OPPI in Media

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India is proposing an ambitious plan to substantially raise spending on providing free drugs for India’s 1.2 billion population. But there are doubts over the plan’s implementation. India wants to spend up to 300 billion rupees ($5.4 billion), or 0.5% of gross domestic product, on procuring drugs to be distributed through governmentrun hospitals and clinics by 2017. Currently, India spends about 60 billion rupees ($1.1 billion), or 0.1% of GDP.
Most government hospitals in India are overcrowded, understaffed and lack medicines and supplies. “Significant shortages in the number of doctors, nurses, paramedics and hospital beds per 1,000 population in India pose a great challenge for speedier
implementation of universal healthcare in the country,” said Tapan Ray, director general of the Organisation of Pharmaceutical Producers of India, or OPPI, a lobby group for Pharma MNCs in India.

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OPPI in Media

  1. 1. OPPI IN MEDIA 2010-12Strong Medicine on procuring drugs to be distributed through government- run hospitals and clinics by 2017. Currently, India spendsJuly 14, 2012, The Times of India, The Crest about 60 billion rupees ($1.1 billion), or 0.1% of GDP, onEdition this......The Rs 28, 000-crore plan to make essential medicines ........Most government hospitals in India arefreely available at government-run hospitals and clinics is overcrowded, understaffed and lack medicines andlaudable. 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 1,000the leaks in the flawed public distribution system. Its population in India pose a great challenge for speedierbeing billed as a game changer in Indian healthcare. The implementation of universal healthcare in the country,”governments multi-crore plan to ensure the supply of said Tapan Ray, director general of the Organisation offree essential medicines at government hospitals and Pharmaceutical Producers of India, or OPPI, a lobbyclinics 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 andanti-ulcer. India To Give Free Medicine To Hundreds Of MillionsGiven the corruption and leakages that plague Indias July 5, 2012, Deccan Heraldpublic distribution system, this skepticism may not be India has put in place a $5.4 billion policy to provide freemisplaced. Even if the procurement of low-priced quality medicine to its people, a decision that could change themedicines is somehow achieved, efficient delivery will be lives of hundreds of millions, but a ban on branded drugsa huge stumbling block. Agrees Tapan Ray director stands to cut Big Pharma out of the windfall. From citygeneral, Organisation of Pharmaceutical Producers of hospitals to tiny rural clinics, Indias public doctors willIndia (OPPI): "The huge shortages in the number doctors, soon be able to prescribe free generic drugs to allnurses, paramedics and hospital beds-per-1000 population comers, vastly expanding access to medicine in a countrywill pose a great challenge in the speedy implementation where public spending on health was just $4.50 perof this project. India should respond to its healthcare person last year. The plan was quietly adopted last yearinfrastructure developmental needs much faster now to but not publicised. Initial funding has been allocated inachieve 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 theMedicines Raises Questions country, argues that the price of drugs is just one factorJuly 6, 2012, Wall Street Journal in access to healthcare and that the scheme need not be detrimental to manufacturers of branded drugs. "I thinkIndia is proposing an ambitious plan to substantially raise this will hasten overall growth of the pharmaceuticalspending on providing free drugs for India’s 1.2 billion industry, as poor patients who could not afford will nowpopulation. 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, 1
  2. 2. OPPI IN MEDIA 2010-12War On Bad Medicine A growing number of countries are adopting Indias intellectual property regulations, which give enoughJuly 5, 2012, The Times of India flexibility to local companies to produce generic versions of popular drugs to safeguard public health. AlthoughWhen you buy a drug over the counter, there is no way to multinational companies have criticised India for beingdetermine if it is substandard or spurious. From lax in enforcing intellectual property (IP) laws, countriesSeptember 2009 till now, the Gujarat Food and Drugs such as China, Argentina and the Philippines are adoptingcontrol administration (FDCA) recalled 615 batches of similar provisions...........tablets, injections, and capsules that did not meetpharmacological standards. Considering this problem, and .........However, MNCs disagree that India could havefollowing an Allahabad High Court ruling in October 2010, been a trigger for Chinas move. Tapan Ray, director-a special task force headed by Gujarat was formed for general of OPPI, the representative body of globalimplementing the unique track-and-trace system for drugmakers in India, said, "Amendment of a law is theevery strip or bottle of medicine you buy off the counter prerogative of the country concerned, and it is specific toanywhere in the country. the countrys requirement." India and China, which together account for about a third of the worldsDrug manufacturers organizations like the Confederation population, form a critical market for MNCs. IP lawsof Indian Pharmaceutical Industry (CIPI), Federation of favourable to MNCs enable them to increase sales inPharma Entrepreneurs (FOPE), Indian Drugs Manufacturers developing countries.Associations (IDMA), and Organization of PharmaceuticalProducers in India (OPPI) had opposed the trackingsystem. They claimed that it will be a huge burden to OPPI Organises Seminar On Cold Chainsmall and medium enterprises. The associations in the Management In Pharma Industryreport said that an SME with exports of around Rs15-20 May 30, 2012, Express Pharmacrore would need to invest Rs 2 crore on barcodemachines (one for each blister machine and one each for Organisation of Pharmaceutical Producers of Indiasyrups and injections). (OPPI) had recently organised a seminar on Stakeholders Engagement—Improving Cold Chain Management inPharma Cos Stay Mum As Govt Seeks Pharmaceutical Industry. Held in Mumbai, the seminarDetails Of Overcharging was attended by stakeholders in large numbers. During the seminar many do’s and donts related to cold chainJune 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 thecharges of overpricing. Literally. Even after four months growth of biological products across the world and withof receiving overcharging notices from the department of increasing demand for products like vaccines, hormonespharmaceuticals (DoP), not even one of the 500-odd and insulin among others, it is becoming imperative thatpharma companies have responded to the charges. The a careful consideration is given by the authorities andDoP 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 productsindustry body of Indian companies, and the Organisation prompts the relevance of having in place a robust pharmaof 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 Mustcompanies to submit the details within 30 days but not For Cold Chain Transport Say Expertseven a single firm has replied,” Raja Sekhar Vundru, May 28 – June 4, 2012, Aviation Cargo Expressjoint secretary of DoP, told Hindustan Times. The DoPnow is mulling to crack the whip on these companies The Organisation of Pharmaceutical Producers of Indiawith the help of the National Pharmaceutical Pricing (OPPI) organised a day long seminar on ‘Improving ColdAuthority (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 cargoMore Nations Adopting Indian custodians like Mumbai International Airport, the seminarIntellectual Property Regulations For featured key industry experts who imparted vital information on effective temperature sensitive logistics .Drug ManufacturingJune 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 2
