They had fever, body aches, runny noses, the normal childhood stuff. The kind of illnesses a doctor would prescribe cough syrup for.
But the condition of the children only worsened. They developed persistent diarrhea and then couldn’t urinate because their kidneys were failing. The very drugs that were supposed to make them better, simple cough syrups imported from India, were killing them instead, as they turned out to be poison.
A total of 70 children in the small West African nation of Gambia are believed to have died in recent months from Indian-made cough syrups. Among them was Muhammad Lamin Kijera, 2, who died on August 4.
“He was lively and friendly – he was everyone’s friend,” said his father, Alieu Kijera, who works as a nurse at an eye clinic in Banjul, the Gambian capital. “How can they allow something like this in the country, destroying lives?”
India has come to call itself “the pharmacy of the world” as its pharmaceutical industry has grown rapidly, providing a lifeline to the developing world by selling drugs, many of them generic, for a range of illnesses. such as malaria and AIDS at lower prices than American or European drugs.
But the deaths in The Gambia have raised alarm bells over what one expert has called a ‘dangerous cocktail’: On the one hand, India’s $50 billion pharmaceutical industry whose regulation has remained loose and chaotic despite calamities repeated, and on the other, poor nations with little or no means of testing the quality of the medicines they import.
India’s pharmaceutical industry is plagued by data fraud, inadequate testing and substandard manufacturing practices, experts say. While people around the world are taking Indian drugs every day without incident, regulatory weaknesses are giving the country’s drugmakers the opportunity to save money and increase profits, experts say.
This has created a dangerous reality far more widespread than the occasional tragic case of mass poisonings, and could shake faith in Indian medicines in places that need them most.
“What happened in The Gambia is happening in other African countries without us even knowing about it,” said Michel Sidibé, the African Union special envoy for the African Medicines Agency, a new body. aimed at harmonizing medicines regulation across the continent.
“Most African countries do not have testing capacities or well-trained regulatory bodies,” Mr Sidibé said. “The African market is very fragmented, but due to poor regulation, drugs are flowing from one country to another.”
India is the world’s third-largest drug maker by volume, producing 60% of the world’s vaccines and 20% of generic drugs. In a sign of the global dependence on Indian medicines, the country’s pharmaceutical exports grew by nearly 20% in the first year of the pandemic, reaching $24 billion, despite lockdowns disrupting supply chains. global supply.
In a sign of approval of the quality of Indian drugs, officials point out that more than half of the drugs manufactured in India are destined for highly regulated markets – “one in three pills in the United States and one in four pills in Eastern Europe sold from India”. according to the Indian Pharmaceutical Alliance.
This is the other half where the danger may lie.
Dinesh Thakur, a public health activist and industry whistleblower who has lifted the curtain on some of his perilous practices, and Prashant Reddy, a lawyer and researcher, have chronicled India’s regulatory shortcomings in a book recent, “The Truth Pill”.
Mr Thakur, Mr Reddy and other experts have long suspected that Indian manufacturers could be taking shortcuts with some drugs destined for export to markets with poorer quality controls. Some of the evidence is anecdotal, but it points to a limited study in which the quality of Indian medicines has been tested in several importing countries, as well as Indian pharmaceuticals that have attracted complaints and blacklists in other countries.
They also note that regulatory bodies in Western countries, such as the Food and Drug Administration in the United States, carry out regular inspections of Indian factories that manufacture drugs for their markets. But poorer countries lack the resources to do the same, leaving products shipped to their countries at the mercy of loose Indian regulations.
“The drugs they export to Africa tend to be of lower quality than other markets,” Mr. Reddy said, “because they know they are more likely to get away with drugs from lower quality”.
The problem with cough syrups is an old one, so old that similar contamination issues contributed to strict drug regulation in the United States and the creation of the FDA nearly a century ago.
Over the past decades, several cases of mass deaths from drugs made in China, a major producer of drugs and pharmaceutical raw materials, have been attributed to cough syrups. In these cases, the counterfeiters were found to have used diethylene glycol and ethylene glycol, which break down into toxic compounds in the body, instead of more expensive non-toxic solvents.
In India, at least five episodes of mass mortality caused by diethylene glycol contamination have been recorded since the 1970s. Indian-made syrups exported to Gambia also contained large amounts of diethylene glycol and ethylene glycol. But they were produced by a licensed manufacturer, and not by counterfeiters, as in China.
