Centre bans sale of cough syrups without doctor’s prescription

The Union government on Tuesday notified an amendment to the 1945 Drugs Rules to ban the over-the-counter sale of all syrups, including those consumed to treat cough. The purchase of syrups will require a doctor’s prescription.

The Ministry of Health and Family Welfare notified an amendment that removed the word “syrup” from the list of items exempted under 1940 Drugs and Cosmetics Act. The rules had earlier exempted syrups, lozenges, pills and tablets for cough.

With the amendment, the sale of cough syrups in villages with a population of less than 1,000 will be required to take place only through licensed pharmacies. The rules had earlier permitted the sale of cough syrups in smaller villages without requiring compliance with some retail sale licensing provisions.

Pills, tablets and lozenges for cough would continue to be available without a prescription.

The change had been made to “strengthen regulatory oversight of syrup formulations” and to align the exemptions with public health and safety requirements, the ministry said.

“The measure is expected to promote responsible distribution and sale of cough syrups while ensuring greater compliance with regulatory standards across the country,” it added.

The rules have been amended following a series of cases of contaminated cough syrups leading to deaths of children.

Starting September, deaths had been reported in Madhya Pradesh and Rajasthan. Several children, who had been suffering from fever and cold, consumed the Coldrif syrup, resulting in vomiting and difficulty urinating.

In February, Reuters quoted Drugs Controller General of India Rajeev Raghuvanshi as having said that the Central Drugs Standard Control Organisation had inspected about 90% of the manufacturers of cough syrup in the country and found compliance lapses.

Written by Nachiket Deuskar. Edited by Tanya Shrivastava.