|
Union Ayush ministry directs state licensing authorities to set up expert panel to facilitate licensing of ASU drugs
|
|
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.
|
|
|
|
|
|
|
|
TOPICS
|
That foods might provide therapeutic benefits is clearly not a new concept. ...
|
|
|
|
|