Examine 16 irrational FDCs for further submission: Health Ministry to DTAB constituted sub-committee

The subcommittee has been further asked to review the 33 rational FDCs as well as the 20 FDCs to see if there are any inconsistencies and inform the chairman of DTAB Dr Sunil Kumar who is also the Director-General of Health Services (DGHS).

This came after considering the recommendation of the Prof. Kokate Committee on pending 17+49 FDCs out of the 294 FDCs and 3 FDCs referred by the High Court of Maharashtra, Nagpur, at the 86th meeting of the Drugs Technical Advisory Board held in early April.

The Medical Dialogues had earlier reported that the Kokate Committee was constituted by the Ministry Of Health And Family Welfare, Government of India, under the chairmanship of Prof. C.K. Kokate, VC, KLE University, Belgaum, Karnataka. The purpose of the committee was to examine the rationality of fixed-dose combination drugs in the country. Further, to evaluate the report submitted by Kokate Committee, a sub-committee had been constituted under the Chairmanship of Dr Nilima Kshirsagar, the Chair in Clinical Pharmacology, ICMR, Mumbai, to examine the FDCs declared as irrational in the assessment report of the committee.

In the latest meeting, the board was apprised that, the Office of Drugs Controller General India (DCGI) had received complaints from Consumer Associations in the year 2007 regarding Fixed Dose Combinations (FDCs) not approved by DCGI but marketed in the country.

As a part of follow up action of the complaints, the office of DCGI had prepared a list of 294 FDCs and directions were issued to all State/UT Drugs Controllers to withdraw these 294 FDCs which were licensed without approval of DCGI. The manufacturers association, however, got a stay from the High Court of Madras in respect of directions issued in the matter.

The matter was then referred to DTAB at its 56th meeting on January 16, 2008, where DTAB had formed a Sub Committee to investigate these FDCs.

As a result of its investigation, the Sub Committee had submitted a report to the DTAB, stating that among 294 FDCs,

(a) For 17 FDCs, data provided by the manufacturer was deemed insufficient to demonstrate rationality, safety, and efficacy.

(b) With regard to 49 FDCs, it was reported that further data generation in terms of safety and efficacy by conducting clinical trial/PMS study.

Thereafter, the Ministry had suggested that all pending issues (17+49) with respect to 294 FDCs may also be dealt with by the Prof. Kokate Committee and once the Prof. Kokate committee submits its report, it may be placed before DTAB for further necessary action.

Furthermore, in light of the High Court of Maharashtra, Nagpur Bench, the 84th DTAB committee suggested on 27.08.2019 that in the case of three FDCs, namely Cefadroxil + Clavulanic acid, Cefixime + Cloxacillin, and Cefixime + Cloxacillin + Lactobacillus, it may be necessary to refer to Prof. Kokate Committee, which was already examining similar FDCs.

In a nutshell, the Prof. Kokate Committee was expected to review all pending issues (17+49 FDCs/out of 294 FDCs) and three FDCs referred by the High Court of Maharashtra, Nagpur Bench.

In connection with the above, Prof. Kokate Committee examined these 17+49+3 FDCs and categorized them into the following categories:-

(a) 33 FDCs considered as rational

(b) 20 FDCs require further data generation

(c) 16 FDCs considered as irrational. The irrational combinations are proposed, not to be allowed for their continued manufacturing and marketing in the country.

Now, in light of the report submitted by the Kokate Committee, the DTAB committee stated,

"The Board examined the Expert Committee report of Prof. Kokate dated 12.03.2021 and in principle agreed to the recommendations of the Prof. Kokate Committee and recommended that the sub-committee under Dr. Nilima Kshirsagar should quickly look at the 33 rational FDCs and 20 FDCs which need further deliberations, to see if there are any inconsistencies and revert back to the Chairman of DTAB. However, the sub-committee shall examine the 16 irrational FDCs in detail as per the earlier procedures. "