Center flags unapproved drug combination, raising safety concerns

NEW DELHI: India’s top drugs regulator has said in a major public health alert that around 90 medicines – from painkillers and antibiotics to cough syrups and vitamin supplements – are being sold without approval, raising concerns about patient safety and law enforcement gaps.In a letter to all state drug controllers, the Central Drugs Standard Control Organization (CDSCO) said that multiple fixed dose combinations (FDCs) found during laboratory testing in 2025 were found to be unapproved and classified as new drugs.Many of these are commonly used drugs sold in pharmacies, suggesting that such combinations may have entered the supply chain widely.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 deeper issues with how combination drugs are used in India.Dr Suranjit Chatterjee, senior consultant, Department of Internal Medicine, Apollo Hospitals, said: “Fixed-dose combination drugs are too widely used in India, but each drug has its own pharmacodynamics and absorption pattern, which is why such combinations require stringent approval. When mismatched drugs are used in combination, their effects and side effects may be inconsistent, making them potentially harmful rather than beneficial.”He added that while such combinations are often promoted as reducing drug burden, the benefits are limited if the combination itself is not justified.“In many cases, medications taken before or after meals are mixed, compromising their effectiveness. Unlike many Western countries that favor separate medications, India has seen a surge in such combinations without adequate scrutiny. Patients are rarely in a position to judge what is appropriate, so the responsibility lies squarely with the regulators,” he said.CDSCO reiterated that as per existing rules, no drug can be manufactured or sold without prior approval and has sought time-bound action reports from states.Public health experts said the move was timely but stressed that continued 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 expense of safety, especially when the combination itself may not be scientific.