REGULATING AYURVEDA IN THE TWENTY-FIRST CENTURY: LEGAL GOVERNANCE, ETHICAL ACCOUNTABILITY, AND PATIENT PROTECTION IN TRADITIONAL HEALTHCARE SYSTEMS
- Dr. Kartik Sharma
Table of Contents
ABSTRACT
Ayurveda is among the oldest systems of medicine in the world and has established its presence as part of the modern health care (HC) system, especially within the context of HC governance. Over the past few decades, there has been a significant increase in the formalization (i.e., institutionalization) of Ayurvedic practice in India through regulation, educational reform, and incorporation into public health programs, which has raised a number of important issues relating to patient safety, professional accountability, and quality of HC. While public trust in Ayurveda is high, as is political support for it, there are continuing concerns about issues such as: informed consent; false or misleading evidence for therapeutic benefit; standardization of treatment protocols; and liability for malpractice. This article reviews the existing legal and regulatory framework applicable to Ayurveda in India, with a focus on comparing it to a sample of other approaches to regulating traditional or complementary medicine internationally. This research uses a doctrinal and comparative policy analysis to assess the effectiveness of current laws, professional regulatory systems, and ethical guidelines for protecting patients. The article also examines how the National Commission for the Indian System of Medicine, consumer protection laws, and the development of health care law have influenced accountability in the practice of Ayurvedic medicine. The study concludes that Ayurveda’s future legitimacy will depend on its continued reliance on its traditional foundation and its ability to meet the current expectations for transparency and evidence-based practice, informed consent, and patient-centered care. The article ends with a proposal for reforms to strengthen the regulatory framework while maintaining the cultural and therapeutic values associated with traditional healthcare systems.
KEYWORDS:
Ayurveda, Healthcare Regulation, Patient Protection, Medical Ethics, Legal Governance, Traditional Medicine, AYUSH, Professional Liability.
INTRODUCTION
The use of traditional forms of medicine is an important aspect of health care systems around the world and the World Health Organization (WHO) recognizes that traditional and complementary forms of medicine are key components of health care systems in many countries, especially developing areas in which availability and cultural acceptability have a considerable bearing on health care choices. Ayurveda, one of the many forms of traditional healthcare, is considered to be one of the most comprehensive and longstanding forms of medical treatment.
India has made extensive efforts to develop and regulate Ayurvedic practice through legal and regulatory organizations, quality of education requirements, licensing criteria and integration with the public health care system. Although there continues to be widespread interest and use of Ayurvedic medicine, the rapid growth of the Ayurvedic market and services has shown deficiencies in the regulatory oversight of medical and therapeutic products, ethical compliance and safety and protection of patients. There are increasing, and significant, demands for legal scrutiny regarding issues related to the professional negligence of practitioners, informed consent policies, advertising standards and testing for scientific validation of practitioners of Ayurvedic medicine.
This article examines whether the existing legal framework adequately protects patients while facilitating the growth of Ayurveda as a recognized healthcare system.
RESEARCH OBJECTIVES
To examine the legal framework governing Ayurveda in India.
To evaluate ethical accountability mechanisms applicable to Ayurvedic practitioners.
To compare Indian regulatory approaches with selected international models.
To assess challenges relating to patient protection and professional liability.
To propose policy reforms for strengthening regulatory governance.
LITERATURE REVIEW
The most recent literature has shown that there is a move from a system of regulating Ayurveda strictly through education and professional registration. This new governance system consists of four elements: patient safety, ethical accountability, quality assurance, and evidence-based healthcare delivery. Most of the previous regulatory systems focused on the credentialing of practitioners and standardising educational curricula; however, the current healthcare governance model requires the use of legal mechanisms to ensure transparency, clinical competence, accountability, and protection of patients’ rights. In addition, this movement reflects the increasing integration of Ayurveda into national health systems and the increasing expectation that all forms of traditional health care will conform with internationally recognised principles of professional regulation and clinical governance.
The WHO Benchmarks for the Practice of Ayurveda (2022) mark an important point in the development of Ayurveda. They establish internationally acknowledged minimal competency requirements for Ayurvedic practitioners, healthcare facilities and infrastructure; Medicaid records or similar clinical documentation; informed consent from patients; patient confidentiality; a written referral process; and regulatory oversight of this practice. The Benchmarks provide guidelines for the integration of traditional medical practices with modern legal and ethical standards, while also protecting and preserving Ayurvedic principles. The NCISM Act of 2020 has also strengthened regulatory governance of all systems of medicine in India, including Ayurveda, through the promotion of competency-based education, institutional accreditation, standardized professional practices, and more accountable delivery of Ayurvedic healthcare.
