Pharmaceuticals, deaths, and work ethics

Yet again, deaths caused by questionable quality pharmaceuticals are in the news.

- BY GEEWANANDA GUNAWARDANA, PH.D.

As someone who had worked in this industry for decades, it is painful to see the way Sri Lankans must face this tragedy repeatedly when standard methods for avoiding them are readily available. An article appeared in this paper (Island 2025/12/31) explaining in detail the technicalities involved in safeguarding the nation’s pharmaceutical supply. However, having dealt with both Western and non-Western players of pharmaceutical supply chains, I see a challenge that is beyond the technicalities: the human aspect.

There are global and regional bodies that approve pharmaceutical drugs for human use. The Food and Drug Administration (USA), European Medicines Agency (Europe), Medicine and Health Products Regulatory Agency (United Kingdom), and the Pharmaceuticals and Medical Devices Agency (Japan) are the major ones. In addition, most countries have their own regulatory bodies, and the functions of all such bodies are harmonized by the International Council for Harmonization (ICH) and World Health Organization (WHO). We Sri Lankan can take solace in knowing that FDA, the premier drug approval body, came into being in 1906 because of tragedies similar to our own. Following the Elixir Sulfanilamide tragedy that resulted in over one hundred deaths in 1938 and the well-known Phthalidomide disaster in 1962, the role and authority of FDA has increased to ensure the safety and efficacy of the US drug supply.

Getting approval for a new proprietary pharmaceutical is an expensive and time-consuming affair: it can take many billions of dollars and ten to fifteen years to discover the drug and complete all the necessary testing to prove safety and efficacy (Island 2025/01/6). The proprietary drugs are protected by patents up to twenty years, after which anyone with the technical knowhow and capabilities can manufacture the drug, call generics, and seek approval for marketing in countries of their choice. This is when the troubles begin.