The Central Government has amended the Drugs Rules, 1945, introducing stricter controls on the sale of medicinal syrups, including cough syrups. Under the revised regulations, consumers will now be required to obtain a prescription from a registered medical practitioner before purchasing such medicines from pharmacies.
Notification released by the Ministry of Health and Family Welfare. (image credit: pib.gov.in)
The decision comes in the wake of recent incidents involving contaminated cough syrups that were linked to the deaths of children in Madhya Pradesh and Rajasthan. The cases reignited concerns about the safety, quality control, and monitoring of liquid medicinal formulations sold across the country.
Consumers to Need Medical Authorisation
The revised framework will require customers to present a valid prescription when purchasing syrups, including commonly used cough medications. The move is expected to change the way consumers access several liquid medicines that were previously available directly from pharmacies without a doctor’s approval.
Amendment Issued Under Drugs and Cosmetics Act
According to the official notification, the amendment has been introduced by the Central Government using powers granted under Sections 12 and 33 of the Drugs and Cosmetics Act, 1940. The notification states that the revised regulations will be known as the Drugs (Fifth Amendment) Rules, 2026.
What is Schedule K
Schedule K is a part of the Drugs Rules, 1945, that lists certain medicines and categories of drugs that are exempt from some requirements related to sale, storage, or distribution under specific conditions. These exemptions are generally provided to make essential medicines more accessible in particular situations. The schedule suggests drugs that can be sold without following specific licensing provisions.
After the omission of the word ‘syrup’ from schedule K in the notification by the Ministry of Health and Family Welfare, the sale of syrups including cough syrups based medicine will have restriction, meaning, a common man needs a doctor’s prescription for buying so.
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The government noted that draft rules proposing the amendment were published on December 30, 2025, seeking objections and suggestions from stakeholders and the public.
The notification announcing the regulatory change was issued by Harsh Mangla, Joint Secretary in the Department of Health and Family Welfare, marking the latest step in the government’s efforts to strengthen oversight of medicinal products.
The notification specifies that the amended rules will come into force from the date of their publication in the Official Gazette.
