Delhi HC quashes government ban on fixed dose combination drugs

  • Delhi high court has quashed the ban on Fixed dose combination (FDCs).  
  • 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. 
  • With this, the banned drugs – including D’Cold, Benadryl and Phensedyl that are widely used to treat headaches and colds – will continue be available freely in the market. 
  • The court observed that the decision was taken by the Centre without following procedure prescribed in the Drugs and Cosmetics Act.
  • It noted that the government had not consulted the Drugs Technical Advisory Board or the Drugs Consultative Committee but had acted on the advice of a ‘technical committee’, which, they said, violated the provisions of the Drugs and Cosmetics Act.

Combination medicines (or fixed-dose combination [FDC] medicines) are:

  • medicines containing two or more active components in fixed proportions in a single dosage form 
  • Several medications in fixed combination to be taken together, presented in composite packaging (co-pack).

Leave a Reply