The CDSCO has banned 35 unapproved fixed-dose combination (FDC) drugs, citing safety concerns due to a lack of central evaluation. States have been directed to immediately stop their manufacture, sale, and distribution, and review approval processes.

The Central Drugs Standard Control Organisation (CDSCO) has instructed all state and Union Territory regulators to halt the manufacture, sale, and distribution of 35 unapproved fixed-dose combination (FDC) drugs. These include formulations such as painkillers, nutritional supplements, and anti-diabetic medications.

In a notice dated April 11, Dr. Rajeev Raghuvanshi, Drugs Controller General of India (DCGI), emphasized that these FDCs were licensed without mandatory central evaluation, raising risks of adverse drug reactions. States have been asked to review their approval processes and comply strictly with the Drugs and Cosmetics Act, 1940, and NDCT Rules, 2019. The directive follows repeated advisories highlighting the dangers of bypassing central regulatory assessment for new drug approvals.

(Source:https://www.cnbctv18.com/india/healthcare/cdsco-halts-manufacture-sale-of-35-unapproved-fixed-dose-combination-drugs-over-safety-concerns-19589762.htm )