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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.
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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.
