Mohammad Abdul Motalib Momin
2013-07-17 19:41:10
Bioequivalence (BE) is a term in pharmacokinetics used to assess the expected in vivo biological equivalence of two proprietary preparations of a drug. If two products are said to be bioequivalent it means that they would be expected to be, for all intents and purposes, the same. During the last two decades, the cost of healthcare has been escalating globally, and this has prompted efforts in most countries to reduce those costs. It is known that most of the interventions of healthcare are done through medication. Since the cost of medication has also been escalating through the years, the contribution of drug costs to the overall costs of healthcare has received considerable attention. A major strategy for lowering the cost of medication, and thereby reducing its contribution to total healthcare costs, has been the introduction in global markets of generic equivalents of brand-name drugs (innovator drugs) which is the bioequivalence study. The strategy has been effective. And the regulatory body demands bioequivalence result ok for submission of new drug or generic. The concept of BE and approaches to its assessment were developed in various stages over the last 35 years. During this period, a drug bioequivalence study panel was formed by the Office of Technology Assessment (OTA) to understand the chemical and therapeutic equivalence relationships of drug products. On the basis of the recommendations put forth by this panel, the FDA formulated regulations for the submission of bioavailability data. These regulations are currently incorporated in the 21st volume of Code of Federal Regulation, Part 320 (21CFR320).
In Bangladesh, the pharmaceutical sector has emerged as one of the fastest growing business sectors. Its current annual market size is about 8,000 crore taka. It is the second highest contributors to our national exchequer. Since 1982, Bangladesh pharmaceutical sector has been growing at a remarkable speed. Today our pharmaceutical market is dominated by local manufacturers and the top 10 pharmaceutical companies are mostly local companies. Today we are moving towards self-sufficiency in medicine by getting 97% of our drugs that are consumed annually from local manufacturers and only 3% from import. Our industries are now exporting drugs to 87 countries.
Another very import point regarding our pharmaceutical industries is that our pharma companies are heading towards self-sufficiency without compromising the quality.
Bangladesh is now capable of producing high-quality pharmaceutical products. This was possible because our industry now uses state-of-the-art manufacturing technology, very sophisticated QC equipment and apparatus, and highly skilled human resource. A good number of these plants have achieved MHRA, EU, GCC, TGA and ANVISA certifications.
Bangladesh now has become one of the cheapest sources of quality medicines in the world. So the generic pharmaceutical market of the world is now open for Bangladesh. But just because our pharmaceutical sector has developed its own backbone does not mean that all our pharmaceutical industries have solved the relevant bioethical questions. If we consider exporting our medicine to the world market, it needs clinical trial and bioequivalence studies. As clinical trials and bioequivalence studies are experiments on human subjects, this means that ethical issues are always to be considered.
For clinical trial and bioequivalence studies, now we depend on another country like Malaysia, India etc. But it is the right time to consider the situation to arrange all the relevant things to do bioequivalence study in our country which will not only save money but also create huge employment. But for BE study ethical issues are always to be considered. If we do not establish these clinical trial and bioequivalence study norms nationally, everything else becomes irrelevant.
Growth of our national pharmaceutical industry or earning a huge foreign currency without bioethical considerations is absolutely impossible and unacceptable. If we can establish these national bioethical norms, this could be the beginning of a new era for the future growth of our pharmaceutical industries vis-á-vis our public health and national economy.
References:
Kamal K. Midha and Gordon McKay, Bioequivalence; Its History, Practice, and Future
A B M Faroque, Biomedical consideration in the manufacture, clinical trial and bioequivalence studies of pharmaceuticals.
Birkett DJ (2003). “Generics – equal or not?”. Aust Prescr 26: 85–7.
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