Ranbaxy’s fraudulent practices- A deception most foul #Healthcare #Pharma


A deception most foul

  • Ranbaxy tablet.
    Ranbaxy tablet.
Ranbaxy’s fraudulent practices may have jeopardised millions of lives in India, Africa and the U.S.

Exactly two weeks ago, the pharmaceuticals industry was rocked by revelations that one of the world’s largest generic drug manufacturers, Ranbaxy Laboratories, pleaded guilty to seven federal criminal charges stemming from its fraudulent production practices dating back to 2008, and agreed to pay U.S. regulators $500 million in fines.

Much has since been said about Ranbaxy’s attempts to wipe the slate clean and institute rigorous testing standards across the board, including Ranbaxy CEO Arun Sawhney’s comment that the “announcement marks the resolution of this past issue,” and his company was “pleased to continue bringing safe, effective and quality medicines to market for the benefit of consumers in the U.S. and other parts of the world.”

Yet, what has been commented on far less after Ranbaxy’s deception came to light is that the lives of millions in India, Africa, the U.S. and elsewhere, who place their faith in national regulators, may have been jeopardised by their consumption of adulterated drugs.

Elusive answers

Why has Ranbaxy been permitted to continue its U.S. operations? Why have the former owners of the company, brothers Malvinder and Shivinder Singh, been permitted to walk free with the $2 billion that they made from selling Ranbaxy to Daiichi Sankyo in 2008?

Finally, few, if any, fingers have been pointed at regulators in India for permitting a fraud of such breathtaking magnitude to occur under their noses, and allowing the venality of a single corporate entity to bring disrepute to “third world generics.”

Three points

Let us set the record straight then, and consider three key facts about this episode. In doing so, we will borrow from one analytic account that has put truth-telling and hard research over sound-bites and euphemisms, Katherine Eban’s “Dirty Medicine” exposé in CNN Money/Fortune.

First, Ranbaxy’s fraud permeated multiple levels of the organisation and its perpetrators’ actions have created a veritable spectrum of health dangers for the public.

Whistleblower and former Ranbaxy Director Dinesh Thakur was a key informant in the case who gave evidence, for example, that Ranbaxy scientists were routinely directed to “substitute cheaper, lower-quality ingredients in place of better ingredients, to manipulate test parameters to accommodate higher impurities, and even to substitute brand-name drugs in lieu of their own generics in bio-equivalence tests to produce better results.”

That Ranbaxy lied to the U.S. FDA and other regulators frequently, and indulged in back-dating and forging data, Mr. Thakur found, was “common knowledge among senior managers of the company, heads of research and development, people responsible for formulation to the clinical people.”

Sometimes it appeared that sheer insensitivity to the plight of clients consuming their dubious products had crossed all bounds.

Another senior official who quit Ranbaxy after her attempts to get management to curb the malpractice failed was Kathy Spreen. On one occasion when Dr. Spreen mentioned her concerns about the quality of Ranbaxy’s AIDS medicines for Africa an executive reportedly said, “Who cares? It’s just blacks dying.”

Second, U.S regulators have at best achieved a pyrrhic victory as the deal they have struck with Ranbaxy still leaves consumers at risk, does not result in charges against a single company official.

Despite several incriminating prior investigations of Ranbaxy plants in Dewas and Paonta Sahib in 2006, the FDA “did nothing to stop all the drugs that were already on the market, drugs that had been approved, or applications submitted from other sites,” Ms. Eban notes.

In February 2009, the FDA finally deigned to punish Ranbaxy by imposing an Application Integrity Policy, which effectively closed down Ranbaxy drug applications.

Yet, in November 2011, it did not see fit to hold Ranbaxy back from selling generic Lipitor, the popular cholesterol-reducer.

Blessed with a six-month exclusivity grant from the FDA, Ranbaxy went on to rake in a cool $600 million through atorvastatin sales.

Ultimately, fate intervened and, in November 2012, Ranbaxy had to issue a massive recall notice for atorvastatin after glass particles were discovered in samples. The FDA backed off from any suggestion that it may have bungled its approvals process for Ranbaxy.

