INDIA Law and Practice Contributed by: Malathi Lakshmikumaran, Vindhya S Mani, Pallaash Shankhdhar and Khushi Lokwani, Lakshmikumaran & Sridharan Attorneys
drugs discovered or developed in India, the CLA is required to either approve or reject the applica- tion within the specified timeline. If no response is issued within that period, the authorisation is considered to have been granted by default. Trials can start only after site‑specific Ethics Committee approval is received, and the study must be regis- tered on the Clinical Trials Registry of India (CTRI) before enrolling participants. • Regulatory review and query responses: CDSCO conducts its regulatory review of the submitted dossier, during which the sponsor must address any regulatory queries raised. Upon satisfaction, the DCGI issues written approval in Form CT‑06. • Ongoing reporting and trial conclusion: sponsors are responsible for ensuring medical treatment and compensation in the event of trial‑related injuries, deaths or permanent disabilities. They must also provide periodic updates, such as quarterly enrol- ment figures and biannual progress reports. If the study is discontinued, they must submit a detailed explanation to the CLA. Throughout the duration of the trial, sponsors must keep all sites accessible for regulatory inspections. Medical Devices The procedures are as follows. • Determine device risk class: clinical investigations of medical devices in India are regulated under the MDR and are based on a risk‑based classifica- tion system (Class A to Class D). Sponsors must first determine the device risk class and prepare a Clinical Investigation Plan, along with technical, pre‑clinical and safety data. • Ethics Committee registration and approval: prior approval from a CDSCO‑registered Ethics Com- mittee is mandatory, with a focus on participant safety, informed consent and risk management. The Ethics Committee reviewing an investigational medical device study must be duly registered with the CLA under the MDR. The sponsor proceeds to the regulatory application phase with the CLA only after receiving Ethics Committee approval. • Application to the CLA (CDSCO) for clinical inves- tigation permission (Form MD-22): the sponsor submits an application to the CLA seeking permis- sion to conduct the pivotal clinical investigation.
The CLA reviews the application to assess the device’s safety, performance and intended use before granting authorisation. • CTRI registration before first enrolment: once approved, the clinical investigation may commence subject to the approved plan and Good Clinical Practice. It must be registered with the CTRI before enrolment, with annual status reports to the CLA, and notification (with reasons) must be provided if the investigation is terminated. • Conduct and Good Clinical Practice: suspected serious adverse events must be reported to the CLA, and sponsors must provide medical manage- ment and compensation for injury or death. It is important to note that sites and sponsor premises are subject to CLA inspections. The first participant must be enrolled within one year of permission (else prior CLA approval is required), and non‑com- pliance may lead to the suspension or cancellation of permission. 2.3 Public Availability of the Conduct of a Clinical Trial The public availability of details regarding the conduct of a clinical trial for medical devices or medicines is a necessity, but the public availability of the results is not mandatory as per the registry. Under the Indian regulatory requirements, trial reg- istration is compulsory before the first participant is enrolled. This is enforced by the DCGI through the CTRI, a publicly accessible registry under the Indian Council of Medical Research). The CTRI is recognised as a primary registry in the World Health Organization (WHO), and all clinical trials must be registered there in context of India, including trials of drugs and vaccines. Registered trials are searchable and include the trial title. Designs, interventions, sponsors and outcomes are freely accessible on the CTRI website via the WHO portal. However, public reporting of detailed trial results is not yet a stringent statutory requirement on the CTRI website. Although the CTRI and regu- lators strongly encourage transparency in reporting results and India is a signatory of the WHO joint state- ment advocating for transparency in the disclosure of results, there is no specific mandate with timelines
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