In order to ensure accountability of regulatory process for ease of doing business, Drugs Controller General of India (DCGI) has made a clarification to the drug manufacturers that same fees can be utilised in case of inadvertent submission of online applications along with fees meant for a specific division but submitted to other division of Central Drugs Standard Control Organization (CDSCO).
This comes in the wake of DCGI observation that many a times, an applicant submits his/her online applications inadvertently to a division or section not related to that application (e.g. New Drug Division, FDC Division, GCT Division, Import & Registration Division etc.)
Applicants are required to submit their applications along with fees in different divisions of CDSCO for obtaining various permissions or approvals.
As per the DCGI notice, “It is to clarify that the fees paid for such application can be considered for submission and processing of that application in the related division of CDSCO headquarters after such application has been declared by applicant or CDSCO as inadvertent and not related to division applied for.
Centre for Development of Advanced Computing (C-DAC) has also been requested to make appropriate system in Sugam Portal so that fees submitted in one division of CDSCO can be utilised by concerned division after declaration of such inadvertent submission either by the applicant or by the division of CDSCO headquarters and publish the procedure.
CDSCO under its e-Governance initiative had rolled out online services for filing of applications through Sugam portal in 2016 for import licensing and registration purpose and offers online licensing services for drugs, cosmetics and biologicals, among others.
A separate medical device online portal has also been started in line with new Medical Device Rules -2017 (MDR-2017) for applications related to medical devices and in-vitro diagnostics (IVDs).
The Union health ministry has also recently devised an action plan to regulate all medical devices under Drugs and Cosmetics (D&C) Act to ensure safety, quality and performance of medical devices.
As per the plan, all manufacturers and importers of all non-regulated medical devices will register the details of the devices manufactured and imported by them in the special Sugam portal developed for the purpose and a notification will be issued under the D&C Act in this regard.