Medicine and Myanmar
Drugs and Drugs sources in Myanmar
Ref: From Dr.Thein Kyaw ( Korea United Pharm Co.,Ltd )
2.1 Population of Myanmar and Drugs ( Medicine ) sources
In Myanmar health care sector, those 51.14 million of population need drugs (
as non-labor input for producing of health care service ) for prevention and
curative measure of
diseases. The needed amount of the drugs are locally manufactured in some and
large portion are imported from foreign countries, because of insufficient local
production.
(see Annex- Table 1, for population figure and growth rate of Myanmar)
There are two main sourcers of drugs for population as above
1.
local manufacturing source and,
2.
importing from other foreign countries.
2.2 Local manufactures and Foreign suppliers of drugs
Local manufacturing
Myanmar Pharamaceuticals Factory and Yangon Pharamaceuticals Factory are
two main
factories of public sector in Myanmar.
(1). Myanmar Pharamaceuticals Factory
It is in Gyogone, Insein Township, Yangon Division and built in 1954, under the
management of the Ministry of Industrial one and produce 212 products in form
of Tablets,Capsules, Injection, Syrup , andLVP (large volume parental). (see
Table
2.1 )
(2).Yangon Pharmaceuticals Factory
It is Mhawbwe, Mingalardon Township, Yangon Division and built in 1994.It
is under management of Ministry of Defense and produce 23 products in form
of Tablets, Capsules, and LVP injection. ( see Table 2.1 )
Table 2.1 The products range manudactured in Myanmar
| Products |
MPF |
YPF |
| POM |
128 |
14 |
| OTC |
77 |
9 |
| CD |
7 |
-- |
| Total |
212 |
23 |
Source: Myanmar Food and Drugs Administrative Committee,Department Of Health.
MP: Myanmar Pharameceuticals Factory
YPF: Yangon Pharamaceuticals Factory
POM: Prescribed Medicine
OTC: Over Counter Drug
CD: Control Drug
Importing from other foreign countries ( Foreign suppliers )
As amount of drugs in local production does not cover the
entire nation and not adequate for entire population, some drugs ( medicines
) were imported
from foreign countries.The importation of drugs are strictly control by Ministry
of commerce, Myanmar FDA and Myanmar Drug Advisory Committee under the Myanmar
National Drug Law. The registered drugs importer imported 5230 items of registered
drugs of 182 manufacturers from 24 foreign countries in year 2002-2003. (see
Annex- Table 2 )
2.3 Importers and Distributors of Drugs in Myanmar
The importers who have been registered as importer at the
Ministry of Commerce and Company administrative office with holding of the
following certificates and documents can import the drugs in to Myanmars territory:
- Drug registration certificate
- Drug importation approval certificate
- Certificate of analysis of imported drugs
- Proforma invoice
- License from Directorate of Trade
- Import / Export License
- Company Registration Certificate
There are 20 importers for drugs in 2003 and main distributors are only 15 in Myanmar.The list of the importers, distributors and their suppliers are shown in Annex-Table 3.
2.4 National Drugs Law and control of drug importation in Myanmar
To provide the good health service to the entire population of Myanmar, we need good quality of drugs, proper storage of drugs, rational use of drugs and availability of drugs are crucial factors. These crucial factors can be created by not only strong drug regulation and legislations but also some ad-hoc apparatus of new laws. For that purpose, Government of Myanmar adopted National Drugs Law in October, 1993 to control of drug importation to Myanmar and quality of drugs.
Chapter II of the National Drug Law provides the formation of the Myanmar Food and Drug Board of Authority is following aims:
- To enable the public to use genuie quality, safe , and effective drugs
- To register the drugs systematically
- To enable the public to genuine quality and safe food
- To control and regulate systematically, manufacture, import, export, storage, distributin and sale of food and drugs.
Chapter II of the National Drug Law provides the functions and duties of the board of Authority are as follow:
- laying down the policy relating to registration of drugs;
- laying down the policy relating to determination of an essential drugs;
- laying down the policy relating to utilization of drugs;
- determining the qualifications of persons entitled to apply for licence and the terms and conditions there of for the manufacture, storage, distribution,and sale of pharmaceutical raw material or registered drugs;
- stipulating terms and conditions for the manufacture, import, export, storage,disstribution and sale of pharmaceutical raw material or registered drugs;
- permitting, refusing, temporary revocation and cancellation of registration of drug:
- granting, refusing, temporary revocation and cancellation of a licensce;
- stipulating terms and conditions relating to labeling of drugs, and advertising;
- determining and canceling any type of substance as a drug;
- forming the comittees in respect of matter relating to expertise and determining the functions and duties of such committees;
- forming Food and Drug Supervisory Committtees in the States, Divisions, Districts and Townships in order to supervise matters relating to food and drugs; determining the functions and duties of such committees;
- prescribing primary laboratories and appellate laboratories;
- stipulating terms and conditions relating to food.
