No defence for these trials

Why then are trials carried out without following this route? Let us look at those cases which have earned India a bad name and see what were the justifications proferred for these unjustified trials. An outside group came to Mumbai and initiated clinical trials on patients with HIV with a new therapeutic intervention without taking anybody8217;s permission. The host investigator and the host institute are answerable for this. The explanation that they did not know the rules is not acceptable.

In another instance, a reputable government cancer centre carried out trials with a new drug in cancer patients in collaboration with a reputable medical centre in the US without approval. The American centre, when this story broke, said their investigator did all this without any consent or approval from it. The Indian investigator countered that he thought he could go ahead with the trial since he had asked for permission. Since he had not received any written approval, he had no right to undertake the trial. A probe found the trial unjustified. The trial has been stopped and the investigator barred from carrying out clinical trials for the time being.

Let us now look at some of the implications of our policy. We have a policy but are not able to implement it effectively because India is a big country and health is a state subject. An anti-malarial drug, quinacrine, was sought to be used for sterilising women. We considered it and stated unequivocally that we do not approve of this. This finding of the Toxicology Review Panel was endorsed by the Drugs Controller General of India and the women8217;s spouses informed. During a recent visit to a metropolis, I was informed that the drug is being used regularly. If this is so, this is illegal, and steps have to be taken to prosecute the doctors using the drug illegally. There is no state agency with teeth to do this. That is our weakness. As in many other areas in our country, the systems are in place but implementation is lacking.

This is why I sometimes wonder whether the Mashelkar Committee8217;s recommendation to strengthen the central drug control organisation misses the point that it is the states which will implement drug regulation and it is the states which should be given more teeth and not have some of their teeth extracted.

It must be unequivocally stated that a drug released for a particular condition should be used only for that condition. A drug which is used for cancer is being used for enhancing fertility. The drug has been cleared for its anti-cancer activity. If it is thought to be good for enhancing fertility, the pharmaceutical house or the investigators should ask for approval for carrying out clinical trials referring to this new activity. I believe that the Association of Obstetrics and Gynaecology has passed a resolution that they have the right to prescribe this drug for enhancing fertility because they have a feeling it is effective. No association of professionals can abrogate to themselves the right of not conforming to national regulatory systems. If every doctor could decide these issues on his or her own, there would be toxicological chaos and therapeutic nihilism. This cannot be allowed, particularly as all pharmaceutical houses and clinical research organisations want to carry out clinical trials in India.

We have no objection to clinical trials being carried out in the country but they must be carried out in accordance with regulations in this country and the trials should be carried out with transparency. Indeed, the ICMR is strengthening the basic structure for carrying out clinical research.

Clinical researchers in India and doctors carrying out or agreeing to carry out such trials both for Indian and foreign companies must first ensure that the Drugs Controller General has approved the clinical trials. If not, they should not proceed with the trial. They should study the protocol carefully to see whether it meets our conditions. The fact that a protocol for a multi-central trial has been accepted in six or seven countries is no reason for automatically accepting that protocol in our country. An institutional ethical committee, properly constituted, should approve the trial from the ethical point of view. Informed consent of the patients or subjects participating in the trial should be appropriately obtained.

If all this is carried out in a spirit of partnership, clinical trials could be carried out in India on Indian subjects. One of the basic tenets in clinical trial methodology is that the person who participates in the trial should benefit in some way from the trial. Let us always keep that in mind.

The writer is chairman, Toxicology Review Panel of the Indian Council of Medical Research