Question : Regulatory Mechanism for Ayurvedic Medicines

Will the Minister of AYURVEDA, YOGA AND NATUROPATHY, UNANI, SIDDHA AND HOMOEOPATHY (AYUSH) be pleased to state:

(a) whether the regulatory mechanism for ayurvedic medicines is quite weak in the country due to which the allopathic medicines are relatively more prevalent and its usage is much more;

(b) if so, the details of the steps being taken by the Government to increase the popularity of ayurvedic medicines;

(c) whether the Government proposes to make the clinical trial of ayurvedic medicines mandatory; and

(d) if so, the details thereof and if not, thr reasons therefor?

ANSWER
THE MINISTER OF STATE (IC) OF THE MINISTRY OF AYURVEDA,
YOGA & NATUROPATHY, UNANI, SIDDHA AND HOMOEOPATHY
(SHRI SHRIPAD YESSO NAIK)
(a) & (b): Drugs and Cosmetics Act, 1940 and Rules thereunder have exclusive provisions for regulation and quality control of Ayurvedic, Siddha and Unani medicines. Accordingly the regulatory mechanism has been evolving in the country distinct from that for allopathic medicines owing to differential nature, methods of manufacturing and quality parameters of Ayurvedic medicines. Central Government makes and amends the regulatory provisions from time to time and extends support to the States through National AYUSH Mission for strengthening the infrastructural and functional capacities of manufacturing units, quality testing centers and the enforcement framework. Ministry of AYUSH has implemented a number of Central Sector Schemes for promoting and popularizing Ayurvedic and other AYUSH medicines.

(c) & (d): Pilot studies for generating proof of effectiveness of certain categories of Ayurvedic, Siddha and Unani medicines is the requirement provided in the Rule 158-B of the Drugs and Cosmetics Rules, 1945 to grant manufacturing license. Any amendment in the Drugs & Cosmetics Rules with regard to clinical trials of Ayurvedic medicines is not intended as of now since there is no such recommendation or proposal under consideration.