PHARMACEUTICAL PROCESSING | APRIL 2015 19 n
n PHARMPRO. COM
relevant APIs is not feasible due to the scale
disadvantages and infrastructure constraints
in the early stages of the value chain.
The machinery for manufacturing the
pharma products also need to be imported.
The leading manufacturers import most of
their equipment from Europe or Japan, other
manufacturers import machinery from China
and India. This creates a cost disadvantage
when compared with their competitors (Indian manufacturers)
who can source the machinery nationally.
BANGLADESH PHARMA EXPORT
Bangladesh is exporting medicines to 87 countries including
the US and a few European nations and it has already received
global recognition from the UK, MHRA, EMEA, TGA and GCC. A
number of companies have already obtained or in the process
of obtaining UKMHRA, EU, TGA, AUSTRALIA and GCC certifications. Bangladesh is also a global hub for the cheapest source
of world class generic medicine and contact manufacturing.
The pharmaceutical sector has also been making its mark
in the field of export. In Fiscal year 2013-14, the country had
fetched more than USD 74 million through export of medicines.
Bangladesh pharma market holds huge potential for export of
low cost generic drugs, which is yet to be unleashed. At present the exports contribute to just 4-5% of the total revenue of
pharma products. The improvement in infrastructure, quality
and regulations will help in increasing the export.
REGULATIONS FAVORING LOCAL MANUFACTURERS
The Directorate of Drug Administration (DDA), the national
drug regulative authority, regulates drug manufacturing, import and quality control of drugs in Bangladesh.
According to the Doha declaration in WTO / TRIPS
Agreement, nations belonging to the least developed countries (LDC) category have the option to manufacture patented
pharma products until 2016. This provides a huge advantage for Bangladesh local manufacturers to legally reverse-engineer patented products for selling in their market and
also export to other LDCs. This also provides Bangladesh
with a huge export opportunity because among all 50 LDCs,
Bangladesh has a strong Pharma manufacturing base. Besides
export opportunity this also provides huge opportunity to
Bangladesh CMOs for contract manufacturing and compulsory Licensing. Since Bangladesh is a market of cheap labour,
MNCs are interested for contract manufacturing and strategic
POSITION OF BIG PHARMA
COMPANIES IN BANGLADESH
Foreign brands are not allowed to be
manufactured under license in Bangladesh
if similar products are being manufactured
in the country. The Drug Control Ordinance
Price Control: Currently there are 209 drugs on the essential
drugs list. For these drugs, prices are fixed for the finished
drugs as well as for their corresponding raw materials. So,
manufacturers cannot set maximum retail prices for these
drugs beyond that limit. For drugs that do not fall into this
“Controlled Category”, the manufacturer can set their own
price but it must be approved by the Drug Control Committee.
This resulted in withdrawal of many foreign companies from
the market. The MNCs that ruled the Bangladesh pharma
market in 1970 with 70% share had now dwindled down to 13%
(2013). This enabled a strong growth in local production and
also created a boon for local pharmaceutical manufacturers.
Bangladesh’s pharmaceutical market is significantly growing
at a fast pace of 17% CAGR. This growth is mainly driven by the
production of import-substituting drugs at a low cost, increase
in healthcare expenditure, favourable regulatory authority for
domestic manufacturers and cheap labour. The local manu-
facturers have started manufacturing the generic versions of
the imported patented drugs and some larger firms (Beacon
Pharma) have started to produce anti-cancer and anti-retroviral
drugs. The products manufactured by the local manufacturers
are meeting 97% of the domestic requirement. The MNCs that
ruled the Bangladesh pharma market in 1970 with 70% share
had dwindled down to 13% in 2013. If the MNCs don’t have a
manufacturing facility in Bangladesh, they cannot sell their prod-
ucts in Bangladesh. The pricing control of drugs, TRIPS agree-
ment and marketing regulations are unfavourable for the MNCs
to penetrate the market in a successful manner. The regulation
and government policies helped the local manufacturers to de-
velop significantly and produced an enhanced growth in local
production. The local manufacturers have made huge invest-
ments in developing their new state of art manufacturing facili-
ties and had already received global
recognition from the UK, MHRA,
EMEA, TGA and GCC for export.
Thus, the future holds good for the
local manufacturers as Bangladesh’s
pharma market is becoming a potential hub for generics. n