Global compliance issue: The aspiration of pharmaceutical industries beyond 2016
Moshiur Rahman | Thursday, 7 August 2008
IT is not that the export opportunity of made-in-Bangladesh medicine has grown in a solitary pace. Noticeably, the pharmaceutical industries here had to track down and encounter a huge competition both in national and international arena to reach this altitude. Until June 27 of 2002, exporting pharmaceuticals was a daydream; the right momentum got accelerated from the Doha declaration. The global trade body, the World Trade Organisation (WTO), has announced and imposed regulation that the "trade-related aspect of intellectual properties right" (TRIPS) will get protection from the day of declaration and the least developed countries (LDCs) have been exempted from this decision. Therefore, the LDCs, along with Bangladesh, will get a lead period up to 2016 to produce the generics brand pharmaceuticals for their own use; the country will, as well, be able to export to the moderately regulated ones.
In fact, the seed of made-in-Bangladesh medicine export was sown in the year back in 1982, just after the declaration of the national drug policy with an objective to ensure the adequate supply and availability of essential drugs at affordable prices to the nation. By this time, the entrepreneurs have successfully made the commitment to, and endorsed, the national agenda, declared in the drug policy. They demonstrated a remarkable growth due to their relentless effort. And that very effort has energised the industry to spend more than 24 years by setting a goal, beyond the national sphere to the international export market. Thus, a huge export potential of made-in-Bangladesh medicine has resulted.
The following attributes are noteworthy to encounter the enormous opportunity of export in the global market:
Strength-time tested manufacturing capacity: Bangladesh has achieved a large manufacturing capacity and has demonstrated a spectacular ability to produce high tech dosage form of generic brand for their own with a surplus to export to the world market. The strength of our pharmaceutical industry is time-tested, currently producing 97-98% of the national requirements by 230 registered pharmaceutical manufacturers of the country. In addition, the rest of the 2.0-3.0% is imported from global sources. Among the LDCs, only Bangladesh has a defined pharmaceutical infrastructure.
Opportunity -- experience of exporting 182 brands to 80 countries: The export opportunity for medicines from Bangladesh to many defined parts of the globe is huge. In the meantime, the country has gathered the experience about exporting 182 brands to 80 countries. It has been noticed/reported that the country has experienced a pleasant growth rate of exporting medicine in the year, 2007, which is double of that of the preceding year in taka value. Based on this statistics, the leaders of the industry and experts are projecting a huge export opportunity of Tk. 100 billion (10,000 crore) in the following years to come.
For further growth and harnessing of this opportunity, a value-driven flexible agenda is needed to be ready from the entrepreneurs' end to ensure a lion's share of the export market. This would provide them a guideline to keep a pace, beyond 2016.
Market segment -- the exporters must choose the potential market segment: However, the moderately regulated market segment has been found suitable for exporting pharmaceutical products from Bangladesh. The prospect of exporting to both the regulated market segment (for their strong regulatory requirements) and the less-regulated market ones (for their less or no gross domestic product (GDP) growth rate being considered as unsuitable). Many of the Asian and European countries belong to the moderately regulated market segment; they are having good annual GDP rate, organised healthcare support industry and consuming a huge quantity of imported medicine from different sources of the world. Moreover, the compliance issues are moderately controlled and the market potential, in terms of revenue, might be satisfactory. But in the long run, there would be a chance of stiff competition from the emergence of their own manufacturing facilities.
The economic parameter -- the factor of production plays an important role in market economy: The labourers are the cheapest available factor of production in Bangladesh and those are highly contributing to our pharmaceutical industry. The externally controlled factors of production are the active pharmaceutical ingredients (APIs), the process and technology that are being imported from the suitable sources either from Europe, the US, India or China. Still we lack in human resource development centre, which would be the requirement of the exporting countries along with the reference laboratories -- the most critical factors for export requirements.
Risk factors -- are they equally contributing to the cent per cent of the country's production requirement? Is the national output of the pharmaceutical production of about 97%-98% coming from these 230 pharmaceuticals manufacturers? Are they equally contributing? All experts working in this industry know this answer and the answer will be only a few of those are contributing to the cent per cent of the production requirement of the country.
Moreover, are they meeting the regulatory requirement, as suggested by the World Health Organisation (WHO) or other global regulatory authority? A ridiculous answer is there. They may not be always in compliance with the exporting countries' regulatory requirements.
Ambition and the image -- pharmaceuticals will be the highest foreign currency generating sector: The export potential of pharmaceuticals can be considered very promising, next to the ready made garments (RMG) and experts are considering this would be one of the highest foreign currency generating sectors in the country. We know that the garments' industry has received a strong support in terms of incentives for defined market access and some sort of immunity, in terms of quota for the US market. This synergises the possibility for an influx of large foreign currency. Unfortunately, the wages that are being paid to the labourers by the Bangladeshi RMG manufacturers have become an issue of non-compliance with the requirements of the global market.
