The New Drug and Clinical Trials (NDCT) Rules were introduced in 2019 amending the Drugs and Cosmetics Rules 1945 and replacing Part XA and Schedule Y of the Drugs and Cosmetics Rules 1945. Several definitions such as New Drug, Investigational New Drug, Clinical Trials, Bioavailability (BA), Bioequivalence (BE), Academic Clinical Trial, BA/BE Study Centre, and Ethics Committee (EC) have been appropriately defined. The definition of New Drugs has been modified to incorporate Novel Drug Delivery Systems (NDDS), deoxyribonucleic acid (DNA) derived product, living modified organism, monoclonal antibodies, stem cell derived products, gene therapeutic products or Xenografts. The rules specify changes to the composition, membership, duties, and functioning of the EC. Increasing the percentage of non-affiliated members in the EC is intended to help decrease bias and facilitate better decision-making. It is necessary for EC members to be trained periodically on Good Clinical Practice (GCP) guidelines such that they are updated on latest regulations and changes. Other requirements are the inclusion of female members for diversity, application for registration and approval of EC with the authority designated by the Ministry of Health and Family Welfare (MoHFW), notifying changes, if any, in the EC membership to the Central Licensing Authority (CLA) within 30 days, validity period of registration (i.e., 5 years), maintenance of records for 5 years following completion of a BA/BE study, and reasons for suspension or cancellation of EC by the CLA. The NDCT rules mandate the approval of a BA/BE centre by the Central Drug Standard Control Organization (CDSCO) for conducting BA/BE studies. Requirements and guidelines for the conduct of a BA/BE study for a new drug or investigational new drug have now been prescribed. A BA/BE study of a new drug or investigational new drug must be registered with the Clinical Trial Registry of India before enrolling the first subject of the study and should be conducted in accordance with the approved study protocol and as per the GCP Guidelines. A detailed procedure for compensation in case of injury or death during a BA/BE study of a new drug or investigational new drug and calculation of the quantum of financial compensation has been prescribed. A detailed procedure for the import of a new drug or investigational new drug for a BA/BE study has also been prescribed. In these NDCT rules, the procedure for approval by an EC and registration of a BA/BE study centre has been made a time bound process eliminating inordinate delay. Moreover, the NDCT rules reference several online forms available on the System for Unmanned Gateways Approval of Manufacturers (SUGAM) portal (presently National Single Window System (NSWS)) to facilitate applications and approvals for clinical trials and BA/BE studies. These digital platforms facilitate the process of submission of an application and tracking system via real-time updates on submissions. In the present form, the Indian regulations for BE requirements is quite sturdy and registration has been made easier by restructuring the procedure and adopting a digital mode.

India

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发表日期：

2025年

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Subhash C. Mandal,
Seeprarani Prabirkumar Rath

摘要

The New Drug and Clinical Trials (NDCT) Rules were introduced in 2019 amending the Drugs and Cosmetics Rules 1945 and replacing Part XA and Schedule Y of the Drugs and Cosmetics Rules 1945. Several definitions such as New Drug, Investigational New Drug, Clinical Trials, Bioavailability (BA), Bioequivalence (BE), Academic Clinical Trial, BA/BE Study Centre, and Ethics Committee (EC) have been appropriately defined. The definition of New Drugs has been modified to incorporate Novel Drug Delivery Systems (NDDS), deoxyribonucleic acid (DNA) derived product, living modified organism, monoclonal antibodies, stem cell derived products, gene therapeutic products or Xenografts. The rules specify changes to the composition, membership, duties, and functioning of the EC. Increasing the percentage of non-affiliated members in the EC is intended to help decrease bias and facilitate better decision-making. It is necessary for EC members to be trained periodically on Good Clinical Practice (GCP) guidelines such that they are updated on latest regulations and changes. Other requirements are the inclusion of female members for diversity, application for registration and approval of EC with the authority designated by the Ministry of Health and Family Welfare (MoHFW), notifying changes, if any, in the EC membership to the Central Licensing Authority (CLA) within 30 days, validity period of registration (i.e., 5 years), maintenance of records for 5 years following completion of a BA/BE study, and reasons for suspension or cancellation of EC by the CLA. The NDCT rules mandate the approval of a BA/BE centre by the Central Drug Standard Control Organization (CDSCO) for conducting BA/BE studies. Requirements and guidelines for the conduct of a BA/BE study for a new drug or investigational new drug have now been prescribed. A BA/BE study of a new drug or investigational new drug must be registered with the Clinical Trial Registry of India before enrolling the first subject of the study and should be conducted in accordance with the approved study protocol and as per the GCP Guidelines. A detailed procedure for compensation in case of injury or death during a BA/BE study of a new drug or investigational new drug and calculation of the quantum of financial compensation has been prescribed. A detailed procedure for the import of a new drug or investigational new drug for a BA/BE study has also been prescribed. In these NDCT rules, the procedure for approval by an EC and registration of a BA/BE study centre has been made a time bound process eliminating inordinate delay. Moreover, the NDCT rules reference several online forms available on the System for Unmanned Gateways Approval of Manufacturers (SUGAM) portal (presently National Single Window System (NSWS)) to facilitate applications and approvals for clinical trials and BA/BE studies. These digital platforms facilitate the process of submission of an application and tracking system via real-time updates on submissions. In the present form, the Indian regulations for BE requirements is quite sturdy and registration has been made easier by restructuring the procedure and adopting a digital mode.