**Summary:**
The Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health and Family Welfare, Government of India, is extending its online portal SUGAM (www.cdscoonline.gov.in) to include online submission of applications for No Objection Certificates (NOCs) for Bioavailability and Bioequivalence (BABE) studies for export purposes. Effective September 13, 2016, all applicants seeking NOCs for BABE studies for export are required to apply online through the SUGAM portal after registering themselves. After this date, CDSCO will no longer accept hard copy applications for this service. This initiative is part of CDSCO's eGovernance implementation.
Key Entities Referenced
Central Drugs Standard Control Organization: A regulatory body under the Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India.
SUGAM: An online portal launched by the Central Drugs Standard Control Organization for filing applications for various services.
Medical Devices: A category of products regulated by the Central Drugs Standard Control Organization, for which online application filing was launched in the first phase of the SUGAM portal implementation.
NOC for BABE studies for export purpose: No Objection Certificate for Bioavailability and Bioequivalence studies for export, a service for which online submission of applications is being extended.
IDMAFICCIOPPICHICSRACRO: A collective reference to concerned associations and stakeholders in the pharmaceutical and healthcare industries.
New Delhi: The location of the FDA Bhawan, Central Drugs Standard Control Organization head office.
Dr. G.N. Singh: The Drugs Controller General of India at the time of the notice.
Directorate General of Health Services: The parent organization of the Central Drugs Standard Control Organization under the Ministry of Health and Family Welfare.
DCG(I)/Misce./2016 (98)
Government of India
Ministry of Health & Family Welfare
Directorate General of Health Services
Central Drugs Standard Control Organization
FDA Bhawan, New Delhi
Dated: 22" August 2016
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 applications for grant of NOC for BA/BE studies for export purpose.
In this regard, it is decided that applicants seeking NOC for BA/BE studies for
export purpose should apply online w.e.f. 13.09.2016. The applicants are required to
register themselves prior to submission of the application.
yows
No hard copy of application will be received after 13.9.2016 for grant of NOC
for BA/BE studies for export purpose.
(Dr. GIN. Singh)
Drugs Controller Gen¢ral (India)
To
1. All Associations concerned e.g. IDMA/FICCI/OPPI/CH/ICSR/ACRO
2. All stakeholders
3. All JDC(1)s/ DDC(1)s of CDSCO (HO)
Copy to:
1. PPS to AS (F&D)
2. PPS to JS(R)
3. Guard File