Though the Indian herbal drug manufacturers are now adhering to the norms set by the Govt of India in providing details of the heavy metal content in the herbs and plants following the orders issued by Department of Ayush, providing those details is proving to be a difficult task for small and medium enterprises (SMEs) due to the stringent norms and costs involved according to industry insiders.
Installing equipment like Atomic Absorption Spectrometer to test heavy metals and TLC/HPTLC/GLC to test crude drugs are expensive for many companies, they point out.
The herbo- metallic compounds are not being officially exported because of heavy metal apprehensions and only pure herbal Ayurveda, Unani and Siddha medicines are being exported from India with effect from January 1, 2006 after certification of heavy metals below the permissible limit by the manufacturing unit.
Indian Ayurveda companies have been serious about the submissions of the details on the heavy metal content in the medicinal preparations for exports but for the domestic market this requirements is optional, said JSD Pani, President, Karnataka Indian Medicine Manufacturers Association.
According to Dr. DBA Narayana, a leading scientist in herbal drugs and plant medicine, the Ayurveda pharmacopeia has also prescribed simple tests to ascertain the metal content. If it is difficult to quantify, then the companies in the herbal industry space have to resort to sophisticated equipment like the Atomic absorption spectroscopy (AAS) which is a spectro analytical procedure for the qualitative and quantitative determination of chemical elements.
In 2009, the Department of Auysh certified eight bhasmas to be safe for use. This validation of eight bhasmas was the maiden project under the Golden Triangle project of the Central government. The project, set up with the support of the Department of Ayush, Indian Council of Medical Research (ICMR) and Council of Scientific and Industrial Research (CSIR) will scientifically validate Ayurveda products.
The standardization, safety and toxicity studies of metallic bhasmas and mineral-based formulations including Kupipakwa Rasayanas have been a major issue for a while for the drug manufacturers, according to Pani,.
The issue of the presence of minerals and heavy metals has bogged down international marketing operations. Therefore the effort by the Ayush Department will now help the industry, Pani added.
The Planning Commission had constituted a Working Group on Access to Health Systems in Ayush which in-turn formed five sub-groups and one of them focused only on the standardization and quality control of Ayush drugs.
The Ayush Department had laid down pharmacopoeial standards for single and compound formulations besides carry out scientific validation of herbo-metallic compounds and address the standardization and quality control of herbal drugs.
The department enforced mandatory testing of heavy metals not only for export of Ayurveda, Siddha and Unani medicines but also for sale in domestic market. Since over 80 per cent of the Ayush manufacturing units are in the small and medium scale sector, the department identified labs to test the drugs for these companies. This is because equipment like Atomic Absorption Spectrometer to test heavy metals and TLC/HPTLC/GLC to test crude drugs are expensive to be installed by many companies.
Pani said that these metals have undergone extensive toxicity studies. There had been no reports of major adverse drug reaction. Standardization and quality control of Ayurveda, Siddha, Unani drugs is a problem area as botanicals do not lend themselves to as precise a quality control as synthetic molecules manufactured under controlled laboratory conditions. This requires state-of-the-art research for developing chemical/biological markers/chromatogram fingerprints/standardized operating procedures and phyto-chemical characterization of bhasmas.
Now with the Department of Ayush being ready with the safety data of the eight bhasmas, this would provide a major fillip for growth for the traditional system of medicine industry, said Dr GG Gangadharan, Joint Director (Traditional System of Medicine), Foundation for Revitalization of Local Health Traditions (FRLHT).
The Indian traditional system of medicine, Ayurveda, sanctions the use of metals and minerals with herbal formulations. Bhasma, a calcined preparation in which a mineral or metal is converted into fine powder, is added to herbal powders and extracts to form Ayurvedic medications. The process of bhasma ensures that toxicity in these heavy metals is completely eliminated.
However, as more and more herbal products are being exported today, heavy metal content in herbal products is becoming a much debated topic. Currently, the guidelines for conventional medicinal products are also being applied to herbal products.
However, as herbal products are derived from nature and are different from these conventional drugs, it is important that two different guidelines are outlined, Dr. Rangesh Paramesh, Head—New Product Initiatives, The Himalaya Drug Company told Pharmabiz in an email interaction.
It is important to note that herbs naturally contain heavy metals, like all agricultural products. There are ways to ensure that heavy metal levels can be controlled. Employing Good Agricultural Practices (GAP), promoting organic farming techniques and conducting regular soil checks are some of the ways to ensure that herbs are safe for consumption and metal levels remain low. It is imperative that a safe and desirable limit is outlined for all herbal products being manufactured in India and across the world, he added
At Himalaya, we follow a ‘seed-to-shelf’ policy for all our products. Products are monitored for quality right from the herb cultivation stage to ensure that only safe and efficacious products reach the market. Clinical trials further scientifically validate the safety and efficacy of all Himalaya products, said Dr. Rangesh.