The Central Government has made testing for heavy metals mandatory before export of herbal medicines and the rule is to take effect from January 1, 2006. The containers of these medicines are to clearly display that "heavy metals are within permissible limits".
According to a recent notification, the permissible limits for arsenic, lead and cadmium will be as recommended by WHO on quality control methods for medicinal plants and materials. In case of mercury, the permissible limit will be one 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.
However, the labelling is to continue as a self-certification process exclusively meant for exports. The responsibility for batch-wise testing would solely be on the drug manufacturers. The process of self-certification would be extended in due course for medicines being sold within the country. An official note from the Department of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homeopathy (AYUSH) states that due to environmental pollution and unsatisfactory agricultural and collection practices relating to the medicinal plants that are used in the preparation of these drugs, the presence of heavy metals above permissible limits, cannot be ruled out. Hence, it has become necessary to make testing for heavy metals mandatory in every batch of these medicines, before export.
It should be noted that the Indian directive comes in the wake of the recent alerts issued by the health regulatory agencies of UK and Canada against Indian Ayurvedic products on the complaints of high-level toxic metal content. Both the regulatory agencies had issued warning notices against a list of ayurvedic medicines allegedly having metallic content beyond permissible limits.