CDSCO halts manufacture, sale, distribution of 35 FDCs over safety concerns

The Central Drugs Standard Control Organisation (CDSCO) has asked all state and union territory (UT) drug controllers to disallow the manufacture, sale and distribution of 35 unapproved fixed drug combinations (FDCs) over concerns of patient safety.

 

The list of unapproved FDCs includes antidiabetics, antibiotics, painkillers, infertility medications and nutritional supplements.

 

FDCs are drugs that contain a combination of two or more active pharmaceutical ingredients (APIs) in a single form, usually manufactured and distributed in a fixed ratio.

 

In a public notice, Drugs Controller General of India (DCGI) Rajeev Raghuvanshi also asked state regulators to review their processes for granting approvals to FDCs and ensure strict adherence to the Drugs and Cosmetics Act, 1940, and the New Drugs and Clinical Trials (NDCT) Rules, 2019.

 

This comes after the CDSCO found instances where state drug authorities had granted licences for such drugs, indicating a lack of uniform enforcement of the NDCT rules across the country.

 

The central drug regulatory body added that certain FDCs had been licensed for sale, manufacture and distribution without prior evaluation for safety and efficacy.

 

“The approval of such FDCs compromises patient safety and may lead to adverse drug reactions, drug interactions, and other hazards due to absence of scientific validation,” it added.

 

The CDSCO also stated that upon issuance of show-cause notices over such FDCs, the manufacturers said they were granted licences by their respective drug licensing authorities and had not violated any rules.

 

The body has urgently asked the states to conduct investigations and take necessary action according to provisions of the NDCT Rules.