Experts warn against use of banned cough syrups without prescription

Hyderabad: Experts have issued a warning advising against the consumption of certain cough syrups, including those from reputed companies, following a ban imposed by the central government on 14 fixed dose drug combinations.

According to Section 26A of the Drugs and Cosmetic Act, 1940 (23 of 1940), the manufacture, sale, and distribution of the fixed dose combination of Nimesulide plus Paracetamol dispersible tablets for human use has been prohibited, as stated in notification number SO 712 (E) issued on March 10, 2016. In response to this, the central government formed an expert committee on April 1, 2022, to submit a report regarding this drug to the central government and Drug Technical Advisory Board. Based on the committee’s report, the central government issued a notification on June 2, banning these drugs.

The expert committee recommended that “there is no therapeutic justification for this fixed dose combination, and it may pose risks to human beings. Therefore, in the best interest of the public, it is necessary to prohibit the manufacture, sale, or distribution of this combination under Section 26A of the Drugs and Cosmetics Act, 1940. Considering this, any form of regulation or restriction to allow its use in patients is not justified. Hence, only prohibition under Section 26A is recommended.”

Akula Sanjay Reddy, a member of the Telangana Pharma Council, stated that the government has banned several drugs used for treating coughs, colds, and respiratory infections, citing a lack of therapeutic rationale. He mentioned that there are at least ten such combinations that violate the regulations, including some from well-known companies. The banned cough syrups include Coughex syrup, Bro Coughex Syrup, Cofdex Plus syrup, and Cofton Syrup from Cipla. Additionally, Codistar Syrup from Mankinds Company and Ascoril C syrup from Glenmark are among the other banned products, as stated by the Pharma Council member.