The Hindu Business Line : Testing for heavy metals in herbal medicine exports made mandatory

AFTER health regulators in the UK and Canada issued warnings on the presence of heavy metals in certain Ayurvedic and Unani products, the Health Ministry has made it mandatory for exporters of such medicines to test for heavy metals like arsenic, lead, mercury and cadmium.

From January 1, 2006, the container of these medicines (which are meant for exports) must clearly display `heavy metals within permissible limits.' The process of self-certification would be extended in due course for medicines being sold within the country.

The Department of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homeopathy (AYUSH) has issued a notification in this regard under the Drugs and Cosmetics Act 1940, which clearly states that testing for heavy metals purely in herbal medicines i.e. Ayurveda, Unani and Siddha, is compulsory for every licensee.

Permissible limits: It said that the licensee must check every batch of these drugs before export. The permissible limits for arsenic, lead and cadmium will be, as recommended by WHO, on `quality control methods for medicinal plants and materials.' In the case of mercury, the permissible limit will be one part per million.

Manufacturers who do not have in-house laboratory facilities will have to get these tested by any approved drug-testing laboratory. The Department of AYUSH has made it clear that such labelling is a process of self-certification for export purposes and the drug manufacturers will be held responsible if proper batch-wise testing is not done.

Pollutants: It has come to the notice of the Department that due to environmental pollution and unsatisfactory agricultural and collection practices relating to the plants used in the preparation of herbal 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.

Commenting on this, a Dabur India official said, "We are already testing for heavy metals using an atomic absorption spectrometer. We will conform to all the new norms framed by the Government."

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