New testing standards 'limiting medicines'
Makers of Chinese formulas say clinical trials needed for approval are too costly
A new registration system for Chinese medicines in Hong Kong is reducing the range of products and increasing retail prices, according to suppliers.
The system is likely to improve quality but laboratory testing is adding to costs and keeping new products off the market, they say.
Introduced under the Chinese Medicine Ordinance passed in 1999, the registration system requires all manufacturers, importers and sellers of Chinese medicine formula products to provide clinical proof of claims.
They must also state the levels of heavy metals and toxins, pesticide residues and microbes contained in their products.
The Chinese Medicine Council had received more than 23,000 applications by the end of the registration deadline last month but has yet to evaluate any.
Tin Wing-fai, chairman of the Hong Kong Chinese Prepared Medicine Traders Association, said the system was steering Chinese medicine towards dealing only in tried and tested products, while avoiding anything new that would cost millions of dollars to register and test.
'New products will find it hard to break into the market,' he said.
The association estimates the required tests will cost at least $40,000 for each product and millions of dollars if long-term toxicity tests are required.
Mr Chan said some smaller manufacturers had limited their range but it was too soon to estimate how many products would come off the market.
Tse Cho-ying, general manager of Han Fong Chinese Medicine Company, said her company had dropped 40 of the 250 products imported from its Taiwan-based factory. 'We have to select products that are worth the investment.'
Ms Tse said the system would ensure better-quality products for consumers, but the added costs would have to be passed on to the public.
She suggested the government should take gradual steps to reform the Chinese medicine market before reaching the highest international standard, which would require a series of costly laboratory tests.
The president of a Hong Kong-based Chinese medicine manufacturer agreed.
'The government required us to do some of the tests in specified laboratories approved by mainland health authorities, but they are not necessarily better or of an international standard,' said Abraham Chan Yu-ling, president of PuraPharm.
He said his firm would need to invest more than $10 million to register 400 formula products.
He has dropped 10 of 40 over-the-counter products now on sale in local pharmacies because the long-term toxicity tests cost up to $200,000 for each product.
