Date: 2020-03-11Category: Not ApplicableState: Union GovernmentCountry: India
Notice regarding Clarification for utilization of same fees in case of inadvertent submission of online applications along with fees meant for a specific divison submitted to other division of CDSCO HQ
**Summary:**
This notice, issued by the Directorate General of Health Services, Central Drugs Standard Control Organization (CDSCO), FDC Division, clarifies the procedure for utilizing application fees submitted to an incorrect division within CDSCO headquarters (HQ) due to inadvertent online submission. Dated 1132702 [Note: Date format appears incomplete/incorrect in the original document], the notice addresses instances where applicants mistakenly submit applications and associated fees to divisions unrelated to the application's subject matter (e.g., New Drug Division, FDC Division, GCT Division, Import Registration Division).
To enhance transparency, accountability, and streamline the regulatory process, the notice clarifies that fees paid for such misdirected applications can be applied to the correct division for processing, provided the application is declared as inadvertently submitted to the wrong division by either the applicant or CDSCO.
Dr. V. G. Somani, Drugs Controller General of India, authorized the notice. The notice also directs CDAC to modify the Sugam Portal to facilitate the transfer of fees between divisions following a declaration of inadvertent submission. The procedure will be published in the Sugam Portal. Stakeholders are notified, as is the PS to JSR, Ministry of Health and Family Welfare. The reference number for this notice is F. No. 04012020DC MISC19. The address for the CDSCO is FDA Bhawan, Kotla Road, New Delhi.
Key Entities Referenced
Central Drugs Standard Control Organization: A national regulatory body for pharmaceuticals and medical devices under the Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India.
FDC Division: A division within the Central Drugs Standard Control Organization (CDSCO) that deals with Fixed Dose Combinations of drugs.
New Drug Division: A division within the Central Drugs Standard Control Organization (CDSCO) responsible for the approval of new drugs.
GCT Division: A division within the Central Drugs Standard Control Organization (CDSCO).
Import Registration Division: A division within the Central Drugs Standard Control Organization (CDSCO) responsible for the registration of imported drugs.
CDSCO, HQ: Central Drugs Standard Control Organization, Head Quarters
Dr. V. G. Somani: Drugs Controller General of India
Sugam Portal: An online portal likely used for application submissions and regulatory processes within the Central Drugs Standard Control Organization (CDSCO).
F. No. 04-01/2020-DC (MISC-19)
Government of India
Directorate General of Health Services
Central Drugs Standard Control Organization
(FDC Division)
FDA Bhawan, Kotla road,
New Delhi
Dated: 11/3/2702
Notice
Subject:- Clarification for utilization of same fees in case of inadvertent
submission of online applications along with fees meant for a
specific division submitted to other division of CDSCO, HQ -
regarding.
Applicants are required to submit their applications alongwith fees in different
Divisions of this Directorate for obtaining various permissions/approvals.
It has been observed that many a times, an applicant submit their online
applications inadvertently to a division/section not related to that application (e.g.
New Drug Division, FDC Division, GCT Division, Import & Registration Division, etc.)
Therefore, in order to ensure transparency, accountability & streamlining of
regulatory process for ease of doing business, 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,HQ after such application has been declared by
applicant or CDSCO as inadvertent and not related to division applied for.
(Dr. V. G. Somani)
Drugs Controller General (India)
Copy to:-
41. CDAC with a request to make appropriate system in Sugam Portal so
that fees submitted in one division of CDSCO can be utilized by
concerned division after declaration of such inadvertent submission
either by the applicant or by the division of CDSCO,HQ & publish the
procedure.
2. All Stakeholders.
3. PS to JS(R), Ministry of Health and family Welfare, Nirman Bhawan,
New Delhi.