New Delhi, June 16: The central government has amended the Drugs Rules of 1945, prohibiting the over-the-counter sale of cough syrups and other syrup-based medications without a doctor’s prescription.
This decision follows the removal of the term “syrup” from the list of exempted drugs under Schedule K, tightening regulatory oversight on these medications.
The amendment is part of the Drugs (Fifth Amendment) Rules, 2026, aimed at ensuring better control over the manufacturing, sale, and distribution of syrup-based drugs.
Previously, Schedule K allowed certain drugs to be sold under specific conditions without adhering to all legal provisions related to their manufacture, sale, and distribution. These exemptions were originally intended to facilitate easy access to medications in specific circumstances.
Before the amendment, cough syrups could be sold in villages with populations under 1,000 without following certain retail licensing regulations. However, this exemption will no longer apply to cough syrups.
Now, the sale and distribution of cough syrups in such villages will only be permitted through licensed pharmacies, in compliance with the Drugs and Cosmetics Act of 1940 and the Drugs Rules of 1945.
Additionally, the Ministry of Health and Family Welfare stated that this amendment aims to strengthen regulatory oversight on syrup-based medications and improve compliance with existing public health and safety requirements.
According to the ministry, this move will promote responsible distribution and sales of cough syrups, ensuring better adherence to regulatory standards across the country.
The ministry has also advised manufacturers, distributors, and sellers of cough syrups to strictly comply with all licensing and regulatory requirements under the Drugs and Cosmetics Act and the Drugs Rules.
Consumers will now be required to present a valid prescription issued by a registered medical professional to purchase such medications, making a doctor’s prescription mandatory for cough syrup purchases.
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