The world is seeing a major shift in production of active pharmaceutical ingredients (APIs) to Asia, primarily India and China, Jeffrey Green, director of Office of Health and Consumer Goods at the US Department of Commerce, said.

He was speaking at a session on anti-counterfeit pharmaceutical products held in Bangkok yesterday, hosted by the US-Asean Council.

Counterfeit production is primarily driven by the high costs in the developed world and the problem is that India and China still lack effective regulatory control of APIs that provides incentives for counterfeiting, said Green.

In the absence of an effective control mechanism in India, for example, there are two production lines of APIs, he said, adding that one went to the regulated market and the other went to the unregulated market worldwide.

In the next 15 years, it is projected that up to 80 per cent of the global production of APIs will be in China and most of the global pharmaceutical production will be done in these two countries, said Green.

Without effective control in the form of global cooperation, the counterfeit-drug problems are likely grow much worse, he said.

"We're not pointing fingers but trying to create cooperation," insisted Green. "Global cooperation is the only way to resolve this global issue."

One measure needed to tackle drug counterfeiting in India and China is to use a system to regulate the production and track the shipment of pharmaceutical ingredients globally, Green added.

The US Centre for Medicines in the Public Interest has projected that counterfeit-drug sales will reach US$75 billion (Bt2.6 trillion) by 2010 - an almost 90-per-cent rise from 2005, he said.

"Organised crime has moved from narcotics to counterfeiting," he added.

In developed countries such as the US, Japan and Europe, counterfeit drugs tend to be the highly priced drugs, whereas in poorer countries counterfeit medicines include drugs for the treatment of malaria, tuberculosis and HIV/Aids.

Meanwhile, some drug companies have suggested that Thailand is likely to be exploited as a base for counterfeit-drug shipment as the country is perfectly situated between India and China, said Edward J Kelly of Tilleke & Gibbins International Ltd's intellectual property division.

As for pharmaceutical counterfeiting in Thailand, Weerawan Tangkeo, the deputy secretary-general of the Thai Food and Drug Administration, said she was concerned that expensive drugs for HIV/Aids treatment, high blood pressure and cancer would become future problems.

In the meantime, the most common counterfeit drugs are anti-erectile dysfunction, malaria and hormones.

Arthit Khwankhom

 The Nation