Have you ever wondered how and where the medicine you buy was manufactured, where the ingredients came from, if the quality of the ingredients was tested, if the medicine end-product was tested before it was registered in the country, how it was transported to your pharmacy, and how it was stored there?

If not, it’s time to think about it because in recent history there have been several incidences of harm from poor quality or unsafe medicine.

For example in 2005, a sophisticated investigation into fake artesunate  (malaria medicine) suggested that the drugs were killing millions (WHO estimates 20% of the 1 million malaria deaths per year come from counterfeit products). The investigators identified two trafficking networks, one from the Thai-Myanmar border and northern Lao People’s Democractic Republic and the other from southern Lao PDR, Viet Nam, and Cambodia.

Three people were arrested for trafficking 240,000 blister packs of fake artesunate into Myanmar containing zero or subtherapeutic amounts of the active antimalarial ingredient. These have caused deaths from untreated malaria, reduced confidence in this vital drug, led to huge economic losses for legitimate manufacturers, and concerns over artemisinin resistance. Another example comes from Pakistan, where 125 patients who died in 2012 received a cardiac drug contaminated with an antimalarial medicine.

Low-quality antibiotics, combined with over-prescription and poor compliance by patients, have led to antimicrobial resistance worldwide, which is recognized as one of the biggest public health threats in human history.

Imagine your child has a common bacterial cold with fever, and none of the antibiotics your doctor prescribed works. Your child develops high fever, eventually has to be admitted to the intensive care unit, develops sepsis and is in dire need of an antibiotic that works and can treat the initially harmless cold. This scenario is not fiction anymore, and we have to do whatever is possible to limit the devastating impact of antimicrobial resistance.

For that, we need to strengthen national regulatory agencies, which register medicine and whose responsibility is to check the quality of registered products at market entry and post-market (when in use). We also need to strengthen regional cooperation on regulatory process, especially in Asia and Pacific, where India and the People’s Republic of China—the pharmacies of the world—are located. India alone produces 80% of the world’s generics. It’s time to work on regional approaches to ensure safe and effective medicine reach patients in Asia and Pacific.

What needs to be done?

1. Strengthen regulatory policies and framework. Countries can develop new and improve existing regulatory policies and frameworks to ensure that regulations are effective and in the public interest, or revise and consolidate the existing ones.
2. Ensure convergent regional and international regulations. For countries to develop regulations convergent within the Asian region, we should map differences, provide guidance on regulations equivalent to regional and international standards, and facilitate convergence of practices within Asia. There are working groups within APEC and ASEAN that need strengthening.
3. Improve information sharing and participation in regional harmonization initiatives. Countries must strengthen collaboration and information sharing about product safety and security of the supply chain.
4. Reform organizational structures to achieve integrated safety surveillance. Countries need to create a single center where problems related to all health products can be reported and post-marketing surveillance carried out. Product quality surveillance, routine inspections, and control of advertising and promotions would be brought into a single unit.
5. Confront falsified and substandard medicines. Donors and technical assistance providers should consolidate their support to expand WHO and regional harmonization initiatives as major instruments for addressing the issues of falsified and substandard products. Countries should be supported to improve their regulatory systems and enforcement capabilities for addressing fake products.

In Asia, medication mishaps have led to public concerns and calls for strengthened regulations. Adverse reactions, poor product quality, medication errors, and therapeutic ineffectiveness waste resources and have a devastating impact on health systems. They lead to treatment failure, drug resistance, loss of confidence in the health system, and increased morbidity and mortality. Adverse drug reactions are the fourth of top six leading causes of death worldwide, and patients who experienced adverse drug events were hospitalized an average of 8 to 12 days longer than patients.

There is a strong and urgent need to strengthen medicine safety both within and across national borders. Developing and developed countries are both suppliers and recipients within an increasingly complex global medical product supply chain. Public health programs, global health initiatives, and indeed entire health systems rely on safe, effective, and good-quality medicines. However, fully functional regulatory systems are not yet in place.

A great opportunity exists to improve the systems required to assure patient safety, and ADB is working to help harmonize regulations within Asia and Pacific with several partners.