Of Pharma Policy
subsidiary of Swiss drug major Novartis and president of November 8, 2011, Pharmbiz, Joseph
the Organisation of Pharmaceutical Producers of India
(OPPI), shares his views with Joe C Mathew on the issue.
Alexander
http://www.pharmabiz.com/NewsDetails.aspx?aid=65926
Edited excerpts: How industry-friendly is the proposed &sid=1
national pharmaceutical pricing policy? OPPI supports the
government’s efforts to improve access to health care The major industry associations in the pharmaceutical
and is happy to partner with it towards this end. The sector are planning to hold joint deliberations on the
national pharmaceutical pricing policy, which has been merits and demerits of the new draft of the National
long in the making, is misguided in the belief that pricing Pharmaceutical Pricing Policy prepared and released by
equals affordability equals access. Access goes far beyond the Department of Pharmaceuticals (DoP), and report to
pricing and the government needs to work with all the department. The associations including Organisation

14


of Pharmaceutical Producers of India (OPPI), Indian Drug India’s new pharmaceutical policy that aims to bring more
Manufacturers Association (IDMA), Federation of Pharma essential drugs under the price control regime has drug
Entrepreneurs (FOPE), and Confederation of Indian makers worried. The department of pharmaceuticals,
Pharmaceutical Industry (CIPI) are likely to join for the which put out a draft policy last week, suggests a system
common meeting being planned for November 18 here to to limit prices to increase the access and availability of
take a close look at the policy draft, sources said. essential drugs. The policy will regulate the prices of at
least 400 drugs, against 34 now. Industry is likely to resist
Apart from sending independent remarks about the its implementation as an impact analysis on the policy
policy, the stakeholders will also prepare a common set shows the prices of drugs could be reduced by up to
of recommendations to be submitted to the DoP which 30%...............
has invited comments from the industry and other
concerned sections on the draft, sources said. This is …………..The Organisation of Pharmaceutical Producers
expected to make the procedure easier for the of India (OPPI), which represents the foreign drug makers
department too. The new draft that seeks to replace the present in in the domestic market, is silent on the issue.
now aborted National Pharma Policy 2006 aims at Abbott India Ltd and Aventis Pharma Ltd, the Indian units
controlling the prices of 60 per cent of formulations, of US drug maker Abbott Laboratories and French drug
based on the national list of essential medicines prepared maker Sanofi Group, respectively, said their responses
by the Union ministry of health. The draft says the policy, will be in line with that of OPPI. A questionnaire sent to
to be finalized in a month, will cover nearly all the 348 OPPI’s director general Tapan Ray remained
medicines in the list. Based on updated data, the list will unanswered.
be expanded to cover about 400 drugs to increase access
and availability of essential medicines. We Must Get The Balance Right: Witty
New Policy To Force Cut In Imported At OPPI AGM
October 16-31, 2011, Express Pharma
Drug Prices http://www.expresspharmaonline.com/20111031/market
November 3, 2011, The Economic Times 18.shtml
http://economictimes.indiatimes.com/news/news-by-
industry/healthcare/biotech/pharmaceuticals/new- An agenda setting address by chief guest Andrew Witty,
policy-to-force-cut-in-imported-drug- global chief executive officer, GSK, was the highlight of
prices/articleshow/10588233.cms the recently held 45th AGM of the Organisation of
Pharmaceutical Producers of India (OPPI), reports Viveka
A key clause in the government's draft drug pricing policy Roychowdhury. With 'encouraging innovation for inclusive
has raised the hackles of foreign drugmakers who fear it growth' as part of the Organisation of Pharmaceutical
could force them to sharply reduce prices of several Producers of India (OPPI) declared mission, each annual
imported medicines by up to 90%...............Since there general body meeting is but naturally a reinforcement of
is no separate price determination (formula) for imported this ideal. But this year's AGM saw a new pragmatism and
brands, their ceiling price has been linked to the cost of acknowledgement of India's role in the pharmaceutical
brands made locally," says Manoj Tongra, a drugs control industry. And each speaker in their own way gave their
officer in Rajasthan. The condition has left foreign perspective on the role India was expected to play.
drugmakers enraged. "The proposal is unfair and
unreasonable," says Tapan Ray, director general of the The mood was set by Ranjit Shahani, president, OPPI
Organisation of Pharmaceutical Producers of India, the and vice president and managing director, Novartis India
association of global drugmakers in India. in his presentation on the 'Opportunity for Innovation'
when he predicted, "There is a great re-balancing and as
The costs of production, one of the key determinants to the economic centre of gravity shifts, there will be the
arrive at the market price of any drug, is significantly emergence of new centres of innovation. Can we could
more in western countries due to various factors, he says. look afresh at the mode of research to decrease the cost
Ray says it is not practical for the association's member of innovation, without compromising patient safety?.".....
companies to have manufacturing plants in each country
they operate. All international players, local or global Having defined the new brand of innovation required to
decide manufacturing locations based on overall business succeed in the pharma industry of today, Witty gave away
requirements, he says. the OPPI Excellence Awards and the Scientists and Young
Scientists Awards. Explaining the rationale of the Awards,
New Pharmaceutical Policy Has Drug Tapan Ray, director general, OPPI said, "Every year OPPI
presents awards of excellence to scientists and young
Makers Worried scientists of the country to recognise, honour, and
November 2, 2011, Livemint encourage innovation in the pharma sector of India.
http://www.livemint.com/2011/11/01232815/New-
pharmaceutical-policy-has.html?atype=tp

