Health Canada to Ban Indian Ayurvedic drugs based on controversial JAMA report

Posted AtPharma Biz

Health Canada, the drug regulatory agency in Canada, has warned the consumers not to use certain ayurvedic medicinal products from India, based on the recent controversial JAMA study report accusing Indian Ayurvedic drugs containing high levels of toxic metal content. A Health Canada communication said it would soon take action to remove these products from the market and to prevent further imports into Canada.

The embargo list includes Karela tablets (Shriji Herbal Products); Karela capsules (Himalaya Drug Co); Maha Sudarshan Churna powder (Zandu Pharmaceuticals), Maha Sudarshan Churna powder (D& K Pharmacy, Bhavnagar), Maha Sudarshan Churna powder (Chhatrisha, Lalpur), Maha Sudarshan Churna powder (Dabur India Ltd); SAFI liquid (Hamdard-WAKF); Yograj Guggul tablets (Zandu Pharmaceuticals); Sudarshan tablets (Zandu Pharmaceuticals); Shilajit capsules (Dabur India Ltd). Health Canada also advised Canadians not to use any other Karela, Safi, Maha Sudarshan Churna, Yograj Guggul, Sudarshan or Shilajit products that lack Â'market authorizationÂ'.

Â"Authorized natural health products will either bear an eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN) or a Homeopathic Drug Number (DIN-HM). This authorization indicates that the product has been assessed by Health Canada for safety, efficacy and quality,Â" said the release.

As Pharmabiz reported earlier, the Journal of the American Medical Association (JAMA) in a study had said one of the 5 Ayurvedic herbal medicine products (HMP) produced in South Asia contains potentially harmful levels of lead, mercury or arsenic above permissible levels, and it said users of Ayurvedic medicine may be at risk for heavy metal toxicity, and testing of Ayurvedic HMPs for toxic heavy metals should be mandatory.

When contacted, Dabur India spokesperson said, "Dabur has not exported any consignment of Mahasudarshan Churna to Canada. We would get in touch with the Canadian Authorities through the ministry of health and family welfare to get details of the product they have tested and the testing procedures to gauge the veracity of their claims. Regarding Shilajit, this medicine is a rock extract and does not contain any metals hence we do not see any reason for this alarm issued by the Canadian Healthcare Authorities."

"Metals form an integral part of many Ayurvedic medicines as they (metals) have therapeutic properties. Ayurveda has well established detoxification procedures to remove toxicity from these metals and make them safe for human use. Companies like Dabur use Good Manufacturing Practices and follows API standards, issued by Government of India, for procurement of raw materials, detoxifying them and for processing them into different formulations. These medicines, therefore, are safe for human consumption," he added.

July 20, 2005