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 the remaining six.
a. 143
b. 243
c. 343
d. 443
FDC means combination of two or more drugs in fixed dosage ratio.
Details:
- 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 the risk of multiple ingredients when one will suffice.
Events that took place in the past:
- In March 2016, The Union Government had banned a total of 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, the Delhi High Court struck down the ban stating that the Government had acted in a haphazard manner.
- The matter then went to Supreme Court, which in December 2017 directed the 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 the issue and submitted its recommendations.
About the Drugs Technical Advisory Board (DTAB):
- DTAB is the 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 a part of Central Drugs Standard Control Organization (CDSCO) in the Ministry of Health and Family Welfare.
Question:
Q. The sub-committee of Drugs Technical Advisory Board (DTAB) has recommended prohibition of how many fixed drug combinations (FDCs)?a. 143
b. 243
c. 343
d. 443
