Myanmar: Country Profile for Pharma

DEMOGRAPHIC (MYANMAR)

• AREA :676,577 SQ KM• POPULATION- Approx 61 million ( CIA World Factbook)

– MALE49.09%– FEMALE50.91%

• NATIONAL GROUPS: 135 ETHNIC• NATIONALITIES: 69% BAMARS AND OTHER CHIN, KACHIN, KAYIN,

KAYAR MON, RAKHINE & SHAN• LIFE EXPECTANCY : 60 YEARS • AVERAGE HOUSEHOLD SIZE: 5 PERSONS

– TV/ HOUSEHOLD: 1/73– CAR / HOUSEHOLD: 1/54– TELEPHONE/HOUSEHOLD: 1/86

• SOURCE FROM: UNDP REPORT

FACTS OF MYANMAR’S MEDICAL INDUSTRY

• Myanmar is now seen as an attractive investment destination for international businesses, thanks to its new incentive policies for foreign investment.

• People in Myanmar also face a dire shortage of essential goods such as medicine, medical equipment.– Number of Specialist Hospitals in Myanmar: 35– Number of Hospitals with more than 25 beds: 302– Number of doctors in State Service: 6331– Number of doctors in Private Practice: 11145

Facts :Medical Industry

FACTS OF MYANMAR’S PHARMACEUTICAL INDUSTRY

• Estimated size of Myanmar’s Pharmaceutical Industry is about USD 100 – 120 Million CIF Value.

• Indian Pharma Companies are about 35- 40% of the market followed by Pharma companies from Bangladesh, China, Thailand, Indonesia, Pakistan and Vietnam.

• Leading Indian players there are Ranbaxy, Cipla, Dr Reddy’s etc.• 2 Major cities Yangon and Mandalay contribute to 60% of total

pharma sales in Myanmar.• Prescription drugs can be sold in open market.• According to the statistics of Myanmar Ministry of Commerce,

Myanmar imported more than 5000 categories of Medicine annually.• Currently there are 6 pharma manufacturers located in Myanmar.

Facts: Pharma Industry

• Dr. Win Sithu, the chairman of Myanmar Pharmaceutical and Medical Equipment Entrepreneurs Association, said that Burma imported medicine worth a total of US $89 million from three neighboring countries in the year from July 2011to 2012.

• India was the largest exporter of medicine to the country, with Thailand second and China third.

• India may be the largest exporter of medicine to Burma because of the short flight time and high quality of medical drugs the country offers, said Win Sithu.

• An official from Aung Capacity Co, a major Burmese medicine importer, said, “Burma mostly imports medicines from India because the country has both small-scale and multinational Western medicine retailers. Indian traders successfully captured the medicinal drug market in Burma long ago.”

• More than 100 varieties of medicines are imported to Burma, according to Win Sithu, adding that the market is more open now that tax has been lowered on widely used drugs such as Paracetamol, Burmeton and Amoxicillin.

BURMA IMPORTS $89M IN MEDICINE FROM NEIGHBORS

Pharma Market Comparison:Myanmar v/s Thailand

Diabetes Prevalence in Myanmar

• The prevalence of diabetes in Myanmar is about 12.14 per cent, according to a

• WHO- Myanmar Country co-operation strategy report for 2008-2011. • The Myanmar Health Department and the World Health Organization

(WHO) jointly conducted a health survey in Yangon and suburban Hlegu Township involving interviews with 5,000 respondents.

• The survey designated Yangon as an urban area and Hlegu as a rural area. The findings showed 14.42 per cent of people in the urban area and 7.4 per cent of people in the rural area had diabetes. However if we accept the findings by International Diabetes Federation as published in the Diabetes Atlas 2010, the prevalence of diabetes in Myanmar could be only 2.8%.

Diabetes Prevalence:Myanmar

Diabetes Market in Myanmar

•Diabetes Mkt is 11Mn USD (yr 2011)•High market growth expected as diagnosis and treatment access improves

Diabetes Market: Myanmar

Myanmar: Opportunities & Challenges.

Opportunities

• Untapped consumer potential. Consumerism on the rise.

• Country will “catch up” – growth will be high next 5-7 years.

• As a developing country the fundamentals are strong.

• The changes are real and irreversible.

