Bioequivalence: Building trust in Bangladesh’s medicines
Pharmaceuticals manufactured locally are a source of pride for the nation in Bangladesh. In addition to being used locally, the companies are exporting them abroad. But having proof of the correct ingredient will no longer be sufficient for us; now we require evidence of how similar the absorption is when compared with some reference product.
Step into any pharmacy in Bangladesh, and you will see several products containing the same ingredient in the same dosage and looking alike too. But the crucial question still remains: would they act similarly once inside the body?
Pharmaceuticals manufactured locally are a source of pride for the nation in Bangladesh. In addition to being used locally, the companies are exporting them abroad. But having proof of the correct ingredient will no longer be sufficient for us; now we require evidence of how similar the absorption is when compared with some reference product.
Understanding bioequivalence in simple words
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Bioequivalence basically means that two products of the same drug produce a similar amount of active ingredient at the same rate of speed in the bloodstream. Researchers analyse the amounts of medicine being absorbed and the peak level reached in the bloodstream. It forms a part of the statistical calculation of the body's similarity in absorbing the two drugs.
Why Bangladesh needs it
Two tablets with the same active ingredient can have different characteristics depending on differences in their composition, formulation, manufacturing process, dissolution, or stability. The routine tests in laboratories provide confirmation of the identity, potency, and purity of the drug. Bioequivalence serves as an additional confirmation of the effects after administration.
Bioequivalence studies are acknowledged as critical for the quality of drugs and their efficacy in the Drugs and Cosmetics Act, 2023. Improved national capacity in this sphere would enhance trust in domestically produced drugs, help in making knowledgeable prescriptions and ensure better access to treatment at a lower cost.
Some local manufacturers have already recognised the importance of the issue. Renata PLC reports the production of 100 bioequivalent drugs available in the domestic market and abroad. It shows that local capacity has been developed.
Not all generics are automatically bioequivalent; this claim needs to be proved by properly conducted human trials or, in case of scientific justification, adequate laboratory results approved by the regulator. Some drugs require special consideration; biological drugs are subject to different comparison procedure.
From assertions to evidence
It would be better for pharmaceutical companies to declare bioequivalence transparently. Instead of just stating "bioequivalent," companies must provide information about which medicine served as a reference medicine for the test, where it took place, and its outcome.
The country can improve the confidence in itself by updating its requirements and establishing a database of products that have proven bioequivalence in the eyes of the country. Health professionals can include bioequivalence into their continuous medical education programs.
Bioequivalence is not simply a technical requirement or just a word from marketing; it bridges the gap between the medicine, which is manufactured in a plant, and its impact on a person. Better standards and evidence can increase the physician confidence, improve access for patients, and the prestige of the pharmaceutical sector in Bangladesh globally.
Amir Abdullah is the Head of Marketing, Oncology and Haematology Portfolio, Renata PLC
Disclaimer: The views and opinions expressed in this article are those of the author and do not necessarily reflect the opinions and views of The Business Standard.
