The Union Health Ministry has banned 16 fixed-dose combination (FDC) drugs across India, citing serious public health concerns and lack of therapeutic justification.
The notification, issued under Section 26A of the Drugs and Cosmetics Act, 1940, prohibits the manufacture, sale, and distribution of these medicines with immediate effect.
Fixed-dose combinations are formulations containing two or more active pharmaceutical ingredients in a set ratio, often marketed to reduce pill burden. However, expert committees found several of these combinations irrational, unsafe, and lacking scientific evidence of benefit.
The banned drugs include combinations used for pain relief, gastrointestinal disorders, diabetes management, and antibiotic therapies. Notable examples are Amoxicillin + Serratiopeptidase, Dicyclomine + Paracetamol + Clidinium Bromide, and Gliclazide + Chromium Picolinate.
The decision follows Supreme Court directions to review irrational FDCs and recommendations from the Drugs Technical Advisory Board (DTAB). The move aims to strengthen rational drug use and protect patients from adverse reactions.
Pharmaceutical manufacturers and retailers have been instructed to halt production and distribution immediately, ensuring only scientifically validated medicines remain available in the market.
This ban is expected to improve patient safety, reduce misuse of antibiotics, and reinforce India’s regulatory oversight in the pharmaceutical sector.
