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.