By NE NOW NEWS
Guwahati: In a significant regulatory change, the Ministry of Health and Family Welfare has amended the Drugs Rules, 1945, bringing syrup-based medicines under stricter control and ending their exemption from prescription requirements.
The amendment, notified through the Drugs (Fifth Amendment) Rules, 2026, removes “syrups” from Schedule K of the Drugs Rules. As a result, medicines in syrup form, including commonly used cough formulations, can no longer be sold over the counter (OTC) and will require a valid prescription from a registered medical practitioner.
The new rules have been issued under the authority granted to the Central Government by Sections 12 and 33 of the Drugs and Cosmetics Act, 1940. According to the notification, the revised provisions take effect immediately upon their publication in the Official Gazette.
Schedule K lists categories of drugs that enjoy exemptions from certain requirements governing manufacture, sale and distribution, subject to specific conditions. By deleting syrup formulations from this schedule, the government has effectively tightened controls over their retail availability.
The move comes amid growing concerns over the indiscriminate use of cough and cold medicines, particularly among children. Health authorities have increasingly advocated greater caution in the use of such products, citing potential safety risks and the need for appropriate medical supervision.
The government’s draft National Formulary of India (NFI) 2026 has already recommended against prescribing or dispensing cough and cold medications to children below two years of age. It further advises that these medicines should generally not be used for children under five unless deemed necessary by a healthcare professional and administered under close monitoring.
Officials say the latest amendment is intended to strengthen patient safety, encourage responsible use of medicines, and ensure that syrup-based formulations are consumed only under proper medical guidance.