After India, Bangladesh is fast emerging as the next leading exporter of active pharmaceutical ingredients (APIs) in South Asia. Though the country comes under the category of a least developed country (LDC), it has built a strong pharmaceutical base and has even started exporting APIs to some of the regulated and other non regulated LDC countries in Asia Pacific and African countries.
With growing foot print in the non- regulated markets, particularly in Asia and Africa, the Bangladeshi pharma companies are gearing up to strengthen their global presence. By the end of the year 2014, the Bangladesh pharma sector is targeting to reach at least 30 new destinations and by 2016, it is aiming to reach 50 LDC nations across Asia and Africa.
According to industry cognoscenti, Bangladeshi pharma industry is growing at around 15 per cent per annum. The industry which is at $1.82 billion today is expected to grow to $5.59 billion by the year 2022.
Since Bangladesh is regarded as LDC, at present it does not come under scanner of World Health organization’s Trade related intellectual property rights (TRIPS) regime. However time is fast running out for it and it is likely to come under WHO fold by the end of year 2016. “As the time is fast running out, it is high time the Bangladeshi government took initiatives to take the advantage of TRIPS. Once the TRIPS regime come into focus it will be difficult for the country to compete in the developed and highly regulated markets. In fact we need to apply for its extension for some more time until the pharma industry in the country establishes a strong base,” said Md. Wahidur Rahman, Manager (international marketing) at ALCO Pharma Ltd.
At present, Bangladesh exports pharma products to 87 countries, including the US and a few European nations, after meeting 98 per cent of the local demand. State-owned Essential Drugs Company Ltd (EDCL) has recently entered the Sri Lankan market with nine products under a government-to-government (G2G) agreement. Beximco Pharma has also started exporting medicines to Europe. Other two local companies namely Eskayef and Square have already carved a niche in the EU markets.
Focusing on the Asian markets, Bangladesh has exported medicines worth TK 400 crore to Sri Lankan State Pharmaceuticals Corporation during the fiscal 2013-2014. M Kadrul Huda EDCL Managing Director said, “last year we have exported a list of 778 medicines and 1284 laboratory items to Sri Lanka. At present Bangladesh produces 75 per cent of these medicines and the Lankan government have allowed us to get the items manufactured by private companies. They prefer our medicines, because we provide quality medicines at much lower price than those from India.”
From the year 2008 to 2012, the state run EDCL has produced medicines more than four- fold from the initial days. This was possible because the Bangladeshi government has increased its spending on healthcare and has taken initiatives to boost the industry in the country.
In another significant move to boost its pharma exports the Bangladeshi government is also expected to sign G2G deal with the Maldives.
Another Bangladeshi company which is focusing on the markets in EU and USA is Beximo Pharma. This pharma player is planning to enter the generic arena with its high quality products at much lower rates in the regulated markets of EU and US. “We have developed a high quality pharmaceutical facility with a competitive cost structure to manufacture and export generic drugs. We are targeting the regulated markets and soon we are planning to launch our products in to EU and US,” said Nazmul Hassan, MD of Beximo Pharma.
Encouraged with growing exports, Bangladesh has set a higher target of TK 16000 crore by the end of 2015 from TK 14000 in 2014, which is possible if the growth rate stays around 15 per cent per annum.
Bangladesh ranks high among LDCs
Among the 50 LDCs, Bangladesh is the only country that has quality pharmaceutical manufacturing base with marketing capability in the overseas. The country’s pharma base is so well established that it has potential to export its medicines and pharmaceutical items to, at least, 80 market-destinations across the world. “There is a need to form a platform among 50 LDCs within the Asia Pacific, Africa, Pharmaceutical Union (AAPU) to avoid the existing re-registration requirement for companies and products within themselves,” says Wahidur Rahman.
For sorting out trade related issues, the industry experts in Bangladesh are looking to build a common platform with all the LDC countries. By doing so all the issues relating to free sales certificates/certificate of pharmaceutical products, valid good manufacturing practice (GMP) certificate and product approved annexure can easily be dealt with, among the LDC members. “This will not only save time and money but also enable the medium-ranking companies to get access to the international marketing domain and the current sales turnover of pharmaceutical items will grow by many folds within the shortest possible time before the implementation of World Trade Organisation’s (WTO’s)/trade-related intellectual property rights (TRIPS) by the year 2016,” points out Rahman.
The Bangladeshi pharma industry feels that as the players in the country have not yet taken advantage of the TRIPS exemption, it needs to be extended to some more time at least until the inauguration of the country’s biggest API) park at Ghazaria in Munshiganj.Otherwise, it will be rather difficult to address the challenges of globalization to retain even the local market share of around US$ 1.29 billon, which was recorded in 2012 showing a 14 per cent growth over the level of 2011 opines Rahman.
At present the global pharmaceutical export market is categorized into three types — stringently regulated markets, mild regulated export markets and less regulated export markets. The entry of pharma products into the US, EU, UK, Australia, Gulf Corporation Council (GCC) countries require certification from the US Food and Drug Administration (USFDA), UK Medicines and Healthcare products Regulatory Agency (UKMHRA), Therapeutic Goods Administration (TGA) of Australia, Current Good Manufacturing Practice (cGMP) regulations, enforced by the US Food and Drug Administration (FDA) and the GCC. “Since it’s difficult and costs huge sums for the Bangladeshi companies to get these certifications, the country needs to be exempted from TRIPS regime for some more time” says Rahman.
As the medium regulated markets like Singapore, Sri Lanka, Vietnam and the Philippines, are also making it mandatory to follow the Asian Common Technical Dossier (ACTD) formats along with bio equivalence clinical test-study reports of pharma products which are critical procedures with time and money consuming factors, to avoid all these stringent and cost incurring issues, the Bangladesh pharma industry is focusing to target the lesser regulated markets within Asia Pacific region and Africa and later wants to push itself to the middle and higher level regulated markets in the future.