On July 16, the Ministry of Health, Labour and Welfare
( MHLW) issued a notice that certain nonprescription
medicines considered "to present no safety concern"
shall be
shifted to quasi-drugs. The notice specified the newly
identified Classification and Scope of the 371 items
recognized to have been actually manufactured during
the
fiscal period of 2003. They are shown in the table.
The shifting shall go into effect as of July 30, 2004.
These 371 items are collectively called "Quasi-drugs
with New Scope".
Any person who wishes to manufacture the products falling
into these new classifications of quasi-drugs shall
file a report to that effect with the MHLW prior to
commencement of production thereof.
Certain matters to be noted in relation to the shifting
are as
follows:
1. Handling of Approvals and Licenses
during the Shifting
(1) Interim Measures
(a) Those who have been granted both approvals to manufacture
or import the nonprescription medicines subject to the
shifting and licenses to manufacture or import those
medicines as of July 30, 2004 (hereinafter referred
to as the "Enforcement Date") shall be regarded
as having duly been granted both approvals and licenses
to manufacture or import the quasi-drugs subject to
the shifting.
(b) The quasi-drugs subject to the shifting shall be
manufactured or imported as quasi-drugs as from the
Enforcement Date and shall cease to be manufactured
or imported and distributed as nonprescription medicines.
However, those products subject to the shifting manufactured
or imported by July 29, 2005 as nonprescription medicines
shall be exempted from labeling as QUASI-DRUG provided
the matters pertaining to nonprescription medicines
are properly indicated on the immediate containers or
wrappers.
Furthermore, those products in question shall be sold
as nonprescription medicines only by persons who have
been granted pharmacy licenses and licenses to sell
medicines.
(c)The same products labeled both as nonprescription
medicines and as quasidrugs shall not be delivered simultaneously
by those, as specified in the above (a), who have been
granted licenses to manufacture or import medicines.
(2) Manufacturing Plants of the Products
Subject to the Shifting In every manufacturing plant,
a responsible technician shall be a pharmacist for supervising
the manufacture in the same manner as the manufacture
of nonprescription medicines.
Furthermore, the qualifications of responsible technicians
for persons who have been granted licenses to import
and sell medicines and the criteria of in-country caretakers
for foreign acquirers of approvals to manufacture medicines
shall likewise remain the same as those applicable to
nonprescription medicines.
(3) Securing Quality
The products subject to the shifting shall continue
to secure quality as much as nonprescription medicines
do, therefore, the methods of production control and
quality
control as stipulated by Cabinet Order shall be the
basis for granting licenses. Consequentially, production
and process control methods have been modified so as
to apply to the quasi-drugs controlled by Good Manufacturing
Practice (GMP) and the procedures have been newly established
for aseptically prepared medicines.
(4) The Products Subject to the Shifting
which are produced at more than Two Manufacturing Plants
When the products subject to the shifting are to be
produced at more than two manufacturing plants, production
processes relating to aseptically prepared medicines
(weighing, dissolution, sterile filtration, filling,
closuring, etc.) shall not be individually and separately
conducted at more than two manufacturing plants.
2.
Labelling of the Products Subject to the Shifting
( 1 ) Names of the active ingredients, their quantities,
etc. shall be indicated on the immediate containers or
wrappers. The letters, "QUASI-DRUG", shall be
indicated on the same face where the product's brand names
are printed in such a manner as will enable purchasers
and the like to see both at one time.
( 2 ) Furthermore, on the outer containers or wrappers,
the important matters out of hose specified below shall
be indicated for each classification in addition to the
matters indicated as nonprescription medicines.
(a) For the users in a specific condition,
"Consult a physician or pharmacist before using
(taking)" the medicine
(b) "Read the package insert carefully"
when using (taking) the medicine (c) "Store"
the medicine, tightly closed, avoiding direct sunshine,
in a less humid, cool place
(d) "Be careful about use in excess" caused
by concomitant use of other medications, observing
administration and dosage (e) Precautions for use
on the part of the body where the medicine is used
(applied)
15
Classifications and Scope of the Newly Shifted Quasi-drugs
CLASSIFICATION
as QUASI-DRUGS
SCOPE of
CLASSIFICATION
1: Stomachics
Internal use for improvement of symptoms such
as Heaviness in the stomach, Loss of appetite, Overeating,
Overdrinking, etc.
