obtained or in the process of obtaining
UKMHRA, EU, TGA, AUSTRALIA and GCC
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
$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 percent
of the total revenue of pharma products.
The improvement in infrastructure, quality
and regulations will help in increasing the
REGULATIONS FAVORING LOCAL
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 labor, MNCs are interested
for contract manufacturing and strategic alliance.
POSITION OF BIG PHARMA COMPANIES
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 (DCO)
prohibits foreign firms from selling products in Bangladesh
unless they have a manufacturing presence in the country.
Thus, Bangladesh pharma companies can only contract
manufacture for domestic distribution with MNCs that already have a manufacturing facility in Bangladesh. For example: Beximco contract manufactures Ventolin, which is an
inhaler for GlaxoSmithKline.
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, man-
ufacturers 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 phar-
Bangladesh’s pharmaceutical market is significantly growing at a fast pace of 17 percent CAGR. This growth is mainly
driven by the production of import-substituting drugs at a
low cost, increase in healthcare expenditure, favorable regulatory authority for domestic manufacturers and cheap labor.
The local manufacturers 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 percent of the domestic requirement. The MNCs that
ruled the Bangladesh pharma market in 1970 with 70 percent
share had dwindled down to 13 percent in 2013. If the MNCs
don’t have a manufacturing facility in Bangladesh, they cannot
sell their products in Bangladesh. The pricing control of drugs,
TRIPS agreement and marketing regulations are unfavorable for
the MNCs to penetrate the market in a successful manner.
The regulation and government policies helped the local
manufacturers to develop significantly and produced an enhanced growth in local production. The local manufacturers
have made huge investments in developing their new state of
art manufacturing facilities 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