In a typical case of putting the cart before the horse, the Health Ministry is now in the process of amending the Drugs and Cosmetics Rules, 1945 to regulate human clinical trials taking place in the country. More than the death of over 2,000 people during 2008-2011 in clinical trials, it was the recent rap by the Supreme Court that has shaken the government from its “deep slumber” and prompted it to make some semblance of initiating steps to regulate the clinical trial “racket” that has been creating “havoc” in the country. These baby steps to regulate the clinical trial industry come eight years after the government amended the 1945 Rules to permit “concurrent phase” trials of drugs developed outside India to be conducted in the country. Prior to this, trials of such drugs could only be conducted with a “phase lag,” thus safeguarding participants’ safety. The amendment was specifically aimed at promoting India as a preferred destination for conducting clinical trials. But opening the clinical-trial floodgates has come at the cost of human life and scant regard to those affected by the investigations. For instance, there is currently no provision under the Rules requiring payment of financial compensation in case of trial-related injury or death of subjects, nor is there any method for assessing the amount of compensation. Though the regulatory body is poorly staffed, the Ministry is just about “planning to increase the strength … to monitor deficient areas including clinical trials.”
Conducting trials on humans is absolutely necessary for ascertaining the safety and efficacy of experimental molecules before they are commercialised. However, abundant caution should be exercised to enrol only healthy subjects who have fully understood the implications of participating in the trial and have provided truly informed consent. Close monitoring and immediate investigation of any serious adverse events/death related to a trial and suspending/calling off the trial instantly when the molecule tested is not found safe, and providing medical attention/compensation to subjects are basic requirements. But many unscrupulous parties — from sponsors to principal investigators — have cared little to follow them in letter and spirit. So much so that animals used in preclinical testing are better monitored and protected than humans during trials. The government’s lackadaisical approach to clinical trials during the last eight years is proof that commercial interests override ethics and subjects’ safety concerns. Will the priorities change by just notifying the rules under duress? The only way out to ensure safer clinical trials is to revoke the 2005 amendment that allows concurrent trials.