In April, a pregnant woman died in Sri Lanka for complications attributed to an anesthetic manufactured in India. A few months earlier, cough syrups manufactured in India were linked to the deaths of children in Gambia and Uzbekistan. This year, poor quality medicines were also found in Marshall Islands and Micronesia before they could cause any damage.
These incidents illustrate a global crisis of unsafe medications that disproportionately affects poor countries. Over the past 20 years, India has emerged as the “pharmacy of the developing world”, the leading manufacturer of generic medicines and drugs, producing more than 20 per cent of the world’s supply. This has helped make a variety of medications available to poor patients around the world.
However, today India is accused of distributing death, since its regulators do not prevent the manufacture and export of substandard medicines. But this is not entirely a made-in-India problem. There is a dirty secret in global health: rich countries get quality medicines, poor countries sometimes get poison.
Developed countries have well-funded regulators who monitor the safety and quality of medicines. However, India’s production is monitored by its Central Drug Standard Control Organization, an opaque agency that has long faced accusations of mismanagement and corruption. Many developing nations do not have the resources to properly evaluate imported medicines.
The World Health Organization estimated in 2017 that one in 10 medicines sold in low- and middle-income countries were believed to be of poor quality or counterfeit. Independent modeling studies indicate this could lead to up to 285 children dying each year from malaria and pneumonia.
As of 2021, India manufactured 62 percent of raw materials for medicines, known as active pharmaceutical ingredients. These ingredients are shipped around the world and made into medicines that must be approved by national regulators with varying levels of oversight and quality standards. Medicines and vaccines enter complex supply chains and end up being administered to pregnant women in Sri Lanka and coughing children in the Gambia.
As HIV spread in the 1990s, new antiretroviral treatments developed in the United States became locked into patent monopolies, keeping prices high and delaying the introduction of affordable generics. Monopolies prevented these life-saving treatments from reaching patients in Africa for almost a decade. In 2003, an estimated 3 million people in sub-Saharan Africa were infected and 2.2 million died of AIDS. By 2004, the region had about two-thirds of all people living with HIV, about 25 million.
However, this tragedy led to one of the greatest and least celebrated successes in global health.
By 2001, the Indian pharmaceutical company Cipla had begun manufacturing an antiretroviral treatment that cost less than $1 a day. Pharmaceutical patents were not recognized under Indian law at the time, allowing India’s generic pharmaceutical industry to reverse engineer HIV medications. By 2002, the average annual cost of antiretrovirals plummeted from $15,000 per patient in the 1990s to just $300. India was poised to become the world’s pharmacy.
In 2001, when Indian-made drugs began circulating around the world, the WHO established the Drug Prequalification Program, or PQP, which set global standards for HIV drugs manufactured by different nations. A year later, it was expanded to include drugs used to treat tuberculosis and malaria..
The PQP became a de facto drug approval authority for developing countries and today guarantees the safety of more than 1,700 medical products, including drugs and vaccines. However, it does not cover all “essential medicines”, a regularly updated WHO list of hundreds of medicines ranging from antibiotics to opioids and anesthetics that are considered vital to any basic healthcare system.
The program should be expanded to cover all of these medications.
However, it relies heavily on voluntary and potentially unequal philanthropic funding. Expanding it will require more funding, which will have to be borne by WHO member states.
Recent deaths have put a spotlight on drug safety. The African Union is creating its own medicines regulatory agency. Last month, a Gambian government task force recommended suing the Indian government over the deadly cough syrup. And yet, last month Administration of Prime Minister Narendra Modi of India pushed a bill through Parliament that includes lighter punishments for the manufacture of substandard medicines, highlighting why individual nations cannot be trusted to tackle the problem.
For much of the pandemic, the United States, the European Union, the United Kingdom and other developed nations presented a unified position to protect the patent monopolies of their Covid vaccine manufacturers. Similar urgency and solidarity must be shown towards substandard medicines.
Equal access to quality health care is a global civil rights issue. Until that right is guaranteed, millions of people will remain vulnerable to the next pandemic.
Vidya Krishnan is an Indian health journalist and author of “The Phantom Plague: How Tuberculosis Shaped History.” Comments to [email protected].
By: Vidya Krishnan
BBC-NEWS-SRC: http://www.nytsyn.com/subscribed/stories/6893470, IMPORTING DATE: 2023-09-14 20:30:07
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