Open AccessComparison of regulatory approval process for vaccines development and manufacturing in India & USA
Author(s) -
Bhargavi Thanuja M,
Ramaiah Maddi
Publication year - 2021
Publication title -
upi journal of pharmaceutical, medical and health sciences
Language(s) - English
Resource type - Journals
ISSN - 2581-4532
DOI - 10.37022/jpmhs.v4i4.36
Subject(s) - license , drug approval , licensure , drug development , medicine , quality (philosophy) , good manufacturing practice , process (computing) , business , regulatory affairs , risk analysis (engineering) , pharmacology , public administration , political science , drug , computer science , law , philosophy , epistemology , operating system , nursing
The Vaccine Development is a complex and time-consuming process because of stringent quality assessment procedures. The vaccine is approved for release into the market, a stringent regulatory procedure to assess quality, efficacy and safety must be maintained. The regulation of vaccine in India with the licensing and GMP is controlled by the drug controller general of India (DCGI). The USA regulation was controlled by the USFDA in center biologics evaluation and research committee (CBER) and Biologics license application (BLA). These Authorities are responsible for vaccine regulations in India & USA. The current review articles highlight the comparison of registration process of vaccines in INDIA and USA.