Centre bans sale of Cough syrups without valid prescription

The Centre has amended the Drugs rule, omitting the word “Syrup” from Schedule K, the list of medicines exempted from the requirement of a prescription by a registered medical practitioner. Lozenges, pills or tablets for cough continue to remain on the list.

With the omission of the word “Syrup” from the said entry, this exemption will no longer be available for cough syrups. Consequently, the sale and dispensing of cough syrups in smaller villages will now be required to take place only through duly licensed pharmacies in accordance with the provisions of the Drugs and Cosmetics Act, 1940 and the Rules framed thereunder.

Schedule K of the Drugs Rules, 1945 provides exemptions from certain provisions of the Drugs and Cosmetics Act, 1940 and the Rules made thereunder for specified classes of drugs. Prior to this amendment, Entry No. 13 of Schedule K permitted the sale of cough syrups in villages with a population of less than 1,000 without requiring compliance with certain retail sale licensing provisions.

The amendment has been undertaken to strengthen regulatory oversight of syrup formulations and to align the exemption framework with contemporary public health and safety requirements. The measure is expected to promote responsible distribution and sale of cough syrups while ensuring greater compliance with regulatory standards across the country.