  3. 3. OPPI IN MEDIA 2010-12chain 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). Secondtransportation from the pharma manufacturers preference:1) Average the prices of all drug brands whichperspective Ranjit Shahani, President OPPI and Vice command a market share of over 1% in the concernedChairman & 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 Nationalpower cuts make the task of maintaining an unbroken List of Essential Medicines (NLEM), 2011. 4) Spare thecold chain challenging in the Indian context. Failure to strengths, combinations not listed in NLEM. Strengths ofmaintain the cold chain affects the product, patient as second preference:well as the organisation. FIPB May Be Allowed To Clear ForeignOPPI Highlights Key Issues In Cold Chain Buys In Pharma CompaniesTransport Of Pharma Goods May 16, 2012, The Economic TimesMay 28 – June 4, 2012, Aviation Cargo Express The Department of Pharmaceuticals has mooted aInsulins and vaccines sector in India growing at 25% per proposal to allow the countrys foreign investmentannum, While India’s manufacturing infrastructure is at approving body to continue clearing stake purchases bypar with the best in the world, distribution infrastructure foreign firms in Indian drug companies, as it seeks to endlags behind, Cold chain infrastructure in India even at the uncertainty that has stalled the investment plans ofmetros was in need of overhaul. A casual approach and MNCs and foreign investors in the sector........untrained manpower was hindering growth of pharmaexports. .............. The unnamed government official quoted above said the inter-ministerial groups decision was notThe 12th edition of the Perishable Cargo Regulations has legally binding and there would no problems if FIPBintroduced new mandatory requirements for the continued to approve pharma M&A deals for some moretransportation logistics of healthcare products such as the time, till new rules are put in place. "Otherwise pendingmandatory use of the time and temperature sensitive applications will pile up," the official said. Thelabel as of July 1st, 2012. These changes are the result of Organisation of Pharmaceutical Producers of Indiathe collaboration by carriers with pharmaceutical (OPPI), the industry body that represents foreigncompanies and associations as well as other stakeholders drugmakers in the country, said there appeared to bein the supply chain, including but not limited to shippers, some issues that were making it difficult to routefreight forwarders, terminal operators, ULD brownfield investments through CCI even after sixmanufacturers, packaging & tracking and tracing months.companies. Drugs Cos Open To Milder PricingAlternatives Before GoM On Pharma FormulaPricing May 16, 2012, Economic TimesMay 19, 2012, Financial Express Foreign drug makers and small local pharma companiesThe draft National Pharma Pricing Policy 2011 have told the panel of ministers, tasked with the mandaterecommended fixing the ceiling price of an essential drug of finalising the country’s drug pricing policy, that theyby taking the Weighted Average Price of top-three brands are willing to accept a toned-down alternative pricingby sales in a particular therapy segment. While the mechanism. This will help allay government’s fears of aformula 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 ofhealth and lately by the department of pharmaceuticals, The Organisation of Pharmaceutical Producers of Indiawho maintained that top-selling brands are also the (OPPI) — the industry body of foreign drug makers in Indiapriciest ones. Health groups claim capping prices at — told the Group of Ministers (GoM) led by agricultureprevailing rates would encourage those selling cheaper minister Sharad Pawar, on Monday, that the MRP ofbrands to jack up prices, thus making the average prices essential drugs can be fixed at the average of all brandsof essential drugs dearer. in a segment, having more than 1% volume share.Following are the views of some of the stakeholders onthe pricing issue... (A) Organisation of PharmaceuticalProducers of India (An industry association comprisingforeign pharma multinationals) First preference:Benchmark ceiling price to Weighted Average Price of 3
  4. 4. OPPI IN MEDIA 2010-12Different Formulae Emerge For Drug companies. The OPPI, however, suggested that medicines with volumes more than one per cent be capped at theirPricing At GoM average price. This would cover over 90 per cent of theMay 16, 2012, Business Line market, the OPPI said.However, this suggestion was not acceptable to the Drug Pricing Policy: IPA Agrees ToOrganisation of Pharmaceutical Producers of India(OPPI), a platform for largely overseas companies. About PMEACs Hybrid Formula60 per cent of the multinational companies would be May 15, 2012, Economic Timesunder this non-transparent cost-based net, the OPPIpointed out, compared with 40 per cent Indian An industry body representing the countrys top drugcompanies. makers has told the panel of ministers, tasked with the mandate of finalising the countrys drug pricing policy,The OPPI, however, suggested that medicines with that it is ready to accept the hybrid drug pricingvolumes more than one per cent be capped at their mechanism suggested by the PMs economic advisoryaverage 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 thePharma Companies Open To Milder Department of Pharmaceuticals proposal of fixing the capAlternative Pricing Mechanism on the average of top three selling brands beMay 16, 2012, The Economic Times implemented...........In addition to the OPPI, Zydus Cadila Managing Director Pankaj Patel, Dr ReddysForeign drug makers and small local pharma companies Laboratories Managing Director & COO Satish Reddy, andhave told the panel of ministers, tasked with the mandate Torrent Pharmas chairman Sudhir Mehta argued theof finalising the countrys drug pricing policy, that they industrys case for a market-based pricing policy.are willing to accept a toned-down alternative pricingmechanism. This will help allay governments fears of a GoM On Pharma Pricing To Gather Morespiraling of medicine prices if a market-based model, Feedbackoriginally sought by the pharma companies, is adopted. May 15, 2012, Business StandardThe 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 tominister Sharad Pawar, on Monday that the MRP of seek feedback from various industry associations, is likelyessential 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 ofperson who attended the GoM briefing told ET that this essential medicines.....will cover a wide representation of the market - about91% - and dispel fears of some stakeholders that the MRP On Friday, two non-government organisations andwas 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 ofDifferent Formulae Emerge For Drug Pharmaceutical Producers of India, the IndianPricing At GoM Pharmaceutical Association and an association of chemistsMay 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 concernsinvolving the pharmaceutical industry. However, different Pharma Inc-GoM Meet To Tackleformulae to tackle the pricing of medicines have emerged ‘Thorny’ Pricingfrom the half-a-dozen presentations made to the Group ofMinisters by the drug industry and distributor May 14, 2012, Financial Expressorganisations....... 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 on60 per cent of the multinational companies would be Monday, two issues will be hotly debated: The span ofunder this non-transparent cost-based net, the OPPI control and the method of price fixation......pointed out, compared with 40 per cent Indian 4
