ABT Myanmar Pharmaceutical Industry

1. Myanmar Pharmaceutical
Market
An over View

2. Myanmar Health Care Information
Myanmar Overview
• Mandalay
• Meikhtila
• Pakokku
• Monywa
• Yangon • Moegok
• Mawlamyine • Myitkyinar
• Bago • Taunggyi
• Pyay • Lashio
• Pathein
• Myeik
• Sittway
• Taungu

3. Myanmar Pharmaceutical Market Overview
• Estimated pharmaceutical market size is about US$ 100-120 millions CIF value.
• Indian Pharma Companies are about 35 % of the total market.
• Leading Indian players are Ranbaxy, Cipla, Dr.Reddy’s…..etc.
• Multi National Companies are less active directly.
• Two major cities (Ygn & Mdy) contribute 60 % of total sales of Pharma Market.
• District areas contribute remaining 40%
• Growing awareness of Health care & modern life style in Major cities are increasing.
• Number of Private Hospitals & pharmacies are increasing as well.
• Some international hospitals like Bumrungrad Hospital, Bangkok Hospital are coming up.
• Prescription drugs can be sold in open market.

4. Myanmar Pharmaceutical Market
YANGON, Mar 30 (Xinhua): Pharmaceutical products from Asian countries are
dominating Myanmar's consumers market with India standing as the country's largest
pharmaceutical products importing country, the local weekly Flower News reported
today.
Accounting for 40 per cent of Myanmar's pharmaceuticals import, India is followed by
Bangladesh, China, Thailand, Indonesia, Pakistan and Vietnam.
According to the statistics of the Ministry of Commerce, Myanmar imported over
5,000 categories of pharmaceutical products annually.
In the fiscal year 2007-08, Myanmar imported pharmaceutical products worth of
115.56 million U.S. dollars, an increase of 15.5 per cent from 2006-07, earlier
statistics shows.
Meanwhile, Myanmar's largest and most modern pharmaceutical factory in the
northern city of Pyin Oo Lwin was established in December 2007 producing 162 kinds
of medicines.

5. With the aim of reducing import-substitute medicines, the Pyin Oo Lwin
Pharmaceutical Factory under the Ministry of Industry-1, produce high-quality modern
medicines such as tablet, capsule, intramuscular, intravenous, lotion and powder.
There has been some five other pharmaceutical factories in Myanmar, including two
special ones, respectively located in Yangon, Sagaing and Inyaung.
These factories are producing medicines that supply 40 per cent of the domestic
market.
Moreover, a famous Myanmar private pharmaceutical company, FAME, will produce
seasonal medicines for Japan and South Korea as proposed by the two countries.
FAME is known as the first private pharmaceutical factory in Myanmar whose
products meet the stringent Good Manufacturing Practices (GMP) standards set by
the World Health Organisation ( WHO).
The company produces 45 different kinds of Myanmar traditional herbal medicines
and its products were exported to countries or regions such as Malaysia, Singapore,
Thailand, Taiwan, South Korea , Germany and Japan

6. Myanmar Pharmaceutical Market 2011-12
Market Share
Therapeutical Segment wise
Sr.No Therapeutical Segement Market share
1 Anti Infective 35%
2 Vitamins 30% Anti Infective
2%
3 Analgesics 11% 2%
3%
3%4% Vitamins
Analgesics
35%
4 Cardiovascular 10% 10% Cardiovascular
Gastrointestinal
5 Gastrointestinal 3% 11% Endocardinal
Respiratory
6 Endocardinal 2% 30% CNS
Others
7 Respiratory 3%
8 CNS 4%
9 Others 2%

7. Share of Export Countries
in
Myanmar Pharmaceutical Market 2011-12
Share of Countries
Sr.No Countries Share
1 India 33% Others
2 Thailand 15% France
3 Phillipines 6% USA
4 UK 5% China
5 Indonesia 4% Korea
Myanmar
6 Myanmar 4% Share
Indonesia
7 Korea 4%
UK
8 China 4%
Phillipines
9 USA 3%
Thailand
10 France 3% India
11 Others 18% 0% 10% 20% 30% 40%

8. Hospital Data
• Medical & Health Facilities & Personnel • Doctors in Myanmar
1 No of Drs in State service 6331
1 Approximate Specialist Hospital 35
2 No of Drs in Private practice 11145
2 Hospital with specialist service 29 Total 17476
3 Hospital above 25 bedded 302
Total 366

9. UNION OF MYANMAR
Ministry of Health
Department of Health
Food and Drug Administration
Office No(47),Nay Pyi Taw, Myanmar
Registration Procedure
• Toapply name registration for assessment fees ( It will take 10 days or 14 days )
• After getting assessment fees documents from FDA, to remit assessment fees on
Monday and Wednesday only at FDA.
- Monday ( variation fees, assessment fees, registration fees )
- Wednesday ( assessment fees, registration fees )
• After remitting the assessment fees, to apply FDA permit ( It will take 10 days )
• After getting FDA permit, to apply FOC Trade permit at Airport Trade Office. ( It will
take 2-3 days only )
- Need to apply Trade permit if the weight of samples is too much. (or) if the products
too much for samples dispatching.
• After getting FDA permit and Trade permit, to inform to dispatch the samples and to
submit at FDA.
• After submitting the samples, to submit the dossiers.

