Becoming a global hub of quality medicine

Publish: 3:39 PM, October 7, 2018 | Update: 3:39 PM, October 7, 2018

After apparels the pharmaceuticals industry has been one of the success stories of Bangladesh in the last three decades. Bangladesh had to depend largely for medicines on multinational companies and imports in the 1970s and early 80s. Now local companies meet almost 98 percent of domestic demand worth around USD 2 billion or Tk 16,000 crore.
The sector is not only catering to domestic needs, but also exporting to 145 countries including the United States and Europe. The value of pharmaceutical exports were close to USD 100 million in fiscal 2016-17.
According to experts , Bangladesh’s pharmaceuticals industry is going to be a major player in the global export market in the next three to five years.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 the 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 a 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 over 160 million people.
Bangladesh now has an average life expectancy of 65 years, which is at the top end in South Asia. Growth in local demand will naturally follow increases in per capita income.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. 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 2032 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.