**Policy Summary:**
This corrigendum, issued by the Drugs Controller General of India (DCGI) under File No. 29Misc.42016DC 65 on July 12, 2017, amends the sensitivity specification criteria for the quality test of Anti-HCV Rapid Kits. It specifically modifies the Office Order of even number dated June 13, 2017, which addressed revised specifications for HIV1 or 2 Ab, HIV1p24 Ag, HCVAb, and HBsAg kits. The change pertains only to the Anti-HCV Rapid Kit, with the sensitivity requirement being revised from "AntiHCV Rapid Kit Sensitivity 99" to "AntiHCV Rapid Kit Sensitivity 99". The acceptance criteria for all other immunodiagnostic kits remain unchanged. This information is disseminated to State Licensing Authorities, Zonal/Sub-Zonal & Port Offices of CDSCO, concerned stakeholders, and The Director, NIB, Noida. Contact point for inquiries is Dr. G. N. Singh, Drugs Controller General India.
Key Entities Referenced
Drugs Controller General India: The regulatory authority responsible for drug control in India.
Directorate General of Health Services: A government organization under the Ministry of Health and Family Welfare in India.
New Delhi: The location of FDA Bhawan, Kotla Road, where the Drugs Controller General of India is located.
AntiHCV Rapid Kit: A rapid diagnostic kit used for detecting Hepatitis C virus antibodies.
HIV1 or 2 Ab, HIV1p24 Ag, HCVAb and HBsAg kits: Immunodiagnostic kits for detecting HIV and Hepatitis markers.
Dr. G. N. Singh: The Drugs Controller General of India at the time of the corrigendum.
State Licensing Authorities: The authorities responsible for issuing licenses related to drugs at the state level in India.
NIB, Noida: National Institute of Biologicals, located in Noida, Uttar Pradesh.
er
F. No. 29/Misc./4/2016-DC (65)
Drugs Controller General (India)
Directorate General of Health Services
(FDA Bhawan, Kotla Road, New Delhi)
Date: 12 JUL 2017 \
CORRIGENDUM
"Sub: Corrigendum with respect to revised specification / criteria of acceptance
for quality test for Ant-HCV (Rapid Kit)- Regarding
This is with reference to the Office Order of even no. dated 13 Jun. 2017
regarding revised specification / criteria of acceptance for quality test for HIV-1 &/ or 2-
Ab, HIV-1p24 Ag, HCV-Ab and HBsAg kits. The criteria of Sensitivity of Rapid Anti-HCV
diagnostic kit is hereby amended as follows:
In place of:
Anti-HCV (Rapid Kit) —Sensitivity- 99%
Read as:
’ Anti-HCV (Rapid Kit) -Sensitivity- > 99%
Further, the acceptance criteria for the other immunodiagnostic kits will remain
same.
(Dr. G. N. Singh)
Drugs Controller Gerieral (India)
Copy to:
1. All State Licensing Authorities
2. All Zonai/ Sub-Zonal/ Port Offices of CDSCO SDT
3. All the concerned Stakeholders
4. The Director, NIB, Noida
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