New Delhi: Domestic drugmakers are likely to face a blow as 324 Fixed Dose Combination (FDCs) drugs have been recommended to be banned by an expert panel under the Central Drugs Standard Control Organization (CDSCO). Probing the efficacy of the FDCs, the committee has found the FDCs “irrational” and has suggested that the manufacture and marketing of the same should be prohibited in India.
The proposal came to light following the submission of the assessment report by the Kokate Committee to the Drugs Technical Advisory Board (DTAB), the highest decision-making body on technical matters related to drugs, on 2 April.
The Committee was headed by Prof. C. K. Kokate, Former Vice-Chancellor, KLE University, Belgaum, Karnataka for examining the Safety and Efficacy of unapproved FDCs which were licensed by State Licensing Authorities without due approval of DCGI.
The Committee examined 418 applications of FDCs and found 324 FDCs as irrational while only 28 FDCs as rational. The panel further said that they require more data for two FDCs and 4 FDCs require further deliberation. It was also observed that out of the remaining 60 FDCs, 48 FDCs have already been prohibited, 11 have been declared rational and one FDC is sub judice.
The Committee in its report said, “these FDCs wherever recommended as “irrational (category ‘a’)” should not be allowed for their continued manufacturing and marketing in the country. The FDCs which have been declared as irrational needs to be prohibited under the Drugs and Cosmetics Act, 1940 as other safer alternatives to those combinations are available.”
The report of the Kokate Committee has been placed before the DTAB for deliberation.
To evaluate the report, the DTAB has also constituted a sub-committee of eight members under the chairmanship of Dr Nilima Kshirsagar, chair of clinical pharmacology at the Indian Council of Medical Research.
Besides the chairperson, the sub-committee members include dr T V Narayana, President, IPA, Bengaluru; Dr. Sandeep Bavdekar, Former Prof. Head Pediatrics, T.N Medical College & BYL Nair Ch. Hospital, Mumbai; Dr. Nirmala Rege, Former Prof. & HOD Pharmacology Seth G S Medical College & KEM Hospital, Mumbai; Dr. R.N.Tandon, Immediate Past Honorary Secretary General, IMA, New Delhi; Dr. B. Gupta, Professor & Head, Dept. of Medicine, NDMC Medical College & Hindu Rao Hospital, New Delhi; Shri H.Mahapatra, Former Drugs Controller, Odisha, Shri. Sanjeev Kumar Convener DDC(I), CDSCO (HQ), New Delhi.
Prior to this, in December 2018, the Government had banned 328 FDCs after. The Drugs Technical Advisory Board (DTAB ) in public interest had recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Therefore, the only prohibition under Section 26A is recommended.”
Fixed-dose combination(FDC), includes two or more active pharmaceutical ingredients (APIs) combined in a single dosage form, which is manufactured and distributed in fixed doses.