Center tightens rules on cough syrups amid safety concerns

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New Delhi, June 16

The Union Health Ministry has amended drug regulations to ensure that syrups, including cough syrups, are sold only with a doctor’s prescription as part of efforts to strengthen patient safety and regulatory oversight.

The amendment has been notified under the Drugs (Fifth Amendment) Rules, 2026, and came into force immediately after its publication in the official gazette.

Under the revised rules, the government has removed the term “syrups” from Schedule K of the Drugs Rules, 1945. Schedule K, as earlier provided, exempts certain categories of medicines related to manufacture, sale, and distribution under prescribed conditions.

The move is aimed at bringing syrup-based formulations under stricter monitoring and regulatory control. Officials said the amendment is expected to improve traceability and ensure stronger compliance with licensing and quality-control standards.

The decision comes amid growing concerns over drug quality and patient safety following reports of contamination-linked child deaths associated with syrup-based medicines in several countries in recent years.

The Health Ministry had issued a draft notification in December last year seeking objections and suggestions from stakeholders before finalising the amendment. According to officials, public feedback was reviewed in consultation with the Drugs Technical Advisory Board, the country’s highest statutory body on technical matters related to medicines.

The government believes the revised framework will strengthen oversight of manufacturers and sellers of syrup-based medicines and reduce the risk of unsafe formulations reaching consumers.