In sickness and in health
OVER the last two decades, the pharmaceutical industry has made considerable progress with modern manufacturing and improved infrastructure. The pharmaceutical market in Bangladesh is valued at over $ 650m, with steady growth of over 10% annually in recent years.
There are 234 registered pharmaceutical companies in Bangladesh, with 164 actively involved in the manufacture or marketing of pharmaceutical products. These companies produce about 8,000 different brands of medicines in over 10,500 dose strengths and formulations. This is sufficient to meet the requirements for 97% of the Bangladesh population.
Although imports, mostly of raw materials, still exceed the export of finished products, Bangladesh has made progress in developing the pharmaceutical export market. Between 2003 and 2006, exports increased to about 67 countries and quadrupled from Tk. 630 million to Tk. 2,660 million.
Despite being a successful industry, there are both internal and external challenges being faced by Bangladeshi pharmaceutical industries. Although pharmaceutical manufacturers have primary responsibility for drug quality control, the government's Drug Testing Laboratories (DTL) and the Directorate of Drug Administration (DDA) have an essential monitoring and supervisory role.
The DDA is also responsible for the registration of drugs as well as for inspection of premises, and for licensing medicines for the Bangladesh market. However, the limited resources of both the DTL and DDA make it difficult to cope with the necessary workload, which is why the quality of locally produced medicines cannot be uniformly ensured.
External challenges include international political issues, such as the World Trade Organisation (WTO) Trade Related Aspects of Intellectual Property Rights Agreement (TRIPS). Prior to this, many developing countries considered that patent protection limited access to cheap medicinal products to the very poorest in society.
Despite the pressure from developed countries to protect the research and development costs incurred by their pharmaceutical industries, the TRIPS agreement allowed certain flexibilities to accommodate the public health needs in poorer countries.
The treaty defined all nations as "developed," "developing" and "least developed countries (LDCs)."
Bangladesh, together with 48 other countries, including Afghanistan, Bhutan, Cambodia, Ethiopia, Liberia, Myanmar, Nepal, Rwanda, Senegal, Zambia and others, falls in the LDC classification.
The LDC status legally permits Bangladesh to make and sell patented medicinal products locally, to other LDC countries, and to countries where the innovator has not sought patent protection or the patent has been revoked or withdrawn.
Amongst the LDC countries, Bangladesh has the most established and advanced pharmaceutical manufacturing facilities, but has hitherto been unable to take full advantage of the flexibilities conferred by TRIPS.
An evaluation of the opportunities in this sector made the following recommendations that could be implemented in Bangladesh to facilitate safe, effective and quality medicines locally and for export.
API manufacture
Bangladesh government had agreed to provide land for situating factories manufacturing raw materials (API). It is reported that at least 20 investors were ready to invest, and in the last few years more than 10 companies, each with Tk. 400 million, have been ready to invest, and yet there appears to be a lack of government initiative to lead this essential activity. API is essential for sustainability and growth of the pharmaceutical industry in Bangladesh, and so it is important to prioritise this as urgent.
Set up facilities for BABE studies
The government has a responsibility to ensure that incentives and tax breaks are provided to set up high quality laboratories, to bring expertise from overseas, and rapidly set up bioavailability and bioequivalence testing (BABE). Expertise in BABE studies will also be essential for generic manufacturing of medicines for export.
TRIPS agreement
The TRIPS agreement permits LDCs to make generic copies of patented drugs for sale in approved markets, and this opportunity is only available until 2016. The government of Bangladesh has an opportunity to further explore how to support the industry to take full advantage of the flexibility afforded by TRIPS.
Collaboration or joint ventures with foreign partners
Bangladesh is unusual in that local companies dominate the industry. This situation arose from the 1982 Drug Ordinance, but today it is essential that collaboration be established between the private and public sectors, and between the industry and academic and research institutions. Collaboration and joint ventures with foreign partners, including India and China, will be essential for future growth of the pharmaceutical sector.
Contract (toll) manufacturing
The drug policy of 2004 offer opportunities for foreign pharmaceutical manufacturers to toll manufacture under license in Bangladesh, form joint ventures, and manufacture branded products in Bangladesh for export.
These opportunities must be realised to make good use of the quality pharmaceutical manufacturing base that exists in Bangladesh.
Development cost of new medications is rising globally and, therefore, many global pharmaceutical companies are looking for opportunities for cheaper development and manufacturing costs.
Bangladesh has a flourishing pharmaceutical industry with an opportunity to improve medications for local use, and compliance with international regulations will benefit the growing export industry. Bangladeshi pharmaceutical manufacturers have an opportunity to excel in high quality generic drug manufacture for export. This requires good facilities for BABE studies and a source of API. Both are opportunities for Bangladesh.
The authors appreciate the complexity of the task required to develop the Bangladeshi pharmaceutical sector to compete in the global marketplace.
While it would be misleading for us to suggest that there is a single or simple intervention it is clear that a cooperative and collaborative public/private partnership is most likely to succeed in introducing meaningful and sustainable change to support and widen the already successful Bangladeshi pharmaceutical sector.
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