India's Bad Drugs and Even Worse Excuses

India's Bad Drugs and Even Worse Excuses
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India's largest drug maker, Ranbaxy, has become its largest corporate criminal. In a $500 million settlement -- a record for any generic pharmaceutical company -- the company has pleaded guilty that its medicines for epilepsy, acne, and various infectious diseases were never properly tested and contained undisclosed impurities.

Ranbaxy also admits making false statements to drug safety officials at the Food and Drug Administration to cover up its wrongs, putting millions of Americans at risk. And this is just the tip of the iceberg. Ranbaxy executives admit that "more than 200 products in more than 40 countries" are affected by "elements of data that were fabricated to support [Ranbaxy's] business needs."

Such a massive fraud is more than a business problem for Ranbaxy; it is a major diplomatic incident for India, which has built medicines into a $15 billion export industry. Yet public health professionals have long known Indian medicines are questionable. Well before the Ranbaxy scandal, a number of actions taken by the Indian government have undermined confidence in its medicines.

Most recently, the Indian government almost single-handedly killed an attempt by the World Health Organization to establish a global task force on substandard and falsified medicines, arguing that it was not WHO's job to police crimes. When the UN Office of Drugs and Crime attempted to take up the mandate, India opposed that too.

Last year, the Ministry of External Affairs also famously pretended to the Guardian newspaper that "no fake medicines have been sent from India to the continent of Africa," despite the fact that numerous scientific and medical journals have documented this trend. The government even once dispatched a former Minister of State for Commerce and Industry, Mr Shri Rajiv Pratap Rudy, to Africa with a blacklist of Indian companies producing fake medicines.  Thus one ministry is falsely denying what another one admits.

It is no secret that India is unable to regulate its drug manufacturers. India's own Parliamentary Standing Committee on Health and Family Welfare candidly admitted in two recent reports that as much as eight percent of medicines in India are of substandard quality, some of which "can harm patients," and others of which were never lawfully approved at all. It warned of an appalling shortage of drug inspectors in India's states: only 846, when 3,200 are required.

It discovered that some states issued drug manufacturing licenses without authorization from the central government, with the result that some drugs sold in India "have not been tested for efficacy and safety." The result, as the Standing Committee nicely put it, is the "continued neglect of the poor and hapless patient" in India.

In other words, the Indian government has become so obsessed with putting a good face on its drug industry to sustain exports, that it has bent rules and covered up the industry's wrongdoing to Indians at home -- possibly harming or killing them with substandard, untested, uninspected medicines. Just last month, it came to light that probably thousands died in the home province of India's Health Minister after taking fake antibiotics that several companies supplied to hospitals.

Might the same be happening to Americans, now that 80 percent of the medicines we consume are imported? India's top medicine export market is, after all, the United States.

Both countries need to face the reality that some of those medicines are bad quality and dangerous.

Congress should rewrite laws to authorize trade sanctions on countries like India that fail to regulate their drug exporters. It could mandate the FDA to certify foreign countries as having satisfactory or unsatisfactory drug regulation. Companies from satisfactory countries would be allowed to sell medicines on the American market, just like any American pharmaceutical company. But companies from unsatisfactory countries would have to provide additional proof that their medicines are safe and effective to get the same permission. We already have similar laws in regard to aviation, terrorism, and human rights. It is time to add medicines to that list.

In India, the central government has to make clear to its pharmaceutical companies that they cannot engage in international organized crime by selling hundreds of products using fraudulent safety data. That requires filling thousands of vacant jobs for pharmaceutical inspectors, raising the stakes on prosecutions, and encouraging whistleblowers to come forward --in all, a seismic attitude adjustment. The former Ranbaxy executive who heroically blew the whistle did so to American officials because Indian officials are too indolent or corrupt to investigate. He was right to be skeptical: India only opened its investigation into Ranbaxy this year, eight years after the FDA did.

If India wants its exports to be trusted around the world, it must do better than this.

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