Combating Counterfeit Drugs in China

Chen Xu Ph.D.
(chenxu@sfda.gov.cn)

Director of Division of Drug Supervision and Inspection

Department of Drug Market Compliance
State Food and Drug Administration
People’s Republic of China 
What legislation is currently used for SFDA to
combating counterfeit drug?

China had first Drug Administration Law in 1985,which

contained special articles for combating counterfeit drugs Drug
Administration Law was revised in 2001, provided more specific
Articles for combating counterfeit drugs.
“Regulations for Implementation of Drug Administration Law”
promulgated in 2002, and also contained special articles for
combating counterfeit drugs.
“The State Council special regulation for strengthens food and
drug security Surveillance” was published and implemented on
July 25, 2007,which contained special articles for combating
counterfeit drug too.
 

2
Article 48(Drug law) Production (including dispensing,
the same below) and distribution of counterfeit drugs
are prohibited.

National definitions of counterfeit drug are followings:

A drug is a counterfeit drug in any of the following cases:

(1) the ingredients in the drug are different from those specified
by the national drug standards; or
(2) a non-drug substance is simulated as a drug or one drug is
simulated as another.
A drug shall be treated as a counterfeit drug in any of the
following cases:
(1) its use is prohibited by the regulations of the drug regulatory
department under the State Council;
(2) it is produced or imported without approval, or marketed
without being tested, as required by this Law;
(3)it is deteriorated;
(4) it is contaminated;
(5) it is produced by using drug substances without approval
number as required by this Law; or
(6) the indications or functions indicated are beyond the specified
scope.
3
Article 49(Drug law) Production and distribution of
substandard drugs are prohibited.

National definitions of substandard drug are followings:

A drug with content not up to the national drug standards is

a substandard drug.
A drug shall be treated as a substandard drug in any of the
following cases;
(1) the date of expiry is not indicated or is altered;
(2) the batch number is not indicated or is altered;
(3) it is beyond the date of expiry;
(4) no approval is obtained for the immediate packaging
material or container;
(5) colorants, preservatives, spices, flavorings or other
excipients are added without authorization; or
(6) other cases where the drug standard are not
conformed.

4
What are gaps in current legislation and how
to meet gaps?

In China, SFDA is responsible for administrative punishment

on counterfeit drug including to investigate & penalize illegal
activities of manufacturing, selling, using counterfeit drugs).
But SFDA is not rresponsible for criminal punishment on
counterfeiting.
In order to meet the gaps, SFDA cooperates with other
government bodies.
–working with the Public Security Ministry for criminal
punishment for manufacturing & selling counterfeit drugs ,
–working with Postal Office for eliminating, closing of mail
orders & mail boxes of counterfeit drugs.
–working with the Customs Office to control of smuggling
counterfeit drug.

5
What is being done to fill the gaps?

Now we, SFDA has established regular and long term cooperation
mechanisms with the above Depts. We have established fixed office,
fixed meeting timetable, fixed hot line, and so on.
For example, during March 25, to September 25,2003 SFDA carried
out jointly by the Ministry of Public Security to combat the production
and selling of counterfeit medicines in a nationwide scale.
SFDA and the Ministry of Public Security had set up a special action
leading group in charge of this special operation command
coordination. The local DRA and public security also set up
specialized agencies, responsible for organization and leadership
work, and to identify hand, is responsible for the coordination of
special action links. This special operation, the goal is to destroy key
areas of production, selling of counterfeit medicines, and sales
networks, and prosecute the illegal production and sale of counterfeit
criminals, and to effectively check the manufacture and sale of
counterfeit medicines. Establish a perfect anti-counterfeit long-term
cooperation mechanism to purify medicine market order, and ensure
the safety of the masses medication.

6
What is being done to fill the gaps?

If the case of counterfeit drugs accords with the demands of criminal

punishment, DRA must promptly transfer it to the public security bodies
according to the stipulation, positively coordinates the judicial bodies to
develop pursues the punishment work, including collects and the
production of evidence. Has a suspect clue of criminal case, SFDA must
propose the public security bodies to involve ahead of time, the
coordination investigation, prevented and avoids the criminal suspect as far
as possible escaping, already escaped must assist the public security
bodies to seize as soon as possible brings to justice.
The conditions for DRA to transfer counterfeit case to the public security
body:
(1) Individual illegal sale counterfeit drug amount 50,000 Yuan (RMB) above, or
illegal obtained amount in 10,000 Yuan (RMB) above;
(2) Unit illegal sale counterfeit drug amount 500,000 Yuan (RMB) above, or
illegal obtained amount in 100,000 Yuan (RMB) above;
(3) The production and sale of counterfeit drug, also sufficiently causes the
human body serious harm, may directly carry on processing by the public security
department according to the criminal law, not above amount limit.

7
What are proposal for actions of IMPACT?

(1)   Measures to be taken:

(a) Signing work cooperation document, making corresponding working
routine.
(b) Establishing special department, the personnel are responsible to
coordinate the routine duties.
(c) Establishing the platform of information exchange, is prompt,
accurately the sharp related counterfeit information.
(2) WHO should do it?
(a) The coordination, management of IMPACT throughout member
countries.
(3)Transsmitting information to related country.
(b)Providing the essential funds, and technical supports to the various
countries.

8
What are proposal for actions of IMPACT?

(3)Critical factors to ensure success

(a) The various countries' work develops and cooperates, WHO
must establish in the equal and in the cooperation foundation,
does not interfere the various countries' investigation work.
(b) Information exchange provided by IMPACT system must be
traceable according to the evidence which may look up.
(c) Funds safeguard.
(4)Realistic timeframe
After completion of above work, all participates of IMPACT can
be in motion together.
(5) Cost estimate
Needs 4 million US dollars funds budget every year in China.