DCGI seeks post-market surveillance data on 2 combination drugs within 3 months

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.

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“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”.

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Notably, DCGI is doing evaluation of certain pre-1988 permitted FDCs for manufacture for sale in the country without Central Licensing Authority.

This comes in the backdrop of DCGI’s direction, in 2013, to all the states/UT drug controllers to ask the pharma companies to prove the safety and efficacy of FDCs. Moreover, a committee was constituted in 2021 to examine 19 FDCs, which considered only two drug combinations as rational.

For Imipramine Hydrochloride IP + Diazepam IP (25mg + 2mg+ 25mg+ 5mg) tablets, the committee noted continued manufacturing and marketing of the FDC and shall be indicated for co-morbid anxiety conditions and duration of the treatment should not exceed 6-8 weeks.

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In relation to the FDC—Chlorpheniramine Maleate IP +Ammonia Chloride IP + Sodium Citrate IP (2mg + 100mg + 50mg/5ml & 2.5 mg + 125mg+ 55mg/5ml syrup), the committee noted that the firms are manufacturing FDC in different strengths. It said that firms can continue manufacturing and marketing the FDCs with the condition that the firms should modify the prescribing information/label by clearly mentioning the dose schedule for adults and children.