PHARMASPIRE - Volume 15, Issue 04, 2023, October-December
Pages: 236-242
Date of Publication: 17-Feb-2024
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Regulatory pathway for pharmaceutical drug product registration and export in Gulf countries
Author: Garg Donee, Sharma Nitin
Category: Pharmaceutics
Abstract:
The Indian pharmaceutical market is the third largest in terms of generic production. It has developed a reputation as a center of industry and research in the international market. India offers some of the cost effective manufacturing facilities globally. The Gulf cooperation council (GCC) region is regarded as a “developing market for pharmaceutical export”. This study assessed the regulatory frameworks of the GCC member countries of Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and the United Arab Emirates (UAE) to build a coordinated approach. GCC regions are exposed to a partially regulated market. Most regulatory changes and developments must be kept up to date by pharmaceutical businesses, and GCC adopted the international council for harmonization common technical document (ICH CTD) format for new product registration. To fulfill the public demand for safe and effective treatments, regulations are needed for pharmaceutical drug products urgently due to rising healthcare costs, R&D expenditures, and other factors. Harmonizing the data on quality, safety, and efficacy reported in the application dossier is a main concern for the ICH committee. This review article provides the regulatory framework of GCC countries for effective control of pharmaceutical products.
Keywords: Drug registration, Export, Gulf cooperation council, Indian pharmaceutical market
DOI: 10.56933/Pharmaspire.2023.15136
DOI URL: https://doi.org/10.56933/Pharmaspire.2023.15136
References:
1. Handoo S, Arora V, Khera D, Nandi PK, Sahu SK. A comprehensive study on regulatory requirements for the development and filing of generic drugs globally. Int J Pharm Investig 2012;2:99.
2. Department of Pharmaceuticals. 2021-22 Annual Report. New Delhi: Government of India Ministry of Chemicals and Fertilizers; 2022.
3. Al-Rubaie M. Evaluation of the Regulatory Review Process of the GCC Centralized Procedure: Development of a Model for Improving the Approval Process (Doctoral Dissertation, Cardiff University).
4. Alsaddique A. Future of the pharmaceutical industry in the GCC countries. Integr Mol Med 2017;4:1-3.
5. Alpen Capital Investment Banking. GCC Pharmaceutical Sector; 2013. Available from: https: alpencapital. com research /2013GCC _Pharmaceuticals_ Industry_Report_March_2013.php [Last accessed on 2023 Jan 12].
6. Ramesh T, Saravanan D, Khullar P. Regulatory perspective for entering global pharma markets. Pharma Times 2011;43:15-20.
7. Pateriya S, Janodia MD, Deshpande PB, Ligade VS, Talole KB, Kulshrestha T, et al. Regulatory aspects of pharmaceuticals’ exports in gulf cooperation council countries. J Young Pharm 2011;3:155-62.
8. Khoja TA, Bawazir SA. Group purchasing of pharmaceuticals and medical supplies by the gulf cooperation council states. East Mediterr Health J 2005;11:217-25.
9. Sravani M, Gowthami B, Prabhahar E, Rao RN. Regulatory aspects of pharmaceuticals in gulf cooperation council countries. Int J Pharma Chem Res 2017;3:397-14.
10. Deep A, Khurana G, Kumar J, Monga A. Comparison of regulatory requirements for registration of pharmaceutical drugs in ASEAN and GCC regions. Appl Clin Res Clin. Trials Regul Aff 2019;6:62-70.
11. Kumar BJ, Ramesh B. Drug product registration in semiregulated market. Int J Drug Regul Aff 2013;1:1-6.
12. Data Requirements for Herbal and Health Products Submission 2023. Available from: https://sfda.gov.sa/ sites/ default/files/201912/ data%20requirement%20 for%20herbal%20%28draft%29.pdf [Last accessed on 2023 Feb 01].
13. Sahithya KS, Kumar DS, Madhavi BL, Goli D, Shanthakumar GS. Regulatory pathway for registration and approval of Indian drug products in overseas market. J Pharm Sci Res 2020;12:1150-61.
14. Pooja M, Ketan S, Pankaj K. Certificate of pharmaceutical product CoPP. Res J Pharm Technol 2015;8:1449-53.
15. Aashigari S, Goud R, Sneha S, Vykuntam U, Potnuri NR. Stability studies of pharmaceutical products. World J Pharm Res 2018;25:479-92.
16. Badjatya JK. Overview of drug registration requirements for pharmaceuticals in emerging market. J Drug Deliv Ther 2013;3:227-32.
17. Basak S. Pharmaceutical market and regulatory contents for export of pharmaceutical products to Latin American countries. IOSR JBM 2018;8:60-72.
18. Indian Trade Portal, How to Export; 2014. Available from: https://www.indiantradeportal.in/ vs.jsp?lang=0&id=0,25,44 [Last accessed on 2023 Jan 12].
19. Saadatnia F, Mehregan MR. Determining and prioritizing factors affecting customers attraction of medical tourism from the perspective of Arabic countries (case study: IranMashhad Razavi hospital). Int J Mark Stud 2014;6:155.
20. Khanna I. Drug discovery in pharmaceutical industry: Productivity challenges and trends. Drug Discov Today 2012;1:1088-102.
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