India has an outdated regulatory model that focuses on verification of the end product. The FDA, on the other hand, has a “process-oriented” regulatory framework, which focuses on quality and safety controls during the manufacture of a drug.
The process fails in India, Mr. Thakur and Mr. Reddy said, due to a lack of resources to carry out product checks, as well as widespread corruption.
Manufacturers are taking advantage of the loopholes of a multi-tiered regulatory system in India’s federal system. The central government is responsible for ensuring the quality of imported drugs and approving new drugs. But state governments are largely responsible for enforcing drug regulations, both for domestic use and manufacture for export.
Mr Thakur said state governments often have far too tight budgets to continuously buy drugs from the markets for testing. Even when a drug in one state is found to be unsafe, jurisdictional issues and weak legal frameworks prevent prompt recalls.
“For state governments, state capacity is very low and drug regulation is an extremely low priority for them,” Reddy said.
Only recently have efforts been made in India to create a consolidated central database where one state’s test results can be easily shared with others. Partial data downloaded from just three states showed about 7,500 failures – due to issues such as insufficient active ingredients, metabolic difficulties or bacterial contamination – of drugs on the market that these states had tested during the last decade.
The four syrups linked to The Gambia deaths were produced by Maiden Pharmaceuticals. The three-decade-old company manufactures drugs in the state of Haryana. Maiden’s website, which states that one of the company’s principles is “at all costs, do not compromise on quality”, shows that its exports reach four dozen countries.
Maiden, in a statement, said it had “valid drug approvals for export of the products in question” and that the raw material for the drugs came from “certified and reputable companies.”
But Maiden had previously been flagged for substandard products. The database shows that in the state of Kerala, five of its products failed tests in 2021. Eight years earlier, India’s Consul General in Ho Chi Minh City named Maiden among 46 Indian companies that Vietnamese drug controllers had “blacklisted for quality violation,” demanding action against them “for bringing a bad name to Indian pharmaceutical industries overseas.”
In the case of The Gambia, the country’s Medicines Control Agency, in collaboration with the WHO, alerted the Indian government to the problems with the syrups on September 29 and ordered a recall on October 4, nearly three months after doctors at Banjul Hospital started seeing a pattern.
A day later, the WHO, which had sent samples to Switzerland and Senegal for testing, announced that laboratory tests had confirmed the presence of “unacceptable amounts” of diethylene glycol and ethylene glycol in the syrups. .
Hundreds of Red Cross volunteers rushed to intercept contaminated syrups in The Gambia, one household and one pharmacy at a time. Of 50,000 contaminated syrup bottles, Gambian police said 41,500 had been recalled, but the rest remained untraceable.
Many children who took the syrups are still fighting for their lives, as Gambian doctors continued to prescribe them until mid-September.
A Gambian health official said this week that the country’s health authorities were still investigating the many casualties and assessing whether the syrup played a role in the deaths of the babies.
The alarm has spread beyond The Gambia. While syrups are not registered for sale in most other West African countries, once a product is in the region, “it is very difficult to control its circulation due to the porosity borders,” said Arnaud Pourredon, the founder of Meditect, an Ivory Coast-based company that helps pharmacists digitize their inventory and track fake medicines.
In India, officials raided the production site in Haryana two days after being alerted by the Gambian government. On October 11, they ordered the closure of the Maiden production plant.
Haryana and national regulators said in a joint statement that ‘the company manufactured and tested drugs without following and in violation’ of accepted manufacturing practices and that Maiden ‘failed to keep and produce records manufacturing and testing in accordance with the rules.”
But the central government has tried to shift responsibility, saying that the responsibility for ensuring quality rests with The Gambia as the importing country.
The Gambian Minister of Health admitted that the country does not have laboratories to test imported drugs. The national drug regulatory body, established in 2014, relies on certificates provided by manufacturers, said Salieu Taal, lawyer and president of the Gambia Bar Association.
He said loose regulations in some exporting countries and lack of resources for testing in recipient countries had left many African countries facing “a very dangerous cocktail”.
“There may be more deaths than we have recorded,” Mr Taal said.
Mady Camara contributed reporting from Dakar.
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