10. • - For dossier submission,
- Need to take number upto 9:30 am on Tuesday for renwal and on
Thursday for new product.
- Firstly FDA accept the dossiers without checking details and
unlimited dossier qty.
- Up to 3 pm only. ( renewal on Tuesday/new on Thursday )
- Then, after two weeks, FDA issue the preview for the complete
dossier, and return back the incomplete dossier to whom concern.
Time is from 3 pm to 4:30 pm.
• Next, two weeks, can pay lab test fees.
• After paid lab test fees, our product is under registration process and
have to follow up and have to wait for approval.
• After getting approval, to pay registration fees.
• After two months, we will get DRC.
- After getting DRC, to apply attachment for DIAC. ( It will take 3
weeks. )

11. Import Procedure for Medicines in Myanmar
• STEP I
• Application of import price confirmation at MPMEEA ( Myanmar Pharmaceutical & Medical Equipment Entrepreneurs'
Association )
• Documents required:
• Data format form issued by MPMEEA for application
• Usage of Medicine
• Respective Original Drug Registration Certificate ( DRC ) issued by Myanmar Food and Drug Board of Authority
• Original Drug Importation Approval Certificate ( DIAC ) issued by Myanmar Food and Drug Board of Authority of import
applied company
• Membership Certificate of MPMEEA
• Database CD contained all import data of respective item ( soft & hard copies )
• Process running time at MPMEEA:
Two days if all documents are correct
• STEP II
• Date entry process at import section ( Yangon ) under Ministry of Commerce
• Documents required:
• Import application document
• Self commitment for import price confirmation
• Usage of Medicine
• Proforma Invoice
• Sale Contract
• Import price confirmation endorsed by MPMEEA
• Market price record for respective medicine
• Process running time at import section ( Yangon ) :
Two days if all documents are correct.

12. • STEP - III
• Bank Credit inspection and online data entry at import section ( Yangon ) under Ministry of
Commerce
• Documents required for Bank credit inspection :
• Application letter
• Original bank credit slip and two copies
• Bank original passport and one copy
• Process running time for bank credit inspection:
One day if all documents are correct.
• Documents required for online data entry:
• Copy of proforma invoice
• Copy of Sale Contract
• Copy of Certificate of Exporter/Importer Registration issued by Directorate of Trade, Ministry
of Commerce
• Usage of medicine
• Company distribution price for respective medicine
• Bank credit slip
• Self commitment for import price confirmation
• Custom H S Code for Section One ( Medicine )
• Process running time for online data entry:
One day if all documents are correct.

13. • STEP IV
• Final import application at import section under Ministry of Commerce in
Naypyitaw ( capital of Union of Myanmar )
• Documents required:
• Import application with company letter head
• Online data entry record ( Original )
• Proforma invoice
• Sale Contract
• Bank credit slip
• Usage of medicine
• Company distribution price for respective medicine
• BOD list of import company
• Import price confirmation endorsed by MPMEEA
• Copy of Certificate of Exporter/Importer Registration issued by Directorate of
Trade, Ministry of Commerce
• Respective Drug Registration Certificate ( DRC ) issued by Myanmar Food and Drug
Board of Authority
• Drug Importation Approval Certificate ( DIAC ) issued by Myanmar Food and Drug
Board of Authority of import applied company
• Data Format Chart of Export Income
• Process running time:
Two weeks if all documents are correct.

14. • STEP V
• L/C opening procedure at Myanma Foreign Trade Bank, Yangon ( MFTB ) or
Myanma Investment and Commercial Bank, Yangon ( MICB )
• Documents required:
Original import licence issued by Ministry of Commerce
• L/C data entry form issued by banks
• copy of Proforma invoice
• Cheque ( 2 sets )
• Bank passport ( 2 copies )
• Import license original and one copy
• Two copies of Proforma Invoice
• Process running time: Three days if all documents are correct.

