Background:
The new Drugs and Clinical Trial Rules, 2019 have been published with effect from 19th March 2019 with a view to regulate New Drugs, Investigational New Drugs for human use, Clinical trials, bioequivalence study, bioavailability, and ethics committee. The Rules provide various Forms for submission of application and grant of approvals of various categories of new drugs and clinical use. Earlier, the applications for approval of New Drugs, Investigational New Drugs for human use, Clinical trials, bioequivalence study, bioavailability, and ethics committee were required to be submitted as per the provisions prevalent in the Drugs and Cosmetics Rules, 1945.
Key Changes in Clinical Trial’s Rules
A. Ethics Committee
- The Ethics Committee shall consist of at least fifty percent of its members who are not affiliated with the institute or organization in which such committee is constituted.
- The Ethics committee registration shall be granted in Form CT-02 within a period of 45 working days.
- The registration granted in Form CT-02 shall remain valid for a period of three years from the date of its issue unless suspended or canceled by the Central Licensing Authority
B. Clinical Trial of New Drugs and Investigational New Drugs
- Any person or institution or organization which intends to conduct clinical trial of a new drug or an investigational new drug shall make an application to the Central Licensing Authority duly filled in Form CT-04.
- if satisfied, that the requirements of these rules have been complied with, CDSCO shall grant the permission to conduct clinical trial for a new drug or investigational new drug in Form CT-06
- In case of rejection, the applicant may request the Central Licensing 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.
- An applicant who is aggrieved by the decision of the Central Licensing Authority under the Ministry of Health and Family Welfare may file an appeal before the Central Government within forty-five days from the date of receipt of such decision and the Government, may, after such inquiry, and after giving an opportunity of being heard to the appellant, dispose of the appeal within a period of sixty days.
- Permission to conduct clinical trial of a new drug or investigational new drug as part of discovery, research, and manufacture 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 Licensing Authority within a period of thirty working days from the date of the receipt of the application
- Provided that, where no communication has been received from the Central Licensing Authority to the applicant within the said period, the permission to conduct clinical trial shall be deemed to have been granted by the Central Licensing Authority and such permission shall be deemed legally valid for all purposes and the applicant shall be authorized to initiate clinical trial under these rules.
- The applicant who has taken deemed approval under sub-rule (1) shall before initiating the clinical trial inform the Central Licensing Authority in Form CT-4A. On the basis of the said information, the Central Licensing Authority shall take on record the Form CT-4A which shall become part of the official record and shall be called automatic approval of the Central Licensing Authority.
- Permission to conduct clinical trial of a new drug already approved outside India: The application shall be disposed of by way of grant of permission or rejection or processed by way of communication to rectify any deficiency, as the case may be, as specified in rule 22, by the Central Licensing Authority within a period of ninety days from the date of the receipt of the application by the said Authority.
