BS RAWAT
The Drugs Controller General of India (DCGI) has approved 471 fixed dose combination (FDCs) medicines as rational and allowed the state licensing authorities (SLA) to grant product licenses without the DCGI’s no-objection certificate.

The move came after the Prof Kokate Committee declared 471 FDCs related to vitamin, minerals and micronutrients as rational. Prof Kokate Committee, the apex panel, reviewed more than 6,600 FDCs since 2016 and classified them under four categories — irrational, requires further deliberations, rational and requires additional data generation.

The DGCI, Dr V.G. Somani, in a letter to states and UTs, said that apart from 1681 FDCs and 450 FDCs, further there are now 471 more FDCs relating to vitamins, minerals and micronutrients, etc, which have been declared as rational by Prof Kokate Committee and report of the committee has been accepted by the union health ministry.

For the grant of product licenses for these 471 approved FDCs, Dr Somani said that the applicant needs to submit the requisite fees preferably through Bharatkosh for each FDC to CDSCO.

The applicant also needs to submit an application to the concerned SLA for grant of product manufacturing licenses giving the details of FDC, serial number of FDC in the list, stability study data (six months accelerated), test specifications of the FDC alongwith the method of analysis as well as label, he said.

The SLA shall verify the quality of such FDCs of each applicant/ manufacturer before grant of license, it added.

Every manufacturer needs to submit the periodic safety update reports as per new Drugs and Clinical Trial Rules 2019 to the central licensing authority as defined in Rule ‘3’ i.e., DCGI. Failure to suit the PSUR will be considered as a contravention of these rules, said the letter.