No More Over-the-Counter Cough Syrups: Centre Makes Prescription Compulsory Under New Drug Rules

The Union Ministry of Health and Family Welfare (MoHFW) has brought all syrup-based medicines, including cough syrups, under prescription-only sale, making them unavailable over the counter without a doctor's prescription. Consumers will now be required to present a valid prescription from a registered medical practitioner to purchase any syrup formulation from pharmacies across the country.

The move comes into effect following the notification of the Drugs (Fifth Amendment) Rules, 2026, issued by the Department of Health and Family Welfare on June 9. The notification was officially gazette notified after the government considered objections and suggestions received on a draft proposal released in December 2025.

What Has Changed Under the New Rules?

The amendment makes a key change to the Drugs Rules, 1945 by removing the word "Syrups" from Schedule K, a list of drugs that are exempt from certain provisions governing their sale and distribution under specific conditions.

The notification stated: "In the Drugs Rules, 1945, in Schedule K, in the column, under the heading Class of Drugs, against serial number 13, in item number (7), the word 'Syrups,' shall be omitted."

As a result, syrup formulations, including commonly used cough syrups, will no longer enjoy the exemption available under Schedule K and can only be sold upon presentation of a doctor's prescription.

The notification further said: "These rules may be called the Drugs (Fifth Amendment) Rules, 2026" and added that they "shall come into force on the date of their publication in the Official Gazette."

Incidents That Prompted Greater Scrutiny

The government's decision comes against the backdrop of several incidents involving contaminated or faulty cough syrup formulations that raised concerns over drug safety and regulatory oversight.

Some of the major incidents include:

• In 2022, contaminated India-made cough syrups were linked to the deaths of dozens of children in The Gambia, triggering global concern over pharmaceutical quality standards.

• In 2022-23, similar concerns emerged in Uzbekistan, where children reportedly died after consuming contaminated cough syrup formulations.

• More recently, children in Madhya Pradesh allegedly died after consuming contaminated cough syrups, prompting investigations and renewed scrutiny of liquid medicines.

• Another case in Rajasthan involving deaths of children linked to contaminated cough syrup formulations further intensified calls for stricter regulation and quality checks.

These incidents renewed demands for stronger oversight of the manufacture, distribution and sale of syrup-based medicines in India.

Government Says Due Process Was Followed

According to the notification, the amendment was introduced after a draft of the proposed rules was published on December 30, 2025, inviting objections and suggestions from the public.

The government said comments received during the consultation period were examined before the amendment was finalised. The notification also stated that the rules were framed by the Central Government "after consultation with the Drugs Technical Advisory Board" in exercise of powers conferred under Sections 12 and 33 of the Drugs and Cosmetics Act, 1940.

Impact on Consumers and Pharmacies

With the amendment now in force, pharmacies across India will have to comply with the revised regulations governing the sale of syrup formulations. Consumers who have traditionally purchased cough syrups and other medicinal syrups directly from chemists will now need medical authorisation before obtaining them.

The measure is expected to significantly alter routine purchases of syrup-based medicines while strengthening regulatory oversight of a category of drugs that has come under increasing scrutiny following a series of safety-related incidents in India and abroad.