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REGULATORY REQUIREMENTS FOR EXPERIMENTAL AND CLINICAL RESEARCH IN TRADITIONAL MEDICINE

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INTRODUCTION

A global resurgence of interest in Indian System of Medicine.
Major challenges in the field of the regulation of Traditional Medicines with respect to assessment of safety, efficacy and quality of Traditional Medicines.
Inclusion of Regulation on ASU medicines in D& C Act,1940, Rules1945
Regulations are specifically for manufacturers, Drug testing labs.
Regulatory requirements are non specific for research in ASU medicines.

Patent & Proprietary ASU medicines

i) Formulations containing ingredients mentioned in the formulae described in authoritative text books
Does not include Injectables
ii)Balya/Poshak/Muqawi/Unavuporutkal/positive health Promoter formulations having ingredients mentioned in books of First Schedule of the Drugs and Cosmetics Act and recommended for promotional and preventive health.
(iii) Saundarya Prasadak (Husane afza)/Azhagh-sadhan formulation having ingredients mentioned in Books of First Schedule of the Drugs and Cosmetics Act and recommended for oral, skin, hair and body care.
(iv) Aushadh Ghana (Medicinal plant extracts – dry/wet) extract obtained from plant mentioned in books of First Schedule of the Act including Aqueous or hydro-alcohol.

Prerequisite for Experimental and Clinical Research

Drug Development
Collection & cultivation of source drug -GAP
Botanical identification
Chemical profile
Preparation of a formulation-GMP (Schedule T)
Drug standardization and quality assurance- GLP.

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