Industry says regulations too stringent, others say they are lax: Minister

The Indian regulatory regime governing clinical trials needs to balance the interests of all stakeholders, Union Minister for Health Ghulam Nabi Azad said on Wednesday.

He was speaking to presspersons after inaugurating the Baxter Global Research Center, located at Biocon subsidiary Syngene’s facility here.

Mr. Azad said, “The industry has complained that the regulations are too stringent, but there have also been complaints by Parliamentarians, NGOs and others that they are too lax, which the Supreme Court had taken note of.

“We are happy with the current balance between the different interests, but industry also needs to be happy,” Mr. Azad observed.

“We have gathered from the (pharmaceutical) industry that the number of clinical trials being conducted in India has halved in recent years. While we are interested in the matter of patient safety, we also want to make sure that innovation is not hampered,” Mr. Azad said.

Earlier, at the inaugural function, Biocon chairperson Kiran Mazumdar-Shaw said there were “challenging aspects to drug discovery and innovation.”

Specifically, she said industry hoped that the regulatory regime for clinical trials would allow innovation to proceed “unhindered and unhampered.”

“The regulatory system needs both reform and reinforcement,” Ms. Mazumdar-Shaw said.

‘Found wanting’

Keshav Desiraju, Secretary, Union Ministry of Health and Family Welfare, said, “We have found too many instances of Indian manufacturing facilities found wanting (in meeting regulatory norms in overseas markets), and this is a matter of concern.”

Referring to the possibility that Biocon may move its projects outside India because of its dissatisfaction with the drug trial regime in India, Mr. Desiraju said this would result in increased costs, which his ministry would “regret greatly.”

Industry would need to remain engaged in a dialogue with his ministry on the matter, he said.

“While it is not our intention to impose unrealistic barriers on industry, it is equally our intention not to take risks, which may compromise the safety of the subjects of clinical trials,” Mr. Desiraju said.

“All those who have followed the debate know that the cause of drug development is not privileged over the cause of patient safety,” he said.

The new facility houses 100 multidisciplinary scientists from Baxter International, an American healthcare company, and Syngene, the Biocon arm that specialises in custom research and manufacturing.

Ms. Mazumdar-Shaw pointed out that the Syngene’s facility in Bangalore, which hosts over 3,000 professionals, was the single biggest cluster for research in life sciences in the world.

Jean-Luc Butel, corporate vice-president-international, Baxter, said the new facility would enable the development of cheaper and high quality drugs for patients around the world.