The India angle

Third, Indian regulators’ monumental failure to address Ranbaxy’s malaise early on has only been compounded by its unwillingness to take strong steps, even at this late stage, to bring the company to justice in Indian courts and save millions of its citizens from avoidable harm.

The media must share blame for not keeping the government’s nose to the grindstone. After Ranbaxy’s knuckles were notionally rapped earlier this month the press has displayed a staggering lack of interest in the core issue, the damage that Ranbaxy’s products have likely caused to Indians and the government’s role in that.

One major newspaper proclaimed, “The good news is that the company’s U.S. revenues, after dipping post-2008 for a couple of years, have now started recovering [sic].” Another declared, “Despite all the noise, the overwhelming majority of generic drugs are as safe and effective as their brand-name counterparts. Brand-name companies have also had their share of quality problems.” It is inconceivable with all the brouhaha about intensifying U.S.-India co-operation that New Delhi could have been entirely in the dark since 2006, when questions were first raised about Ranbaxy in the U.S. What were India’s Ministry of Health and Drug Controller General doing since then?

Even as late as last week, the Ministry’s Joint Secretary Arun Panda was on record saying “There is no order from the health ministry which has been issued to Drug Controller General of India to launch a probe against the company as of today.”

One can only wonder what further evidence against Ranbaxy officials hoped to obtain when one of them said, “Launching a probe against a company is a serious matter and a decision to that effect would be taken after due consideration of all aspects in the Ranbaxy case.”

Coming as it does after the Supreme Court’s landmark decision in the Novartis Glivec case, the government’s inaction hardly helps the cause of the generics business. Now we should expect influential branded-drug manufacturers to redouble their lobbying efforts to get lawmakers to block the rising tide of generic alternatives.

Similar to high-level corruption cases it may be that the government will respond adequately only when there is a surge of public protest. Otherwise, the next time you fall ill, the prescription may well be glass particles.

narayan.thehindu@gmail.com

 

Drug Patent Rights India Wins First Round Novartis Full Text of Judgement


 

The instances of Multinationals stealing indigenous medicines is well-known.

So are the capricious overpricing of life saving Drugs, like Cancer Drugs.

The Intellectual Property Appellate Board rejected the German drug maker’s appeal of the 2012 ruling on Monday. It also ruled that under the license Natco must pay 7 per cent in royalties on net sales to Bayer.

Bayer sells a one month supply of the drug for about $5,600. Natco’s version would cost Indian patients $175 a month, less than 1/30th as much.

Western pharmaceutical companies have been pushing for stronger patent protections inIndia to regulate the country’s $26 billion US generics industry, which they say frequently flouts intellectual property rights. However, health activists and aid groups counter that Indian generics are a lifesaver for patients in poor countries who cannot afford Western prices to treat diseases such as cancer, malaria and HIV.’

Big Court Ruling Favors Generic Drugs: The Times’s Katie Thomas explains why a ruling in India favoring generic drugs has rippling effects around the world.

Big Court Ruling Favors Generic Drugs: The Times’s Katie Thomas explains why a ruling in India favoring generic drugs has rippling effects around the world.

India drew first blood in a Patent case in The Supreme Court .

DOWNLOAD FULL JUDGEMENT

‘People in developing countries worldwide will continue to have access to low-cost copycat versions of drugs for diseases like H.I.V. and cancer, at least for a while…

Production of the generic drugs in India, the world’s biggest provider of cheap medicines, was ensured on Monday in a ruling by the Indian Supreme Court.

Cost of Glivec used for targeted therapy in CML patients: 1 lakh per month (approx)

Cost of its generic versions : 8,000 -10 ,000 per month

No. of cancer centres in India: 450 approx (half are in the private sector)


The debate over global drug pricing is one of the most contentious issues between developed countries and the developing world. While poorer nations maintain they have a moral obligation to make cheaper, generic drugs available to their populations — by limiting patents in some cases — the brand name pharmaceutical companies contend the profits they reap are essential to their ability to develop and manufacture innovative medicines.

