Comparative overview of Registration and Approval process for Generic Drugs in BRICS Countries

  • Dhanashree R. Deore
  • Pinkal H. Patel

Abstract

BRICS are economically incorporated the developing markets of Brazil, Russia, India, China, and South Africa. In, the Pharmaceutical market rapidly increasing growth in the administration framework of Medication and Administrative Medication Law. The main objective of this study is to compare the Registration and Approval process in different Countries for Generic Drugs. The Registration process in India and China are different. Even, though Brazil, Russia, and South Africa also follow CTD format in Module I for Requirement of registration. All countries include the highest world pharmaceutical economy in the world. To create a significant opportunity for pharmaceutical companies by direct foreign investment and showing growth. They have the largest entity on the global stage of the world. The main goal of this study is to the comparison of generic medication of drug registration process in BRICS countries, in, that Russia and Brazil have different approval processes so that the newer technologies we have found in the countries. India, South Africa, and China have CTD format requirements so, that this Module-1 is very different. More rising largest globally emerging BRICS markets are having significant or beneficially Opportunities. According to different guidelines, we are opinion to and that regulation are carry out. In, Brazil are having good, human service and current medication it is economically good for the developing market in global prospect. ICH prefers that the anniversary of preparing a dossier for Safety, Quality, and Security of API and Product Specification. So, that in this review we have discussed the above Registration and Approval Process BRICS countries.

Keywords: Regulatory Requirement, BRICS, Generic Products, CTD, GMP, CDSCO, DCGI, API, CFDA, SFDA, ICH

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References

1. Radu RI, Isai V, Constandache E, Comparative Study of Accounting Standards in BRICS and EU. Risk in Contemporary Economy [Internet]. wikipedia ;2014 May [cited 2022 Jan 21];9:339-45. Available from:
http://en.wikipedia.org /wiki/BRICS
2. Drug Approval procedure in India, [Internet]. Pharmatutor; 2011 Jun 17 [cited 2022 Jan 21] Available from:
https://www.pharmatutor.org/articles/new-drug-approval-procedure-india;.
3. Prajapati V, Goswami R, Makvana P, Badjatya JK. A REVIEW ON DRUG APPROVAL PROCESS FOR US, EUROPE AND INDIA. Int J Drug Reg Affairs [Internet]. 2014Mar.6 [cited 2022 Jan.31]; 2(1):1-11. Available from:
http://ijdra.com/index.php/journal/article/view/7
4. Power Scope of economical interbrics trade [Internet]. 2010 Jan 22 [cited 2022 Jan 23] Available from:
http://in.rbth.com/economics/2015/06/23/pharma_can_power_interbrics_trade_43817
5. Role of BRICS in developing world [Internet]. 2021 [cited 2022 Jan 24] Available from: http://bookshop.europa.eu/en/the-role-of-brics-in-the-developing world-pbBB3112634
6. National Health Surveillance Agency: Resolution no nº 3.675 [Internet]. [cited 2022 Feb 03] Available from:
http://www.anvisa.gov.br/eng/legis/resol/136_03_redc_e.htm
7. Introduction to Regulatory Affairs. Regulatory Affairs Professional Society (RAPS) [Internet]. RAPS [cited 2022 Feb 03] Available from:
raps.org/uploadedFiles/Site_Setup/Home_Page/About_RAPS/The_Regulatory_Profes sio n/PDF_Framework_Whitepaper.pdf
8. Handoo S, Arora V, Khera D, Nandi PK, Sahu SK. A comprehensive study on regulatory requirements for development and filing of generic drugs globally. Int J Pharm Investing. 2012 Jul; 2(3):99-105.
9. Russian federation [Internet]. roszdravnadzor.ru; 2018 [cited 2022 Feb 03]. Available from:
https://credevo.com/articles/2018/07/30/russia-clinical-trial-regulatory-process
10. Shakeel SM, Basha SS, Nagabhushanam MV, Reddy DN, Bonthagarala B. Comparision of Regulatory Requirements for Generic Drugs Dossier Submission in United States and Canada. International Journal of Pharmaceutical Science and Health Care. 2016 Nov-Dec; 6(6):1-19.
11. Raghotham S, Balamuralidhara V, Sidharth Malhotra. ‘SUGAM’ Pathway for Pharmaceutical Products in India: An Easy Approach. Research J. Pharm. and Tech 2018; 11(10): 4635-4639.
doi: 10.5958/0974-360X.2018.00847.89.
12. Reddy SV, N.V.N M, S. A, L. E, M.V. N, D. N, B. B. REGULATORY REQUIREMENTS OF ‘SIMILAR BIOLOGICS’ FOR MARKETING AUTHORIZATION IN INDIA. Int J Drug Reg Affairs [Internet]. 2018Feb.14 [cited 2022 Feb.12];5(1):20-4. Available from:
http://ijdra.com/index.php/journal/article/view/193
13. Budhwaar V, Rohilla Y, Choudhary M, kumar P. REGULATIONS OF REGISTRATION AND IMPORT OF MEDICAL DEVICE IN INDIA. Int J Drug Reg Affairs [Internet]. 2018Mar.15 [cited 2022 Feb.12];6(1):8-12. Available from:
http://ijdra.com/index.php/journal/article/view/222
14. Badjatya JK. Regulatory requirements and registration process of Generic Drugs in China. PharmaTutor [Internet]. 2016 Feb 1 [cited 2022 Feb.12];4(2):13-8. Available from:
eng.sfda.gov.cn/WS03/CL0756/
15. Steps involved in Registration of Imported Drugs in China [Internet]. SFDA [cited 2022 Feb 11];4(2):13-8. Available from:
eng.sfda.gov.cn/WS03/CL0769/98162.html
16. Dossier registration Pharmaceutical product [Internet]. pharmareg.ru [cited 2022 Feb 11]. Available from:
http://pharmareg.ru/upload/docs%20for%20registration%20russia.pdf
17. National Health Surveillance Agency: Resolution no nº 3.675 [Internet]. ANVISA [cited 2022 Feb 10]. Available from:
http://www.anvisa.gov.br/eng/legis/resol/136_03_redc_e.htm
18. V. S, Srianitha L, Baviyapriyadharshini R. REGULATORY REQUIREMENTS FOR DRUG PRODUCTS REGISTRATION IN SOUTH AFRICA. Int J Drug Reg Affairs [Internet]. 2018Feb.13 [cited 2022 Feb 10];3(4):1-8. Available from: http://ijdra.com/index.php/journal/article/view/171
19. Pereira S and Jawahar. N. The Development and Future of BRICS Countries in the Pharmaceutical Sector. J. Pharm. Sci. & Res. [Internet]. 2018 [cited 2022 Feb 10];10(6):1336-1341. Available from:
https://www.jpsr.pharmainfo.in/Documents/Volumes/vol10Issue06/jpsr10061806.pdf
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How to Cite
R. Deore, D., and P. H. Patel. “Comparative Overview of Registration and Approval Process for Generic Drugs in BRICS Countries”. International Journal of Drug Regulatory Affairs, Vol. 10, no. 1, Mar. 2022, pp. 40-50, doi:10.22270/ijdra.v10i1.509.