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Regulatory Requirements For Registration Of Nutritional Supplements And Herbal Products In India: A Case Study | 6027
Journal of Analytical & Bioanalytical Techniques
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S-FDA regulates fi
nished dietary supplement products and dietary ingredients
under the Dietary Supplement Health and Education Act of 1994 (DSHEA).
e Directive 2002/46/EC of the European Parliament and Council of 10
established harmonized rules for the labeling of food supplements and introduced
c rules on vitamins and minerals in food supplements. Th
e aim was to harmonize
the legislation and to ensure that these products are safe and appropriately labeled so
that consumers can make informed choices. In India, the Food Safety and Standards
Act, 2006 and Rules, 2011 regulate manufacture, storage, distribution, sale and import
of food articles to ensure their safe and wholesome availability for human consumption.
ere are no separate guidelines for nutritional supplements in India. Th
requirements for nutritional supplements are also same as for food products. Th
no control over imported food products. In US, regulatory management of botanical
drug products is the same as non-botanical drug products (under the Federal Food,
Drugs & Cosmetics Act, 1938). For new botanical drug, FDA regulations require NDA
for marketing submitted under Section 505(b). Th
ere is no separate regulation for herbal
products in U.S. In EU, there are three regulatory routes for herbal remedies by which
medicines can reach the consumer namely as Unlicensed herbal remedies, Products
registered under the Traditional Herbal Medicines Registration Scheme (THMRS) and
Licensed herbal medicines. In India, Drugs & Cosmetics Act, 1940 and corresponding
Rules, 1945 regulate herbal and Ayurvedic products. In this presentation, based on the
compilation and comparative studies of regulations governing Nutritional Supplements
and Herbal Products in USA and UK/ EU and in India, a gap analysis would be presented
nally what should be the befi
tting appropriate regulations in Indian perspective
would be arrived at.
Professor Dr. B.P. Nagori is presently working as Professor and Director at Lachoo Memorial College of Science & Technology, Jodhpur, India. Dr. Nagori has a blend of 29 years of experience in teaching, research, development & administration. He is the founder Dean of Faculty of Pharmacy, Rajasthan University of Health Sciences, Jaipur. He has designed a new branch in M. Pharm. (Pharmaceutical Management & Regulatory Affairs) for the fi rst time in the country with his background knowledge of pharmacy, management and law. His areas of interest include Pharmaceutical Management, Regulatory Affairs, IPR, Quality Assurance, Pharmaceutical Chemistry, Medicinal & Pharmaceutical Applications of various Gums, Institutional Management and Total Quality Management. He has been guiding 12 Ph.D. scholars and 2 have been awarded Ph.D. degree under his guidance. He has attended and presented 23 papers in Scienti fi c Conferences and has published 38 papers in International and National Journals of repute. He has also authored two books. He is recipient of the Principal of the Year 2010 Award conferred by Association of Pharmaceutical Teachers of India.
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