Biologics are composed of proteins, sugars, or nucleic acids or combinations of these substances, or may be living entities such as cells and tissues. Biologics are isolated from a variety of natural sources and may also be produced by rDNA based technologies. In contrast to most drugs that are chemically synthesized and their structure is known, most biologics are more complex that are difficult to characterize with available analytical tools. Therefore, setting standards for biologics requires special attention. A separate Biologics Section was created at IPC in October 2015 with an objective to develop biologics standards for Indian Pharmacopoeia which include but not limited to:

  • Vaccines and Immunosera for Human Use

  • Blood and Blood Related Products

  • Allergen Products

  • Biotechnology Derived Therapeutic Products

Setting standards for biologics involves detailed consultation and discussion with stakeholders including manufacturers, regulatory laboratories, and research and academic institutes. In addition, Biologics Section also collaborates with national and international agencies for the establishment of Reference Standards for biologics.


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