Photo credit: IANS NEW DELHI: In a major public health alert, India’s top drug regulator has flagged around 90 medicines—ranging from painkillers and antibiotics to cough syrups and vitamin supplements—being sold without approval, raising concerns over patient safety and gaps in enforcement.In a communication to all state drug controllers, the Central Drugs Standard Control Organisation (CDSCO) said multiple fixed-dose combinations (FDCs) identified during lab testing in 2025 were found to be unapproved and categorised as new drugs.Many of these are commonly used medicines available across pharmacies, pointing to how widely such combinations may have entered the supply chain.The regulator has directed states to verify approvals, investigate violations and take action against manufacturers, marketers and other stakeholders warning that the presence of such drugs in the supply chain is a serious public health concern.Israel Iran WarUS-Israel-Iran War News Live Updates: Israel says more missiles launched from Iran; Kuwait claims drone attacks by TehranTrump Talks Iran Deal Window: US president sees major points of agreement; five day period to test talks’Fake news’: Iranian Speaker says Trump’s talk claims aimed at manipulating oil marketsExperts say the issue goes beyond regulatory compliance and points to a deeper problem with how combination drugs are used in India.“Fixed-dose combinations are being used far too widely in India, but each drug has its own pharmacodynamics and absorption pattern, which is why such combinations require strict approval. When mismatched drugs are combined, their effects and side effects may not align, making them potentially harmful rather than beneficial,” said Dr. Suranjit Chatterjee, Senior Consultant, Internal Medicine, Apollo Hospital.He added that while such combinations are often promoted as reducing pill burden, the benefit is limited if the combination itself is irrational.“In many cases, drugs meant to be taken before and after meals are combined, compromising their effectiveness. Unlike in many Western countries where individual drugs are preferred, India has seen a surge of such combinations without adequate scrutiny. Patients are rarely in a position to judge what is appropriate, so the responsibility lies squarely with regulators,” he said.The CDSCO has reiterated that no drug can be manufactured or sold without prior approval under existing rules and has sought time-bound action reports from states.Public health experts say the move is timely, but stress that sustained enforcement will be key to ensuring unsafe or unnecessary drug combinations are removed from the market.The bottom line is clear: the convenience of a single pill should not come at the cost of safety, especially when the combination itself may not be scientifically sound.About the AuthorAnuja JaiswalAnuja Jaiswal is a Senior Assistant Editor at The Times of India, with an impressive 18-year career in narrative journalism. She specializes in health and heritage reporting, expertly simplifying complex health information to make it engaging and understandable for readers. Her deep dives into heritage topics are well-researched, resulting in captivating narratives that resonate with her audience. Over the years, she has worked in Chandigarh, Chhattisgarh and West UP, gaining diverse on-ground experience that shapes her storytelling.Read MoreEnd of ArticleFollow Us On Social MediaVideosIndia Issues RFI for Engine Test Complex, Facility To End India’s Foreign Engine Testing DependencyIndia, US Hold Talks As West Asia Crisis Raises Energy ConcernsTwo More Indian LPG Ships Pine Gas And Jag Vasant Transit Strait Of Hormuz Amid Iran-Israel War’India Moving Ahead With Resolve’: PM Modi’s Big Message On West Asia Conflict’Never Faced Such Humiliation’: Jaya Bachchan Slams VIP Culture In RS, Flags Traffic DisruptionsUS Finally Ready For De-Escalation? 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NEW DELHI: In a major public health alert, India’s top drug regulator has flagged around 90 medicines—ranging from painkillers and antibiotics to cough syrups and vitamin supplements—being sold without approval, raising concerns over patient safety and gaps in enforcement.In a communication to all state drug controllers, the Central Drugs Standard Control Organisation (CDSCO) said multiple fixed-dose combinations (FDCs) identified during lab testing in 2025 were found to be unapproved and categorised as new drugs.Many of these are commonly used medicines available across pharmacies, pointing to how widely such combinations may have entered the supply chain.The regulator has directed states to verify approvals, investigate violations and take action against manufacturers, marketers and other stakeholders warning that the presence of such drugs in the supply chain is a serious public health concern.Experts say the issue goes beyond regulatory compliance and points to a deeper problem with how combination drugs are used in India.“Fixed-dose combinations are being used far too widely in India, but each drug has its own pharmacodynamics and absorption pattern, which is why such combinations require strict approval. When mismatched drugs are combined, their effects and side effects may not align, making them potentially harmful rather than beneficial,” said Dr. Suranjit Chatterjee, Senior Consultant, Internal Medicine, Apollo Hospital.He added that while such combinations are often promoted as reducing pill burden, the benefit is limited if the combination itself is irrational.“In many cases, drugs meant to be taken before and after meals are combined, compromising their effectiveness. Unlike in many Western countries where individual drugs are preferred, India has seen a surge of such combinations without adequate scrutiny. Patients are rarely in a position to judge what is appropriate, so the responsibility lies squarely with regulators,” he said.The CDSCO has reiterated that no drug can be manufactured or sold without prior approval under existing rules and has sought time-bound action reports from states.Public health experts say the move is timely, but stress that sustained enforcement will be key to ensuring unsafe or unnecessary drug combinations are removed from the market.The bottom line is clear: the convenience of a single pill should not come at the cost of safety, especially when the combination itself may not be scientifically sound.
