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HEAVY METALS CONTENTS IN AYURVEDIC
PRODUCTS
Question: Will the Minister of Health And Family Welfare be pleased to
state: -
(a) Whether the level of lead, mercury and arsenic in some of the ayurvedic
products exported by the Indian manufacturers has been found beyond
the permissible limit;
(b) if so, the details thereof and the response of the Government thereto;
and
(c) the steps taken by the Government in this regard?
Answer: The Minister Of State For Health & Family Welfare (Smt.
Panabaka Lakshmi)
(a), to (c) The permissible level of lead, mercury and arsenic in Ayurvedic
products as per WHO standards, which has been acceptable by the
Department is 10 ppm, 1 ppm and 3 ppm respectively.
As per the article published in Journal of American Medical Association
(JAMA) dated 27th August 2008, one fifth of the Indian manufactured
Ayurvedic products bought on the Internet contain detectable levels of lead,
mercury and arsenic. After the report is published, Government has taken
immediate steps to test the reports appearing in JAMA article by reputed
and accredited laboratories. Central Council for Research in Ayurveda and
Siddha (CCRAS) has also undertaken a study to test the toxicity/safety
profile of metal-based bhasmas. The study is jointly being carried out with
the Industrial Toxicology Research Center (ITRC), Council for Scientific
and Industrial Research (CSIR), Lucknow. Pharmacopoeial Laboratory of
Indian Medicine (PLIM), Ghaziabad has also been directed to procure
samples of all the products mentioned in JAMA article and send them
to Indian Institute of Chemical Technology (IICT), Hyderabad for heavy
metal analysis by electron spectroscopic chemical analysis as well as
X-ray flourescence spectroscopy.
The manufacturers of Ayurvedic medicines have been directed to get safety/
toxicity studies carried out for their products by National Accreditation
Board for Testing and Calibration Laboratories / Good Laboratories
Practices (NABL/GLP accredited laboratories and send their report in
respect of acute, sub acute and chronic safety/toxicity drugs studies.
After examination it is found that no exported herbal ayurvedic medicine
from India contain heavy metals beyond the permissible limit. As far as
purely herbal Ayurvedic formulations are concerned presence of heavy
metals is not detected. As regard herbo-mineral and herbo- metallic
preparations metals are an essential ingredient of these formulations and
therefore are bound to be present in these, however they are permitted
to be used only after due purification and only in small quantities to act
as catalysts for activation of other herbal ingredients in order to increase
the efficacy of the medicines. The metallic preparations in the form of
compounds of metals triturated in the form of Bhasmas are rendered safe
after purification with herbs and burning in fire for a prescribed number
of times.
# A Press release was issued on 2nd September, 2008 with detailed
comments by the Department of AYUSH, after article published in JAMA
(U.S.) 27th August, 2008 alleging heavy metals in Ayurvedic medicines.
# The following other necessary orders have also been issued by the
Central government to ensure safety and efficacy of AYUSH products in
the country and abroad.
• Government has introduced mandatory testing for heavy metals in all
purely herbal Ayurveda, Siddha and Unani medicines to be exported
with effect from 01.01.06 onwards. This has been done to meet the
regulatory requirements of importing countries.
• State Drug Licensing Authorities have been directed to ensure full
compliance by all ASU drug manufacturers of the provisions of Rule
161 (1) and (2) relating to displaying on the label of the container or in
a leaflet to be inserted in the package of an ASU drug, the true list of
all the ingredients used in the manufacture of the preparation together
with the quantity of each of the ingredients incorporated therein.
• 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 use Bhasmas and to carry out their toxicity studies.
• Good Manufacturing Practices have been made mandatory for all
Ayurveda, Siddha and Unani drug manufacturing units in the country.
• Department of AYUSH has discussed with Minister of Commerce to
set up an AYUSH Export Promotion Council under the Department of
AYUSH to take care of critical issues like testing and certification of
Ayurveda, Siddha and Unani medicines for export.
• Govt. have constituted Pharmacopoeia Committees of Ayurveda, Siddha
and Unani systems of medicines for preparation of Pharmacopoeias to
ensure the quality of Ayurveda, Siddha and Unani drugs.
• Captain Shreeniwasmurti Drug Research Institute for Ayurveda,
Chennai, India Toxicology Research Centre (presently IITR, Indian
Institute of Toxicology Research), Lucknow and Sri Ram Institute
for Industrial Research, New Delhi have analyzed about 600 plants
and it was found that lead arsenic and mercury levels were within the
permissible limit.
• State Licensing Authorities have been directed to constitute an Expert
Committee under the provision of Rule 154 (2) of the Drugs and
Cosmetics Rule, 1945 for streamline the system for licensing of patent
and proprietary Ayurveda, Siddha and Unani products.
MEDICINAL PLANTS ON THE VERGE
OF EXTINCTION
Question: Will the Minister of Health And Family Welfare be pleased to
state: -
(a) Whether the Medicinal Plants are on the verge of extinction;
(b) if so, the details thereof and the reasons there for; and
(c) the steps taken by the Government in this regard?
Answer: Minister of State in the Ministry of Health and Family Welfare
(Smt. Panabaka Lakshmi)
(a) & (b): No, Sir. However, the medicinal plants, like other groups of
plants and animals, are threatened largely due to degradation of forests
owing to various anthropogenic factors.
(c): The Ministry of Environment & Forests formulates policies for
protection of forests. The Indian Forest Act, 1927 and the Wild Life
(Protection) Act, 1972 have provisions for protection of forests and
wildlife, including medicinal plants. The National Biodiversity Act,
2002 regulates the access to forest resources, including medicinal plants.
The Ministry of Environment & Forests is also supporting a number of
projects on conservation by setting up Medicinal Plants Conservation
Areas (MPCAs) that are primarily located in forest areas. Plantation of
medicinal plants in degraded forest lands is supported through schemes of
the National Afforestation & Eco-development Board (NAEB), Ministry
of Environment & Forests.
Government has also set up Medicinal Plants Board to coordinate matters
relating to medicinal plants with Ministries/ Departments and other
stakeholders for ensuring availability of medicinal plants of quality to the
industry on a sustained basis.
The Board has undertaken various programmes for conservation and
development of medicinal plants. Central assistance is provided under the
following schemes:
i) “Central Sector Scheme for Conservation, Development and
Sustainable Management of Medicinal Plants”
The activities for which assistance is provided are as under:
• Survey, Inventorisation and in-situ conservation of rare, endangered
and threatened species of medicinal plants and setting up Medicinal
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