Loopholes in PCM registration system

SOME Po Chai Pills which Li Chung ShingTong (an old business in Hong Kong) has soldin the SAR have been found to contain acarcinogenic pharmaceutical. The company ordered aproduct recall last January in Hong Kong withoutinforming the Department of Health of it. That is veryserious indeed. The health authorities must look intothe affair and have offenders punished. "Testing andcertification services" and "medical services" areregarded as industries where Hong Kong hasadvantages. The "registered in Hong Kong" label isregarded as a guarantee of quality. Many mainlanderswould come here solely to buy proprietary Chinese medicines (PCMs) made in Hog Kong. However, suchproducts are monitored far more loosely than Westerndrugs. Furthermore, the government has yet tointroduce a sound PCM registration system. If thegovernment cannot improve the testing and certification of such products, how can Hong Kong begin to talk about developing industries where it hasadvantages?

On March 25, Li Chung Shing Tong insisted atnoon that Po Chai Pills that contained harmfulpharmaceuticals had not been distributed in HongKong. It did not tell the truth until the Department ofHealth gave the lie to its statement a few hours later.It has clearly tried to keep the public in the dark. Thecentury-old firm has long had Hong Kong people'strust. However, when it found some Po Chai Pills to betainted, it recalled them without informing the public. Ithas tried to safeguard its own interests at the expenseof public health. Such a move is utterly unconscionable.

The affair has aroused concern over Hong Kong'sPCM registration system. The Po Chai Pill is awell-known PCM made in Hong Kong, where manyhad sworn by it. However, there is in fact a bigloophole in Hong Kong's PCM registration system. Forexample, Li Chung Shing Tong does not meet GMP(good manufacturing practice) standards. Furthermore,the Department of Health has yet to introduce a soundPCM registration system under which all such productsavailable in the territory must be tested for theirefficacy and safety.

The registration requirements of PCMs are verydifferent from those of Western drugs. Under thelegislation in force, a "notice of confirmation oftransitional registration" may be issued in respect of aPCM on sale in Hong Kong before March 1999 if theapplicant provides basic information for safeguardingpublic health and commercial documents. The system isfar less strict that than that pertaining to Western drugs.

The incident involving the pharmaceuticalcompany has aroused public concern mainly becausethe quality monitoring system has long been the prideof Hong Kong. Not only Hong Kong citizens but alsovisitors are convinced that the "registered in HongKong" label on a PCM is a guarantee of its goodquality. The government has vowed to develop sixindustries where Hong Kong has advantages. Amongthem are "testing and certification services" and"medical services". It can thus be seen that "qualityguarantee" is the lifeblood of Hong Kong's economy.

The Po Chai Pill affair has served as a warning tothe SAR government. It has given it to understand thatit must strictly punish pharmaceutical companies forbreaking the rules, safeguard the reputation of theHong Kong brand and hasten to put in place a soundPCM registration system. Unless it does so, peoplemay think there are no rules governing themanufacturing and sale of PCMs in Hong Kong, andour dream of developing the six industries where HongKong has advantages will fall through.

明報社評2010.03.29

不堵中藥制度漏洞優勢產業美夢難圓

香港老字號李眾勝堂在本港銷售的「保濟丸」，不單含可能致癌並禁用的西藥，更在今年1 月私下回收並隱瞞衛生署，事態嚴重，香港衛生當局在查明事件後必須懲處違規者。檢測和認證、醫療服務都被視為香港的優勢產業， 「香港註冊」被視為優質的保證，不少內地遊客到港就是要搜購香港的成藥，然而，香港對中成藥的規管遠較西藥寬鬆，完善的中成藥註冊制度仍未落實。如果政府無法加強中成藥的品質驗證，優勢產業又從何談起？

李眾勝堂3 月25 日中午堅稱含有害西藥的藥丸沒有在香港出售，但數小時後被衛生署踢爆，才改口承認，明顯是刻意欺騙公眾，企圖瞞天過海。一家百年老店，備受香港人信賴，但是發現藥丸出事後只顧私下回收，沒有即時通知公眾；只顧自身利益，置公眾的健康於不顧，令企業的良知蕩然無存。

這次事件更令人關注到香港的中成藥註冊制度。保濟丸是香港有名的中成藥，備受港人信賴，但原來香港的中成藥註冊制度仍然存在極大漏洞。例如，李眾勝堂原來並未獲中藥GMP（生產質量管理規範，製造商證明書）資格，而衛生署目前亦仍未實施「註冊中成藥制度」，要求所有在市面銷售的中成藥，其藥效、藥理和安全均須通過檢證。

中成藥的註冊與西藥有極大分別，根據現行法規，1999 年3 月前已在本港銷售的中成藥，只要提交基本保障公共衛生資料和商業文件，便可獲發「過渡性註冊通知書」，監管遠不如西藥般嚴謹。

一家藥廠出事，為何會引起公眾的關注，主因就是香港的品質監察制度一直是港人的驕傲。不單是港人，就連內地遊客也堅信， 「香港註冊」就是成藥的「品質保證」。特區政府早亦已表明要發展六大優勢產業，其中兩項正正是「檢測和認證」和「醫療服務」，由此可見， 「品質保證」實在是香港經濟的命脈。

這次保濟丸出事，正好給予香港政府一個警號，提醒政府必須嚴懲違規藥商，捍衛香港品牌的聲譽，也應盡快推行完善的註冊中成藥制度。否則，一旦香港被冠上「中成藥原來無王管」的標籤， 「優勢產業」這個美夢勢將付諸流水。

Glossary

give the lie toIf you give the lie to something, you show thatit is not true.swearIf you swear by something, you are certain thatit is good or useful.fall through not happen or not be completed.