Govt bans 35 fixed-dose combo drugs from manufacture, sale

They have also been asked to review their approval process for such fixed dose combination drugs (FDC) and ensure strict compliance of the provisions of the Drugs and Cosmetics Act 1940 and rules.

FDC drugs are those which contain a combination of two or more active pharmaceutical ingredients (APIs) in a fixed ratio.

The regulator issued the directions after it found that certain FDC drugs have been licensed for manufacture, sale, and distribution without prior evaluation of safety and efficacy, posing a serious risk to public health and safety.