Part 1 of our Ayurvedic Medicine in Contemporary Times series discussed the regulations and clinical evaluations governing Ayurvedic drugs and proprietary Ayurvedic medicines. The recent global resurgence of Ayurveda and a renewed interest in nutraceuticals and supplements derived from natural sources has led to an increased demand for biological resources. While this trend does lay emphasis on sustainable farming practices and effective resource management, not every natural product qualifies as an Ayurvedic product despite natural biological resources, such as plants, animal extracts, and minerals, being the primary building blocks of these Ayurvedic single-ingredient drugs or compound formulations.
The crucial aspect here is that for classification as Ayurvedic Drugs/Proprietary Ayurvedic Drugs in India, such formulations must be based on, or include, ingredients as described in the authoritative Ayurvedic texts under the Drugs and Cosmetics Act, 1940 (“D&C Act”). Ayurveda, however, is not limited to only drugs and medications, but it also finds application in products regulated as food in India. Natural products include novel ingredients and small molecules produced by living organisms, including plants, invertebrates, and microorganisms, and companies have since long used natural products as a significant source for discovering novel bioactive compounds.
Ayurvedic Products and BDA 2002
Recognising the immense potential of traditional medicines, herbs, and particularly Ayurvedic products, the Government of India introduced the Biological Diversity (Amendment) Act, 2023 (“Amendment”), which serves several purposes, including reducing pressure on wild medicinal plants by promoting their cultivation and nurturing the Indian system of medicine. The primary objective of this Amendment is to facilitate simplified access to India’s rich biodiversity for research and development while ensuring environmental conservation and equitable benefits for local communities. By enabling this access, the Amendment encourages the expansion of the traditional health and wellness sector and helps bridge the gap between ancient wisdom and modern scientific exploration.
The Biological Diversity Act, 2002 (“BDA 2002”), requires entities to seek approvals from the National Biodiversity Authority[1] or inform the State Biodiversity Board[2] in advance, as the case may be, before accessing any biological resource in India or its associated knowledge for commercial use. Notably, the BDA 2002 provides an exemption[3] on the use of biological resources by “vaids”, “hakims”, and “Ayush practitioners” who have dedicated their professional lives to practicing indigenous medicine. While the BDA 2002 is silent on the particulars/qualifications of practitioners for classification as “vaids”, “hakims”, and “Ayush practitioners”, some State-specific laws have defined these terms. For example, in Uttar Pradesh, a practitioner of Ayurvedic system of medicineand surgery is a “vaidya”,[4] and a practitioner of the Unani Tibb system of medicine and surgery is a “hakim”.[5] In Bihar, a “vaidya” is a practitioner of Ayurvedic system of medicine[6] and a “hakim” is a practitioner of the Unani Tibb system of medicine.[7]
Ayurveda in Food Products
Ayurveda lays significant emphasis on health promotion and disease prevention. The concepts of “Ahara” (wholesome diet) and “Anna” (wholesome food) drive this approach, as Ayurveda recognises the critical role food plays in health and wellness. Certain concepts with respect to food, dietetics, and nutrition are unique to Ayurveda and comprehensively explain the importance of food, the measure of food, taste of food, code of dining, metabolism, incompatible foods and processes, personalised diet based on individual “Prakrti”, and wholesome and unwholesome dietary articles.
The Food Safety and Standards Act, 2006 (“Food Act”), states that “foods for special dietary uses”, “functional foods”, “nutraceuticals” and “health supplements”[8] do not include “Ayurvedic, Siddha, and Unani Drugs”[9], implying drugs and wellness products containing Ayurvedic ingredients or those medicines formulated in terms of the authoritative books of Ayurveda need to seek approvals under the D&C Act regulatory regime.
Food products containing Ayurvedic components, however, have separate regulations on regulating “Ayurvedic Aahara”,[10] which has been prescribed under the Food Safety and Standards (Ayurveda Aahara) Regulations, 2022 (“Ayurveda Regulations”). Ayurveda Aahara is a food prepared in accordance the authoritative books of Ayurveda listed under “Schedule A” of the Ayurveda Regulations. While it includes products with botanical ingredients that comply with the specification of Ayurveda Aahara, it excludes the following:
- Ayurvedic drugs or proprietary Ayurvedic medicines and medicinal products;
- cosmetics;
- narcotic or psychotropic substances;
- herbs listed under Schedule E(1) of D&C Act and the Drugs Rules, 1940; and
- metal-based Ayurvedic drugs or medicines, bhasma, or pishti.
Regulation of “Ayurveda Ahara”
Food Business Operators are required to formulate Ayurveda Aahara as per Schedule B of the Ayurveda Regulations and are permitted to use only those additives contained in Schedule C of the Ayurveda Regulations. A prohibition also prevents the sale and manufacture of Ayurveda Aahara products that do not comply with the Ayurveda Regulations. Furthermore, Ayurveda Aahara products’ labelling should follow the Food Safety and Standards (Labelling and Display) Regulations, 2020 and ensure that the labelling, presentation, and advertisement do not claim that the Ayurveda Aahara product has the property of preventing, treating or curing a human.
