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The Ayurvedic Pharmacopoeia of India and Quality Standards

What the Ayurvedic Pharmacopoeia of India is, what India's quality rules for Ayurvedic medicines say about metals, microbes and manufacturing, and the limits of what a standard guarantees.

Content last updated . This page has not been medically reviewed.

What the pharmacopoeia is

The Ayurvedic Pharmacopoeia of India (API) is described in a 2017 review as a book of standards for the quality, purity and strength of selected drugs that are manufactured, distributed and sold by licensed manufacturers across India. [1] It has two parts. Part one holds monographs of single medicinal substances of natural origin. Part two holds selected compound formulations taken from classical Ayurvedic books listed in the First Schedule of the Drugs and Cosmetics Act, 1940. [2]

The same review traces its history. The first part of the Ayurvedic Formulary of India was published in 1978. The first volume of single-drug monographs followed in 1989, and later volumes were given legal status under the Drugs and Cosmetics Act. [3] A 2023 analysis found that Part I of the API includes 621 single botanical drugs sourced from 393 plant species. [4]

This page covers India's rules first, because India is where the pharmacopoeia is written. Other countries regulate Ayurvedic products under their own rules, covered at the end.

What the Indian guidance says

India's Central Council for Research in Ayurvedic Sciences (CCRAS, Ministry of AYUSH) published a first edition (2018) of general guidelines for drug development of Ayurvedic formulations. The text below is from that document, read 2026-10-22.
  • Raw plant material limits. It says heavy metal limits as prescribed in the ASU (Ayurveda, Siddha, Unani) pharmacopoeias should be observed: lead 10 ppm, cadmium 0.3 ppm, mercury 1 ppm and arsenic 3 ppm. [5] It also lists microbial limits, with Staphylococcus aureus, Salmonella, Pseudomonas aeruginosa and E. coli absent, and aflatoxin limits. [6] [7]
  • Good manufacturing practice. Schedule T of the Drugs and Cosmetic Rules specifies factory premises and hygienic conditions, and compliance is mandatory for all manufacturers of ASU drugs. [8]
  • Expiry dates. A 2016 amendment requires an expiry date to be conspicuously displayed on the label. [9]
  • Poisonous substances. Schedule E1 lists poisonous substances in the Ayurvedic system, including plants such as dhattura and vatsanabha and minerals such as parada, hartala and hingula. [10]
  • Test lists by form. The document gives test parameters for powders, tablets, fermented liquids, oils and others. See forms of Ayurvedic preparations.

We could not read the current API volumes or the PCIM&H (Pharmacopoeia Commission for Indian Medicine and Homoeopathy) website, which did not load in readable form. The numbers above are those quoted in the CCRAS document, and may differ from current official text.

Does a standard guarantee a clean product?

No. A standard describes what a product should meet. Studies show gaps between standards and what is sold.
FindingSourceNote
20 over-the-counter fermented formulations from 3 manufacturers showed significant differences in ethanol content, which the authors read as poor compliance with good manufacturing practice. [11] [12]Indian market studySmall sample
Adulteration of expensive raw drugs with inferior plant species has become a routine practice, and the authors propose a national certification agency for raw drug authentication using DNA barcoding. [13] [14]South India study using DNA barcodingRaw material authentication
Three case reports describe harm from an unknown tablet containing a steroid as an adulterant and from an Ayurvedic medicine containing reserpine. [15] [16]Case reportsEvidence of harm, not a rate
20.7% of Ayurvedic medicines bought online had detectable lead, mercury or arsenic; 75% of the metal-containing ones claimed good manufacturing practices. [17] [18]2008 US studySample, not whole market

A 2024 review states that Ayurvedic medications frequently lack standardized manufacturing processes and quality control. [19] See heavy metals and product quality and rasa shastra and bhasma.

Outside India

  • United States. FDA says there are no FDA-approved Ayurvedic products. [20] NCCIH notes that dietary supplements are not approved by FDA before they are sold. [21]
  • Canada. Health Canada has issued public advisories about unauthorized Ayurvedic products found to contain lead and mercury. See the 28 January 2019 advisory on A1 Herbal Ayurvedic Clinic Ltd. [22]
  • United Kingdom. The NHS says herbal medicines and complementary therapies are not tested in the same way as standard medicines to see how well they work. [23]

We did not read Australian or European regulator pages on Ayurvedic products for this page, so we make no claim about their rules.

How to use this information

  • Ask whether the seller can provide a batch-specific laboratory report for metals and microbes, and treat "meets pharmacopoeial standards" on a label as a claim to check, not a proof.
  • Be cautious with products bought online or with no ingredient list.
  • Ask a clinician or pharmacist before use, especially in pregnancy, with prescription medicines, or for children. See Ayurvedic herbs: interactions, pregnancy and children.

