Health Ministry prohibits manufacture, sale and distribution of Fixed Dose Combinations

Union Ministry of Health and Family Welfare has prohibited manufacture, sale, distribution of 328 Fixed Dose Combinations (FDCs) for human use with immediate effect. It has also restricted manufacture, sale or distribution of six FDCs subject to certain conditions. This ban was imposed by Health Ministry by exercising powers conferred to it section 26A of Drugs and Cosmetics Act, 1940.

Fixed dose combinations (FDC) Drugs
FDC drugs are drugs having two or more active ingredients in a single dosage. They are widely used to improve patient compliance as it is easier for them to take one drug than several. They are acceptable only when the drugs so combined have a therapeutic advantage.

Background

India is one of the world’s largest markets for FDC drugs that make up almost half the market share. The Union Health Ministry had imposed the ban on 344 FDC drugs under Section 26A of Drugs and Cosmetics Act in March 2016 for being unsafe and not having a therapeutic justification. The ban was imposed based on the recommendations of Kokate committee. It was imposed over fears that these drugs cause anti-microbial resistance and might even cause organ-failure because of high toxicity. It was also aimed at curbing the misuse of medicines. However, pharmaceutical companies contend that no prior enquiry was made from them or show cause notice issued prior to ban notification by the Central Government. They also held that these drugs in the same combination are being marketed in other countries.
The Drugs Technical Advisory Board (DTAB) in compliance with directions given by Supreme Court of India in its judgment (December, 2017) had examined this issue of banning FDCs. DTAB had recommended that there is no therapeutic justification for ingredients contained in 328 FDCs and that these FDCs may involve risk to human beings. It also had recommended that it is necessary to prohibit manufacture, sale or distribution of these FDCs in the larger public interest. With regard to six FDCs, it had recommended restriction for their manufacture, sale and distribution subject to certain conditions based on their therapeutic justification

Drugs Technical Advisory Board (DTAB)

DTAB is highest statutory decision-making body on technical matters related to drugs in the country . It is constituted as per the Drugs and Cosmetics Act, 1940. It is part of Central Drugs Standard Control Organization (CDSCO) in the Ministry of Health and Family Welfare.

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