**Summary:**
The Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health and Family Welfare, Government of India, is holding a stakeholder meeting to gather feedback on new modules developed for the SUGAM portal, CDSCO's eGovernance platform for online application submissions. The meeting aims to solicit input before the modules are officially launched.
The stakeholder meetings are scheduled as follows:
1. **Granting of NOC for registration of drugs meant for export:** July 17, 2017, 11:00 AM
2. **Grant Renewal of Blood Bank and CLAA workflow:** July 20, 2017, 11:00 AM
3. **COPP Certificate:** July 20, 2017, 3:00 PM
4. **Online Process for New Drugs, Fixed Dose Combinations, Subsequent New Drugs:** July 25, 2017, 11:00 AM
5. **CT post Approvals SAE Reporting:** July 24, 2017, 11:00 AM
The meetings will be held at the Conference Room, 1st floor, FDA Bhawan, Kotla Road, New Delhi-110002.
Organizations requested to nominate representatives include: COONAN, Indian Pharmaceutical Alliances (IPA), Indian Drug Manufacturers Association (IDMA), Organization of Pharmaceutical Producers of India (OPPI), Confederation of Indian Industry (CII), Confederation of Indian Pharmaceutical Industry (CIPI), Federation of Pharma Entrepreneurs (FOPE), Associated Chambers of Commerce and Industry of India (ASSOCHAM), Association of Control Research Organization (IBHA), India Beauty and Hygiene Association (IBHA), and AWN.
Nomination details should be sent to ithelpdeskcdsco.nic.in.
The communication is issued by Dr. G.N. Singh, Drugs Controller General of India.
Key Entities Referenced
Central Drugs Standard Control Organization: A national regulatory body for pharmaceuticals and medical devices under the Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India.
SUGAM: eGovernance program for filing online applications at CDSCO.
NOC registration of drugs: Granting of No Objection Certificate for registration of drugs meant for export.
Blood Bank and CLAA: Grant and Renewal of Blood Bank licenses and CLAA (specific definition not provided in text).
COPP Certificate: Certificate of Pharmaceutical Product
New Drugs, Fixed Dose Combinations, Subsequent New Drugs: Refers to the online process for application and approval of new drugs, fixed dose combinations and subsequent new drugs.
CT post Approvals SAE Reporting: Clinical Trial post Approval Serious Adverse Events Reporting
New Delhi, Delhi: Location of the meeting at FDA Bhawan, Kotla Road.
CDSCO/IT/2017-(30)
Government of India
Ministry of Health & Family Welfare
Directorate General of Health Services
Central Drugs Standard Control Organization
Meeting Notice
Sub: Sugam - meeting of the stakeholders for feedback on new modules-
reg
CDSCO has initiated a comprehensive e-Governance program for filing online
applications through SUGAM portal. Several modules has been developed and made
live. Now the modules mentioned below have been developed and it has been decided
that the views of the stakeholders are taken before the applications are made live.
Therefore, you are requested to nominate your representatives for meeting on
the below mentioned dates to view the demo and give your valuable feedback.
S.No | Process Date of stakeholders
meeting
i Granting of NOC & registration of drugs meant for | 17* July 2017, 11:00
export.
2: Grant & Renewal of Blood Bank and CLAA | 20t July 2017, 11:00
workflow
COPP Certificate 20% July 2017, 15:00
4. Online Process for New Drugs, Fixed Dose | 25t" July 2017, 11:00
Combinations, Subsequent New Drugs.
5. CT post Approvals & SAE Reporting 24 July 2017, 11:00
The meeting will be held at Conference room, 1st floor, FDA Bhawan,
Kotla Road, New Delhi-110002.
Details of the nominees shall be sent to it-helpdesk@cdsco.nic.in
(Dr. GN. Singh)
Drugs’Controller
General (India)
To:
COONAN Indian Pharmaceutical Alliances (IPA)
Indian Drug Manufacturer’s Association (IDMA)
Organization of Pharmaceutical Procedures of India (OPPI)
Confederation of Indian Industry (Cll)
Confederation of Indian Pharmaceutical Industry (CIPI)
Federation of Pharma Entrepreneurs (FOPE)
Associated Chambers of Commerce and Industry of India (ASSOCHAM)
Association of Control Research Organization (IBHA)
India Beauty and Hvgiene Association (IBHA)
AWN