**Summary:**
This office memorandum, issued by the Central Drugs Standard Control Organization (CDSCO) on May 1, 2017, announces the implementation of a new module on the SUGAM portal for the issuance of test analysis reports in Form 13. As part of CDSCO's eGovernance program, this module aims to expedite the communication of drug quality information to stakeholders, particularly concerning drugs identified as Not of Standard Quality (NSQ). Effective May 15, 2017, all Directors of Central Drugs Testing Laboratories (CDTL) and Regional Drugs Testing Laboratories (RDTL) are mandated to issue test analysis reports in Form 13 exclusively through the SUGAM portal. This initiative intends to facilitate the immediate recall of NSQ drugs by providing instant communication to relevant parties. Technical queries regarding the module can be directed to ithelpdesk@cdsco.nic.in or Sh. R. Chandrashekar, Deputy Drugs Controller India, eGovernance Cell at ranga.cscdsco.nic.in.
Key Entities Referenced
Central Drugs Standard Control Organization: A department under the Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India, responsible for drug regulation in India.
SUGAM Portal: An online portal developed by CDSCO for various services related to drug regulation.
Form 13: A form related to test analysis reports, issued through the SUGAM portal.
CDTLRDTL: An acronym for Central Drugs Testing Laboratories and Regional Drugs Testing Laboratories, responsible for drug testing.
Drugs Inspector: Official responsible for collecting drug samples for testing.
DrG.N.Singh: Drugs Controller General India
New Delhi: Location of FDA Bhawan and office issuing the memo.
Ministry of Health Family Welfare: Government of India ministry responsible for health and family welfare policies and programs.
CDSCO/IT/2017 — (17)
Government of India
Ministry of Health & Family Welfare
Directorate General of Health Services
Central Drugs Standard Control Organization
FDA Bhawan, New Delhi
Dated: 01.05.2017
Office Memo
Sub:- Issue of reports for test/analysis in Form 13 on SUGAM Portal-regarding
CDSCO as part of its comprehensive e-Governance program has launched the online portal
“SUGAM” for various services rendered by it. The portal is being developed in phases and has various
modules for various purposes.
In the latest phase, a module for issue of reports for test/analysis in Form-13 has been developed
under SUGAM and has been made live on the portal. The module provides for receiving the details of the
samples of drugs sent by the Drugs Inspectors to the laboratories and generates reports of test/analysis in
Form-13. At present, the dissemination of the information of not of standard quality drugs through
conventional channels of communication is taking time leading to delays in recall of such drugs. The
module provides for instant communication to all the stakeholders with an intention for effective
stopping of use of not of standard quality drugs and immediate recall.
Therefore, all the Directors of CDTL/RDTL with effective from 15.05.2017 are required to
mandatorily issue reports of test/analysis in Form-13 only through SUGAM portal. Action taken in this
regard may be informed to this office.
For any technical queries in this regard, you may contact it-helpdesk@cdsco.nic.in or Sh.
R.Chandrashekar, Deputy Drugs Controller (India), e-Governance Cell at ranga.cs@cdsco.nic.in.
Dr{G.N.Singh,
Drugs Controller General (India)
To
The All the Directors CDTL/RDTLs
PS to JS(R), MoHFW