The sub-committee of Drugs Technical Advisory Board (DTAB) has recommended prohibition of 343 fixed drug combinations (FDCs) after reviewing 349 and called for regulation and restriction of remaining six. FDC means combination of two or more drugs in fixed dosage ratio.
The expert sub-committee in its reports suggested banning 343 FDCs, three should be restricted for specific indications or diseases and other three FDCs should be restricted to specific quantities of ingredients and for specific indications. It stated that for most FDCs, their use will lead to unnecessary overuse and patients will be exposed to risk of multiple ingredients when one will suffice.
In March 2016, Union Government had banned total 344 FDC on suggestion of Kokate committee, which had studied irrationality of various FDCs, recommended ban on 344 of them, citing rising “antibiotic resistance” in the country as one of reasons. Later in December 2016, Delhi High Court struck down ban stating that Government had acted in haphazard manner.
The matter then went to Supreme Court, which in December 2017 which directed health ministry’s expert body DTAB for fresh review of safety, efficacy and therapeutic justification of these 349 FDCs. It had stated that DTAB or its subcommittee will have to decide whether it is necessary in larger public interest, to regulate, restrict or prohibit manufacture, sale or distribution of such FDCs. Therefore, DTAB had formed sub-committee, which studied issue and submitted its recommendations.
Drugs Technical Advisory Board (DTAB)
DTAB is highest statutory decision-making body on technical matters related to drugs in the country . It is constituted as per the Drugs and Cosmetics Act, 1940. It is part of Central Drugs Standard Control Organization (CDSCO) in the Ministry of Health and Family Welfare.