Regulatory aspects for vaccines in India and US

  • Vivek Kumar Bihania M.pharm (Pharmaceutics)
  • Ashutosh Badola

Abstract

Vaccines are the most significant health mediation. A vaccine is a biological preparation that builds resistance to a particular disease. The improvement of a vaccine is a perplexing and repetitive procedure. Throughout the development of a vaccine for its authorization, a strict administrative procedure must be made for determining the safety, efficacy, and quality. Center for Biologics Evaluation and Research (CBER) under the USFDA regulates the vaccines in the USA. Similarly, in India, the Indian National Regulatory Authority (CDSCO) is the regulatory body who is liable for the assembling and import of vaccines. To the clinical field, biotechnology gives inventive solutions with more than 200 biologic medications and vaccines. For registration of vaccines, Biologics License Application (BLA) in the USA, and in India, an application is made to the Drug Controller General of India (DCGI) on form 44 along with CMC reports and accessible pre-clinical and clinical examinations. After the enlistments of an immunization, post-marketing surveillance framework, i.e. Vaccine adverse event reporting system (VAERS) is made in the USA.

Keywords: Vaccines, Conceptualization, Registration process, BLA, VAERS

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References

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How to Cite
Bihania, V. K., and A. Badola. “Regulatory Aspects for Vaccines in India and US”. International Journal of Drug Regulatory Affairs, Vol. 8, no. 1, Mar. 2020, pp. 44-50, doi:10.22270/ijdra.v8i1.383.