New Delhi, June 16 (IANS): The Centre has amended the Drugs Rules, 1945, removing an exemption that previously allowed the sale of cough syrups in small villages without compliance with certain retail licensing requirements. According to the Ministry of Health and Family Welfare, the change has been notified through the Drugs Rules, 1945 (Fifth Amendment) and involves the omission of the word “syrup” from Schedule K of the Drugs Rules. Schedule K provides exemptions from specific provisions of the Drugs and Cosmetics Act, 1940, and related rules for certain categories of drugs. Earlier, cough syrups could be sold in villages with populations below 1,000 without adhering to some retail licensing norms. With the latest amendment, this exemption has been withdrawn, making licensed pharmacies the only authorised outlets for the sale and dispensing of cough syrups in such areas.
The Health Ministry said the amendment has been introduced to strengthen regulatory oversight of syrup formulations and align existing exemptions with current public health and safety requirements. It stated that the measure is expected to encourage responsible distribution and sale of cough syrups while ensuring greater compliance with regulatory standards nationwide. Manufacturers, distributors and retailers dealing in cough syrups have been advised to strictly follow all applicable licensing and regulatory requirements under the Drugs and Cosmetics Act and the Drugs Rules. As a result of the amendment, consumers will now be required to obtain a valid prescription from a registered medical practitioner to purchase such medications, reinforcing tighter control over their distribution and use.