  5. 5. OPPI IN MEDIA 2010-12.........During Monday’s meeting, the first ever involving pharmaceutical market is the fourth largest in the worldall stakeholders since an unsuccessful, earlier one when in terms of volume, according to the Organisation ofRam Vilas Paswan was minister for chemicals and Pharmaceutical Producers of India (OPPI). It generatesfertilisers, top pharma manufacturers bodies including $12 billion in sales every year.the Indian Drug Manufacturers’ Association (IDMA), theOrganisation of Pharmaceutical Producers of India Indian Drug Regulator Accused Of(OPPI) and the Indian Pharmaceutical Alliance (IPA) willbe unanimous in putting across evidence to prove why the Malpracticeearlier method of cost-based pricing was flawed, and May 9, 2012, Financial Timesstress on the need to move to a market-based pricingmechanism. IDMA represents domestic pharma India’s drug regulator colluded with globalcompanies, while OPPI is the body for international drug pharmaceutical companies to expedite the approval ofcompanies operating in India. drugs, according to a parliamentary report whose findings were swiftly challenged by manufacturers. The results ofHealth Panel Rap To Drug Regulator, a year long investigation by parliament’s health committee concluded that the Central Drugs StandardBoost 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 theOn an average DCGI is approving one drug every month lives of millions of people.without trials. This cannot be in public interest by anystretch of imagination,” says a parliamentary panel Tapan Ray, director-general of the Organisation ofreport on health, hugely critical on how medicines are Pharmaceutical Producers of India, said all his membersapproved for sale in the country. In a massive shot in the complied with domestic regulations. “The issue nowarm for consumers and public health, the report opens a appears to be in their appropriate implementation by thecan of worms on the “invisible hands” of drug-makers in regulatory authorities.” GSK said its cited druggetting favourable opinions from experts on medicines ambrisentan to treat pulmonary arterial hypertension hadseeking 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 manyfactors as specified in the ‘Parliamentary Committee Unclear Rules Stop FDI In Pharmareport,” Mr Tapan J. Ray, Director General of theOrganisation of Pharmaceutical Producers of India Companies(OPPI) told Business Line. A platform for foreign drug- May 8, 2012, The Economic Timesmakers, the OPPI added that its members were“committed to sponsoring clinical trials that fully comply The government has recently stopped giving permission towith all legal and regulatory requirements in India.” foreign companies and overseas investors to buy intoResponses from individual drug companies are still Indian drugmakers till clear guidelines regarding foreignawaited. direct investment in the sector are finalised. The Foreign Investment Promotion Board (FIPB), the nodal agency thatProbe Finds Collusion Between Drug approves investments in India, deferred four proposals at its March 30 meeting on the grounds that specificRegulator, Pharma Firms conditions for considering cases of brownfield foreignMay 9, 2012, Deccan Herald investment in the pharma sector were under formulation.Officials of Indias drug regulator have been colluding with There have been no restrictions on foreign investments inpharmaceutical firms to speed up approval procedures, pharma for the past decade, but a series of high-profileallowing some drugs that are not permitted in other acquisitions in the sector has prompted the governmentcountries to go on sale, according to an 18-month to tinker with the approval process, resulting in delays.investigation by MPs. The parliamentary panels 78-page "Foreign direct investment (FDI) of 100% through thereport names a number of major international drug automatic route in the pharma sector was opened just acompanies and Indian firms. The report may fuel concerns decade back...and there was no tangible reason to revisitover 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 causingincreasingly 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
  6. 6. OPPI IN MEDIA 2010-12DoP Says Competition Doesnt Always industry associations in the country have urged the Department of Pharmaceuticals (DoP) not to deviate fromLead To Cheaper Drugs; Raises Concern its proposal in the draft policy on the method of priceAmong Industry fixation and the span of the price control.April 30, 2012, The Economic Times Expressing concern over the final recommendations of theThe Department of Pharmaceuticals has told a group of DoP on the draft pharma policy, major pharma industryministers 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) andindustry that the department is moving away from its Organisation of Pharmaceutical Producers in Indiastance on pricing of essential medicines. "In a drug (OPPI) in a joint representation to union minister formarket, competition does not lead to lowering of prices. chemicals and fertilisers MK Alagiri said that the two keyIn majority of cases, it has been observed that the brand issues affecting the industry immediately and availabilityleader is also the price leader," the department said in a of medicines in the long run are span of price control andpresentation to the group of ministers last week...... method of price fixation............... "If this is true, then the department is Pharma Majors Block Better Deal Forcontradicting what it has proposed publicly - to do away Victimswith the cost-based mechanism," said Tapan Ray, directorgeneral, Organisation of Pharmaceutical Producers of April 10, 2012, The PioneerIndia. "This is an utter confusion and lack oftransparency." But one person close to the development Victims of clinical trials in India will continue to be givensaid the departments presentation was a mere briefing to a raw deal, as drug companies are calling the shots in thethe group of ministers about the character of the pharma panel set up by the Government to decide on themarket and it did not represent the departments 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 theGoM May Decide Drug Pricing Policy On Drug Controller General of India (DCGI) on March 18 toWednesday deliberate on the guidelines for payment of compensationApril 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 decidethe formula to cap the retail prices of 348 essential drugs ..........At the meeting chaired by YK Gupta, Professorand their combinations that seek to make medicines and Head of Pharmacology Department, AIIMS, in manyaffordable 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 thoughminister Sharad Pawar, will look into several pricing Indian Drugs Manufacturers Association (IDMA) of which itmodels suggested by stakeholders. is member, had two other participants. Similarly, GlaxoSmithkline participated as a drug firm despite beingAccording to few government and industry officials represented by the Organisation of Pharmaceuticalfamiliar 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-Basedthat are at loggerheads on several drug policy matters -- PricingOPPI the lobby body of foreign drug makers in India andIPA and IDMA representatives of local companies -- have April 7, 2012, The Times of Indiajointly demanded the government to stick to its draftpolicy to fix maximum retail price of drugs based on Its rare to find three industry associations, each holdingmarket-based model. divergent views, to come together on a controversial issue. But for the first time probably in years, threeIndustry Urges Dop Not To Deviate pharma associations - Indian Pharmaceutical AllianceFrom Method Of Price Fixation, Span Of (IPA), Indian Drug Manufacturers Association (IDMA) and Organisation of Pharmaceutical Producers of IndiaControl As In Draft Policy (OPPI) have rallied and submitted a uniform proposal toApril 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 pharmapolicy led by union agriculture minister Sharad Pawar is Interestingly, IPA represents the interests of the domesticscheduled to hold its first meeting on April 25 to decide home-grown industry, while OPPI fights for issueson national pharma pricing policy (NPPP), major pharma concerning multinationals. The development comes at a 6
