The Government on Wednesday prohibited the manufacture for sale, sale or distribution for human use of 328 Fixed Dose Combinations (FDCs) with immediate effect.
The Ministry of Health and Family Welfare through an official statement also announced to have restricted the manufacture, sale or distribution of six FDCs subject to certain conditions.
FDCs which are combination of two or more drugs in a fixed ratio, may involve risk to human beings, the Ministry believes.
The move stems from the Government’s March 2016 decision where the ministry had prohibited manufacture for sale and distribution for human use of 344 FDCs under section 26 A of the Drugs and Cosmetics Act, 1940.
The decision was then opposed by the manufacturers in various High Courts and the Supreme Court of India. Following an Apex Court’s order, a Drugs Technical Advisory Board was constituted which examined the matter and later submitted its report to the Central Government.
“The Drugs Technical Advisory Board recommended, amongst other things, that there is 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 is 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,” the official release said.
Earlier, an Expert Committee appointed by the Central Government had also examined these FDCs and made similar recommendations.