CHENNAI: The Centre has amended the Drugs Rules, 1945, making a doctor's prescription mandatory for the purchase of syrups, including cough medicines, across the country.
The move comes amid increased regulatory scrutiny following reports of deaths linked to contaminated cough syrups in recent years.
The amendment has been notified through the Drugs (Fifth Amendment) Rules, 2026, issued under Sections 12 and 33 of the Drugs and Cosmetics Act, 1940, in consultation with the Drugs Technical Advisory Board (DTAB), according to a Daily Thanthi report.
It aims to bring syrup-based formulations under stricter regulatory oversight and strengthen patient safety measures.
However, following Tuesday’s (June 16, 2026) change, lozenges and pills and tablets for cough would still be available over the counter.
Under the amendment, the word "syrup" has been removed from Entry No 13 of Schedule K of the Drugs Rules, 1945. Earlier, this provision allowed the sale of cough syrups in villages with a population of less than 1,000 without requiring compliance with certain retail sale licensing requirements.
With the exemption withdrawn, cough syrups can now be sold and dispensed only through duly licensed pharmacies in accordance with the provisions of the Drugs and Cosmetics Act, 1940, and the rules framed under it.
Consumers will now have to produce a prescription issued by a registered medical practitioner to purchase certain syrup-based medicines, including commonly used cough syrups.
The change is expected to affect routine purchases of such medicines, which were previously available without a prescription in several areas.
Schedule K of the Drugs Rules, 1945, provides exemptions from certain provisions of the Drugs and Cosmetics Act, 1940.
It specifies categories of drugs that are exempt from certain provisions relating to their manufacture, sale and distribution, subject to prescribed conditions.
The Union Health Ministry said the amendment was introduced to strengthen regulatory oversight of syrup formulations and align existing exemptions with current public health and safety requirements.
The amendment follows a draft notification issued in December last year seeking objections and suggestions from stakeholders. The final notification was issued after considering the feedback received.