Centre Tightens Rules on Cough Syrup Sales

Small villages can no longer sell cough syrups without licensed pharmacies under amended Drugs Rules

  • Health Ministry amends Drugs Rules, 1945 to remove exemption for cough syrup sales.
  • Small villages must now sell cough syrups only through licensed pharmacies.
  • Amendment aims to strengthen regulation and public health safeguards.
  • Manufacturers and retailers directed to comply with licensing requirements.

GG News Bureau
New Delhi, 16th June: The Ministry of Health and Family Welfare has amended the Drugs Rules, 1945, withdrawing the exemption that allowed the sale of cough syrups in villages with a population of less than 1,000 without certain retail licensing requirements.

The amendment, notified through Gazette Notification G.S.R. 927 (E), removes the word “Syrup” from Schedule K, Serial No. 13, Entry 7 under the “Class of Drugs” category. As a result, cough syrups will now be sold and dispensed only through duly licensed pharmacies under the provisions of the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945.

The Ministry said the move has been introduced to strengthen regulatory oversight of syrup formulations and align the exemption framework with current public health and safety requirements.

The amendment is expected to ensure responsible distribution and sale of cough syrups while improving compliance with regulatory standards across the country.

The Ministry has advised manufacturers, distributors and retailers dealing with cough syrups to strictly follow the applicable licensing and regulatory provisions.