  7. 7. OPPI IN MEDIA 2010-12time when the Group of Ministers (GoM) is slated to innovation to flourish. The Indian economy on the wholefinalize the model for fixing retail prices of essential is on a growth trajectory which means there is plenty ofmedicines, and when certain health groups and ministries opportunity out there in the marketplace. It is thereforeare opposing the suggested pricing model in the national not uncommon for people to switch jobs and careerspharma 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 amongControlled’ 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 toMultinational 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 willhealthcare sector. Ranjit Shahani, vice-chairman and MD contribute to making the sector more attractive and willof Novartis India and president of the Organisation of help in getting more good talent into the sector. WePharmaceutical 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 propertyrights and public health. Excerpts: Debate: A Sweet Or Bitter Pill?What’s your opinion on the recent order on compulsory March 22, 2012, Financial Expresslicencing to Natco Pharma? Do you see more Indian By Mr. Ranjit Shahani, president of the Organisation ofcompanies using this route for generic version of patented Pharmaceutical Producers of India and Ms. Leenadrugs? We believe compulsory licences should be used Menghaney, project manager for MSF’s Accessonly in exceptional circumstances, such as in times of a Campaign in Indianational 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/926728/0will be to the long term detriment of the patient. Thepoor in developing countries will suffer needlessly until a It’s been seven years since the pharmaceutical industrywide variety of issues such as lack of diagnosis, welcomed the re-introduction of product patent laws inhealthcare 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 AttentionApril 1-15, 2012, Express Pharma Early last week, the controller general of patents, on hisTapan Ray, Director General, Organisation of last day in office, chose to award the first compulsoryPharmaceutical Producers of India licence for a pharmaceutical product in India. In our endeavour to be seen as the guardians of the poor and toOverall, there is nothing significant in this budget for the making medicines available,…. we are actually doing ahealthcare sector, as such. However, we appreciate the disservice to the long-term interests of patients and theannouncements for the healthcare as well as for the challenge of tackling unmet medical needs.pharma sector of the Finance Minister in his budgetspeech with reference to the following areas: HR Issues Could Trip PharmaceuticalInfrastructure Building: Existing vaccine units to be Sector In Indiamodernised and new integrated vaccine unit to be set up March 16-31, Express Pharmain Chennai. Improving access to medicines: Scope of http://www.expresspharmaonline.com/20120331/pharma‘Accredited Social Health Activist’ – ‘ASHA’ is being life01.shtmlenlarged. 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 ‘Humanannouncing a cut in medicine prices for these deadly Resource Management in Pharmaceutical Industry:diseases. Challenges and Future Directions’ in Mumbai. The Organisation of Pharmaceutical Producers of IndiaTalent Hunt : The Race Intensifies (OPPI), the umbrella body representing mostly MNC pharma companies, actively supported this initiative toApril 1-15, Express Pharma analyse the importance of human resources (HR) in aRanjit Shahani, President, OPPI and Vice Chairman and start-up, budding or a well-established pharma company.Managing Director, Novartis India analyses the situationand comments, “India became a product patent countryin 2005 but is yet to provide the right ecosystem for 7
  8. 8. OPPI IN MEDIA 2010-12Talent acquisition, employee retention and management Amit Sengupta and Ranjit Shahaniare some of the important topics which experts at theconclave discussed in the context of what more can be The decision by the Indian Patent Office to issue adone to improve the organisation. compulsory licence (CL) to Natco for Bayers anti-cancer drug Sorafenib means the drug will now be available at RsPharma Industry Disappointed 8,800 per month, a 97 % reduction from Bayers Rs 2.8 lakh. Globally, people working on public health andMarch 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 ofThe Pharmaceutical and healthcare industry said it was product patent laws in 2005. Intellectual property rightsdisappointed with the Budget as it did not have any are the driving forces behind the pharmaceutical industrysignificant proposals for the sector. “In our view, the without which the world would have no new medicines tohealthcare concerns of the country have not been given meet unmet medical needs of today and tomorrow.....adequate importance in the Union Budget proposals tohelp improving the healthcare needs of the nation,” saidthe Organisation of Pharmaceutical Producers of India. Pharma, Healthcare Sectors Hoping For Impetus From Union BudgetThe Finance Minister has only tweaked the duty structure March 14, 2012, Pharmabiz, Josephon some life saving medicines for cancer and HIVpatients. There is also a proposal to extend concessional Alexanderbasic customs duty of 5 per cent with full exemption from http://pharmabiz.com/NewsDetails.aspx?aid=67989&sid=1excise duty/CVD to 6 specified life saving drugs/vaccines. As the countdown has started for the Union Budget presentation on March 16, the pharmaceutical andNatco Ruling Is A Watershed healthcare sectors are waiting with bated breathMarch 15, 2012, Hindu Business Line announcement of some encouraging budget proposalshttp://www.thehindubusinessline.com/opinion/article29 ensuring necessary impetus to these sectors. A check on95239.ece the cross-section of various segments of these two industries on the eve of the budget reveals that theThe day of the nation-wide trade union strike, few people leaders are harbouring high hopes from the Union Financeare on the roads and in offices in Mumbai. But on the Minister Pranab Mukherjee........second floor of the Patent Controllers office, a handful ofpeople sit around a horse-shoe-shaped table, in a post- ........Benefits for such units can be provided vialunch session. They are listening to final arguments on deduction from profits linked to investments, whichpharmaceutical company Natcos application, seeking a includes permitting research tax credits to offset futurecompulsory licence on Bayers Nexavar, an advanced tax liability,” a spokesman of the Organisation ofkidney 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 Producersof India (OPPI), a platform largely for foreign companies, Licenceis disappointed with the CL judgment. “Compulsory March 13, 2012, Livemintlicences 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=tpIf used arbitrarily, compulsory licences will serve toundermine the innovative pharmaceutical industry and In a landmark decision, India’s intellectual property officewill be to the long-term detriment of the patient,” says on Monday allowed Hyderabad-based Natco Pharma Ltd toMr Ranjit Shahani, OPPI President, and the India-head of make and sell a copycat version of German drug makerNovartis. For better access, you need improved Bayer AG’s patented cancer treatment Nexavar. It’s thehealthcare infrastructure and distribution, he points out. first time that an Indian company has been granted the so-called compulsory licence to market a generic versionShould Compulsory Licensing Be of a patented drug.Allowed? .....The foreign drug makers’ lobby, the Organisation ofMarch 14, 2012, The Times of India Pharmaceutical Producers of India, echoed itsBy Amit Sengupta who is with the All India Peoples disappointment. “Today’s announcement to issue aScience Network & compulsory licence is disappointing, as such measuresBy Ranjit Shahani who is Novartis India V-C & MD and cannot be the permanent solution of improving access toalso heads OPPI innovative medicines in India, while creating an 8
