Author(s): Chenmala Karthika, Raman Sureshkumar

Email(s): sureshcoonoor@jssuni.edu.in

DOI: 10.5958/0974-360X.2020.00525.9   

Address: Chenmala Karthika, Dr. Raman Sureshkumar*
Department of Pharmaceutics JSS College of Pharmacy, Ooty (Affiliated to JSS Academy of Higher Education and Research).
*Corresponding Author

Published In:   Volume - 13,      Issue - 6,     Year - 2020


ABSTRACT:
Generics are playing a vigorous role in human health. As there is a widespread growth in population, demand for different disease types have also been increased and where drug players are concentrating for newest design, growth and profit. Pharmaceutical product registration is a strenuous task for emerging markets, and also for regulated markets. Although the need for pharmaceuticals and its registration have been standardised and harmonised by various International agencies and Health Authorities in the countries still many of the manufacturers face difficulties in getting their product approval which is due to many changes and constant amendments or changes in the process, rules, guidelines. It is compelling that all emerging markets of pharmaceutical industry should follow the regulatory requirements set, henceforth for the betterment of public health. This following is about the emerging market “Africa” registration process of its pharmaceuticals and brief on challenges faced for acceptance and its market. This review mainly aimed at the African pharmaceutical regulations which are required for the drug products registration, such as the pharmaceutical products and its evolution in the emerging market, the steps involved in the registration processes from the initial step till the final approval.


Cite this article:
Chenmala Karthika, Raman Sureshkumar. A Forecast on Strategies for Regulatory Requirement of Drug Product Registration in African Pharmaceutical. Research J. Pharm. and Tech 2020; 13(6): 2966-2970. doi: 10.5958/0974-360X.2020.00525.9

Cite(Electronic):
Chenmala Karthika, Raman Sureshkumar. A Forecast on Strategies for Regulatory Requirement of Drug Product Registration in African Pharmaceutical. Research J. Pharm. and Tech 2020; 13(6): 2966-2970. doi: 10.5958/0974-360X.2020.00525.9   Available on: https://rjptonline.org/AbstractView.aspx?PID=2020-13-6-78


REFERENCES:
1.    Ahen F, Salo-Ahen OM. Governing pharmaceutical innovations in Africa: Inclusive models for accelerating access to quality medicines. Cogent Medicine. 2018 Jan 1;5(1):1-22.
2.    Misganaw A, Haregu TN, Deribe K, Tessema GA, Deribew A, Melaku YA, Amare AT, Abera SF, Gedefaw M, Dessalegn M, Lakew Y. National mortality burden due to communicable, non-communicable, and other diseases in Ethiopia, 1990–2015: findings from the Global Burden of Disease Study 2015. Population health metrics. 2017 Dec;15(1):29.
3.    Edwards DJ, Coppens DG, Prasad TL, Rook LA, Iyer JK. Access to hepatitis C medicines. Bulletin of the World Health Organization. 2015;93:799-805.
4.    Logendra R, Rosen D, Rickwood S. Africa: A ripe opportunity Understanding the pharmaceutical market opportunity and developing sustainable business models in Africa.2013
5.    Rosales-Mendoza S. Perspectives for the algae-made biopharmaceuticals field. InAlgae-Based Biopharmaceuticals. Springer, Cham. 2016
6.    Banda G. Finance as a ‘forgotten technological capability’for promoting African local pharmaceutical manufacture. International Journal of Technology Management & Sustainable Development. 2013;12(2):117-35.
7.    Banda G. Financing ARV drug manufacture in Zimbabwe: implications for technological capability upgrading and innovation for African local pharmaceutical production (Doctoral dissertation, The Open University).
8.    Barker C. The Mozambique pharmaceutical policy. The Lancet. 1983 Oct 1;322(8353):780-2.
9.    WAHO makes progress in developing regional and national good manufacturing practice. Roadmap for the ECOWAS Region. Johannesburg: African Medicines Regulatory Harmonization Programme; 2015. Available from: http://amrh.org/waho-makes-progress-in-developing-regional-and-national-good-manufacturing-practice-gmp-roadmap-for-the-ecowas-region.html (cited 2015 Nov 19).
10.    Dong J, Mirza Z. Supporting the production of pharmaceuticals in Africa. Bulletin of the World Health Organization. 2016 1;94(1):71.
11.    Bassat Q, Tanner M, Guerin PJ, Stricker K, Hamed K. Combating poor-quality anti-malarial medicines: a call to action. Malaria journal. 2016;15(1):302.
12.    Olson DJ, Piller A. Ethiopia: an emerging family planning success story. Studies in Family Planning. 2013;44(4):445-59.
13.    Union A. Pharmaceutical manufacturing plan for Africa business plan. Addis Ababa http://sa. au. int/en/sites/default/files/pmpa% 20bp. 2012;20.
14.    Sidibé M, Yong LI, Chan M. Commodities for better health in Africa? time to invest locally.
15.    Union A. Progress report on the Pharmaceutical Manufacturing plan for Africa: business plan.

Recomonded Articles:

Research Journal of Pharmacy and Technology (RJPT) is an international, peer-reviewed, multidisciplinary journal.... Read more >>>

RNI: CHHENG00387/33/1/2008-TC                     
DOI: 10.5958/0974-360X 

1.3
2021CiteScore
 
56th percentile
Powered by  Scopus


SCImago Journal & Country Rank

Journal Policies & Information


Recent Articles




Tags


Not Available