New Delhi: The Centre on Tuesday prohibited the over-the-counter (OTC) sale of syrup-based medicines, including cough syrups, without a doctor’s prescription by amending the Drugs Rules, 1945.
The move comes after the government removed the word “syrups” from a category of exempted drugs under Schedule K, tightening regulatory oversight of such formulations.
The change was notified through the Drugs (Fifth Amendment) Rules, 2026, and is aimed at strengthening regulatory control over the manufacture, sale and distribution of syrup formulations.
‘Schedule K’ of the Drugs Rules, 1945 contains categories of drugs that are exempt from certain provisions of the law governing their manufacture, sale and distribution, subject to specified conditions. These exemptions were originally introduced to facilitate easier access to certain medicines by relaxing some compliance requirements under defined circumstances.
Before the amendment, the provision allowed cough syrups to be sold in villages with a population of less than 1,000 without requiring compliance with certain retail sale licensing norms. With the latest change, the exemption will no longer apply to cough syrups.
Now, the sale and dispensing of cough syrups in such villages will now have to be carried out only through duly licensed pharmacies in accordance with the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945.
In addition, the Health Ministry said the amendment has been introduced to strengthen regulatory oversight of syrup formulations and align the exemption framework with current public health and safety requirements.
According to the ministry, the measure is expected to promote responsible distribution and sale of cough syrups while ensuring greater compliance with regulatory standards across the country.
Moreover, the ministry advised manufacturers, distributors and retailers dealing in cough syrups to ensure strict adherence to all applicable licensing and regulatory requirements under the Drugs and Cosmetics Act and the Drugs Rules.
As a result, consumers will now need a valid prescription from a registered medical practitioner to purchase such medications.
(IANS)
