Date: 2022-05-05 Category: Not Applicable State: Union Government Country: India

Updated list of laboratories for conducting Performance evaluation of IVD reagents/kit

Issued by Ministry of Health and Family Welfare · Central Drugs Standard Control Organization

Research with AI Agent Chat with Document Generate Summary Translate Helpful Share Add to Project Create Task

Executive Summary & Key Takeaways

Gazette Notification

The gazette notification dated 05 May 2022 provides an updated list of laboratories authorized to conduct performance evaluations of In-Vitro Diagnostic Medical Devices in India.
The notification lists testing facilities categorized by the type of In-Vitro Diagnostic Medical Device (IVDMD) reagents/kits they are authorized to evaluate.

Key Changes

The notification updates the list of laboratories for performance evaluation of In-Vitro Diagnostic Medical Devices.
The list includes 22 categories of In-Vitro Diagnostic Medical Devices reagents/kits.
Each category lists multiple testing facilities authorized for performance evaluation of specific IVDMD reagents/kits.
The testing facilities include National Institutes, ICMR Institutes, Medical Colleges & Hospitals and other research centers across India.
For certain categories like 'Detection of markers for Congenital disorders', 'Detection of autoimmune Disorders' and 'Reagents/ Kits for human Genetic testing', any Central Government or State Government Laboratory of any hospital or of any institute is authorized.

Impact Analysis

IVDMD Manufacturers

Manufacturers should establish agreements with listed laboratories to conduct performance evaluations as per regulatory guidelines.

Testing Laboratories

Laboratories should proactively engage with IVDMD manufacturers to offer their services and build partnerships.

Healthcare Providers and Patients

Healthcare providers can have increased confidence in the performance of IVDMDs that have been evaluated by the listed laboratories.

Government and Regulatory Bodies

The availability of multiple testing facilities promotes competition and reduces the risk of monopolies in the testing market.

Key Entities Referenced

National Institute of Biologicals (NIB): A testing facility listed for multiple categories of IVDMD reagents/kits. ICMR Institutes: Various institutes under the Indian Council of Medical Research (ICMR) are listed as testing facilities. Christian Medical College & Hospital (CMC): A medical college and hospital listed as a testing facility for multiple categories of IVDMD reagents/kits. All India Institute of Medical Sciences (AIIMS): A medical college and hospital listed as a testing facility for multiple categories of IVDMD reagents/kits. In-Vitro Diagnostic Medical Devices (IVDMD): Medical devices used for in-vitro diagnostics.

