According to official regulatory changes reported by Hindustan Times, the Union Health Ministry has amended the Drugs Rules, 1945, through the Drugs (Fifth Amendment) Rules, 2026. The amendment removes the word “syrup” from Schedule K, which previously provided exemptions for certain medicines, thereby bringing all syrup-based formulations under stricter regulatory control.
Under the revised framework, all oral liquid medicines classified as syrups, including cough syrups, now require mandatory prescription for sale. Pharmacies are no longer permitted to sell these products over the counter without medical authorization. Solid alternatives such as tablets and lozenges remain available without prescription.
The regulatory overhaul follows a series of fatal incidents, including child deaths in Madhya Pradesh and Rajasthan, where contaminated cough syrups were linked to organ failure and fatalities. Authorities confirmed that in Madhya Pradesh’s Chhindwara district alone, at least 22 children died after consuming syrups later found to contain diethylene glycol at levels far exceeding permissible safety limits.
International cases have also intensified concern, with Indian-manufactured cough syrups previously linked to child deaths in The Gambia, Uzbekistan, and Cameroon. These incidents prompted heightened scrutiny of manufacturing standards and regulatory enforcement across the pharmaceutical sector.
As reported by Financial Express, the amended rules apply broadly to all oral liquid formulations classified as syrups, rather than targeting specific brands or products. The Central Drugs Standard Control Organisation has been reviewing regulatory gaps and strengthening oversight mechanisms to prevent recurrence of such tragedies.
The amendment process followed a draft notification issued in December 2025, during which stakeholders were invited to submit objections and suggestions. Officials stated that public feedback was reviewed before finalising the amendment, which was subsequently published in the official gazette and enforced immediately.
The National Formulary of India (NFI) 2026 had earlier recommended that cough and cold medicines should not be prescribed or dispensed for children under two years of age, reinforcing concerns regarding paediatric safety in syrup-based formulations.
The new regulatory framework is expected to significantly enhance traceability, licensing compliance, and quality control in the pharmaceutical supply chain, marking a major shift in India’s approach to regulating oral liquid medicines.
About The Author
-(1).jpg)
.png)
Comment List