The Ministry of Health and Family Welfare issued a notification on 14th October 2022 in notification no. GSR 778 (E) informed about the amendment of the New Drugs and Clinical Trials (Third Amendment) Rules, 2022. The draft for the same amendment was notified vide notification no. GSR 32 (E ) dated 21st January 2022, which has subsequently been finalised into this amendment.
Overview of the New Drugs and Clinical Trials Rules, 2019
The New Drugs and Clinical Trials Rules, 2019, were introduced on 19th march 2019 by the Indian Government. The new rules have specific requirements for the ethics committee or EC. As per the new rules, the EC must follow the rules accordingly and is required to forward the report to the Central Licensing Authority (CLA). The rules are applied to all the new drugs Investigational new drugs for humans, bioequivalence study, clinical trial, bioavailability study and ethics committed.
Amendments in New Drugs and Clinical Trials Rules, 2019
The New Drugs and Clinical Trials (Third Amendment) Rules, 2022, were introduced to make further amendments to the New Drugs and Clinical Trials Rules, 2019. New provisos have been inserted through the recent amendment, which is as follows-
In Rule 8 (3) (ii), the following proviso has been inserted-
“The registration of the Ethics Committee would be deemed to be granted by the Central Licensing Authority and would be legally valid for all purposes; provided, however, that the applicant will be authorised to initiate clinical trials in accordance with these rules if In the specified forty-five working day period, the Central Licensing Authority has not communicated with anyone.”
In Principal rules, Rule 8(3), the following proviso has been inserted-
“(3A) Before the Ethics Committee begins its duties, the applicant who has received deemed approval under the proviso to clause (ii) of sub rule (3) must notify the Central Licensing Authority in Form CT-02A. Based on the information provided, the Central Licensing Authority shall record the Form CT-02A, which will be a part of the official record and be referred to as deemed registration of the Central Licensing Authority.”
In Principal rules, Rule 22(2), the following proviso has been inserted-
“The Central Licensing Authority shall be deemed to have granted permission to conduct all clinical trials, and those permission shall be known to be legally valid for all purposes; provided, however, that If the Central Licensing Authority does not communicate with the applicant within the 90 working day period, the applicant is permitted to begin clinical trials in accordance with these rules.”
“(2A) Before beginning the clinical trial, the applicant who has received deemed approval under the proviso to subrule (2) must notify the Central Licensing Authority in Form CT-06A. The Central Licensing Authority will then, based on the information provided, take a record of the Form CT-06A, which will become a part of the official record and be referred to as the Central Licensing Authority’s deemed approval.”
In Principal rules, Rule 24, the following proviso has been inserted-
“The Central Licensing Authority shall be deemed to have granted permission to conduct all clinical trials, and such permission shall be known to be legally valid for all purposes; provided, however, that the applicant shall be authorised to initiate a clinical trial in accordance with these rules if the Central Licensing Authority has not sent any communication within the period of ninety working days: Furthermore, the applicant who received deemed approval under this rule must notify the Central Licensing Authority in Form CT-06A prior to beginning the clinical trial. The Central Licensing Authority will then, based on the information provided, record the Form CT-06A, which will be a part of the official record and be referred to as the Central Licensing Authority’s deemed approval.”
In Principal rules, Rule 34 (2), the following proviso has been inserted-
“The applicant will be permitted to begin the study under the Central Licensing Authority’s guidelines if the Central Licensing Authority does not communicate with the applicant within the period as mentioned earlier of ninety working days, and the permission to conduct a bioequivalence or bioavailability study of the investigational new drug or a new drug shall be presumed to have been granted by the Central Licensing Authority.”
“(2A) Before starting a bioavailability or bioequivalence study of investigational new drug or a new drug, the applicant who has received deemed approval under the proviso to subrule (2) must notify the Central Licensing Authority in Form CT-07A. The Central Licensing Authority will then, based on the said information, take Form CT-07A on record, which will become a part of the official record and be referred to as the Central Licensing Authority.”
In Principal rules, Rule 53, the following proviso has been inserted-
(1)-“The Central Licensing Authority shall be deemed to have granted the permission to manufacture investigational new drugs or new drugs for clinical trials, bioavailability or bioequivalence studies, test and analyses, and such permission shall be presumed to be granted by the Central Licensing Authority, and the applicant shall be authorised, If the Central Licensing Authority does not communicate with the applicant within the period of ninety working days.”
