Clinical drug trial incident in France builds a case for strict phase-I norms in India

It is being described by France’s Health Minister Marisol Touraine as “an accident of exceptional gravity”.

Late last week, news reports emerged from France of an early stage clinical trial involving an experimental painkiller medicine that left one person brain dead and five hospitalised.

It is still early days to establish what caused the incident. Was it the experimental drug, or were protocols breached in administering the drug to volunteers participating in the Phase-I trial, where volunteers are exposed to the drug for the very first time.

But as France investigates the incident, its outcome will be closely watched by policymakers across the world so they can amend their laws, if need be.

India, for instance, does need strong laws governing “first in human” exposure or Phase-I trial of a medicine, say experts, on the early learnings from the incident in France.

Though India has been tightening its rules governing clinical trials, over the last three years, there still is much ground to cover. And in this case, as industry is encouraged to innovate in India, its time to tighten Phase-I norms, say experts.

Regulatory framework Not many Phase-I trials are at present done in India; even with those done here, institutions are not equipped to handle it in terms of an emergency response, for example, says industry veteran Arun Bhatt.

In 2006, after a clinical trial went awry in the UK, the regulatory framework was streamlined with clarity on where such trials should be done (high risk trials in a hospital), the emergency response (training for staff) etc, he says, pointing out that India needs to have a similar framework governing early stage trials. Of late, Europe has been looking to relax its norms to facilitate more trials in the region, observes Amar Jesani, Editor with the Indian Journal of Medical Ethics . But it’s not clear if the incident is connected to this trend, he clarifies.

Phase-I trials require a different infrastructure and India needs clear rules on where it can be done and the response system when something goes wrong, he says. Besides, in case of an emergency, is there just a one-time follow up with the volunteer participating in the trial or will there be repeated follow ups, he asks.

The Centre also needs to address bio-availability / bio-equivalence clinical studies done in healthy volunteers for drugs whose safety profile is already established in a different market, he says. It needs greater transparency so volunteers are not exploited, he adds.

When India liberalised its clinical trial regime in 2005 to allow late stage global trials in India, alongside the overseas study – it still kept the door locked on Phase-I trials.

But local companies do undertake Phase-I trials and they need stringent governance, he points out.

Fear comes back? But will the French incident put fear and distrust back into clinical trials? The fear of unknown outcomes and the distrust that patients and volunteers would be fairly treated, even compensated?

There is no other alternative but to undertake clinical trials to bring out new drugs, says Jesani.

Clinical trials are undertaken by drug companies and research institutions to test the safety and efficacy of medicines before they are marketed. The experimental drug is put through toxicity studies in animals, followed by different stages of testing in humans.

Infact, adds industry expert Shoibal Mukherjee, given the large population and disease burden, “India needs to create new medicines for diseases prevalent in the country. No one else will do it for us.”

jyothi.datta@thehindu.co.in