• Health ministry bans 328 fixed dose combination drugs with immediate effect

    • September 13, 2018
    • Posted By : admin
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    Around 6,000 brands of drugs, with a combined market size of between Rs 2,000 crore and Rs 2,500 crore, are likely to be affected.

    The Ministry of Health and Family Welfare on Wednesday banned the manufacture, sale and distribution of 328 fixed dose combination drugs with immediate effect, and placed certain conditions on six others. Fixed dose combination drugs, popularly known as FDCs, are medicines that are a cocktail of two or more drugs sold by the Indian pharmaceutical industry.

    Around 6,000 brands are likely to be affected, according to The Times of India. This includes painkiller Saridon, skin cream Panderm, combination diabetes drug Gluconorm PG, antibiotic Lupidiclox and antibacterial Taxim AZ. They are expected to have a combined market size of between Rs 2,000 crore and Rs 2,500 crore, according to News18.

    Popular medicines such as cough syrup Corex and D-Cold Total, which were among the drugs prohibited by the government in 2016, have now escaped the ban.

    On March 10, 2016, the Central Drugs Standard Control Organisation, or CDSCO as it commonly known, issued a notification prohibiting the manufacture, sale and distribution of 344 Fixed Dose Combinations of drugs. It later added five more FDCs.

    The ban was poised to hit the profits of the pharmaceutical industry since there are thousands of FDCs in the market. The pharmaceutical industry challenged the ban on the grounds that the central government had not consulted the Drugs Technical Advisory Board, which is an advisory body set up under Section 5 of the Drugs and Cosmetics Act, 1940.

    In December 2016, the Delhi High Court set aside the orders banning the FDCs. Later, this judgement was appealed against by the central government and the Supreme Court overruled the High Court’s ruling, concluding that Section 26A of the Drugs and Cosmetics Act, 1940, does not require the Central government to consult the advisory board. It then ordered the Drugs Technical Advisory Board to examine these drugs and submit a report to the Centre.

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