Doctor's prescription now mandatory for all cough syrup purchases

The government has tightened regulations governing the sale of medicinal syrups, including widely used cough formulations, by making a doctor's prescription mandatory for their purchase from pharmacies across the country.

The move follows growing concerns over medicine safety after contaminated cough syrups were linked to the deaths of children in Madhya Pradesh and Rajasthan earlier this year. The incidents sparked renewed calls for stricter oversight of the manufacture, distribution and sale of liquid medicines.

Under a notification issued on June 9, the government amended the Drugs Rules, 1945, removing "syrups" from a category of medicines listed under Schedule K. The change effectively ends their over-the-counter availability and places them under tighter regulatory control.

As a result, consumers will now need a valid prescription from a registered medical practitioner to purchase cough syrups and other medicinal syrup formulations from retail pharmacies.

Several commonly used cough syrups sold across India, including Benadryl, Glycodin, Zedex, Tusq DX, Grilinctus, Cofsils, Himalaya Koflet and Dabur Honitus, will now fall under the revised requirement.

The amendment was issued by the Central Government under Sections 12 and 33 of the Drugs and Cosmetics Act, 1940.

According to the notification, titled the Drugs (Fifth Amendment) Rules, 2026, the revised provisions came into effect from the date of their publication in the Official Gazette.

The amendment specifically omits the word "Syrups" from Item 7 under the "Class of Drugs" category in Schedule K of the Drugs Rules, 1945, thereby withdrawing the exemption that previously allowed their sale without a prescription.

Impact on consumers

The regulatory change is expected to alter the way consumers purchase cough syrups and other medicinal syrups that have traditionally been available directly from pharmacies.

Going forward, pharmacists will be required to dispense these products only upon presentation of a prescription issued by a registered medical practitioner.

Health authorities believe the move will strengthen monitoring of syrup-based medicines and help prevent misuse, while improving accountability across the pharmaceutical supply chain.

Amendment follows public consultation

The government noted that draft rules proposing the amendment were published on December 30, 2025, inviting objections and suggestions from stakeholders and the public.

After reviewing the feedback received during the consultation period, the Centre finalised the amendment and issued the notification through Harsh Mangla, Joint Secretary in the Department of Health and Family Welfare.

With the revised rules now in force, pharmacies across India will be required to comply with the new prescription mandate for the sale of syrups and related formulations.