Traditional Chinese medicine (TCM) manufacturers have launched a new campaign to garner a greater share of Western drug markets, but industry analysts caution that the road to success is likely to be very bumpy.

"Under the current regulatory systems in major Western countries, especially that of the US Food and Drug Administration (FDA), it is still very hard to gain acceptance of TCM as a legitimate branch of the pharmaceuticals trade," said Ji Shen, a senior TCM researcher with the Shanghai Institute of Drug Controls.

Recently, the China National Corporation of Traditional and Herbal Medicine (CNCTHM) got FDA approval to launch clinical trials for one of its TCM products, a necessary step to obtain a licence for sale and use of a drug in the United States.

So far, no TCM is sold in the US market as a drug. Dozens of traditional Chinese medicines being sold in the United States and European markets are sold as dietary supplements, not as drugs, which means they cannot be sold through hospitals.

China exports TCMs valued at about US$500 million annually. Most of the country's TCMs are exported to East and Southeast Asian countries.

Han Pei, an official of Technical Marketing Department of the Beijing-based CNCTHM, said the drug in question has been proven effective in curing lung cancer, but she refused to reveal any further details about it. She said she is currently negotiating with US partners to finance clinical trial in the United States and to market the medicine there.

"Although we can sell our products in the US market as dietary supplements, we have not done so, because we want our products to be sold through hospitals and doctors. TCMs cannot prove their curative effects if they are limited to use as dietary supplements, and, more importantly, patients may misuse them," Han said.

The side-effects caused by patients' improper use of TCMs often lead the FDA to ban the products, Han told China Business Weekly during an exclusive interview.

But to obtain an FDA drug licence is much more difficult than getting a sales licence for a dietary supplement.

In 1997, for the very first time, two traditional Chinese medicines were given FDA approval to launch clinical trials in the United States. One of them was Tianjin Tasly Group's cardiotonic pill, and the other was Shanghai Xingling Pharmaceutical's ginkgo compound.

However, neither of them completed the required three phases of their clinical trials, and they failed to get licences for sale in the United States as drugs.

The FDA requires that all ingredients of a drug must be clearly specified, as well as dosage, curative properties and possible side-effects. But with TCMs, especially those with complex formulas consisting of dozens of ingredients, it is impossible to accurately give the chemical content of each ingredient, according to TCM researcher Ji Shen.

She added that in the synthesis of some TCMs, poisonous elements may be combined with other elements to produce a drug that is effective in fighting some specific disease.

Han said that TCM cannot be accepted by FDA and mainstream Western medical theories en bloc, but that separate medicines with simple formulas could well be accepted. If such a medicine eventually obtains a FDA drug licence, it will be a great stimulus for TCM manufacturers to standardize their drug formulas and sell them internationally.

But the huge costs involved in conducting clinical trials in the United States remain a seemingly insurmountable barrier for TCM manufacturers.

The average cost of a clinical trial in the United States is US$80 to US$100 million. Few TCMs sell in great enough volumes to be able to afford such a trial. In China, the annual research budget of even the largest pharmaceutical firms is less than 500 million yuan (US$60.38 million).

Few drug makers in China can afford the cost of such a clinical trial in the United States.

From ChinaDaily.com.cn