In exercise of the powers conferred by clause b of sub section 1 of section 10 of the National Commission for Homoeopathy Act

EXTRAORDINARY PART III—Section 4 PUBLISHED BY AUTHORITY No. 797] NEW DELHI, MON DAY , DEC EMBER 4, 2023/ AGRAHAYANA 13, 1945 CG-DL-E-05122023-250430 NATIONAL COMMISSION FOR HOMOEOPATHY NOTIFICATION New Delhi, the 1st December 2023 F.No. 3 -36/2021/NCH/HEB/R.C. —In exercise of the powers conferred by clause (b) of sub - section (1) of section (10) of the National Commission for Homoeopathy Act, 2020 (15 of 2020), the National Comm ission for Homoeopathy hereby makes the following regula tions, namely: — 1. Short Title and Commencement .—(1) These regulations may be called the National Commission for Homoeopathy (Medical Research in Homoeopathy) Regulations, 2023. (2) They shall come into force on the date of their publication in the Officia l Gazette. 2. Definitions .– (1) In these regulations, unless the context otherwise requires, – (a) “Act” means the National Commission for Homoeopathy Act, 2020 (15 of 2020); (b) “Biomedical and Health Research ” means research including studies on basic, applied and operational research designed primarily to increase the scientific knowledge about diseases and conditions (physical or socio -behavioural), their detection, cause and evolving strategi es for health promotion, prevention, or amelioration of disease and rehabilitation including clinical research; (c) “Clinical Research” means research that directly involves a particular person or group of people to study the effect of interventions, or uses materials or dat a from humans indirectly, such as their behaviour or biological samples for prevention, treatment and diagnosis of a disease condition or health disorder; (d) “Clinical study” means research according to a protocol involving one or more human participants to evaluate biomedical or health -related outcomes, including interventional studies and obse rvational studies in which the investigator does not assign human participants to interventions but observes them who have been given interventions in the course of routine clinical care, and may also include retrospective reviews of patient medical record s or relevant literature; (e) “Clinical trial” under purview of regulat ion means any systematic study of existing or new Homoeopathy drug in human participants to generate data for discovering symptomatic information under drug proving and or verifying its cl inical, pharmacological, including pharmacodynamics or pharmacokinet ics, and or adverse effects with the objective of determining safety and or efficacy of the drug; (f) “Clinical trial” of non -regulatory nature means any research or study that prospectively assigns human participants or groups of humans to evaluate the effect s on biomedical and health outcomes interventions like marketed homoeopathic drugs, public health interventions or observations durin g course of routine clinical care; (g) “Ethics Committee” means a committee responsible for the scientific and ethical review of all proposals involving human participants, their biological materials and data and is constituted as per Ethical Guidelines for Biomedical Research on Human Participants issued by the Indian Council of Medical Research, 2017 and Good Clinical Practice Guidelines for Clinical Trials in Homoeopathy published by Central Council for Research in Homoeopathy, Ministry of Ayush, Government of India; (h) “ Homoeopathic drug” includes “ any drug intended for internal or external use for diagnosis, treatment, preven tion of diseases or disorder in human beings and animals recorded in Homoeopathic proving or therapeutic efficacy an d established through clinical experience or research as described in authoritative Homoeopathic literature as may be specified from time to time by the Central Government by notification, and is manufactured in accordance with techniques of Homoeopathic pharmacy covering combination of ingredients of such Homoeopathic medicines, but does not include a medicine which is administered by injecta ble route”; (i) “investigational new drug in Homoeopathy” means new drug as defined under ‘k’ below and whose standards are drawn and is now ready for investigation in clinical trial regarding its safety and efficacy; (j) “investigator” means a person who is respo nsible for conducting clinical trial or clinical investigation at a site; (k) “new drug” means, – (i) a drug not specified in the respective authoritative books of Homoeopathy as notified by Central Government and prepared by using modern advances with respective t herapeutic claims in human beings or animals; (ii) a drug, single or in combination of pharmacopeial Homoeopathic drugs, intended for certain claims and proposed to be marketed with modified or new claims including indication, route of administration, dosage an d dosage form. (l) “Principal Investigator” means the investigator who has the responsibilities to coordinate between the different members of the research team involved in a study at a site(s); (m) “Protocol” means a document that states the background, rational e, objective(s), design, methodology, statistical considerations and organization of the trial and the conditions under which it is to be performed and managed. A list of items to be included in a homoeopathic clinical research protocol is compiled in vari ous guidelines in section 4 below. The content and format of the protocol should take into consideration the relevant regulatory requirements and the guiding principles for the trial. The term protocol, unless otherwise specified, relates to the latest ame nded version of the docum ent, in conjunction with all its appendices and enclosures; (n) “research organisation” means a person or an organisation to whom a sponsor may transfer or delegate one or more of its functions and duties regarding conduct of research study. (2) Words and expressions used herein and not defined but defined in the Act shall have the meanings respectively assigned to them in the Act. 3. Scope .