Azad gives pharma firms hopes of easing clinical trial norms

Amid a growing clamour by the biopharmaceutical lobby for India to ease regulations regarding clinical trials of new formulations, union health and family welfare minister Ghulam Nabi Azad on Wednesday said the rules governing clinical trials need to balance the interests of all stakeholders.

Speaking to mediapersons after inaugurating the Baxter Global Research Center at Biocon subsidiary Syngene's facility in Bangalore (See: Biotech firm Biocon ties up with Baxter for new research centre), 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 has taken note of.''

But giving some cause for cheer to the biotechnology companies, he added, ''I think we have done our bit at the ministry level. But at the same time I think we will have to accommodate the viewpoint of the industry as well. We are happy with the current balance between the different interests, but industry also needs to be happy.

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

Earlier, Biocon chairperson Kiran Mazumdar-Shaw said the industry hoped that the regulatory regime for clinical trials would allow innovation to proceed ''unhindered and unhampered''. Pointing out that there were ''challenging aspects to drug discovery and innovation'', she said, ''The regulatory system needs both reform and reinforcement.''

Keshav Desiraju, secretary to the ministry of health and family welfare, however 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, Desiraju said this would result in increased costs for the company, and his ministry would ''regret greatly'' such a move.

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.''

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