  9. 9. OPPI IN MEDIA 2010-12appropriate ecosystem to foster innovation in the Natcos baby step may pave the way for a giant leap ofcountry,” 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 forNatco Pharma Bags Licence To Sell a country like India, says Mr Shamnad Basheer, an intellectual property expert.Bayers Cancer Drug NexavarMarch 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 of00.cms Pharmaceutical Producers of India, said that the issue of compulsory licenses should be used only in exceptionalThe government has allowed a local drugmaker to make circumstances. “The poor in developing countries likeand sell a patented cancer drug at a fraction of the price India will suffer needlessly until a wide variety of issuescharged by Germanys Bayer AG, setting a precedent for such as lack of diagnosis, healthcare infrastructure andmore such efforts by Indian firms and heightening the distribution are solved. Existence of trained healthcareglobal pharmaceutical industrys anxiety over the use of staff and infrastructure, cultural acceptability ofthe 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 forthe 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 Reformcompanies in India, expressed their disappointment at thedevelopment. "The solution to helping patients with Process, But Caught In A Politicalinnovative medicines does not lie in breaking patents," Quagmiresaid OPPI Director-General Tapan Ray. March 1-5, 2012, Express Pharma http://www.expresspharmaonline.com/20120315/managBudget Expectations: Pharma Producers ement01.shtmlBody Calls For Infra Status To Tapan J Ray, Director General, Organisation ofHealthcare Pharmaceutical Producers of India (OPPI).March 13, 2012, Moneycontrol.com Implementation of Goods and Services Tax (GST), firstThe writer is President, Organisation of Pharmaceutical proposed in 2005, will be a path breaking financial reformProducers of India and Vice-Chairman, MD, Novartis process in India, which has generated great expectationsIndia 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 politicalstatus-to-healthcare_679049.html quagmire and has already missed two deadlines, the first being April 2010. The proposed GST is expected toAs 16 March draws close, Indian healthcare is once again subsume most of the existing Central and State taxesat the crossroads waiting with bated breath for the Union including the Excise Duty and VAT. Under the present taxBudget in the hope that it will provide the necessary system, the pharma industry faces Excise Duty on theimpetus to the pharmaceutical industry. Announcing manufacture and VAT on the sale of pharmaceuticalInfrastructure status for Healthcare would be just what products.the doctor ordered. IIHMR Organises Conclave On HumanThe reality is that rural and semi-urban India lacks eventhe most basic healthcare infrastructure. Since setting up Resource Strategy In Pharma Sectorfacilities in such areas involves substantial investments February 27, 2012, Pharmabizwith long gestation periods, tax incentives are http://pharmabiz.com/NewsDetails.aspx?aid=67726&sid=2imperative. A weighted deduction for expenditureincurred in rural/semi-urban areas is therefore required. Indian Institute of Health Management Research (IIHMR), Jaipur has organised the national conclave on ‘HumanHealth Groups Hail Verdict, Pharma Resource Management in Pharmaceutical Industry: Challenges and Future Directions’ at Hotel Grand Hyatt inBody Disappointed Mumbai today. The conclave, supported by OrganizationMarch 13, 2012, Hindu Business Line of Pharmaceutical Producers of India (OPPI) – thehttp://www.thehindubusinessline.com/companies/article umbrella body representing mostly MNC pharma2988316.ece companies, analysed the importance of human resources in a start-up, budding or a well-established pharmaceutical company. 9
  10. 10. OPPI IN MEDIA 2010-12It has been predicted that by the year 2015, the Indian reforms and put in place transfer pricing normsPharmaceutical industry would be the third largest all immediately. To deepen rural health infrastructure, theover 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 alsocompanies and to deliver the required high-skilled felt that companies investing in the rural and semi-urbanemployees. The focus of product patent era in India has markets have long gestation period.shifted to ‘Research & Development’ for thepharmaceutical companies to survive in the global The Indian Pharmaceutical Industry: Amarket. In pharma industry no one can rely on genericdrugs 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, Pharmaphotumthese 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 RayField Of Biologics Organisation of Pharmaceutical Producers of IndiaFebruary 23, 2012, Pharmabizhttp://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 industryIndian Pharmacopoeia Commission (IPC) and the US and what he thinks the future of pharmaceuticals in IndiaPharmacopoeial Convention (USP) stressed on looks like.strengthening its collaboration in the field of biologics todevelop biological standards and references substance Interview summarythat will enable the companies to manufacture quality RA: What are your thoughts on the Department ofmedicines for people across the world. There was a Pharmaceutical’s recently introduced draft code ongeneral consensus among the organisers, regulators and pharma marketing practices?the industry representatives to take strategic decisions inthis matter so that it will help India to churn out its own TR: OPPI appreciates the initiative taken by Departmentreference 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 itsAssociation of Biotechnology Led Enterprises (ABLE), the interaction with Healthcare Professionals. The documentBulk 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 havePharmaceutical Association (IPA), and the Organisation of done in putting all details of pharmaceutical marketingPharmaceutical Producers of India (OPPI). practices together in this document in a very comprehensive manner. OPPI is happy to notice that the Department has takenPharma Industrys Pre Budget note of various suggestions put forth by OPPI in the draftMemorandum Seeks Duty Cuts, Uniform Code of Pharmaceutical Marketing Practices submitted by OPPI along with other Industry AssociationsIncentives From FM to the Department of Pharmaceuticals in November 2009.February 22, 2012, Pharmabiz, JosephAlexander Mumbai To Host IPC-USP Science &http://pharmabiz.com/NewsDetails.aspx?aid=67637&sid=1 Standards Symposium On Feb 22-23With another Union Budget is round the corner, February 14, 2012, BioSpectrum Asiaexpectations and apprehensions are building up in the http://www.biospectrumasia.com/content/140212IND182pharmaceutical industry which has already submitted the 39.aspwish-lists to the Finance Minister who will table thebudget on March 16. Tax reforms, sops for promoting India’s role as a leading figure in global pharmaceuticalresearch 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 publiclife-saving drugs in view of the GST that is set to be rolled health at the 11th IPC-USP Science & Standardsout are among the wish-list by the industry, even as it is Symposium on February 22–23 in Mumbai. Hosted by thetoo early to get feelers from the Finance Ministry. Indian Pharmacopoeia Commission (IPC) and the US Pharmacopeial Convention (USP), the nearly 400 expectedOrganisation 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
