Bangalore: In a discovery that could impact the online sales of herbal medicines, one-fifth of Ayurvedic medicines made in the US and India and sold in the US through the Internet have been found to contain more than permissible levels of toxic metals, according to a new study in Wednesday’s issue of the Journal of American Medical Association (JAMA).
The new study is an extension of a December 2004 research published in JAMA, which showed that Ayurvedic medicines manufactured in South Asia and sold in Boston area stores in Massachusetts contained high levels of heavy metals.
“We wanted to know if our 2004 findings also applied to a larger international sample of Ayurvedic medicines,” said lead author Robert B. Saper, department of family medicine, Boston Medical Center.
Randomly selecting 193 products from 37 manufacturers selling through 25 websites, researchers found all medicines that contained metals exceeded one, or more standards for acceptable daily intake of lead, mercury, or arsenic. Among products containing metals, 95% were sold by US websites and 75% claimed good manufacturing practices (GMP), an international standard for drug manufacturing.
Researchers also wanted to check if Ayurvedic medicines made in the US contained high levels of metal. “In 2004, many in the US stated that there is not a similar problem in the US-made products,” said Saper, who thinks this study addresses that question by comparing US and Indian products.
Ayurvedic medicines are largely divided into two categories—herbal-only and rasaushadhas (made on the basis of the Rasa Shastra, an ancient Indian text on metals), which are meant to contain metals, such as mercury and lead, by design.
“To state that rasaushadhas contain metals is simply reinforcing the obvious as it is not possible to prepare a rasaushadha formulation without adding metals,” said S.K. Mitra, executive director (research and development) at Himalaya Global Holdings Ltd, an Ayurvedic medicines company in Bangalore. What needs to be explored, according to Mitra, is whether the formulation is safe and efficacious, and this will have to be proven through empirical data and scientific research.
India’s Ayurvedic Drug Manufacturers Association (Adma), an industry body, is unhappy that the study has “dragged its name” in on the basis of some of its member companies being involved in the study. “Why is the industry association mentioned in this academic paper and why were we not consulted?” asked Ranjit Puranik, general secretary of Adma in Mumbai.
He said quality standards, clearly laid down by the government’s department of Ayurveda, yoga and naturopathy, unani, siddha and homoeopathy (AYUSH), are there for “everyone to follow”.
The Rs8,000 crore by sales herbal medicine market in India, according to Adma, received a blow from the 2004 study that triggered banning of Ayurvedic medicines in some countries, including Canada and the UK. “We are still reeling under that damage,” said Puranik.
Researchers, however, argue that India has laid down regulations for toxic metal limits for herbal-only medicines exported from India.
“There are no limits for domestically consumed medicines, or Rasa Shastra medicines,” said Saper, who recommends strictly enforced, government-mandated daily dose limits for toxic metals in all dietary supplements. “All manufacturers (should) demonstrate compliance through independent third-party testing.”
Though Saper and colleagues have urged Congress to revisit the way dietary supplements are regulated in the US, their concern is also valid in the Indian context. In a July 2008 paper in the Indian Journal of Pharmacology, Urmila Thatte and colleagues, department of clinical pharmacology, TNMC and the BYL Nair hospital, Mumbai, have said there’s no pharmacovigilance of Ayurvedic medicines in India and that the problem of spurious drugs is serious.
Out of 154 complaints for adverse reactions to Ayurvedic medicines coming at her centre, “we knew the exact ingredients (because of labelling) of only 22 formulations; 132 were from the informal sector”, says Thatte.
While Adma, with 260 direct members and 400 affiliates, agrees that there is a “lack of harmonious standard” in Ayurvedic medicines, it says JAMA should initiate a dialogue rather than corner the industry. The government’s AYUSH department has already initiated efforts to bring rasaushadhas under the purview of GMP.
“If this study aims at a dialogue about caution in over-the-counter sale of Ayurvedic medicines, or whether there should be a regulation supervising online sale of such medicines, we are willing to take it forward,” said Puranik. If not, then it’s simply “muddying the waters”.