Doctor's prescription now mandatory for cough syrups as Centre amends rules

Doctor's prescription must for all syrups: Government cracks down on over-the-counter cough syrup sales

In Short

• Buying a bottle of cough syrup will now need a prescription
• Pharmacies must comply with new syrup sale regulations
• New rules come into force from June 9

The Centre has tightened rules governing the sale of syrups, including cough syrups, with a fresh amendment to the Drugs Rules, 1945 that will require consumers to obtain a doctor's prescription before purchasing such medicines from pharmacies.

The move comes months after contaminated cough syrups were linked to the deaths of children in Madhya Pradesh and Rajasthan, raising fresh concerns over the safety and regulation of commonly used liquid medicines. The incidents renewed calls for tighter oversight and stricter checks on the manufacture and sale of syrup formulations.

The notification, dated June 9, 2026, was published after considering public comments on a draft proposal issued in December last year.

The amendment removes the word "Syrups" from a category of medicines listed in Schedule K of the Drugs Rules, a move that effectively ends their over-the-counter availability and places them under stricter regulatory control.

WHAT THE NOTIFICATION SAYS

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."

The amendment specifically says that in Schedule K of the Drugs Rules, 1945, under the heading "Class of Drugs", the word "Syrups" in item number seven shall be omitted.

IMPACT ON CONSUMERS

The regulatory change means syrups, including commonly used cough syrups, will no longer be available for purchase over the counter without medical authorisation.

Consumers seeking to buy such medicines will now be required to present a prescription issued by a registered medical practitioner.

The move is expected to affect routine purchases of cough and other medicinal syrups that have traditionally been available directly from pharmacies.

DRAFT RULES WERE PUBLISHED EARLIER

The notification says draft rules proposing the amendment were published on December 30, 2025, inviting objections and suggestions from the public.

The government said 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.

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.

- Ends