Medicine or simple chalk? Drug manufacturers warn of fake drugs on the market

Over-the-counter medications can be a lifesaver, especially when health insurance doesn’t cover the drugs, but they can come at a painful cost.

Some mystery shoppers—researchers hired to pose as customers—recently revealed the dangers patients sometimes face.

The drugmakers’ lobby, the Kenya Association of the Pharmaceutical Industry (KAPI), sponsored the mystery shoppers, who discovered that 17 percent of the drugs they bought were of poor quality or counterfeit.

“Seventeen percent of the products that were analyzed from samples collected through mystery shopping exercises did not meet the standards according to the specifications of the monograph,” said Juma Mwashuruti, associate director, anti-counterfeit medicines Africa, at Novartis Sub-Saharan Africa. The exercise was done in 2017, but no other studies have shown any improvement.

Juma spoke on World Anti-Counterfeiting Day, observed globally on June 4. The activity was organized by KAPI.

He said that such counterfeit medicines pose a great risk to the health of patients.

“This highlights the urgent need for action to curb the manufacture, distribution, sale and use of counterfeit drugs in the country,” he said.

The World Health Organization says that counterfeit medical products can contain no active ingredient, the wrong active ingredient, or the wrong amount of the right active ingredient.

“Also, they usually contain corn starch, potato starch or chalk.”

Many are produced in poor and unsanitary conditions by unskilled personnel, contain unknown impurities and are sometimes contaminated with bacteria, the WHO said.

The WHO said substandard and counterfeit medical products are also difficult to detect.

“They are often designed to look identical to the original product and may not cause a noticeable negative reaction. However, they will often fail to adequately treat the disease or condition for which they are intended and can lead to serious health consequences including death,” WHO said in a statement.

KAPI issued a statement calling on regulatory agencies, including the Anti-Counterfeiting Authority and the Competition Authority of Kenya, to take decisive action in promoting standardization and uniformity of requirements for the importation, distribution and sale of drugs.

“KAPI also requires these agencies to respect and enforce safeguards for intellectual property rights, preventing unauthorized traders from marketing drugs without clear authority from IP rights holders,” the statement said.

Dr Onesmus Saidimu, the regulatory officer in charge of product safety at the Pharmacy and Poisons Board, the drugs regulator, said the levels of counterfeit drugs in Kenya are low, but did not give figures.

He said counterfeit drugs range from expensive cancer products to cheap painkillers.

“Anti-malarials and antibiotics are among the most counterfeited products,” he said.

He said the board conducts regular post-trade surveillance to weed out counterfeit products.

“Some counterfeit medicines are almost identical to the original product and are difficult to detect. However, many can be identified by examining the condition of the packaging, spelling mistakes or grammatical errors,” he said.

It also advised pharmacists and consumers to check the manufacture and expiry dates and ensure that the details on the outer packaging match those on the inner packaging. “Make sure the medicine looks correct, is not discolored, degraded or has an unusual smell,” he said.

In January, PPB signed an agreement with the Anti-Counterfeiting Authority to work together in combating the problem of counterfeit drugs in the country.

The Memorandum of Understanding signed between the two aimed to strengthen the regulation and enforcement of the rights of health and technology product owners.

The focus will be on preventing the circulation of counterfeit health products within Kenya.

The main components of the agreement include information sharing, joint investigations, cooperation in training programs, research, exchange of expertise, technical exchanges and field activities.

“Working committees will be created for the implementation of the Memorandum of Understanding, focusing on detailed planning and execution of collaborative activities, defining the scope of action,” the statement said.