Bottleneck in drug testing: Sri Lanka's bioequivalence challenge

SRI Lanka's drive to boost local pharmaceutical manufacturing is running up against a critical bottleneck: the scarcity of bioequivalence testing facilities.

- By Manusha Weeraratne and Chinthaka Abeysekera

For Sri Lankan drug makers trying to prove their generic medicines work as well as the original brands, the journey often leads overseas adding delays and costs. Industry experts warn that without local capacity for bioequivalence studies, the country's ambitions to expand its pharma sector and assure medicine quality face an uphill battle. Yet recent developments also hint at opportunities to turn this challenge around.

What is bioequivalence, and why does it matter?

Bioequivalence (BE) studies are how regulators ensure that generic medicine can deliver the same effect as the brand-name version. During a BE study, a group of healthy volunteers are given the generic drug and the original drug separately, and are tested to see if both produce the same levels of the medicine in the bloodstream over time. If the generic releases its active ingredient into the body at the same rate and amount as the original, the two are considered bioequivalent.

Such studies are crucial for generic drugs because they prove the copy is as effective and safe as the innovator. For patients, this means confidence that a more affordable generic will perform the same as the pricier brand. For regulators, BE evidence is key to approving generics and allowing them to substitute for brand-name drugs. Without BE data, a generic drug might not gain approval or acceptance, no matter how well it's manufactured.

Bioequivalence testing sounds straightforward, but it's a complex, resource-intensive process, requiring specialised clinical facilities to administer drugs to volunteers, advanced laboratories to measure tiny drug concentrations in blood samples, and stringent ethical and quality controls. Therefore BE studies can be expensive and technically demanding.

Limited local testing options