– All types of research for better academic understanding; for the advancement of Homoeopathy on scientific lines; interventional or non -interventional; fundamental or basic research, experimental, preclinical and clinical trials of different phases; with one or more pre -specified outcome measures; and studies of interdisciplinary na ture or an integra tive approach. 4. Guidelines, Rules to be followed for undertaking Research in Homoeopathy .– All investigators, research organizations are expected to follow the following guidelines for ethical and scientific reasons some of which are mand atory as per not ification: (a) All clinical trials relating to Homoeopathy (homoeopathic clinical trials) must be conducted in accordance with the Good Clinical Practices of Homoeopathy. (b) Additionally, they should not be in contravention of any of the internati onal or national regulatory guidelines for bio-medical research including but not limited to Drugs and Cosmetics Act (1940), and Rules (1945) and applicable amendments thereafter. (c) Declaration of Helsinki (2013 or later versions, as applicable). (d) Good Clinical Practices Gui delines of the Ministry of Health and Family Welfare, Government of India (2001 or later versions, as applicable). (e) National Guidelines for Biomedical and Health Research Involving Human Participants (2017 or later versions as applicab le). (f) National Ethical Guidelines for Biomedical Research Involving Children (2017 or later versions as applicable). (g) Indian Council of Medical Research Policy on Research Integrity and Publication Ethics (2019 or later versions as applicable), and other rel evant regulations and guidelines, wherever applicable. (h) For animal experiments, Rules and guidelines as notified by Committee for the Purpose of Control and Supervision of Experiments on Animals, Government of India are to be followed. 5. Responsible Party .– The sponsor of an ap plicable trial will be considered the responsible party, unless a qualified principal investigator or coordinator initiates a research or trial (investigator -initiated research or trial) where she or he will be responsible and designat ed so by a grant, con tractor, or award as the responsible party. 6. Registration .– All interventional clinical trials or studies shall be registered by the responsible party with Clinical Trial Registry of India before the enrolment of the first participant in the specific cli nical trial. 7. Submission of Research Records .– The Commission has the power to call for all the information and documents, on an online platform or in the form and manner as specified, from the responsible party related to research or trial for assessmen t of regulatory compliances and for any violations including details of financial resources for the project. The responsible party shall submit an affidavit stating that the submitted clinical trial information is not false or misleading. 8. Research Audit .– The Commission can authorise a team of experts or third -party agency for the audit of the research or trial at any time during or after the trial for which the responsible party shall cooperate fully and provide logistic support as may be required by th e auditors. 9. Publication of Research in Peer -Reviewed Journals .– It is advised that authors should publish their articles in non -predatory peer -reviewed journals. 10. Misconduct of Research .– (1) Research misconduct is defined as,– (a) Fabrication, falsifica tion and plagiarism in proposing, carrying out or reporting results of research; (b) Deliberate, dangerous or negligent deviations from accepted practices in carrying out research; (c) It includes failure to follow established protocols. If this failure r esults in unreasonable risk or harm to humans or the environment and facilitates misconduct in research by collusion in, or concealment of, such actions by others; and (d) It also includes intentional, unauthorised use, disclosure or removal of, or damage to, research - related property of another, including apparatus, materials, writings, data, hardware or software or any other substances or devices used in or produced by the conduct of research. (2) Responsibilities of the organization conducting research, – (a) It is the respon sibility of the organisation to investigate all allegations of research misconduct made against its research team in an unprejudiced manner. Findings of research misconduct would also be matters for consideration under the Institutional ethics co mmittee. T he onus of disciplinary action lies on the institutional head based on the recommendations of the Institutional Ethics Committee, a copy of which should be essentially sent to the sponsor, Commission and other associated bodies related to researc h; (b) The org anisation should define the responsibilities of each participant in research at every level; (c) The outcome of any investigations on research misconduct or non - compliance or violation of mandatory guidelines should be essentially conveyed to the sp onsor, Com mission and other associated bodies related to the research; and (d) Commission’s research regulation clearly states that research misconduct should be taken seriously by the organisation and that any member of staff raising bonafide concerns can do so confide ntially without fear of suffering any detriment, as also that malafide allegations will invite disciplinary action. (3) Organisation’s guidelines for investigating allegations of research misconduct or non -compliance of regulatory guidelines, – (a) Each organisatio n shall have in place