Clinical trial processes for medical devices are similar to that of drugs

Can you advice how clinical trials can be done using indigenous medical devices in India? J. Vijayakumar As of today, most medical devices (a comprehensive & updated list available from the CDSCO website) are considered as drugs for the purpose of clinical trial and come under the purview of the D&C Act. The clinical trial/evaluation process for these devices are similar to that of clinical trial process for drugs in India. Recently, CDSCO has also released a draft guideline for comments: ● Requirements for conducting clinical trial(s) of medical devices in India ● Guidance document on common submission format for registration of medical devices in India These guidelines suggest the approach for application/permission for clinical trials. The overall approach is similar to drug trials with specific differences as per nature/type/class of device. Another draft guideline, the Schedule MIII is available from CDSCO website which outlines the clinical trial process and requirements for devices. Some specific points are as follow; however, this guideline is only a draft and is awaiting finalization. ● Trial should aim at verifying whether the device conforms to 'essential requirements' for medical devices as stipulated in the guideline ● Trial should be compliant to ISO 14155 standard, in addition to Declaration of Helsinki What are the concerns if we want to set up a Central EC within same group of hosps? What are the issues with having 2 ECs - Central and Local at individual hospitals? Dr. Sanjay Basumatary Although the idea looks sound in principle, some concerns remain. These are: Overall time frame for approval from 2 ECs. If there is a dispute, whose decision will be final. Additional burden of the investigator in complying to the documentation/queries of 2 committees Central EC oversight at trials at different hospitals Impact duplication of reporting progress report/SAE etc Perception of sponsors re: above issues and impact on selection of the hospital as a site. Is there any special requirement for sending the literature cases (articles to accompany the case report) to the DCGI? Moreover, is there any requirement laid down by the Indian regulations to periodically search the relevant literature databases (i.e. Medline) for drugs marketed in India? Niharika Mathur There is no specific guidance on this issue. However, the Schedule Y PSUR guidance covers "all the relevant new information from appropriate sources". Hence, it would be important to report literature cases as part of PSUR. See Schedule Y section below: Post Marketing Surveillance - Subsequent to approval of the product, new drugs should be closely monitored for their clinical safety once they are marketed. The applicants shall furnish Periodic Safety Update Reports (PSURs) in order to report all the relevant new information from appropriate sources. How should the consumer reports be treated for reporting purposes? Niharika Mathur If these are safety reports, depending on seriousness, they would be reported either as post-marketing spontaneous reports or as part of PSUR. For clinical trial events, is any cross reporting required by DCGI for the cases occurring in the same clinical trial in the other centres of the trial (outside India)? Niharika Mathur There is no clarity on this issue. Schedule Y and Indian GCP use the words "any" or "all". Hence, most sponsors/CROs report all SAE/ SUSARs from India and other countries to DCGI and participating sites ECS. See Schedule Y section below: (iv) Any unexpected serious adverse event (SAE) (as defined in GCP guidelines) occurring during a clinical trial should be communicated promptly (within 14 calendar days) by the sponsor to the licensing authority and to the other investigator(s) participating in the study (see Appendix XI). Indian GCP 3.1.11. Adverse Drug Reaction Reporting: The sponsor should provide ADR / AE reporting forms to the investigator(s) / institution(s). The sponsor should expedite the reporting to all concerned (including the EC and the regulatory authorities) of all serious and/or unexpected adverse drug reactions. Also, I have heard that the only way to report to the DCGI is to visit their office in person and get the case report (clinical/post marketing) stamped for acknowledgement? Does the same hold true for PSUR/ annual reports too? All safety information - SAE / PSUR, has to be submitted in hard copy form personally. This will facilitate getting the acknowledgement on the safety information. There is new annexure form for all notifications to DCGI.