LCQ1: Medicinal capsules

     Following is a question by the Dr Hon Joseph Lee and a reply by the Secretary for Food and Health, Dr York Chow, in the Legislative Council today (May 30):


     It has recently been discovered in Hong Kong that the amount of chromium contained in the capsules of some proprietary Chinese medicines (pCms) in capsule dose form exceeds the recommended limit.  The Department of Health (DH) has pointed out that ingestion of very large amount of chromium may be harmful to health, and may even cause death.  Given that apart from pCms, some generic western drugs produced by local pharmaceutical manufacturers are also in capsule dose form, will the Government inform this Council:

(a) apart from the three pCm products the capsules of which contain amount of chromium exceeding the recommended limit, as announced by DH, of the types, quantities and exceedances of other pharmaceutical products in capsule dose form which have so far been found by the authorities as containing excessive amount of chromium;

(b) of the existing mechanism adopted by the authorities to test the safety of the capsules of pharmaceutical products; whether they will immediately conduct large-scale testing to ensure that pCms in capsule dose form available on the market comply with the specifications; if they will, of the details; if not, the reasons for that; whether they have assessed if the existing mechanism can effectively prevent problematic pharmaceutical products in capsule dose form, including western drugs and pCms, from being put on the market; and

(c) whether the authorities will, with a view to safeguarding public health, initiate as soon as possible the full implementation of the Good Manufacturing Practice in respect of Proprietary Chinese Medicines, or before the full implementation of that, make reference to the practices of other countries to improve the existing pCm testing mechanism, so as to prevent the occurrence of similar incidents; if they will, of the details; if not, the reasons for that?



     The Department of Health (DH) has all along maintained a mechanism whereby products are collected from the market on a regular basis for testing according to risk assessment, in order to monitor the quality and safety of western drugs and proprietary Chinese medicines (pCm) in Hong Kong.  Regarding pCms, the level of heavy metals, pesticide residues, microbial limit and western drugs adulteration etc. are tested.  DH collects over 4 000 western drugs and pCm samples for testing each year. If any non-compliance is found, DH will make prompt announcement and follow up on the case in accordance with the law.

     Upon media reports of capsules containing chromium at a level exceeding the recommended limit in the Mainland, DH has immediately taken a series of measures to ensure that the safety and quality of local registered pCms in capsule dose form are up to standard with a view to safeguarding public health.

     Firstly, DH has immediately issued letters to request all local pCm manufacturers and wholesalers to examine their pCm products and ascertain the source of empty medicinal capsules they use.  If they use empty capsules supplied from the Mainland, pCm traders are required to submit laboratory test reports on the amount of chromium to prove that the product in question meets the standard limit for chromium of 2 ppm as prescribed in the Pharmacopoeia of the People's Republic of China (2010 version). Compared with the relevant limits adopted in other countries, the aforesaid Mainland standard limit is more stringent. If pCm traders are unable to make declaration to DH on the source of capsules used for their pCm products by end of May, they will have to submit laboratory test reports furnished by the manufacturers of their empty capsules, pCm manufacturers or authorised laboratories to prove that the empty medicinal capsules they use meet the relevant standard limit whenever they apply for import and export licences for their pCm products.

     As at May 28 this year, around 920 pCm traders already declared to DH on the source of capsules they used for their pCm products.  Of the 920 pCm traders, 220 declared Mainland as place of manufacture of their pCm capsules. Among them, around 200 have submitted supporting laboratory test reports. One laboratory testing shows that the amount of chromium therein exceeds the required limit. There are two other cases whereby the traders could not provide DH with valid laboratory testing reports. DH then collected relevant samples for testing and found the amount of chromium in the 2 pCm products to exceed the standard limit. DH has made prompt announcement and instructed product recalls.

     Secondly, DH has since May 1 this year, required all pCm traders to obtain laboratory test reports for chromium from capsule suppliers if they import pharmaceutical products in capsule dose form from the Mainland.  These reports should be properly kept and, where necessary, submitted to DH.

     Thirdly, market surveillance for pCm capsules has also been stepped up.  DH has so far collected over 40 pCm capsule samples for testing by the Government Laboratory.  The test results so far show that with the exception of the three cases announced by DH earlier, the chromium content in the remaining 30 odd samples are within the limit.  DH will follow up on the remaining test results and collect further samples for testing. In general, if one consumes the pCms according to their respective dosage instructions, the level of chromium intake will unlikely cause acute harmful effects by taking reference to the recommendation made by the World Health Organization.

     As for western drugs, at present, manufactures of both imported and locally-manufactured western medicines must ensure that all capsules used for the manufacture of medicines meet the relevant quality standard.  DH has liaised with all local western medicines manufacturers and importers of products in capsule dose form from the Mainland and requested them to provide proof of the quality of capsules of their products. Local western medicines manufacturers and importers of products in capsule dose form from the Mainland have all submitted laboratory test reports as proof that their capsules are in compliance with the requirements stated in the Pharmacopoeia.  DH has collected 30 capsule samples from importers and manufacturers, all samples are found in compliance with the requirements stated in the Pharmacopoeia.

     DH will closely monitor the situation of capsules polluted by excessive chromium in the Mainland and continue to maintain close liaison with the Mainland regulatory bodies to obtain more production information about the raw material of capsules used by Mainland manufacturers of medicines registered in Hong Kong.

     Regarding the implementation of Good Manufacturing Practice (GMP) in respect of pCm, the Chief Executive announced in his 2010-11 Policy Address that a timetable should be worked out for mandatory compliance with the GMP for the manufacture of pCms.  In this connection, wide consultation is now being conducted by DH to gather the views of the Chinese medicine trade.  DH will consider the views from the Chinese medicine trade and the actual circumstances, taking into account the interest of the public in formulating the implementation timetable.

Ends/Wednesday, May 30, 2012
Issued at HKT 12:04