Specifically, the decision allows Indian makers of generic drugs to continue making copycat versions of the drug Gleevec, which is made by Novartis. It is spelled Glivec in Europe and elsewhere. The drug provides such effective treatment for some forms of leukemia that the Food and Drug Administration approved the medicine in the United States in 2001 in record time. The ruling will also help India maintain its role as the world’s most important provider of inexpensive medicines, which is critical in the global fight against deadly diseases. Gleevec, for example, can cost as much as $70,000 a year, while Indian generic versions cost about $2,500 a year.

The ruling comes at a challenging time for the pharmaceutical industry, which is increasingly looking to emerging markets to compensate for lackluster drug sales in the United States and Europe. At the same time, it is facing other challenges to its patent protections in countries like Argentina, the Philippines, Thailand and Brazil.

“I think other countries will now be looking at India and saying, ‘Well, hold on a minute — India stuck to its guns,’ ” said Tahir Amin, a director of the Initiative for Medicines, Access and Knowledge, a group based in New York that works on patent cases to foster access to drugs.

In trade agreements — including one being negotiated between the United States and countries in the Pacific Rim — the drug industry has lobbied for stricter patent restrictions that would more closely resemble protections in the United States.

 

 

#India – Govt has no plans for National Health Bill #WTFnews


PIB RElease, March 22, 2013

The Government has no plans to introduce National Health Bill. In order to
provide relief to the common man in the area of healthcare, a countrywide
campaign in the name of “Jan Aushadhi Campaign” has been initiated by the
Department of Pharmaceuticals, in collaboration with the State Governments,
by way of opening up of Jan Aushadhi Generic Stores in the Government
Hosptials to supply of generic medicines through Central Pharma Public
Sector Undertakings, to make available quality generic medicines at
affordable prices to all. So far, 149 Jan Aushadhi Stores have been opened
in different States/UTs in the country as on 28.02.2013.

Further, under the provisions of the Drugs (Prices & Control) Order, 1995
(DPCO, 1995), the prices of 74 bulk drugs listed in its First Schedule and
the formulations containing any of these scheduled drugs are controlled.
National Pharmaceutical Pricing Authority (NPPA) fixes or revises prices of
scheduled drugs/formulations as per the provisions of the DPCO, 1995. In
respect of drugs not covered under DPCO, 1995 i.e. non-scheduled drugs,
manufacturers fix the prices by themselves without seeking the approval of
the Government/NPPA. However, the trend in prices of non-scheduled drugs is
monitored and suitable action is taken by NPPA where price increase is more
than 10% in a period of one year on moving basis.

The National Pharmaceutical Pricing Policy -2012 (NPPP-2012) notified on
07.12.2012 provides all the manufacturers/importers manufacturing /
importing the medicines as specified under National List of Essential
Medicines 2011(NLEM-2011) shall be under the purview of price control. The
objective of NPPP-2012 is to put in place a regulatory framework for
pricing of drugs so as to ensure availability of required medicines
essential medicines” at reasonable prices.

The Government is also providing support to the States under the NRHM for
providing free Generic Drugs in Public health facilities. States have been
encouraged to bring out essentials Drugs lists (EDL) facility wise and
Standard Treatment Guidelines to promote safe and efficacious drug use.

This information was given by Minister of State for Health & Family Welfare
Shri AbuHasem Khan Choudhuryin written reply to a question in the LokSabha
today.

 

Link patented drug prices to per capita income: Panel #patientrights


SEEKING AFFORDABILITY

Ag overnment panel has proposed that prices of patented medicines be based on the country’s per capi ta income, a move that would substantially reduce prices of costly drugs made by global pharmaceutical firms. 

