The Government of India has banned 156 fixed-dose combination (FDC) medicines, including widely used antibiotics, painkillers, and multivitamins, citing safety and efficacy concerns.
The ban, which took effect in August 2024, aims to protect public health from potentially harmful drug combinations lacking therapeutic justification.
In response to a Lok Sabha query, the Ministry of Chemicals and Fertilizers confirmed that the ban was implemented under the Drugs and Cosmetics Act, 1940.
This law enables authorities to regulate or prohibit the manufacture and sale of drugs deemed risky for human or animal health. An expert committee led by Professor C.K. Kokate reviewed the safety and effectiveness of these FDCs, identifying many as irrational or unlicensed, prompting the prohibition.
The Drugs Technical Advisory Board (DTAB) recommended the ban after thorough evaluations.
Manufacturing, selling, or distributing these medicines now constitutes a punishable offense, with state licensing authorities authorized to enforce the ban. The complete list of prohibited FDCs is available on the Central Drugs Standard Control Organisation (CDSCO) website.
The government underscored its commitment to ensuring the availability of safe and effective medicines, emphasizing the importance of curbing irrational drug combinations to safeguard public health.