Regulatory aspects for vaccines in India and US

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


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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1. Dobariya J, Dedania R, Dedania Z, and Jain V. A comprehensive study of regulatory requirements for registration of vaccines in USA, Europe and Canada. Int. J. of. Rec. Sci. Res [Internet]. 2019 Apr [cited 2020 Jan 15]; Vol 10. Available from:
2. CDSCO. Department of Biotechnology Ministry of Science and Technology. Guidelines on Similar Biologics: Regulatory requirements for marketing authorization in India [Internet]. CDSCO; 2012 [cited 2020 Jan 16]. Available from:
3. Shah A, Shah D, and Maheshwari D. A comprehensive study on comparison of registration process of vaccine in India and USA. JPSBR [Internet]. 2:2014 [cited 2020 Jan 20]; Vol.4. Available from:
4. Vashishtha V.M., National vaccine policy of India. Research gate [Internet]. 2014 Jan [cited 2020 Jan 20]. Available From:
5. Pashikanti S, A.N.V.L S, Durga V JS. Regulatory requirements for Vaccine registration in United States. Int J Drug Reg Affairs [Internet]. 2018 Jun 15 [cited 2020 Jan 24]; 6(2):85-1. Available from:
6. U.S. FDA. “21 CFR part 312 Investigational New Drug Application” [Internet]. FDA; 2018 [cited 2020 Jan 07]. Available from:
7. Marshall V, Baylor NW. Food and Drug Administration regulation and evaluation of vaccines. Pubmed [Internet]. Pubmed; 2011 Apr 18 [cited 2020 Jan 17]. Available from:
8. Vaccine product approval process [Internet]. USFDA [cited 2020 Jan 8]. Available from: Blood Vaccines/ Development Approval Process/Biologics License Applications BLA Process/ucm133096.htm.
9. Shah A, Maheshwari MD. A Comprehensive Study on Comparison of Registration Process of Vaccine in INDIA and USA. Journal of Pharmaceutical sciences and bioscientific research [Internet]. 2014 [cited 2020 Jan 08]; 4(2):163-71. Available from:
10. Epidemiology and prevention of vaccine- preventable diseases. Centers for Disease control & Prevention [Internet]. CDC; 2015 Sept 08 [cited 2020 Jan 15]. Available from:
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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.