Challenges• Current market size is small• Local talent pool for executive

positions is limited • Lack of complete market

information. • Infrastructure needs to be

upgraded. • Legal framework still

developing. • Market is not virgin. Many

players.

Opportunities & Challenges: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

Import Procedure for Medicines in Myanmar

• 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.

Import Procedure for Medicines in Myanmar

Import Procedure for Medicines in Myanmar(Cont..)

• 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.

Import Procedure for Medicines in Myanmar(Cont..)

• 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.

Import Procedure for Medicines in Myanmar(Cont..)

• 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.

Import Procedure for Medicines in Myanmar(Cont..)

FDA Registration Procedure

• To apply 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.

- 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. )

FDA Registration Procedure: Myanmar

Initial application for Registration(1)

• An application for registration of drug must be submitted to the Department of Health, Food and Drug Administration in the original prescribed form (Form 1 Registration). Form (1) is available at one hundred kyats each at office of the Food and Drug Administration.

• Separate registration has to be applied for pharmaceutical preparations of different strength or different dosage form.

• Form 1 must be filled out in type print. Enclosures submitted together with application form shall be mar ked with proper reference. A form which is filled incompletely or improperly will not be accepted.

• Form (1) must also be accompanied with two sets of documents on complete information of drugs. (See Annex-I for type of documentation required). Documents have to be submitted in file in an order as listed in “Documents Required for Registration of Drugs”. A list of documents submitted should be shown on the first sheet of the file.

• An application with incomplete documentation will not be accepted.• (a) an application must be submitted in person by an authorized representative of owner of

drug. * Any application made by mail or facsimile or means other than in person, will not be accepted. An authorized representative has to be a resident in Myanmar.(b) Should an authorization for representation be granted to the local company, the representative shall be a company employee authorized to serve as a contact person.

• Registration assessment fees must have been remitted to Myanmar Foreign Trade Bank (MFTB) in favor of Drug Advisory Committee Account No.(IDA-06-91892) when submission of the application form is made. *Product licence holder at country of origin

Initial Application for Registration: Myanmar

• (a) If it is an application for registration of drugs manufactured outside Myanmar. The Food and Drug Administration will issue “Approval for importation of Drug Samples” (Annex II) after receiving application. The drug samples as specified in the approval shall then be imported into the country. The holder of the approval shall comply not only with the conditions stipulated in the approval shall comply not only with the conditions stipulated in the approval but also with the regulations of commerce and Customers Department. (b) As per Ministry of Health Notification 3/93dated 5-8-93 paragraph 5, prior approval shall be obtained from Food and Drug Administration for importation of sample drug. For the importation of sample drug without prior approval of the FDA, the FDA will not issue approval certificate.

• (a) The following kind of drug samples are normally required. - Drug samples the quantity of which is sufficient for clinical trial on sixty patients. For certain rare diseases fewer numbers of samples may be acceptable. - Samples for laboratory analysis. - Samples for retention. (b) For the total numbers of sample drugs to be submitted, please refer to FDA circular 1/97(a) “Required quantities of sample drugs for registration” (Annex III) (c) All drug samples must be accompanied with their respective analytical report (the certificate of analysis). The name and designation of an official who signs the report must be stated. The photocopy of report is not acceptable.

FDA Registration Procedure: Myanmar(cont..)

• The evaluation process for registration will be started only when all the requirements for registration application have been met; viz: (a) remittance of Registration Assessment Fees, (b) complete set of documents, (c) sufficient quantity of drug samples.

• (a) When the drug is approved for registration, the applicant will be notified to remit 200 United States Dollar as Registration Fees. The notification will be made only on the notice board of FDA. (b) Failure to remit registration fees within 90 days from the date of intimation will constitute forgoing of an application by an applicant. If so happens, neither the Registration Assessment fees remitted nor registration documents and drug samples will be returned.

• Failure to make a follow-up of an application by an applicant for more than six months from the date of remittance of assessment fees, will be taken as forgoing of an application.

• The Registration Certificate (Form II) will be issued only when the acknowledgement of receipt of payments is submitted, issued by MFTB submitted.

• The submitted dossiers are not reclaimable in case of rejection of application.

FDA Registration Procedure: Myanmar(cont..)