DCGI to meet stakeholders soon to discuss improvements in clinical trials
clinical trials in the country, the Drugs Controller General of India (DCGI) will meet key representatives from the pharma industry next month to understand areas of improvement in global clinical trials.
A meeting to be attended by representatives from the Indian Society for Clinical Research, Organisation of Pharmaceutical Producers of India (OPPI), Indian Pharmaceutical Alliance will be held on November 14. India's drug regulator has received several representations raising concerns on the processing of global clinical trial applications.
«In this regard it has been decided to conduct a meeting to understand areas of improvements in global clinical trials,» said the notice by DCGI dated October 25.
The discussions will be within the framework of New Drugs and Clinical Trials Rules, 2019, it further said. The industry has been expressing their concerns regarding delay in processing the applications across different therapeutic areas, delay in issuing permissions and delay of inclusion of proposals in the subject expert committee, thus losing valuable time before initiating a global clinical trial.
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