Transcript Country Presentation Myanmar

Country Presentation
Myanmar
First ASEAN-China Conference on
Combating Counterfeit Medical
Products
Jakarta, 13-15 November 2007
Presented by
Dr. Tun Zaw
FDA, Myanmar
Legislative Infrastructure
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1972
1992 October
1993 August
Notifications
- Public Health Law
- National Drug Law
- Registration
- Manufacturing
- Sales and Distribution
- Importation
- Labelling and Advertisement
1995 January - Establishment of Food and
Drug Administration (FDA)
The National Drug Law (1992)
Chapter XI. Prohibitions
 15(a) No one shall manufacture, import,
export, store, distribute or sell the following
drug; (i) a drug which has not been
registered;
(ii) a drug whose registration has
been revoked temporarily or
cancelled;
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The National Drug Law (1992)
(iii) fake drug, drug differing from
standards, deteriorated drug, adulterated
drug;
 (iv) a drug which has been manufactured
with harmful substances;
 (v) a dangerous drug which is determined
as not fit for utilization by the Ministry of
Health by notification.
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The National Drug Law (1992)
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(b) No one shall import or export a
registered drug without permission under
any existing law.
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16. No one shall manufacture, store,
distribute or sell a pharmaceutical raw
material or drug without a licence.
The National Drug Law (1992)
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17. A person who has obtained a licence –
(a) shall not fail to abide by any condition
of the licence;
(b) shall not fail to abide by the orders and
directives issued by the Ministry of Health
or by the Board of Authority under this
Law.
The National Drug Law (1992)
Chapter XII. Offences and Penalties
 18. Whoever violates any provision of
section 15 shall, on conviction be
punished with fine which may extend from
a minimum of kyats 5,000 to a maximum
of kyats 50,000 or with a imprisonment for
a term which may extend to 7 years or
with both. In addition, the exhibits involved
in the offence shall also be liable to be
confiscated.
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The National Drug Law (1992)
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19. Whoever violates any provision of
section 16 shall, on conviction –
(a) If it is an offence relating to an
unregistered drug, be punished with fine
which may extend from a minimum of
kyats 5,000 to a maximum of kyats 50,000
or with imprisonment for a term which may
extend to 7 years or with both;
The National Drug Law (1992)
(b) If it is an offence relating to a registered
drug, be punished with fine which may
extend from a minimum of kyats 1,000 to a
maximum of kyats 10,000 or with
imprisonment for a term which may extend
to 2 years or with both;
(c) the exhibits involved in the offence shall
also be liable to be confiscated.
The National Drug Law (1992)
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20. A person who has obtained a licence
and who violates any provision of section
17 shall, on conviction be punished with
fine which may extend from a minimum of
kyats 500 to a maximum of kyats 5,000 or
with a imprisonment for a term which may
extend to 1 years or with both.
National Definition of Counterfeit Drug
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2 (d) Fake drug means the following; (i) a drug the whole or part of the label of
which is an imitation or resemblance by
various means or is written similarly;
(ii) a drug in respect of which the
expiration date or manufacturer or
distributor or place of manufacture or
country of manufacture is fraudulently
shown;
National Definition of Counterfeit Drug
(contd.)
(iii) a drug in respect of which it is
fraudulently shown that it is manufactured
according to the formula mentioned at the
time of registration of the drug;
Legislative Infrastructure
Gaps/ Insufficiencies
 Penalty for the offences pertaining to
Counterfeit drugs is same as other
offences pertaining to unregistered drugs,
etc.
 It should be more harsh punishment for
offences pertaining to Counterfeit drugs
 Revising The NDL and will be proposed to
Attorney General’s Office
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National Coordination
ORGANIZATIONAL STRUCTURE
Cabinet of Ministers
National Health Committee
Ministry of Health
Minister
Myanmar Food and Drug
Board of Authority
(MFDBA)
Central Food and Drug
Supervisory Committee
( Central FDSC)
Drug Advisory
Committee
(DAC)
Department of Health
Director General
Food & Drug Administration
Director
State/Division
FDSC
District
FDSC
Township
FDSC
Deputy Director (Drug)
Asst. Director
Asst. Director
Lab Service (Drug) Drug Control
Deputy Director (Food)
Asst. Director
(Medical Devices &
Safety Lab)
Asst. Director
Lab. Service (Food)
Asst. Director Asst. Director
Food Control (Bio& Chemical
Safety Lab)
National Coordination
Myanmar Food and Drug Board of
Authority (MFDBA) is the highest authority
for the control of food and drug affairs and
is chaired by the Minister for Health
 MFDBA members come from various
related departments and agencies e.g.
General Administrative Dept., Myanmar
Police Force, Custom, Trade,
Development Affairs Dept. etc.
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National Coordination
Various levels of Food and Drug
Supervisory Committees (FDSC) were
formed – Central to Township level
 Members;
Health
General Affairs
Police Force
Development Affairs
Livestock Breeding and
Veterinary Dept.
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National Coordination
There is close collaboration between FDA
(NRA) and other law enforcement
agencies like Custom and Police Force in
combating sub-standard, unregistered and
counterfeit medical products.
 Benefits; The TFDSC was vested with the
authority to inspect – routine and
unannounced – drug retailers’ and
wholesalers’ houses, and to issue licence
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National Coordination
Benefits; (contd.)
 The TFDSC has the right to conduct
market surveillance and if there any
counterfeit medical product has been
detected, the committee might act upon
the case according to the provisions of
The NDL.
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International Coordination
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Recent example of benefit:
MPF, Chinese PF and Interpol coordinated
and acted on information about fake
artesunate trafficking across the trilateral
border between Myanmar, PR china and
Thailand at the end of Oct. 07. and seized
two criminals with considerable amount of
fake artesunate on Myanmar land, which
was conducted with the name of Jupiter
Operation.
Number of Cases
SUSPECTED
CONFIRMED IMPORTED/
DOMESTIC
2006
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0 / 25
Imported
2005
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2 / 34
Imported
VITAL
MEDICINES
Number of Cases
How these cases detected ?
 Detection of these cases rarely comes
from patients complaints and Health
professionals reports.
 It usu. come from enforcement/
investigation work, routine and periodic
checks and reported by affected
manufacturers
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Number of Prosecutions/
convictions/ Pending
Manufacturer Wholesaler/ Importer Informal
Retailer
sector
2006
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8/0/0
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2005
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5/0/0
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Proposals for Action
Measures to be taken:
 Strengthening of coordination and
cooperation between China and ASEAN
countries in combating counterfeit medical
products esp. cross-border trafficking.
 Strenghening of prompt and effective
information exchange system among our
countries
 Holding meeting at regular basis
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Proposals for Action
Who should do it?
 Every country should participate actively
and all the stakeholders as well.
 Assignment of Focal Point for our region
 Establishment of contact point in each
country
 NDRA should do most
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Proposals for Action
Critical factors to ensure success
 Effective intra-regional cooperation is of
great importance
 Prompt information exchange between
stakeholders is critical
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Proposals for Action
Realistic timeframe
 Ongoing process
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Cost estimate
 ? funding agencies
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