country presentation myanmar first asean-china conference on combating counterfeit medical products...

Country PresentationCountry PresentationMyanmarMyanmar

First ASEAN-China Conference on First ASEAN-China Conference on Combating Counterfeit Medical Combating Counterfeit Medical

ProductsProductsJakarta, 13-15 November 2007Jakarta, 13-15 November 2007

Presented byDr. Tun ZawFDA, Myanmar

Legislative InfrastructureLegislative Infrastructure 19721972 - Public Health Law - Public Health Law 1992 October1992 October - National Drug Law - National Drug Law 1993 August 1993 August - Registration - Registration NotificationsNotifications - Manufacturing - Manufacturing

- Sales and Distribution- Sales and Distribution - Importation- Importation - Labelling and Advertisement- Labelling and Advertisement

1995 January1995 January - Establishment of Food and - Establishment of Food and Drug Administration (FDA)Drug Administration (FDA)

Chapter XI. ProhibitionsChapter XI. Prohibitions15(a) No one shall manufacture, import, 15(a) No one shall manufacture, import,

export, store, distribute or sell the following export, store, distribute or sell the following drug; (i) a drug which has not been drug; (i) a drug which has not been

registered;registered;

(ii) a drug whose registration has (ii) a drug whose registration has been revoked temporarily or been revoked temporarily or cancelled;cancelled;

The National Drug Law (1992)The National Drug Law (1992)

(iii) (iii) fake drug, fake drug, drug differing from drug differing from standards, deteriorated drug, adulterated standards, deteriorated drug, adulterated drug;drug;

(iv) a drug which has been manufactured (iv) a drug which has been manufactured with harmful substances;with harmful substances;

(v) a dangerous drug which is determined (v) a dangerous drug which is determined as not fit for utilization by the Ministry of as not fit for utilization by the Ministry of Health by notification.Health by notification.


(b) No one shall import or export a (b) No one shall import or export a registered drug without permission under registered drug without permission under any existing law.any existing law.

16. No one shall manufacture, store, 16. No one shall manufacture, store, distribute or sell a pharmaceutical raw distribute or sell a pharmaceutical raw material or drug without a licence.material or drug without a licence.


17. A person who has obtained a licence –17. A person who has obtained a licence –

(a) shall not fail to abide by any condition (a) shall not fail to abide by any condition of the licence;of the licence;

(b) shall not fail to abide by the orders and (b) shall not fail to abide by the orders and directives issued by the Ministry of Health directives issued by the Ministry of Health or by the Board of Authority under this or by the Board of Authority under this Law.Law.


Chapter XII. Offences and PenaltiesChapter XII. Offences and Penalties18.18. Whoever violates any provision of Whoever violates any provision of

section 15 shall, on conviction be section 15 shall, on conviction be punished with fine which may extend from punished with fine which may extend from a minimum of kyats 5,000 to a maximum a minimum of kyats 5,000 to a maximum of kyats 50,000 or with a imprisonment for of kyats 50,000 or with a imprisonment for a term which may extend to 7 years or a term which may extend to 7 years or with both. In addition, the exhibits involved with both. In addition, the exhibits involved in the offence shall also be liable to be in the offence shall also be liable to be confiscated.confiscated.


19. Whoever violates any provision of 19. Whoever violates any provision of section 16 shall, on conviction – section 16 shall, on conviction –

(a) If it is an offence relating to an (a) If it is an offence relating to an unregistered drug, be punished with fine unregistered drug, be punished with fine which may extend from a minimum of which may extend from a minimum of kyats 5,000 to a maximum of kyats 50,000 kyats 5,000 to a maximum of kyats 50,000 or with imprisonment for a term which may or with imprisonment for a term which may extend to 7 years or with both;extend to 7 years or with both;


(b) If it is an offence relating to a registered (b) If it is an offence relating to a registered drug, be punished with fine which may drug, be punished with fine which may extend from a minimum of kyats 1,000 to a extend from a minimum of kyats 1,000 to a maximum of kyats 10,000 or with maximum of kyats 10,000 or with imprisonment for a term which may extend imprisonment for a term which may extend to 2 years or with both;to 2 years or with both;

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


20. A person who has obtained a licence 20. A person who has obtained a licence and who violates any provision of section and who violates any provision of section 17 shall, on conviction be punished with 17 shall, on conviction be punished with fine which may extend from a minimum of fine which may extend from a minimum of kyats 500 to a maximum of kyats 5,000 or kyats 500 to a maximum of kyats 5,000 or with a imprisonment for a term which may with a imprisonment for a term which may extend to 1 years or with both. extend to 1 years or with both.


