Products OK, Yunnan Baiyao says

Traditional Chinese Medicine (TCM) maker Yunnan Baiyao Group Co Ltd announced that it has revised its product information as required by China's drug authority and claimed that its products are safe, according to a statement it filed on the Shenzhen Stock Exchange Tuesday.

Following a notice issued last November from the China Food and Drug Administration (CFDA) on revising product instruction of TCM containing toxic components, the company revised all related product information by the end of last year, according to the filing. Yunnan Baiyao's products are intended mainly to relieve traumatic injury and muscle pain.

The company also said that more than 1,000 kinds of TCM across the country needed to have their information revised.

If the drugs that TCM makers produce contain any one or more of the 28 toxic components listed in a set of rules that the State Council published in 1988, the companies should label these components in their product instructions, the CFDA said in a notice released November 4.

The CDFA also noted that TCM made with State secret recipes should also obey the order.

Chinese pharmaceutical administration law also requires medicine components to be named in the drug packaging, but Yunnan Baiyao still has not revealed the full components for its products.

A staff member of Yunnan Baiyao, who declined to be named, told the Global Times Tuesday that the company did not disclose the ingredients of its medicine because that was classified as a State secret by the State Council in 1956.

"It is outdated to pursue protection with an administrative document released decades ago," Yu Mingde, chairman of Chinese Pharmaceutical Enterprises Association, told the Global Times Tuesday.

It is understandable that medicine recipes were protected with an administrative document at that time because China had no intellectual property rights protection law, according to Yu.

But it is not reasonable to do so now since China added medicine intellectual property rights protection into its patent law in 1993, Yu said.

Media reports said Yunnan Baiyao's products sold in the US revealed all components in the instruction. The anonymous staff member said this was done in accordance with US administrative regulations.

A TCM product often contains dozens of herbal ingredients and it is common to not reveal some special or tiny amounts of components, Zhang -Wensheng, a partner lawyer of Beijing Jinghan Law Firm and also a former physician, told the Global Times Tuesday.

However this might not be safe for some patients in special conditions, Zhang said, noting regulation and -supervision of medicine instructions should be strengthened.

Yunnan Baiyao has already experienced a recall in Hong Kong.

On February 5, 2013, the Hong Kong Department of Health (HKDH) ordered a recall of five Yunnan Baiyuan products, including capsule, powder, plaster, aerosol and tincture, as they had been found to contain undeclared aconitum alkaloids, which is a toxic herbal ingredient used in TCM.

Yunnan Baiyao then released a statement on its website on February 6, 2013 saying that its products contain -aconitum, but the company's special processing technology has greatly -reduced the toxicity.

If used improperly, aconitum alkaloids can cause discomfort like numbness of the mouth and limbs, nausea, vomiting and peripheral weakness, and even lead to life-threatening conditions like breathing difficulties and cardiac arrhythmia, according to the HKDH.

The statement said that the company's observation of side effects had showed the products are safe.

According to the products' registration details and the Chinese medicine literature, the ingredients in the products could not account for the presence of aconitum alkaloids as detected, the recall statement said.

Yunnan Baiyao said in the Tuesday statement filed on the Shenzhen Stock Exchange that -+after updating the products' registration details, the HKDH had allowed their products to be placed back onto store shelves in November 2013.