AYUSH: Guidelines & Criteria for approval on ASU Clinical Trials.

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AYUSH

The Ministry of AYUSH (Ayurveda, Yoga&Naturopathy, Unani , Siddha and Homeopathy) have come up with Guidelines and Criteria for the approval of clinical trials on ASU products.

The following data is from the guideline and is OPEN FOR REBUTTAL until 15-Jan-2014, after which it will officially printed in the gazette.

The applicant is required to submit the information of the intended clinical trial in the following format:-

a)  Application seeking approval of the Central Government must accompany with an undertaking that the clinical trial shall be conducted following the GCP Guidelines for ASU   published   by   the   Department   of   AYUSH   and   available   in   the   website- www.indianmedicine.nic.in

b) Complete Protocol including Case Record Form, Informed Consent Form (also in vernacular language) and Institutional Ethics Committee approval Status to be submitted. Protocol should be as per the format specified in GCP Guidelines for ASU published by the Department of AYUSH.

c)    Investigator’s  Brochure of trial drug(s) shall include the following-

3.1  Information on the Ingredients including:

3.1.1          Description  of  botanical,  chemical  and  therapeutic  attributes  of  each ingredient of the formulation.

3.1.2          Available pharmaceutical information on ingredient(s) from authoritative texts listed in First schedule of the Drugs & Cosmetics Act 1940 and/or from scientific literature (wherever available) with Official Name / Scientific Names.

3.2  Data on Formulation:

3.2.1         Introduction –   A brief description of the drug and the disease condition for which it is indicated.

3.2.2          Physical properties (organoleptic) and Description

3.2.3          Dosage form

3.2.4           Mode of administration

3.2.5          Details of manufacturing process

3.2.6           Details of the formulation (including details of Excipients, preservatives, additives etc. added with exact quantity

3.2.7          Analytical     Data     with     methods,     if      not     given      in      official Ayurveda/Siddha/Unani pharmacopoeias (in-house or from accredited laboratory) of at least three batches

3.2.8          Finished Product Specification

3.2.9          Stability data of the formulation in clinical trial intended pack at proposed storage conditions

3.2.10        Specific references from authoritative books

d)  Pre-clinical data on formulation

4.1 Proof of pharmacological actions /properties to the extent possible

4.2 Pre-clinical Safety data (as per the below mentioned table)

5. Clinical Data (if available) /other relevant information or data in support of claimed efficacy

Download the complete guideline and criteria HERE.

 

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