Expert Committee on FDCs calls for information from stakeholders

The Committee also prescribed a format in which the stakeholders can submit their details including presentation copy on the said formulations.

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Meeting Committee FDA
Picture: Pixabay

Last Updated on July 29, 2021 by The Health Master

The expert committee, constituted by the Union health ministry for examining the permission of licenses for 19 fixed dose combinations (FDCs) approved before 1988, has sought the stakeholders to submit information on these combinations in prescribed format, as part of its proceedings.

A meeting of the expert committee, constituted under the chairmanship of Dr M S Bhatia, professor and head, department of psychiatry, University College of Medical Sciences, New Delhi, was held recently and has desired that the concerned stakeholders shall submit the information on the rationality, safety and efficacy with regard to the said FDCs as per the prescribed format.

A Central Drugs Standard Control Organisation (CDSCO) in a notice issued on July 26 requested all the concerned stakeholders to submit the information in the prescribed format along with relevant supporting documents in hard copy as well as soft copy the office latest by August 25, 2021 till 5 pm.

CDSCO FDA

The expert committee was constituted by the central government following the Supreme Court of India in its judgements dated December 15, 2017 and February 14, 2019, passed an order that the Central Government may carry out an inquiry as to whether fixed dose combinations licensed prior to 1988 should be permitted for manufacture for sale in the country without due approval from the Central Licensing Authority.

The FDCs under question include nimesulide pulse paracetamol dispersible tablets, paracetamol plus phenylephrine plus caffeine, amoxicillin plus bromhexine, pool coding plus promethazine, imipramine plus diazepam, chlorpheniramine maleate plus dextromethorphan plus dextromthorphan plus gualfenesin plus ammonium chloride plus menthol, among others.

The Committee also prescribed a format in which the stakeholders can submit their details including presentation copy on the said formulations.

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