 "India needs US whistleblower policies to stop spurious drugs")
Trade war between India and US refuses to settle down. It shifted to a higher gear during the Uruguay Round Agreement of 1994 and continues till date. It has only picked up speed after the Supreme Court judgement on Novartis over its anti-cancer drug Glivec, where the court declared that Novartis is only tweaking its existing product to gain more exclusivity.
Coincidentally even as the case was being argued in the courts, US FDA (Food and Drug Administration) seemed proactive in penalising a number of Indian companies. Some of the cases were settled out of the court while some attracted severe fines by the US FDA. Indian companies have complained to the Indian government, who are taking the case with US authorities that fine charged by the US authorities are too high.
Apart from these issues a new area of conflict has emerged especially after the Ranbaxy episode. A report in Economic Times says that India has called for a review of the US whistleblower policy as it feels that the generous incentives offered by the US FDA to reveal malpractices in their companies may encourage disgruntled executives to tamper with data to use against their employers.
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Clearly there are more than one battle being fought by the two countries on the pharmaceutical front.
Arvind Panagariya, professor of Columbia University, in an article in Business Standard says that Big Pharma (a group of some of the largest pharmaceutical companies operating in the US) has convinced the US government that the country's interests are synonymous with its own. Big Pharma is currently using its considerable clout to pressure US government to designate India as a 'priority foreign country' in its 2014 Special 301 report due on April 30, 2014.
Their grouse is India does not respect the patent laws that are valid in US and most of the western world. But India is not supposed to follow their laws but has to align our laws with those dictated under TRIPS (Trade Related Aspects of Intellectual Property Rights) under the WTO agreement. Commerce and Industry minister, Anand Sharma, has rightly stated that India will never accept a 'TRIPS plus' arrangement. And why should it; just so that Big Pharma can make big money.
While India is on a strong footing on its patent battle with Big Pharma, that might not be the case with its fight with US FDA. The US drug authority has a right to check what enters their country and the process used to produce it. In most of the cases that have been raised by the US FDA, Indian companies have genuinely not followed the best trading practice. It is in the interest of the companies themselves that they follow the best practices that are globally accepted rather than the lenient ones followed in India. Indian companies however, have a point that their view should be heard before the US FDA pronounces its judgement.
However, it is on the whistleblower case that India is on its weakest wicket. Dinesh Thakur, the whistleblower in Ranbaxy's case walked away with a $48 million compensation for pointing out how the company falsified its test data. Indian companies feel that the compensation is too high which might prompt other employees to tamper with data.
It is very unlikely that this would happen. If we look at the Ranbaxy case, Dinesh Thakur noticed that same set of test numbers were reported by the third party which was conducting the clinical trials. These were tests that were not conducted by Ranbaxy. Even if an employee tampers with the data at the companies end a separate set of data is maintained at the third party which the company can produce in its defence. There are other checks and balances which prevents such an incident to take place.
In fact, if such violation of data is noticed then USFDA should be more stricter with its policy and ban the company from selling it product by using unethical means, but after giving the company a fair chance to protect itself. Moreover Indian FDA too should come out with similar policies to prevent spurious drugs that are flooding the market.