Drug testing on trial

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.

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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.