The city's drug watchdog said yesterday they would continue to improve management of medicine made by hospitals and crack down on cases which flout regulations.

Medicine made by hospitals came under the spotlight recently after the Punan Hospital in Pudong New Area was penalized by the Shanghai Food and Drug Administration for prescribing a medicine which had not been registered with the city's FDA.

The medicine, Gankang, is a traditional Chinese herbal medicine developed by Dr Liu Zhihua from the Punan Hospital to treat fatty liver. A clinic to treat the liver using traditional Chinese medicine was established by the hospital in May 2005.

However, the clinic was said to have been prescribing the Gankang liquid medicine packed in bag which did not have the medicine's name, instructions or production date, and doctors just wrote code names such as "Gankang No. 1" or "Gankang No. 4" on their prescriptions.

The Shanghai Food and Drug Administration began to investigate the case after a tip-off, and found that the hospital had asked a local traditional Chinese medicine company, Yanghetang, to boil down the medicinal herbs for them from October 2006 to October 2007. This had not been reported to the administration and had not undergone the necessary examination and approval.

According to the city's FDA, medicine made by hospitals which has not been registered with the FDA is regarded as counterfeit and in breach of the law, and the prescription process of the clinic was not accordance with regulations.

The hospital was fined about 400,000 yuan (US$54,054) and ordered to rectify the situation in October last year.

However, according to the Punan Hospital, they just wrote name codes in the prescriptions in order to avoid the medicine constituents being made public.

According to the inventor Liu Zhihua, the medicine is a Chinese herb which, to ensure its effects and safety, underwent tests on animals for more than a year. He then applied to conduct clinical tests.

Dr Liu has been involved in the study of hepatitis B, fatty liver and cirrhosis for more than 30 years.

(Shanghai Daily January 5, 2008)