New Delhi, June 16: The government has announced a significant change in the Drugs Rules, 1945, effectively ending the exemption that allowed cough syrup to be sold in small villages without adhering to certain retail licensing regulations. This announcement was made by the Ministry of Health and Family Welfare in an official statement released on Tuesday.
According to the statement, this amendment has been implemented through a notification. It removes the term ‘syrup’ from Schedule K of the Drugs Rules, 1945.
Previously, Schedule K provided exemptions for specific categories of drugs from certain provisions of the Drugs and Cosmetics Act, 1940. Before this amendment, it was permissible to sell cough syrup in villages with a population of less than 1,000 without following certain retail licensing rules. However, under the new regulations, this exemption will no longer apply to cough syrup.
Now, the sale and distribution of cough syrup in such villages can only be conducted through duly licensed pharmacies. Compliance with all provisions of the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945, will be mandatory.
The health ministry stated that this amendment aims to strengthen regulatory oversight on syrup-based medications and enhance compliance with existing public health and safety requirements.
According to the ministry, this move will promote responsible distribution and sale of cough syrup, ensuring better adherence to regulatory standards across the country.
Additionally, the ministry has advised manufacturers, distributors, and retailers of cough syrup to strictly comply with all licensing and regulatory requirements under the Drugs and Cosmetics Act and the Drugs Rules.
Following this change, consumers will now need to present a valid prescription issued by a registered medical professional to purchase such medications. This means cough syrup will only be available through licensed medical stores in accordance with the established regulations.
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