Now a doctor’s prescription will be necessary to buy many types of medicinal syrups including cough syrup across the country. By making changes to the Drugs Rules, 1945, the central government has decided to ban over-the-counter (OTC) sale of the syrup. After the new rules come into effect, it will be necessary to produce a prescription written by a registered doctor to purchase the syrup from the pharmacy.
What is the new rule?
The Central Government has enacted the Drugs (Fifth Amendment) Rules, 2026, vide a notification issued on June 9, 2026. This change was made under Sections 12 and 33 of the Drugs and Cosmetics Act, 1940 and came into effect immediately after its publication in the Official Gazette.
What changes have been made in the drugs rules?
The government has removed the word “syrup” from the category of drugs specified in Schedule K of the Drugs Rules, 1945. As a result, syrups will no longer be classified as over-the-counter medicines and their sale will be subject to strict regulatory controls.
Cough syrup will not be available without prescription
Under the new rules, customers will have to produce a prescription from a registered doctor to purchase medicinal syrups, including cough syrups. This will affect the regular purchase of those syrups which people used to buy directly from medical stores earlier.
The decision was taken after cases of death of children
This step of the government has come at a time when incidents of death of children due to drinking adulterated cough syrup in Madhya Pradesh and Rajasthan have raised serious questions on the quality and monitoring of the medicine. Following these incidents, demands for stricter control over the manufacture and sale of syrup intensified.
Changes were implemented after taking suggestions from people
The draft of the changes was released on December 30, 2025, inviting objections and suggestions from the general public. The government said that after considering the suggestions received, notification of the final changes was issued.
Pharmacy must follow new rules
According to the notification issued by Harsh Mangla, Joint Secretary, Department of Health and Family Welfare, now pharmacies across the country will have to follow the changed rules regarding the sale of syrups and related drug formulations. Under these rules, it will no longer be possible to sell such medicines without a doctor’s prescription.