New Delhi: The Centre has tightened regulations governing the sale of cough syrups, restricting their retail distribution to licensed pharmacies in an effort to improve oversight and curb misuse.
The Ministry of Health and Family Welfare has removed cough syrups from Schedule K of the Drugs Rules, 1945. The category previously allowed certain medicines to be sold without complying with some retail licensing requirements, particularly in villages with populations below 1,000.
With the latest amendment, cough syrups will no longer qualify for those exemptions. As a result, their sale and dispensing will now be permitted only through licensed pharmacies operating under the provisions of the Drugs and Cosmetics Act, 1940 and related rules.
“Consequently, the sale and dispensing of cough syrups in smaller villages will now be required to take place only through duly licensed pharmacies in accordance with the provisions of the Drugs and Cosmetics Act, 1940 and the Rules framed thereunder,” said the health ministry’s statement.
The move comes amid concerns over the misuse of cough syrups and a series of incidents involving contaminated formulations. Authorities have previously flagged the growing use of certain cough syrups as substitutes for alcohol and narcotics, particularly because of their easy availability and low cost.
The issue has also drawn attention following several cases involving unsafe products. Last year, at least 22 children, mostly in Rajasthan, died after consuming contaminated cough syrup. Investigations found the product contained diethylene glycol (DEG), a toxic industrial chemical, at levels far exceeding permissible limits. Indian-made cough syrups have also been linked to child deaths in countries including The Gambia and Uzbekistan in recent years.
The government is also seeking to strengthen controls over illegal trade. Security agencies have repeatedly seized large quantities of India-manufactured cough syrups being smuggled across the Bangladesh border.
Explaining the rationale behind the amendment, the health ministry said, “The amendment has been undertaken to strengthen regulatory oversight of syrup formulations and to align the exemption framework with contemporary public health and safety requirements. The measure is expected to promote responsible distribution and sale of cough syrups while ensuring greater compliance with regulatory standards across the country.”
The ministry has asked manufacturers, distributors and retailers to ensure compliance with all licensing and regulatory requirements applicable to cough syrup sales under the Drugs and Cosmetics Act.
BI Bureau
