More stringent rules on drug safety

The government is in the process of changing the law to ensure drug manufacturers do not compromise on safety standards.

There is a plan to give manufacturers long-term licences, to instill more accountability. Further, an official stated, the drugs controller will pull up companies for even small mistakes. Recall of drugs that come under safety alerts issued to manufacturers will become mandatory.

At present, recall is voluntary.

The source said eight committees had been formed to prepare the details. The final draft should be ready in about six weeks.

The Central Drugs Standard Controls Organization is putting the details of all its processes online. Software is also in the pipeline that will have details of all drugs that received safety alerts from the regulator.

Also, a number of fixed dose combination drugs might be banned, on grounds of irrationality, as recommended by the Kokate committee.