The next area relates to the non-compliance issues that are often raised against food processing industries the exporters of seafood and shrimp. The latter are now under tremendous pressure from the European Union (EU), resulting in a threat of losing both the image of, and the valuable foreign exchange earnings for, the country.
Besides, a large influx of remittance from the overseas employment market is likely to become uncertain because of non-conformity and non-compliance issues. The greedy manpower agents, who either do not comply with the relevant rules or manipulate the overseas rules, are largely to blame for this.
Practically, a limited number of pharmaceutical companies in Bangladesh have been striving for the export of made-in-Bangladesh pharmaceutical products. These are, of course, the part of the 230 manufacturers of the country; many of them are producing adulterated medicine, low-quality antibiotic and some systemic medicine. Recently, the media has reported about their failure to produce medicines having the necessary therapeutic effect. Policy-makers should remember that the access to information superhighway is open and anyone can get the information under any circumstances. This may impair the image of the industry as well can create some repercussions for the operations of our ambitious export programmes.
Requirement -- the export of Bangladeshi medicine is imperative: Design and implementation of an assistance programme are imperatives for the sick industries to comply with the requirement for producing the right dosage form by following the quality guidelines, as are described by the WHO in its cGMP guidelines. Deviation and failure to comply with these guidelines would need to be considered as a punishable offence for any manufacturer, bringing them under judicial norms with the possibility of imposition of a ban on manufacturing any dosage form either for local use or for exporting the same even to a less regulated country.
Simultaneously, capacity building of the local academic institutions should be launched immediately as a continuous process to produce quality human resources to meet the global need and compliance issues. The blending of management skills and technical ones are to be considered as major concerns. The entrepreneurs should invest in programmes in order to attract the talent.
However, the industry was dominated until 1982 by the multilateral companies (MNC). Currently most of the large local companies are being ruled by the management and process technology inherited back in 1982 from the MNCs. The MNC should be invited under appropriate policy guidelines to operate in our country with new process, technology and management skills.
The government should promote and patronise the local production of API to meet the requirements of the country and to cater to the export needs. The entrepreneurs should be provided with a special incentive plan as it has been demanded by the leaders of the industry. Good news is that the government has declared and categorised the pharmaceutical industry as a thrust sector. The concerned entrepreneurs do hope that the successive governments will uphold this, with full support.
Moreover, exporting to the defined export market for Bangladeshi manufactured medicines is not a dream to the nation. The export of medicine from Bangladesh is now a reality and it is a matter of pride. The nation may score more successes before 2016 with a substantial amount of GDP growth facilitated by increased export earnings in this sector, by keeping in mind the needs to address the compliance issues in both home and the overseas markets. The public-private partnership would be useful in planning and implementing the defined capacity building programme in both short- and long-terms. Deviation from this required path of path could put at risk the exporting opportunities for Bangladeshi pharmaceuticals in the world market.
The writer is a Human Resource Professional & Pharmacist. He is a member of the faculty, University of Development Alternative, Pharmacy Department & School of Business, Dhaka. He can be reached at e-mail is
rmsr2@hotmail.com
In fact, the seed of made-in-Bangladesh medicine export was sown in the year back in 1982, just after the declaration of the national drug policy with an objective to ensure the adequate supply and availability of essential drugs at affordable prices to the nation. By this time, the entrepreneurs have successfully made the commitment to, and endorsed, the national agenda, declared in the drug policy. They demonstrated a remarkable growth due to their relentless effort. And that very effort has energised the industry to spend more than 24 years by setting a goal, beyond the national sphere to the international export market. Thus, a huge export potential of made-in-Bangladesh medicine has resulted.
The following attributes are noteworthy to encounter the enormous opportunity of export in the global market:
Strength-time tested manufacturing capacity: Bangladesh has achieved a large manufacturing capacity and has demonstrated a spectacular ability to produce high tech dosage form of generic brand for their own with a surplus to export to the world market. The strength of our pharmaceutical industry is time-tested, currently producing 97-98% of the national requirements by 230 registered pharmaceutical manufacturers of the country. In addition, the rest of the 2.0-3.0% is imported from global sources. Among the LDCs, only Bangladesh has a defined pharmaceutical infrastructure.
Opportunity -- experience of exporting 182 brands to 80 countries: The export opportunity for medicines from Bangladesh to many defined parts of the globe is huge. In the meantime, the country has gathered the experience about exporting 182 brands to 80 countries. It has been noticed/reported that the country has experienced a pleasant growth rate of exporting medicine in the year, 2007, which is double of that of the preceding year in taka value. Based on this statistics, the leaders of the industry and experts are projecting a huge export opportunity of Tk. 100 billion (10,000 crore) in the following years to come.
For further growth and harnessing of this opportunity, a value-driven flexible agenda is needed to be ready from the entrepreneurs' end to ensure a lion's share of the export market. This would provide them a guideline to keep a pace, beyond 2016.
