Don't clear FDCs sans evaluation of safety data: Drugs regulator

FDC DRUGS ARE THOSE WITH A COMBINATION OF TWO OR MORE ACTIVE PHARMACEUTICAL INGREDIENTS IN A FIXED RATIO

- Rhythma Kaul

NEW DELHI: The national drugs regulator has issued a directive to state licensing authorities asking them to treat fixed dose combinations (FDCs) strictly as new drugs and not approve them without evaluating adequate safety and efficacy data, people familiar with the matter said.

FDC drugs are those that contain a combination of two or more active pharmaceutical ingredients in a fixed ratio, referred to as "cocktail" drugs.

The central regulator—Central Drugs Standard Control Organisation—has asked state authorities to review the approvals they are granting for such fixed dose combinations and ensure strict compliance with the provisions of the Drugs and Cosmetics Act 1940 and rules.