2: Intestinal regulators
Internal use for Regulating bacteria in the intestines
and Controlling movement of the intestines
3: Digestants
Internal use for stimulating digestion of foodstuffs
in the digestive tracts
4: Gastrointestinal remedies
(Therapeutic claims of more
two indications of Stomachics Digestants, and Intestinal
Regulators)
Internal use for improvement of plural gastrointestinal
symptoms such as Loss of appetite, Stimulating digestion,
Regulating intestines, etc.
5: Purgatives
Internal use for improvement of constipation ,
etc. by staying
and/or swelling in the intestines
6: Health drugs containing Vitamins
Internal use for supplying nutrients vitamins
such as Vitamins, Amino acid, etc. necessary for
maintaining physical strength
7: Health drugs containing mainly calcium
Internal use for supplying calcium
8: Health drugs containing mainly natural drugs
Natural drug preparations, internal use, for supplying
nutrients for Weak constitution, Physical fatigue,
Loss of appetite, Period
of growth
9: Drugs for relief of stuffy nose (External use
only)
External application for alleviating symptoms
of a common cold such as Stuffy nose, Sneezing,
etc. by applying to chest or throat
10: Antiseptics
Sterilization and disinfection of Fingers, Skin
or Wounded areas, etc.
11: Drugs for chilblain, chaps
Alleviation of Chilblain, Chaps, Clefts, etc.
on fingers, skin, lips
12: Gargles
Sterilization, disinfection, cleansing, etc. of
the Oral cavity or Throat, used as gargles
13: Lotion for wearing contact
lenses
Facilitation of wearing Soft contact lenses or
Hard contact lenses
14: Snore suppressant
Temporary suppression /alleviation of Snore, applied
as collunarium
15: Drugs for oral cavity
Alleviation of Pain/Swollen throat due to sore
throat, used as troche to be slowly melted in the
mouth or by spraying/applying in the oral cavity
Awareness
of "Self-Medication"
More than 50% awareness - A result obtained through
Website survey
Most presumably, not a single day has ever passed without
people from all walks of life hearing or seeing the
term, "Self-Medication" per se in the English
language, however, since there is no exact Japanese
equivalent of the term, JSMI has been making every endeavour
to ingrain in the Japanese people the concept of "Self-Medication"
through the constant use of its transliteration in the
Katakana rendition or the simplest form of the Japanese
alphabet.
JSMI has been conducting a series of a consumer opinion
survey on nonprescription medicines by means of a questionnaire
in an advertorial in the Asahi Shimbun dailies.
Besides this regular campaign to promote "Self-Medication",
recently JSMI conducted anew a survey on the health
consciousness of people through its Website, for which
a valid number of respondents was 788.
Part of the outcome of the Website survey is shown below:
QUESTION
1
"Self-Medication" is defined as self-diagnosis
and self-treatment of minor illnesses or injuries by use
of nonprescription medicines available without professional
supervision. Do you know this term
QUESTION
2
When purchasing medicines, do you expect to be given professional
explanations by pharmacists ?
QUESTION
3
Are you interested in the issue of allowing medicines
to be sold at convenience stores and the like ?
QUESTION
4
Why are you interested in this issue ?
QUESTION 5
If and when medicines are freely sold at convenience stores,
where would you want to purchase your medicines ?
Strategic
Alliance Conference Organized
On June 17, Thursday, Strategic Alliance Conference for
Business Promotion (SACBP) was convened for the first
time, chaired by Akira Uehara (President, Taisho Pharmaceutical
Co., Ltd.) and co-chaired by Hiroshi Ohtsuki (President,
Consumer Healthcare Company, Takeda Pharmaceutical Co.,
Ltd.).
