Pharma Industry Emerging As A Major Export Sector - Barriers & Potential

Pharma Industry emerging
as a major export sector –

Barriers & Potential
1
Presented by
Abdul Muktadir
Chairman and Managing Director,
Incepta Pharmaceuticals Ltd
Incepta Vaccine Ltd
• B.Pharm, University of Dhaka

• M.Pharm, University of Dhaka
• M.S. in Industrial Pharmacy, Long Island
University, USA
Research on –
1. Anti-tumor antibiotic, University of Dhaka &
IPGMR (BSMMU)
2. Dosage Form Design, Long Island University,
USA 2
3. Special research interest on Aerosol, Nanotechnology, Sustain
Current Pharma Situation
Country Statistics
• Population: ~ 160 Million (2015)
• GDP (current price) : 223.94 B USD (2016

est)
• GDP per capita : 1386.51 USD (2016 est)
• GDP growth: 7.1% (2016 est)
• Income level: Lower Middle Income (July 01,

2015)
Source: International Monetary Fund (IMF),

Bangladesh Bureau of Statistics (BBS)
3
Human Capital
• Population: ~ 160 million (2015)
• Country position for population in the world :
9
• Population dividend: 1980 to 2040
70 64.25%
60
50
40
31.62%
30
20
10 4.13%
0
0-14 years 15-64 65 & over
years
Source: CIA world fact book
Age Structure (2015 est.) 4
Dr. Khan A. Matin, 2012 (ISRT, DU)
Pharma Companies in
Bangladesh
• Total Number of Registered Companies : 265
• Number of Companies in : 213

operation (including importers)
Ref: Directorate General of Drugs Administration (DGDA) ,

Bangladesh
5
Market Share Distribution
Companies Market Share Cumulative

Market Share
Top 1 - 5 47.78% 47.78%
Top 6 - 10 21.10% 68.88%
Top 11 - 15 10.29% 79.17%
Top 16 - 20 7.13% 86.30%
Top 21 - 25 5.25% 91.55%
Top 26 - 30 3.13% 94.68%
Next 31 – 150 (120 5.32% 100%
companies)
Ref: IMS 3Q, 2016

6
Local Production vs. Import

• Local Production :
97%
• Import : 3%
3%
97%
Ref: Directorate General of Drugs Administration ,

Bangladesh
7
Bangladesh is almost self-sufficient, many of

our neighbours import significant part of
their requirement.
• Singapore 80%
• Malaysia 70%
• Philippines 65%
• Vietnam
60%
8
Pharmaceuticals Sector of
Bangladesh
• In 3Q 2016, market size was 2.11 B US$
• Growth rate was 38.31%
• Per Capita consumption ~ 13.18 US$
Source: Institute for Healthcare Informatics (IMS)
9
Pharmaceutical Sector
 Growth pattern (in Million US$)
(38%)
2500
(15%) 2 11 0
2000 (12%)
(8%) 1671
(24%) (12%) 1461
1500 1271
(24%) 11 7 5
11 3 5
932
1000
500
2010 2 0 11 2012 2013 2014 2015

2016
(Estimated)
Market almost doubled in about 5 years

Source: Institute for Healthcare Informatics (IMS) 10
Future prospect of Pharma Industry considering

15% annual growth (Value in $ Million)
6000
5 11 2
5000
4445
3866
4000
3361
2923
3000
2542
2210
2000
1000
0
2017 2018 2019 2020 2021 2022 2023
11
Production Facility
Bangladesh Pharmaceutical Industries are capable
of producing all types of dosage forms -
• Tablet, • Lyophilized vials,

• Capsule, • Eye drops,
• Liquid preparations, • Meter Dose
• Dry suspension, Inhalers,
• Injections, • Large
• Ointment/cream, volume
• Nasal spray, parenterals
• Granules in sachets, ,
• Pre-filled
syringes
12
etc.
Tablet Compression
13
Liquid filling
14
Meter Dose Inhaler
15
Large Volume Parenterals (LVP)
16
Lyophilized vials for injection
17
Vial filling for injection
18
Pre-filled syringes
19
Eye Drops
20
Nasal Sprays
21
Greenish environment in the
factory premises ensures
fresh air
22
Greenish environment
23
Environmental Protection:
Effluent Treatment Plant (ETP)
24
Bangladesh is capable to produce many

specialized delivery products
• Inhalers
• Pre-filled syringe
injections
• Lyophilized
Injections
• DPI
• Sustain Release
formulations, 25
Formulation:
• Total number of Brand : 25,656
• Total number of generic : 1,326
• Dosage forms : 40
• Number of Pharmacy : 116,826
Active Pharmaceuticals Ingredients (API):

