Fixed dose combinations (FDC) Drugs ban issue


What are Fixed Dose Combination (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.
  • India is one of the world’s largest markets for FDC drugs that make up almost half the market share.
What is the issue?
  • 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 does the court say?
  • 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.

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