The Ministry of Health and Family Welfare in India has announced amendments to the New Drugs and Clinical Trials Rules, 2019, effective September 19, 2024. These changes, formalized as the New Drugs and Clinical Trials (Amendment) Rules, 2024, are designed to streamline the approval process for new drugs and clinical trials, improve patient safety protocols, and ensure compliance with global standards.
Definition and Registration of Clinical Research Organizations (CROs)
A significant update is the introduction of a formal definition for Clinical Research Organizations (CROs). According to the new rules, a CRO is defined as any entity, whether commercial, academic, or otherwise, that a sponsor may delegate tasks, duties, or obligations related to clinical trials or bioequivalence studies. CROs are now required to register with the Central Licensing Authority (CLA) before conducting any clinical trials or bioequivalence studies involving new or investigational drugs on human subjects.
To register, CROs must submit an application using Form CT-07B, along with a fee of INR 5,00,000 (Indian Rupees five lakh). However, centers already registered for conducting bioavailability or bioequivalence studies are considered registered under the new rules. The CLA will review applications within 45 working days and may grant approval (Form CT-07C), reject the application with written reasoning (allowing for reconsideration within 60 days), or request rectification of deficiencies.
Conditions for Registration and Operational Requirements
Registered CROs must maintain facilities and qualified staff as outlined in the Ninth Schedule of the NDCT Rules, 2024. They can only initiate clinical trials or bioequivalence studies after receiving protocol approval from an Ethics Committee (EC) and permission from the CLA. If a trial site lacks its own EC, it can obtain approval from an EC at another site or an independent EC registered under Rule 8, provided the approving EC is responsible for the study and located within a 50-kilometer radius of the trial site. All EC approvals must be reported to the CLA, and all trials must be registered with the Clinical Trial Registry of India before the enrolment of the first subject.
Studies must adhere to approved protocols, Good Clinical Practices Guidelines, and relevant regulations. Early termination of a study requires prompt communication to the CLA. Serious adverse events must be reported to the CLA within 14 days, following specific procedures. In cases of injury, disability, or death during a study, the CRO must provide appropriate medical management and compensation as outlined in Chapter VI of the rules, with details of compensation reported to the CLA within 30 days of the order. Any changes in the constitution or ownership of the CRO must be reported within 30 days.
CROs are required to maintain all study-related data, records, and documents for five years post-study completion or at least two years after the expiration date of the drug batch studied, whichever is later. The CLA is authorized to inspect CROs, with or without prior notice, to review records related to clinical trials. The CLA can also impose additional conditions on specific clinical trials to ensure they meet targeted objectives and standards.
Renewal and Validity of Registration
The registration for CROs is valid for five years from the date of grant, unless suspended or cancelled earlier. Renewal requires submitting Form CT-07B with specified documents before the current registration expires. If the renewal application is submitted before the expiration date, the existing registration remains valid until a decision is made. The CLA will review the renewal application and can either renew the registration using Form CT-07C or request rectifications.
Impact and Conclusion
The NDCT Rules, 2024, aim to enhance the clinical trials landscape in India by providing a structured framework for the operation of CROs. By aligning more closely with international standards and addressing critical concerns around patient safety and regulatory efficiency, these amendments aim to strengthen India's position as a leading global hub for clinical trials while ensuring the protection of patient interests.
