The fight against counterfeit medicines in Africa has been stepped up to meet the growing demand for quality medicines.

The United States Pharmacopeial Convention’s Centre for Pharmaceutical Advancement and Training (CePAT) in Ghana, in partnership with African countries, has expanded continent’s quality control testing and training capabilities by opening a new pharmaceutical microbiology laboratory.

The microbiology laboratory will train pharmaceutical and regulatory professionals across Africa on how to identify medicines that have been contaminated by external factors such as bacteria, fungus or poor temperature control.

“Such complex testing has historically been a challenge in Africa. This ‘model’ lab can be replicated in other countries across the continent, as it is purposefully built to operate in low-resource settings,” said Patrick Lukulay CePAT vice-president, global health programmes — Africa.

The facility is meant to provide the skills to detect medicines that have been contaminated by micro-organisms, including bacteria. It will also respond to the demand for microbiological testing of medicines and help fill testing gaps in the region. 

In many African countries, regulatory systems are not equipped to detect substandard or counterfeit medicines and remove them from the market.

Often, policies preventing their sale and distribution are either lacking or not followed.

“Millions of Africans depend on national regulatory systems to ensure the quality and safety of their medicines and, too often, these systems cannot deliver; this has to change,” said Kelly Willis, USP’s senior vice president for global public health. 

Drug-resistant strains

According to Dr Lukulay, counterfeit and substandard medicines are contributing to the emergence of drug-resistant strains of microbes that cause diseases such as malaria, tuberculosis and other infections.

Drug resistance renders even quality-assured treatments ineffective and, thus, deadly diseases virtually untreatable, posing a grave threat to public health, not only in Africa, but globally.

“The challenge is that in many African countries, regulatory systems are not equipped to detect substandard or counterfeit medicines and remove them from the market. Often, policies preventing their sale and distribution are either lacking or not followed,” said Dr Lukulay.

USP plans to provide scholarships to 12 regulatory professionals from six African countries every two months, with the ultimate aim of building a cadre of well-trained individuals who can help ensure that medicines reaching Africans are safe, effective and beneficial.

It is estimated that up to one-third of medicines in some parts of Africa are counterfeit and even more are substandard – meaning they are either ineffective or harmful to patients.

The costs of poor-quality medicines in African countries are enormous. It is estimated that more than 122,000 African children under the age of five die each year because of counterfeit antimalarials alone.

More patients face failed treatments or fall into poverty because of the costs of procuring additional medicines or paying hospital bills.

“Poor-quality medicines place an enormous economic strain on families and health systems. Counterfeit and substandard drugs are contributing to the rise of drug-resistant strains of various diseases, including malaria, tuberculosis and common infections,” noted Dr Lukulay.

Regulation

In 2013, USP-Ghana launched the CePAT in Accra with the aim of building a cadre of well-trained regulatory professionals across the continent and, ultimately, improving the capacity of national regulatory authorities to detect counterfeit and substandard medicines at the local level.

Since its launch, CePAT has trained 190 professionals from 32 African countries in various regulatory functions.