icmr interview with dr muthuswamy

Which agencies have control over different aspects of supervision of a trial?

Every doctor is governed by the MCI Act. Any doctor doing wrong in a trial or in practice can be prosecuted. The hospital can be closed. The MCI Act is very strong, the MCI has the power to take punitive measures. Whether they are using the power or not, we cannot say.

The Drugs Controller has authority over any clinical trial for which DCGI permission has been sought and functions under the Drugs and Cosmetics Act. (Trials of recombinant or biotechnology products come under the Environmental Protection Act and the Department of Biotechnology and the Ministry of Environment have a regulatory role.)

But if someone did a trial without asking the Drugs Controller because it is an approved drug and something goes wrong then the Drug Controller will not come to know.

What do you fear?

The fear is that India is being projected as a global hub for clinical trials. Will the ethics committees of each institution be strong enough? For example, will they understand the implications of post-trial benefits? Now the pharmaceutical industry will have its strategies, like selecting 30 centres with 10 cases each to arrive at the statistically valid sample of 300, but it is invalid per centre. Will the local institutional ethics committee have the power to ask the right questions?

Should such responsibility be left to local institutional committees? They may give in to pressures which the ICMR would have the power to withstand.

That’s the only way of controlling research at the moment. We think that ethics committees have certain powers, you have to empower them to ask questions.

The second concern is that all these new contract research organisations are coming up to get their clinical trials done fast. Now some of them may be good, some may not be that good. Their intentions or ulterior motives may be different. And they get paid for the trials…