Official Source Record View Original Source →

See Full Document Text

                Dated: 05 May 2022
Updated list of Laboratories for conducting Performance Evaluation of
In - Vitro Diagnostic Medical Device
Sr. Category of In vitro Name of Testing facility
No. Diagnostics Medical
Devices
1) National Institute of Biologicals, Plot No. A-32,
Sector-62, Institutional Area, Noida, Uttar Pradesh
201309
2) ICMR-National AIDS Research Institute. (ICMR).
73, 'G'-Block MIDC Bhosari, Pune - 411026,
Maharashtra , India
3) ICMR- National Institute of Virology, 20/ A, Dr.
Ambedkar Road, Post Box No. 11 Pune 411001,
In-Vitro Diagnostic India
1. Reagents/ Kits for 4) Christian Medical College & Hospital, Ida Scudder
detection for HIV Road, Vellore, Tamil Nadu 632004
5) Department of Clinical Virology, Institute of Liver &
Biliary Sciences, D-1, Vasant Kunj New Delhi-70
6) ICMR- National Institute for Research in
Reproductive Health, Jehangir Merwanji Street,
Parel, Mumbai, Maharashtra 400012
7) ICMR-National Institute of Cholera and Enteric
Diseases, P-33 C.I.T. Road, Scheme-XM,
Beliaghata Kolkata-700010
1) National Institute of Biologicals, Plot No. A-32,
Sector-62, Institutional Area, Noida, Uttar Pradesh
201309
2) ICMR-National AIDS Research Institute. (ICMR).
73, 'G'-Block MIDC Bhosari, Pune - 411026,
Maharashtra , India
3) ICMR- National Institute of Virology, 20/ A, Dr.
Ambedkar Road, Post Box No. 11 Pune 411001,
India
In-Vitro Diagnostic
4) Christian Medical College & Hospital, Ida Scudder
2. Reagents/ Kits for
Road, Vellore, Tamil Nadu 632004
detection for HBV
5) Department of Clinical Virology, Institute of Liver &
Biliary Sciences, D-1, Vasant Kunj New Delhi-70
6) ICMR- National Institute of Immunohaematology,
13th floor, New Multistoreyed Building, KEM
Hospital Campus, Parel, Mumbai, Maharashtra
400012
7) ICMR-National Institute of Cholera and Enteric
Diseases, P-33 C.I.T. Road, Scheme-XM,
Beliaghata , Kolkata-700010
1) National Institute of Biologicals, Plot No. A-32,
Sector-62, Institutional Area, Noida, Uttar Pradesh
201309
2) ICMR-National AIDS Research Institute. (ICMR).
In-Vitro Diagnostic
73, 'G'-Block MIDC Bhosari, Pune - 411026,
3. Reagents/ Kits for
Maharashtra , India
detection for HCV
3) ICMR- National Institute of Virology, 20/ A, Dr.
Ambedkar Road, Post Box No. 11 Pune 411001,
India
4) Christian Medical College & Hospital, Ida Scudder
Page 1 of 6Road, Vellore, Tamil Nadu 632004
5) Department of Clinical Virology, Institute of Liver &
Biliary Sciences, D-1, Vasant Kunj New Delhi-70
6) ICMR- National Institute of Eipidemiology, R 127,
3rd Avenue, Second Main Road, Tamil Nadu
Housing Board, Ayapakkam, Near Ambattur,
Chennai, Tamil Nadu 600077
7) ICMR-National Institute of Cholera and Enteric
Diseases, P-33 C.I.T. Road, Scheme-XM,
Beliaghata, Kolkata-700010
1) National Institute of Biologicals, Plot No. A-32,
Sector-62, Institutional Area, Noida, Uttar Pradesh
201309
2) Indian Red Cross Society, 1, Red Cross Road,
New Delhi
3) ICMR- National Institute of Pathology, Sadarjang
In vitro Diagnostic
Hospital Campus, Ansari Nagar West, New Delhi,
Reagents/ Kits for
4. Delhi 110029
Blood Grouping or
4) ICMR- National Institute of Immunohaematology,
Tissue Typing
13th floor, New Multistoreyed Building, KEM
Hospital Campus, Parel, Mumbai, Maharashtra
400012
5) ICMR-Regional Medical Research Centre, N.E.
Region, P.O.- Lahowal, Dibrugarh - 786 010
Assam, INDIA
1) ICMR- Institute of Cytology and Preventive
Oncology (ICPO), I-7, Sector - 39, Noida 201301
Uttar Pradesh, INDIA
2) ICMR- National Institute of Pathology, ICMR-
National Institute of Pathology, Sadarjang Hospital
Campus, Ansari Nagar West, New Delhi, Delhi
110029
3) ICMR-Regional Medical Research Centre, N.E.
In vitro Diagnostic
Region, P.O.- Lahowal, Dibrugarh - 786 010
5. Reagents/ Kits for
Assam, INDIA
detection of Cancer
4) Medical College and Hospital (Department of
Oncology/ Medical Oncology), 88, College St,
Calcutta Medical College, College Square, Kolkata,
West Bengal 700073
5) Tata Memorial Hospital, Dr. E Borges Road, Parel,
Mumbai - 400 012 India
6) Tata Medical Center, 14 MAR (E-W), New Town,
Rajarhat, Kolkata 700156
1) ICMR- National Institute for Research in
Tuberculosis, Mayor Sathiyamoorthy Road,
Chetpet, Chennai – 600 031, India
2) ICMR- National Jalma Institute of Leprosy and
other mycobacterial diseases P.O BOX 101, Dr. M.