15


Going the R&D way: TRIPS tale Delay In CCI As Regulator For Pharma
October 16-31, Express Pharma Deals Irks MNCs
http://www.expresspharmaonline.com/20111031/researc October 22, 2011, Financial Express
h01.shtml http://www.financialexpress.com/news/delay-in-cci-as-
regulator-for-pharma-deals-irks-mncs/863726/
"I think it is a fallacy to say that money is not a problem
for MNCs. Businesses around the world are feeling the The Foreign Investment Promotion Board (FIPB) route for
pressures of a declining world economy, and the pharma FDI proposals from the pharma sector may be here to stay
industry is no different." Ranjit Shahani, Vice Chairman & for a much longer period than the preparatory time of six
Managing Director, Novartis India months that the prime minister has given to the
Competition Commission of India (CCI) to take on its new
In 1995 India signed the Trade Related Intellectual role as a filter, if sources in the commerce ministry are to
Property Rights (TRIPS) agreement so have these be believed. This is creating unease among the pharma
amended laws done the trick for pharma MNCs' R&D plans MNCs, which have long maintained that they prefer a CCI
for the Indian market and made India more attractive? scrutiny to the FIPB option. They feel policy
Not so, say some. "The innovative pharmaceutical uncertainities such as these may deter foreign investors
industry is greatly attracted to the Indian market, but the from firming up decisions to pump in resources in India…..
roles of TRIPS and improved patent laws have been over-
emphasised. In truth, India's economic growth and the ……..A clear framework also needs to be put in place
growing desire among Indians for quality healthcare, before the CCI filter for pharma deals is institutionalised.
including quality medicines, have played a much greater “We expect that the new system will be put in place
role. At the moment, less than one per cent of the Indian within a period of six months and note that as an interim
pharma market consists of patented medicines," Ranjit measure, all brownfield pharma M&A proposals will be
Shahani, vice chairman and managing director, Novartis routed through FIPB for a period not exceeding six
India, explains. months,” said Tapan Ray, director general, Organisation
of Pharmaceutical Producers of India, an industry body
Encouraging Innovation In representing multinational pharma firms in the country.
Pharmaceuticals Through Public Private Pfizer India’s managing director Kewal Handa has already
expressed his concerns on the matter. “Ideally, the
Partnerships competition commission should have looked into it and
October 2011, IFPMA Newsletter, Issue 26 framed the guidelines for M&As in the pharma sector.
Going back to the FIPB route is a retrograde step. This
To encourage innovation in the area of pharmaceutical will add to uncertainty, which will defer foreign
research and development in India, the Organisation of investors’ decisions to invest in India,” Handa had said
Pharmaceutical Producers of India (OPPI) has immediately after the government announced its decision
collaborated with two premier R&D focused institutions, on pharma FDI early this month.
National Institute of Pharmaceutical Education &
Research (NIPER) and Council of Scientific & Industrial Should FDI In Pharma Be Restricted?
Research (CSIR) as part of its Public Private Partnership
(PPP) initiative. OPPI, in 2009, instituted “Scientists and
October 7, 2011, Financial Express
Young Scientists Awards” at both the institutes. In http://www.financialexpress.com/news/should-fdi-in-
addition, the Award is extended for scientists from pharma-be-restricted/856876/5
Pharmaceutical Research Centres/ Academic Institutions.
The selection of the awardees is based on the Tapan Ray - The consolidation process within the
recommendation of an independent panel of juries— pharmaceutical industry in India started gaining
experts in the field. The Award carries a trophy, a momentum since 2006, with the acquisition of Matrix Lab
citation and a cash prize of Rs.1 lakh each. by Mylan. 2008 witnessed one of the biggest mergers in
the industry till that period, when Daiichi Sankyo of Japan
In a recent OPPI Annual Award Function for “Scientists acquired Ranbaxy of India for $4.6 billion.
and Young Scientists” in Mumbai, Mr. Andrew Witty, CEO,
GlaxoSmithKline plc., who graced the occasion as Chief Last year, Abbott’s acquisition of Piramal Healthcare for
Guest, said, “the efforts taken by the OPPI to $3.72 billion followed several media reports on the
acknowledge the work of these young talents is really government’s keen interest in instituting new restrictions
appreciable. As the industry, it is our responsibility and on foreign direct investment (FDI) in the pharmaceutical
duty to provide them with the inspiration so that they can sector due to various apprehensions. First, it feared that
continue doing the good work.” this will create an oligopolistic market, with an adverse
impact on public health interest.

16

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