Myanmar Food & Drug

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Country PresentationMyanmar

First ASEAN-China Conference onCombating Counterfeit Medical

ProductsJakarta, 13-15 November 2007

Presented by

Dr. Tun Zaw

FDA, Myanmar


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Legislative Infrastructure

1972 - Public Health Law

1992 October - National Drug Law

1993 August - Registration

Notifications - Manufacturing- Sales and Distribution

- Importation

- Labelling and Advertisement

1995 January - Establishment of Food andDrug Administration (FDA)


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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been revoked temporarily or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;

The National Drug Law (1992)


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(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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(b) No one shall import or export a

registered drug without permission under

any existing law.

16. No one shall manufacture, store,

distribute or sell a pharmaceutical raw

material or drug without a licence.



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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.



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Chapter XII. Offences and Penalties

18. Whoever violates any provision ofsection 15 shall, on conviction be

punished with fine which may extend froma minimum of kyats 5,000 to a maximumof kyats 50,000 or with a imprisonment fora term which may extend to 7 years orwith both. In addition, the exhibits involvedin the offence shall also be liable to beconfiscated.



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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 mayextend to 7 years or with both;



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(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 withimprisonment for a term which may extend

to 2 years or with both;

(c) the exhibits involved in the offence shallalso be liable to be confiscated.



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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 ofkyats 500 to a maximum of kyats 5,000 or

with a imprisonment for a term which may

extend to 1 years or with both.



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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


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(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;

National Definition of Counterfeit Drug(contd.)


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Gaps/ Insufficiencies

Penalty for the offences pertaining toCounterfeit 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 Generals Office

Legislative Infrastructure


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National Coordination


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ORGANIZATIONAL STRUCTURE

Cabinet of Ministers

National Health Committee

Ministry of Health

Minister

Myanmar Food and Drug

Board of Authority

(MFDBA)

Central Food and Drug Drug Advisory Department of Health

Supervisory Committee Committee Director General

( Central FDSC) (DAC)

Food & Drug AdministrationDirector

State/Division Deputy Director (Drug) Deputy Director (Food)

FDSC

District Asst. Director Asst. Director Asst. Director Asst. Director Asst. Director Asst. Director

FDSC Lab Service (Drug) Drug Control (Medical Devices & Lab. Service (Food) Food Control (Bio& Chemical

Safety Lab) Safety Lab)

Township

FDSC


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Myanmar Food and Drug Board ofAuthority (MFDBA) is the highest authorityfor 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., MyanmarPolice Force, Custom, Trade,Development Affairs Dept. etc.



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Various levels of Food and DrugSupervisory Committees (FDSC) wereformed Central to Township level

Members; HealthGeneral Affairs

Police Force

Development AffairsLivestock Breeding and

Veterinary Dept.



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There is close collaboration between FDA(NRA) and other law enforcementagencies like Custom and Police Force in

combating sub-standard, unregistered andcounterfeit medical products.

Benefits; The TFDSC was vested with theauthority to inspect routine andunannounceddrug retailers andwholesalers houses, and to issue licence



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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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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 offake artesunate on Myanmar land, which

was conducted with the name ofJupiter

Operation.

International Coordination


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Number of Cases

SUSPECTED CONFIRMED IMPORTED/

DOMESTIC

VITAL

MEDICINES

2006 - 0 / 25 Imported

2005 - 2 / 34 Imported


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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

Number of Cases


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Number of Prosecutions/

convictions/ Pending

Manufacturer Wholesaler/

Retailer

Importer Informal

sector

2006 - 8 / 0 / 0 - -

2005 - 5 / 0 / 0 - -


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Proposals for Action

Measures to be taken:

Strengthening of coordination andcooperation between China and ASEAN

countries in combating counterfeit medicalproducts esp. cross-border trafficking.

Strenghening of prompt and effective

information exchange system among ourcountries

Holding meeting at regular basis


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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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Critical factors to ensure success

Effective intra-regional cooperation is of

great importance

Prompt information exchange between

stakeholders is critical



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Realistic timeframe

Ongoing process

Cost estimate

? funding agencies



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Documents

Myanmar Food & Drug