ABSTRACT

A biological product is a substance that either contains or is derived from a living organism and is used for the prevention or cure of diseases. Biologic products may contain proteins that control the action of other proteins and cellular processes, genes that control production of vital proteins, modified human hormones, or cells that produce substances that suppress or activate components of the immune system. Biologic drugs are sometimes referred to as biologic response modifiers because they change the manner of operation of natural biologic intracellular and cellular actions. Biologics are significantly different from conventional medicines in that they contain enormous, complex chemicals that are created utilizing genetically modified cells. Thus, each molecule of a biologic is unique. Our goal is to construct a step-by-step guide as to how to get crucial regulatory information for biologicals throughout India that can be referred to as a reference. Have a system that will collect, analyze, document, disseminate, and maintain data for lifecycle management and regulatory compliance purposes. Keywords: CDSCO, Biologicals, DBT, GDP, GLP, GMP
Publication date: 01/12/2022

https://ijbpas.com/pdf/2022/December/MS_IJBPAS_2022_6673.pdf

Download PDF
https://doi.org/10.31032/IJBPAS/2022/11.12.6673