Govt proposes abolishing clinical trials on proven drugs
New Delhi: In a move aimed at speeding up the availability of new drugs, the government has proposed doing away with clinical trials for drugs that have proved their efficacy in developed markets.
According to a proposed new set of rules, a part of which has been reviewed by Mint, the government suggested waiving local clinical trials for drugs that have not had any major adverse effects on patients.
These drugs should have been approved and marketed for at least two years in the European Union, UK, US, Australia, Canada and Japan. The ministry of health and family welfare has sent the draft proposal to the ministry of law and justice for vetting before it can be notified.
The move is expected to reduce the time taken by a company to introduce new drugs in the market from 5-6 years to as few as 45 days. According to the drug regulator, the move will also lower the cost of drugs.
“This will end unnecessary repetition of trials and speed up the availability of new drugs in the country—a win-win situation for both the industry and consumers,” Drug Controller General of India G.N. Singh said in a phone interview.
Lengthy clinical trial and approval procedures deprive Indians of advanced medicines, said R.K. Vats, additional secretary in the health ministry.
“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 for 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 C.M. Gulati, editor of the Monthly Index of Medical Specialities, and an expert on the rational use of drugs.
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.
Significantly, the ministry also suggested relaxing rules for clinical trials in the case of drugs used to treat patients suffering from life-threatening or serious diseases such as drug-resistant tuberculosis, hepatitis C, H1N1, dengue, malaria and HIV.