HEALTH: Clinical Trial Registry India (CTRI) needs to be strengthen

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.

There are only two leading groups engaged in testing new drugs in   India , each conducting 22 trials over the past year. There is definitely a need to adopt safety standards in the case of drug trials and Indian citizens are not reduced to the level of laboratory animals.
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 had admitted that 1,725 persons had lost their lives to drug trials in last four years.

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.

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 Clinical Trials Registry India (CTRI) who registers the trial has  to be strengthened to thoroughly study a trial involving human  participants of any intervention such as drugs, surgical procedures,  preventive measures, lifestyle modifications, devices, education or  behavioral  treatment, rehabilitation strategies etc. so that the  number of loss of life is reduced to the minimum.  The government should also take up the case of those who killed during drug trials,  
as a test case, with the concerned authorities for bringing tougher  norms for clinical trials.

The laws against such damaging clinical trials should be made stringent and heavy penalties should be imposed on the violators.

(Oct 09, 2012)