DTAB: Examination of RMP requirement for sale of Cough Syrups

USV Pvt Ltd also requested exemption from the mandatory warning label, "To be sold by retail on the prescription of an RMP only."

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DTAB Drug Technical Advisory Board
DTAB

Last Updated on January 6, 2024 by The Health Master

Examination of RMP Requirement for sale of Cough Syrups

The Drugs Technical Advisory Board (DTAB) has recently proposed the establishment of a sub-committee to assess the necessity of a Registered Medical Practitioner (RMP) requirement for the sale of different cough syrups across the country.

This recommendation was made following a representation submitted by USV Pvt Ltd, a Mumbai-based pharmaceutical company, regarding their approved drug, Dried Ivy Leaf Extract Cough Syrup.

The company sought to move the drug from a prescription drug category to Schedule K of the Drugs and Cosmetics Rules, 1945.

In response, the DTAB has initiated further evaluation through the formation of a sub-committee.

Recommendation for Examination of RMP Requirement:

During a meeting, the DTAB thoroughly discussed the matter and concluded that a sub-committee should be constituted to carefully examine the proposal put forth by USV Pvt Ltd.

Additionally, the committee aims to assess the requirement of an RMP for the sale of various cough syrups throughout the country.

This decision highlights the growing emphasis on the quality of cough syrups manufactured and exported from India.

Supporting Documentation and Recommendations:

USV Pvt Ltd provided supporting documentation to the committee, including patient safety data, details of Saponin concentration in the product, information on countries where the product is marketed, package inserts, and regulatory status.

These documents were crucial in presenting the company’s case for the marketing of their approved drug, “Dried Ivy Leaf Extract Cough Syrup,” under Schedule K (Rule 123).

USV Pvt Ltd also requested exemption from the mandatory warning label, “To be sold by retail on the prescription of an RMP only.”

Moreover, the Subject Expert Committee (SEC), responsible for advising the drug regulator on Pulmonary therapeutic segment matters, recommended exempting the drug from the warning label requirement during their 60th meeting on June 7, 2022.

The SEC further suggested seeking the opinion of a phytopharmaceutical expert for additional input in the decision-making process.

USV Pvt Ltd’s Prospan Brand:

USV Pvt Ltd currently sells the Prospan brand of dried ivy leaf extract-based cough syrup in the market.

The company’s website claims that the exclusive extract derived from the leaves is meticulously produced using a patented extraction process and is supported by extensive clinical research.

Conclusion:

The decision to form a sub-committee to examine the necessity of an RMP for the sale of various cough syrups in India underscores the increased focus on the quality and regulations surrounding these products.

This initiative comes in response to the representation submitted by USV Pvt Ltd to move their approved drug, Dried Ivy Leaf Extract Cough Syrup, to Schedule K.

As the evaluation progresses, the sub-committee will assess the proposal, review supporting documentation, and consider the SEC’s recommendation for exemption from the warning label requirement.

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