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WELCOME TO MY

PRESENTATION
LEGAL ISSUES FOR ENTREPRENEURS
IN BANGLADESH
&
FACILITIES PROVIDED BY THE GOVT.
TO THE ENTREPRENEURS

OVER 100
COMPANIES ARE
IN OPERATION.

HIGHLY
CONCENTRATED
AS TOP 20
COMPANIES
PRODUCE 85% OF
THE REVENUE

PHARMACEUTICAL
INDUSTRY IN
BANGLADESH
THIRD LARGEST
INDUSTRY IN TERMS
OF CONTRIBUTION
TO GOVERNMENTS
REVENUE

CONTRIBUTES
ABOUT 1% OF THE
TOTAL GDP

MARKET COMPETITION
SJ

Name of Company

Market Share (%)

Square Pharmaceuticals

18.63

Incepta Pharmaceuticals

9.68

Beximco Pharmaceuticals

8.83

Opsonin Pharma

5.38

Renata Pharmaceuticals

4.94

Eskayef

4.64

Aristopharma

4.18

ACI

4.17

Acme

3.98

Drug International

3.78
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EXPORT SITUATION OF
PHARMACEUTICAL INDUSTRY

Pharmaceutical

sector

of

Bangladesh

can

meet

97

percent of the total medicine requirement of the local


market.

Pharmaceutical

exports

of

Bangladesh

rose

around 15 percent in FY 2013-14 from FY 2012-13. Export


data over the last five years is given below:

Fiscal Year

Export in USD million

2013-14

69.23

2012-13

59.82

2011-12

48.25

2010-11

44.27

2009-10

40.97

Industry Advantages:

Pharmaceutical industry of Bangladesh has created more


than 0.10 million jobs. Besides the sector provides high
quality

products

which

has

already

gained

global

acceptance.

As a member of TRIPS agreement in Bangladesh, any


pharmaceutical company can manufacture the patent
product exclusively at any price for the patented period
which is 12 to 20 years.

The sector is almost self-sufficient as it can meet the


most local demand of medicines.

Industry Disadvantages:
Main

drawback

pharmaceutical

of

this

industry

sector
is

not

is

that

the

local

backward-integrated.

Bangladesh has to import 90 percent of total requirement


of main ingredient of Pharmaceutical products. Total import
value in a year is over BDT 2,500 crore.
Pharmaceutical industry is a capital intensive industry
requiring huge fixed costs in machinery and extensive R&D
expenditure which makes it hard for the companies to enter
into the market.
8

Governments facilitation policy to the


industry:
The sector is protected from external competition as
imports are completely restricted for similar drugs that
are manufactured locally.
Government has reduced customs duties on 40 basic raw
materials used in the manufacture of medicines to 5
percent from 10-25 percent.
Customs duties on 14 items used in anti-cancer
medicines have been withdrawn in the Budget of FY
2014-15.
Government also gives tax holiday facilities for new
pharmaceutical companies established within the period
of June 2019.
Government has already taken an initiative to establish
an Active Pharmaceutical Ingredient (API) park to lower
9
the dependence on import.

DRUG ACT 1982

The drug Act 1982 is the parliamentary approved rule


for regulating the pharmaceutical industry in
Bangladesh

10

MAIN FEATURES OF DRUG ACT 1982


Drug Control Committee
Registration of Medicines
Cancellation or suspension

No
Themedicine
licensingofauthority
any kind shall
shall not
be
A
registration
shall,
unless
manufactured
register a medicine
for sale
unless
or such
be
cancelled earlier, be valid for a
imported,
registration distributed
is recommended
or sold
by
period of five years.
unless
the Committee.
it is registered with the
oflicensing
registration
authority.

Fees for registration


Restriction on import of certain pharmaceutical
raw material
Restriction No
on pharmaceutical
manufacture raw
of certain
under
materialdrugs
necessary
for the
manufacture of any medicine specified in any of the
license.
Schedules shall be imported.

Employment of pharmacists.
No person shall publish or take any part
in die publication of any advertisement

Control of advertisement
andtoclaims
respect
which relates
the use in
of any
drug orof
drugs.

contains any claim in respect of


therapies or treatment without the prior
approval of the licensing authority.

11

CONCLUSIO
N

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