The proposal, which seeks the input of other government agencies as well as industry groups, could provoke the ire of Big Pharma, which has clashed with India over protec tion of intellectual property price regulations for generic drugs, and compulsory licens es for costly medicines.
A panel formed under the ministry of chemicals and fertilizers has recommended setting up a committee to negotiate with drugmakers to fix prices of costly drugs used to treat deadly diseases such as cancer, HIV and hepatitis.
The proposal is the latest in a series of measures taken by India to make medicines more affordable for the coun try’s 1.2 billion population.
“If we compare the per capita income with the prices of patented medicines in countries like Australia or France, prices in India are compara tively high and hence, they need to be regulated,” a senior ministry official told Reuters, declining to be identified because he was not authorized to speak with media.
Generic medicines account for more than 90% of India’s $13 billion pharmaceuticals market. US-based Abbott Laboratories has the largest share of the overall Indian drug market followed by Cipla.
The proposal, posted late on Monday on the ministry website, cites as an example the lung-cancer drug erlotinib HCL, sold by Roche Holding as Tarceva. In India, it costs Rs 35,450 for a month’s course of 100 mg tablets, equivalent to Rs 1,21,085 in France and Rs 1,21,650 in Australia.
Based on per capita gross national incomes, if the drug costs Rs 35,450 in India, its respective cost would be just Rs 11,643 in France and Rs 10,309 in Australia based on per capita income in the respective countries, the report said.
The Organization of Pharmaceutical Producers of India, which represents for eign drugmakers in India, did not reply to questions from Reuters.
“If stringent price regula tions are enforced then latest drugs will not be made availa ble in India,” said Ameet Hariani, managing partner at Hariani & Co, a Mumbaibased law firm that advises drugmakers and other companies. REUTERS

 

 

#India-State sponsored competition works -Pharmacies to sell medicines at 60% less #goodnews



11 December 2012
statesman news service

SILIGURI, 11 DEC: All medicine-shop owners around North Bengal Medical College and Hospital (NBMCH) have decided to sell generic drugs at 60 per cent less than the maximum retail print price.
The shops’ owners displayed a notice in this regard in front of their shops today. The medicine shop owners’ association affiliated to the Bengal Chemists and Druggist Association, Darjeeling district, adopted the resolution on Sunday after they came to know that NBMCH would open a fair price medicine shop.
The Zonal Secretary of the association in Siliguri, Mr Atul Roy, said: “In order to survive in competition with the government’s fair price shop, the medicine sellers have decided to sell generic drugs at 60 per cent less than the printed price.”
Mr Roy also said: “Several companies supply generic products to us at 80 per cent less than the printed price. If we deduct 60 per cent, the profit of margin would be 20 per cent. People will be able to buy medicines at even lesser price from us than the state-run outlet.”

 

(The tussle between NBMCH and Chemists’ and > Druggists’Association is providing medicines at cheaper rates. Is it going
to be for a short time or would it be continued continuously. Any how patients have  benefited.

 

India- Free medicine scheme gets Rs 1,300 crore boost #rightohealth


Kounteya SinhaKounteya Sinha, TNN | Sep 20, 2012, 02.12AM IST

Union health minister Ghulam Nabi Azad has cleared Rs 1,300 crore under the National Rural Health Mission (NRHM) for states to support their purchase of medicines.
NEW DELHI: India has made its first major move towards providing free medicines for all.

Union health minister Ghulam Nabi Azad has cleared Rs 1,300 crore under the National Rural Health Mission (NRHM) for states to support their purchase of medicines. The largesse will not only help buy general drugs for government-run hospitals but also those needed under the Janani-Shishu Suraksha Karyakram (JSSK).

Under the JSSK, all pregnant women delivering in public health institutions are entitled to free and cashless delivery, free C-section, exemption from user charges, free medicines, blood, consumables and diagnostics and free diet for three days in case of normal delivery and seven days in case of C-section.

The minister has also asked the states to prepare a policy articulation document, an essential drugs list and standard treatment protocols and introduce a procurement system and supply chain management.

“States already have a budget to purchase drugs but it isn’t enough. The latest allocation is to support the state budget for 2012-13,” said a ministry official.

Officials said that states will have to procure drugs through an open tender. Companies applying for the tenders will have to have good manufacturing practices compliance certificate, a no-conviction certificate and should have a specified annual turnover. The drugs will also have to carry a not-for-sale label printed on the packaging.

The ministry says upto 75% of private out-of-pocket (OOP) health expenditure is on purchasing drugs of which 76% is spent on purchasing OPD drugs.

