Combating Counterfeit Drugs in China

1
Combating Counterfeit Drugs in China

• Chen Xu Ph.D.
• (chenxu_at_sfda.gov.cn)
• Director of Division of Drug Supervision and
  Inspection
• Department of Drug Market ComplianceState Food
  and Drug AdministrationPeoples Republic of
  China 

2
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.
•  

3
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.

4
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.

5
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.

6
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.

7
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.

8
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.

9
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.

10
Thank You !