15. Economical Indicators of Myanmar Market
Myanmar Population Growth Rate, Birth Rate, Death Rate, Net Migration Rate
Myanmar Age Structure, Median Age, Gender and Urbanization
Myanmar Life Expectancy Rate, Infant Mortality Rate and Total Fertility Rate
Myanmar HIV, AIDS and Other Major Infectious Disease Rates
Myanmar Industries and Industrial Growth Production Rate

16. Economical Indicators of Myanmar
• Myanmar Population Growth Rate, Birth Rate, Death Rate, Net Migration Rate :
• Population growth rate: 1.084%
• Birth rate: 19.31 births/1,000 population
• Death rate: 8.16 deaths/1,000 population
• Net migration rate: -0.31 migrant(s)/1,000 population
• Myanmar Age Structure, Median Age, Gender and Urbanization :
• Age structure: 0-14 years: 27.5% (male 7,560,859/female 7,278,652)
• 5-64 years: 67.5% (male 18,099,707/female 18,342,696)
• 65 years and over: 5% (male 1,184,291/female 1,533,599)
• Median Age: total: 26.9 years male: 26.3 years female: 27.5 years
• Sex ratio: at birth: 1.06 male(s)/female under 15 years: 1.04 male(s)/female
• 15-64 years: 0.99 male(s)/female 65 years and over: 0.77 male(s)/female
• total population: 0.99 male(s)/female

17. Economical Indicators of Myanmar
• Myanmar Life Expectancy Rate, Infant Mortality Rate and Total Fertility Rate :
• Life expectancy at birth: total population: 64.88 years male: 62.57 years female: 67.33 years
• Infant mortality rate: total: 49.23 deaths/1,000 live births male: 56.16 deaths/1,000 live births
female: 41.88 deaths/1,000 live births
• Total fertility rate: 2.26 children born/woman
• Myanmar HIV, AIDS and Other Major Infectious Disease Rates :
• HIV/AIDS - adult prevalence rate: 0.6%
• HIV/AIDS - people living with HIV/AIDS: 240,000
• HIV/AIDS - deaths: 18,000
• Major infectious diseases: degree of risk:
• very high food or waterborne diseases:
• bacterial and protozoal diarrhea, hepatitis A, and typhoid fever vectorborne diseases:
• dengue fever and malaria water contact disease: leptospirosis animal contact disease: rabies
note: highly pathogenic H5N1 avian influenza has been identified in this country;
• it poses a negligible risk with extremely rare cases possible among US citizens who have close
contact with birds

18. Economical Indicators of Myanmar
• Myanmar Industries and Industrial Growth Production Rate :
• Industries: agricultural processing; wood and wood products;
• copper, tin, tungsten, iron; cement, construction materials;
• pharmaceuticals; fertilizer; oil and natural gas; garments,
• jade and gems
• Industrial production growth rate: 4.3%

19. Economical Indicator Forecast up to
2016 for Myanmar Markets

20. Year 2012 Year 2013 Year 2014 Year 2015 Year 2016
Sr. No. Economic Indicator Listing for Myanmar Indicator Value Indicator Value Indicator Value Indicator Value Indicator Value
1 GDP Growth (Constant Prices, National Currency) 5.50% 5.67% 5.68% 5.68% 5.69%
2 GDP (Current Prices, National Currency) MMK 45,931.80 Billion. MMK 51,820.81 MMK 58,469.01 Billion. MMK 65,974.81 Billion. MMK 74,449.42 Billion.
Billion.
3 GDP (Current Prices, US Dollars) US$ 53.451 Billion US$ 55.839 Billion US$ 58.338 Billion US$ 60.953 Billion US$ 63.689 Billion
4 GDP Deflator 608 (Index, Base Year 649.159 (Index, Base 693.104 (Index, Base 740.023 (Index, Base Year 790.119 (Index, Base Year
as per country's Year as per country's Year as per country's as per country's accounts as per country's accounts =
accounts = 100) accounts = 100) accounts = 100) = 100) 100)
5 GDP Per Capita (Constant Prices, National Currency) MMK 118,648.72 . MMK 122,903.20 . MMK 127,319.28 . MMK 131,903.40 . MMK 136,662.25 .
6 GDP Per Capita (Current Prices, National Currency) MMK 721,384.39 . MMK 797,836.85 . MMK 882,454.45 . MMK 976,115.75 . MMK 1,079,794.52 .
7 GDP Per Capita (Current Prices, US Dollars) US$ 839.475 US$ 859.7 US$ 880.472 US$ 901.81 US$ 923.723
8 GDP (PPP), US Dollars US$ 87.221 Billion US$ 93.348 Billion US$ 100.102 Billion US$ 107.579 Billion US$ 115.748 Billion
9 GDP Per Capita (PPP), US Dollars US$ 1,369.85 US$ 1,437.19 US$ 1,510.80 US$ 1,591.66 US$ 1,678.79
10 GDP Share of World Total (PPP) 0.10% 0.11% 0.00105 0.00106 0.11%
11 Implied PPP Conversion Rate 526.615 555.138 584.096 613.27 643.2
12 Investment (% of GDP) 13.51% 12.93% 0.12688 0.12618 12.59%
13 Gross National Savings (% of GDP) 16.26% 15.83% 0.17977 0.17967 14.15%
14 Inflation, Average Consumer Prices (Indexed to Year 2000) 2,223.42 (Index, Base 2,401.31 (Index, 2,593.44 (Index, Base 2,800.93 (Index, Base 3,025.03 (Index, Base Year
Year 2000 = 100) Base Year 2000 = Year 2000 = 100) Year 2000 = 100) 2000 = 100)
100)
15 Inflation (Average Consumer Price Change %) 8.25% 8.00% 8.00% 8.00% 8.00%
16 Inflation, End of Year (Indexed to Year 2000) 2,184.02 (Index, Base 2,358.75 (Index, 2,547.47 (Index, Base 2,751.29 (Index, Base 2,971.41 (Index, Base Year
Year 2000 = 100) Base Year 2000 = Year 2000 = 100) Year 2000 = 100) 2000 = 100)
100)
17 Inflation (End of Year Change %) 8.00% 8.00% 0.08001 0.08001 8.00%
18 Import Volume of All Items Including Goods and Services (Percent 4.73% 4.77% -0.00767 -0.00798 -0.69%
Change)
19 Import Volumes of Goods Only (Percent Change) 8.66% 6.22% 0 0 0%
20 Export Volume of All Items Including Goods and Services (Percent 14.77% 48.71% 0.00271 0.00711 0.64%
Change)

