The Indian government has taken a significant step to protect public health by banning 14 fixed dose combination (FDC) drugs in the country. The decision was made due to the absence of therapeutic justification for these medicines and the potential risks they pose to patients. The move comes after recommendations from an expert committee and a notification issued by the Health Ministry.

FDC drugs are formulations that combine two or more active pharmaceutical ingredients (APIs) in a fixed ratio. Among the banned drugs are popular combinations such as Nimesulide and Paracetamol dispersible tablets, as well as Chlopheniramine Maleate and Codeine syrup. These medicines are commonly used to treat various infections, cough, and fever.

The expert committee determined that there is no valid therapeutic justification for these FDCs and that their usage may pose risks to human health. Consequently, under Section 26 A of the Drugs and Cosmetics Act, 1940, the government deemed it necessary to prohibit the manufacture, sale, and distribution of these FDC drugs. This decision is based on the larger public interest and the goal of safeguarding patient well-being.

It’s worth noting that these 14 banned FDC drugs were part of a larger group of 344 drug combinations that were previously prohibited in 2016. Back then, an expert panel set up at the request of the Supreme Court highlighted that these combinations lacked scientific data to support their usage. The manufacturers challenged the ban in court, but the current decision reinforces the earlier verdict.

The government’s action underscores its commitment to ensuring the availability of safe and effective medicines in the country. By regulating the pharmaceutical industry and addressing concerns related to FDC drugs, the authorities aim to protect the health and well-being of the Indian population.