The most current evidence supports the need for accountability through professional ethics in the regulation of Ayurveda. The latest research demonstrates that professional ethics should include both traditional values as well as aspects of contemporary professional ethics such as: informed consent, patient autonomy, confidentiality, appropriate documentation, responsible prescribing, and compliance with defined standards of care. Additionally, pharmacovigilance, quality control of Ayurvedic products, adverse event reporting, and evidence-based clinical practice guidelines are now viewed as important tools to enhance patient safety and build confidence in Ayurveda. As stated in recent policy analyses, key components to improving the governance of Ayurveda include: implementing mandatory accreditation, using electronic patient records, having standardized clinical practice guidelines, developing a mechanism for ongoing professional education, having strong systems for monitoring the safety of medications, being non-partisan when handling disciplinary procedures, and having credible legal systems to provide oversight.
RESEARCH METHODOLOGY
This study adopts a doctrinal and comparative legal research methodology. Primary sources include statutory enactments, governmental regulations, judicial decisions, and policy documents. Secondary sources include scholarly articles, books, reports of international organizations, and academic commentaries. Comparative analysis is undertaken with regulatory frameworks governing traditional and complementary medicine in selected jurisdictions including China, the United Kingdom, and Australia.
LEGAL GOVERNANCE OF AYURVEDA IN INDIA
Evolution of Regulations in Ayurveda Through History
The regulation of Ayurveda as a formal body has undergone many changes from when Ayurveda was first recognized by colonists/colonial governments as an indigenous form of medicine to a contemporary statutory regulatory framework. The government has developed a number of initiatives since 1947 encouraging the development of a code of ethics to protect traditional knowledge-based systems while still providing for the regulation, standardization, and professionalization of Ayurvedic and other traditional healing systems.
National Commission For Indian Medicine Act (NCISM) 2020
There has been substantial reform to Ayurvedic governance with the National Commission for Indian Medicine Act 2020. The statute streamlined previously existing regulatory regulations; this act created standards for education, licensure as a practitioner, and oversight of the delivery of Ayurvedic services.
The NCISM Act aims to increase transparency, accountability, and quality assurance regarding services delivered under the Indian system of medicine; however, challenges remain related to the implementation and enforcement of this legislation.
The Ministry of AYUSH As The Primary Governmental Authority
The Ministry of AYUSH serves as the primary government entity charged with the formation of policies and regulations, promoting research, and coordinating with institutions that work with Ayurveda and other forms of traditional medicine.
ETHICAL ACCOUNTABILITY IN AYURVEDA
Ethics and Responsibilities of Practitioners
Practitioners must maintain the following top priorities; the welfare of patient, confidentiality, competence and professional integrity. As the practice of Ayurveda continues to evolve, so too do all the ethical standards that have been established for modern healthcare observers.
Informed Consent and Autonomy of Patients
Obtaining informed consent is becoming an essential principle within the field of health care law. Patients are to be informed about their condition, available options, the benefits, disadvantages, and risks of the identified options.
Patients do not fully understand the requirements of informed consent and conditions associated with using Ayurvedic remedies. Since most patients view Ayurvedic remedies as “natural” and thus, “safe”, a lack of disclosure with regard to possible adverse consequences or side effects of Ayurvedic methods is more common than with conventional methods.
Fraudulent Advertising & Misleading Therapies
As the market for Ayurvedic therapy grows, so does the concern over the existence of exaggerated therapeutic claims made by practitioners. Ethical regulatory oversight and guidance requires the use of legitimate data to support marketing initiatives and to genuinely promote Ayurvedic therapies without misleading prospective customers.
PATIENT PROTECTION AND LEGAL LIABILITY
CONSUMER PROTECTION - LAWS THAT PROTECT CONSUMERS OF HEALTHCARE
The Consumer Protection Act 2019 provides a mechanism for addressing the grievances of consumers concerning healthcare services; therefore, Ayurveda practitioners can be liable for claims made by patients as a result of failures or deficiencies in the health services provided.
PROFESSIONAL NEGLIGENCE BY AYURVEDA PRACTITIONERS
The issue of determining whether professional negligence has occurred in traditional medicine is complicated legally. In making this determination, courts must apply both traditional healing practices and contemporary standards of reasonable professional conduct of the practitioner.
Professional liability may arise from:
- Failure to diagnose correctly;
- Providing the wrong treatment;
- Failure to obtain consent from patients before treatment;
- Failing to maintain legible and accurate records; and
- Making representations to patients regarding their chances of success or perceived benefit from
a treatment.
CURRENT TRENDS IN JUDICIAL DECISIONS
There has been an increasing trend among key Indian courts (“high courts”) in India to recognize the rights of patients and the importance of accountability and transparency from healthcare providers in providing patients with services/products. The body of case law in India directly addressed to Ayurveda is limited; however, the principles of medical negligence are increasingly applicable to traditional practitioners of medicine.
