In exercise of the powers conferred under clause e of sub section 2 of section 55 of the National Commission for Indian System of Medicine Act

EXTRAORDINARY PART III—Section 4 PUBLISHED BY AUTHORITY No. 776] NEW DELHI, TUESDAY , NOVEMBER 28 , 2023/ AGRAHAYANA 7, 1945 CG-DL-E-30112023-250311 THE NATIONAL COMMISSIO N FOR INDIAN SYSTEM OF MEDICINE NOTIFICATION New Delhi, the 28th November , 2023 F. No. Sec/NCISM/Regulation/2023 -1— In exercise of the powers conferred under clause (e) of sub -section (2) of section 55 of the National Commission f or Indian System of Medicine Act, 2020 (14 of 2020), the Commission hereby makes the following regulations, namely – 1. Shot Title and Commencement . – (1) These regulations may be called the National Commission for Indian System of Medicine (Medical Research in Indian System of Medicine) Regulation, 2023. (2) They shall come into force on the date of their publication in the Official Gazette. 2. Definitions . – (1) In these regulations, unless the context otherwise requires, - (a) “Act” means the National Commissi on for Indian System of Medicine, Act, 2020 (14 of 2020); (b) “Clinical study” means research according to protocol involving one or more human participants to evaluate bio medical or health related outcomes, including int erventional studies and observational 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 revie ws of patient medical record or relevant literature; (c) “Clinical trial” means any systematic studies of existing or new Ayurveda or Unani or Siddha or Sowa - Rigpa research, investigational new drug in human participants to generate data for discovering or verifying its clinical, pharmacological, including pharmacodynamics or pharmacokinetic properties, or adverse effects with the objective of determining safety, efficacy or tolerance of the drug; (d) “Committee” means the research monitoring committee constitu ted under regulation 11 of these rules. (e) “Drug” means an Ayurveda or Unani or Siddha or Sowa -rigpa drug as per the definition given in the Drug and Cosmetic Act, 1940; (f) “Ethics committee” means the ethics committee constituted as per ethical guidelines f or bio medical research on human subject issued by any Research Council of Indian System of Medicine or Indian Council of Medical Research (ICMR); (g) “Indian System of Medicine” means Ayurveda, Unani, Siddha, Sowa -rigpa systems of medicine. (h) “Misconduct of research” means, - (i) Fabrication, falsification, plagiarism, self -plagiarism, or deception in proposing, carrying out or reporting results of research; (ii) Deliberate, dangerous or negligent deviations from accepted practices in carrying out research; (iii) Failur e to follow established protocols if this failure results in unreasonable risk or harm to humans or the environment and facilitate misconduct in research by collusion in, or concealment of, such actions by others; (iv) Intentional, unauthorized use, disclosure or removal of, or damage to, research -related property of another, including apparatus, materials, writings, data, hardware or software or any other substance(s) or device(s) used in or produced by the conduct of research; (i) “New drug” means, - (i) A drug not specified in the authoritative books of Indian System of Medicine as notified by Central Government and prepared by using such modern advances.’ with respective therapeutic clams in human being or animal. (ii) “A drug” a single or in combination of ph armacopeia Ayurveda or Unani or Siddha or Sowa - Rigpa drug intended for certain claims and proposed to be marketed with modifies or new claims including indication, roots of administration, doses and dosed form. (j) “Principal Investigator” means the investi gator who have the responsibilities to co -ordinate between the different investigators involve in a study at one site or different sites in case of multi -centre study; (k) “Protocol” means a document containing background, objective, rationale, design, metho dology including performance, management, adverse event and organisation of the trial and the conditions under which it is to be performed and managed; (l) “Research ethics” means an ethics that addresses the questions, dilemmas and issues related to the eth ical conduct of scientific research; (m) “Research in Indian System of medicine” means a scientific approach of answering research questions, solving a problem, or generating new knowledge through a systematic experimentation and or orderly collection of ancie nt literature, organisation and analysis of information with an ultimate goal of making the research useful for the society at large. Explanation .