Efficacy and safety validation of traditional products--current regulatory status in lndia
- Author:
BHARATRAJ Kumar DINESH
1
Author Information
1. National Institute of Nutrition
- From:
Chinese Journal of Pharmacology and Toxicology
2018;32(4):247-248
- CountryChina
- Language:Chinese
-
Abstract:
The traditional medicine differs from country to country and region to region and is dependent on indigenous cultural practices. Since one decade there is a growing demand of natural products as potential preventive and therapeutic agents all over the world.Many international agencies especially WHO recognized Ayurveda, Unani, siddha as a part of integrated system of medicine to achieve health for all. Despite WHO recognition acceptance of Ayurveda has been limited mainly due to:i) Lack of scientific validation in current acceptable terms;ii) A general inadequacy of Good Manu-facturing Practices;iii)Non availability of safety profile at pre-clinical and clinical levels;iv)In-adequate documentation of true extent of toxicity;iv)Contamination of herbal products.Therefore,validating ther-apeutic claims of traditional preparation and evaluation of safety profile has become important not only for global acceptance but for compliance to National and International regulatory guidelines. Our efforts at Centre for Advanced Research for Preclinical Toxicology(PCT),Food and Drug Toxi-cology Research Centre (FDTRC), National Institute of Nutrition (NIN), Hyderabad a premier research organization of ICMR has undertaken safety and efficacy evaluations of various traditional formulations by applying the modern approaches. Anti-inflammatory evaluation of Rasna panchaka:The study plan was initiated in consultation with qualified Ayurvedic physician and after confirming the potential benefits in a limited clinical trial. This was followed by experimental evaluation using in vitro anti-oxidant activity,ex-plant culture system,in situ mimicking model (rat paw edema and granuloma pouch).The experimental study results have substantiated the anti-inflammatory activity as reported and near matching to clinical observations. i. Anti-atherosclerotic potentials with traditional herbs and nutraceuticals-PHF:The study was designed based on the traditional literature and other modern scientific documents.The modern tools include ethano-botanical validation, in vitro (molecular techniques), in silico,in vivo (advanced techniques) systems have been utilized to confirm the anti-atherosclerotic property of the poly herbal formulation(PHF). ii. The role of Terminalia arjuna as a cardiotonic in various Ayurvedic formulations is well docu-mented.We have evaluated the potential health benefits of Arjuna Ksheera Paka(AKP). iii. Occimum sanctum (O. sanctum) a known herb in every household as Tulasi. There is a belief and a traditional literature mentioning that it has immunomodulatory and carminative property.The investi-gations carried out in vitro (Th1/Th2 cytokines) and in vivo (myelosuppressed mice model) demonstrated potential immunomodulatory action. The validation of herbal plant Cocculus hirsutus,Cuscuta reflexa, Tinospora cordifolia&Achyranthus aspera as immunomodulatory and anti-inflammatory agents is under progress. In India,many national and international laboratories are working in the areas of natural medicines. The clarity and regulatory systems still needs to be identified between natural medicine and traditional system of practices.The Act of Ayurvedic,Siddha and Unani(ASU)drugs is regulated under the provi-sions of Drugs and Cosmetics Act,1940 and the Drugs and Cosmetics Rules,1945 made there under. Rule 158-B is for the manufacture of products.In addition,the rules required proof of effectiveness for Ayurvedic, Siddha and Unani drugs under Section 3(a) of the Act are under the process of revision to make it mandatory. The studies were carried out with traditional system of medicine in India requires strategic collabo-rations with innovative initiatives.
