Supreme Court bans clinical trials

Need of the hour : Proper monitoring and stringent laws on violators

The Central Health and Family Welfare Ministry has banned the clinical trials after the intervention of Supreme Court on asking the Centre and the State governments as to what steps have been taken to save the patients from the dangerous clinical trials by the multinational companies, who are creating havoc in the country and failing to stop the rackets which has caused deaths.

It is not a good thing that on the issues relating to public interest, the court should ask all the time to the governments.  Moreover, it was necessary because of the fact that during the last of two and a half year, there had been 1317 deaths and about 2000 clinical trials are already going on, for which the authenticity of documents would be reexamined.

According to Drug Controller, GOI, India exports medicines to 218 countries and then it is its responsibility to establish an proper monitoring system and only after that the permission to market the new medicines should be given.

It is pertinent to mention that for the first time when six tribal girls from Gujarat and Andhra Pradesh involved in the clinical trials of anti-cervical cancer HPV vaccine died, the government has admitted that 1725 persons have lost their lives to drug trials in last four years.

In fact, Pharmaceutical industry has become a powerful industry, driven only by profit. The MNCs conduct clinical trials of new drugs, on the people who are economically weak and underprivileged. The poor, who has become a trial subject in lieu of a meager amount of money.

Many of the drugs being tested are not even of specific relevance to the country and could have been tested anywhere. Equally shocking is the fact that the rules, under the Drugs and Cosmetics Act, entirely trust the trial investigator with the reason attributed for the death of a subject. This is resulting in gross under-reporting of actual deaths during clinical trials.

No doubt, in our country, guidelines do exist for enrolment of volunteers for clinical trials, which include obtaining consent, clearance of trial from an institutional ethics committee, due care of the volunteers, during and after the trial, if any physical injury occurs to the volunteer but they have a weak legal sanction.  More-over, doing clinical trials without giving proper knowledge to the patients is illegal.

The improper clinical trials not only put the patients in danger on which the trials are conducted but would create a havoc for all those patients who are given the medicines after its sanction.  No doubt, such trials were also being conducted in the past but using the citizens of an independent and democratic country, is a blot on our system. 

Since the cost of testing in India is 80 per cent less than in the developed world, firms come here, there is need to frame rules to specify that trials will be allowed only in cases where the firm in question undertakes to make the drug available to Indians at affordable prices. 

The need of the hour is that laws against such damaging clinical trials should be made stringent and heavy penalties should be imposed on the violators.

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