  11. 11. OPPI IN MEDIA 2010-12standards can help ensure good quality medicines in India policy, the Supreme Court has asked the Union ministry ofand 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 poorBiotechnology Led Enterprises, the Bulk Drug people of the country. Come up with your view on theManufacturers Association, the Indian Drug Manufacturers policy by February 9, or else the Court will give itsAssociation, the Indian Pharmaceutical Association, and direction on the issue, the Supreme Court said...........the Organization of Pharmaceutical Producers ofIndia..... The two-member SC bench also posed a question to the Organisation of Pharmaceutical Producers of IndiaThe Indian Pharmaceutical Industry: A (OPPI), an organisation of multinational pharma companies in India, who was also made a party in theTime Of Growth And Change (Part 1) case. The SC bench asked its counsel U Lalit, why youFebruary 13, 2012, Pharmaphotum cannot reduce the prices of essential medicines to makehttp://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 SkilledOrganisation of Pharmaceutical Producers of India Manpower In The IndustryThe pharma industry in India continues to grow rapidly Tapan Ray, Director General, Organisation ofand as it does the regulatory environment continues to Pharmaceutical Producers of India, shares hisshift. With over thirty years experience in pharma Tapan views on challenges faced by pharma andRay has a broad overview of how Indian pharma currently healthcare sector, hiring trends, need for skilledlooks, 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.comthoughts with us. http://info.shine.com/Article/Industry-Buzz/Pharma-Interview summary High-demand-for-skilled-manpower-in-the- industry/5588/cid819.aspxRA: Could you please start by telling me about yourbackground 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 internationalexperience in the Pharmaceutical and Healthcare Industry In my view, following are the key traits to be a goodbased in India and the U.K. I currently hold the position of manager:Director General of the Organisation of PharmaceuticalProducers of India (OPPI).  Performance orientation  Interpersonal relationshipIn the past I have held various senior positions, such as  People management skillsInternational Marketing Strategy Manager, Glaxo plc.U.K.; Director in the Board of Glaxo India Ltd; Non-  Ability to develop subordinatesExecutive Director of Biddle Sawyer India Ltd.; Managing  ‘Right first time’ Decision makingDirector of Abbott Laboratories India Ltd.; Managing  Crisis managementDirector of Kopran Limited, India; CEO and Director ofSami Labs. Ltd., India, Chairman of the Board of Shasun What, according to you, will be the major areas ofPharma Solutions Ltd., Northumberland, England, U.K. concern for pharma and healthcare companies in 2012?and Non-Executive Director in the Board of ShasunChemicals 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 talentFraming Pharma Policy To Make  Simultaneous top line and bottom line focusEssential Drugs Affordable To Poor  Ability to leverage technologyPeople  Effective product life-cycle managementFebruary 4, 2012, Pharmabiz, Ramesh  Ethical business conducts and value standards,Shankar  Compliance to regulatory standardshttp://pharmabiz.com/NewsDetails.aspx?aid=67362&sid=1In what can virtually be termed as an indictment of theirdilly-dallying tactics on the issue of framing a pharma 11
  12. 12. OPPI IN MEDIA 2010-12Drug Firms’ Petition Dismissed price of the top three brands in the respective segments. Sales of these drugs form three-fifths of the countrysJanuary 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 askedA division bench of the Bombay High Court has dismissed the government to fix ceiling prices separately forthe petitions of Indian Drug Manufacturers Association imported formulations because making the same drugsand the Organisation of Pharmaceutical Producers of outside the country is more costly.India challenging the show cause notices to theirmembers, who produce bulk drugs, about their liabilityunder paragraph 7 (2) of the Drugs Prices Control Order OPPI Urges Govt To Reconsider Decision(DPCO) 1979. To Exclude APIs From Price Control InThe authorities had also asked them to furnish NPPP-2011information regarding prices between 1979 and 1987. December 17, 2011, PharmaBizTheir reply was that the department of chemicals had no http://www.pharmabiz.com/NewsDetails.aspx?aid=66592power or authority to issue such notices. According to &sid=1them, on a true interpretation of the DPCO, 1979 readwith 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 pharmaceuticalsBulk Drugs Should Remain Under Price (DoP) to reconsider its decision to bring bulk drugs andControl, Say Pharma MNCs intermediates out of the purview of price control in theDecember 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, “OPPImncs/888806/0 strongly urges the reconsideration of para 4(2) recommendation that price regulation would not apply toIn a surprising turn of events, the pharma multinationals any upstream products such as bulk drugs andhave sought that government should not do away with intermediates. We have a strong apprehension that thereprice control on bulk drugs if it must regulate the prices will be a significant increase in prices of bulk drugs/APIsof formulations. Many of the heads of MNCs had after their price controls are lifted. Moreover, there willpreviously lauded the government’s proposal to make the be a time lag between increase in cost of bulk drugs/APIstransition to regulating formulation following their first used as inputs for finished formulations and the priceinstincts. Multinationals have expressed fear that once neutralization of input costs can only be taken at the enddecontrolled, 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 pricedearer.............. increase for 348 bulk drugs as done in case of formulations viz. the same per cent rise as given forHence, there is no scope for any price review in case of formulations”.an increase in the bulk drug prices in the proposedpolicy,” said Tapan J Ray, DG, OPPI, an industry Help In The Hour Of Needassociation of multinational drug firms. November 16-30, 2011, Express Pharma http://www.expresspharmaonline.com/20111130/retrospNew Drug Policy Draft Faces Public ective04.shtmlHeat "Though this is a patent law-related issue, unfortunatelyDecember 19, 2011, India Today it has been hyped up as a ‘major victory for public healthhttp://economictimes.indiatimes.com/news/news-by- and access to affordable treatment." Tapan Ray, Directorindustry/healthcare/biotech/pharmaceuticals/new-drug- General, Organisation of Pharmaceutical Producers ofpolicy-draft-faces-public-heat/articleshow/11162212.cms India.The governments new drug pricing policy draft is facing Tapan Ray, Director General, Organisation ofstiff 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 notPharmaceuticals Pricing Policy 2011, circulated in granted patents by the Indian Patent Office with theOctober 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
