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The Ranbaxy case highlights larger lapses in the drug regulation system

The Ranbaxy case highlights larger lapses in the drug regulation system

India’s largest drugmaker,Ranbaxy,recently pleaded guilty in an American court to several criminal offences related to the fraudulent manufacture and sale of adulterated drugs. Ranbaxy admitted that its medicines for epilepsy,acne and various infectious diseases were never properly tested,that they contained undisclosed impurities and that to cover-up,it made fictitious statements to US authorities. For this,Ranbaxy agreed to pay a $500 million settlement,the largest ever for a generic pharmaceutical company.

But the story of Ranbaxy isn’t over with a single settlement in the US. Company executives wrote that “more than 200 products in more than 40 countries” are affected by “elements of data that were fabricated to support business needs”. Such a massive fraud is more than a business problem for Ranbaxy; it is a diplomatic incident for India. Brand India has worked hard to build medicines into a $15 billion export industry,but unfortunately,the Indian government seems bent on damaging it. Well before the Ranbaxy debacle,a number of uncomfortable revelations have undermined foreign confidence in Indian medicines.

In foreign eyes,India’s government is not a partner in the global fight against substandard and falsified medicines,but the main problem. When the WHO launched a global task force to fight these products,Indian diplomats killed it by arguing that it was not the WHO’s job to police crimes. Then,when the UN Office of Drugs and Crime tried taking up the mandate,India’s diplomats attempted to stymie it too. Such cynical diplomacy is interpreted as India sheltering its medicines industry from outside scrutiny. The Ranbaxy cover-up proves that this interpretation is correct.

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Nor is the Centre truthful when responding to foreigners’ concerns. Last year,when The Guardian reported that Africans were imperilled by fake medicines imported from India,the MEA called this “totally incorrect”,and said that “no fake medicines have been sent from India to the continent of Africa”. But several scientific and medical journals report discoveries of fake Indian medicines in Africa,some of which contained no proper ingredient.

The Centre’s health officials also engage in untruths to conceal the scope of India’s bad medicine problem. In 2010,the ministry of health and family welfare carried out a flawed study,which concluded that just 0.046 per cent of Indian medicines are spurious. The WHO reckons that about 1 per cent of medicines are fake in highly advanced countries. Can one seriously believe that India’s medicine market is 20 times cleaner than America’s or Europe’s?

The only government institution to take these issues seriously is the parliamentary standing committee on health and family welfare. It candidly admitted that 7-8 per cent of medicines in India are of substandard quality; some “can harm patients” and others were never lawfully approved at all. It warned of an appalling shortage of drug inspectors in the states: only 846,when 3,200 are required. It discovered that some states had issued drug manufacturing licences without authorisation from the Centre,so that some drugs now sold in India “have not been tested for efficacy and safety”. The result,as the standing committee put it,is the “continued neglect of the poor and hapless patient” in India.

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There is an irony to the standing committee’s findings: the Union government has become so obsessed with putting a good face on India’s drug industry to sustain exports that it has bent rules and covered up the industry’s wrongdoing to Indians at home. The approach is counterproductive,for in falsely denying that medicine quality problems exist,the government seems dishonest,and therefore worrisome for foreigners thinking of doing business here.

The Centre’s disregard of medicine quality has handed the perfect stick to opponents to beat India with. Western governments and drug companies are angry that India has violated patents,but the Centre has moved with immaculate care to deny these opponents a chance to retaliate under the WTO’s patent rules. Medicine quality,however,is a different matter. Even though the West cannot act directly on patent grievances,the Centre has given it justification to retaliate indirectly,by toughening inspections of India’s medicine manufacturers or barring imports of some products altogether. In trade law,any risk to human health permits erecting barriers to trade.

The Centre could restore confidence by sanctioning Ranbaxy and doubling oversight of all other drug companies,but that would require a seismic attitude adjustment. The Gurgaon-based executive who disclosed Ranbaxy’s wrongs in 2005 did so to the Americans,because India’s whistleblower laws are feeble. Eight years later,the American prosecution of Ranbaxy is done. Only now is the drug controller general of India opening an investigation.

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When India’s government foils global efforts to improve medicine quality,it only drives foreigners away from exports. It also condemns hapless Indians patients to injury or death from dangerous medicines on the domestic market. A more misguided policy would be hard to imagine.

The writer is Canada Research Chair in Law,Population Health and Global Development Policy,Faculties of Law and Medicine,University of Ottawa

First published on: 21-06-2013 at 12:48:21 am
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