**Policy Summary:**
Effective immediately, the Central Drugs Standard Control Organization (CDSCO) announces that the Subject Expert Committee (SEC) division will conduct meetings for the evaluation of Investigational New Drug (IND) proposals following established procedures. Applicants are required to submit presentation materials electronically via the e-Vartalap Sugam Portal to the relevant CDSCO division. This submission must occur after receiving the invitation letter from CDSCO and well in advance of the scheduled meeting. This notice, reference number F. No.12012024DC SEC, is issued by the Directorate General of Health Services, Central Drugs Standard Control Organization (CDSCO), Expert Committee Coordination Division, FDA Bhawan, New Delhi, and is addressed to all stakeholders. Ankit Sharma, Deputy Drugs Controller India, is the issuing authority.
Key Entities Referenced
Directorate General of Health Services: An organization under the Government of India responsible for public health.
Central Drugs Standard Control Organization (CDSCO): National Regulatory Authority responsible for regulation of Drugs & Cosmetics in India.
Expert Committee Coordination Division: A division within the CDSCO.
FDA Bhawan, New Delhi: The location of the CDSCO office in New Delhi, Delhi.
Investigational New Drugs (IND): New Drug application for evaluation of new drug proposals.
SEC division: Division responsible for conducting IND meetings.
evartalap Sugam Portal: Portal for submission of documents to CDSCO.
Ankit Sharma: Deputy Drugs Controller of India
F. No.12-01/2024-DC (SEC)
Directorate General of Health Services
Central Drugs Standard Control Organization
(Expert Committee Coordination Division)
FDA Bhawan, New Delhi
Dated: 3\-¢\- 282%
NOTICE
It has now been decided that the meetings of Investigational New Drugs (IND) for
evaluation of IND proposals will be conducted by SEC division as per the procedures
followed.
In this regard, applicants are requested that the copy of presentation must be
submitted through e-vartalap (Sugam Portal) only to concerned division well in advance,
after receipt of the invitation letter from CDSCO.
This is for compliance with immediate effect.
“a
Ankit Sharma
Deputy Drugs Controller (India)
To,
All Stakeholders & CDSCO website.