Reality check for pharmaceutical industry
Monday, 27 October 2008
Shawkat Haider
RECENT news on ineffective 'kalaazar' therapy from a locally manufactured drug causes serious concern, particularly for the manufacturers of pharmaceutical products, who are expecting to be a significant player in generic drugs in the region. We do export our drugs mostly to unregulated markets where the bioequivalence testing of drugs is not required to prove that the generic version of a drug is equivalent to originator or brand product in terms of safety and efficacy.
This bioequivalence test is mandatory for product approval and registration in any developed market like the US, European Union (EU) or Australia, even many Asian and Middle East markets require this testing for product registration. It is unfortunate that although prospects of pharmaceutical sector are well publicized, little has been done to realize its potential.
However, it is time for a reality check because we don't have world class drug regulatory mechanism whereby the safety and effectiveness of our drugs can be fully ensured. This is a major concern for the consumers because they have to rely heavily on locally manufactured drugs due to import restriction on foreign brands. We want to believe that our medicines are equally effective and that can be ensured by bioequivalence testing or clinical trials.
Besides such testing, efforts should be made to improve further on our formulation capabilities to meet the regulatory requirements in developed markets. You can sometimes hear complaints from end users like they do not feel any better after using prescribed medicines; to the contrary, their condition is aggravated due to improper dosage or therapy from such medicines. Patients with acute conditions who require immediate relief may complain about products like antihistamines, pain killer or antipyretics (anti-fever) as these products fail to produce any visible effects. Many patients even change doctors when their conditions do not improve at all.
In the worst case scenario, patients with chronic diseases like hypertension, diabetes, arthritis, gastric ulcer etc., where they have to take medication for a longer period, such medicines, not only result in ineffective treatment, they may cause serious complications, sometimes even cause death. In our country there are hundreds of manufacturers in the pharmaceutical sector, but not all are manufacturing quality drugs. So there is of course shortage of quality medicines, which translates into inadequate disease management for this huge population.
We do not have a strong drug regulatory authority which can ensure that safe and effective drugs are manufactured by all these companies, so still today a lot depends on the manufacturers' moral obligations to follow ethics and willingness to comply with good manufacturing practice. It is not unlikely to find that many pharmaceutical companies buy their raw materials from cheaper, unreliable sources for more profit, compromising the product quality. These drugs often contain impurities which are toxic to human health and are able to cause serious complications in the liver, renal, or nervous system.
Again, a large number of manufacturers are involved in copying brands of leading companies using little or no active ingredients, and most of these are marketed in the rural areas, targeting the uneducated, lower income group consumers. Besides, a substantial quantity of spurious medicines from our neighbouring country is flooding the local market, and they are available at a much cheaper price.
There is no effective mechanism in our country to prevent this serious problem; there is no well-equipped laboratory or testing facility, no surveillance to check quality of raw materials, no post marketing surveillance to ensure that marketed products are stable and do not lose labelled potency during its shelf life.
Unless we improve our surveillance through strengthening the regulatory system, we cannot ensure the quality of medicines. Spurious or counterfeit drugs remain -- and will continue to be -- a big problem with much too high a price to pay under the given circumstances.
The writer is a PhD and professor of computer engineering at the American International University of Bangladesh
RECENT news on ineffective 'kalaazar' therapy from a locally manufactured drug causes serious concern, particularly for the manufacturers of pharmaceutical products, who are expecting to be a significant player in generic drugs in the region. We do export our drugs mostly to unregulated markets where the bioequivalence testing of drugs is not required to prove that the generic version of a drug is equivalent to originator or brand product in terms of safety and efficacy.
This bioequivalence test is mandatory for product approval and registration in any developed market like the US, European Union (EU) or Australia, even many Asian and Middle East markets require this testing for product registration. It is unfortunate that although prospects of pharmaceutical sector are well publicized, little has been done to realize its potential.
However, it is time for a reality check because we don't have world class drug regulatory mechanism whereby the safety and effectiveness of our drugs can be fully ensured. This is a major concern for the consumers because they have to rely heavily on locally manufactured drugs due to import restriction on foreign brands. We want to believe that our medicines are equally effective and that can be ensured by bioequivalence testing or clinical trials.
Besides such testing, efforts should be made to improve further on our formulation capabilities to meet the regulatory requirements in developed markets. You can sometimes hear complaints from end users like they do not feel any better after using prescribed medicines; to the contrary, their condition is aggravated due to improper dosage or therapy from such medicines. Patients with acute conditions who require immediate relief may complain about products like antihistamines, pain killer or antipyretics (anti-fever) as these products fail to produce any visible effects. Many patients even change doctors when their conditions do not improve at all.
In the worst case scenario, patients with chronic diseases like hypertension, diabetes, arthritis, gastric ulcer etc., where they have to take medication for a longer period, such medicines, not only result in ineffective treatment, they may cause serious complications, sometimes even cause death. In our country there are hundreds of manufacturers in the pharmaceutical sector, but not all are manufacturing quality drugs. So there is of course shortage of quality medicines, which translates into inadequate disease management for this huge population.
We do not have a strong drug regulatory authority which can ensure that safe and effective drugs are manufactured by all these companies, so still today a lot depends on the manufacturers' moral obligations to follow ethics and willingness to comply with good manufacturing practice. It is not unlikely to find that many pharmaceutical companies buy their raw materials from cheaper, unreliable sources for more profit, compromising the product quality. These drugs often contain impurities which are toxic to human health and are able to cause serious complications in the liver, renal, or nervous system.
Again, a large number of manufacturers are involved in copying brands of leading companies using little or no active ingredients, and most of these are marketed in the rural areas, targeting the uneducated, lower income group consumers. Besides, a substantial quantity of spurious medicines from our neighbouring country is flooding the local market, and they are available at a much cheaper price.
There is no effective mechanism in our country to prevent this serious problem; there is no well-equipped laboratory or testing facility, no surveillance to check quality of raw materials, no post marketing surveillance to ensure that marketed products are stable and do not lose labelled potency during its shelf life.
Unless we improve our surveillance through strengthening the regulatory system, we cannot ensure the quality of medicines. Spurious or counterfeit drugs remain -- and will continue to be -- a big problem with much too high a price to pay under the given circumstances.
The writer is a PhD and professor of computer engineering at the American International University of Bangladesh