The Ministry of Health and Family Welfare on January 21, 2022 has issued the New Drugs and Clinical Trials (......Amendment) Rules, 2022 to amend the New Drugs and Clinical Trials Rules, 2019.
The following amendment have been made:
• In rule 8, in subrule 3(ii), at the end, the following Proviso shall be inserted, namely:
Provided that, where no communication has been received from the Central Licensing Authority to the applicant within the forty-five working days period, the registration of ethics committee shall be deemed to have been granted by the Central Licensing Authority and such registration shall be deemed to be legally valid for all purposes and the applicant shall be authorized to initiate clinical trial in accordance with these rules.
• In rule 8, after sub-rule 3, the following sub-rule shall be inserted, namely:
(3A) The applicant who has taken deemed approval under the Proviso to sub-rule 3(ii) shall before initiating the functions of the Ethics Committee, inform the Central Licensing Authority in Form CT-02A and the Central Licensing Authority shall on the basis of the said information, take on record the Form CT-02A which shall become part of the official record and shall be called deemed registration of the Central Licensing Authority.
• In rule 22, in sub-rule (2), the following proviso shall be inserted, namely:
Provided that, where no communication has been received from the Central Licensing Authority to the applicant within the ninety working days period, 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 authorized to initiate clinical trial in accordance with these rules.
• In rule 22, after sub-rule (2), the following sub-rule shall be inserted, namely:
(2A) The applicant who has taken 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.
• In rule 24, the following proviso shall be inserted, namely:—
Provided that, where no communication has been received from the Central Licensing Authority to the applicant within the ninety working days period, 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 authorized to initiate clinical trial in accordance with these rules:
Provided further that the applicant who has taken deemed approval under this rule 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.
• In rule 34, in sub-rule (2), the following Proviso shall be inserted, namely:—
Provided that, where no communication has been received from the Central Licensing Authority to the applicant within the ninety working days period, the permission to conduct bioavailability or bioequivalence study of the new drug or investigational new drug 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 authorized to initiate such study in accordance with these rules.
• In rule 34, after sub-rule (2), the following sub-rule shall be inserted, namely:—
(2A) The applicant who has taken deemed approval under the proviso to sub-rule (2) shall before initiating bioavailability or bioequivalence study of the new drug or investigational new drug, inform the Central Licensing Authority in Form CT-07A and the Central Licensing Authority shall on the basis of the said information, take on record the Form CT-07A which shall become part of the official record and shall be called deemed approval of the Central Licensing Authority.
• In rule 53, in sub-rule(1) and sub-rule (2), the following Proviso shall be inserted, namely:—
Provided that, where no communication has been received from the Central Licensing Authority to the applicant within the period of ninety working days, the permission to manufacture new drugs or investigational new drugs for clinical trial or bioavailability or bioequivalence study or test and analysis 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 authorized to manufacture the new drug or investigational new drug for said purposes in accordance with these rules.
• In rule 53, after sub-rule (2), the following sub-rule shall be inserted, namely:—
(2A) The applicant who has taken deemed approval under the proviso to sub-rule (1) and sub-rule (2) shall before manufacturing the new drug or investigational new drugs for the said purposes inform the Central Licensing Authority in Form CT-11 A and the Central Licensing Authority shall on the basis of the said information, take on record the Form CT-11A which shall become part of the official record and shall be called deemed approval of the Central Licensing Authority.
• In rule 60, in sub-rule (1)(ii), following proviso shall be inserted, namely:—
Provided that, where no communication has been received from the Central Licensing Authority to the applicant within the period, to manufacture unapproved active pharmaceutical ingredient for development of pharmaceutical formulation for test or analysis or clinical trial or bioavailability and bioequivalence study 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 authorized to manufacture the new drug or investigational new drug for said purposes in accordance with these rules.
• In rule 60, in sub-rule (2)(ii), for the proviso attached thereto, the following shall be substituted, namely:—
Provided that, where no communication has been received from the Central Licensing Authority to the applicant within the period, to manufacture unapproved active pharmaceutical ingredient for development of pharmaceutical formulation for test or analysis or clinical trial or bioavailability and bioequivalence study 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 authorized to manufacture the new drug or investigational new drug for said purposes in accordance with these rules.
Provided further that in case of rejection, the applicant may request the central Licencing Authority, to consider the application within a period of sixty 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.
• In rule 60, after sub-rule (2), the following sub-rule shall be inserted, namely:—
(2A) The applicant who has taken deemed approval under the proviso to sub-rule (1) shall before manufacturing the new drug or investigational new drugs for the said purposes inform the Central Licensing Authority in Form CT-15A and the Central Licensing Authority shall on the basis of the said information, take on record the Form CT-15A which shall become part of the official record and shall be called deemed approval of the Central Licensing Authority.
[Notification No. G.S.R. 32(E)]