21. Year 2012 Year 2013 Year 2014 Year 2015 Year 2016
21 Export Volumes of Goods Only (Percent Change) 14.42% 49.97% 0 0 0%
22 Value of Oil Imports US$ 1.431 Billions US$ 1.56 Billions US$ 1.664 Billions US$ 1.77 Billions US$ 1.884 Billions
23 Value of Oil Exports US$ -- Billions US$ -- Billions US$ -- Billions US$ -- Billions US$ -- Billions
24 Unemployment Rate (% of Labour Force) 4.02% 4.02% 0.0402 0.0402 4.02%
25 Population 63.672 Million 64.952 Million 66.257 Million 67.589 Million 68.948 Million
26 General government revenue (National Currency) MMK 3,060.03 Billions. MMK 3,452.72 MMK 3,936.99 Billions. MMK 4,499.01 Billions. MMK 5,127.83 Billions.
Billions.
27 General government revenue (% of GDP) 6.66% 6.66% 0.06733 0.06819 6.89%
28 General government total expenditure (National Currency) MMK 4,582.86 Billions. MMK 4,987.38 MMK 5,590.00 Billions. MMK 6,334.78 Billions. MMK 7,233.47 Billions.
Billions.
29 General government total expenditure (% of GDP) 9.98% 9.62% 0.09561 0.09602 9.72%
30 Total Government Net Lending/ Borrowing (National Currency) MMK -1,522.83 Billions. MMK -1,534.66 MMK -1,653.01 Billions. MMK -1,835.77 Billions. MMK -2,105.65 Billions.
Billions.
31 Total Government Net Lending/ Borrowing (% of GDP) -3.32% -2.96% -0.02827 -0.02783 -2.83%
32 Total Government Gross Debt (National Currency) MMK 21,978.24 Billion. MMK 25,264.67 MMK 28,776.90 Billion. MMK 29,478.91 Billion. MMK 32,897.38 Billion.
Billion.
33 Total Government Gross Debt (% of GDP) 47.85% 48.75% 0.49217 0.44682 44.19%
34 Fiscal Year Gross Domestic Product, Current Prices MMK 45,931.80 MMK 51,820.81 MMK 58,469.01 MMK 65,974.81 Billions. MMK 74,449.42 Billions.
Billions. Billions. Billions.
35 Current Account Balance (US Dollars) US$ -2.425 Billion US$ 0.646 Billion US$ 1.893 Billion US$ 2.266 Billion US$ 3.232 Billion
36 Current Account Balance (% GDP) -4.54% 1.16% 0.03244 0.03717 5.08%

22. Sales Projections for Myanmar
Pharmaceutical Markets for 2013-14
Sales Projection
Others
CNS
Respiratory
Endocardinal
Gastrointestinal
Sales Projection
Cardiovascular
Analgesics
Vitamins
Anti Infective
0% 5% 10% 15% 20% 25% 30% 35%

23. Expenses for Registration of Pharmaceutical Company
or Drug Product
• Expense Head :
• Registration of Pharmaceutical Company:
• 10- 15 Lacs
• Registration of Pharmaceutical product:
• 30-45 Lacs
• Agents basis : 40-45 Lacs depending upon the
type of the Product to be registered

24. References
• Financial Express Dhaka :
• Economic Times
• Union of Myanmar, Minisitry of Health, Department of Health, Food And
Drug Administration Medipower Myanmar, Burma

25. • Thank You