The Indian Society for Clinical Research (ISCR), an association of clinical research professionals, has welcomed the union health ministry's recent decision to modify the newly added clause 122 DAB of the Drugs and Cosmetic (D&C) Rules, 1945 to further relax the norms on compensation in the case of injury or death during the clinical trials. The ISCR has also welcomed the ministry's decision to modify the timeline for reporting the serious adverse events in line with the international practices.
This is an encouraging development and we are glad that the regulatory bodies are addressing the concerns of all stakeholders. Collaboration, transparency and open dialogue are important to ensure the progress of the industry, while securing the rights and safety of patients, said ISCR president Suneela Thatte.
When the government issued a notification on compensation in January this year, the ISCR had submitted a memorandum to the health ministry pointing out that the current compensation rules make the continuing conduct of high quality, scientifically valid clinical trials in India virtually impossible, negatively impacting the availability of scientific data to assess the benefits and risks of medicine for the Indian population.
In the memorandum, the ISCR, which aims to build awareness on clinical research as a specialty in India, had also expressed concern on the norms on compensation in the case of injury or death during the clinical trials and the timeline for reporting the serious adverse events.
Acting on the concerns of the clinical trial industry, the Drug Technical Advisory Board (DTAB) of the union health ministry had recently recommended that free medical management in the case of an injury occurring to trial subjects will be provided in case the injury is due to clinical trial related activities only, as the free medical management may create undue influence for patient to enroll in a clinical trial.
Apart from modification in the compensation rules, the timeline for reporting the serious adverse events will also be changed. The requirements of sponsor and investigator to report the Serious Adverse Events after due analysis in 10 days will b changed to 14 days while the timeline to be followed by the Ethics Committee to forward the reports along with their opinion on quantum of compensation will be 30 days, instead of 21 days stipulated now.
The independent expert committee will be given 60 days to examine the adverse events of death and recommend to the DCGI about the cause of death. At present, it is required to report to DCGI within 30 days.