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JSS College of Pharmacy, Mysore

Regulatory Status of Herbal Drugs in India An overview

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Students of program: 1st M. Pharm students of Pharmaceutical Regulatory Affairs, Pharmaceutical Quality Assurance and Pharmacognosy Dr Venkatesh M.P Assistant Professor, Department of Pharmaceutics introduced about the speaker to the students and delivered opening remarks. Mr. Nishith delivered a talk on the Regulatory status of herbal drugs in India. He started the session by giving information on traditional system of medicine and its classification, organizational set up in the country and also described about AYSUH which is included in The Drug and Cosmetic Act, 1940. He highlighted few examples, defined and differentiated the terms like misbranded drug, adulterated drug, and spurious drugs and also informed us about the provisions of regulation for manufacturing, packaging, labeling and sale of Ayurveda Siddha and Unani drugs. He explained about different rules, forms, and standards of regulations for traditional medicines and briefed about the history of herbals products. He shared his professional experience as a District Drug Inspector and on the various cases handled by him. He discussed about the procedure for manufacturing license approval process, Guidelines to issue license for manufacturing of traditional medicines in India, controlling of advertisements related to herbal products, offences and about penalties. He emphasized the importance of schedule T which includes Factory requirements, Area and List of minimum equipment required for manufacturing of herbal drugs and cosmetics. He concluded the session by updating the students about the scope of their profession, clarifying their doubts and by describing challenges and problems in Pharmaceutical Sciences.

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