Opinion | Global Regulation of Essential Medicines Is a Dangerous Mess

Opinion | Global Regulation of Essential Medicines Is a Dangerous Mess

In April, a pregnant woman died at a hospital in Kandy, Sri Lanka, of complications blamed on an anaesthetic manufactured in India. A few months earlier, Indian-made cough syrups were linked to the deaths of children in Gambia and Uzbekistan. Substandard medicines also were found this year in the Marshall Islands and Micronesia before they could do any harm.

These incidents in far-flung corners of the world reveal the contours of a global crisis of unsafe drugs that inordinately affects poor countries. Over the past two decades, India emerged as the “pharmacy of the developing world,” the leading manufacturer of generic drugs and medicines, producing more than 20 percent of the world’s supply. This has helped to make a range of medicines available to poor patients around the world who previously had to do without.

Today, however, India stands accused of distributing death, as its regulators fail to prevent the manufacture and export of substandard medicines. But this isn’t entirely a made-in-India problem. There is a dirty secret in global health: Rich countries get quality medicines, the poor sometimes get poison.

The problem lies mainly in regulatory inequities between rich and poor nations. Developed countries have well-funded regulators keeping an eye on the safety and quality of drugs. India’s output, however, is overseen by its Central Drugs Standard Control Organization, an opaque agency that has long faced allegations of mismanagement and corruption. Many developing nations don’t have the resources to properly vet imported medicines.

The World Health Organization estimated in 2017 that one in 10 medicines sold in low- and middle-income countries were thought to be substandard or falsified. Independent modeling studies based on those numbers indicate that this could result in as many as 285,000 children dying every year from malaria and pneumonia. The W.H.O. has not released more recent numbers, and there is limited data on exactly how much of this comes from India.

The global drug supply system is a vast and complex network. As of 2021, India manufactured 62 percent of the raw materials for drugs, known as active pharmaceutical ingredients. China manufactures 23 percent, and the United States and Europe make most of the remainder. These ingredients get shipped all over the world and are turned into drugs that have to be vetted by national regulators with varying levels of oversight and quality standards. The resulting medicines and vaccines enter intricate supply chains and end up being administered to pregnant women in Sri Lanka and coughing children in Gambia.

The recent deaths bring with them a strong sense of déjà vu. As H.I.V. spread in the 1990s, new antiretroviral treatments first developed in the United States were locked in patent monopolies, which kept prices high and delayed the introduction of affordable generics. The monopolies prevented these lifesaving treatments from getting to patients in Africa — where the H.I.V. crisis was snowballing — for nearly a decade. In 2003 alone, an estimated 3 million people in sub-Saharan Africa were newly infected, and 2.2 million died of AIDS. By 2004, the region — then home to around 10 percent of the world’s population — had close to two-thirds of all people living with H.I.V., some 25 million.

This tragedy led, however, to one of the greatest and least celebrated successes in global health.

By 2001, the Indian drug maker Cipla had begun making an antiretroviral treatment that cost less than $1 a day. Patents on pharmaceutical products were not recognized under Indian law at the time, allowing India’s generic pharmaceutical industry to reverse-engineer H.I.V. drugs. It was a watershed moment. By 2002, the average annual cost of antiretrovirals plummeted from as much as $15,000 per patient in the 1990s to as little as $300 — and India was on its way to becoming the pharmacy of the world.

As Indian-made drugs began flowing across the globe, the W.H.O. in 2001 set up a groundbreaking program to monitor safety and quality, called the Prequalification of Medicines Program or P.Q.P., which set global standards for H.I.V. medicines made by different nations. A year later, it was expanded to include medicines used to treat tuberculosis and malaria. With that, there was new hope in the fight against three of the biggest plagues of our time. The program is one of those unsung policies that keep the global health structure ticking.

The P.Q.P. effectively became a de facto drug approval authority for developing countries, and today it assures the safety of over 1,700 medical products — including medicines, vaccines, diagnostics and a wide range of other medical and disease-control equipment. Yet it does not cover all “essential medicines,” a regularly updated W.H.O. list of hundreds of drugs ranging from antibiotics to opioids and anesthetics that are considered vital for any basic health care system.

The program should be expanded to cover all of these medicines. However, it relies largely on voluntary and potentially unsteady philanthropic funding from organizations like the Gates Foundation. Expanding it will surely require more funding, which should be borne by W.H.O. member states.

American and European regulators can and do conduct their own on-site inspections of foreign facilities churning out essential medicines. India has the largest number of Food and Drug Administration-approved plants outside the United States. But many developing nations remain vulnerable.

The recent deaths have drawn new attention to drug safety. The African Union is setting up its own drug regulatory agency. Last month, a Gambian government task force recommended suing the Indian government over deadly cough syrup. Yet the administration of Prime Minister Narendra Modi of India last month pushed a bill through Parliament that features lighter punishments for manufacturing substandard medicines, highlighting why individual nations cannot be relied on to address the problem.

India needs to clean up its act for its own good — its growth into a powerhouse of generic drug production has polluted its rivers with antibiotic waste, spawned dangerous superbugs and made it a global hot spot for drug-resistant tuberculosis. For the rest of the world, the main benefit of India becoming the pharmacy of the poor was to break Big Pharma’s control of lifesaving medicines. More cases involving deadly Indian-made medicines could undo that positive achievement by causing irreparable harm to the global reputation of cheap generics.

Our response to the Covid pandemic was far from perfect, but it showed that the world can come together during an emergency, scaling up vaccine production and vaccination rates. W.H.O. member-states are now discussing a new pandemic treaty, which would have been unprecedented a few years ago.

For much of the pandemic the United States, the European Union, the United Kingdom and other developed nations presented a unified stand to protect the patent monopolies of their Covid vaccine manufacturers. Similar urgency and solidarity must be shown toward the scourge of substandard medicines.

Equal access to quality health care, regardless of wealth, nationality or race, is a global civil rights issue. Until that right is assured, millions will remain vulnerable to the next pandemic.

Vidya Krishnan (@VidyaKrishnan) is an Indian journalist specializing in health issues and is the author of “The Phantom Plague: How Tuberculosis Shaped History.”

Source photographs by Irena Sowinska, Monty Rakusen, Tek Image, Carlos Duarte, Jordan Lye, FotografiaBasica, and Thomas Barwick/Getty Images

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