New Delhi : The Union health ministry has issued a final notification amending the New Drugs and Clinical Trials (ND&CT) Rules 2019, to include provisions for deemed approval for various steps involved in the clinical trial for new drugs, including registration of ethics committees, conducting clinical trials and manufacturing new drugs for test or analysis or clinical trials. The move is expected to help fast-track the drug discovery and development process to the marketing stage.
The Ministry, on January 21, 2022, published a draft notification, seeking the stakeholders to submit objections and suggestions within 15 days. The objections and suggestions received from the public on the rules have been considered by the Central government before finalising the notification, it added.
According to the amendment, in the ND&CT Rules, in Rule 8, Sub Rule 3(ii), a provision shall be inserted that if there is no communication received from the Central Licensing Authority (CLA) to the applicant within the forty-five working days period, the registration of ethics committee shall be deemed to have been granted by the CLA and such registration shall be deemed to be legally valid for all purposes and the applicant shall be authorised to initiate clinical trial in accordance with these rules.
The applicant who has taken deemed approval under the above said provision shall before initiating the functions of the Ethics Committee, inform the CLA in Form CT-02A and the CLA shall on the basis of this information, take on record the Form CT-02A which shall become part of the official record and shall be called deemed registration of the CLA.
The next provision to be inserted is under Rule 22, Sub-Rule (2), wherein if there is no communication from the CLA to the applicant within the 90 working days period, the permission to conduct all clinical trial shall be deemed to have been granted by the CLA and such permission shall be deemed to be legally valid for all purposes and the applicant shall be authorised to initiate clinical trial in accordance with these rules.
In Rule 24, a provision to be added under which if there is no communication from the CLA to the applicant within 90 working days period, the permission to conduct all clinical trials shall be deemed to be legally valid for all purposes and the applicant shall be authorised to initiate clinical trials in accordance.
In Rule 34, Sub-Rule (2), a provision is added that if no communication has been received from the CLA to the applicant within the 90 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. A Sub-Rule, (2A) is proposed to be added so that the applicant who has taken deemed approval shall before initiating bioavailability or bioequivalence study of the new drug or investigational new drug, inform the CLA in Form CT-07A and the CLA shall on the basis of the said information take on record the Form which shall become part of the official record and shall be called deemed approval of the CLA.
In Rule 53, in Sub-Rule (1) and (2), a provision will be inserted under which if no communication has been received from the CLA 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 CLA and it shall be deemed to be legally valid for all purposes and the applicant shall be authorised to manufacture the new drug or investigational new drug for the said purpose, after submitting a Form CT-11A.
Similarly, under the Rule 60, Sub-Rule (1)(ii), if no communication has been received from the CLA 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 CLA and such permission shall be deemed to be legally valid for all purpose and the applicant shall be authorised to manufacture the new drug or investigational new drug for said purposes in accordance with these Rules.
In Rule 60, the Sub-Rule (2)(ii) shall also be amended, stating that in case of rejection, the applicant may request the CLA 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.
The ministry has also inserted various forms to enable the deemed approval system it is bringing in through the amendment.
