Certain fixed-dose combination drugs may face ban in India

India's drug regulator has stepped up efforts to stop the sale of unapproved antibiotic cocktail combinations over the counter. The regulator has warned that certain fixed-dose combinations (FDCs) will be banned unless scientific trials are conducted to verify their regularisation before they can be distributed, reports The Pharma Letter’s India correspondent.

Recognizing that 19 FDCs have been marketed without prior regulatory approval, the regulator has asked the relevant drug manufacturers to generate security information by conducting Phase IV scientific trials, even though a license has been granted by the state licensing authority for the marketing of these cocktail drugs.

Many of the FDCs under the regulatory glare are regularly sold over-the-counter (OTC) to treat headaches, migraines, arthritis, muscular pain, nausea, and vomiting, among other conditions.