CDSCO extends deadline to submit details of 19 FDC drugs

New Delhi: Following several requests for an extension of the deadline for submitting information on the rationality, safety, and efficacy of pre-1988 permitted Fixed Dose Combinations (FDCs), the Directorate General of Health Services, Central Drugs Standard Control Organization (CDSCO), has extended the deadline to October 25th, 2021 at 5:00 PM, from August 25th, 2021 at 5:00 PM.

Earlier, the Medical Dialogue Team had reported that in order to assess the status of fixed dose combination drugs licensed prior to 1988, the Directorate General of Health Services, Central Drugs Standard Control Organization (CDSCO) expert committee had invited concerned stakeholders to submit information on the rationality, safety, and efficacy of such fixed dose combinations (FDCs) in the specified format.

The list of fixed-dose combination drugs licensed prior to 1988 includes 19 FDCs. The list includes Nimesulide plus Paracetamol dispersible tablets, Paracetamol, Phenylephrine, Caffeine combination, Pholcodine and Promethazine combination, lmipramine and Diazepam combination, Salbutamol and Bromhexine combination, etc.

In continuation, In addition, the Directorate General of Health Services, through its recent notice, announced ," Various representations were received requesting for further extending the timeline for submission of the information."

Further, the notice stated that the issue was considered by this office and it has been decided that concerned stakeholders may be permitted to submit the information in the prescribed format by 25.10.2021 till 5:00 PM.

In view of the above, the notice added, "All the concerned stakeholders may note that the date for submission of information in the prescribed format along with relevant supporting documents in hard copy as well as soft copy (i.e. in C.D. Form) is extended upto 25.10.2021 till 5:00 PM."

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