Fate of Fixed Drug Combinations (FDCs)

New Delhi: In order to decide the fate of Fixed Drug Combinations (FDCs) considered as irrational by Prof. Kokate Committee, the Drugs Technical Advisory Board (DTAB) sub-committee has proposed to give a hearing to all stakeholders for deliberation.

Recently, DTAB has invited the concerned stakeholders for a hearing with effect from 19.04.2021. The meeting will be conducted through WebEx (Video Conference).

It has also been notified that the schedule of the hearing will be published from time to time on the CDSCO website i.e. www.cdsco.nic.in.

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. Time and time again, the committee declared many drugs as irrational.

It had earlier reported that the Kokate Committee in early 2020 declared 450 drugs as irrational.

Read Also: CDSCO Declares 450 FDCs As Rational, Issues Directions For Manufacturers

Government Actions on Irrational FDCs

The issue of irrational FDCs has also been raised time and time again by government authorities. In order to keep a strict vigil on fixed-dose combination (FDC) drugs in India, the National Pharmaceuticals Pricing Authority (NPPA) has decided to conduct a "prescription audit" to understand the usage of drug cocktails in the country.

Also Read: Rationalizing Drug Cocktails: NPPA to conduct prescription audit of FDC drugs

Further, at the level of the CDSCO, to evaluate the report submitted by the 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 this regard, earlier a meeting of the Sub-committee of DTAB had been held and in order to give an opportunity to the manufacturers of said FDCs and the concerned stakeholders for presenting the precise data concerning these FDCs, the Sub-committee had asked the manufacturers and other stakeholders to submit the information in the prescribed format for further action.

Currently, to proceed further, the Sub-committee has invited stakeholders for a meeting with effect from 19.04.2021 and the schedule of the hearing will be published from time to time on the CDSCO website i.e. www.cdsco.nic.in.

Also Read: Approval of FDCs: NPPA flags prospects of over medication, profiteering