World

Indian Drugs, Sold Worldwide, Sometimes Deadly


They have fever, aches and pains, runny nose, normal things of childhood. Types of diseases for which a doctor will prescribe cough syrup.

But the children’s condition only got worse. They have persistent diarrhea, then can no longer urinate, because their kidneys fail. Instead, it was the drugs that were supposed to make them better, the simple cough syrups imported from India, that killed them, because they turned out to be poisonous.

In all, 70 children in the tiny West African nation of Gambia are suspected to have died in recent months from being contaminated with Indian-made cough syrup. Among them is the boy Muhammad Lamin Kijera, 2 years old, who died on August 4.

“He was lively and likeable – he was everyone’s friend,” said his father, Alieu Kijera, who works as a nurse at an eye clinic in Banjul, the Gambia’s capital. “How can they allow things like this into the country, ruining lives?”

India has called itself “the world’s pharmacy” as its pharmaceutical industry expands rapidly, providing a lifeline to the developing world by selling medicines, many of which are it’s a generic drug, for a range of diseases like malaria and AIDS for less than the price of an American or European drug.

But the deaths in the Gambia have raised alarm over what one expert calls a “dangerous cocktail”: India’s $50 billion pharmaceutical industry on the one hand, with still lax regulation. and chaos despite successive natural disasters, and on the other hand poor countries with little or no way to check the quality of the medicines they import.

According to experts, India’s pharmaceutical industry is rife with data fraud, inadequate testing and substandard manufacturing practices. While people around the world use Indian drugs every day without incident, regulatory weaknesses give the country’s drugmakers the opportunity to cut profits, experts say profits and increase profits, experts say.

That has created a dangerous reality far more widespread than the frequent cases of mass poisoning, and could shake confidence in India’s medicines where they are needed most.

“What happened in the Gambia is happening in other African countries without our knowledge,” said Michel Sidibé, the African Union’s special envoy for the African Medicines Agency, a new body that aims to satisfy harmonize drug regulations across the continent.

“Most African countries do not have the testing capacity nor well-trained regulatory bodies,” Mr. Sidibé said. “The African market is very fragmented, but due to poor regulations, drugs move from country to country.”

India is the world’s third largest drug producer by volume, producing 60% of global vaccines and 20% of generic drugs. In a sign of the world’s reliance on India’s drugs, the country’s pharmaceutical exports jumped nearly 20% in the first year of the pandemic to $24 billion, despite shutdowns that made the country’s pharmaceutical industry worse. global supply chain disruptions.

As a seal of approval for India’s drug quality, officials point out that more than half of drugs made in India go to heavily regulated markets – “every third pill in the US and every fourth pill in Europe is sold from India”. according to the Pharmaceutical Union of India.

That’s the other half where danger can lie.

Dinesh Thakur, a public health activist and industry whistleblower who lifted the curtain on some of its dangerous practices, and Prashant Reddy, a lawyer and researcher, documented the holes India’s regulatory gaps in a recent book, The Truth Pill.

Mr. Thakur, Mr. Reddy and other experts have long suspected that Indian manufacturers may be taking shortcuts with some drugs bound to export to markets with less quality control. . Some of the evidence is anecdotal, but they point to a limited study in which the quality of Indian medicines was tested in many importing countries, as well as Indian medicinal products that were subject to complaints. complaints and blacklisting in other countries.

They also note that the regulatory bodies of Western countries, such as the Food and Drug Administration in the United States, carry out regular inspections of factories in India that manufacture drugs for the market. their. But poorer countries don’t have the resources to do the same, leaving products shipped to their countries under India’s lax regulations.

“The drugs they export to Africa are of lower quality than other markets, because they know they are more likely to get poor quality drugs,” Mr. Reddy said.

The the problem with cough syrup is an old problemSo old that similar contamination problems helped lead to strict U.S. drug regulations and the introduction of the FDA nearly a century ago.

In recent decades, a number of mass deaths from drugs made in China, a major producer of drugs and pharmaceutical ingredients, have been traced back to cough syrups. In those cases, the counterfeiters were found to have used diethylene glycol and ethylene glycol, which break down into toxic compounds in the body, rather than the more expensive non-toxic solvents.

