In a significant move aimed at tightening drug regulations, the Union Health Ministry has proposed major changes that could alter how common cough remedies are sold across India. The ministry has issued a draft notification suggesting amendments to the decades-old Drug Rules, 1945.
Key Proposals in the Draft Notification
The central proposal is to remove cough "syrups" as a class of medical products from the list of drugs exempted from certain sale-licensing rules. Currently, these exemptions allow general stores and non-pharmacy outlets to sell such syrups over-the-counter (OTC) without a dedicated drug license.
If the amendment is finalized, cough syrups would no longer be freely available in neighborhood kirana stores or supermarkets. Their sale would be restricted to licensed chemists and pharmacies, ensuring they are dispensed under professional supervision.
Ban on Nimesulide: A Parallel Move
In a related but distinct action, the draft notification also proposes a ban on the drug Nimesulide. Nimesulide is a painkiller and anti-inflammatory medication used for conditions like acute pain and fever. Its use has been controversial globally due to potential liver toxicity risks, and several countries have already restricted or banned it.
The Health Ministry's move to ban it in India aligns with a growing body of evidence highlighting its adverse effects, particularly on liver function. This would mark a decisive step in phasing out a drug whose safety profile has long been under scrutiny by medical experts.
Implications for Consumers and Retailers
The potential delisting of cough syrups as OTC products means greater regulatory oversight. For the average consumer, it translates to needing a visit to a licensed pharmacy to purchase these common remedies. The intention is to prevent misuse, promote appropriate use under guidance, and enhance pharmacovigilance.
For thousands of general store owners across the country, this change would mean they can no longer stock and sell these syrups, potentially impacting a small stream of revenue. The move underscores the government's focus on treating medicinal syrups, especially in the wake of past controversies regarding quality and misuse, with greater seriousness.
The draft notification was reported by Kalyan Ray and was last updated on 31 December 2025, at 16:35 IST. The ministry has invited objections and suggestions from stakeholders before finalizing the rules, a standard procedure for such regulatory changes.
Looking Ahead
These proposed changes signal a shift towards stricter control of drug accessibility in India. By reclassifying cough syrups and banning Nimesulide, the Health Ministry aims to prioritize patient safety and rational drug use. The final decision, after considering public feedback, will have a direct impact on public health policy and the retail landscape for medicines in India.
