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National Institute of Biologicals

(राष्ट्रीय जैविक संस्थान)

Ministry of Health & Family Welfare, Government of India

स्वास्थ्य एवं परिवार कल्याण मंत्रालय,भारत सरकार

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Brief Profile



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Dr. Surinder Singh did his MBBS from Medical College, Jammu in the year 1985 and M.D. (Microbiology) from Medical College Rohtak, Haryana in the year 1988. He did his senior residency in Microbiology from All India Institute of Medical Sciences, New Delhi (1988 - 1991).


He took over the charge of Drugs Controller General of India in February-2008 and continued to work in the same position till 2nd November, 2011.    Presently, Dr. Surinder Singh is the Director of National Institute of Biologicals, Ministry of Health & Family Welfare, Government of India which is the National Control Laboratory for testing of all Biologicals including Vaccines and Bio-pharmaceuticals. He is trained in Good Manufacturing Practices (cGMPs) at Massachusettes Biologic Laboratory, Boston, USA and has also attended Public Health Laboratory Training Programme at Maryland Public Health Laboratory, Baltimore (USA) in 1997.

He was appointed in October 2012 by the State Government of Punjab as Chairman of the Expert Committee constituted to develop an Institutional Development Plan (IDP) for "Strengthening of Drugs Regulations & Drugs Testing Laboratory in the State of Punjab during 12th Five Year Plan."




Awarded Dr. B. C. Roy Memorial Award 2014 for Excellent Contribution towards Blood Safety Programme in India on Doctors Day 1st July 2014click

  Awarded Pharma-Bio World Awards 2011 - for "Outstanding Initiatives in Regulatory Environment" given by - CHEMTECH FOUNDATION, India


  Featured in the list of the world's 40 most influential people in the global pharma industry, for three consecutive years i.e. Year 2011, 2010 & 2009 as adjudged by a panel of experts of the UK Pharma magazine "World Pharmaceutical Frontiers".

Other Highlights of the Career 


a) Conceptualized, launched and implemented Pharmacovigilance & Haemovigilance Programme of India in Year 2010 and Year 2012 respectively, 


b) Expert Member in WHO National Regulatory Authority (NRA) pre- assessment of South Africa in Year 2013 and WHO NRA assessment of Thailand in Year 2007 & 2012,


c) Head of Central Drugs Laboratory, Kasauli & Government Analyst for Vaccine & Sera (Year 1994 - 1997),


d) Published 33 Scientific papers and audited more than 70 Vaccine and Biologicals manufacturing units in the country.

World Pharmaceutical Frontier Year 2011 click 

World Pharmaceutical Frontier Year 2010 click

World Pharmaceutical Frontier Year 2009 click

Notifications !!  


 Revised conditions 

 for purchase of :


1. Sera Panels


2. National Reference Standards




Revised specification/criteria of acceptance for quality test performed on HIV 1 &/or 2-Ab, HIV 1 p24 Ag, HCV-Ab and HBsAg kits


Acceptance Criteria for Test & Examination of Blood Glucose Test Strips as per ISO 15197:2003new


Turnaround time for testing new




Guidance Document for Industry : submission of stability data and related documents for review & expert opinion for granting post approval changes in shelf life of Recombinant Biotherapeutic Products and Therapeutic Monoclonal Antibodiesnew



Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in Indianew





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