The WHO calls the existence of substandard and falsified medicine an unacceptable risk to public health. Yet every region of the world is flooded with fake medicines. In India, particularly, a flood of fraudulent medicines is threatening the health of tens of thousands of people. I joined a team of 200 experts at the recently held international conference on Medicine Quality Public Health at the University of Oxford to understand what can be done to stop fake medicines.
The conference highlighted various aspects of the problem from research perspective and policy viewpoint. The panel discussions debated about the global pandemic of falsified medicines. Everyone seemed to agree that the number of outright fakes may have declined but the problem of substandard medicines has worsened.
Sometimes a medicine degrades because it has not been properly packed, stored or handled. But often the manufacturer may deliberately reduce the amount of active ingredients.
What is more worrying is that majority of people don’t even know that counterfeit drugs exist. Oksana Pyzik, Senior teaching fellow at the University College London, School of Pharmacy pointed to a recent survey conducted by a student-led initiative called UCL Fight the Fakes. The survey found 77% of over 200 student respondents hadn't heard about fake medicines.
“The problem with substandard and falsified medicines is huge and goes into so many directions” explains Marya Leiberman, Professor, University of Notre Dame, Indiana. She said that the problem is so huge and complex that by the time a fake product is confirmed by the lab, it is no longer available in the markets.
Anti-malaria drugs are a particular problem. More than 120,000 children in sub-Saharan countries under the age of 5 died in 2013 because of ineffective malaria medicines, according to one study. Similar problems beset antibiotics. Another study in Southeast Asia found that 65 percent of the ampicillin samples were substandard
“In Asia, for every 10 medications that you buy one of them will be substandard or falsified,” said Sachiko Ozawa, Professor, University of North Carolina.
She said her research findings suggest that poor quality essential medicines are a substantial and understudied problem in most of the low and middle-income countries like India.
The major hurdle in understanding the issue is that the problem is not only about fake medicines but about medicines that contain the wrong ingredients or too little of the right ones. The fraudulent medicines harms patients and can trigger anti-microbial resistance. Professor Paul Newton, Director of Lao-Oxford-Mahosot Hospital-Wellcome Research Unit explains that “keystones for reducing the public health threat of substandard and falsified medicines are functional national medicines regulatory authorities (NMRA) that are needed in each country and have the infrastructure, staff and funding to allow them to sustainably regulate the supply of medicines and other medical products”.
A study which analysed seven medicines in 15 countries in Africa to assess cardiovascular disease drug quality found 16.3% of sample deemed to be poor quality. “Substandard and falsified medicines burden health systems by diverting resources to ineffective or harmful therapies, causing medical complications, and prolonging illnesses” said Sachiko Ozawa.
Despite falsified medicines pose a serious public health problem, there is little quantitative or qualitative information about the extent of their impact on people's health, according to Dr Mohammad Safiqur Rahman, Assistant Professor at University of Asian Pacific in Bangladesh.
Sauman Singh, Consultant WHO-TDR presented attention-grabbing study which explored how Indian firms are placing WHO prequalified products on the market to gain legitimacy and this study investigated the marketing strategy of five Indian pharmaceutical firms.
The analysis found that Indian firms have not only registered WHO prequalified formulations in Mali but they also hold product authorisations from the Malian regulatory authority for not-prequalified anti-malarials.
What's more, these firms are using the same brand name for products which are approved by rigorous regulatory scrutiny and those which are not.
Micheal Deats, Group Lead SF Products at WHO, said to fight fake medicine there is a need of financial help, technical assistance and training to improve oversight of medicines. He also said that access to accredited laboratories, more effective education and awareness campaign and political support is essential to combat fake medicine.
There was consensus that countries whose companies make many of the generic drugs, need to crack down on the wrongdoers. The punishments making or selling fake medicines need to be severe, especially for those who sell medicines on the WHO’s list of essential drugs.
The author was offered fellowship by the Concept Foundation, Hong Kong to attend the Medicines Quality and Public Health Conference at the University of Oxford in September 23-28, 2018.