Cough Syrup Now under Licence as Quality Concerns and Alcohol Dominate Thinking

Ø Key Amendment to Drugs Rules to Enhance Regulatory Control Over Cough Syrups notified

Key Points Summary

· The Ministry of Health and Family Welfare has amended the Drugs Rules, 1945 to strengthen regulation of cough syrup sales.

· Under the amendment, the word “Syrup” has been removed from Schedule K, Entry 13.

· Earlier, cough syrups could be sold in villages with a population of less than 1,000 without complying with certain retail drug licensing requirements.

· With this exemption withdrawn, cough syrups can now be sold and dispensed only through licensed pharmacies, even in small villages.

· The change has been made to improve regulatory oversight, public health protection, and patient safety.

· The amendment aims to ensure the responsible distribution and sale of cough syrups across the country.

· Manufacturers, distributors, and retailers have been directed to comply strictly with the licensing provisions under the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945.

· The amendment was notified through Gazette Notification G.S.R. 927(E) dated 29 December 2025.

[ABS News Service/16.06.2026]

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 29^th 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”.

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.

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 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.

Gazette notification