Pharmaceutical companies are a commercial business licensed to research, develop, market and/or distribute drugs, most commonly in the context of healthcare. Pharmaceutical companies may deal in generic or brand medications and medical devices. They are subject to a variety of laws and regulations that govern the patenting, testing, safety, efficacy and marketing of drugs. The pharmaceutical industry plays a significant role in developing medications and vaccines to reduce the incidence of diseases, to treat diseases and enhance the quality of life of people.
The Zambian pharmaceuticals industry comprises of bio medical research, biotechnology firms, originator and generic medicine companies and service related segments including wholesaling and distribution.
Laws and regulations in Zambia
In Zambia the pharmaceutical sector is under the full authority of the Pharmaceutical Regulatory Authority (PRA), which is a semi-autonomous public board created under the National Drug Policy. The Pharmaceutical Regulatory Authority is in charge of registration and regulation, procurement and distribution of drugs, financial management, as well as issues concerning quality control of drugs and rational use of medicines.
Most producers of medicines circulating on the Zambian drug markets are foreign producers. To receive the market authorization, they must all comply with anyone of the following set of regulation: the WHO certification, the certification standards of the country of origin of the drugs and/or re-testing by the Zambia Food and Drug Laboratory. Medicines produced by local manufacturers must be certified by the Zambia Food and Drugs Laboratory before being introduced on the market.
Pharmaceutical industry in Zambia
The Zambian pharmaceutical industry has continued to register strong growth mainly due to the overall population growth, underlying economic growth of about 6.5% that had been experienced for almost a decade. Despite the last two years reduced GDP growth rate that the economy has experienced mainly due to the tanking of international copper prices and power bottlenecks, the pharmaceutical industry is expected to continue its growth trajectory. The World Health Organization (WHO) report showed that the Zambian pharmaceutical market size had reached $241 million by 2014, but like many African countries, the country remained behind in local manufacturing, leading to dependency on imports for its budding industry. The manufacturing potential of the pharmaceutical industry has great promise due to the rise in consumer spending, increased medical needs as well as improved diagnostic services.