Uniform rules for licence and testing facilities for AYUSH MEDICINES

UNIFORM RULES FOR LICENCES AND TESTING FACILITIES FOR AYUSH MEDICINES

Unstarred question (No-2) on uniform rules for licences and testing facilities for Ayush medicines was raised in the Rajya Sabha by Shri Darshan Singh Yadav. The followed questions were raised by the member:

(a) whether Government proposes to formulate uniform rules with regard to grant of licenses for manufacturing Ayurveda, Siddha, Unani and Homoeopathic drugs and to ensure their safety, quality and standards across the country, if so, the details thereof; and

(b) the details of the existing drug testing institutions/laboratories along with the steps being taken for their upgradation and also for setting up new testing facilities to ensure safety and quality of these drugs indicating the funds earmarked and allocated for the purpose, State/Union Territory-wise?

Shri Shripad Yesso Naik, the Minister of State (IC) of the ministry of Ayurveda, yoga & naturopathy, Unani, Siddha and homoeopathy provided the following answers for the above questions:

(a): Regulatory provisions and Rules for Ayurveda, Siddha, Unani and Homoeopathic drugs are already in place under the Drugs and Cosmetics Act, 1940, which is a Central Act applicable throughout the country. Rules 85-A to 85-I and Rules 151 to 159 of the Drugs and Cosmetics Rules, 1945 respectively provide the regulatory provisions for grant of licenses to manufacture Homoeopathic and Ayurveda, Siddha and Unani drugs respectively and promote their safety and quality by implementing Good Manufacturing Practices. The standards of Homoeopathic medicines to be complied with are prescribed in Schedule II of the Drugs & Cosmetics Act, 1940 and of Ayurveda, Siddha and Unani drugs in Rule 168 of the Drugs and Cosmetics Rules, 1945. In this regard, financial support has also been provided for improving infrastructural and functional capacity of State Pharmacies, Drug Testing Laboratories and enforcement mechanism and a component of funding quality control activities for Ayurveda, Siddha, Unani and Homoeopathic drugs is provided in the scheme of National AYUSH Mission notified in September 2014.

(b): The list of Central and State Drugs Testing Laboratories and the laboratories licensed under Drugs & Cosmetics Rules, 1945 for testing of AYUSH drugs is provided in Annexure-I. Under National AYUSH Mission implemented since September 2014, grant-in-aid proposals of the states for the quality control of Ayurveda, Siddha, Unani and Homoeopathic drugs including setting up of new laboratories, strengthening of existing laboratories and testing of drug samples are considered. State/Union Territory wise tentative allocation and approved release of funds for quality control activities in 2014-15 and 2015-16 is given in Annexure-II.

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