In clinical trials, all are being punished for errors of few: Satish Reddy, Dr Reddy’s Labs

Soma Das | Economic Times | 15 May 2014

Satish Reddy, who was appointed chairman of Dr Reddy’s Labs on Tuesday, told Soma Das that in the clinical trials space the entire drug industry was being punished for errors committed by a few. Reddy, also chief of the Indian Pharma Alliance, a grouping of top local drugmakers, feels that the US threat of trade sanctions is far from over.

What are your thoughts on the US threat of downgrading India’s intellectual property environment and possibility of subsequent trade sanctions, which has been delayed for the time being?

There is a lot of pressure being mounted on India over intellectual property issues. It was largely expected that in the middle of elections here, the US is unlikely to do something drastic like downgrade India but now they have called for an ‘out of cycle’ review, which basically leaves a window to put more pressure on India. On this front, our government’s stand across ministries is very clear. We are a developing country with our own needs and we have made some commitments during TRIPS (Trade Related Aspects of Intellectual Property Rights) negotiations. We will fulfill our global obligations in a manner that best suits the realities of our country. These IPR (intellectual property rights) issues being raised have also been deliberated in detail in Indian courts, which are not kangaroo courts. Now the US should be asked to delineate specific areas of violations and discrimination for India. But these so called ‘deviations’ should be from the global obligations and not from the western standards of IPR. And if the US is not satisfied with India’s response, as the government here has said, it is free to move the World Trade Organisation to settle the dispute.

Many industry captains have voiced their concerns on the uncertainty in clinical trials regulations. But public health groups allege that many companies have not paid compensation to trial victims and not taken proper consent before trials.

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