Clinical trial of new drug or investigational new drug (Rule 19)
(1) No person or institution or organisation shall conduct clinical trial of a new drug or investigational new drug,—
(i) except in accordance with the permission granted by the Central Licencing Authority; and
(ii) without the protocol thereof having been approved by the Ethics Committee for clinical trial registered in accordance with the provisions of rule 8.
(2) Every person associated with the conduct of clinical trial of a new drug or investigational new drug shall follow the general principles and practices as specified in the First Schedule.
(3) No person or institution or organisation shall conduct clinical trial of a new drug or investigational new drug except in accordance with the procedure prescribed under the provisions of the Act and these rules.
Application for permission to conduct clinical trial of a new drug or investigational new drug (Rule 21)
(1) Any person or institution or organisation which intends to conduct clinical trial of a new drug or an investigational new drug shall make an application to the Central Licencing Authority duly filled in Form CT-04.
(2) The application made under sub-rule (1) shall be accompanied with the information and documents as specified in the Second Schedule and fee as specified in the Sixth Schedule:
PROVIDED that no fee shall be payable for conduct of a clinical trial by a person of an institution or organisation funded or owned, wholly or partially by the Central Government or by a State Government.
Grant of permission to conduct clinical trial (Rule 22)
(1) The Central Licencing Authority may, after scrutiny of the information and documents furnished with the application in Form CT-04 and such further enquiry, if any, as may be considered necessary—
(i) if satisfied, that the requirements of these rules have been complied with, grant the permission to conduct clinical trial for a new drug or investigational new drug in Form CT-06;
(ii) in case, where the Central Licencing Authority considers that there are some deficiencies in the application and the same may be rectified, the said Authority shall inform the applicant about the deficiencies;
(iii) if not satisfied that the requirements of these rules have been complied with, reject the application, for the reasons to be recorded in writing.
(2) The decision under sub-rule (1) shall be taken within ninety working days. Provided that, where no communication has been received from the Central Licensing Authority within the said period of ninety working days, the permission to conduct all clinical trial shall be deemed to have been granted by the Central Licensing Authority and such permission shall be deemed to be legally valid for all purposes and the applicant shall be authorised to initiate clinical trial in accordance with these rules.
(2A) The applicant who has got deemed approval under the proviso to sub-rule (2) shall, before initiating the clinical trial, inform the Central Licensing Authority in Form CT-06A and the Central Licensing Authority shall on the basis of the said information, take on record the Form CT-06A which shall become part of the official record and shall be called deemed approval of the Central Licensing Authority.
(3) The applicant, after being informed, as referred to in clause (ii) of subrule (1), by the Central Licencing Authority, may—
(i) rectify the deficiencies within a period specified by the Central Licencing Authority;
(ii) where the applicant rectifies the deficiency, as referred in sub-rule (1), and provides required information and documents, the Central Licencing Authority shall scrutinize the application again and if satisfied, grant permission to conduct clinical trial of the new drug or investigational new drug, or if not satisfied, reject the application within a period of ninety days reckoned from the day when the required information and documents were provided:
PROVIDED that in case of rejection, the applicant may request the Central Licencing Authority, to reconsider the application within a period of sixty working days from the date of rejection of the application on payment of fee as specified in the Sixth Schedule and submission of required information and documents.
(4) An applicant who is aggrieved by the decision of the Central Licencing Authority under sub-rule (1) or sub-rule (3), may file an appeal before the Central Government in the Ministry of Health and Family Welfare within forty-five days from the date of receipt of such decision and that the Government, may, after such enquiry, and after giving an opportunity of being heard to the appellant, dispose of the appeal within a period of sixty working days.