• 15 Companies are currently producing API
• APIs like, Azithromycin, Diclofenac Na,
Flucloxacillin, Amoxicillin, Paracetamol etc.
are produced locally
26
Bangladesh is capable of producing

high quality Products
The industry employs -
• State-of-the-art manufacturing facilities
• Sophisticated production & analytical
equipment and apparatus
• Highly skilled human resources
Finest quality
medicine
27
Driving Force of the Industry

Trainable graduates are available
• Pharmacist • Engineers
• Chemist • Biochemist
• Microbiologist • Doctors
 From 40 different Universities thousands of

professionals are entering this industry
every year
 So, no shortage of educated, trainable
Human Resources
28
A number of pharmaceutical companies have

already obtained GMP certifications from -
• US FDA,
• UKMHRA,
• EU,
• TGA Australia,
• ANVISA
• MOH Turkey,
• Other recognized regulatory
authorities etc.
By 2018, another 10 companies may receive
certification from these regulatory authorities 29
A number of Biosimilar products are now

produced by Bangladeshi Companies
• Human Insulin
• Erythropoeitin
• Filgrastim
Biosimilar from Bulk stage are
• Insulin Glargine now produced locally
• Peg-interferon alpha • Peg-Filgrastim,

• Peg-interferon alpha,
• Peg- Erythropoietin, etc.
30
Competitive advantage of
Bangladesh in global market
• Confidence to produce high quality
product
• Technology
• Human Resource
• Language (English Speaking)
31
Pharmaceutical Export from Bangladesh

Now,
Bangladesh Pharmaceutical Industry is
successfully exporting its quality products to about
124 countries in -
 Asia
 Africa
 North America
 South America
 Europe
Export revenue for 2015-2016 was USD 82.10

million, Growth rate of 18.25% 32
Export from Bangladesh 124 Countries Ref: DGDA
1 Afghanistan 26 Ethiopia 51 Liberia 76 Rumania 101 U.A.E
2 Algeria 27 Fiji 52 Libya 77 Russia 102 Uganda
3 Armenia 28 France 53 Lithuania 78 Samoa 103 UK
4 Australia 29 Gabon 54 Macau 79 Serbia 104 Ukraine
5 Austria 30 Gambia 55 Malaysia 80 Seychelles 105 USA
6 Azerbaijan 31 Germany 56 Maldives 81 Siera Leone 106 Uzbekistan
7 Barkina Faso 32 Ghana 57 Mauritius 82 Singapore 107 Vanuatu
8 Belarus 33 Guam 58 Mexico 83 Slovenia 108 Venezuela
9 Belgium 34 Guatemala 59 Moldova 84 Solomon Islands 109 Vietnam
10 Belize 35 Guyana 60 Mongolia 85 Somalia 110 Yemen
11 Bhutan 36 Honduras 61 Morocco 86 South Africa 111 Palestine
12 Botswana 37 Hong Kong 62 Mozambique 87 Spain 112 Lebanon
13 Brazil 38 Hungary 63 Myanmar 88 Sri Lanka
113 Kuwait
14 Burundi 39 India 64 Nepal 89 Sudan
114 Qatar
15 Cambodia 40 Indonesia 65 New zealand 90 Swaziland
115 Argentina
16 Canada 41 Iraq 66 Nicaragua 91 Switzerland
116 Montenegro
17 Chad 42 Iran 67 Nigeria 92 Taiwan
117 Egypt
18 Chile 43 Italy 68 Pakistan 93 Tajikistan
118 Lesotho
19 China 44 Jamaica 69 Palau 94 Tanzania
119 Malawi
20 Colombia 45 Japan 70 Panama 95 Thailand
120 Mali
21 Costa Rica 46 Jordan 71 Papua New Guinea 96 The Netherlands
121 Senegal
22 Denmark 47 Kenya 72 Philippines 97 Togo
122 Laos
23 Ecuador 48 Kiribati 73 Poland 98 Tonga
123 Kyrgyzstan
24 Eritrea 49 Korea 74 Portugal 99 Tunisia
124 Ireland
25 Estonia 50 Latvia 75 Republic of Dominican 100 Turkey 33
LDC Pharma Intellectual