  13. 13. OPPI IN MEDIA 2010-12it has been hyped up as a ‘major victory for public health In what could be a shot in the arm for government, theand access to affordable treatment’.” domestic pharma industry has endorsed price regulation model as suggested in the draft policy, subject to certainRs.3,000 Crore Loss To Industry If Draft exemptions for indigenous research drugs. Recently, the department of pharmaceuticals had proposed priceDrug Policy Implemented control on all 348 essential medicines (National list ofDecember 6, 2011, Livemint essential medicines) through a market-based pricinghttp://www.livemint.com/2011/12/05222308/3000- mechanism. Though initially reports suggested thecrore-loss-to-industry.html?atype=tp industry was unhappy with the scope of price control being extended from the existing 74 drugs, it may notIndia’s pharmaceuticals industry could lose Rs.3,000 crore oppose it now. However, the MNC-led body OPPI hasin local profits if the government implements a proposed already made its concerns public by intervening in thedrug 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 receivingindustry 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), whichimpact top local firms, the group said, which will represents the domestic industry, has said in a note totranslate 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 inwill 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 medicinesCentrum Broking Pvt. Ltd. The Organisation of which is done at discounted rates, to go up by six toPharmaceutical Producers of India, which counts foreign seven times in the 12th Plan. This will provide a hugedrug 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 CounterfeitsDecember 6, 2011, The Economic Times November 16-30, 2011, Express Pharma(epaper page 15) http://www.expresspharmaonline.com/20111130/retrosphttp://lite.epaper.timesofindia.com/getpage.aspx?pagei ective04.shtmld=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, DirectorDrug companies have asked the Department of General, Organisation of Pharmaceutical Producers ofPharmaceuticals to modify the present draft drug policy India. There is also increased effort on the part ofas it doesnt achieve the purpose of ensuring essential voluntary organisations such as Clinton Foundation, Billmedicines at affordable prices or encourage innovation and Melinda Gates Foundation, Médecins Sans Frontièresand 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 withof Pharmaceutical Producers of India, two lobby groups generic medicines.representing domestic and foreign companies, haveobjected to 75% of drugs coming under price control and Tapan Ray, Director General, Organisation ofasked 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 citedIndian Pharma Firms Back Price that they lacked inventive ingenuity.RegulationDecember 6, 2011, The Times of Indiahttp://timesofindia.indiatimes.com/business/india-business/Indian-pharma-firms-back-price-regulation/articleshow/11001287.cms 13
  14. 14. OPPI IN MEDIA 2010-12MNCs Move SC Over Drug Price Control stakeholders to improve access to quality health care. Further efforts to bring over 60 per cent of the IndianNovember 23, 2011, The Times of India pharmaceutical market under price control will onlyhttp://timesofindia.indiatimes.com/business/india- impede the industry’s growth and development, with abusiness/MNCs-move-SC-over-drug-price- long-term negative impact on the nations’ health carecontrol/articleshow/10836944.cms goals.Till now, pharma companies, opposing price control, havebeen trying to make their voices heard in the corridors of Setting New Standardspower. With the courts recently stepping in to bring November 1-15, Express Pharmaessential medicines under a price control regime, http://www.expresspharmaonline.com/20111115/managmultinational-led industry body OPPI (Organization of ement01.shtmlPharmaceutical Producers of India) has moved theSupreme Court seeking to be heard on the drug pricing "The main challenge of the DoP would be to ensure thatissue. OPPI through an application seeking "impleadment" all companies across the pharma industry follow the samein the ongoing public interest litigation on the drug standards in their marketing practices and interactionspricing issue in the Supreme Court, wants to be a formal with the healthcare practitioners" Tapan Ray, Directorparty in the case. Sources said that the OPPI filed the General, The Organisation of Pharmaceutical Producersapplication to engage with the government "more of India. Reactions to the Department of Pharmaceuticalsactively, and wanted to ensure that its case is heard. recently introduced draft code on pharma marketing practices range from resigned acceptance, uncertainityThe PIL was filed by health groups led by All India Drug on its clauses, cynicism that it will only increaseAction Network, seeking essential drugs to be regulated corruption in the system to a call for a Jan Lokpal for theunder a price control regime in 2003. The "impleadment" pharma industry. More discussion and debate on the draftapplication was filed on November 12, and later admitted code will be required to find a win-win solution for allby the court. "The OPPI moved the Supreme Court to get stakeholders, writes Viveka Roychowdhury......impleaded as a party in the ongoing PIL because the drugpricing issue affects our industrys ability to sustainably ....Indeed, India is now globally the third largest marketprovide medicines-both innovative and generic-to the in terms of volume of production and not having such apopulation in India, and, hence will have an effect on regulation in place could spell disaster. In India thepublic 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 2010president Ranjit Shahani told TOI. (called the “OPPI Code”), based on the IFPMA Code. The Indian Drug Manufacturers Association (IDMA) alsoQ&A: Ranjit Shahani, President, OPPI released another set of guidelines for its members. Tapan Ray, director general, OPPI points out that the decision ofNovember 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, atshahani-president-oppi/455085/ least since 2004. He quotes from the January–March, 2004 issue of The Indian Journal of Medical Ethics (IJME) whichEight years after the national pharmaceutical policy was in context of marketing practices for ethical pharmastruck down by the judiciary, the Department of products in India had commented: “If the one whoPharmaceuticals, under the chemicals and fertilisers decides, does not pay and the one who pays, does notministry, has attempted to re-frame a pricing policy for decide and if the one who decides is ‘paid’, will truthmedicines sold in the country. The new policy draft stand any chance?”attempts to suggest a model that brings in all essentialmedicines under price control, as the Supreme Courtsuggested. There are differing views on the efficacy of Industry Bodies To Jointly Examinethis attempt too. Ranjit Shahani, chief of the Indian Merits Of New Draft Of Pharma Policysubsidiary of Swiss drug major Novartis and president of November 8, 2011, Pharmbiz, Josephthe 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=65926Edited excerpts: How industry-friendly is the proposed &sid=1national pharmaceutical pricing policy? OPPI supports thegovernment’s efforts to improve access to health care The major industry associations in the pharmaceuticaland is happy to partner with it towards this end. The sector are planning to hold joint deliberations on thenational pharmaceutical pricing policy, which has been merits and demerits of the new draft of the Nationallong in the making, is misguided in the belief that pricing Pharmaceutical Pricing Policy prepared and released byequals affordability equals access. Access goes far beyond the Department of Pharmaceuticals (DoP), and report topricing and the government needs to work with all the department. The associations including Organisation 14
