Bangladesh poised to become global hub of quality medicines

From The Korea Times:

The pharmaceutical sector in Bangladesh, one of the fastest growing sectors of the economy, is poised to transform the country into a global hub of quality medicines. The $700 million sector with more than 230 manufacturers is continuously expanding with new products to new international destinations.

The export value of pharmaceuticals is small but growing at 50 percent per year. Exports increased from $8.2 million in 2004 to $28.3 million in 2007, while export destinations climbed from 37 countries to 72 during the period.

The industry's inception dates back to the 1950s when a few multinationals and local entrepreneurs started with manufacturing facilities in the then East Pakistan. By 1982, many top ranking multinationals established their manufacturing facilities in this part of the world. Prominent among them were Pfizer (NYSE:PFE) , Glaxo, Fisons, Squibb, Hoechst, ICI, May & Baker and Organon.

Pharmaceutical industries in Bangladesh are gifted with unparalleled potential to grow in the days ahead as they enjoy a number of competitive advantages.The industry's ability to comply with guidelines of quality assurance has put it on a solid base. Almost all companies are equipped with World Health Organization (WHO) Good Manufacturing Practice (GMP) standards.

Bangladesh's ability to face competition from developing countries like India, China, Brazil and Turkey in its export markets is due to Bangladesh pharmaceutical's strict quality compliance.
The most important indicator is the capability of the industry to achieve excellence and go beyond general international standards.

A good number of companies including Square Pharma, Renata and Eskayef have won accreditation from the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA).
Incepta and Beximco Pharma have been accredited by EMEA (Austria) and the Therapeutic Goods Administration (TGA-Australia), respectively. These accreditations will allow them to enter the lucrative market with very competitive prices and standards as reputed global players. The government of Bangladesh emphasizes on its national drug policy that all the pharmaceutical manufacturers must strictly comply with thee standards.

The Current Good Manufacturing Practice (cGMP) is a term recognized worldwide as a holistic approach for the control and management of manufacturing and quality control testing of food and pharmaceutical products.

Bangladeshi pharmaceutical industries are expanding exportable items quite fast.
Bangladesh is now exporting wide range of pharmaceutical products covering all major therapeutic classes and dosage forms like tablets, capsules and syrups.

Bangladesh is also exporting high-tech specialized products like, HFA, inhalers, suppositories, hormones, steroids, oncology, immunosuppressant products, nasal sprays, injectibles and IV infusions. The sector enjoys sound footing due to the local pull of heavy demand for medicines by the country's 150 million people.

The industries are now producing quality medicines at an affordable price for millions of people in Bangladesh and has made Bangladesh almost self reliant in pharmaceutical products.
Now, 97 percent of local demand for medicines is met by the sector.

Major epidemics of Bangladesh are malaria, dengue fever, cholera and typhoid. Morbidity and mortality from these scourges has also been reduced substantially over the years in Bangladesh.
Increased affordability and availability of medicines have contributed to this achievement.

Bangladesh now has an average life expectancy of 61 years, which is at the top end in South Asia.
Growth in local demand will naturally follow increases in per capita income.Per capita consumption of medicines is one of the lowest in South Asia.

The industry welcomed over 50 new factories in the last three years, of which about two dozen started marketing with an aggressive sales and promotion strategy during 2008.
Out of 230 companies, 200 have their own manufacturing facilities of which five are multinationals.

The sector is active in API (active pharmaceutical ingredients). Twenty-one different companies now locally manufacture 41 API's. However, compared to huge local demand, more API industries need to be set up.Pharmaceutical industries' potential has multiplied with the recently approved API industrial park in Munshigonj at a cost of $30 billion.

The API Park will inject fresh momentum into the pharmaceutical industry. The country can save at least 70 percent of the amount and the park is expected to transform the industry as a major export earner with the potential to export products worth $750 million per year within the next five years.

At this moment, Bangladesh imports 80 percent of its pharmaceutical raw materials from aboard. A good number of skilled professionals from home and abroad are joining the industry's human resources pool every year.

Bangladesh can continue with the patented products up to 2015 as per trade related intellectual property rights (TRIPS). Pharmaceutical industries are now legally allowed to reverse engineer, manufacture and sell generic versions of on-patent pharmaceutical products for domestic consumption as well as for export to other LDCs.

This has created a big opportunity to make Bangladesh as a new chemical entity.
With about 45 years of experience in pharmaceutical formulation and marketing Bangladesh is in a position to share those with both LDCs and developing countries where needed. Apart from the regular investment in pharmaceutical industries and API, opportunities of bioequivalence study, validation report, clinical trials and manufacturing plant audit mechanism have been created.

Currently, bio equivalency tests are conducted in Singapore, Malaysia and in European countries resulting in huge expenditure of pharmaceutical industries. More investments in these sub-sectors would be needed in future. Foreign investors can take advantage of the flourishing industries.

It is estimated that over $250 million have been invested in this sector over the last couple years in terms of facility modernization as well as new facilities.

Needless to mention that all of these investments were directed towards developing full cGMP compliant facilities, which can meet stringent regulatory requirement of any country of the world.

Such investment has already started paying off as most of these companies have either already received certification or are on the verge of getting approval from world toughest regulatory bodies like U.S. FDA, U.K. MHRA, TGA Australia and European Union.

This has opened up wider range of opportunities for the industry whereby these Bangladeshi companies can now export pharmaceutical products to any part of the globe capitalizing on the $600 billion plus global pharmaceutical market.