Clinical trials: draft rules put onus of injuries, death on drugmakers

IF THE SPONSOR FAILS TO PROVIDE “MEDICAL MANAGEMENT” TO THEIR TRIALS, THE TRIAL WILL BE CANCELLED AND THE COMPANY WILL BE RESTRICTED FROM HOLDING ANY MORE TRIALS, THE RULES SAY

NEWDELHI: Pharmaceutical firms conducting clinical trials of drugs in India will no longer be able to escape responsibility in case of injury or death of participants.

According to new draft rules for clinical trials and new drugs, if the sponsor fails to provide “medical management” to their trials, not only will the trial be cancelled, but the company will also be restricted from holding any more trials.

However, in a boost to firms wanting to conduct trials on drugs proposed to be manufactured and marketed in India, the permission for trials will be granted within 45 days.

According to the new rules in the works, the sponsor of the trial or bioavailability or bioe- quivalence (BA/BE) study of a new drug will have to provide free medical management for as long as required.

BA/BE studies measure the rate and extent of absorption of drugs in the human body.

Additionally, if the trial subject suffers from any other illness during the clinical trial or BA/BE study, the sponsor should provide necessary medi- cal management and ancillary care. “Where the sponsor or the person who has obtained permission from the central licensing authority fails to provide medical management, the licensing authority shall, after affording an opportunity of being heard, suspend or cancel the clinical trial or BA/BE study or restrict the sponsor to conduct any further clinical trial,” says the proposed regulatory framework for clinical trials and new drugs. Mint has reviewed a copy of the final draft.

As per the draft new drugs and clinical trials rules, 2017, companies will have to pay compensation if the drug fails to provide the intended therapeutic effect or where the required standard care or rescue medication, although available, was not provided to the subject.