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Critical evaluation of regulations for handling poisonous plant-based drugs in Ayurveda, highlighting safety measures.
Introduction: The Drugs and Cosmetics Rules, 1945 were established by the Government of India under the authority of the Drugs and Cosmetics Act, 1940. This Act is designed to ensure that drugs and cosmetics sold in India meet standards for quality, safety, and effectiveness. Schedule (E1) of these rules identifies poisonous substances of plant origin that are used in the Ayurvedic, Siddha and Unani systems of medicine. The focus of the present work is on the safe handling and use of plant origin poisonous drugs used in Ayurvedic system of medicine. Methodology: A thorough evaluation of literature was done, including the relevant portions of the Drugs and Cosmetics Rules, 1945, authoritative text books of Ayurveda, published research papers in reputed journals. Results: The Drugs and Cosmetics Rules, 1945, which mandates that ASU drugs in which the Ayurvedic system classifies fourteen medications with vegetable origins under the category of poisonous substances. Despite being part of the Visha-Upavisha which is a category of poisonous substances, these medications are not hazardous because Ayurveda recommends a special method of cleansing called Shodhana before utilizing them for therapeutic purposes. Schedule E (1) of the Drugs and Cosmetics Rules, 1945, is associated with Rule 161(2). Conclusion: Ayurvedic drug manufacturers, dealers, Vaidya and physicians must be aware and focus on the safe manufacturing practices of medicines, rational prescription and safe dosage of medicines and sale of such medicines should be done only under the valid prescription. By ensuring appropriate information to patients regarding the dosage and administration.
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Rachna et al. (2025) studied this question.
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