Delhi High Court reverses ban on fixed dose combination drugs

The Delhi High Court has quashed ban imposed on 344 fixed dose combination (FDC) drugs by the Central Government over fears that they are potential health and safety hazards.
The HC held that Centre had acted in a haphazard manner and did not take the advice of the statutory bodies under the Drugs and Cosmetics Act before issuing ban notification.

What is the issue?

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 also aimed at curbing the misuse of medicines. However, the 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.

What Delhi High Court ruling says?

The Central Government acted in a haphazard manner without following procedure prescribed in the Drugs and Cosmetics Act. Government did not take the advice of the statutory bodies such as Drugs Technical Advisory Body (DTAB) and the Drugs Consultative Committee (DCC) before imposing ban. Power cannot be exercised in public interest for any reason other than the drug being risky or not having any therapeutic value.

What are 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.

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