Crackdown on Unapproved Fixed-Dose Combination Drugs

CDSCO has directed state and UT drug controllers to halt the production and distribution of 35 unapproved fixed-dose combination drugs. Concerns about safety and efficacy prompted this action. State bodies are urged to ensure compliance with the Drugs and Cosmetics Act 1940.

Apex regulatory body, CDSCO, has called upon drug controllers across states and Union territories to suspend the production, sale, and distribution of 35 unapproved fixed-dose combination (FDC) drugs that include painkillers, nutrition supplements, and anti-diabetics.

State authorities have been urged to refine their approval process and strictly adhere to the provisions outlined in the Drugs and Cosmetics Act of 1940. These FDC drugs consist of combined active pharmaceutical ingredients (APIs).

This directive comes in response to findings that suggest certain FDCs have been licensed without necessary evaluations of safety and efficacy, posing significant risks to public health and safety.

(With inputs from agencies.)