Regulation for Conducting trial for New Drug in India

Definition: ) “academic clinical trial” means a clinical trial of a drug already approved for a certain claim and initiated by any investigator, academic or research institution for a new indication or new route of administration or new dose or new dosage form, where the results of such a trial are intended to be used only for academic or research purposes and not for seeking approval of the Central Licencing Authority or regulatory authority of any country for marketing or commercial purpose;

Regulations:

1. Whoever intends to conduct clinical trial or bioavailability study or bioequivalence study shall be required to have approval of an Ethics Committee for clinical trial registered under rule 8.
2. No person or institution or organisation shall conduct clinical trial of a new drug or investigational new drug, except in accordance with the permission granted by the Central Licencing Authority; and without the protocol thereof having been approved by the Ethics Committee for clinical trial registered in accordance with the provisions of rule 8

Application for permission to conduct clinical trial of new drug or investigational new drug: (Rule 21 & 22 of the guidance)

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 formation and documents as specified in the Second Schedule and fee as specified in the Sixth Schedule:
3. 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.
4. 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;
5. 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;

Permission to conduct clinical trials of new drug/ investigational new drug: (Rule 23 of the Guidance)

1. Notwithstanding anything contained in these rules, where any person or institution or organisation make an application under rule 21 to conduct clinical trial of a new drug or an investigational new drug which is complete as per these rules and fulfills the following conditions, namely:
2. the drug is discovered in India; or
3. research and development of the drug are being done in India and also the drug is proposed to be manufactured and marketed in India, such application shall be disposed by way of grant of permission or rejection or processed by way of communication to rectify any deficiency of the application, as the case may be, as specified in rule 22, by the Central
4. Licencing Authority within a period of thirty working days from the date of the receipt of the application by the said authority:
5. If someone has received provisional approval according to a specific rule, they need to let the Central Licensing Authority know by filling out a form called CT-4A. The Central Licensing Authority will then review the information in that form and consider it as an automatic approval. This means that the approval is granted without the need for any additional steps, and the information becomes an official record for the authority.

Conditions of permission for conduct of clinical trials: (Rule 25 of the Guidance)

1. 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
2. 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
3. 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
4. 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
5. 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;
6. 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
7. 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;
8. 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;
9. 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
10. 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
11. 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

Validity of permission to initiate a clinical trials:

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