Property (IP) Waiver Until
2033 Approved By WTO
TRIPS Council on Nov’15
Patent waiver for Bangladesh: until 1 Jan 2033
Source: The Council for Trade-Related Aspects of Intellectual Property

Rights (TRIPS)
• In 1982, multinational companies dominated

the market with 80% market share.
• Today, the market is mainly dominated by
local manufacturers.
13%
Multinationals
87% Local
Top 10 pharmaceutical companies are

local manufacturers.
35
Future Potential
Global Market
• Current (2015) global spending on medicine
is $ 1.1 trillion
Global Spending US$Bn
$856 Bn $1100 Bn
$583 B
$548 B
$429 B
$231 B
$77 B $88 B
B ra n d s Generics O th e r Brands Generics Other
2010 2015
Source: IMS Institute for Healthcare Informatics, Outlook Through
2015
Future Potential
Pure Generic Market in $ Billion
80
70 B
70
60
50
40
30
20
10.5 B
8.12 B 7.92 B
10 4.3 B 4.5 B 3.9 B 3.36 B
0
Canada France Germany Italy Spain UK USA Japan
Total = 112.6 B$ 37
Source: IMS Institute for Healthcare Informatics, Outlook Through
2015
Future Potential
Action needed
• Generic Market has fierce price competition
and whoever can offer less price will win
• To win against competitors we have to find
innovative and smart process for both
API and Formulation
• Current CEP may be 5-20 years old and
they can not change easily
• But, we can come up with cost effective
process by using modern technology
& innovative Processes
38
Future Potential
Global Market
API Formulation
• CEP = Certificate of • Pure Generics
suitability to European (USA, EU, Others)
Pharmacopoeia
• Branded Generics
• ASMF = Active - South East Asia
substance Master File - India
- China
• DMF (US) = Drug - Latin America
Master File - Africa
39
Future Potential
API Park
• Government has established API Park at
Bausia in Munshiganj, about 40 km
away from Dhaka
• About 40 API industry will be established
• Central ETP, Incinerator & other facilities
• BAPI will aim for all 40 companies to be

approved by regulated markets
40
Future Potential
API Park
• BAPI will aim to produce about
800- 1000 generic bulk drugs
• Most of the bulk materials will

have CEP, ASMF, DMF etc.
41
PIC/S
• PIC/S is abbreviation to describe both
the
Pharmaceutical the
Inspection Convention (PIC) and the
Pharmaceutical Inspection Co-operation Scheme
(PIC Scheme) operating together in parallel.
• The purpose of PIC/S is -
 to facilitate the networking between participating

authorities and the maintenance of mutual
confidence
 the exchange of information and experience in the
field of GMP and related areas, and
 the mutual training of GMP inspectors
42
PIC/S Members
1. Argentina 18. Greece 38. Romania
2. Australia 19. Hong Kong 39. Singapore
3. Austria 20. Hungary 40. Slovak Republic
4. Belgium 21. Iceland 41. Slovenia
5. Canada 22. Indonesia 42. South Africa
6. Chinese Taipei 23. Ireland 43. Spain
(Taiwan) 24. Israel 44. Sweden
7. Croatia 25. Italy 45. Switzerland
8. Cyprus 26. Japan 46. Thailand
9. Czech Republic 27. Korea 47. Ukraine
(SUKL) 28. Latvia 48. United Kingdom
10. Czech Republic 29. Liechtenstein (MHRA)
(ISCVBM) 30. Lithuania 49. United Kingdom
11. Denmark 31. Malaysia (VMD)
12. Estonia 32. Malta 50. USA
13. Finland 33. Netherlands
PARTNERS TO PIC/S
14. France 34. New Zealand
(ANSM) 35. Norway • EDQM
15. France 36. Poland • EMA
(ANSES) 37. Portugal • UNICEF
16. Germany • WHO 43
(BMG)
Benefits to become a PIC/S
Member
Benefit for the Regulatory Authority
• High quality standards: It forces improvements in the

GMP inspection system and procedures. This
results in increased efficiency of the GMP
inspectorate.
• Training opportunities
• Networking with other DRA

