India Tightens Grip on Cough Syrup Sales with Stricter Regulations

Govt amends rules to bring cough syrups under stricter regulatory oversight | India News

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New Delhi, In a bid to ensure patient safety and drug quality, the Union Health ministry has amended rules to prohibit the sale of cough syrups without a doctor's prescription across the country.

The move aims to bring syrup-based formulations under stricter regulatory oversight, officials said, following a draft notification issued in December last year.

Earlier, cough syrups were exempt from certain retail sale licensing provisions in villages with a population of less than 1,000, but this exemption has been removed.

Consequently, the sale and dispensing of cough syrups in smaller villages will now be required to take place only through duly licensed pharmacies in accordance with the provisions of the Drugs and Cosmetics Act, 1940 and the Rules framed thereunder.

The amendment has been notified through the Drugs Rules, 2026, published in the official gazette, and is expected to promote responsible distribution and sale of cough syrups while ensuring greater compliance with regulatory standards.