REGULATORY GUIDANCE FOR EMERGENCY AUTHORIZATION, EXPORT AND IMPORT OF COVID-19 VACCINES IN INDIA AND USA
AbstractThis research primarily focuses on the process and impact of marketing authorizations, import, and export of COVID-19 vaccines in India and the United States. Pharmaceutical firms now have great legal grounds in India and the United States for vaccine manufacture and distribution. In this pandemic, the regulatory authority of India CDSCO and the US FDA updated the guidelines to provide approval for vaccines in less than a month through emergency use authorization. The Indian medical regulatory system and the USFDA have made it easier for COVID-19 vaccines to obtain clearance for commercialization. These new rules have made pharmaceutical companies easily get their vaccines to users. In today’s competitive world, shortening the time to launch a product is considered to company’s success. All pharmaceutical manufacturers/importers, regulatory, preclinical, formulation scientists, and clinical trial professionals who are directly or indirectly engaged in the covid-19 registration process will benefit from this study. We require expertise and broad views to properly handle the regulatory process for vaccination licensure in India and the United States because regulatory authorities do not compromise with quality.
Article Information
8
2686-2694
1117 KB
344
English
IJPSR
G. Yamini Divya Teja *, Koushik Yetukuri and Rama Rao Nadendla
Department of Pharmaceutical Regulatory Affairs, Chalapathi Institute of Pharmaceutical Sciences, Guntur, Andhra Pradesh, India.
yaminiguntupalli24101998@gmail.com
29 August 2022
22 October 2022
18 November 2022
10.13040/IJPSR.0975-8232.14(6).2686-94
01 June 2023
Download