The Union Health Ministry on September 12, 2018 prohibited the manufacture, sale and distribution of 328 Fixed Dose Combinations (FDCs) for human use with immediate effect.
The Ministry has also restricted the manufacture, sale and distribution of six FDCs subject to certain conditions. The action has been taken by the Ministry under the powers conferred by section 26A of the Drugs and Cosmetics Act, 1940.
The Union Government through a notification published on the March 10, 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.
• The prohibition on the FDCs was contested by the affected manufacturers in various High Courts and the Supreme Court.
• The matter was examined by the Drugs Technical Advisory Board constituted under section 5 of the Drugs and Cosmetics Act, 1940, in compliance with the directions given by the apex court. The board then submitted its report on these drugs to the Union Government.
• In its recommendations, the drugs advisory board stated 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 in the larger public interest.
• With regard to the six FDCs, the board recommended that their manufacture, sale and distribution be restricted subject to certain conditions based on their therapeutic justification.
• The 15 FDCs out of the 344 prohibited on the March 10, 2016, which were claimed to be manufactured before September 21, 1988, have been kept out of the purview of current notifications.
• An expert committee appointed by the Union Government had also examined the FDCs earlier and had made recommendations in line with those of the board.
• Based on the recommendations of the Expert Committee and Drugs Technical Advisory Board, the Government came to a conclusion 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.
Fixed Dose Combination drugs mean when two or more therapeutic ingredients are contained in a single dosage form.
The fixed dose combinations reduce the number of pills taken by a person each day. These drugs are majorly used to simplify disease management for chronic diseases such as HIV, asthma, diabetes, lipid regulation and hypertension.
Initially, the FDCs were developed to target a single disease, however, they may also target multiple diseases or conditions.
The FDCs include anti-diabetic drugs, HIV drugs, antibiotics and analgesics such as Saridon, Panderm Plus and Taxim AZ.
The domestic pharmaceutical market size is around Rs 1.25 trillion and FDCs make up almost half of the sales.
The FDCs covered under the ban make up sales of around Rs 28 billion, almost 2.3 per cent of the total market.
Hence, the ban could have a huge impact on the overall sales of the pharmaceutical sector.
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