SUMMARY

Buying a common cough syrup may no longer be as simple as walking into a pharmacy. The Centre has tightened the rules for the sale of syrups, including cough syrups, through a fresh amendment to the Drugs Rules, 1945, meaning these medicines will no longer be available over the counter and can now be bought only on the prescription of a registered medical practitioner. The amendment was notified on June 9, 2026, after the government considered public comments on a draft proposal issued in December last year.

The move comes months after contaminated cough syrups were linked to the deaths of children in Madhya Pradesh and Rajasthan, triggering fresh concern over the safety and regulation of commonly used liquid medicines. The incidents led to renewed calls for tighter oversight, stricter checks on the manufacture and sale of syrup formulations, and stronger scrutiny of the supply chain. With the amendment now in force, pharmacies across the country will have to comply with the revised rules governing the sale of syrups and related formulations.

What has changed?

The amendment removes the word “Syrups” from a category of medicines listed in Schedule K of the Drugs Rules, 1945. Specifically, it says that in Schedule K, under the heading “Class of Drugs”, the word “Syrups” in item number seven shall be omitted. This effectively ends their over-the-counter availability.

What does the notification say?

According to the notification, the Central Government exercised powers under Sections 12 and 33 of the Drugs and Cosmetics Act, 1940, to amend the Drugs Rules, 1945. The notification reads: “These rules may be called the Drugs (Fifth Amendment) Rules, 2026” and adds that they “shall come into force on the date of their publication in the Official Gazette.”

Why was this move made?

The regulatory change follows reports linking contaminated cough syrups to child deaths in Madhya Pradesh and Rajasthan. Last year, the NHRC issued notices to Madhya Pradesh, Rajasthan and Uttar Pradesh, while the WHO issued an alert on three India-made cough syrups identified as “substandard”. The WHO also said, “Increased surveillance of the informal/unregulated market is also advised.”

What does this mean for consumers?

Consumers seeking to buy syrups, including commonly used cough syrups, will now have to present a prescription issued by a registered medical practitioner. This means people who earlier bought such medicines directly from pharmacies will first need a doctor’s written advice before making the purchase. Pharmacies will no longer be able to sell these products over the counter, changing the process for routine purchases of cough and other medicinal syrups that were traditionally available without a prescription.

How was the rule finalised?

The notification said draft rules proposing the amendment were published on December 30, 2025, inviting objections and suggestions from the public. The government said the comments received during the consultation period were considered before the amendment was finalised. The notification was issued by Harsh Mangla, Joint Secretary, Department of Health and Family Welfare.

Published on: Jun 16, 2026 12:08 PM IST