formal written procedures, complying to various rules and guidelines legally tenable for dealing with allegations of research misconduct against its staff and students and other researchers; (b) A declaration of independent and impartial investigation should be issued in each enquiry; (c) Confidentiality shall be strictly maintained; (d) The allegation shall be dealt with in a fair and timely manner. Proper records of the proceedings should be kept; (e) All interested parties shall be informed of the allegation at an appropriate stage in the proceedings; (f) The outcome shall be made known as quickly as possible to all interested parties; (g) During the period of enquiry both the whistle blower and the alleged should be protected; (h) Anyone accused of misconduct or found guilty of misconduct shall have the right to be heard and make an appeal; (i) Appropriate sanctions and disciplinary procedures should be in place as per the law for cases when the allegation is upheld; and (j) If appropriate, efforts should be made to restore the reputation of the organisation and or accused party if the allegation is dismissed. (4) Responsibilities of the Commission, – (a) In case of direct appea l to the Commission, the enquiry will be rerouted to the concerned organisation or authority; and (b) The commission may wish to undertake the enquiry at its level, depending on the nature of the allegations. The organisational support for the same shall be ma ndatory. (5) Sanctions and or disciplinary actions in proven research misconduct or non - compliance or vi olation of mandatory guidelines shall be in proportion to the findings which may be as under on case -to-case basis, – (a) Warning or Reprimand letter; (b) Penalties - Withdrawal of grant or Withdrawal of publications or as decided on case -to-case basis; (c) Guidelines for future monitoring; and (d) Legal action, as per experts advise 11. Homoeopathic Research Regulation Committee .– (1) The committee shall be constituted by the Commission as per the following composition. – a. Advisor (Homoeopathy) Ministry of Ayush – Chairman; b. Director General Central Council for Research in Homoeopathy – Member; c. Two experts from homoeopathy with a minimum of twenty years of research experience in homoeopathy in a recognised organisation or institute of the Government of India; d. One academic exper t in Homoeopathy with minimum of twenty years of teaching experience and having proven track record in research; e. One expert Bioethicist – Member; f. One expert in Bio -statistics with a minimum of twenty years of professional experience in biomedical research institution – Member; g. Two experts from Basic sciences or Pharmacy or Biotechnology or Modern Medicine or Public Health with a minimum of twenty years of professional experience in biomedical research – Member; h. One pharmaco logist with a minimum of twenty years of professional experience in pharmacological research - Member; and i. President – Homoeopathy Education Board – Convener. The Committee may, if necessary, with prior approval of the Chairman, the Commission, co - opt member(s) or invite Government or Non -Government expert(s) for dealing with any specific issue and problem relating to different subjects such as legal, intellectual property, basic sciences etc. to seek their advice. (2) Terms of reference. – (a) The term of committee shall be three years from the date of constitution; (b) The committee shall meet at least twice a year. The committee shall meet more frequently depending upon the applications submitted for consideration as per the directions of the Chairperson. Travelling allowance and sitting fee for the committee members sh all be borne by the Commission. ; (c) The Commission will draw the stand ard operating procedures for the committee detailing the issues of conflicts of interest, non -disclosure of deliberations and codes of conduct for the members; (d) The committee shall work on the agenda drawn by the homoeopathy education board; (e) The committee shall draw guidelines on specific issues as referred to it from time to time, for homoeopathic research, ensuring superior performance in terms of quantity, consiste ncy, collaboration, quality and other aspects of excellence and ensuring high est standards of ethics and participant protection; (f) The committee shall have the power to appoint an arbitrator in a time bound manner to resolve conflicts between parties underta king research, as per the need of the case referred to it for consideration; (g) The committee shall have the power to monitor a study progress for a definite time period as per the need of the case referred to it for consideration; (h) The committee shall give its recommendations on the research projects, referred to it by authorities, relating to violation of the mandatory guidelines issued by the Government of India from time to time; and (i) The Committee shall deal with appeals of aggrieved party relating to resea rch misconduct as referred by the Commission and shall submit a report with recommendations to the Commission. 12. Interpretation and Power to Relax .– (1) Where any doubt arises to the interpretation of these regulations, it shall be referred to the Commis sion for clarification. (2) Where the Commis sion is satisfied that the operation of any of these regulation causes undue hardship in any case, it may by order for the reasons recorded in writing, dispense or relax the regulation to such extent and subject to such exceptions and conditions as it may consider necessary for dealing with the case in a just and equitable manner. DR. TARKESHWAR JAIN , President, Homoeopathy Education Board [ADVT. -III/4/Exty./ 579/2023 -24] Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi -110064 and Published by the Controller of Publications, Delhi -110054.