Summarised below are the categories, ingredients, safety data requirements, and label claims in relation to Ayurveda Ahara under the Ayurveda Regulations:
| Category | Description | Ingredients Permitted and Process | Safety Data (Prior Approval of Product) | Label Claim | |
| Health Benefit | Disease Risk Reduction | ||||
| A | Ayurveda Aahara prepared in accordance with the Authoritative Ayurveda Texts in Books listed in Schedule A | As provided in the Authoritative Ayurveda Texts in Books listed in Schedule A | Not required | Prior approval of the Food Authority not required if claim is as per the Authoritative Ayurveda Texts in Books listed in Schedule A | Evidence-based prior approval of the Food Authority required |
| B | A new recipe of Ayurveda Aahara using ingredients listed in the Authoritative Ayurveda Texts in Books listed in Schedule A, along with other botanicals used in Ayurveda Dietetic Principles (viz. Rasa, Guna, Virya Vipaka, and Karma) | Text reference required for using new recipe or ingredient(s) provided in the Authoritative Ayurveda Books listed in Schedule A | Required[11] | Prior approval required based on the Authoritative Ayurveda Texts in Books listed in Schedule A | Evidence-based prior approval of the Food Authority required |
| B1 | Ayurveda Aahara presented in a format different from that specified in the Authoritative Texts of Books listed in Schedule A | As provided in the Authoritative Ayurveda Texts in Books listed in Schedule A | Not required | Rationale and Efficacy Data of new format including the target population, required for prior approval of the Food Authority | Evidence-based prior approval of the Food Authority required |
| B2 | Ayurveda Aahara for Specific Medical Purpose[12] | As provided in the Authoritative Ayurveda Texts in Books listed in Schedule A | Not required | Rationale and Efficacy Data for the specific medical purpose including the target population, required for prior approval of the Food Authority | Evidence-based prior approval of the Food Authority required |
Conclusion
The practice of Ayurveda diverges significantly from that of modern allopathy and nutrition. The globally escalating healthcare costs are a cause for concern for both developing and developed nations. Understanding how to manage individual health and emphasizing wellness can potentially mitigate these soaring expenses. Ayurveda’s primarily preventive role positions it favourably to answer this challenge. Prevention and interventions at the primary level can ensure cost reductions and loads at the secondary/tertiary levels of healthcare.
A product labelled Ayurveda Aahara without having complied with the requirements of Ayurveda Regulations cannot be termed and promoted as such. Labelling a food product as “Ayurvedic”, especially health supplements and nutraceuticals without complying with the Ayurveda Regulations is not an exercise done in good faith and can lead to the erosion of public trust and credibility associated with genuine and regulated Ayurvedic products. The recent trend of companies obtaining dual licenses for their nutraceuticals and health supplements products under both the D&C Act and Food Act is not ideal. Companies should assess and evaluate the correct classification of their products and only obtain necessary approvals and licenses under one regulatory regime.
Lately, the Government of India has been playing an active role in the integration of traditional and modern system of medicine to promote wellness among its citizens. The Ministry of Ayush recently released an advisory note stating that all Ayush drugs manufacturers are required to strictly adhere to the labelling provisions and advertisements of Ayush drugs and any misleading advertisement/claim in any form or on any platform will attract consequent legal actions by the competent authorities. The development of Ayurvedic drugs and food products is at an exciting juncture, however, stringent safety & efficacy testing and scientific validation remain elusive. To prevent the deception of the general public, manufacturers and sellers should avoid making exaggerated, misleading, or inconclusive claims about Ayurvedic ingredients without robust scientific evidence. Standardising safety testing protocols, rigorous scientific validation, and transparent quality control will pave the way for more global trust and acceptance in Ayurvedic drugs, treatment, and food products.
For further information, please contact:
Biplab Lenin, Partner, Cyril Amarchand Mangaldas
biplab.lenin@cyrilshroff.com
[1] In terms of section 19 of the Biological Diversity Act, 2002.
[2] In terms of section 7 of the Biological Diversity Act, 2002.
[3] Section 7 of the Biological Diversity Act, 2002
[4] Section 2(x) of United Provinces Indian Medicine Act, 1939
[5] Section 2(xi) of United Provinces Indian Medicine Act, 1939
[6] Section 2(q) of the Bihar Development of Ayurvedic and Unani System of Medicine Act, 1951
[7] Section 2(d) of the Bihar Development of Ayurvedic and Unani System of Medicine Act, 1951
[8] Explanation 1(b)(i) to Section 22 of the Food Safety and Standards Act, 2006.
[9] As defined under the Section 3(h) of the Drugs and Cosmetics Act, 1940.
[10] As defined under regulation 2(b) of the Food Safety and Standards (Ayurveda Aahara) Regulations, 2022.
[11] Rationale, and Safety Data (including mutagenicity, carcinogenicity, and teratogenicity testing) of the new recipe or ingredient(s) or supporting published modern scientific evidence.
[12] Ayurveda Aahara intended to provide a health benefit, or as an adjuvant, to support a specific disease condition, or disorder specified/ not specified in the Authoritative Texts of Books listed in Schedule A.
