(a) whether the herbal formulations, including drugs manufactured in the country contain hazardous substances like lead, arsenic, nickel, cobalt, chromium and copper;
(b) if so, the details thereof; and
(c) the action taken by the Government in this regard?
THE MINISTER OF STATE FOR HEALTH & FAMILY WELFARE
(SMT. PANABAKA LAKSHMI)
(a) & (b) Manufacture of Ayurveda, Siddha & Unani medicines containing plants/herbal,
herbo-mineral and herbo-metallic preparations in India is regulated under the provisions of
the Drugs & Cosmetics Act, 1940 and Rules 1945. The herbo-mineral and herbo-metallic
preparations are allowed only after purification in ayurvedic medicines in small quantity to
act as catalyst to activate other herbal ingredients, to increase the efficacy of the medicine
and to increase the shelf life of the medicine.
(c) The Government has taken following steps:
(i) Mandatory testing for heavy metals in all purely herbal Ayurveda, Siddha and Unani medicines
to be exported has been made mandatory from 01.01.2006 onwards.
(ii) State Drug Licensing Authorities have been directed to ensure full compliance by all ASU
drug manufacturers of the provision relating to printing of ingredients with quantities
thereof on the label or a leaflet in the container for information of consumers.
(iii) 29 State Drug Testing Laboratories have been strengthened and 26 Pvt. Drug Testing
Laboratories and other NABL accredited laboratories have been approved for testing of ASU
drugs in the country.
(iv) As there are certain concerns regarding the herbo-metallic medicines, a research project
has been sanctioned to various laboratories of Council of Scientific and Industrial Research
(CSIR) under the Golden Triangle Partnership Project to study the physiochemical
characteristics of 8 most widely used Bhasmas and to carry out their toxicity studies.
(v) Good Manufacturing Practices have been made mandatory for all Ayurveda, Siddha and Unani
drug manufacturing units in the country.