Market segment -- the exporters must choose the potential market segment: However, the moderately regulated market segment has been found suitable for exporting pharmaceutical products from Bangladesh. The prospect of exporting to both the regulated market segment (for their strong regulatory requirements) and the less-regulated market ones (for their less or no gross domestic product (GDP) growth rate being considered as unsuitable). Many of the Asian and European countries belong to the moderately regulated market segment; they are having good annual GDP rate, organised healthcare support industry and consuming a huge quantity of imported medicine from different sources of the world. Moreover, the compliance issues are moderately controlled and the market potential, in terms of revenue, might be satisfactory. But in the long run, there would be a chance of stiff competition from the emergence of their own manufacturing facilities.
The economic parameter -- the factor of production plays an important role in market economy: The labourers are the cheapest available factor of production in Bangladesh and those are highly contributing to our pharmaceutical industry. The externally controlled factors of production are the active pharmaceutical ingredients (APIs), the process and technology that are being imported from the suitable sources either from Europe, the US, India or China. Still we lack in human resource development centre, which would be the requirement of the exporting countries along with the reference laboratories -- the most critical factors for export requirements.
Risk factors -- are they equally contributing to the cent per cent of the country's production requirement? Is the national output of the pharmaceutical production of about 97%-98% coming from these 230 pharmaceuticals manufacturers? Are they equally contributing? All experts working in this industry know this answer and the answer will be only a few of those are contributing to the cent per cent of the production requirement of the country.
Moreover, are they meeting the regulatory requirement, as suggested by the World Health Organisation (WHO) or other global regulatory authority? A ridiculous answer is there. They may not be always in compliance with the exporting countries' regulatory requirements.
Ambition and the image -- pharmaceuticals will be the highest foreign currency generating sector: The export potential of pharmaceuticals can be considered very promising, next to the ready made garments (RMG) and experts are considering this would be one of the highest foreign currency generating sectors in the country. We know that the garments' industry has received a strong support in terms of incentives for defined market access and some sort of immunity, in terms of quota for the US market. This synergises the possibility for an influx of large foreign currency. Unfortunately, the wages that are being paid to the labourers by the Bangladeshi RMG manufacturers have become an issue of non-compliance with the requirements of the global market.
The next area relates to the non-compliance issues that are often raised against food processing industries the exporters of seafood and shrimp. The latter are now under tremendous pressure from the European Union (EU), resulting in a threat of losing both the image of, and the valuable foreign exchange earnings for, the country.
Besides, a large influx of remittance from the overseas employment market is likely to become uncertain because of non-conformity and non-compliance issues. The greedy manpower agents, who either do not comply with the relevant rules or manipulate the overseas rules, are largely to blame for this.
Practically, a limited number of pharmaceutical companies in Bangladesh have been striving for the export of made-in-Bangladesh pharmaceutical products. These are, of course, the part of the 230 manufacturers of the country; many of them are producing adulterated medicine, low-quality antibiotic and some systemic medicine. Recently, the media has reported about their failure to produce medicines having the necessary therapeutic effect. Policy-makers should remember that the access to information superhighway is open and anyone can get the information under any circumstances. This may impair the image of the industry as well can create some repercussions for the operations of our ambitious export programmes.
Requirement -- the export of Bangladeshi medicine is imperative: Design and implementation of an assistance programme are imperatives for the sick industries to comply with the requirement for producing the right dosage form by following the quality guidelines, as are described by the WHO in its cGMP guidelines. Deviation and failure to comply with these guidelines would need to be considered as a punishable offence for any manufacturer, bringing them under judicial norms with the possibility of imposition of a ban on manufacturing any dosage form either for local use or for exporting the same even to a less regulated country.
Simultaneously, capacity building of the local academic institutions should be launched immediately as a continuous process to produce quality human resources to meet the global need and compliance issues. The blending of management skills and technical ones are to be considered as major concerns. The entrepreneurs should invest in programmes in order to attract the talent.
However, the industry was dominated until 1982 by the multilateral companies (MNC). Currently most of the large local companies are being ruled by the management and process technology inherited back in 1982 from the MNCs. The MNC should be invited under appropriate policy guidelines to operate in our country with new process, technology and management skills.
The government should promote and patronise the local production of API to meet the requirements of the country and to cater to the export needs. The entrepreneurs should be provided with a special incentive plan as it has been demanded by the leaders of the industry. Good news is that the government has declared and categorised the pharmaceutical industry as a thrust sector. The concerned entrepreneurs do hope that the successive governments will uphold this, with full support.
Moreover, exporting to the defined export market for Bangladeshi manufactured medicines is not a dream to the nation. The export of medicine from Bangladesh is now a reality and it is a matter of pride. The nation may score more successes before 2016 with a substantial amount of GDP growth facilitated by increased export earnings in this sector, by keeping in mind the needs to address the compliance issues in both home and the overseas markets. The public-private partnership would be useful in planning and implementing the defined capacity building programme in both short- and long-terms. Deviation from this required path of path could put at risk the exporting opportunities for Bangladeshi pharmaceuticals in the world market.
The writer is a Human Resource Professional & Pharmacist. He is a member of the faculty, University of Development Alternative, Pharmacy Department & School of Business, Dhaka. He can be reached at e-mail is
rmsr2@hotmail.com