Fixed Dose Combination Drugs

The Centre has prohibited the manufacture, sale and distribution of 16 fixed-dose combination (FDC) drugs, saying they lack "therapeutic justification" and their continued use was not considered beneficial in relation to the potential risks involved. The move, the Union Health Ministry said, was to safeguard public health and promote rational use of medicines while ensuring only effective and scientifically validated medicines are available to the public. FDC drugs are those which contain a combination of two or more active pharmaceutical ingredients (APIs) in a fixed ratio. The decision follows a review of FDCs undertaken in compliance with the Supreme Court's directions. The Drugs Technical Advisory Board (DTAB) had constituted an expert committee to examine various drug combinations and identify those that were irrational, therapeutically unjustified or potentially harmful. "The manufacture for sale, sale, distribution and supply of the identified 16 FDCs for human use shall sta

Over 60 per cent of the fixed-dose combination (FDC) drugs used for treating mental health disorders in India are 'unapproved' and lack proven therapeutic value, the study found

The controversy arose after the central govt issued a notification on March 10 pursuant to the Doctor Kokate panel report banning 344 Fixed Dose Combination drugs