In vitro Diagnostic
Miyazaki Marg, Tajganj, Agra – 282001
Reagents/ Kits for
6. 3) ICMR-Regional Medical Research Centre, NALCO
Detection of
Nagar, Chandrasekharpur, Bhubaneswar, Odisha
Tuberculosis (TB)
751023
4) National Institute of Tuberculosis & Respiratory
Diseases, Sri Aurobindo Marg, Near Qutub Minar
New Delhi- 110030
Page 2 of 65) National Tuberculosis Institute, 8, Bellary Road,
Bangalore 560 003, India,
6) Rajan Babu T.B. Hospital, Kingsway Camp, GTB
Nagar, Delhi 110009
7) Shantabai Devarao Shivaram Tuberculosis
Research Centre & Rajiv Gandhi Institute of Chest
Diseases, Someshwara Nagar 1st Main Road,
Dharmaram College Post, Bangalore - 560 029
8) Dept. of Microbiology, The Postgraduate Institute of
Medical Education and Research, Chandigarh,
Sector 12, Chandigarh, 160012
9) National Reference Laboratory for Tuberculosis,
Department of Microbiology, Bhopal Memorial
Hospital & Research Centre, under ICMR, DHR,
Raisen Bypass Road, Near Karond Chouraha,
Bhopal - 462038
1) ICMR- National Institute of Malaria Research
(NIMR), Sector 8, Dwarka, Delhi-110077 (India)
2) ICMR- National Institute for Research in Trible
Health, Nagpur Road, Near NSCB Medical College
In vitro Diagnostic Jabalpur, Madhya Pradesh, 482003.
7. Reagents/ Kits for 3) ICMR- Vector Control Research Centre, Medical
Detection of Malaria Complex, VCRC Road, Indra Nagar, Priyadarshini
Nagar, Puducherry, 605006
4) All India Institute of Medical Sciences, Division of
Clinical Microbiology & Molecular Medicine, New
Delhi-110029
1) ICMR- Vector Control Research Centre, Medical
Complex, VCRC Road, Indra Nagar, Priyadarshini
Nagar, Puducherry, 605006
2) ICMR- National Institute of Malaria Research
(NIMR), Sector 8, Dwarka, Delhi-110077 (India)
3) National Institute of Biologicals, Plot No. A-32,
Sector-62, Institutional Area, Noida, Uttar Pradesh
201309
In vitro Diagnostic
4) National Institute of Cholera and Enteric
8. Reagents/ Kits for
Diseases,P- 33, C.I.T. Road, Scheme XM,
Detection of Dengue
Beleghata, Kolkata 700010
5) Christian Medical College & Hospital, Ida Scudder
Road, Vellore, Tamil Nadu 632004
6) King Institute, Guindy Flyover, Guindy Institutional
Area, SIDCO Industrial Estate, Guindy, Chennai,
Tamil Nadu 600032
7) Department of Clinical Virology, Institute of Liver &
Biliary Sciences, D-1, Vasant Kunj New Delhi-70
In vitro Diagnostic 1) ICMR-National Institute for Research in Trible
Reagents/ Kits for Health, Nagpur Road, Near NSCB Medical College
Detection of Jabalpur, Madhya Pradesh, 482003.
Chikungunya 2) ICMR- National Institute of Cholera and Enteric
Diseases,P- 33, C.I.T. Road, Scheme XM,
9. Beleghata, Kolkata 700010
3) ICMR- Vector Control Research Centre, Medical
Complex, VCRC Road, Indra Nagar, Priyadarshini
Nagar, Puducherry, 605006
4) ICMR- National Institute of Malaria Research
(NIMR), Sector 8, Dwarka, Delhi-110077 (India)
Page 3 of 61) National Institute of Biologicals, Plot No. A-32,
Sector-62, Institutional Area, Noida, Uttar Pradesh
201309
2) ICMR-National AIDS Research Institute. (ICMR).
73, 'G'-Block MIDC Bhosari, Pune - 411026,
Maharashtra , India (Including HIV, HBV, HCV &
Syphilis in single kit)
In vitro Diagnostic
3) ICMR- National Institute of Virology, 20/ A, Dr.
Reagents/ Kits for
Ambedkar Road, Post Box No. 11 Pune 411001,
10. Detection of
India (Including HIV, HBV, HCV & Syphilis in single
Treponema pallidum
kit)
(Syphilis)
4) ICMR- National Institute for Research in
Reproductive Health, Jehangir Merwanji Street,
Parel, Mumbai, Maharashtra 400012
5) ICMR-National Institute of Epidemiology, R 127,
3rd Avenue, Second Main Road, Tamil Nadu
Housing Board, Ayapakkam, Near Ambattur,
Chennai, Tamil Nadu 600077
1) ICMR-National Institute for Research in Trible
Health, Nagpur Road, Near NSCB Medical College
Jabalpur, Madhya Pradesh, 482003.
In vitro Diagnostic 2) ICMR-National Institute of Cholera and Enteric
11. Reagents/ Kits for Diseases, P-33 C.I.T. Road, Scheme-XM,
Detection of Typhoid Beliaghata, Kolkata-700010
3) Dept. of Microbiology, The Postgraduate Institute of
Medical Education and Research, Chandigarh,
Sector 12, Chandigarh, 160012
1) ICMR- National Institute of Virology, 20/ A, Dr.
Ambedkar Road, Post Box No. 11 Pune 411001,
India
2) ICMR-Regional Medical Research Centre, N.E.
Region, P.O.- Lahowal, Dibrugarh - 786 010
Assam, INDIA
In vitro Diagnostic
2) Division Bacteriology, ICMR-National Institute of
