Author(s): Raj Shekhar, P Muralidharan, Namrata Hallur, SB Puranik, Sumitha Jagadibabu, Phatru Patel

Email(s): shekar.gcp@gmail.com

DOI: 10.52711/0974-360X.2023.00663   

Address: Raj Shekhar1*, P Muralidharan1, Namrata Hallur2, SB Puranik3, Sumitha Jagadibabu4, Phatru Patel5
1Department of Pharmacy, PRIST Deemed University, Thanjavur, Tamilnadu, India.
2Assistant Drugs Controller, Drugs Controller Department, Karnataka, India.
3Head Regulatory Affairs, Anthem Bioscience Pvt. Ltd, Karnataka, India.
4Department of Microbiology, JBAS College for Women, Teynampet, Chennai.
5Regulatory Professionals Affairs, Drishiti Institute of Distance Learning, Bangalore, Karnataka, India.
*Corresponding Author

Published In:   Volume - 16,      Issue - 9,     Year - 2023


ABSTRACT:
Corona Virus (Covid-19) infection was developed from the SARS-CoV-2 virus. People have infected by the virus in all around the world with moderate issues on the respiratory system. As well the recovery has successful without taken any special treatment. As per the world record, illness and death have the serious medical attention on the chronic diseases; maximum infected people belongs to the diabetes (Type I and Type II), Cardio vascular issues, asthma, respiratory illness, more immunity disorder and cancer etc. In Indian, CDSCO board (Central Drugs Standard Control Organization), Ministry of Health and Family Welfare, India, DBT (Dept. of Biotechnology), Ministry of Science and Technology, Indian council of Medical Research (ICMR) has published the notification to the public section with the NDCT (New Drugs Clinical Trials) rules. In addition, various other rules were applicable for the designing the COVID-19 drugs such as Drugs and Cosmetics Act and Rules, on Similar Biologics with the Regulatory aspects to make the market authorization in India. Biosimilar drug has designing with rules and regulation of COVID-19 repurposed medicines (drugs) were approval in emergency aspects during the COVID-19 infection in India around March 2020 to till date. In this study, we have emphasize the pandemic COVID -19 situation i) biosimilar drugs used in emergency aspects; ii) the list of biosimilar drugs under Govt. of India approval regulatory aspects; iii) the list of biosimilar repurposed drugs doses, time period, sources of the respective drugs and the applications with the successful rate were optimized in the COVID -19 emergencies period.


Cite this article:
Raj Shekhar, P Muralidharan, Namrata Hallur, SB Puranik, Sumitha Jagadibabu, Phatru Patel. Alternative biosimilar drugs impact on Global COVID-19 Pandemic and Regulatory approval Repurposed in Emergency periods (2020-2022). Research Journal of Pharmacy and Technology 2023; 16(9):4042-8. doi: 10.52711/0974-360X.2023.00663

Cite(Electronic):
Raj Shekhar, P Muralidharan, Namrata Hallur, SB Puranik, Sumitha Jagadibabu, Phatru Patel. Alternative biosimilar drugs impact on Global COVID-19 Pandemic and Regulatory approval Repurposed in Emergency periods (2020-2022). Research Journal of Pharmacy and Technology 2023; 16(9):4042-8. doi: 10.52711/0974-360X.2023.00663   Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2023-16-9-7


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