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Standardisation and Certification of Traditional Medicines

Standardisation and Certification of Traditional Medicines

Standardisation and Certification of Traditional Medicines

Government has set up Central Council for Research in Ayurvedic Sciences (CCRAS), which is an autonomous organization under the Ministry of AYUSH and is conducting clinical research through its 22 peripheral Institutes.

The Government has set up Pharmacopoeia Commission of Indian Medicine & Homoeopathy and Ayurvedic Pharmacopoeia Committee to develop the standards of Ayurvedic drugs. The quality standards of Ayurvedic drugs are published in the Ayurvedic Pharmacopoeia, which is mandatory for the manufacturers to follow. Certification of Good Manufacturing Practices (GMP) for manufacturing of Ayurvedic drugs is required under the provisions of Drugs and Cosmetics Rules, 1945. System of WHO-GMP and Certification of Pharmaceutical Products has been made applicable on voluntary basis to Ayurvedic drugs. Quality certification of Ayurvedic medicines on voluntary basis is also implemented by the Quality Council of India. For scientific validation of Ayurvedic medicines, Good Clinical Practice guidelines have been published for facilitating clinical trials and Rule 158-B provided in the Drugs and Cosmetics Rules, 1945 to seek the proof of effectiveness and safety of various categories of Ayurvedic medicines.

This information was given by the Minister of State (Independent Charge) of the Ministry of AYUSH, Shri Shripad Yesso Naik in a written reply to an unstarred question in the Rajya Sabha.

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