This public notice from the Central Drugs Standard Control Organisation (CDSCO), dated May 30, 2016, announces the ongoing initiative to digitize its services to expedite processes and enhance transparency. The CDSCO launched a portal, www.cdscoonline.gov.in, in November 2015 to provide IT-enabled services. Currently, the portal facilitates the following: issuance of licenses for import of drugs for personal use; grant of Registration Certificates for import of bulk drugs, medicines, and medical devices; issuance of import licenses for test and analysis for R&D purposes; grant of Registration Certificates for import of cosmetics; and registration of Ethics Committees. Future phases will include online processing for clinical trial and bioequivalence study permissions, online fee payments, and new drug approvals. Stakeholders are encouraged to utilize the online portal, and suggestions for service improvements are welcomed. The notice was issued by Dr. G. N. Singh, Drugs Controller General.
Key Entities Referenced
Central Drugs Standard Control Organisation: The National Drug Regulatory Authority of India (CDSCO)
Ministry of Health Family Welfare: A department of the Government of India.
Directorate General of Health Services: An attached office of the Department of Health and Family Welfare, Government of India.
New Delhi: Location of Central Drugs Standard Control Organisation (CDSCO) - Union Territory of Delhi, India
www.cdscoonline.gov.in: A portal launched in November 2015 for providing IT enabled services by CDSCO.
Import of drugs: Services provided via online portal, including license and registration for import of drugs, bulk drugs, medicines, medical devices, and cosmetics.
Clinical trials: Regulatory work to be digitized in future phases, including permissions for conduct of clinical trials and Bioequivalence studies.
Dr. G. N. Singh: Drugs Controller General
CDSCO / IT / 2016 — (25)
Government of India
Ministry of Health & Family Welfare
Directorate General of Health Services
Central Drugs Standard Control Organisation
FDA Bhavan, Kotla Road
New Delhi
Date: 30/05/2016
PUBLIC NOTICE
The National Drug Regulatory Authority, i.e., Central Drugs Standard
Control Organisation (CDSCO) is on the pathway to put its services online so as to fast
track and bring in complete transparency in its operations. A portal
www.cdscoonline.gov.in was launched in November, 2015 for providing IT enabled
services.
2. In the initial phases, the following services have been put on portal:-
1. Grant of license for Import of drugs for personal use
il. Grant of Registration Certificate for Import of Bulk drugs, Medicines,
and Medical Devices
iii. Grant of Import License for test and analysis for R&D purpose
iv. Grant of Registration Certificate for import of Cosmetics
Vv. Registration of Ethics Committee
3. It is further to bring to your notice that in the future phases, the following other
regulatory work would be on digital mode:-
i. Grant of permissions for conduct of clinical trials and Bioequivalence
studies
ii. Online payment of fees for various applications
iii. Approval of New Drugs
4. All Stakeholders are requested to make use of this facility for ease of doing business.
Any suggestions to improve the services shall be welcome and will be addressed
appropriately and expeditiously.
(Dr. G. N. Singh)
Drugs Controller General (1)
Copy to:
OA PPS to Secretary (Health & Family Welfare)
PPS to DGHS
PPS to AS (F&D)
PS to JS (KLS)
Guard File
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