Saridon, Dolo Cold and 3 Other Cocktaol Medicines Get Conditional Approval | Details Here

New Delhi: India's top drug regulator has given conditional approval to the production and sale of five fixed-dose combination (FDC) medicines, previously considered for a ban. These include antidepressants, cough syrups, cold and flu medications, and pain relievers such as D Cold Total, Saridon Triple Action, Piriton Syrup, and Dolo Cold.

Manufacturers are required to provide post-marketing safety and efficacy data for three combinations, while changes to dosage and information labels are needed for the remaining two. The regulator suggests conducting phase IV clinical trials to generate additional safety and clinical data for certain combinations.

FDCs, or cocktail medicines, combine multiple drugs in a single pill, raising concerns about antibiotic resistance. In June, the Union government, following orders from the Central Drugs Standard Control Organisation (CDSCO), banned 14 FDCs out of 19 due to a lack of therapeutic relevance. The lax regulatory framework has allowed unscientific combinations to flood the market, raising fears of increased drug resistance.

Manufacturers approved to produce the specified FDCs must submit periodic safety update reports (PSURs) to the Central Licensing Authority in compliance with the New Drugs and Clinical Trial Rules, 2019. This move aims to address concerns about the safety and efficacy of these drug combinations.

“Failure to submit the PSURs shall be considered as contravention of these rules,” read the order undersigned by the Drug Controller General of India, Rajeev Singh Raghuvanshi, who heads the CDSCO.