The New Drugs and Clinical Trial Rules, 2019 is a set of regulations introduced by the Ministry of Health and Family Welfare in India to govern the clinical trial of drugs, medical devices, and other related products. The rules replace the previous regulations that were in place since 2013. The New Drugs and Clinical Trials (Third Amendment) Rules, 2022 is a set of regulations introduced by the Ministry of Health and Family Welfare in India to further streamline and improve the clinical trial process in the country. These rules amend the existing New Drugs and Clinical Trial Rules, 2019.
1) Rule 8: Registration of Ethics Committee relating to clinical trial, bioavailability and bioequivalence study
Rule 8 of New Drugs and Clinical Trial Rules, 2019 talks about Registration of Ethics Committee relating to clinical trial, bioavailability and bioequivalence study. Every committee has to make an application for getting themselves registered under Central Licencing Authority under Form CT-01.
By means of the Amendment, a Rule 8(3) has been added which mentions that the Central Licensing Authority shall scrutinize the application and accordingly must reject or accept the registration of Ethics committee., If the authority does not communicate about status of registration, the applicant can start with the clinical trial after a period of forty-five days from the date of the application.
Proviso inserted under Rule 8(3) states that after registration of the applicant and before initiating the duties, it should be notified through Form CT-02A to Central Licensing Authority, which will be an official record of registration under Central Licensing Authority.
2) Rule 22: Grant of permission to conduct clinical trial.
Rule 22 states that after the scrutiny of the documents and the information the authority accordingly grants the permission furnished under Form-CT-04, further the reasons are also to be recorded by the authority for the same.
Further, the rule 2A has been inserted with the amendment, which states that the applicant, after getting the deemed approval of the committee under this rule and before initiating a clinical trial, must inform the committee to officially take on record the deemed approval with Form CT-06A.
It further states that the Authority must grant permission to conduct clinical trial of the applicant within ninety days. Proviso inserted thereunder states that if the Central Licensing Authority does not communicate to the applicant regarding the permission, such applicant canstart conducting Clinical trials after ninety days.
3) Rule 24: Permission to conduct clinical trial of a new drug already approved outside India
Rule 24 states that when a person or institution or organisation makes an application under rule 21 to conduct a clinical trial of a new drug already approved outside India, the same shall be disposed of by way of permission or rejection or rectification.
In this rule the proviso clause has been added, which states that the Central Licensing Authority communicates the approval of permission or rejection within ninety days of receipt of application. The applicant can further initiate clinical trial of this new drug if no communication is made from the side of authority as it will be considered deemed granted.
If approval is granted the applicant should further notify the authority with Form CT-06A which will be an official record and referred to by Central Licensing Authority as official approval.
4) Rule 34: Grant of permission to conduct bioavailability or bioequivalence study
Rule 34 states that the central authority, after the scrutiny of the document under Form CT-05 shall make further enquiry, if any, as may be deemed necessary by the authority.
By means of the amendment, Rule (2A) hasbeen inserted, which states that if applicant has received the deemed approval beforeproceeding with the same, such applicant has to notify the Central Licensing Authority in Form CT- 07A so as to be taken on record officially and shall be considered a deemed approval.
For this the proviso is also inserted, that the Central Licensing Authority has to communicate the Grant of permission to conduct bioavailability or bioequivalence study of new drug or investigation of new drug will be considered deemed approved until the specific rejection within ninety days communicated to the applicant and such permission will be considered valid to proceed with the study according to the rules prescribed.
5) Rule 53: Grant of permission to manufacture new drugs or investigational new drugs for clinical trial or bioavailability or bioequivalence study, or for examination, test and analysis
The Central Authority after the scrutiny of the information and the given document under Form CT-10, shall conduct enquiry, if any, as may be deemed necessary by the authority.
The amendment of the rule was regarding the time period for the consideration of approval or rejection of the given information and document which must be communicated within ninety days or else the applicant can presume the approval of Central Licensing Authority.
In case of any deficiencies in the application it should be rectified, approved or disapproved by Central Licensing Authority in ninety days failing to which the applicant may presume the approval of permission.
If the Central Licensing Authority has approved the grant to manufacture new investigational drugs for clinical trial or bioavailability or bioequivalence study the applicant should notify the authority through Form CT-11A which will be an official record and can be referred to as official approval by the authority.
6) Rule 60: The grant of permission to manufacture unapproved active pharmaceutical ingredient for development of pharmaceutical formulation for test, analysis, clinical trial, bio-availability and or bioequivalence study.
In this rule the Scrutiny of the application under Rule 59 in Form CT-12 or CT-13, will take place.
The approval or rejection of permission (also rectification) must be communicated within ninety days after receiving the application failing to which the applicant may presume the approval of permission.
If the application is rejected the applicant may send another application for revaluation to the Central Licensing Authority within 60 days with prescribed fees with necessary paperwork and payment of fees as specified under schedule six of the rules.
If approval is granted, before initiating manufacturing of unapproved active pharmaceutical ingredient the applicant has to notify the Central Licensing Authority in Form CT-15A (for manufacturing) and CT-14A (for developing) so the authority can keep a record of approval.
These rules are expected to enhance the quality of clinical trials in India and attract more investment from global pharmaceutical companies. However, it’s important to note that regulations related to drugs and clinical trials are subject to change and evolve over time based on new scientific discoveries, regulatory considerations, and public health priorities. Therefore, it’s important to check with official government sources or legal experts for the most up-to-date information on any changes to the rules and their implications.