Schwabe News Volume 4 | Issue 6 | June 2013
This report from the Press Information Bureau gives an insight on the regulatory mechanism of AYUSH medicines. Ayurvedic, Unani and Homoeopathic medicines are regulated in the country under the provisions of Drugs & Cosmetics Act, 1940 and the Rules there-under. For this purpose, the Licensing Authorities are appointed by the State Government to grant license for manufacturing of Ayurveda, Unani and Homoeopathic medicines and enforce the legal provisions for their sale or marketing and quality standards. In this regard, the Central Government is empowered to make or amend the law & rules. Besides, the Department of AYUSH in the Ministry of Health & Family Welfare has taken a number of regulatory measures for quality control of these medicines including enforcement of compliance to quality standards of drugs, compliance to Good Manufacturing Practices (GMP), notification of a schedule of poisonous substances, regulatory guidelines for licensing of Ayurvedic and Unani (A&U) medicines, use of excipients, preservatives, etc., notifications regarding permissible limits of heavy metals, alfatoxins, pesticide residue and microbial load and shelf life of medicines. Also, Quality Standards of 600 single Ayurvedic drugs, 152 compound Ayurvedic formulations, 298 single Unani drugs, 100 compound Unani formulations, and 1045 Homoeopathic drugs have been developed and published in Pharmacopoeias. The pricing of Ayurveda, Unani & Homoeopathic medicines is not covered under the Drugs Price Control Order (DPCO) 1995. By and large, the rising prices of these medicines are of usual nature, prices of some medicines may have increased higher due to market forces. Government has set up National Medicinal Plants Board to coordinate matters related to sustainable development of medicinal plant sector. In order to keep the prices of Ayurveda, Unani and Homoeopathic drugs under control, it is important to keep the price of raw materials within reasonable limits for which National Medicinal Plants Board has been supporting cultivation of identified medicinal plants by farmers and augment the supply of medicinal plant raw materials. This information was given by the Minister for Health & Family Welfare Shri Ghulam Nabi Azad in written reply to a question in the Rajya Sabha.
It is also being informed that the Union Health Ministry is planning to increase the fees for licenses of homoeopathic drugs as there is some ambiguity in the existing rules, especially in the case of granting approvals to additional items by the license holders. “Rule 85-B(5) provides for fee of Rs.50 for approval of additional item by license holders . As per Rules 85-B(2), there is no limit for the items to be approved at the time of grant of license. Thus an applicant can have as many items as he wants by depositing just Rs.250 while a license holder is required to pay Rs.50.per item as additional items. It appears that, there is some ambiguity in the Rules, which needs to be looked into,” sources said.
Source: Press Information Bureau, Government of India & Pharmabiz.com
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