The Ministry of Health and Family Welfare has prohibited the manufacture for sale, sale or distribution for human use of 328 Fixed Dose Combinations (FDCs) with immediate effect, according to a direction issued here on Wednesday. It 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 10th March, 2016, in the Gazette of India, prohibited the manufacture for sale, sale and distribution for human use of 344 FDCs under Section 26 A of the Drugs and Cosmetics Act, 1940. Subsequently, the government had prohibited five more FDCs in addition to the 344 under the same provisions,” said a Ministry release. However, the matter was contested by manufacturers in various High Courts and the Supreme Court. In compliance with the Supreme Court judgment dated December 15, 2017, the matter was examined by the Drugs Technical Advisory Board which gave its report to the Central government.