- Here “research” includes all types of researches for better academic understanding, for the advancement of I ndian System of Medicine on scientific lines, interventional or non -interventional studies; fundamental or basic research, experimental, preclinical and clinical trial’ of different phases; with one or more pre -specified outcomes measures; includes studies of interdisciplinary in nature as well as of integrative approach; Research also includes literary research regarding ancient text, menu scripts of related to Indian System of Medicine and other relevant Indian sciences. (n) “Research organisation” means a person or an organisation or hospital to whom a sponsorer may transfer or delegate one or more its functions and duties regarding conduct of research study; (2) The words and expressions used herein and not defined but defined in the Act or in the guidelines mentioned herein this regulation shall have the same meaning respectively assigned to them in the Act. 3. General Consideration. - General consideration for conducting research for Indian System of Medicine. While conducting the research all stake holders ar e expected to follow the following guidelines for ethical and scientific reasons, namely: - (a) All clinical trials related to Indian System of Medicine must be conducted in accordance with the good clinical practice guidelines issued by relevant research coun cils of Indian System of Medicine. (b) Additionally, they should not be in contravention to any of the international or national regulatory guidelines for bio medical research including but not limited to Drugs and Cosmetic Act 1940, and rules (1945) (includin g schedule Y), and applicable amendments thereafter; (c) Declaration of Helsinki (2012 or later versions, as applicable); (d) Good Clinical Practice guidelines of the Ministry of Health and Family Welfare, Government of India (2001 or later versions, as applicable ); (e) National Guidelines for Biomedical and Heath Research involving Human Participants (2017 or later versions as applicable); (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 relevant regulations and guidelines, wherever applicable; (h) For animal experiments, rule and guide lines as notified by the Committee for the Purpose of Control and supervision of Experiments on Animal, the Government of India are to be followed. 4. Registration. - All interventional clinical trials/studies shall be registered by the responsible party with Clinical Trial Registry of India (CTRI) before the enrolment of the first participant in the specific clinical trial. 5. Submission of research records. - the Commission has the power to call for all the information and documents, on online platform or in th e form and manner as specified, from the responsible party related to research trial for assessment of regulatory compliances and for any violation(s) including details of financial resources for the project. Responsible party shall submit an affidavit sta ting that submitted clinical trial information is not false or misleading. 6. Publication of research outcomes in peer -reviewed -journals. - It is advised that the researchers’ authors should publish their studies in non - predatory peer reviewed journals. 7. Patent. - It is advised that the researcher may go for patenting his innovation in place of publication if deemed fit by the researcher. 8. Research Audit. - the Commission may authorise a team of experts or third party agency for the research audit of the tria l at any time during or after the trial for which responsible party shall cooperate fully and provide logistic support as may be required by the auditors. 9. Responsible party. - The sponsor of an applicable trial will be considered the responsible party, unl ess and until the sponsor designates a qualified principal investigator of such trial if so, designated by a sponsor, grantee, contractor, or awardee as the responsible party. 10. Misconduct of research. - (A) Responsibilities of the organization conducting r esearch. - (a) it is the responsibility of the research organisation to investigate all allegations of research misconduct made against its research team in an unprejudiced manner. Findings of research misconduct would be matters for consideration under the In stitutional Ethics Committee. The 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 or r egulatory bodies in the field of research; (b) the organization should define responsibilities of each research participant in research at every level; (c) the outcome of any investigation(s) on research misconduct / non - compliance or violation of mandatory guidelines, should be essentially conveyed to the sponsor, Commission and other associated bodies in the research; (d) the Commission's research regulations clearly state that research misconduct is taken seriously in the organisation and that any member of staff raising bona fide concerns can do so confidentially, and without fear of suffering any detriment, as also that malafide allegations will invite disciplinary action. (B) Organisation's guidelines for investigating allegations of research misconduct or non -comp liance of regulatory guidelines, - (a) Each organisation must have in place formal written procedures for dealing with allegations of research misconduct against its staff and students and other researchers; (b) if