(2)-“The Central Licensing Authority shall be deemed to have granted the permission to manufacture investigational new drugs or new drugs for clinical trials, bioavailability or bioequivalence studies, test and analyses, provided that the Central Licensing Authority does not communicate with the applicant within said period of ninety working days. In this case, the applicant shall be authorised and the permission shall be known to have been granted by the Central Licensing Authority.”
(2A)-“Before manufacturing new drugs or investigational new drugs for the aforementioned purposes, an applicant who has received deemed approval under the proviso to subrules (1) and (2) must notify the Central Licensing Authority in Form CT-11A. Based on the information provided, the Central Licensing Authority will then take the Form CT-11A on record, which will become a part of the official record and be referred to as the Central Licensing Authority’s deemed approval.”
In Principal rules, Rule 60, the following proviso has been inserted-
(1)- “Provided, however, that permission to manufacture an unapproved active pharmaceutical ingredient or a pharmaceutical formulation for testing, analysis, clinical trials, or bioavailability and bioequivalence studies shall be granted by the Central Licensing Authority and shall be legally valid for all purposes where the Central Licensing Authority does not communicate with the applicant within the aforementioned period of ninety working days.”
(2) (ii) –With the caveat that permission to manufacture an unapproved active pharmaceutical ingredient or to manufacture pharmaceutical formulation for testing, analysis, clinical trials, or bioavailability and bioequivalence studies shall be presumed to have been granted by Central Licensing Authority and shall be deemed to be valid for all purposes, provided that the Central Licensing Authority does not communicate with the applicant within the said period of ninety working days.
Furthermore, if the application is rejected, the applicant may ask the Central Licencing Authority to reevaluate it within 60 days of the rejection date by paying the fee outlined in the Sixth Schedule and submitting the necessary paperwork.’
(2A) – “Before manufacturing an unapproved active pharmaceutical ingredient or its pharmaceutical formulation for the aforementioned purposes, the applicant who has received deemed approval under proviso to rule (1) shall notify the Central Licensing Authority in Forms CT-15A and CT-14A, respectively. The Central Licensing Authority shall then, based on the said information, take on record the Forms CT-15A and CT-14A, which shall be a part of official record and shall be known as deemed.”
New forms inserted in New Drugs and Clinical Trials (Third Amendment) Rules, 2022
The New Drugs and Clinical Trials (Third Amendment) Rules, 2022 has made various amendments to the New Drugs and Clinical Trials Rules 2019. The new amendment has inserted new forms, which are as follows-
FORM CT-02A–
The New Drugs and Clinical Trials (Third Amendment) Rules, 2022 have inserted form CT-02A after the form CT-02 in the eighth schedule of the act for Information to Initiate the Functioning of Ethics Committee Relating to Bioavailability and Bioequivalence Study or Clinical Trial.
FORM CT-06A
The New Drugs and Clinical Trials (Third Amendment) Rules, 2022 have inserted form CT-06A after form CT-06 for Information to Initiate Clinical Trial of Investigational New Drug or New Drug.
FORM CT-07A
The New Drugs and Clinical Trials (Third Amendment) Rules, 2022 have inserted form CT-07A after form CT-07 for Information to Initiate Bioavailability or Bioequivalence Study of Investigational New Drug or New Drug.
Form CT-11A
The New Drugs and Clinical Trials (Third Amendment) Rules, 2022 have inserted form CT-11A after form CT-11 for Information to Manufacture Investigational New Drug or New Drug for Bioavailability or Bioequivalence Study or Examination, Clinical Trial, Test and Analysis.
Form CT-14A
The New Drugs and Clinical Trials (Third Amendment) Rules, 2022 have inserted form CT-14A after form CT-14 for Information to Manufacture the Formulation of Unapproved Active Pharmaceutical Ingredient for Bioavailability or Bioequivalence Study or Test or Analysis or Clinical Trial.
Form CT-15A
The New Drugs and Clinical Trials (Third Amendment) Rules, 2022 have inserted form CT-15A after form CT-15 for Information to Manufacture Unapproved Active Pharmaceutical Ingredients for Development of Formulation for Bioavailability or Bioequivalence Study or Test or Analysis or Clinical Trial.
Conclusion
The New Drugs and Clinical Trials[1] (Third Amendment) Rules, 2022 was notified by Ministry of Health and Family Welfare on 14th October 2022, which was intended for the amendment of the New Drugs and Clinical Trials Rules, 2019. The amendment introduced various new rules and regulations regarding New Drugs and Clinical Trials.
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