CDSCO evaluates certain pre 1988 permitted FDCs for manufacture for sale in the country.

The Central Drugs Standard Control Organisation vide its notification dated 26th July 2021 has reviewed the fixed-dose combination (FDC) drugs that were exempted from the government ban in 2016.

In this regard, a meeting of the expert committee was held and the Committee has desired that the concerned stakeholders shall submit the information on the rationality, safety, and efficacy with respect to these FDCs along with relevant documents supporting documents in hard copy as well as soft copy before August 25, 2021, till 5 pm.

An FDC refers to a combination of two or more active ingredients into a single pill in a fixed dosage ratio.

Some of the popular brands that will come under latest review include piramal enterprises, saridon, abbott’s, phensedyl and tixylix, griffon’s  Grilinctus,  Cofdex, Nocold and Bromoli, Intas’ Despol and Reckitt Benckiser’s D-Cold, among others.

RECENT UPDATES