New Delhi: The government has proposed a set of safety and quality limits for the root bark of Mundulea sericea, a medicinal plant used in traditional treatment for various conditions, including epilepsy.
A draft proposal, seen by Mint, sets maximum limits for toxic heavy metals, aflatoxins, pesticide residues and microbial contaminants in the plant material. The proposal has been prepared by the Bureau of Indian Standards’ (BIS) Ayurveda Sectional Committee and is currently under consideration, two government officials said.
The proposed limits include 10 parts per million (ppm) for lead, 1 ppm for mercury, 0.3 ppm for cadmium and 3 ppm for arsenic. It also sets maximum limits of 2 ppm for aflatoxin B1 and 5 ppm for total aflatoxins.
The move assumes significance as India seeks to expand the global markets for the traditional medicine sector, where consistent quality and safety standards are important to maintain the sector’s credibility and competitiveness.
India’s AYUSH services economy stood at $36.92 billion in FY25, while AYUSH product exports rose from $869.81 million in FY21 to $1.27 billion in FY25 before easing marginally to $1.25 billion in FY26, according to government data.
The proposed norms cover the root bark of Mundulea sericea, a plant belonging to the Fabaceae family, that grows up to 10-15 feet and is found in several parts of Karnataka, including Bagalkote, Belagavi, Ballari, Bijapur, Chikkamagaluru, Chitradurga, Hassan, Kolar, Tumakuru and Uttara Kannada.
The root bark has traditionally been used for conditions such as epilepsy, poisonous bites, wounds, hernia and infertility, as well as bilharziasis (schistosomiasis). These uses are based on traditional practices and should not be interpreted as evidence of clinical efficacy, said the first of the two officials cited above.
The draft proposal describes the plant as “extra-pharmacopoeial”, meaning it is not currently included in the official pharmacopoeia.
From contaminants to plant identification
“The proposed standards are intended to ensure that the plant material used in Ayurvedic products meets basic quality and safety requirements, rather than being sold as an unregulated raw material in roadside shops,” said the first official. “This can help consumers get products of consistent quality, while ensuring that manufacturers use properly identified and tested plant material.”
The root bark must be free from foreign matter and meet set limits for ash and extractives, the officials said. The proposed norms also set microbiological requirements, including the absence of Staphylococcus aureus, Pseudomonas aeruginosa and Salmonella in specified forms of the material, as well as limits for Escherichia coli, total microbial count, yeast and mould.
The draft proposal further requires testing for a range of pesticide residues. If pesticides not listed in the standard are used before or after harvesting, the material would also have to be tested under the relevant BIS method, with limits calculated using an acceptable daily intake-based formula.
To identify the plant material, the proposed norms require high-performance thin-layer chromatography (HPTLC) testing, which creates a chemical “fingerprint” of the root bark. The test would look for 14 spots at 254 nanometres and 9 spots at 366 nanometres, which would be compared with a reference standard to confirm the material's identity.
HPTLC is a laboratory test used to identify plant materials and check their quality.
The draft also prescribes packaging requirements including the botanical name, producer or packer’s name and address, batch number, net quantity, state and country of production, packing date and storage instructions.
The proposed norms are based mainly on the Monographs on Anukta Dravya, Volume 2, published by the Institute for Teaching and Research in Ayurveda, Jamnagar.
“India is a global leader in Ayurveda and traditional medicine, and as the sector expands its presence in international markets, maintaining consistent standards for quality and safety is critical,” said Dr Rakesh Kotwal, medical officer (ayurveda) at sub-district Hospital (SDH) Padder in the Kishtwar district of Jammu and Kashmir.
“Developing standards for medicinal plants that are increasingly being used in Ayurvedic formulations can help ensure that consumers get safe and consistent products and strengthen confidence in Indian traditional medicines,” Kotwal said.
Dr Smita Pankaj Naram, chairperson of ayurvedic healthcare centre chain Ayushakti Ayurveda said, “We follow such testing for all our herbal ingredients, so I support the move to introduce clear standards for medicinal plants. It can help ensure that raw materials are properly tested for contaminants and meet consistent quality requirements before they are used in Ayurvedic products.”
The Research and Information System for Developing Countries (RIS) estimates that India’s AYUSH services economy stood at $36.92 billion in FY25, growing at a compound annual growth rate of 16.91% since FY23. The study projects the sector to reach $216-318 billion by 2047.
Queries sent to the department of consumer affairs remained unanswered till the press time.