Rationality of FDC drugs: DTAB Sub Committee invites stakeholders for hearing
DTAB has invited the concerned stakeholders for hearing with effect from 19.04.2021. It has also been notified that the schedule of hearing will be published from time to time on CDSCO website i.e. www.cdsco.nic.in.
New Delhi: In order to decide the fate of Fixed Drug Combinations (FDCs) considered as irrational by Prof. Kokate Committee, 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 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 hearing will be published from time to time on 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 Prok. 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 commitee decalred many drugs as irrational
The issue of irrational FDC 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.
Further at the level of the CDSCO< 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 this regard, earlier a meeting of 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 19.04.202 and schedule of hearing will be published from time to time on CDSCO website i.e. www.cdsco.nic.in.
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