328 FDC Medicines banned over safety concern: Health Ministry Notification

DTAB 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

New Delhi: The Ministry of Health and Family Welfare has maintained the ban on 328 medicines with the Fixed Dose Combinations (FDCs) over safety purpose. A combination drug is a fixed-dose combination that includes two or more active pharmaceutical ingredients combined in a single dosage form, which is manufactured and distributed in fixed doses.

The government prohibited the manufacture for sale, sale or distribution for human use of 328 Fixed Dose Combinations (FDCs) with immediate effect. It has also restricted the manufacture, sale or distribution of six FDCs subject to certain conditions.

The ban is expected to shave off over Rs1,500 crore from India's Rs1.18-lakh crore pharmaceutical industry and would impact medicine brands across several therapy areas, according to pharmaceutical market research firm AIOCD Awacs PharmaTrac. This includes brands like Piramal's Saridon, Macleods Pharma's Panderm Plus cream and Alkem Laboratories' Taxim AZ, as reported in ET.

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.

In compliance with the directions given by the Supreme Court of India in its judgment dated the 15th December 2017, the matter was examined by the Drugs Technical Advisory Board (DTAB) constituted under section 5 of the Drugs and Cosmetics Act, 1940 which furnished its report on these drugs to the Central Government.

DTAB 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. 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.

The Central Government considered the recommendations of the Expert Committee and Drugs Technical Advisory Board, and based on such consideration, it was concluded that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of these 328 FDCs in the country.

Accordingly, the Ministry of Health and Family Welfare has, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940, prohibited the manufacture for sale, sale or distribution for human use of 328 FDCs through its gazette notifications dated 7th September 2018 it has also restricted the manufacture, sale or distribution of six FDCs subject to certain conditions. These notifications will take immediate effect.

Read Also: List of Banned Fixed Dose Composition drugs