New Delhi : The Drugs Technical Advisory Board (DTAB) has recommended formation of a sub-committee to examine aspects including the requirement of Registered Medical Practitioner (RMP) for sale of various cough syrups in the country.
A recent meeting of the DTAB made the recommendation while looking into a representation received from Mumbai-based USV Pvt Ltd to move its approved drug Dried Ivy Leaf Extract Cough Syrup, from prescription drug to the Schedule K of the Drugs and Cosmetics Rules, 1945.
USV has requested for marketing of approved drug “Dried Ivy Leaf Extract Cough Syrup” under Schedule K (Rule 123) and requested exemption from the “WARNING: “To be sold by retail on the prescription of a RMP only”
It has also submitted the proposal and a recommendation from the Subject Expert Committee for the consideration of the Board.
“DTAB deliberated the matter and recommended that a sub-committee should be constituted to examine the proposal and also to examine the requirement of RMP for sale of various cough syrups in the country,” concluded the Board.
The SEC, which advises the drug regulator on matters related to Pulmonary therapeutic segment, in its 60th meeting on June 7, 2022, recommended for exemption of the drug from ‘Warning’ label requirement for marketing of the cough syrup. It also opined that an opinion from a phytopharmaceutical expert may be obtained for further proceedings.
Prior to the recommendation, the company presented patient safety data, details of concentration of Saponin in the reduction and the details of countries in which the product is marketed, package insert and regulatory status before the committee.
USV sells Prospan brand of dried ivy leaf extract based cough syrup in the market. The company, in its website claims that the exclusive extract from the leaves is carefully made using a patented extraction process and backed by years of clinical research.
It may be noted that the decision to look into the requirement of RMP for the same of various cough syrups in the country comes at a time when there has been an increased focus on the quality of cough syrups manufactured and exported from the country.