2 (d) 2 (d) Fake drug Fake drug means the following; -means the following; -

(i) a drug the whole or part of the label of (i) a drug the whole or part of the label of which is an imitation or resemblance by which is an imitation or resemblance by various means or is written similarly;various means or is written similarly;

(ii) a drug in respect of which the (ii) a drug in respect of which the expiration date or manufacturer or expiration date or manufacturer or distributor or place of manufacture or distributor or place of manufacture or country of manufacture is fraudulently country of manufacture is fraudulently shown;shown;

National Definition of Counterfeit DrugNational Definition of Counterfeit Drug

(iii) a drug in respect of which it is (iii) a drug in respect of which it is fraudulently shown that it is manufactured fraudulently shown that it is manufactured according to the formula mentioned at the according to the formula mentioned at the time of registration of the drug;time of registration of the drug;

National Definition of Counterfeit DrugNational Definition of Counterfeit Drug(contd.)(contd.)

Gaps/ InsufficienciesGaps/ InsufficienciesPenalty for the offences pertaining to Penalty for the offences pertaining to

Counterfeit drugs is same as other Counterfeit drugs is same as other offences pertaining to unregistered drugs, offences pertaining to unregistered drugs,

etc.etc. It should be more harsh punishment for It should be more harsh punishment for

offences pertaining to Counterfeit drugsoffences pertaining to Counterfeit drugsRevising The NDL and will be proposed to Revising The NDL and will be proposed to

Attorney General’s OfficeAttorney General’s Office

Legislative InfrastructureLegislative Infrastructure

National CoordinationNational Coordination

ORGANIZATIONAL STRUCTURE ORGANIZATIONAL STRUCTURE Cabinet of MinistersCabinet of Ministers

National Health CommitteeNational Health Committee

Ministry of HealthMinistry of Health MinisterMinister

Myanmar Food and Drug Myanmar Food and Drug Board of AuthorityBoard of Authority (MFDBA)(MFDBA)

Central Food and Drug Drug Advisory Central Food and Drug Drug Advisory Department of Health Department of HealthSupervisory Committee Committee Supervisory Committee Committee Director General Director General ( Central FDSC) (DAC) ( Central FDSC) (DAC)

Food & Drug AdministrationFood & Drug Administration DirectorDirector

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

DistrictDistrict Asst. Director Asst. Director Asst. Director Asst. Director Asst. Director Asst. Asst. Director Asst. Director Asst. Director Asst. Director Asst. Director Asst. DirectorDirector

FDSCFDSC Lab Service (Drug) Drug Control (Medical Devices & Lab. Service (Food) Food Control (Bio& Lab Service (Drug) Drug Control (Medical Devices & Lab. Service (Food) Food Control (Bio& ChemicalChemical Safety Lab) Safety Lab) Safety Safety Lab)Lab)

TownshipTownshipFDSCFDSC

Myanmar Food and Drug Board of Myanmar Food and Drug Board of Authority (MFDBA) is the highest authority Authority (MFDBA) is the highest authority for the control of food and drug affairs and for the control of food and drug affairs and is chaired by the Minister for Healthis chaired by the Minister for Health

MFDBA members come from various MFDBA members come from various related departments and agencies e.g. related departments and agencies e.g. General Administrative Dept., Myanmar General Administrative Dept., Myanmar Police Force, Custom, Trade, Police Force, Custom, Trade, Development Affairs Dept. etc.Development Affairs Dept. etc.


Various levels of Food and Drug Various levels of Food and Drug Supervisory Committees (FDSC) were Supervisory Committees (FDSC) were formed – Central to Township levelformed – Central to Township level

Members; Members; HealthHealthGeneral AffairsGeneral AffairsPolice ForcePolice ForceDevelopment AffairsDevelopment AffairsLivestock Breeding and Livestock Breeding and

Veterinary Dept.Veterinary Dept.


