**Summary:**
This Office Memorandum, reference number F. No.: 29Misc42016DC12, issued by the Director General of Health Services, Central Drugs Standard Control Organisation (CDSCO), addresses the underutilization of the National Institute of Biologicals (NIB), Noida for Quality Control testing of biologicals. Dated 5/1/16, the memorandum references a request from NIB (letter 1Dir.off.201415NIB3349 dated 14.01.2016) to increase sample submissions to optimize laboratory infrastructure usage for the financial year 2015-16.
The memorandum directs DDCI of Zonal, ADC I of Sub-Zonal, and Port Offices of CDSCO to instruct Drugs Inspectors to increase the collection of biological samples, specifically immunodiagnostic kits, blood grouping reagents, and molecular diagnostic kits used for blood screening, and forward them directly to the Director, NIB, Noida for Quality Control testing. A concrete plan for sample collection is requested, with monthly reports to be submitted to the CDSCO.
Copies of the memorandum have been sent to the Joint Secretary Regulation, Ministry of Health & Family Welfare, Nirman Bhawan, New Delhi; SO, DFQC Section, Nirman Bhawan, New Delhi; and the Director, National Institute of Biologicals, A32, Sector-62 Institutional Area, Noida 201309. The contact person for this memorandum is Dr. G. N. Singh, Drugs Controller General India.
Key Entities Referenced
Central Drugs Standard Control Organisation: A national regulatory body for pharmaceuticals and medical devices under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India.
NIB, Noida: National Institute of Biologicals, located in Noida, Uttar Pradesh. It is a laboratory for Quality Control testing of Biologicals.
Director General of Health Services: An office under the Government of India.
FDA Bhawan, Kotla Road New Delhi: Location of the office of Drugs Controller General India (DCG I).
State Drugs Controllers: Drug regulatory authorities at the state level within India.
immunodiagnostic kits: A type of biological product subject to quality control testing.
blood grouping reagents: A type of biological product subject to quality control testing.
molecular diagnostic kits: A type of biological product used for blood screening and subject to quality control testing.
E No + 20/Mice/AI2N16.NC/19\)
F. No.: 29/Misc/4/2016-DC(12)
Government of India
Director General of Health Services
Central Drugs Standard Control Organisation
Olo DCG (I)
FDA Bhawan, Kotla Road
New Delhi-110002 _
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OFFICEMEMORANDUM 3.U ins UG
SUB: Capacity utilization for Quality Control testing of Biologicals at NIB, Noida-
Regarding
The National Institute of Biologicals (NIB) has requested this office vide letter
1/Dir.off./2014-15/NIB/3349 dated 14.01.2016 to draw more samples by various CDSCO
offices as well as State Drugs Controllers of biologicals particularly immunodiagnostic
kits, blood grouping reagents and molecular diagnostic kits used for blood screening
also so that available laboratory infrastructure at NIB could be optimally utilized for the
financial year 2015-16 (Copy enclosed).
In view of above, you are requested to direct your Drugs Inspectors to draw more
samples of biologicals particularly immunodiagnostic kits, blood grouping reagents and
molecular diagnostic kits used for blood screening and forward directly to the Director,
NIB, Noida for Quality Control testing.
You are also requested to prepare a concrete plan to draw the said samples
under intimation to this office & details of the samples collected monthly may be
forwarded to this office accordingly.
An early action in regard would be highly appreciated.
(Dr. G. N. Singh)
Drugs Controller General (India)
To, re)
DDC(I) of Zonal/ Ze WW b
ADC (I) of Sub Zonal & Port Offices
of CDSCO 4
Copy to,
1. Joint Secretary (Regulation), Ministry of Health & Family Welfare, Nirman Bhawan,
New Delhi
2. SO, DFQC Section, Nirman Bhawan, New Delhi.
3. Director, National Institute of Biologicals, A-32, Sector-62 (Institutional Area, Noida-
201309.