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NPTEL

Herbal Product Technology and Regulatory Science

NPTEL via Swayam

Overview

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ABOUT THE COURSE:This subject gives the student the knowledge of basic understanding of herbal drug industry, the properties of raw materials, guidelines for quality of herbal drugs, and excipients. The course also gives us knowledge about the application of herbs in traditional formulation as well as in cosmetics and nutraceuticals. It shed light on possible interactions of drugs with other medications. Students will gain knowledge about Intellectual property rights regarding natural products. The subject also emphasizes on Good Manufacturing Practices (GMP) and regulatory issues of herbal drugs inclusive of the Bioprospecting.INTENDED AUDIENCE: Bachelors of Pharmacy, Technology and Health Science CoursesPREREQUISITES: Should have Completed Higher Secondary Certificate Examination from Science stream with Physics, Chemistry and Biology as core subject or Should have Completed Diploma in PharmacyINDUSTRY SUPPORT: Dr. Palep's Medical Research Foundation, Sandu Pharmaceuticals Ltd., CIRA Herbals LLP, Encube Ethicals Pvt Ltd.

Syllabus

Week 1: Herbs as raw materials: Herbal drug preparation, Source of Herbs Selection, identification and authentication of herbal materials, Processing of herbal raw material
Week 2:Indian Systems of Medicine: Basic principles involved in Ayurveda, Siddha, Unani and Homeopathy.
Week 3:Preparation and standardization of Ayurvedic formulations viz Aristas and Asawas, Gjutika and Bhasma.
Neutraceuticals: General aspects, Market, growth, scope and types of products available in the market.
Week 4:Herbal Cosmetics and Excipients: Sources and classification of raw materials of herbal origin used such as fixed oils, waxes, gums colours, sweeteners, flavors & perfumes in products such as skin care, hair care and oral hygiene products.
Week 5:Herbal-Drug and Herb-Food Interactions: General introduction to interaction and classification. Study of following drugs and their possible side effects and interactions: Hypercium, Ginko biloba, Ginseng and Black Pepper
Week 6:Herbal formulations: Conventional herbal formulations like syrups, mixtures, and tablets.
Introduction to phytosomes with suitable examples
Week 7:Standardization of Herbal drugs using Spectroscopic methods, such as UV-Vis, and chromatographic techniques such as HPTLC and HPLC analysis methods
Week 8:Evaluation of Drugs WHO, ICH, and Pharmacopoeial guidelines for the assessment of herbal drugs
Week 9:Patenting aspects of Traditional Knowledge: Definition of the terms: Patent, IPR & Bioprospecting.
Week 10:Regulatory Issues - Regulations in India (ASU DTAB, ASU DCC), Regulation of manufacture of ASU drugs.
Week 11:General Introduction to Herbal Industry: A brief account of plant-based industries and institutions involved in work on medicinal and aromatic plants in India.
Week 12:Schedule T–Good Manufacturing Practice of Indian systems of medicine: Components of GMP (Schedule – T) and its objectives, Infrastructural requirements, machinery and equipment, documentation and records.

Taught by

Prof. Swati Sanjay Patil, Dr. Galvina Pereira, Prof. Mandar Bhalchandra Mulik

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