Bangladesh is confronted by high burden of infectious disease and cases of chronic non-communicable diseases are also on the increase. Efforts at confronting these challenges have been remarkable. In addition, the pharmaceutical market in Bangladesh is more than US$ 1.8 billion with the pharma exports over US$ 50 million. The industry also exports medicines to global markets, including Europe. Pharmaceutical companies are expanding their business with the aim to expand the export market. The pharmaceutical industry in Bangladesh is one of the most developed technology sectors within Bangladesh. Manufacturers produce insulin, hormones, and cancer drugs. This sector provides 97 per cent of the total medicinal requirement of the local market.

These achievements in health and economic development of the pharmaceutical industry are at times stymied by poor quality products. In 2009, about 25 children died from toxic paracetamol manufactured locally. It is estimated that spurious medicines cost the Bangladesh pharmaceutical industry up to US$ 150 million per year. These challenges and the opportunities for tremendous growth in the pharmaceutical industry highlight the need for Bangladesh to develop a world-class drug regulatory authority.

Bangladesh also has Complementary and Alternative Medicine (CAM) which includes Ayurvedic drug therapy , Unani drug therapy, herbal drug therapy, homoeopathic & biochemic drug therapy in addition to allopathy therapy.

The industry exports active pharmaceutical ingredients (APIs) and a wide range of pharmaceutical products, covering all major therapeutic classes and dosage forms, to 79 countries. Along with regular forms like tablets, capsules and syrups, Bangladesh also exports specialized products like HFA inhalers, CFC inhalers, suppositories, nasal sprays, injectables, IV infusions, etc. These products have been well accepted by medical practitioners, chemists, patients and the regulatory bodies of all of their importing nations. The packaging and the presentation of the products of Bangladesh are comparable to any international standard.

The Directorate General of Drug Administration (DGDA), Bangladesh’s national regulatory authority (NRA) was established in 1976 and is charged with the responsibility of regulating Bangladesh’s medical sector which includes allopathic, unani, ayurvedic, herbal, and homeopathic, and biochemic products. The DGDA has a list of more than 50,000 products registered in the country. The pharmaceutical industry in Bangladesh provides almost all of the local needs while through its export activities, contributes to foreign exchange earnings.

Regarding the manpower and funding, DGDA is severely understaffed to fulfill its mandate and support the local industry, given the rapidly growing pharmaceutical market, large number of registered products, and large population size. Funding to cover the critical activities of the DGDA and implement the operational plan is inadequate. Fees charged for regulatory services adjusted by growth national income (GNI) per capita are significantly lower than in other countries. A comprehensive costing analysis is needed for the DGDA on the adequate level of resources including staffing required to effectively implement its responsibilities.

Pricing policy
Pricing policy is also regulated by DGDA and contributes to keeping the prices of pharmaceuticals low in Bangladesh, particularly for the primary healthcare listed medicines. Also, the price marked in the packing materials is another good mechanism to control prices of medicines. However, there is no systematic price-monitoring system in Bangladesh. Absence of a price-monitoring system and inadequate inspections can incentivize retail pharmacies and medicines shops to make illegal profits. Introducing a robust price monitoring system, such as barcodes in product packages, can ensure the affordability of medicine and prevent counterfeiting.

Import & export
The National Drug Policy and the Drugs (Control) Ordinance 1982 and its amendments gave protection to local manufacturers by restricting the import of pharmaceutical products that are locally manufactured in Bangladesh. It helped to keep out less-regulated manufacturers from other countries. An import license is required before the products can be imported in Bangladesh, once the manufacturer and product are registered successfully. However, Bangladesh is still relying on pharmaceutical imports, particularly for raw materials and APIs. About 70-80 per cent of APIs worth US$ 179 million were imported, in 2011.

The top 10 pharmaceutical companies are Square Pharmaceuticals, Beximco, Eskayef, Incepta, Acme Laboratories, Advanced Chemical Industries, Opsonin, Renata, Aristopharma, and Drug International. Some of the top local manufacturers meet international GMP standards and are certified by the Medicines and Healthcare Products Regulatory Agency (MHRA), Therapeutic Goods Administration (TGA), and US Food and Drug Authority (FDA). However, the rest of the local manufacturers, particularly smaller companies, have yet to meet GMP standards.

The medical device market in Bangladesh is relatively small, approximately worth US$ 250 million because of underfunding of healthcare facilities and high out-of-pocket contributions. However, according to the BMI market forecast, the medical device market will grow about 10 per cent per year over the next five years and account for five per cent of total healthcare expenditures in Bangladesh. Currently most of the heavy devices are imported from India, China and western countries.

Exports have been growing, reaching a value of US$ 50 million, although the local subsidiary of the multinational Swiss company Novartis accounts for half of exports from Bangladesh. Bangladesh exports a wide range of products to 87 countries including high-tech specialized products such as hydrofluoroalkanes (HFAs), inhalers, suppositories, hormones, steroids, oncology, immunosuppressant products, nasal sprays, injectables, and intravenous infusions. Demand for Bangladesh’s pharma products is growing in Asia, Africa and European markets as manufacturers follow international standards that ensure better quality.

Regulatory aspects
The key legislation in Bangladesh includes The Drug Act 1940 and its amendments (The Drug Rules 1945 and The Drug Rules 1946) and The Drug (Control) Ordinance 1982 and its amendments [Drug (Control) (Amendment) Ordinance 1984 and Drugs (Control) (Amendment) Act 2006]. The National Drug Policy 2005 sought to remove medicines considered harmful, useless, and unnecessary from the market to product the public and provide pharmaceuticals at an affordable price.

Provided that the pharmaceutical industry is given high priority by the GOB and expands its manufacturing capacity and exports rapidly, the National Drug Policy provides a clear vision to support the local industry to manufacture and export good quality medicines and strengthen the capacity of the DGDA. Bangladesh can continue to produce patented products until 2016 as per trade related intellectual property rights (TRIPS).

The estimated time taken to register new products is estimated at eight months to a year, whereas the citizen charter provides an expected timeline of six months for registration. Currently, there are only five staffs in DGDA screening the dossier and preparing the summary report for more than 50 application dossiers submitted per month. Severe understaffing in DGDA has a significant impact on the local pharmaceutical industry by delaying the introduction of quality-assured products into the market.

The pharmaceutical sector in Bangladesh is growing rapidly and provides an example of how health and economic development intermix. The justification to strengthen the Bangladesh pharmaceutical regulatory system is compelling because of the dual contribution in improving health outcomes and economic development from a strong, local pharmaceutical industry.

The DGDA’s capacity should be strengthened to protect public health while advancing industrial development in Bangladesh. The sound regulatory system can ensure quality, safety, and efficacy of medicines and support the achievement of quality standards in pharmaceutical manufacturing in Bangladesh. The way forward should be towards effective implementation of priority actions identified through this assessment and the subsequent action plans developed by stakeholders. To achieve those objectives, political leadership, commitment, and substantial investment in human and infrastructural resources will be needed.