The Central Drugs Standard Control Organisation (CDSCO) has extended the deadline till September 25, 2021 for the stakeholders to submit details of the 19 fixed dose combinations (FDCs) permitted before 1988 for manufacture and sale in the country without due approval from the Central Licensing Authority vide DCGI’s notice dated 19-08-2021.
The regulator on July 26, has said that an expert committee examining the permission of licenses for these FDCs, has sought the stakeholders to submit information on these combinations in prescribed format, as part of its proceedings.
CDSCO then 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.
In a new notice, the Organisation said that it has received various representations requesting for further extending the timeline for submission of the information. The issue was considered by the Organisation, which ordered, “…date for submission of information in the prescribed format along with relevant supporting document in hard copy as well as soft copy (i.e. in CD Form) is extended up to September 25, 2021 till 5 pm”.
Earlier, the Organisation said that 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 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.
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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