Government amends rules to bring cough syrups under stricter regulatory oversight

Amid drug quality and patient safety concerns, the Union Health Ministry has amended rules to prohibit the sale of syrups, including cough syrups, without a doctor's prescription.

The amendment has been notified through the Drugs (Fifth Amendment) Rules, 2026, (Unsplash/Representative)

The move is aimed at bringing syrup-based formulations under stricter regulatory oversight and comes amid heightened scrutiny of liquid oral medicines following reports of contamination-linked child deaths in several countries.

The amendment has been notified through the Drugs (Fifth Amendment) Rules, 2026, and came into force immediately upon publication in the official gazette on June 15.

Also Read: Cough syrup purchase to now require doctor's prescription as govt ends over-the-counter sales

What has changed?

Under the amendment, the word "syrups" has been omitted from Item 7 in the "Class of Drugs" column of Schedule K of the Drugs Rules, 1945.

Schedule K specifies categories of drugs that are exempt from certain provisions relating to the manufacture, sale and distribution of medicines under the Drugs and Cosmetics Act and Rules, subject to prescribed conditions.

Before the amendment, cough syrups were among the products that could be sold under relaxed regulations in villages with populations of fewer than 1,000 people. The exemption allowed vendors with restricted retail licences, often operating in smaller towns and villages without pharmacies, to stock and sell such products.

Consumers could often purchase cough syrups from non-pharmaceutical retail outlets without going through standard pharmacy channels.

With the latest amendment, cough syrups and other syrup-based formulations have been removed from the exemption list. Consequently, their sale and dispensing will now be required to take place only through duly licensed pharmacies in accordance with the provisions of the Drugs and Cosmetics Act.

Pills, tablets and lozenges continue to remain covered under Schedule K.

Why now?

The Health Ministry said the amendment was undertaken to strengthen regulatory oversight of syrup formulations and align the exemption framework with contemporary public health and safety requirements.

"The measure is expected to promote responsible distribution and sale of cough syrups while ensuring greater compliance with regulatory standards across the country," the ministry said.

The move follows a draft notification issued in December last year seeking objections and suggestions from stakeholders. The ministry said comments received from the public were considered before finalising the amendment after consultation with the Drugs Technical Advisory Board (DTAB), the country's highest statutory body on technical matters related to drugs.

According to official sources, the amendment is expected to enhance traceability and regulatory supervision of syrup-based medicines by ensuring that manufacturers and sellers comply with stricter licensing and quality-control requirements.

Contamination-linked deaths

The decision comes against the backdrop of increased regulatory scrutiny of cough syrups and other liquid oral formulations in recent years following reports of contamination-linked deaths of children in several countries.

Since 2022, India-manufactured cough syrups have been linked to the deaths of more than 140 children in Africa and Central Asia, hurting the country's reputation as the "pharmacy of the world".

In one such case, Coldrif syrup manufactured by Sresan Pharmaceutical was linked to the deaths of 24 children last year.

India has since come under pressure to tighten oversight of its pharmaceutical industry, which is dominated by small manufacturers and is projected to reach a value of $130 billion by 2030.

(With agency inputs)