Cough syrups no longer over-the-counter, prescription now mandatory

The Union Health Ministry has mandated that syrup medicines, including cough syrups, will no longer be sold over the counter. Consumers will now require a doctor's prescription to purchase them, following an amendment to the Drugs Rules, 1945.

The Union Ministry of Health and Family Welfare on Tuesday issued a notification under which syrup medicines, including cough syrups, will no longer be available over the counter. Consumers will now require a doctor's prescription to purchase such medicines.

Amendment to Drugs Rules, 1945

The change comes after the Centre amended the Drugs Rules, 1945, through the Drugs (Fifth Amendment) Rules, 2026, notified in the Official Gazette on June 9. Under the amendment, the word "Syrups" has been removed from item number (7) under serial number 13 of Schedule K of the Drugs Rules, 1945.

Schedule K lists categories of medicines that are exempt from certain provisions of Chapter IV of the Drugs and Cosmetics Act, 1940, subject to specified conditions. With the omission of syrups from the list, such medicines will now be subject to the applicable regulatory requirements.

The amendment follows a draft notification issued on December 29, 2025, inviting objections and suggestions from stakeholders and the public. The government said all comments received on the draft rules were considered before the final notification was issued.

Official Notification Text

The notification stated, "Now, therefore, in exercise of the powers conferred by sections 12 and 33 of the said Act, the Central Government, after consultation with the Drugs Technical Advisory Board, hereby makes the following rules further to amend the Drugs Rules, 1945, namely."

The amendment further read, "In the Drugs Rules, 1945, in Schedule K, in the column, under the heading Class of Drugs, against serial number 13, in item number (7), the word 'Syrups,' shall be omitted."

The notification was issued after consultation with the Drugs Technical Advisory Board. The Drugs Rules, 1945, framed under the Drugs and Cosmetics Act, 1940, regulate the manufacture, sale and distribution of medicines in India. (ANI)

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