By Stewart Eisenhart, Emergo Group
The Drug Controller General (India) (DCGI) has announced plans to prescreen registration applications for medical devices and pharmaceutical products upon receipt beginning December 1, 2011.
The DCGI prescreening plan is intended to expedite device and drug registration applications by allowing regulatory reviewers to more quickly notify applicants if any required documentation is missing or insufficient.
Emergo Group staff in India have learned that DCGI officials will use a checklist to make an initial evaluation of applications and at that point let applicants know if anything is out of sorts rather than sending questions during later stages of the registration process.
All divisions of India’s Central Drugs Standard Control Organization (CDSCO) will implement the prescreening protocol.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.