  15. 15. OPPI IN MEDIA 2010-12of Pharmaceutical Producers of India (OPPI), Indian Drug India’s new pharmaceutical policy that aims to bring moreManufacturers Association (IDMA), Federation of Pharma essential drugs under the price control regime has drugEntrepreneurs (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 systemcommon meeting being planned for November 18 here to to limit prices to increase the access and availability oftake 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 resistApart from sending independent remarks about the its implementation as an impact analysis on the policypolicy, the stakeholders will also prepare a common set shows the prices of drugs could be reduced by up toof recommendations to be submitted to the DoP which 30%...............has invited comments from the industry and otherconcerned sections on the draft, sources said. This is …………..The Organisation of Pharmaceutical Producersexpected to make the procedure easier for the of India (OPPI), which represents the foreign drug makersdepartment 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 unitscontrolling the prices of 60 per cent of formulations, of US drug maker Abbott Laboratories and French drugbased on the national list of essential medicines prepared maker Sanofi Group, respectively, said their responsesby the Union ministry of health. The draft says the policy, will be in line with that of OPPI. A questionnaire sent toto be finalized in a month, will cover nearly all the 348 OPPI’s director general Tapan Ray remainedmedicines in the list. Based on updated data, the list will unanswered.be expanded to cover about 400 drugs to increase accessand availability of essential medicines. We Must Get The Balance Right: WittyNew Policy To Force Cut In Imported At OPPI AGM October 16-31, 2011, Express PharmaDrug Prices http://www.expresspharmaonline.com/20111031/marketNovember 3, 2011, The Economic Times 18.shtmlhttp://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 ofprices/articleshow/10588233.cms the recently held 45th AGM of the Organisation of Pharmaceutical Producers of India (OPPI), reports VivekaA key clause in the governments draft drug pricing policy Roychowdhury. With encouraging innovation for inclusivehas raised the hackles of foreign drugmakers who fear it growth as part of the Organisation of Pharmaceuticalcould force them to sharply reduce prices of several Producers of India (OPPI) declared mission, each annualimported medicines by up to 90%...............Since there general body meeting is but naturally a reinforcement ofis no separate price determination (formula) for imported this ideal. But this years AGM saw a new pragmatism andbrands, their ceiling price has been linked to the cost of acknowledgement of Indias role in the pharmaceuticalbrands made locally," says Manoj Tongra, a drugs control industry. And each speaker in their own way gave theirofficer in Rajasthan. The condition has left foreign perspective on the role India was expected to play.drugmakers enraged. "The proposal is unfair andunreasonable," says Tapan Ray, director general of the The mood was set by Ranjit Shahani, president, OPPIOrganisation of Pharmaceutical Producers of India, the and vice president and managing director, Novartis Indiaassociation of global drugmakers in India. in his presentation on the Opportunity for Innovation when he predicted, "There is a great re-balancing and asThe costs of production, one of the key determinants to the economic centre of gravity shifts, there will be thearrive at the market price of any drug, is significantly emergence of new centres of innovation. Can we couldmore in western countries due to various factors, he says. look afresh at the mode of research to decrease the costRay says it is not practical for the associations member of innovation, without compromising patient safety?.".....companies to have manufacturing plants in each countrythey operate. All international players, local or global Having defined the new brand of innovation required todecide manufacturing locations based on overall business succeed in the pharma industry of today, Witty gave awayrequirements, 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 youngMakers Worried scientists of the country to recognise, honour, andNovember 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
  16. 16. OPPI IN MEDIA 2010-12Going the R&D way: TRIPS tale Delay In CCI As Regulator For PharmaOctober 16-31, Express Pharma Deals Irks MNCshttp://www.expresspharmaonline.com/20111031/researc October 22, 2011, Financial Expressh01.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 problemfor MNCs. Businesses around the world are feeling the The Foreign Investment Promotion Board (FIPB) route forpressures of a declining world economy, and the pharma FDI proposals from the pharma sector may be here to stayindustry is no different." Ranjit Shahani, Vice Chairman & for a much longer period than the preparatory time of sixManaging Director, Novartis India months that the prime minister has given to the Competition Commission of India (CCI) to take on its newIn 1995 India signed the Trade Related Intellectual role as a filter, if sources in the commerce ministry are toProperty Rights (TRIPS) agreement so have these be believed. This is creating unease among the pharmaamended laws done the trick for pharma MNCs R&D plans MNCs, which have long maintained that they prefer a CCIfor the Indian market and made India more attractive? scrutiny to the FIPB option. They feel policyNot so, say some. "The innovative pharmaceutical uncertainities such as these may deter foreign investorsindustry 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, Indias economic growth and the ……..A clear framework also needs to be put in placegrowing 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 placerole. At the moment, less than one per cent of the Indian within a period of six months and note that as an interimpharma market consists of patented medicines," Ranjit measure, all brownfield pharma M&A proposals will beShahani, vice chairman and managing director, Novartis routed through FIPB for a period not exceeding sixIndia, explains. months,” said Tapan Ray, director general, Organisation of Pharmaceutical Producers of India, an industry bodyEncouraging 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, thePartnerships competition commission should have looked into it andOctober 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. ThisTo encourage innovation in the area of pharmaceutical will add to uncertainty, which will defer foreignresearch and development in India, the Organisation of investors’ decisions to invest in India,” Handa had saidPharmaceutical Producers of India (OPPI) has immediately after the government announced its decisioncollaborated 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 ExpressYoung 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/856876/5Pharmaceutical Research Centres/ Academic Institutions.The selection of the awardees is based on the Tapan Ray - The consolidation process within therecommendation of an independent panel of juries— pharmaceutical industry in India started gainingexperts in the field. The Award carries a trophy, a momentum since 2006, with the acquisition of Matrix Labcitation 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 JapanIn 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 forGuest, said, “the efforts taken by the OPPI to $3.72 billion followed several media reports on theacknowledge the work of these young talents is really government’s keen interest in instituting new restrictionsappreciable. As the industry, it is our responsibility and on foreign direct investment (FDI) in the pharmaceuticalduty to provide them with the inspiration so that they can sector due to various apprehensions. First, it feared thatcontinue doing the good work.” this will create an oligopolistic market, with an adverse impact on public health interest. 16

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