Related pages

Frequently asked questions

What is the Ayurvedic Pharmacopoeia of India?

It is an official book of standards for the quality, purity and strength of Ayurvedic drugs made and sold by licensed manufacturers in India. [1]

How many herbs does it cover?

Part I includes 621 single botanical drugs from 393 plant species, according to a 2023 analysis. [4]

Does India require good manufacturing practice for Ayurvedic medicines?

Per the CCRAS document, Schedule T compliance is mandatory for all manufacturers of ASU drugs. [8]

Does meeting a standard make a product safe for me?

Not by itself. Studies found contamination and adulteration in products on sale, and safety also depends on your health, other medicines and pregnancy. [17] [14]

Can I find the pharmacopoeia online?

We could not read the official volumes this session. Ask a pharmacist or the manufacturer for the specification of a product you are considering.

References
  1. Joshi et al., The Ayurvedic Pharmacopoeia of India, development and perspectives. J Ethnopharmacol 2017. Read 2026-10-22.
  2. Joshi et al. (2017), structure of the API. Read 2026-10-22.
  3. Joshi et al. (2017), history of the API. Read 2026-10-22.
  4. Yao et al., Single botanical drugs in the Ayurvedic Pharmacopoeia of India: a quantitative ethnobotanical analysis. Front Pharmacol 2023. Read 2026-10-22.
  5. CCRAS, Ministry of AYUSH, India, General Guidelines for Drug Development of Ayurvedic Formulations (first edition 2018), raw plant material heavy metal limits. Read 2026-10-22.
  6. CCRAS, Ministry of AYUSH, India, General Guidelines for Drug Development of Ayurvedic Formulations (first edition 2018), microbial limits. Read 2026-10-22.
  7. CCRAS, Ministry of AYUSH, India, General Guidelines for Drug Development of Ayurvedic Formulations (first edition 2018), aflatoxin limits. Read 2026-10-22.
  8. CCRAS, Ministry of AYUSH, India, General Guidelines for Drug Development of Ayurvedic Formulations (first edition 2018), Schedule T. Read 2026-10-22.
  9. CCRAS, Ministry of AYUSH, India, General Guidelines for Drug Development of Ayurvedic Formulations (first edition 2018), expiry rule. Read 2026-10-22.
  10. CCRAS, Ministry of AYUSH, India, General Guidelines for Drug Development of Ayurvedic Formulations (first edition 2018), Schedule E1 list (Ayurvedic mineral entries: Gauripashna, Hartala, Manahashila, Parada, Rasa Karpura, Tuttha, Hingula). Read 2026-10-22.
  11. Maithani et al. (2019), difference. Read 2026-10-22.
  12. Maithani et al., Ethanol content in traditionally fermented ayurvedic formulations. Am J Drug Alcohol Abuse 2019. Read 2026-10-22.
  13. Dev et al. (2021), proposal. Read 2026-10-22.
  14. Dev et al., Quantification of adulteration in traded ayurvedic raw drugs employing machine learning approaches with DNA barcode database. 3 Biotech 2021. Read 2026-10-22.
  15. Paudyal et al., Adverse events with ayurvedic medicines: possible adulteration and some inherent toxicities. Wellcome Open Res 2019. Read 2026-10-22.
  16. Paudyal et al. (2019), reserpine case. Read 2026-10-22.
  17. Saper et al., Lead, mercury, and arsenic in US- and Indian-manufactured Ayurvedic medicines sold via the Internet. JAMA 2008. Read 2026-10-22.
  18. Saper et al., JAMA 2008, good manufacturing claims. Read 2026-10-22.
  19. Sikder (2024), full text, manufacturing. Read 2026-10-22.
  20. FDA, FDA warns about heavy metal poisoning associated with certain unapproved ayurvedic drug products (content current as of 12/02/2025), approval statement. Read 2026-10-22.
  21. NCCIH, Ashwagandha, regulation statement. Read 2026-10-22.
  22. Health Canada, Health Canada warns that products sold by A1 Herbal Ayurvedic Clinic Ltd. may pose serious health risks (advisory dated January 28, 2019). Read 2026-10-22.
  23. NHS, Herbal medicines. Read 2026-10-22.
Education, not medical advice. This page is for general information. It does not diagnose or treat any condition and is not a substitute for care from a qualified health professional. Natural does not automatically mean safe. Ask a clinician or pharmacist before changing your care, especially if you take medication, are pregnant or breastfeeding, or have a health condition.