Traditional healer's hut

Steve Allison

In recent years a number of biotech companies from developing nations have tried to market their traditional medicines to the developed world.

But in the US at least, the tremendous costs of international clinical trials and strict regulations of the Food and Drug Administration (FDA) has meant that none has so far succeeded in their venture, reports Paroma Basu in this article in Nature Biotechnology.

The only way to avoid huge initial outlay — developing a drug in the US costs about $900 million — is to market the drugs as dietary supplements. No clinical trial is required, but dietary supplements can only claim to prevent a disease's symptoms, not cure it. Also, recent concerns over the safety of these supplements have made regulators in the developed world even more suspicious.

There might be signs of easier market entry in the future says Basu. This month, the traditional Chinese medicine Kanglaite will have come farther than any traditional medicine in being approved in the US. The EU and Canada have recently eased the entry of traditional medicines in the market and the FDA might formally adopt new, looser, regulations on 'botanical drugs'.

Some optimists in the developing world's biotech sector say that western medical professions and regulators are slowly warming up to their local botanical drugs. Developed nations, on their side, are hoping to bring more scientific vigour into the selection and use of traditional medicines. 

Link to full article