Aiming to stop the risk posed by fixed doses, 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.
In compliance with the directions given by the apex court in its judgment of December 15, 2017, the matter was examined by the Drugs Technical Advisory Board constituted under Section 5 of the Drugs and Cosmetics Act, 1940 which furnished its report on these drugs to the Central Government. The Drugs Technical Advisory Board recommended, among other things, that there was no therapeutic justification for the ingredients contained in 328 FDCs and that these FDCs may involve risk to human beings.
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.