There is close collaboration between FDA There is close collaboration between FDA (NRA) and other law enforcement (NRA) and other law enforcement agencies like Custom and Police Force in agencies like Custom and Police Force in combating sub-standard, unregistered and combating sub-standard, unregistered and counterfeit medical products.counterfeit medical products.

Benefits;Benefits; The TFDSC was vested with the The TFDSC was vested with the authority to inspect – routine and authority to inspect – routine and unannounced – drug retailers’ and unannounced – drug retailers’ and wholesalers’ houses, and to issue licencewholesalers’ houses, and to issue licence


Benefits; Benefits; (contd.)(contd.)

The TFDSC has the right to conduct The TFDSC has the right to conduct market surveillance and if there any market surveillance and if there any counterfeit medical product has been counterfeit medical product has been detected, the committee might act upon detected, the committee might act upon the case according to the provisions of the case according to the provisions of The NDL.The NDL.


Recent example of benefitRecent example of benefit::

MPF, Chinese PF and Interpol coordinated MPF, Chinese PF and Interpol coordinated and acted on information about fake and acted on information about fake artesunate trafficking across the trilateral artesunate trafficking across the trilateral border between Myanmar, PR china and border between Myanmar, PR china and Thailand at the end of Oct. 07. and seized Thailand at the end of Oct. 07. and seized two criminals with considerable amount of two criminals with considerable amount of fake artesunate on Myanmar land, which fake artesunate on Myanmar land, which was conducted with the name of was conducted with the name of Jupiter Jupiter Operation.Operation.

International CoordinationInternational Coordination

Number of CasesNumber of Cases

SUSPECTEDSUSPECTED CONFIRMEDCONFIRMED IMPORTED/ IMPORTED/ DOMESTICDOMESTIC

VITAL VITAL MEDICINESMEDICINES

20062006 -- 0 / 250 / 25 ImportedImported

20052005 -- 2 / 342 / 34 ImportedImported

How these cases detected ?How these cases detected ?Detection of these cases rarely comes Detection of these cases rarely comes

from patients complaints and Health from patients complaints and Health professionals reports.professionals reports.

It usu. come from enforcement/ It usu. come from enforcement/ investigation work, routine and periodic investigation work, routine and periodic checks and reported by affected checks and reported by affected manufacturersmanufacturers

Number of CasesNumber of Cases

Number of Prosecutions/ Number of Prosecutions/ convictions/ Pendingconvictions/ Pending

ManufacturerManufacturer Wholesaler/ Wholesaler/ RetailerRetailer

ImporterImporter Informal Informal sectorsector

20062006 -- 8 / 0 / 08 / 0 / 0 -- --

20052005 -- 5 / 0 / 05 / 0 / 0 -- --

Proposals for ActionProposals for Action

Measures to be takenMeasures to be taken::Strengthening of coordination and Strengthening of coordination and

cooperation between China and ASEAN cooperation between China and ASEAN countries in combating counterfeit medical countries in combating counterfeit medical products esp. cross-border trafficking.products esp. cross-border trafficking.

Strenghening of prompt and effective Strenghening of prompt and effective information exchange system among our information exchange system among our countriescountries

Holding meeting at regular basisHolding meeting at regular basis

Who should do it?Who should do it?Every country should participate actively Every country should participate actively

and all the stakeholders as well.and all the stakeholders as well.Assignment of Focal Point for our regionAssignment of Focal Point for our regionEstablishment of contact point in each Establishment of contact point in each

countrycountryNDRA should do mostNDRA should do most


Critical factors to ensure successCritical factors to ensure successEffective intra-regional cooperation is of Effective intra-regional cooperation is of

great importancegreat importancePrompt information exchange between Prompt information exchange between

stakeholders is criticalstakeholders is critical


Realistic timeframeRealistic timeframeOngoing processOngoing process

Cost estimateCost estimate? funding agencies? funding agencies


country presentation myanmar first asean-china conference on combating counterfeit medical products...

Documents

following drug

national drug law

deteriorated drug

drug differing

adulterated drug

dangerous drug

unregistered drug

d fake drug