In a move aimed at strengthening regulatory oversight and ensuring safer distribution of medicines, the Ministry of Health and Family Welfare (MoHFW) has amended the Drugs Rules, 1945, withdrawing a long-standing exemption that allowed the sale of cough syrups in small villages without compliance with certain retail licensing requirements.
The amendment, notified through Gazette Notification G.S.R. 927(E) dated December 29, 2025, removes the word “Syrup” from Schedule K, Serial No. 13, Entry 7 under the category “Class of Drugs.” The notification was published in the Gazette of India Extraordinary on December 30, 2025.
With the amendment now coming into effect, cough syrups can no longer be sold under the exemption previously available to villages with populations below 1,000. As a result, the sale and dispensing of cough syrups in such areas will now be permitted only through duly licensed pharmacies operating in accordance with the provisions of the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945.
Exemption Removed from Schedule K
Schedule K of the Drugs Rules, 1945 provides exemptions from certain provisions of the Drugs and Cosmetics Act and related rules for specified categories of drugs.
Before the amendment, Entry No. 13 of Schedule K allowed the sale of certain medicines, including cough syrups, in villages with a population of less than 1,000 without requiring full compliance with retail drug licensing provisions. This exemption was intended to improve access to essential medicines in remote and underserved areas where licensed pharmacies were often unavailable.
However, by removing “Syrup” from the exempted category, the Government has effectively brought cough syrups under stricter regulatory control, requiring them to be sold only through authorized and licensed drug retailers.
Focus on Public Health and Safety
According to the Ministry, the amendment has been introduced to strengthen oversight of syrup-based formulations and align the regulatory framework with contemporary public health and safety requirements.
The Ministry said the measure is expected to promote responsible distribution, dispensing, and sale of cough syrups while ensuring greater compliance with drug regulations across the country.
The Ministry has advised manufacturers, distributors, wholesalers, and retailers dealing with cough syrups to ensure strict adherence to all applicable licensing and regulatory requirements under the Drugs and Cosmetics Act and associated rules.
