CDSCO Cracks Down on Unapproved FDC Drugs Posing Public Health Risks

The Central Drugs Standard Control Organisation has directed state drug controllers to stop the manufacturing and distribution of certain unapproved Fixed Dose Combination drugs due to safety risks. The directive follows concerns over drugs approved without proper evaluation under NDCT Rules 2019.

The Central Drugs Standard Control Organisation (CDSCO) has issued a strict directive aimed at halting the production and marketing of certain unapproved Fixed Dose Combination (FDC) drugs. This move follows growing concerns over these drugs, which have bypassed essential safety and efficacy evaluations.

An official letter from DCGI Rajeev Singh Raghuvanshi expressed alarm that several FDC drugs have been licensed without proper approval as mandated by the NDCT Rules 2019 under the Drugs and Cosmetics Act 1940. The directive calls for immediate cessation of sale and distribution of 35 specific FDC drugs across states and union territories.

Despite manufacturers' claims that their licenses were granted in compliance with regional authorizations, the CDSCO sees these actions as a threat to uniform enforcement of national drug standards. This bold move reflects CDSCO's commitment to protecting public health by ensuring regulatory compliance across the nation.

(With inputs from agencies.)