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Shardul Nautiyal, Mumbai June 10 , 2019
In order to facilitate the licensing or approval of Ayurvedic, Siddha and Unani (ASU) drugs in a streamlined manner, the union Ayush ministry has directed state licensing authorities to constitute expert committee with specific terms of reference as per Section 33-P of the Drugs & Cosmetics (D&C ) Act, 1940.

The expert committee shall consist of the senior most Ayurveda, Siddha and Unani officer in the office of state licensing authority or director (Ayush), an expert of Dravyaguna, Ilmul Advia and Gunapadam, an expert of ASU Pharmacy or of Ras-shastra, Saidala and Marunthu- Alunur and an ASU Drug Inspector.

The expert committee shall examine the license application and  associated documents, proof of concept and testing protocols of intended patent or proprietary ASU drug as provided in Section 3 (h)(i) of the D& C Act, 1940 and Rules thereunder.

It will verify the reference of the proposed ASU drug and its ingredients from authoritative books and ascertain that the excipients used in the formulation are in accordance with the provisions of Rule 169. It will also ascertain that the supporting evidence or proof of safety and effectiveness for the classical or shastriye ASU drug with new dosage form or new indication and patent or proprietary ASU drug is in accordance with the provisions of Rule 158-B of D & C Rules, 1945.

The expert committee shall also examine the proposals and send its recommendations to the licensing authority within 15 days of the receipt of application for consideration of granting approval to the intended ASU formulation.

All state ASU drug controllers or licensing authorities shall comply with the order from immediate effect and henceforth, the proposals and applications of ASU drugs requiring any clarification or advice may be referred to drug control cell, Ministry of Ayush, Government of India.

The office of state licensing authority shall convene the meetings of expert committee at regular intervals as specified in the order. The senior most member of the expert committee by virtue of designation shall chair the meetings of the expert committee. Technical Officer in the office of licensing authority shall be responsible to prepare and keep the minutes of expert committee meetings and forward them to the licensing authority after approval of the chairman.

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