gambia, india, pharmaceutical, export, drugs, drugmaker, investigation,
A mother in Gambia, Mariama Kuyateh, holds up a picture of her late son Musawho who died from acute kidney failure over the weekend. Gambian police and the WHO link those deaths to cough syrups made by the Indian Pharma company Maiden Pharmaceuticals. Photo: Milan Berckmans / AFP. 

69 Babies Died From Cough Syrup in Gambia. Now, India’s $24.5B Drug Export Is Under Scrutiny.

India is among the leading exporters of cheap, life-saving generic medicines. Yet its drug regulators aren’t known for quality checks.
Pallavi Pundir
Jakarta, ID

Mothers holding photos of their babies are out on the street in the tiny African nation of The Gambia. They say their children had the flu and they gave them cough syrup. The flu went away, but the children stopped peeing. Days later, they were dead. 

At least 69 children have died since July, while 81 more are in the hospital, say Gambian authorities, as protests and candlelight vigils sway the country. Last week, when Gambian authorities looked into the cough syrups given to the babies, they traced it to an inconspicuous company thousands of miles away, in India. 

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A 32-year-old company called Maiden Pharmaceuticals Limited had exported a giant batch of cough syrups last year to U.S.-based Atlantic Pharmaceuticals, who, then, exported them to Gambia. Last week, the World Health Organization (WHO) found “unacceptable” amounts of toxic solvents in them. One of these solvents, diethylene glycol, is a common adulterant in India that has sickened and killed Indian children. 

Now, many Indian states are banning the sales of Maiden’s products. Gambian authorities, along with Red Cross workers, are going door-to-door to confiscate every last of those imported bottles. 

As Indian health authorities shut down Maiden indefinitely and started an investigation, the incident has rattled the country’s $42-billion pharmaceutical sector, the third largest in the world. The country’s $24.5-billion pharmaceutical export industry, which services over 200 countries, has come under tough scrutiny too. Over the years, India has gained the reputation of being the “pharmacy of the world” for providing cheap, life-saving generic medicines, 45% of which go to Africa. 

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But Indian public health experts say this is a wake up call for themselves and the international community. They say Indian medicine exports lack drug regulation and checks and balances, especially in African countries where regulatory bodies are either poorly managed, or not there at all. Gambia doesn’t have its own testing lab to keep a check on its $1.2 million-worth of pharmaceutical imports, so it relies on other countries to do it themselves. 

India’s national regulatory body is the Central Drugs Standard Control Organisation (CDSCO), which is responsible for issuing certificates to companies under WHO’s frameworks before they can export. But how those certificates are issued is not transparent. 

“For most part, the CDSCO is very opaque, dysfunctional and unaccountable to the people of India whose health it is charged with protecting. It functions more as a spokesperson for the pharma industry and than a guardian of public health,” Dinesh Thakur, a public health expert who recently co-authored The Truth Pill: The Myth of Drug Regulation in India with lawyer Prashant Reddy, told VICE World News. 

Thakur is among the best-known whistleblowers exposing dangerous practices of India’s drug industry. In 2013, he blew the whistle on Ranbaxy, one of India’s biggest drugmakers, for not just manufacturing and selling adulterated drugs, but also falsifying drug data. 

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Thakur said there’s no way to know whether the CDSCO actually inspected Maiden’s facility before giving them a go-ahead to export their medicines. The body has previously come under scrutiny for colluding with drug firms to circumvent approval processes. In June this year, India’s Central Bureau of Investigation arrested a CDSCO official allegedly for taking bribes from Biocon, India’s biggest pharmaceutical company worth $316 billion, over trials of an insulin drug. 

On its website, Maiden said it produces 2.2 million litres of syrups every year. Over the years, the company was accused of producing poor-quality medicines in seven Indian states. One state, Bihar, even blacklisted them. In 2014, Maiden was among 45 Indian drugmakers banned by Vietnam over quality concerns. Despite the track record, Maiden continued its business. 

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Maiden did not respond to VICE World’s News’ interview request, but last weekend, they told an Indian news agency that they’re “shocked” by the events. They said the Indian authorities visited their factory in a dusty industrial township in Haryana last week, and since the matter is subjudice, no further comments will be issued. 

A survey conducted by CDSCO between 2014 and 2016 found that 4.5 percent of Indian drugs are of substandard quality. But independent studies found that substandard medicines could be three times more prevalent than that. 

One independent research report published by scientists from the University of Ottawa and the University of Maryland found that Indian manufacturers are more likely to sell poor quality medicines to Africa. India is the second-largest healthcare trading partner with sub-Saharan Africa, after China. The study found that “made in India” drugs purchased from Africa are of “worse quality than those purchased within India, and from Non-Africa countries outside of India.” 

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Shortly after this report was released, the Indian government threatened a U.S. think tank, of which one of the research scholars Roger Bate was the author of the study, with legal action. Government officials back then called the study a “malicious campaign against the country.”

Indian health officials are mum on the allegations of laxity. Yesterday, CDSCO and other state drug regulators in India started nationwide quality checks on cough syrups being sold in markets. “The drug inspectors are directed to collect samples and test if any of the samples have unacceptable amounts of diethylene glycol and ethylene glycol,” an official from Maharashtra, which has 1,000 pharmaceutical units, told the media.

Thakur said that the Gambia incident has exposed major failings by Indian pharma companies who could do a lot of good for nations, both rich and poor, in controlling healthcare costs. “[Instead], they act with impunity and ship substandard and adulterated products to these countries because they know they can get away with it,” he said. 

He added that he’s not very confident this incident will set a precedent. “We do, however, hope that Africa and the WHO take steps to ensure that Indian companies cannot continue to export substandard medicine to Africa,” he said. 

Follow Pallavi Pundir on Twitter.