The Department of Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy (AYUSH) of the Ministry of Health and Family Welfare has published a list of approved Ayurveda, Siddha & Unani (ASU) drug testing laboratories under rule -160 A to J of the Drugs and Cosmetics Rule 1945. This follows the Centre's recent decision to make testing for heavy metals- arsenic, lead, mercury and cadmium, mandatory for export purposes in respect of every batch of purely herbal ASU drugs by every licensee, with effect from 1st January 2006.
The list of approved labs include Varun Herbals Pvt. Ltd., Hyderabad, Sipra Labs Pvt. Ltd., Hyderabad, Captain Srinivasa Murti Drug Research Institute for Ayurveda (CCRAS) at Arumbakkam, Chennai, Sowparnika Herbal Extracts & Pharmaceuticals Pvt. Ltd., SIDCO Industrial Estate, Chennai, Regional Research Laboratory (CSIR), Jammu, ARBRO Pharmaceuticals Ltd., New Delhi, Shriram Institute for Industrial Research, Bangalore, Bangalore Test House, Bangalore, FRLHT at Yelahanka near Bangalore, M.S. Ramaiah Drugs and Allied Products Testing Laboratories, Bangalore, Ozone Pharmaceuticals Ltd., Haryana, Standard Analytical & Research Laboratories at Indore, Anusandhan Analytical & Biochemical Research Laboratory Pvt. Ltd., Indore,Choksi Laboratories Ltd., Indore, Quality Control Laboratory, Bhopal, J.R.D. Tata Foundation for Research in Ayurveda and Yoga Sciences at Satna, M.P.
Apart from this, any NABL accredited labs and GLP compliant NABL accredited laboratories like International Institute of Bio-technology (IIBAT) at Kanchipuram, Tamil Nadu, Rallis Research Centre, Bangalore and Jai Research Foundation, Vapi have been approved by the Government. Permissible Limits as per W.H.O & F.D.A for heavy metal content are lead (Pb)-10 ppm, cadmium (Cd) 0.30 ppm, arsenic (As) 10 ppm and mercury (Hg.) 1 ppm.
The manufacturers of Ayurveda, Siddha and Unani, who do not have in-house laboratory facilities, will have to get these tested by any approved drug-testing laboratory. "Due to unsatisfactory agricultural and cultivation practices relating to the medicinal plants used in preparation of ASU drugs and general environmental pollution, the presence of heavy metals above the permissible limit therein cannot be ruled out. Therefore, it has become expedient in the interest of public health to introduce mandatory testing for heavy metals for every batch of ASU drug manufactured by all licensees," reasoned the government notification mandating heavy metal testing compulsory. Further, it is mandatory to display on the container of purely herbal ASU drugs to be exported with the words "HEAVY METALS WITHIN PERMISSIBLE LIMITS" with effect from January 1, 2006.
As reported earlier, ASU Drug manufacturers who do not have in-house laboratory facility shall get their drugs tested by any approved drug-testing laboratory. This is a process of self-certification for export purposes and the ASU drug manufacturer will be held responsible if proper batch-wise testing is not done before self-certification, which will be extended for sale within the country in due course, according to the government.