Resident Fellow Roger Bate

Anecdotal reports by health-care workers in Africa and Southeast Asia reveal a worrying new trend: Drugs successfully used for years to combat malaria, tuberculosis, and HIV are failing more and more often. Misdiagnosis of disease, coupled with the (related) misuse and overuse of drugs, likely plays a role, especially in resource-constrained countries where scientific diagnostic tests are unavailable or too expensive to be practical. But many doctors suspect another culprit: counterfeit drugs.

Nothing is more dangerous for a poor patient with a potentially fatal disease than taking drugs that do not work. Not only can faulty drugs poison the patient (over 100 children died in Panama, for example, after taking cough syrup that had been mixed with diethylene glycol, a common component of antifreeze), they also eliminate the possibility of effective treatment. The doctor has no way of knowing whether the patient is simply not responding as expected or if the drug itself is to blame. Faulty drugs that contain too little active ingredient to work properly can also breed resistance, undermining the long-term effectiveness of authentic therapies.

Studies suggest that many of the substandard drugs in Africa and Southeast Asia--as well as other medical products such as non-sterile blunt needles and syringes--are produced in and imported from China and India. Products proliferate along the Mekong Delta, notably in Cambodia, and local authorities appear bemused as to how to respond. An example for them is Dora Akunyili, director general of Nigeria's drug regulatory authority who is taking the attack back to exporting nations. "India and China are not helpful, Chinese officials don't care about the problem. Indian ones are not serious either," she bristles. She has banned over 20 companies from India and China from exporting to Nigeria.

A key problem is that both countries have gaping holes in their domestic regulation: India lacks a federal drug agency; its state regulators are often influenced by political considerations and plagued by corruption. Take Haryana Province, home to the well-known counterfeiter Paval Garg. A secret BBC camera crew recorded Mr. Garg boasting about providing counterfeit drugs on demand and paying off local officials to prevent disclosure. When discussing exporting fakes out of the country, he put it succinctly, "My country is my problem, your country is your problem."

Even when manufacturers attempt to make high-quality pills, hygiene standards are often woeful. When I was shown around one factory in Hyderabad my guide picked up a handful of pills, without gloves on, to show me the quality, and then replaced them in the production line. The Indian government claims that fewer than 0.5% of products in India are counterfeit and under 8% substandard in total, but local experts told me that the government doesn't do proper random testing, essentially giving notice to pharmacists that they're coming to do collections, which obviously biases any results.

China has similar problems. It has thousands of drug producers and, according to Dr. Akunyili, corrupt politicians are paid off to not inspect the producers' manufacturing facilities or assess the quality of drug they produce. Insiders tell me that a small factory that made fake drugs in northern China was even housed inside a military base--a significant deterrent to would-be whistleblowers. When copy DVDs and commercial software were produced inside military bases in Guangdong Province a few years ago, local authorities were incapable of preventing it.

Research by Prof. Jin Shaohong, director of China's National Institute for the Control of Pharmaceutical and Biological Products, suggests that drug quality is improving. In 1998 about 14% of drugs were substandard; today the figure is below 10%. Beijing has spent hundreds of millions of dollars on random testing in the field. Yet, as Dr. Jin reminded me, "criminals are very smart and chemically competent."  Fake products are often deliberately engineered to pass basic quality tests, using, for example, a substitute ingredient that mimics the chemical activity of the authentic ingredient closely. This was the case with Chinese exports of heparin, toothpaste and pet food to U.S. in the past three years. Greater vigilance is required to detect these fakes. While some authorities in Beijing are taking action, if state politicians continue to protect criminals, and military-run factories continue to thrive, substandard medicines will be ever present.

For while anti-counterfeiting laws can and should be improved in China and India, the real problem is a lack of enforcement of existing laws. In both countries there are too few inspectors to examine all suspicious manufacturing sites; those inspectors are rarely exacting when they find poor performance. When they have the courage to act, few prosecutions occur.

This can change but only if the U.S., EU, Asian and African officials continue to pressure Beijing and New Delhi for more rigorous inspections and better policing. India has taken a step forward by agreeing to partner with the U.S. Food and Drug Administration to allow more foreign inspectors. And the FDA plans to establish eight, full-time permanent positions in China.

China's execution of FDA head Zheng Xiaoyu last year, for receiving bribes from local pharmaceutical companies, was a strong political response. Still, grand gestures such as this will do little to improve the drugs reaching, and killing, the poorest Africans and Asians, unless they are accompanied by more mundane, but vital quality checks at the production and distribution level.

Roger Bate is a resident fellow at AEI.