12. Reagents/ Kits for
Cholera and Enteric Diseases, P-33 C.I.T. Road,
Detection of Influenza
Scheme-XM, Beliaghata, Kolkata-700010
3) Department of Clinical Virology, Institute of Liver &
Biliary Sciences, D-1, Vasant Kunj New Delhi-70
4) Sawai Man Singh Medical College, Jawahar Lal
Nehru Marg, Gangawal Park, Adarsh Nagar,
Jaipur, Rajasthan 302004
1) Division Bacteriology, ICMR-National Institute of
Cholera and Enteric Diseases, P-33 C.I.T. Road,
In vitro Diagnostic
Scheme-XM, Beliaghata , Kolkata-700010
Reagents/ Kits for
13. 2) ICMR-National Institute of Epidemiology, R 127,
Detection of
3rd Avenue, Second Main Road, Tamil Nadu
Toxoplasma Gondii
Housing Board, Ayapakkam, Near Ambattur,
Chennai, Tamil Nadu 600077
1) ICMR- National Institute of Virology, 20/ A, Dr.
Ambedkar Road, Post Box No. 11 Pune 411001,
In vitro Diagnostic
India
Reagents/ Kits for
2) ICMR- National Institute for Research in
14. Detection of Rubella
Reproductive Health, Jehangir Merwanji Street,
Virus &
Parel, Mumbai, Maharashtra 400012
Cytomegalovirus
3) ICMR-National Institute of Epidemiology, R 127,
3rd Avenue, Second Main Road, Tamil Nadu
Page 4 of 6Housing Board, Ayapakkam, Near Ambattur,
Chennai, Tamil Nadu 600077
1) ICMR-National Institute of Epidemiology, R 127,
3rd Avenue, Second Main Road, Tamil Nadu
In vitro Diagnostic
Housing Board, Ayapakkam, Near Ambattur,
Reagents/ Kits for
15. Chennai, Tamil Nadu 600077
Detection of
2) ICMR-National Institute for Research in
Pneumonia
Tuberculosis, Mayor Sathiyamoorthy Road,
Chetpet, Chennai – 600 031, India
1) ICMR-National Institute of Epidemiology, R 127,
3rd Avenue, Second Main Road, Tamil Nadu
In vitro Diagnostic Housing Board, Ayapakkam, Near Ambattur,
Reagents/ Kits for Chennai, Tamil Nadu 600077
Detection of 2) ICMR-National Institute of Cholera and Enteric
16.
Methicilline-Resistant Diseases, P-33 C.I.T. Road, Scheme-XM,
Staphylococcus Beliaghata, Kolkata-700010
Aureus 3) Dept. of microbiology All India Institute of Medical
Sciences, Sijua, Patrapada, Bhubaneswar, Odisha
751019
1) ICMR- National Institute of Virology, 20/ A, Dr.
In vitro Diagnostic Ambedkar Road, Post Box No. 11 Pune 411001,
Regents/Kits for India
17.
detection of Entero 2) ICMR-National Institute of Cholera and Enteric
Virus (A/B) Diseases, P-33 C.I.T. Road, Scheme-XM,
Beliaghata , Kolkata-700010
1) ICMR- National Institute for Research in
Reproductive Health, Jehangir Merwanji Street,
Parel, Mumbai, Maharashtra 400012
2) ICMR-National Institute of Epidemiology, R 127,
In vitro Diagnostic 3rd Avenue, Second Main Road, Tamil Nadu
Reagents/ Kits for Housing Board, Ayapakkam, Near Ambattur,
18. Detection of markers Chennai, Tamil Nadu 600077
for Congenital 3) Division of Genetics, Dept. of Paediatrics’, All India
disorders Institute of Medical Sciences, New Delhi
4) Division of Genetics, Dept. of Paediatrics’, Maulana
Azad Medical College, New Delhi
5) Any Central Government or State Government
Laboratory of any hospital or of any institute.
1) ICMR- National Institute for Research in
Reproductive Health, Jehangir Merwanji Street,
Parel, Mumbai, Maharashtra 400012
In vitro Diagnostic
2) ICMR-Regional Medical Research Centre, NALCO
Reagents/ Kits for
19. Nagar, Chandrasekharpur, Bhubaneswar, Odisha
Detection of Neisseria
751023
Gonorrhoeae
3) ICMR- National Institute of Virology, 20/ A, Dr.
Ambedkar Road, Post Box No. 11 Pune 411001,
India
1) ICMR- National Institute of Virology, 20/ A, Dr.
Ambedkar Road, Post Box No. 11 Pune 411001,
In vitro Diagnostic
India
Reagents/ Kits for
2) ICMR- National Institute for Research in
20. Detection and typing
Reproductive Health, Jehangir Merwanji Street,
of Human Papilloma
Parel, Mumbai, Maharashtra 400012
Virus infection
3) ICMR-National Institute of Epidemiology, R 127,
3rd Avenue, Second Main Road, Tamil Nadu
Page 5 of 6Housing Board, Ayapakkam, Near Ambattur,
Chennai, Tamil Nadu 600077
In vitro Diagnostic Any Central Government or State Government
Reagents/ Kits for Laboratory of any hospital or of any institute.
21.
Detection of
autoimmune Disorders
In vitro Diagnostic Any Central Government or State Government
22. Reagents/ Kits for Laboratory of any hospital or of any institute.
human Genetic testing
***
Page 6 of 6
            

Continue your research

Get AI Summary & Executive Breakdown

Chat with this Document

Search across full 480K+ policy library