The Journal of American Medical Association early this year had published a report charging that the Indian ayurveda products contain high toxic metal contents which are harmful. Shortly after this report, the US and European countries placed restrictions on the import of ayurveda products from India. The JAMA report and the subsequent restrictions on their imports from India triggered a debate in ayurveda circles and in the Department of Ayush in the country over the need for setting standards for heavy metal compounds in herbal preparations. The Centre's decision to introduce compulsory testing of heavy metals for herbal drugs before their exports from January 1 is a culmination of this debate. A notification, in this regard, was issued by the Department of AYUSH under the Drugs and Cosmetics Act last week prescribing permissible limits of mercury, arsenic, lead and cadmium as recommended by WHO. The container labels of these herbal preparations thus should also clearly state that the "heavy metals are within permissible limits". The manufacturers of ayurveda, siddha and unani medicines who do not have in-house laboratory facilities, should get their products tested by any approved drug testing laboratories. The notification also points out that the labeling and batch wise testing of products will be the sole responsibility of the exporters.
The department's directive on heavy metal contents is largely welcomed by organized sector units of ISM industry. They are right in holding the view that compulsory heavy metal testing is the only way to ensure high quality standards of herbal drugs and to get their wide acceptance in the international market. In fact, a good number of ayurveda and herbal exporters from India have been maintaining high quality standards of their products for some years now. And there has been a tremendous growth in demand for ayurveda and herbal products from India in most developed countries of late. The government's directive, thus, is to give a big push to the exports of this class of products while maintaining their reputation in the coming years. Currently there are a dozen large, 100 medium scale and 8000 small scale units producing ayurveda and herbal drugs in the country. And there are about 500 raw materials mainly sourced from forest areas are used for the formulation preparations. But there are no standards laid down for the purity of these compounds which could contain a lot of impurities including metals. The Department also needs to work on the standardization of these raw materials procured from different forest regions of the country. It is true that many of these preparations are made in small quantities and their batch wise testing for heavy metals may add to the costs of these products. But to keep up quality norms and the image of Indian products in the international market, no regulatory compromises should be allowed.