Comparison of regulatory approval process for vaccines development and manufacturing in India & USA
DOI:
https://doi.org/10.37022/jpmhs.v4i4.36Keywords:
DCGI, CBER, USFDA, BLA, CDSCOAbstract
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.
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References
Vaccine Introduction Guidelines, “General introduction on vaccines”, http:// whqlibdoc. who.int/hq/2005/WHO_IVB_05.18.pdf
World Health Organization, “Brief description of Vaccines”, http://who.int/ topics/vaccines/en/
Immunization Standard, “National Regulatory Authorities”, http://www.who .int/immunization _standards/national_regulatory_authorities/role/en/
OPPI position paper on vaccine, “Organization of Pharmaceutical Producers of India”, http://www.indiaoppi.com.
IAP guide book on immunization, “Vaccine introduction guidelines – adding a vaccine to a national immunization program: decision and implementation, 2005’’.
U.S Food and Drug Administration, “about CBER” http://www.fda.gov/AboutFDA/Centers Offices/Office of Medical Products and Tobacco/CBER/ucm123340.htm
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