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The
world pharmaceutical market has witnessed an
increase in the number of pharmaceutical products
circulating worldwide, leading to a rapid growth
in both medicine consumption and expenditures.
However, WHO estimates that, as of 1997, at
least one-third of the world's population still
lacks access to essential medicines, either
because these are not available or are too expensive,
or because there are no adequate facilities
or trained professionals to prescribe them.
In poorer areas of Asia and Africa this figure
may be as high as one-half. As a result, millions
of children and adults die or suffer needlessly,
although their diseases could have been prevented
or treated with cost-effective and inexpensive
essential medicines.
Country Status:
Bangladesh formulated its National
Drug Policy (NDP) and promulgated the Drugs
Control Ordinance, in 1982, to ensure that common
people can get the essential and necessary drugs
easily and to ensure the quality and safety
of these essential drugs. It identified 150
drugs as essential drugs with controlled price.
Since 1993, the number of the price-controlled
drugs has been reduced to 117 primary health
care drugs.
Since 1982 the growth of local drug production
has been accelerated. According to the Directorate
of Drug Administration records, in the year
2002, all the essential drugs were produced
locally and about 44.78% of the local drugs
production was related to essential drugs. There
are 10000 brand named drugs on the market, which
involve 1872 generic and locally produced drugs
that meet 93.4% of the local drug demand. There
are 224-licensed pharmaceutical factories in
the country, six of them are owned by multinational
companies producing about 10.4% of the local
production. 85% of the raw materials used in
the local production are imported. Only about
1.1 % of the locally produced drugs is exported.
Being a drug exporting least developed country,
Bangladesh has a unique position in the region,
for not having to adhere to the TRIPS Agreement
until 2016.
WHO Support
WHO, through its country collaborative
programme in Bangladesh, has been supporting
the National Drug Regulatory Authority, the
Directorate of Drugs Administration, under Ministry
of Health and Family Welfare of the People's
Republic of Bangladesh since it was established
in 1976. This includes the technical and administrative
capacity building and implementing interventions
for improving access, quality and rational use
of essential drugs.
WHO, While implementing EDM Work Plan 2002-2003,
had provided support to the related national
authorities in the following areas:
- Capacity building of the Essential Drugs
Company Limited in monitoring and improving
the quality of essential drugs produced. This
included the supply of the necessary equipment
and the local and external training of the
manpower on quality improvement.
- Capacity building of the Directorate of
Drug Administration to perform its functions
as the National Drug Regulatory Authority.
This included the procurement of the necessary
supplies and equipment and the training of
manpower on legal and administrative aspects
of drug registration and quality monitoring.
- The capacity building of Drug Testing Lab
in the Institute of Public Health and Chittagong
Drug Testing Lab. Both labs were supplied
with quality control equipment and the necessary
reagents in addition to training the relevant
manpower.
- Implementing training on Good Manufacturing
Practices for quality managers in the pharmaceutical
sector.
- Drug's post marketing surveillance, where
2022 samples were collected during 2002-2003
and the substandard rate was found to be 2.2%.
Bangladesh is in the process
of updating the National Drug Policy, which
was developed in 1982. There is lack of detailed
publicly available information about the impact
of price control on production, availability
and access to essential drugs. There is also
limited awareness among related government officials
about the impact of relevant trade agreements
(TRIPS) and globalisation on access to essential
drugs
WHO will support the GOB in addressing these
issues while implementing the collaborative
Work Plan of 2004-2005, which includes the delivery
of the following products:
- Enhanced awareness about the impact of TRIPS
on access to essential drugs in Bangladesh:
Bangladesh, as one of the least developed
countries, is in a unique position, in the
region, of not having to adhere to the TRIPS
Agreement until 2016. Stakeholder will be
made aware about the impact of this agreement
on access to essential drugs in Bangladesh
through developing the related documents and
organising awareness workshops.
- Strengthening of the Directorate of Drug
Administration, as a National Regulatory Authority
for drugs, vaccines and herbal medicines:
The capacity of technical staff of the Directorate
of Drug Administration will be improved through
training. The available drugs in the market
will be monitored through Post Marketing Surveillance
to check its quality.
- Strengthened evidence base for reviewing
essential drug pricing policy: An assessment
will be conducted to provide evidence about
the success of pricing control in ensuring
essential drugs affordability and whether
or not it has made manufacturers concentrate
on non-essential drugs and the findings will
be disseminated to the related stakeholders.
- Strengthened drug testing laboratory: The
capacity of both the Drugs Testing Labs in
the Institute of Public Health and Chittagong
Drug Testing Lab will be enhanced through
manpower development and procurement of supplies
and equipment.
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