First ASEAN-China Conference on Combating Counterfeit Medical Products Jakarta, 13-15 November 2007
Presented by Dr. Tun Zaw FDA, Myanmar
Legislative Infrastructure
- Public Health Law - National Drug Law - Registration - Manufacturing - Sales and Distribution - Importation - Labelling and Advertisement 1995 January - Establishment of Food and Drug Administration (FDA)
(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.
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.
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;
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.
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;
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 Generals Office
National Coordination
ORGANIZATIONAL STRUCTURE
Cabinet of Ministers
Ministry of Health Minister Myanmar Food and Drug Board of Authority (MFDBA)
Food & Drug Administration Director State/Division FDSC Deputy Director (Drug) Deputy Director (Food)
District FDSC
Asst. Director Asst. Director Food Control (Bio& Chemical Safety Lab)
Township FDSC
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.
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.
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
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.
International Coordination
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 VITAL MEDICINES
2006
0 / 25
Imported
2005
2 / 34
Imported
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
2006
8/0/0
2005
5/0/0