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Amid the gloom in many spheres of international trade, caused in large part by international trading practices as well as the rule-based system governing trade, one remarkable prospect that beacons Bangladesh is the opportunity of large-scale increase in production, domestic marketing and export of medicines. This came in the consensus reached recently among the World Trade Organisation (WTO) members to allow the least developed countries (LDCs) a further breathing time before they are ready to comply with the rules regarding pharmaceutical patents. Following a decision taken by the WTO's Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS) on November 6, WTO members at the Ministerial Conference at Nairobi, Kenya last month agreed that the LDCs will be allowed to maintain maximum flexibility in their approach to patenting pharmaceutical products until at least 2033.
This, no doubt, is the most reassuring news for Bangladesh's pharma sector. For years now, the sector has been in a state of uncertainty as to whether the patent waiver so long enjoyed by the LDCs would be extended on expiry in 2016. Now that the uncertainty is gone with a fresh lease of life for another 17 years to continue with manufacturing generic drugs without having to pay hefty licence fees to the original patent holders, the big issue is -- how best to capitalise on the opportunity.
Forecasts on prospects of the country's pharmaceutical sector have been doing the rounds for quite some time -- for well-deserved reasons. However, given the strictly regulated global pharmaceutical regime coupled with the highly capital-intensive nature of the industry, its expansion is dependent on factors a good deal of which is beyond the capacity of individual entrepreneurs. This is particularly so when it comes to accessing overseas markets, especially those in the developed countries. As for meeting the demands of the domestic market, medicines produced locally- generic drugs of brand medicines - are, according to reports, now in a position to meet 97 per cent of consumer demand.
Despite the problems the sector has been fraught with, much of its success today should be traced to the Drug Control Ordinanc-1982 which played the catalytic role to not only facilitate entrepreneurship but also, equally importantly, bring together the knowledge and innovative drive required to face the challenges so integrally linked to the flourishing of the industry. The country's pharma industry today produces medicines almost to the tune of self-sufficiency, and the growth it has registered over the years is monumental. The current annual growth of the sector is estimated to be more than 24 per cent. Presently, there are around 240-plus registered pharmaceutical manufacturing companies in the country, and a good number of these companies are engaged in manufacturing active pharmaceutical ingredients (APIs) and a wide range of formulations covering major therapeutic categories. Development of healthcare infrastructure in the country, increased marketing penetration in rural areas, increased health awareness of the people coupled with rising purchasing power, and modern diagnostic facilities are the major supportive factors that have contributed to this growth. In addition to meeting domestic demand, this sector is also fast emerging as a prospective source of value-added export. The industry today exports, besides a large spectrum of generic drugs, high-tech specialised products like HFA inhalers, suppositories, nasal sprays, IV infusions, etc., to nearly 100 countries. However, it remains to be said that in view of the highly regulated markets of the advanced countries, most of the exports are confined to the less regulated markets in the developing world.
According to industry insiders, Bangladesh is capable of producing high-quality products as the industry employs state-of-the-art manufacturing facilities, sophisticated quality control equipment and skilled human resources. This is well complemented by the capacity and heavy investment by local companies in the past years. Over the last three years, approximately $250 million was reportedly invested in the sector and preparations are reportedly afoot to raise the investment to $1.0 billion in as many years to come.
Cashing in on generic drugs is what the local manufacturers should be eying now more vigorously than ever. Around 80 per cent of the global population consumes generic drugs, and the major suppliers are China and India. The global generic market for medicine currently stands at $180 billion. Given the present standing of Bangladesh's pharma industry and its growth potential, industry experts opine that aiming to capture 10 per cent of the global market is not too ambitious a target.
However, one of the major deterrents to the desired expansion of the industry is believed to be the lack of accredited laboratories. Industry insiders are of the view that medicine exports from the Bangladesh, given its potential, could have increased manifold had there been accredited labs in the country to conduct proper bio-equivalence and bio-availability tests of the generic drugs produced by the pharmaceutical companies. Although at present Bangladesh exports generic medicines to a good number of low-end markets in the Asian, Middle Eastern, Latin and African regions where markets are less regulated, the real opportunity for the country's pharmaceutical sector to grow, despite the attendant challenges, lies in penetrating the high-end advanced markets.
In the absence of the accredited lab facility, local manufacturers are forced to send their products abroad for required tests and compliance certification which is very expensive and renders the exported products less competitive. Besides accredited lab facilities, there may be a host of other means whereby strengthening the pharmaceutical industry could be contemplated by all stakeholders.