**Summary:**
The Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health and Family Welfare, Government of India, issued a notice on August 29, 2016, regarding the expansion of its online portal, SUGAM (www.cdscoonline.gov.in), to include online submission of Clinical Trial (CT) applications. This initiative is part of CDSCO's eGovernance implementation. A meeting with all stakeholders involved in CT NOC applications was scheduled for August 10, 2016, at 11:30 AM in FDA Bhawan, Kotla Road, New Delhi, to provide a live demonstration of the software and gather feedback. Due to space limitations, each association was limited to a maximum of two representatives. The notice was issued by Dr. Gi N. Singh, Drugs Controller General of India, and distributed to concerned associations including IDMA, FICCI, OPPI, CII, ICSR, and ACRO, as well as all JDCIs and DDCIs of CDSCO HQ.
Key Entities Referenced
Central Drugs Standard Control Organisation: A department under Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India, responsible for regulation of pharmaceuticals and medical devices.
New Delhi: The location of FDA Bhawan and CDSCO headquarters.
SUGAM: Online portal (www.cdscoonline.gov.in) launched by CDSCO for filing applications for various services.
Medical Devices: Products that were included in the first phase of online application filing through SUGAM portal.
CT NOC: Abbreviation for Clinical Trial No Objection Certificate, related to online submission of CT applications.
IDMA: An association concerned with pharmaceuticals, invited to the meeting.
FICCI: Federation of Indian Chambers of Commerce & Industry, an association concerned, invited to the meeting.
Dr. Gi N. Singh: Drugs Controller General of India
DCG(I) / Misc. / 2016 — (93)
Government of India
Ministry of Health & Family Welfare
Directorate General of Health Services
Central Drugs Standard Control Organisation
FDA Bhawan, New Delhi
. Dated: 029 -0g—- 20/6
Notice
Central Drugs Standard Control Organization (CDSCO) in pursuance to
implement e-Governance in its offices has launched an online portal ‘SUGAM’
(www.cdscoonline.gov.in) on 14.11.2015.
The portal is intended for filing applications for various services rendered by
CDSCO. In the first phase, filing of applications for import and registration of drugs,
Medical Devices were launched. Now, the service is being extended to online
submission of CT applications.
In this regard, it is decided to convene a meeting of all stakeholders i.e. firms
involved in applications of CT NOC on 10" August, 2016 at 11.30 AM in FDA Bhawan,
Kotla Road, New Delhi. It is also proposed to conduct live demonstration on software
and input / suggestions may be provided by the stakeholders on the same during the
meeting.
It may be noted that there should not be more than two representatives from
each associations due to space constraints.
(Dr. Gi N. Singh)
Drugs Controller General (India)
To
= All Associations concerned e.g. IDMA / FICCI / OPPI/ Cll / ICSR / ACRO
2: All JDC(I)s / DDC(I)s of CDSCO (HQ)
Copy to
1. PPS to AS(F&D)
2. PPS to JS(R)
3. Guard File