Health Ministry has barred over-the-counter sale of syrups, requiring consumers to present a valid doctor’s prescription amid renewed safety concerns
In a significant regulatory move, the Union Ministry of Health and Family Welfare has made it mandatory for consumers to obtain a doctor’s prescription before purchasing syrups, including cough medicines, from pharmacies across the country.
With the new notification now in force, syrup-based medicines will no longer be available over the counter (OTC). Consumers will be required to present a valid prescription issued by a registered medical practitioner before pharmacists can dispense such medicines.
The decision comes months after contaminated cough syrups were allegedly linked to the deaths of several children in Madhya Pradesh and Rajasthan, triggering fresh concerns over medicine safety standards and regulatory oversight. The incidents renewed calls for stricter monitoring of the manufacture, distribution and sale of liquid medicinal formulations.
The notification, issued on June 9, 2026, follows a review of public feedback received on a draft proposal circulated by the government in December last year.
As part of the amendment, the Centre has removed the term “Syrups” from a category of medicines listed under Schedule K of the Drugs Rules. The change effectively ends the over-the-counter sale of such products and places them under a stricter regulatory framework.
According to the notification, the amendment has been made under Sections 12 and 33 of the Drugs and Cosmetics Act, 1940.
“The rules may be called the Drugs (Fifth Amendment) Rules, 2026,” the notification stated, adding that the revised regulations came into effect upon publication in the Official Gazette.
The move is expected to significantly alter how commonly used cough and medicinal syrups are sold across India, while strengthening safeguards aimed at protecting public health.
For all the latest updates, download PGurus App.