The free medicines for all the programmes are estimated to cost Rs 28,560 crore during the 12th five year plan.

At present, the public sector provides healthcare to 22% of the country’s population and it is likely to swell to 52% by 2017 once medicines are provided for free from 1.6 lakh sub-centres, 23,000 primary health centres, 5,000 community health centres and 640 district hospitals.

Planning Commission says 39 million Indians are pushed to poverty because of ill health every year.

Around 30% in rural India didn’t go for any treatment for financial constraints in 2004. In urban areas, 20% of ailments were untreated for financial problems the same year. About 47% and 31% of hospital admissions in rural and urban India, respectively, were financed by loans and sale of assets.

A ministry official said it is being made mandatory for all doctors in the public sector to prescribe generic drugs and salt names and not brands.

The Cabinet has approved the setting up of a Central Procurement Agency (CPA) for bulk procurement of drugs.

“Only a handful states will be able to roll out free medicines by this year end,” a ministry official said.

Strongly backed by Prime Minister Dr Manmohan Singh himself, the free-medicines-for-all scheme has been referred to as the “real game-changer”.

The ministry has sent the National List of Essential Medicines, 2011, (348 drugs which includes anti-AIDS, analgesics, anti-ulcers, anti psychotic, sedatives, anesthetic agents, lipid lowering agents, steroids and anti platelet drugs) to all the states to use it as reference to prepare their EDL.

Tamil Nadu has been providing free medicines in its public health centres for the past 15 years, while Rajasthan introduced it last October. Both these states have a corporation that runs the show with complete functional autonomy.

A Planning Commission panel had said drug prices have shot up by 40% between 1996 and 2006. It said that during the same period the price of controlled drugs rose by 0.02%, while those in EDL increased by 15%. The price of drugs that were neither under price control, nor under EDL grew by 137%.

States have cut down on spending to purchase drugs, adding to aam aadmi’s woes.

A study by the Public Health Foundation of India recently found that while India’s per capita OOP expenditure for healthcare costs has gone up from Rs 41.83 in 2005 to Rs 68.63 in 2010, the per capita spending on drugs increased from 29.77% to 46.86% during the same period, while hospitalization cost went up from 11.20% to 22.47%.

Outpatient expenditure also increased from 30.63% to 46.16%.

Catastrophic spending, or percentage of households spending more than 10% of their overall income on healthcare, is nearly 15% in states that have insurance in place as against 11% in those that don’t have such policies.

Times View

Indians spend heavily out of their own pockets to purchase out-patient drugs, so providing free essential medicines is a welcome move from the government. However, it will remain a meaningless gesture unless good-quality drugs are provided, doctors are monitored to ensure that they prescribe generic drugs rather than branded ones and states put in place a transparent procurement system and supply chain management.

Free medicines for all from October



Kounteya Sinha, TNN | Jun 23, 2012, 01.51AM IST

NEW DELHI: India‘s ambitious policy to provide free medicines to all patients attending a government health facility across the country will be rolled out from October.

Strongly backed by Prime Minister Manmohan Singh himself, the free-medicines-for-all scheme — being referred to as the “real game changer” — has received its first financial allocation  from the Planning Commission for 2012-13.

At present, the public sector provides healthcare to 22% of the country’s population.

The ministry estimates that this will increase to 52% by 2017 once medicines are provided for free .

The ministry has sent the National List of Essential Medicines, 2011, (348 drugs which includes anti-AIDS, analgesics, anti-ulcers, anti psychotic, sedatives, anesthetic agents, lipid lowering agents, steroids and anti platelet drugs) to all the states to use as reference.

The states, however, have been asked to create their own Essential Drugs List (EDL), keeping in mind the diseases that worst affect them. Around 75% of the funds under the scheme will be borne by the Centre, while the rest will be the state’s responsibility.

Around 5% of the district funds will be allowed to be used to purchase drugs outside the EDL. The Cabinet has approved the setting up of a Central Procurement Agency (CPA) for bulk procurement of drugs.