In India, at least five mass deaths due to diethylene glycol contamination have been recorded since the 1970s. Indian-made syrups exported to Gambia were also found to contain large amounts of diethylene glycol and ethylene. glycol. But they are made by a licensed manufacturer and not a fake like in China.

India has an archaic regulatory model that focuses on final product inspection. In contrast, the FDA has a “process-oriented” regulatory framework that focuses on quality and safety checks during drug manufacturing.

Mr. Thakur and Mr. Reddy said the process was not carried out in India because of a lack of resources to conduct product checks, as well as widespread corruption.

Manufacturers take advantage of loopholes in the multi-layered 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 primarily responsible for enforcing drug regulations, both for domestic use as well as for production for export.

Thakur said that state governments often have too small budgets to constantly buy drugs from the market for testing. Even if a drug in one state is found to be dangerous, jurisdictional issues and a weak regulatory framework will prevent a quick recall.

“For state governments, the capacity of states is very low, and drug regulation is an extremely low priority for them,” Mr. Reddy said.

Only recently have there been efforts in India to create a unified central database where test results from one state can be easily shared with others. Partial data uploaded from the three states showed about 7,500 failures – due to problems such as insufficient active ingredients, difficulty in metabolism or bacterial contamination – of marketed drugs those states tried. experience in the past decade.

Four syrups linked to death in the Gambia are manufactured by Maiden Pharmaceuticals. The three-decade old company manufactures drugs in the state of Haryana. Maiden’s website, which says one of the company’s principles is “no compromise on quality at all costs,” shows that the company’s exports have reached four dozen countries.

Maiden, in a statement, said that it had “valid drug approvals for the export of the products in question” and that the raw materials for the drugs came from “certified and reputable companies”. credit.”

But before that Maiden was flagged for substandard products. The database showed that in the state of Kerala, five of their products failed the test by 2021. Eight years earlier, the Indian consul general in Ho Chi Minh City had named Maiden among 46 Indian companies. was “blacklisted for quality violations” by Vietnamese pill control, “Action is required against them” for giving a bad name to the Indian pharmaceutical industry abroad. “

In the case of Gambia, the country’s Drug Control Authority, in collaboration with WHO, alerted the Indian government to problems with the syrup on September 29 and ordered a recall on October 4, almost three months after the doctors at Banjul hospital started seeing a pattern.

A day later, WHO, which 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 syrup.

Hundreds of Red Cross volunteers raced to stop contaminated syrup in the Gambia, household and pharmacy at a time. Of the 50,000 bottles of tainted syrup, Gambia police said 41,500 had been recovered, but the rest remained untested.

Many children who took the syrup are still fighting for their lives, as doctors in the Gambia resumed prescribing them at the end of September.

The alarm has spread beyond the Gambia. Arnaud Pourredon, founder of Meditect, Ivory Coast, said: “Although the syrup is not registered for sale in most other West African countries, once the product is available in the region,” It is very difficult to control the circulation due to the porous contour,” said Arnaud Pourredon, founder of Meditect, from Ivory Coast. based company that helps pharmacists digitize their inventory and track counterfeit drugs.

In India, officials raided the production site in Haryana two days after they were alerted by the Gambian government. On October 11, they ordered the closure of Maiden’s production facility.

Haryana and national regulators said in a joint statement that “the company manufactured and tested the drug without and without compliance” with accepted manufacturing processes and that Maiden “failed to maintain maintain and fail to produce adequate production and testing records as required. “

But the central government has tried to shift responsibility, saying the burden of quality assurance rests with Gambia as the importing country.

The Gambia Health Minister admitted that the country does not have a laboratory to test imported drugs. Salieu Taal, a lawyer and president of the Gambia Bar Association, said the country’s drug regulator was established in 2014 based on certificates provided by manufacturers.

He said that lax regulations in some exporting countries and a lack of resources to test in receiving countries have left many African countries facing “a very dangerous cocktail”.

“There may be more deaths than we have recorded,” Mr. Taal said.

Mady Camara contribution report from Dakar.

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