Comparative perspectives
China
China has created an integrated regulatory system in that it combines traditional Chinese medicine with mainstream health care. The various types of regulatory oversight include practitioner licensing, research standards and methods of quality control.
United Kingdom
The United Kingdom takes a relatively cautious stance on the regulation of traditional and
complementary therapies. Its regulatory structure is built on the premise of providing consumer
protection, professional registration, and truthful advertising.
Australia
Australia provides national regulation for complementary medicine through health care and consumer protection laws. There is a strong emphasis placed on supporting evidence for making claims about treatments and consumer safety.
The comparative analysis shows that the effective regulation of traditional and complementary therapies requires:
- Specific licensing standards;
- Strong protections for patients’ rights;
- Transparent regulatory mechanisms for disciplining practitioners;
- Scientific evidence supporting the therapeutic claims made by practitioners; and
- Strong mechanisms for consumers to pursue their complaints against practitioners.
ISSUES THAT POLICY MAKERS WILL ENCOUNTER IN THE 21ST CENTURY
Almost all regulations regarding the use of Ayurvedic medicine will need to be improved upon in order to address the following issues:
– The absence of standard operating procedure (SOP) for performing treatments
– The low rate of integration of informed consent throughout the continuum of care
– A lack of public knowledge regarding their rights as patients
– A significant lack of monitoring of advertisements and commercial claims for Ayurvedic products
– Variability in the quality and competency level of the education received by Ayurvedic
practitioners.
By addressing these issues we will build public trust in Ayurvedic medicine, as well as improve
health outcomes
POLICY RECOMMENDATION
- Creation of an Adult Informed Consent Policy Method Specific to Ayurveda
- Use of Independent Grievance Resolution Processes for Patients Receiving Allopathic Medicine
- Strengthening Regulation and Oversight over all Advertising of Health Care Products and on the
Internet and Providing Alternatives for Electronic Marketing - Promotion of Evidence-Based Clinical Research into All Types of Health Care While Respecting
Traditional Knowledge Systems - Increase the Availability of Ethics Training in Ayurveda Education and Workforce
- Creation of National Standards for the Maintenance of Patient Records and Clinical
Documentation - Greater Coordination between AYUSH Regulators and Agencies Responsible for Consumer
Protection.
CONCLUSION
The importance of Ayurveda in India’s health care system and cultural identity will remain as long as there are strong legal and ethical protections. In order for traditional medical systems to continue to be recognized as both legitimate and sustainable in the 21st century, and to serve as responsible health care providers, they must operate within a framework that values patient autonomy, accountability, transparency, and safety.
India has made gains in its ability to regulate Ayurveda through formalized legislative changes and the establishment of institutional regulations. However, serious issues remain regarding issues such as professional liability, informed consent, advertisements, and safeguarding patients. Overall, these issues could benefit from more relevant legislation and policy. The experience of other places provides that successfully regulating traditional medicine is not necessarily detrimental to the body of evidence that supports it. Instead, good governance of traditional healing methods and their practitioners could contribute to enhancing public trust and improving Ayurveda’s role in today’s health care system.
REFERENCES
1.The National Commission for Indian System of Medicine Act, 2020, No. 14 of 2020, Government of India.
2. World Health Organization, WHO Benchmarks for the Practice of Ayurveda (WHO, Geneva, 2022).
3. World Health Organization, WHO Global Centre for Traditional Medicine Strategy 2025–2034: Draft for Consultation (WHO, Geneva, 2025).
4. The Consumer Protection Act, 2019, No. 35 of 2019, Government of India.
5. Ministry of AYUSH, Government of India, Annual Report 2022–2023 (New Delhi, 2023).
6. World Health Organization, WHO Traditional Medicine Strategy 2014–2023 (WHO, Geneva, 2013).
7. G. Bodeker & F. Kronenberg, “A Public Health Agenda for Traditional, Complementary, and Alternative Medicine,” 92(10) American Journal of Public Health 1582–1591 (2002).
8. B. Patwardhan, A.D.B. Vaidya & M. Chorghade, “Ayurveda and Natural Products Drug Discovery,” 86(6) Current Science 789–799 (2004).
9. D. Shankar & B. Patwardhan, “AYUSH for New India: Vision and Strategy,” 8(3) Journal of Ayurveda and Integrative Medicine 137–139 (2017).
10. World Health Organization, Global Report on Traditional and Complementary Medicine (WHO, Geneva, 2023).
+919458479236
Questions of medical negligence have acquired increasing importance in India as healthcare has moved into a more rights-conscious and legally supervised environment.… Continue reading
Waste generation has emerged as one of the most serious environmental challenges facing India today. Population growth, rapid urbanization, and increasing consumption patterns have… Continue reading
Environmental protection has become a global priority as industrialization and urban development continue to expand rapidly. Industries contribute significantly to economic growth… Continue reading