With its major goal being set as "How to revive the
sluggish nonprescription medicines business", SACBP
agreed to place an emphasis on the industry's concrete
stance with high feasibility to cultivate news areas such
as, inter alia, medicines for prevention of diseases and
to make a persuasive approach with the competent authorities
in line with this stance rather than to endlessly replenish
the conventional business operation programmes which are
simply geared towards expanding the current OTC share
and rolling back the uphill struggle against the rampantly
flourishing health food categories. SACBP also agreed
to make an action plan for implementation of these new
areas.
So far, JSMI fully supported by those concerned has compiled
a report including various suggestions for achieving the
SACBP plans. These suggestions can be considered as having
laid the groundwork for making a desirable action plan.
The steps to be taken for making the plan have been conceived
as follows:
Phase 1: To thoroughly review the suggestions in
the report in order to identify themes for which actions
must be taken:
Phase 2: To clearly verify how each theme as identified
has been handled:
Phase 3: To finally make a most desirable action
plan for materialization of themes thus eventually identified:
International
Drug Price
Comparison Issued by MHLW
On July 7, Economic Division, MHLW issued a report, "Results
of International Survey on Prices of Medicines|2003".
1: SURVEY RESULTS
Comparison by exchange rate (With Tokyo taken as 100)
Cold
remedies: Prices in all six cities are lower than the
price in Tokyo.
Antacids: Prices in all six cities are lower than the
price in Tokyo.
Antipyretics Prices in London, Paris, and Dusseldorf are
higher than the price in Tokyo while those in
& Analgesics: other cities are lower than the price
in Tokyo.
Exchange Rate (Tokyo Foreign Exchange Market: March
31, 2004
NB: The survey compared top
ranked products in each city and did not compare the identical
items. Furthermore, as for medicines, multi-ingredient
products are commonly available in Japan.
2: SURVEY OBJECTS Most ideally, such a survey comparing
the prices of nonprescription medicines should be conducted
with the items having the same specifications (types of
active ingredients, their quantities and other properties)
for ensuring fair and accurate comparison of the survey
objects that are easily available and accessible throughout
the world.
Practically speaking, however, there are no such nonprescription
medicines as could meet these comparison criteria. Consequently,
in the same manner as last year, three therapeutic categories,
namely, Cold remedies, Antacids (Gastrointestinal drugs),
and Antipyretics & Analgesics and five top brands
in the categories sold in the seven cities were chosen
as a yardstick for comparison.
3:CITIES
SURVEYED Tokyo, New
York, Los Angeles, London, Paris, DuNsseldorf, Singapore
4: SURVEY METHOD Conducted the survey of actual selling
prices (Sales or Consumption Taxes included) at retail
outlets of pharmaceuticals.
5: SURVEY PERIOD February - March 2004
REFERENCE TABLE 1
Comparison by Purchasing Power Parity (With Tokyo taken
as 100)
Purchasing Power Parity (PPP):
A type of currency exchange rate obtained by calculating
so that the goods and amount of services which can be
purchased by the currency of one country and the currency
of another country become equal
Example:
If the same item is purchased for YEN 10,000 in Japan
and for US$ 80 in the US, PPP is YEN 125/1 US$ (10,00080).
GDP: Gross Domestic Product
GDP Base: (Calculated by OECD in 2003)
PPP in each country was calculated by OECD using, in lieu
of effects of exchange rate,
price data for goods and services which make up GDP of
the OECD member countries, for
the purpose of assessing the actual purchasing power.
Singapore was not included in the comparison by PPP on
GDP Base as data of GDP Base
were not available.
REFERENCE TABLE 2-1
Comparison of cost for daily dose of the top five brands
(Calculated on exchange rate)
REFERENCE TABLE 2-2
Comparison of cost for daily dose of the top five brands
(Calculated on PPP base)
REFERENCE TABLE 3
Comparison of average number of active ingredients contained
in the top five brands
