**Policy Summary: CDSCO Online Application Transition**
This notice from the Central Drugs Standard Control Organisation (CDSCO), dated February 16, 2016, announces the transition to an online system for processing applications related to import licenses and registration certificates for drugs. Effective February 15, 2016, all new applications for these services are to be submitted online through the CDSCO website, using the Sugam online application portal. To facilitate a smooth transition to this eGovernance system, applicants with pending hard-copy applications for registration certificates in Form 41 (received before February 15, 2016) are also requested to submit their applications online via the Sugam portal. This will allow for continued processing of these applications. The CDSCO website provides detailed instructions on the online application process. A facilitation cell was operational from February 16, 2016, to February 25, 2016, between 3:00 PM and 4:00 PM at the Prescreening Centre, CHEB FDA Bhawan, New Delhi, to address stakeholder queries.
Key Entities Referenced
Central Drugs Standard Control Organisation: A department under Directorate General of Health Services and Ministry of Health & Family Welfare, Government of India responsible for regulating pharmaceuticals and medical devices.
CDSCO: Abbreviation for Central Drugs Standard Control Organisation.
Ministry of Health Family Welfare: A ministry of the Government of India.
Directorate General of Health Services: An attached office of the Ministry of Health and Family Welfare, Government of India.
New Delhi: Capital of India, location of CDSCO headquarters. It is a Union Territory.
Import licenses: Licenses required for importing drugs into India, regulated by CDSCO.
Registration certificate of drugs: Certificate required for registering drugs, regulated by CDSCO. Mentioned in context with Form 41.
Sugam: CDSCO's online portal for submitting applications related to drugs and medical devices.
CDSCO/IT/2016(1)
Government of India
Ministry of Health & Family Welfare
Directorate General of Health Services
Central Drugs Standard Control Organisation
FDA Bhawan, New Delhi,
Dated 16.02.2016
NOTICE
The on-line services have been initiated by Central Drugs Standard
Control Organisation (CDSCO) for quick delivery of services. It is
proposed to receive all new applications for obtaining import licenses and
registration certificate of drugs by way of online receipt from
15.02.2016. In the interest of smooth transition to the e-Governance
system applications for obtaining registration certificate of drugs in Form
41, which were received prior to 15.02.2016 in hard copies and which
are under processing at various stages at CDSCO (HQ), may also be made
online through CDSCO website (Sugam on line application) to take
further action in the matter, from the stage of process of application.
Stake holders are requested to go through Sugam online
application on CDSCO website where the online application
steps/requirement are given in simple manner. Further, for any queries of
the stakeholders, a facilitation cell has been made operational from
16.02.2016 to 25.02.2016 between 3.00 PM to 4.00 PM at Pre-screening
centre, CHEB FDA Bhawan, New Delhi.
All are requested to co-operate for successful transition to online
system.
(Arun Sharma)
Director (Admin)
PON All Pharmaceutical Associations
All JDC(1)s/DDC(I)s/ADCls of CDSCO (HQ)
PPSs to DGHS/AS(KBA)/JS(KL).
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