New Delhi: Amid drug quality and patient safety concerns, the Union Health ministry has amended rules to prohibit sale of syrups, including cough syrups, without a doctor’s prescription across the country.
The move is aimed at bringing syrup-based formulations, including cough syrups, under stricter regulatory oversight, officials said.
Earlier, 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, the ministry said in a statement.
With the omission of the word “syrup” from the said entry, this exemption will no longer be available for cough syrups.
“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 statement said.
The amendment has been notified through the Drugs (Fifth Amendment) Rules, 2026, published in the official gazette.
The 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.
It specifies categories of drugs that are exempt from certain provisions relating to manufacture, sale and distribution under the Drugs and Cosmetics Act and Rules, subject to prescribed conditions.
The move follows a draft notification issued by the government in December last year seeking objections and suggestions from stakeholders.
The amendment has been undertaken to strengthen regulatory oversight of syrup formulations and to align the exemption framework with contemporary public health and safety requirements, the statement said
“The measure is expected to promote responsible distribution and sale of cough syrups while ensuring greater compliance with regulatory standards across the country,” the health ministry said.
“Manufacturers, distributors and retailers dealing with cough syrups are advised to ensure strict adherence to the applicable licensing and regulatory requirements under the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945,” it stated.
The decision comes against the backdrop of increased regulatory scrutiny of cough syrups and other liquid oral formulations in recent years following reports of contamination-linked deaths of children in several countries.
According to sources, the latest amendment is expected to enhance traceability and regulatory supervision of syrup-based medicines by ensuring that manufacturers and sellers comply with stricter licensing and quality-control requirements.