The PMO has asked the ministry to set up the CPA as early as possible. At present, 78% of the entire health expenditure in India is from out of pocket (OOP). Purchasing drugs alone accounts for 72% of this OOP expenditure.

They have also been asked to devise standard treatment protocols in order to avoid unnecessary and irrational treatments.

The states will procure drugs directly from manufacturer or importer through an open tender. Companies applying for the tenders will have to have GMP compliance certificate, a no conviction certificate and should have a specified annual turnover. The drugs must carry a not-for-sale label printed on the packaging.

A district-level state-of-the-art warehouse will have to be set up by states to store the drugs and a passport driven system will move the medicines to district hospitals, CHCs and PHCs will then send the drugs to the sub centres.

It is being made mandatory for all doctors in the public sector to prescribe generic drugs and salt names and not brands. Action will be taken against doctors found prescribing brands.

A Planning Commission panel had said drug prices have shot up by 40% between 1996 and 2006. It said that during the same period the price of controlled drugs rose by 0.02%, while those in the EDL increased by 15%. The price of drugs that were neither under price control, nor under the EDL grew by 137%.

The Commission says 39 million Indians are pushed to poverty because of ill health every year. Around 30% in rural India didn’t go for any treatment for financial constraints in 2004. In urban areas, 20% of ailments were untreated for financial problems the same year. About 47% and 31% of hospital admissions in rural and urban India, respectively, were financed by loans and sale of assets.

Outpatient expenditure  increased from 30.63% to 46.16%. Catastrophic spending, or percentage of households spending more than 10% of their overall income on healthcare, is nearly 15% in states that have insurance in place as against 11% in states that lack such policies

“Free Medicines for All” soon to be a reality in Govt Hospitals


Feb 13, 2012 NEW DELHI: Free medicines to all patients visiting any government health facility across the country could soon be a reality with the health ministry ready to roll out a nearly Rs 30,000 crore ‘free-medicines-for-all’ scheme with the PMO‘s strong backing.

The free medicine initiative along with an expansion of the National Rural Health Mission to urban areas, a more district-oriented approach and implementation of recommendations of the K Srinath Reddy committee on universal health coverage will be important focus points of UPA-2’s health policy. The scheme is also expected to be strongly backed by the Sonia Gandhi-chaired NAC at a meeting on February 17.

At a meeting chaired by Pulok Chatterjee, principal secretary to the PM, on Friday, the medicine-for-all scheme and other thrust areas got a thumbs up with PM Manmohan Singh keen to roll out health sector initiatives. The medicine proposal will help cut India’s tremendously high out-of-pocket (OOP) expenditure on health care.

Speaking to TOI, a ministry official said, “We are ready to roll out the scheme which will provide free generic medicines to all those who visit government health care facilities across the country. This will reduce OOP expenditure and also encourage more people to visit government health facilities. However, we can’t make the announcement now with the elections on as it would violate EC guidelines.”

Instead of increasing public spending on drug procurement when millions of Indian households have no access to medicines, several large states have decreased fund allocation. Consider the case of Kerala. Even though the state spent the highest in India on drug procurement last year – 12.5% of its health expenditure – the expense was significantly less than in 2001, when it stood at 17%.

“We estimate that an increase in the public procurement of medicines from around 0.1% to 0.5% of GDP will ensure universal access to essential drugs, greatly reduce the burden on private OOP expenditures and increase the financial protection for households,” a report has said. Drug prices have shot up phenomenally in India over the past decade and a half. This has been the main reason for the rising costs of medical care, which more than tripled between 1993-94 and 2006-07.

Free Medicines in Rajasthan, India


India is known as the pharmacy of the world but 65% of Indians have no access to essential medicines. Watch this video to see how the State of Rajasthan in India is tackling the problem by promoting generic medicines and providing these free of charge in the public sector.

This week negotiations continue on the EU-India Free Trade Agreement. Worldwide there are serious concerns that the deal will include stricter intellectual property rules than necessary and result in a deadly escalation in medicine prices for developing countries. Such a deal would also threaten innovative and progressive schemes like this one in India itself.

 

Watch the Video here 

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