required, legal advice may be sought; (c) advice of Commission may be sought on the decision of the organization; (d) declaration of independent and impartial investigation should be issued in each enquiry; (e) confidentiality should be strictly maintained; (f) all interested parties should be informed of the alleg ation(s) at an appropriate stage in the proceedings; (g) anyone accused of misconduct should have the right to respond h. (h) the allegation should be dealt with in a fair and timely manner. Proper records of the proceedings should be kept, - (i) The outcome should be made known as quickly as possible to all interested parties; (ii) Anyone found guilty of misconduct should have the right to appeal; (iii) Appropriate sanctions and disciplinary procedures should be in place for cases when the allegation is upheld; (iv) if appropriate, e fforts should be made to restore the reputation of the organization and/or accused party if the allegation is dismissed; (C) Responsibilities of the Commission: - (a) in case of direct appeal to Commission, the enquiry will be re -routed to the organization. (b) the C ommission may wish to undertake the enquiry at its level, depending on the nature of allegation(s). The organizational support for the same will be mandatory. (D) sanctions and or disciplinary actions in proven research misconduct noncompliance or violation of mandatory guidelines, shall be in proportion to the findings which may be as under on case to case basis, - (a) Warning; (b) Reprimand letter; (c) Penalty; (d) Withdrawal of grant; (e) Withdrawal of publications etc; (f) Guidelines for future monitoring; and (g) Legal action, as per expert advice. 11. Research monitoring committee for Indian System of Medicine. - (A) There shall be constituted a committee as given below to monitor the research activities in the field: - (1) Constitution of the committee to monitor the research as per the following composition. - (a) President, Board of Ayurveda – Chairman; (b) President Board of Unani Siddha and Sowa -Rigpa - Co-Chairman; (c) Director General, Central Council for Research in Ayurvedic Sciences – Member; (d) Director General, Central Council for Research in Unani Medicine - Member; (e) Director General, Central Council for Research in Siddha; and (f) One expert from basic science. 2. The Committee may, if considered necessary, with prior approval of the Chairman, Commission co -opt member(s) or invite Government or Non -Government experts) for dealing with any specific issue and problem relating to different subjects such as legal, intellectual property, basic sciences, genetics, etc. to seek their advice. 3. The Committee shall work on the agenda drawn by the Board of Ayurve da and Board of Unani, Siddha and Sowa -Rigpa. (B) Terms of reference. - (i) The term of the Committee shall be three years from the date of constitution; (ii) The Committee shall meet at least once 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 shall be borne by the Commission; (iii) The Commission will draw the standard operating procedures for the co mmittee detailing the issues of conflicts of interest, non -disclosure of deliberations and codes of conduct for the members; (iv) The Committee shall draw guidelines on specific issues as referred to it from time to time, for Indian System of Medicine research , ensuring high quality performance in terms of quantity, consistency, collaboration, quality and other aspects of excellence and ensuring highest standards of ethics and participant protection in the research domain; (v) The Committee shall have the power to appoint an arbitrator in a time bound manner to resolve conflicts between parties undertaking research, as per need of the case referred to it for consideration; (vi) The Committee shall have the power to monitor a study progress for a definite time period as p er need of the case referred to it for consideration; (vii) The committee shall give its recommendations on the research projects), referred to it by the authorities, relating to violation of the mandatory guidelines issued by the Government of India from time t o time; and (viii) The Committee shall deal with appeals of aggrieved party relating to research misconduct as referred by the Commission and shall submit report with recommendations to the Commission. 12. Funding for Research & Publication. - National Commission for Indian System Medicine may by signing Memorandum of understanding with the research Councils, Industry, Non -governmental Organisation may generate fund for research or Publication. 13. INTERPRETATION AND POWER TO RELAX. - (a) Where any doubt arises to the in terpretation of these regulations, it shall be referred to the Commission for clarification; (b) Where Commission 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 writin g, 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. PROF. (DR.) B. L. MEHRA , Secy . In-charge [ADVT. -III/4/Exty./558/2023 -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.