DCGI seeks post-market surveillance data on 2 combination drugs within 3 months
Subscribe to enjoy similar stories. Drugs Controller General of India (DCGI) has sought active post-market surveillance data from the drugmakers of two fixed-dose combination (FDC) medicines—Imipramine Hydrochloride IP + Diazepam IP tablets used to ease co-morbid anxiety conditions, and Chlorphenamine Maleate IP + Ammonia Chloride IP + Sodium Citrate IP syrup used to relieve cough and respiratory distress.
The top drug regulator has given three months' time to the companies to submit the report, failing which appropriate regulatory action would be taken. The drugs were given manufacture and sale licence by state/Union territory (UT) governments without due approval from the Central Licensing Authority.
Post-market surveillance data is information about a drug's safety and efficacy after it has been approved and released for sale. Also Read | India steps up medical devices safety drive; DCGI mandates BIS compliance “Manufacturers who are already holding licences from State Licensing Authority for such FDCs before 1.10.12 and did not apply to DCG (I) were required to submit their applications for phase VI clinical trial protocol/ active post-marketing surveillance to this directorate.
The date for filing such applications expired on 11.7.2024 and already passed approximately 12 months from the date of above-mentioned notice," Rajeev Singh Raghuvanshi, DCGI, said in a communication to all the states/UT drug controllers, dated 24 February, and seen by Mint. “However, it has been observed that most of the firms have not submitted their application to this directorate.
It has been decided that the manufacturers/stakeholders who were holding license prior to 1.10.12 may submit applications...within 3 months". Also Read | Cosmet
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