The Ministry of Health and Family Welfare has prohibited the manufacture, sale or distribution of 328 fixed dose combinations (FDCs) for human use with immediate effect. It has also restricted the manufacture, sale or distribution of six FDCs, subject to certain conditions.
Earlier, the Central Government had, through its notifications published on the March 10, 2016 in the Gazette of India, prohibited 344 FDCs under Section 26 A of the Drugs and Cosmetics Act, 1940. Subsequently, the Government had prohibited five more FDCs under the same provisions.
However, the matter was contested by the manufacturers in various high courts and the Supreme Court of India.
Drugs Technical Advisory Board view
In compliance with the
The Board recommended that it was necessary to prohibit the manufacture, sale or distribution of these FDCs under Section 26 A of the Drugs and Cosmetics Act, 1940 in the larger public interest. With regard to six FDCs, the Board recommended that their manufacture, sale and distribution be restricted subject to certain conditions based on their therapeutic justification. Fifteen FDCs out of the 344 prohibited on the March 10, 2016, which were claimed to be manufactured prior to September 21, 1988, have been kept out of the purview of current notifications [ Reconsider move to ban 15 fixed-drug combos, apex court tells Health Ministry ].
Earlier, an expert committee appointed by the Central Government had also examined these FDCs and made recommendations in line with those of the Board.
The Central Government considered the recommendations of the Expert Committee and Drugs Technical Advisory Board and concluded that it was necessary and expedient in public interest to prohibit these 328 FDCs.
[Also read: Government needs to stop speaking in different voices on FDCs ]