The Indian government has banned 156 combination drugs commonly used as painkillers, multivitamins, antibiotics, and for treating fever and cold.
This decision, announced in a gazette notification dated August 21, addresses concerns over the potential health risks associated with these drugs.
Reasons for the Ban
The Drugs Technical Advisory Board (DTAB) recommended the prohibition after an expert committee evaluated the Fixed Dose Combination (FDC) drugs.
These drugs, which include a mix of enzymes and other ingredients, were deemed “irrational” and potentially harmful.
The DTAB found no therapeutic justification for these combinations and recommended their ban under Section 26A of the Drugs and Cosmetics Act of 1940.
The banned list includes not only common painkillers and antibiotics but also drugs used for hair treatments, antiparasitic treatments, skincare, and anti-allergic purposes. Known as “cocktail drugs,” these FDCs combine multiple medicines into a single pill.
Support and Future Regulations
The Indian Pharmaceutical Alliance (IPA) supports the government’s decision. Sudarshan Jain, Secretary General of the IPA, stated that the ban is a positive step for patient safety.
He emphasized that companies were given the opportunity to provide data supporting their products, and those without sufficient data would need to withdraw from the market.
Expert Recommendations and Industry Response
The ban follows recommendations from the Drugs Technical Advisory Board and an expert committee, which found the FDCs to be “irrational” and lacking therapeutic justification.
The advisory board highlighted that these drugs might pose risks to human health and thus should be prohibited under Section 26 A of the Drugs and Cosmetics Act, 1940.
The banned list also includes drugs used for hair treatments, antiparasitic, skincare, and anti-allergic purposes. These combination drugs, also known as cocktail drugs, were deemed unsafe.
The Indian Pharmaceutical Alliance supports the government’s decision. Sudarshan Jain, Secretary General of the IPA, praised the move as beneficial for patient safety, noting that companies have been given the chance to provide supporting data for their products.
Those unable to do so will have to withdraw their products from the market.
