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Research Journal of Pharmacy and Technology
Year : 2020, Volume : 13, Issue : 2
First page : ( 1050) Last page : ( 1054)
Print ISSN : 0974-3618. Online ISSN : 0974-360X.
Article DOI : 10.5958/0974-360X.2020.00193.6

Regulatory Requirements for Biological product approval process in India

Lokesh C.*, Sonia K., Kamaraj Raju

Department of Pharmaceutical Regulatory Affairs, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulatur-603203, Kanchipuram, Tamil Nadu, India

*Corresponding Author E-mail: jackylokesh9019@gmail.com

Online published on 9 April, 2020.


“Biologicals are restorative, therapeutic, analytic, preventive arrangements created or got from living life forms and their turn off for human use”. They incorporate serums, antibodies, counteragents, blood, antigens and blood segments, quality treatment, tissues and so forth. The Indian administrative expert (CDSCO), is the body that is in charge of the advancement and promoting of organic items in India. Biotechnology furnishes creative answers for therapeutic field with in excess of 200 biologic prescriptions and antibodies. These advancements benefit a large number of patients worldwide and in excess of 600 items a work in progress. “At present these items can likewise be created by makers other than the trend-setter, with the expiry of some of licenses. These new biotechnological prescriptions usually alluded to as "comparable biologics" offer a noteworthy chance to give more prominent access to sensible social insurance for a few lifesaving drugs. These might be viewed as extremely basic conservative/helpful component for the pharmaceutical market in India. The Indian Regulatory Authority is viewed as in charge of assessing security, adequacy and nature of all pharmaceuticals in India. The Department of Biotechnology in India is the office that controls the advancement, pre-clinical investigations of all Biologicals.



Biologicals, CDSCO, RCGM, IBSC.


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