Subhash Chand | Scientist-III & Head, Therapeutic Monoclonal Antibody Laboratory,
National Institute of Biologicals, (Ministry of Health & Family Welfare, Govt. of India) | India

Subhash Chand, Scientist-III & Head, Therapeutic Monoclonal Antibody Laboratory,, National Institute of Biologicals, (Ministry of Health & Family Welfare, Govt. of India)

Almost 10 years of Experience in Quality Control & Regulations of Biologicals (Viral Vaccines & Therapeutic Monoclonal Antibodies) and Pharmaceuticals. Worked previously in Torrent Pharmaceuticals Ltd. Baddi, H.P. from 2008 to 2010. Joined NIB in March 2010 and presently working as Scientist –III & Head of Therapeutic Monoclonal Antibody laboratory at NIB. Done M.Sc. (Microbiology) from Himachal Pradesh University, Shimla (India) and MBA in ‘Human Resource Management’ from Symbiosis University, Pune (India). Have 05 publications in his credit and attended more than 15 conferences. Participated in more than 05 Regulatory Inspections with CDSCO as a Subject Expert including GMP inspections, CMC data verification and Adverse Drug Reaction (ADR) inspection.


Brief about the Institute Presently Working
 
National Institute of Biologicals (NIB) is an autonomous institute under the Ministry of Health and Family Welfare, Government of India, with the mandate to test Biological products, both imported and manufactured indigenously. It has been notified under the Drugs and Cosmetics Act to function as Central Drugs Laboratory i.e. National Control Laboratory and has been accredited by National Accreditation Board for Testing and Calibration Laboratories (NABL) as per ISO 17025.

Appearances:



Conference Day 2 @ 13:30

Ensuring uniformity of GMP inspections in biologics manufacturing

Countries across the globe are concerned about the safety and efficacy of the drugs supplied. As India expands its biologics supply globally, there is an increased emphasis in ensuring uniformity in inspection requirements for drugs manufactured in India. This panel discusses how global regulators such as US FDA, EMA can work closer together with CDSCO in ensuring uniformity in GMP inspections.
  • Overview of India’s inspection landscape and updates
  • Understanding the differences and overlaps in current standards
  • Exploring ways for various regulators to work closer together, including more combined inspections for newly recruited CDSCO inspectors

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