Clinical trials for drugs used in US, UK may be waived

“The new rules will make it easier for the pharma companies to introduce drugs in India which are already in use in well-regulated countries. The rules have been sent for scrutiny to the law ministry and will be notified soon,” he said. Pfizer Ltd, the Indian unit of US drug maker Pfizer Inc., did not respond to an email requesting comment by press time. A spokesperson Cadila Pharmaceuticals Ltd declined to comment. The health ministry also suggested exemption from trials for drugs that show no evidence of having a significantly different effect on the Indian population in terms of their absorption rate and efficacy. “Local trials may not be required for those where there is no evidence, on the basis of existing knowledge, of significant difference in Indian population of the genes involved in the metabolism of the new drug,” the health ministry proposal said.

The proposed rules could have legal implications, said an expert.

“The issue is subjective. It is like saying that only these countries are conducting trials ethically so we will just follow them. The clinical trials conducted in South Africa are better too, so are we saying that trials conducted in SA are not better regulated,” said CM Gulati, editor of the Monthly Index of Medical Specialities.

According to D.G. Shah, secretary general of industry lobby group Indian Pharmaceutical Alliance, the proposal would improve ease of doing business for drug makers. The health ministry recommended relaxing regulations on tests conducted on animals in case of drugs approved and marketed for more than two years in well-regulated overseas drug markets.