By Samson H. Chowdhury
Chairman of Square Pharmaceuticals
With an annual turnover of about $650 million, Bangladesh's pharmaceutical industry is one of the fast growing sectors in Bangladesh thanks to science and it's pulsating private sector, which efficiently utilized all available resources from government initiatives.
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In a land of 140 million people with frequent natural disasters, poverty and many other drawbacks, the pharmaceutical industry has increased in strength since the independence of Bangladesh in 1971.
The industry is now making available quality medicines at an affordable price to millions who were beyond reach.
Among the 49 least developed countries (LDCs), Bangladesh is the only country that is nearly self-sufficient in pharmaceuticals.
Bangladesh's pharmaceutical industry now caters to 96 percent of the country's pharmaceutical needs, worth about $700 million.
The remaining 4 percent includes Insulin, vaccines and high-end anti-cancer drugs, the production of which are very capital intensive and therefore not economically feasible for Bangladesh.
Bangladesh is basically a branded generic market. The industry's major competence lies in formulation.
In total, more then 230 companies have operations in Bangladesh. About 200 have their own manufacturing facilities, of which five are multinationals.
It is also active in active pharmaceutical ingredients (API). Twenty-one different companies now locally manufacture 41 APIs.
The industry's inception dates back to the 1950s when a few multinationals and local entrepreneurs started manufacturing facilities in then-eastern Pakistan. By 1982, many top-ranking multinationals had established manufacturing facilities there.
Prominent among them were Pfizer, Glaxo, Fisons, Squibb, Hoechst, ICI, May & Baker and Organon.
Nineteen eighty-two brought in a substantial change in the Bangladeshi pharmaceutical scenario. In June of that year, Drug (Control) Ordinance of 1982 was promulgated against the backdrop of the rising cost of medicines, with emphasis on the manufacturing of low-tech products with negligible or doubtful needs.
The ordinance sought to bring down the prices of ``Essential Drugs," discontinue production of pharmaceuticals of doubtful or negligible use and encourage local production of pharmaceuticals.
After about 22 years, it can now be said that the major objectives of the ordinance are largely fulfilled.
Some of the major achievements of the Bangladeshi pharmaceutical industry so far are:
Affordability of medicine to a substantial portion of the population: Major health hazards in Bangladesh are Malaria, including Dengue fever, Cholera and Typhoid. Morbidity and mortality from these scourges has reduced substantially over the years.
Increased affordability and availability of medicines has contributed toward this achievement. Bangladesh now has an average life expectancy of 61 years, which is at the top end in South Asia.
Near self-sufficiency in pharmaceutical manufacturing: The role of imports has diminished substantially and now stands at about 4 percent, covering mainly Insulin, Vaccines and anti-cancer drugs.
Strong footing in the local industry and local entrepreneurs: Local companies cater to about 80 percent of the market. Local companies continue their expansions and upgrade their facilities to international levels.
Export of pharmaceuticals: After catering to the country's needs, pharmaceuticals from Bangladesh are now being exported to 68 countries in Asia, Africa and Europe. In 2006-2007, total exports were $28.12 million with a growth rate of 47 percent.
Quality assurance: All major companies comply with WHO GMP guidelines and Bangladesh's ability to face competition from developing countries like India, China, Brazil, Turkey in exports is due to strict quality compliance.
A few top-level companies are going beyond WHO GMP guidelines, aiming to get into regulated markets like the U.S. and EU countries etc., putting up manufacturing facilities of U.S. FDA and U.K. MHRA standards.
Among them are Square Pharmaceuticals, the leader of the industry. Its state of the art and International GMP standard pharmaceutical manufacturing facility went into commercial operation in 2002.
The pharmaceutical industry feels that there are still some weaknesses in government policy on pharmaceuticals which need to be addressed to increase the performance of the industry.
They are:Restrictions on manufacturing under license: This has reduced the availability of products in Bangladesh from multinationals that do not have a direct presence in the country.
Bangladesh is also being deprived of the technology transfer where the major strength of the multinationals lie. With fast-changing pharmaceutical manufacturing processes, such knowledge is important to make the local industry more efficient in the domestic and overseas markets.
Adherence to single active products: Due to advances in science, combination drugs in vitamins and cardiovascular and dermatological treatment are common in advanced countries. Local regulatory authorities' reluctance to allow multiple active drugs is depriving the country of recent advancements in pharmaceutical formulation.
Restrictions on dietary supplements and OTC products in mass media: These are quite common in advanced economies because of research findings but are not allowed in Bangladesh.
This has created a major scope for illegal import of such drugs from neighboring countries and promoted on satellite channels. Local industry is facing undue competition due to this ban.
The government is now aware of these weaknesses and has reviewed the current situation with all concerned. Future health policies are expected to take care of these hindrances.
Bangladesh's pharmaceutical industry's progress so far is praiseworthy. It has made the country nearly self-sufficient in pharmaceuticals, became the second largest contributor to the state exchequer, is now a major employer of knowledge-based workers, made pharmaceuticals accessible and affordable to the majority of the population and forayed into export markets with success.
The industry can still go a very long way. Some of the areas where it has great potentials are:
Export of formulation products: Bangladesh is already exporting its pharmaceuticals to 52 countries in Asia, Africa and Europe.
With its quality-assured products, it can and will expand its footing in existing markets. The reach can be expanded further to newer countries. Most important is the export of generic drugs to regulated markets such as the U.S. and EU countries.
A few local companies have already put in place pharmaceutical manufacturing facilities to comply with U.S. FDA and U.K. MHRA standards.
Contract/toll manufacture: The U.S. FDA / U.K. MHRA standard manufacturing facilities of a few local companies are already in commercial production.
Prominent among them is industry leader Square Pharmaceuticals. Multinational companies that outsource manufacturing jobs may avail of these facilities. Bangladesh is in a position to toll manufacture products maintaining international standards at a cost much lower than her such sources.
Continuation with newer molecules: As an LDC, Bangladesh can continue with patented products up to 2015. This has created a big opportunity to make available NCEs (new chemical entities) to the LDC's until then.
Transfer of technology and marketing knowledge: With about 45 years of experience in pharmaceutical formulation and marketing, Bangladesh is in a position to share with LDCs and developing countries where needed.