• Sharing of information
• Rapid Alert System
• International GMP harmonization

44
Benefits to become a PIC/S
Member
Benefit for the Industry
• PIC/S Membership will right away give us
easy access to all PIC/S member countries
• Many non PIC/S Member country also accept GMP
certificates from PIC/S Participating Authorities
• Huge cost will be saved by reducing duplication of
GMP inspections
• Entry to the market will be quick as dossier review
will be much faster as PIC/S member
inspectors share information between them
• Product quality will be improved as we will have to
maintain a high quality standard
45
As a result,
Medium & small scale

companies will get
access to huge
export market
46
Challenges
• BE study cost
 12 – 15 companies are in Export market

 Cost per BE study is around 1,00,000 USD
depending on product nature
 Each company may need 100 BE study so
1,00,000 X 100 = 10 M USD
 For 12 companies it is = 12 X 10 = 120 M
USD
47
Challenges
• Rich but No foreign currency for
Investment
 A large number of companies have abilities
to invest outside
 Hardly any foreign currency is available to
them for investment
 Almost all our foreign competitors have no
such difficulties
 Recently DRL and Intus purchased a large
number of MAs divested by Teva
48
Challenges
• Approved NRA
 DGDA is not yet functional

in the eyes of WHO
 Government has done a lot but
DGDA still needs further resource
allocation
 Work should start in achieving PIC/S
membership
49
Conclusion
(Present situation)
• At present, we can make high quality medicines

but may not be able to face global competition
• Export is limited to mainly emerging countries

and based on combined success of Bangladeshi
manufacturers & their representatives
• API capability is very limited
• NRA is not approved by WHO and DGDA is yet
to be a member of PIC/S
50
Conclusion
(Actions needed)
• Top 30 companies should aim for stringent
regulatory approval
• Develop API industry & develop it fast -
 DGDA should be proactive in approval
procedure
 Import of solvents and intermediates should
be easy
• Expand own marketing & sales team in
the emerging markets
• Buy MAs & penetrate US / EU generic market with
competitive products
• PIC/S membership and WHO approval of NRA 51
Everything is possible,
Let’s do it.
52
Thank You
53

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Pharma Industry emerging

as a major export sector –

• B.Pharm, University of Dhaka

• GDP (current price) : 223.94 B USD (2016

• GDP per capita : 1386.51 USD (2016 est)

• GDP growth: 7.1% (2016 est)

• Income level: Lower Middle Income (July 01,

Source: International Monetary Fund (IMF),

• Number of Companies in : 213

Ref: Directorate General of Drugs Administration (DGDA) ,

Companies Market Share Cumulative

Ref: IMS 3Q, 2016

Local Production vs. Import

Ref: Directorate General of Drugs Administration ,

Bangladesh is almost self-sufficient, many of

• Growth rate was 38.31%

• Per Capita consumption ~ 13.18 US$

Source: Institute for Healthcare Informatics (IMS)

2010 2 0 11 2012 2013 2014 2015

Market almost doubled in about 5 years

Future prospect of Pharma Industry considering

• Tablet, • Lyophilized vials,

Meter Dose Inhaler

Large Volume Parenterals (LVP)

Lyophilized vials for injection

Bangladesh is capable to produce many

Active Pharmaceuticals Ingredients (API):

Bangladesh is capable of producing

Driving Force of the Industry

 From 40 different Universities thousands of

A number of pharmaceutical companies have

A number of Biosimilar products are now

• Peg-interferon alpha • Peg-Filgrastim,

Pharmaceutical Export from Bangladesh

Export revenue for 2015-2016 was USD 82.10

LDC Pharma Intellectual

Patent waiver for Bangladesh: until 1 Jan 2033

Source: The Council for Trade-Related Aspects of Intellectual Property

• In 1982, multinational companies dominated

Top 10 pharmaceutical companies are

B ra n d s Generics O th e r Brands Generics Other

• About 40 API industry will be established

• Central ETP, Incinerator & other facilities

• BAPI will aim for all 40 companies to be

• Most of the bulk materials will

• The purpose of PIC/S is -

 to facilitate the networking between participating

• High quality standards: It forces improvements in the

• Networking with other DRA

• Rapid Alert System

• International GMP harmonization

Medium & small scale

 12 – 15 companies are in Export market

 DGDA is not yet functional

• At present, we can make high quality medicines

• Export is limited to mainly emerging countries

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