He said China has become a major supplier of pharmaceutical products to African countries, especially the anti-malaria treatments that have become increasingly familiar in local pharmacies, and that companies such as Tongmei Laboritoire, a Chinese-invested pharmaceutical company based in Togo, have established manufacturing plants on the continent.

Because many developing countries have weak or poorly functioning national regulatory authorities that are unable to ensure the quality of medicines, the WHO established its Pre-qualification of Medicines Programme in 2001 as a unique initiative to evaluate and monitor the quality of medicines used to treat priority diseases in developing countries in Africa and elsewhere.

"However, although China has begun to use the pre-qualification program as a means of bolstering the reputation of its products, there is a lack of strong programs in African countries to support the anti-counterfeiting efforts of the public health and safety authorities in those countries," Simons says.

The WHO's PQP has pre-qualified 29 anti-malarial medicines and roughly one-third of them are manufactured in China, according to O'Leary.

"The WHO ensures that the medicines procured through the scheme are safe and effective," he says.

However, he says the WHO PQP doesn't cover all anti-malarials produced in, and exported by, China, and the organization couldn't comment on the quality of such medicines.

Also, the WHO has organized training for Chinese manufacturers and regulatory authorities to strengthen production and regulatory practices and ensure that Chinese-made medicines meet international standards.

The responsibility for regulating the pharmaceutical sector remains with the national health authorities of each country, says O'Leary.

"In Africa, as well as in Asia, there is a need for major investment in strengthening the capacities of national health authorities," he says.

Increased collaboration

Kikule urges greater collaboration between the regulatory agencies and governments to ensure drug safety and combat counterfeiting.

Meanwhile, Chinese producers have begun to form partnerships with African pharmaceutical authorities and distributors to facilitate the tracking of their medicines. Anti-counterfeit labels have now been added to drug packaging, making illegal production even more difficult, according to Yu.

The Chinese authorities attach great importance to drug safety, and the regulations concerning exported drugs are in line with international practice, said Foreign Ministry spokeswoman Hua Chunying, who refuted the foreign media reports.

Moreover, no efforts have been spared in cracking down on fake drugs.

In June, the authorities in China and the United States launched a joint campaign to close 18 Chinese-language websites selling counterfeit drugs in the US.

Christopher Hickey, director of the US Food and Drug Administration's China office, says the administration hopes for continued collaboration with China in the global fight against counterfeit drugs.

However, investigators were unable to establish where the counterfeits were produced, says Hickey.

In 2007, Chinese police uncovered a massive counterfeit-drug syndicate based in South China, which sold fake anti-malaria drugs in Southeast Asia.

During the probe, conducted jointly with Interpol and the WHO, 24,000 packs of counterfeit Artesunate were seized, according to Chinese media reports.

The drugs were sold mainly in Vietnam, Cambodia and Laos, according to a suspect arrested during the operation. Malaria remains an endemic problem in those countries.

Ultimately though, concerted multinational action is required to ensure that counterfeit medicines, whatever their origin, are eradicated.

"China is a very important manufacturer of quality anti-malarial medicines and can play a substantial role to help secure safe and quality drug provision in Africa by closely cooperating with global stakeholders," says O'Leary.

Contact the writers at shanjuan@chinadaily.com.cn and lilianxing@chinadaily.com.cn

(China Daily 03/15/2013 page10)