National Drug Law Chapter V provides the meaning, purpose and process of drug registeration.
Drug registeration
Drug registeration means the registeration of the drug with the Board of Authority.
Purpose of registeration
For purpose of manufacture, import, export, distribution, and sale of the
durgs
Drugs Registration process
- Starts with respective company applied to FDA in prescribed form, after
the payment of US$ 100 to the Myanmar Foreign Trade Bank, the simples and
dossiers
were submitted.
- Only the complete and assessed case the applications were put up to the
DAC for submission and consideration.
- The acceptance and rejection of applications were considered at the meeting
and after the application was accepted. The submitted samples were distributed
to the respective hospitals for conformity clinical trials and some are analysed
at the FDA laboratory whether it conform with their specification.
- After completion of the clinical trials and conformation for specifications
are noted, the list of drugs are compiled and submitted to the nearest
DAC meeting for approval of registration.
- These cases are further forwarded to Ministry of health for confirmation
and companies are informed to remit another US$ 200 for approval.
- Once the credit advice from the bank was received , the Registration Certificate
was issued, which had a validity of 5 years.
Notification No.5/93 August 1993
The Notification 5/93 is concerned with the durg Importation and process
of obtaining the Drug Importation Approval Certificate and durg manufacture's
license.
Drug Importation Approval Certificate
For importation of durgs, one need to be have drug importation approval certificate,
- the applicant shall submit the prescribed form to FDA, together with the
photographs of ware house. The amount of fees to be remitted to the bank
account of respective township health office is 10,000 Kyats.
- after submission of application the responsible officers form FDA, accompanied
by the members of Township Food and Drug Supervisory Committee will inspect
the ware house and check the facilities whether it compiles to the required
specification and also check the drugs items whether it was register or
not.
- those application which satisfy with the requirements mentioned in the
specification are put up to CFDSC for consideration and approval. These
case are then forwarded
to MOH for confirmation. After approval, the Drug Importation Approval
certificate was issued to applicant, which had a validity of 3 years.
Drug Manufacture license
The drug manufacture means the operations to be carried out in the manufacture
of a durg. This expression also includes, the performance of all operations
carried out in precesses commencing from pharmaceutical raw material or
performance of any stages of those process. For obtaining drug manufacturer's
licence,
- The applicant shall apply to FDA in prescribed from with documents, photographs
of manufacturing premises and equipments used.
- The applicant has to remit 10,000 Kyats to the Bank account of respective
township health office.
- Inspection team from FDA accompanied by the Township Food and Drugs Supervisory
committee will inspect the premises and factory, using inpeciton check
list.
- The Sample are also taken from laboratory analysis at FDA. The FDA will
reply to the applicant in writing, giving instruction and suggestion so
as to comply
with GMP according to the guide from FDA.
- After complying to the requirement as suggested by the inspection team,
the manufacuture will give intimation to FDA, and if it is completed,
the application will be put up to CFDSC meeting for consideration and approval.
- After confirmation was received from MOH, the Drug Manufacturer's license
was issued, which had validity of 3 years.
Control of Importation and quality of durgs
After receiving the Drug Importation Approval Certificate;
- the importer applies for import license at Directorate of Trade
- When the drugs arrived by air, sea or land, the custom officials will
check the documents from FDA, Directorate of Trade, Proforma Invoice ect.,
and illeally
imported drugs are confiscated by the customs. But because of the lack
of the pharmacist at the check point, there are limitation in checking the
drugs
entering the country.
The Chapter 2 expressed the market of drugs ( Pharmaceuticals products) including
the local manufacturers, importers, governments intervention on control of
quality of durgs importation by rules, regulation and documents needed for
importation. The aim of the Chapter is introduction to know the Drugs market(
Pharmaceuticals market) of Myanmar and systemic
controlling of administrative department concerning by National Durg Law.
