Ayurveda practice needs to be regulated and monitored on the basis of prescribed standards and quality control parameters with regard to:
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.
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:
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.
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:
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:
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:
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 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):
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:
© 2022. All Rights Reserved. NIMA TS & AP