India Proposes Pre-Application Submission Meetings

On January 28, 2015, India’s Central Drugs Standard Control Organization (CDSCO) announced that it would offer a formalized system of optional pre-application submission meetings for a new medical device, pharmaceutical, and clinical trial application. This consultation system, at least in theory, should save an applicant time and money while making the application process more transparent and efficient.

After the applicant submits the specific product or trial information, the expected regulatory pathway, and pays the appropriate consultation fee, the CDSCO will determine a meeting date. During the consultation, the applicant will present in more detail the medical device, drug, or clinical trial information to the CDSCO officials. The officials and the applicant will then determine the specific regulatory pathway that should be followed. The meeting will be recorded, and a copy of the minutes can be submitted by the applicant along with the formal device, drug, or clinical trial application.