Achin Jain,
Neenu Ganesh,
- Manager Procter and Gamble Home Product Private Limited, Mumbai Maharashtra India
- Associate Professor Department of Pharmaceutical Chemistry, Oriental College of Pharmacy Maharashtra India
Abstract
The significant burden of diseases in Zambia and its neighboring countries, such as malaria, HIV/AIDS, and other ailments. These health challenges necessitate a high consumption of pharmaceutical products. Currently, the majority of essential health drugs in Zambia are imported from outside of Africa. This reliance on external sources presents an opportunity for new investments in the local manufacturing of pharmaceutical products. Although Zambia may not be the largest pharmaceutical market in Africa, it possesses several advantages that make it an attractive prospect for investors. The country’s demand for pharmaceutical products is consistently triggered by the prevalence of diseases, creating a stable market. By establishing pharmaceutical manufacturing facilities within Zambia, companies can cater to this demand more efficiently and reduce the country’s dependence on imported medications. The health sector in Zambia is currently grappling with a substantial human resource crisis, which greatly hampers its ability to deliver essential healthcare services to the population. The shortage of healthcare professionals and the resulting strain on the healthcare system emphasize the need for increased investments in the pharmaceutical sector. By expanding local manufacturing capabilities, Zambia can improve access to essential health drugs and enhance the overall healthcare infrastructure. The primary focus of the study mentioned is to shed light on the regulatory requirements for drug registration in Zambia. Understanding and complying with these requirements are crucial for gaining easy market access and conducting pharmaceutical business in the country. The study encompasses various aspects, including the organizational structure of Zambia, the classification of medicinal products, the registration process, and the fee structure for different types of applications. By following these guidelines, pharmaceutical companies can navigate the registration process more effectively, ensuring that their products meet the necessary standards for market entry in Zambia.
Keywords: National Drug Policy (NDP), Zambia, Pharmaceutical Regulatory Agency (PRA), Medicinal product, Basic Health Care Package (BHCP), Medicines Transparency Alliance (MeTA), Logistics Management Information System (LMIS).
[This article belongs to Research & Reviews: A Journal of Drug Formulation, Development and Production(rrjodfdp)]
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| Volume | 11 |
| Issue | 02 |
| Received | April 19, 2024 |
| Accepted | July 3, 2024 |
| Published | July 16, 2024 |