Conditions of permission for conduct of clinical trial (Rule 25)
The permission granted by the Central Licencing Authority to conduct clinical trial under this Chapter shall be subject to following conditions, namely:—
(i) clinical trial at each site shall be initiated after approval of the clinical trial protocol and other related documents by the Ethics Committee of that site, registered with the Central Licencing Authority under rule 8;
(ii) where a clinical trial site does not have its own Ethics Committee, clinical trial at that site may be initiated after obtaining approval of the protocol from the Ethics Committee of another trial site; or an independent Ethics Committee for clinical trial constituted in accordance with the provisions of rule 7:
PROVIDED that the approving Ethics Committee for clinical trial shall in such case be responsible for the study at the trial site or the centre, as the case may be:
PROVIDED FURTHER that the approving Ethics Committee and the clinical trial site or the bioavailability and bioequivalence centre, as the case may be, shall be located within the same city or within a radius of 50 kms of the clinical trial site;
(iii) in case an ethics committee of a clinical trial site rejects the approval of the protocol, the details of the same shall be submitted to the Central Licensing Authority prior to seeking approval of another Ethics Committee for the protocol for conduct of the clinical trial at the same site;
(iv) the Central Licencing Authority shall be informed about the approval granted by the Ethics Committee within a period of fifteen working days of the grant of such approval;
(v) clinical trial shall be registered with the Clinical Trial Registry of India maintained by the Indian Council of Medical Research before enrolling the first subject for the trial;
(vi) clinical trial shall be conducted in accordance with the approved clinical trial protocol and other related documents and as per requirements of Good Clinical Practices Guidelines and the provisions of these rules;
(vii) status of enrolment of the trial subjects shall be submitted to the Central Licencing Authority on quarterly basis or as appropriate as per the duration of treatment in accordance with the approved clinical trial protocol, whichever is earlier;
(viii) six monthly status report of each clinical trial, as to whether it is ongoing, completed or terminated, shall be submitted to the Central Licencing Authority electronically in the SUGAM portal;
(ix) in case of termination of any clinical trial the detailed reasons for such termination shall be communicated to the Central Licencing Authority within thirty working days of such termination;
(x) any report of serious adverse event occurring during clinical trial to a subject of clinical trial, shall, after due analysis, be forwarded to the Central Licencing Authority, the chairperson of the Ethics Committee and the institute where the trial has been conducted within fourteen days of its occurrence as per Table 5 of the Third Schedule and in compliance with the procedures as specified in Chapter VI;
(xi) in case of injury during clinical trial to the subject of such trial, complete medical management and compensation shall be provided in accordance with Chapter VI and details of compensation provided in such cases shall be intimated to the Central Licencing Authority within thirty working days of the receipt of order issued by Central Licencing Authority in accordance with the provisions of the said Chapter;
(xii) in case of clinical trial related death or permanent disability of any subject of such trial during the trial, compensation shall be provided in accordance with Chapter VI and details of compensation provided in such cases shall be intimated to the Central Licencing Authority within thirty working days of receipt of the order issued by the Central Licencing Authority in accordance with the provisions of the said Chapter;
(xiii) the premises of the sponsor including his representatives and clinical trial sites, shall be open for inspection by officers of the Central Licencing Authority who may be accompanied by officers of the State Licencing Authority or outside experts as authorised by the Central Licencing Authority, to verify compliance of the requirements of these rules and Good Clinical Practices Guidelines, to inspect, search and seize any record, result, document, investigational product, related to clinical trial and furnish reply to query raised by the said officer in relation to clinical trial;
(xiv) where the new drug or investigational new drug is found to be useful in clinical development, the sponsor shall submit an application to the Central Licencing Authority for permission to import or manufacture for sale or for distribution of new drug in India, in accordance with Chapter X of these rules, unless otherwise justified;
(xv) the laboratory owned by any person or a company or any other legal entity and utilised by that person to whom permission for clinical trial has been granted used for research and development, shall be deemed to be registered with the Central Licensing Authority and may be used for test or analysis of any drug for and on behalf of Central Licensing Authority;
(xvi) the Central Licencing Authority may, if considered necessary, impose any other condition in writing with justification, in respect of specific clinical trials, regarding the objective, design, subject population, subject eligibility, assessment, conduct and treatment of such specific clinical trial;
(xvii) the sponsor and the investigator shall maintain the data integrity of the data generated during clinical trial
Validity period of permission to initiate a Clinical Trial (Rule 26)
The permission to initiate clinical trial granted under rule 22 in Form CT-06 or automatic approval under rule 23 in Form CT 4A shall remain valid for a period of two years from the date of its issue, unless extended by the Central Licencing Authority.
Suspension or cancellation of permission to conduct clinical trial (Rule 30)
(1) Where any person or institution or organisation to whom permission has been granted under rule 22 in Form CT-06 or rule 23 in Form CT-4A fails to comply with any provision of the Act and these rules, the Central Licencing Authority may, after giving an opportunity to show cause and after affording an opportunity of being heard, by an order in writing, take one or more of the following actions, namely:—
(i) issue warning in writing describing the deficiency or defect observed during inspection or otherwise, which may affect adversely the right, or well- being of a trial subject or the validity of clinical trial conducted;
(ii) reject the results of clinical trial;
(iii) suspend for such period as considered appropriate or cancel the permission granted under rule 22 in Form CT-06 or rule 23 in Form CT-4A;
(iv) debar the investigator or the sponsor including his representatives to conduct any clinical trial in future for such period as considered appropriate by the Central Licencing Authority.
(2) Where a person or an institution or an organisation to whom permission has been granted under rule 22 in Form CT- 06 or rule 23 in Form CT-4A or the sponsor is aggrieved by the order of the Central Licencing Authority, the person or the institution or the organisation may, within a period of sixty working days of the receipt of the order, make an appeal to the Central Government and that Government may, after such enquiry, as deemed necessary, and after affording an opportunity of being heard, pass such order in relation thereto as may be considered appropriate in the facts and circumstances of the case.
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