India moves closer to approving OTC sale of common medicines including paracetamol and ibuprofen | cliQ Latest

In a move that could significantly improve access to basic healthcare, India is reviewing a proposal to allow the over-the-counter (OTC) sale of 27 commonly used medicines, including popular drugs like paracetamol, ibuprofen, and levocetirizine. The shift, if approved, would mark a major policy change in the way non-prescription drugs are regulated and sold across the country, making them available not only in medical stores but also in general retail outlets.

Key drugs identified for OTC sale

According to sources, a panel formed by the Central Drugs Standard Control Organisation (CDSCO) has submitted its report recommending the reclassification of 27 prescription-only drugs as OTC medications. These include generic formulations from key therapeutic categories known for their safety and effectiveness. For instance, levocetirizine is widely used for treating allergies, ibuprofen as a painkiller, and paracetamol as an antipyretic. The sub-committee has also clearly defined the dosage strengths that would be permissible under OTC classification, aiming to prevent misuse or overconsumption—particularly of drugs like ibuprofen, where higher doses could be harmful if taken without medical guidance.

The sub-panel, headed by Dr. Anupam Prakash from Lady Hardinge Medical College, includes experts from top medical institutions and health bodies such as the Director General of Health Services and PGIMER. Their focus has been on ensuring a balance between greater accessibility and patient safety.

Push for legal and regulatory framework

India currently lacks a well-defined regulatory framework for OTC drugs. In May, the CDSCO formed the sub-committee to evaluate the necessary amendments to the Drugs Rules of 1945. The recommendations now submitted propose not only a new list of OTC drugs but also detailed legal and labelling norms. These include establishing criteria for drug eligibility, application processes, and the introduction of a separate schedule under the rules.

The recommendations have been forwarded to the Drugs Technical Advisory Board (DTAB), which is expected to deliberate on them in an upcoming meeting scheduled for April. However, the final approval process is likely to span several sessions, as the central government works toward designing a comprehensive policy before implementing any official change.

If adopted, the move could set the stage for better self-care options and reduce the burden on healthcare infrastructure by making essential medications more easily accessible to the public.

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