Fixed Dose Combinations (FDCs) Ban Issue

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.
What is the decision related to FDCs?
  • 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.
Why this decision has been taken?
  • 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

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