In its latest directive, the Ministry said, the word “Syrup” would be omitted from “Schedule K, Serial No 13, Entry 7 under the heading “Class of Drugs”. | Photo Credit: istock.com

The Centre has tightened its norms on cough syrups, banning over-the-counter (OTC) sale of the product without a doctor’s prescription, the Union Health Ministry said in its latest notification involving a product segment that has been in the eye of many storms, in India and overseas.

As a result of the Ministry’s latest notification, the sale of cough syrups in smaller villages (less than 1000 people) has also been disallowed, and dispensing will now take place only through “duly licensed pharmacies” in line with provisions of the Drugs and Cosmetics Act, 1940 and the Rules, it added.

Locally-made cough syrups have been in the dock in multiple cases – from possible links to the death of children in Gambia (2022), for example, to the case closer home, when deaths of children in Madhya Pradesh were linked to cough syrups, and subsequent investigation by the health authorities lead to finding samples with the contaminant Diethylene Glycol (DEG). 

The Union Health Ministry’s latest notification to amend the Drugs Rules, 1945, disallowing OTC sale of cough syrups without a doctor’s prescription follows consultation with the Drugs Technical Advisory Board. The Centre has in the past mandated testing of cough syrups, before it left domestic shores as exports (2023). In October 2025, it also called for online tracking of high-risk solvents used in products.

Regulatory radar  

In its latest directive, the Ministry said, the word “Syrup” would be omitted from “Schedule K, Serial No 13, Entry 7 under the heading “Class of Drugs”.

Schedule K of the Drugs Rules, 1945 “provides exemptions from certain provisions of the Drugs and Cosmetics Act, 1940 and the Rules made thereunder for specified classes of drugs. Prior to this amendment, Entry No. 13 of Schedule K permitted the sale of cough syrups in villages with a population of less than 1,000 without requiring compliance with certain retail sale licensing Provisions,” it explained, adding that dropping “Syrup” meant the exemption would no longer be available for cough syrups.

The amendment seeks to strengthen “regulatory oversight of syrup formulations and to align the exemption framework with contemporary public health and safety requirements,” the Ministry said. “The measure is expected to promote responsible distribution and sale of cough syrups while ensuring greater compliance with regulatory standards across the country,” it added.

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Published on June 16, 2026