National Integrated Medical Association

Regulatory, legal and ethical aspects of Ayurveda practice

Ayurveda practice needs to be regulated and monitored on the basis of prescribed standards and quality control parameters with regard to:

  •  the training and professional competence of the Ayurveda practitioner;
  • the infrastructure, hygienic and sanitary conditions, and safety measures adopted in the clinical setting;
  • the place of administering therapeutic procedures;
  • the safety, efficacy and quality of products used in the practice;
  • the knowledge and skills of assistants and therapists;
  • compliance with professional codes of conduct, etiquette and medical ethics by the staff of the clinical establishment.

Ayurveda practice in a Member State may be facilitated by setting up an appropriate quality control mechanism. Desirable qualities of Ayurveda practice, practitioners, medicines, therapeutic devices and professional conduct based on specified benchmarks should be notified and placed in the public domain for the purpose of compliance by stakeholders.

Ayurveda practice should be monitored by regulators or administrators. Quality checks or technical audits should be carried out periodically to ensure compliance with prescribed standards and to take regulatory or corrective measures in cases of deviation.

Necessary provisions are required to prevent and rectify unwanted omissions, commissions and

violations of norms in the practice of Ayurveda. A system should also be in place to take cognizance of public complaints and incidences of irregularities and poor-quality services in Ayurveda practice and to issue alerts or warnings to such defaulters.

Licensing and registration of Ayurveda practitioners and clinical establishments

Ayurveda practitioners and Ayurveda clinical establishments should obtain licensing, registration and accreditation with the appropriate regulatory or certifying body according to the regulatory provisions of the Member State, provided such provisions are available and implemented in the Member State.

Ayurveda practitioners should be able to identify critical and emergency conditions that may arise during practice. In such a case, when their clinical skills are not enough to manage clinical emergencies, they should be able to refer the patient in a timely manner to an appropriate higher-level medical establishment with enough facilities and expertise to manage such cases. Ayurveda practitioners and members of regulatory and accreditation organizations are encouraged to read the following publications to get more insights on the subject:

  • The two-way communication mechanism between T&CM practitioners and registered medical practitioners (RMPs) in Ministry of Health (MoH) hospitals (27);
  • Ayurveda and conventional medicine: a cross-referral approach for select disease conditions (28).

Notifiable Diseases

Any notifiable disease encountered during Ayurveda practice should be notified to the appropriate authorities according to the prevalent regulations and health advisories in the Member State. The Ayurveda practitioners should be aware of, and adhere to, the observations, instructions and guidelines issued by health authorities, state administration, and professional bodies.

Pharmacovigilance

Appropriate precautions and measures must be taken to support the detection, evaluation, understanding and avoidance of adverse effects or any other medicine-related problem in Ayurveda practice.

Adverse effects must be reported within the specified timeframe to local health authorities, pharmacovigilance centers and other relevant organizations in the Member State, according to the prevalent regulatory provisions. This may also include the data and analysis report on the safety of commonly used Ayurveda medicines in the practice and the dosages and duration of their use by individual patients.

Ayurveda practitioners and members of regulatory and accreditation organizations are encouraged to read the following WHO publications for more insight:

  •  The importance of pharmacovigilance (29);
  • Safety monitoring of medicinal products: reporting system for the general public (30);
  • The safety of medicines in public health programmes: pharmacovigilance, an essential tool (31);
  • WHO guidelines on safety monitoring of herbal medicines in pharmacovigilance systems (32);
  • Key technical issues of herbal medicines with reference to interaction with other medicines (33);
  • Medication errors: technical series on safer primary care (23).

Regulatory Requirements For Research

Ayurveda practitioners engaged in clinical research activities should be knowledgeable about methodologies, guidelines and ethics of research. Research in Ayurveda should adhere to the general principles of Ayurveda medicine and follow internationally accepted modules and rules and regulations for medical research.

In addition to consulting with learned Ayurveda researchers and scholars, Member States may refer to the following WHO documents and other relevant guidelines and prevalent laws pertaining to medical research in the Member State:

  • General guidelines for methodologies on research and evaluation of traditional medicine (34);
  • Handbook for good clinical research practice (GCP): guidance for implementation (35);
  • Guideline for good clinical practice: ICH harmonised guideline (ICH GCP) (36); Standards and operational guidance for ethics review of health-related research with human participants (37);
  • Good clinical practice guidelines for clinical trials in Ayurveda, Siddha and Unani medicine (GCPASU)
    (38);
  • General guidelines for drug development of Ayurvedic formulations (39);
  • General guidelines of safety/toxicity evaluation of Ayurvedic formulations (40);
  • General guidelines for clinical evaluation of Ayurvedic interventions (41)

Principles Of Ethics Relating To Practice

Ayurveda practitioners should have knowledge of general principles of ethics to be followed in clinical practice. For more on ethics in clinical practice, see the documents referenced in Section 8.5 and the following:

  • Code of conduct for registered health practitioners (42);
  • “Putting ethical principles into clinical practice” (43);
  • “Ethical aspects of clinical practice” (44).

Practitioners should refer to relevant guidelines describing requirements for regulatory compliance with prevalent laws of the Member State pertaining to ethics in clinical practice.

The Practitioner-Patient Relationship, Rights & Privacy, And Information For Patients

The regulatory aspects relevant to the practitioner-patient relationship should be governed according to the laws and regulations prevalent in the Member State. The Ayurveda practitioner should (45):

  • be aware of the rights of patients and respect the individual rights of all people who come to the clinical establishment for care;
  • protect the rights of the patient and their family and inform them about their responsibilities during Ayurveda medicine care;
  • respect individual beliefs and values and involve the patient and their family in decision-making processes;
  • be aware that the patient and their family have the right to be informed about their health-care needs, proposed treatment and intervention plans, and the related costs and time.

The clinical practice should establish a documented process for obtaining the informed consent of the patient or their family at appropriate times during treatment, as laid down by the prevalent laws of the Member State.

The practice should provide correct and appropriate information to the patients. Ayurveda practitioners and members of regulatory and accreditation organizations are encouraged to read the following WHO and other relevant documents while developing information for patients:

  • Guidelines on developing consumer information on the proper use of traditional, complementary and alternative medicines (46);
  • Consumer guidelines for proper use of traditional and complementary medicine in Malaysia (47);
  • Patient rights and responsibility (48);
  • Public notice to consumers and stakeholders for promoting the safe use of ASU drugs (49).