**Policy Summary:**
This notification, reference number F. No. 29Misc.42016DC24, dated April 9, 2017, from the Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services, Ministry of Health & Family Welfare, addresses the testing of notified diagnostic kits for Hepatitis C. The notification informs Sh. S. K. Sarin, Director of the Institute of Liver and Biliary Sciences (ILBS), New Delhi, that ILBS may serve as an alternative laboratory for the evaluation of Hepatitis C Virus (HCV) kits in instances where the National Institute of Biologicals (NIB), Noida, lacks the necessary in-vitro diagnostics testing facilities. The communication is signed by Dr. S. Eswara Reddy, Joint Drugs Controller. The CDSCO is located at Food & Drugs Administration Bhawan, Kotla Road, New Delhi-110002. The reference letter from ILBS is dated December 16, 2016.
Key Entities Referenced
Central Drugs Standard Control Organisation: A regulatory body in India responsible for drug regulation.
Directorate General of Health Services: An attached office of the Ministry of Health and Family Welfare in India.
Ministry of Health Family Welfare: The Indian government ministry responsible for health policy.
S. K. Sarin: Director of the Institute of Liver and Biliary Sciences (ILBS).
Institute of Liver and Biliary Sciences, Delhi: An autonomous institute under the Government of the National Capital Territory of Delhi, India, focused on liver and biliary diseases.
Vasant Kunj, Delhi: A residential area in Delhi, India, where the Institute of Liver and Biliary Sciences (ILBS) is located.
Hepatitis Kit: Diagnostic kits used for detecting Hepatitis.
NIB, Noida, Uttar Pradesh: National Institute of Biologicals, an autonomous institution under the Ministry of Health & Family Welfare, Government of India
Central Drugs Standard Control Organisation
Directorate General of Health Services
Ministry of Health & Family Welfare
(Medical Devices and Diagnostics Division)
Food & Drugs Administration Bhawan,
Kotla Road, New Delhi-110002
F, No. 29/Misc./4/2016-DC(24) Dated: 9 g APR 2017
To,
Sh. S. K. Sarin, Director
Institute of Liver and Biliary Sciences (ILBS),
D-1, Vasant Kunj, New Delhi
Subject: Testing of Notified Diagnostics kits for Hepatitis Kit at ILBS, New Delhi—
regarding.
Sir, :
Please refer to your letter no. nil dated 16/12/2016 received by this office on the
.
above cited subject.
In this connection, you are hereby informed that where the facility for testing of in
vitro. Diagnostics is not available with NIB, Noida, in such cases, ILBS, New Delhi may
be considered as alternate laboratory for evaluation of HCV kits.
Yours faithfully,
(Dr. S Eswara Reddy)
Joint Drugs Controller (I)