Testing of heavy metals in herbal medicines must
SHOULD BE WITHIN PERMISSIBLE LIMITS
DISPLAY MUST ON CONTAINER
MANDATORY FROM JANUARY 1ST.
Testing for heavy metals purely in herbal medicines i.e Ayurveda, Unani and Siddha has become compulsory for every licensee. The container of these medicines must clearly display “Heavy Metals within permissible limits”, which are meant for exports. Such labeling becomes mandatory from Ist January next year.
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. The testing for heavy metals like, arsenic, lead, mercury and cadmium has become mandatory for export purposes. The licensee must check every batch of these drugs for this 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 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.
The Department of AYUSH has made it clear that such labeling is a process of self-certification for export purposes and the drug manufacturers will be held responsible if proper batch-wise testing has not been done. The process of self-certification would be extended in due course for medicines being sold within the country.
It has come to the notice of the Department that due to environmental pollution and unsatisfactory agricultural and collection practices relating to the medicinal plants that are used in the preparation of Ayurveda, Siddha and Unani 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.
VKS/NSK/SR