Replies to LegCo questions
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):
Question:
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?
Reply:
President,
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
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