Delhi, June 16: Amid drug quality and patient safety concerns, the Union Health Ministry has amended the rules to prohibit the sale of syrups, including cough syrups, without a doctor's prescription.
The move is aimed at bringing syrup-based formulations, including cough syrups, under stricter regulatory oversight.
The amendment has been notified through the Drugs (Fifth Amendment) Rules, 2026, published in the official gazette. The amendment came into force with immediate effect from the date of its publication.
“The Ministry of Health and Family Welfare has notified an amendment to the Drugs Rules, 1945, vide Gazette Notification G.S.R. 927 (E) dated 29th December 2025, published in the Gazette of India Extraordinary on , Part II, section 3, sub-section (i), dated the 30th December, 2025, omitting the word “Syrup” from Schedule K, Serial No. 13, Entry 7 under the heading “Class of Drugs,” said a Ministry of Health and Family Welfare release.
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 stated.
“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,” it added.
It further stated, “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 measure is expected to promote responsible distribution and sale of cough syrups while ensuring greater compliance with regulatory standards across the country.”
“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.
