Chinese regulator must crack down on drug producers who cut corners

PUBLISHED : Wednesday, 11 July, 2012, 12:00am
UPDATED : Wednesday, 11 July, 2012, 12:00am


The World Health Organisation approves a few Chinese drugs for sale to the poorest and most vulnerable people around the world. These drugs are cheap and save lives when deployed by global health programmes. But recent evidence from my own research shows some of these are failing quality control tests.

The real problem is Beijing's. Until the Chinese government starts punishing sloppy manufacturers, pharmaceuticals from China will continue to put people in harm's way wherever they are sold.

Before the WHO approves a Chinese drug, it is usually registered with China's State Food and Drug Administration. In theory, this should ensure that a quality product will be consistently produced.

My research mostly bears this out. We collected off the shelf and tested over 2,500 drugs to treat malaria, tuberculosis and bacterial infections in low- and middle-income cities around the world. In general, registered products were far less likely to fail quality tests compared with unregistered products.

Yet, when we drilled down to manufacturers, we found that products made by Chinese companies - even those certified by the WHO and sold in Africa - too often failed quality control tests. This is true to a lesser extent of Indian products.

The failures were not randomly distributed; they occurred in markets with the poorest regulation. For nations with little oversight like Rwanda, Kenya or Angola, the quality was notably worse than in nations like Brazil and Turkey, where national regulators enforce some quality control in the aftermarket. It was also far worse than in China itself.

Chinese antibiotics sold across Africa were roughly four times more likely to be substandard than those sold in China. This may be partly explained by the higher circulation of fake Chinese products in Africa than in China, but at least half of the samples were legal products that simply did not work as they should. The discrepancy is less marked with Indian products. They nevertheless failed in Africa twice as often as they did in India.

The lesson here is if a regulator is incapable of enforcing drug quality control, or can be bribed not to do so, then even good-quality manufacturers may cut corners to increase profits, since they are unlikely to be exposed.

We know this is happening in New Delhi. In May, a major parliamentary report concluded that officials of India's drug regulator, the Central Drugs Standard Control Organisation, were colluding with pharmaceutical firms and approving medicines of dubious provenance.

It's clear from the report that companies did not always comply with the law. What it really highlighted for public health economists, like myself, is how untrustworthy the regulator has become.

We have no such view into the opaque Chinese government. But the body of data on substandard Chinese drugs in markets around the world is only growing. China knows the WHO has effectively no budget to ensure drug quality after it approves products. And the WHO, which is eager to increase access to cheaper generic drugs, has assumed good behaviour from manufacturers it knows can make good products. Based on the data we've shared, the WHO has launched an investigation, but in the future, it might do better to rely less on good faith.

When my team looked at generic malaria drugs sold in Accra, Ghana, and Lagos, Nigeria, through a massive new donor health programme called the Affordable Medicines Facility for malaria, we found that about 8per cent of products approved by the WHO didn't pass quality control tests. Nearly all of them were manufactured in China and contained too little active ingredient.

The problem could be product degradation, but our research points to sloppy manufacturing instead. None of the products that were made in Switzerland, for instance, failed quality control tests.

Donors have ordered more than 100 million of these treatments in West Africa alone. If our research were extrapolated across this supply, it could translate into about eight million underdosed drugs in Africa. That would cause significant harm to poor patients and build population-level resistance to the best malaria drugs we have - which is precisely the problem this particular programme aims to solve.

With Western countries now sourcing 80per cent of their pharmaceutical ingredients and 40per cent of the finished products from abroad, the problem is not confined to Africa. Most of the drugs from India and China will be of the highest quality, but until corner-cutting is consistently punished in Beijing and New Delhi, their substandard drugs will put all of us at risk.

Roger Bate is a resident scholar at the American Enterprise Institute and author of Phake: The Deadly World of Falsified and Substandard Medicines. His research has just been published in Research and Reports in Tropical Medicine