Health Ministry amends Drugs Rules, 1945

Srinagar, Jun 16: In a significant move aimed at strengthening drug regulation and promoting the rational use of medicines, the Union Ministry of Health and Family Welfare has notified an amendment to the Drugs Rules, 1945, making it mandatory for consumers to produce a valid doctor’s prescription to purchase all syrups, including cough syrups.
The decision comes through the Drugs (Fifth Amendment) Rules, 2026, notified by the Ministry on June 9, 2026, and has come into force with immediate effect following its publication in the Official Gazette.
According to the notification, the government has amended Schedule K of the Drugs Rules, 1945, by removing the word “Syrups” from the list of medicines that were previously exempted from certain provisions governing retail sale. As a result, syrups can no longer be sold over the counter without a prescription.
The amendment follows a public consultation process initiated through a draft notification issued in December 2025. The Centre stated that objections and suggestions received from stakeholders and the public were examined before the final rules were notified after consultation with the Drugs Technical Advisory Board.
Health experts believe the move is intended to curb the growing trend of self-medication and misuse of liquid formulations, particularly cough syrups. In recent years, concerns have been raised over the indiscriminate use of cough syrups containing ingredients that may cause adverse effects when consumed without medical supervision.
Officials said that requiring a prescription would help ensure that patients receive appropriate diagnosis and treatment rather than relying on self-prescribed medicines for symptoms that could indicate more serious health conditions.
The new rule is also expected to improve monitoring of medicine sales and promote responsible dispensing practices among pharmacists.
With the amendment taking effect, pharmacies across the country will be required to dispense syrups only upon presentation of a valid prescription issued by a registered medical practitioner.
Consumers who previously purchased cough syrups, fever syrups, antibiotic syrups, digestive syrups, and other liquid medications directly from medical stores will now need to consult a doctor before obtaining these medicines.
Pharmacists may face regulatory action if found selling syrups without adhering to the revised provisions.
The Ministry said the amendment forms part of broader efforts to enhance patient safety and ensure the rational use of medicines. Public health experts have repeatedly highlighted the dangers of uncontrolled access to medicines, including antibiotic resistance, delayed diagnosis, drug interactions, and adverse health outcomes.
The latest amendment is expected to bring greater accountability in medicine dispensing practices while encouraging patients to seek professional medical advice before consuming prescription medications.
The notification has been issued under the powers conferred by Sections 12 and 33 of the Drugs and Cosmetics Act, 1940, and is now applicable across India. (KNO)