When Ebrima Saidy’s three-year-old daughter Adama fell sick in September last year, her doctor prescribed a generic drug called promethazine. Nine days later, she died in a hospital, a victim of what has become one of the world’s worst scandals related to the sale of over-the-counter medicine.
At least 70 Gambian children under the age of seven who took promethazine or similar drugs died of acute kidney injury between June and October last year, according to a joint report by the World Health Organization and the Gambian health ministry.
Their deaths have sparked concerns about quality control in India, the self-styled pharmacy of the world, as well as under-resourced regulatory agencies in low-income nations. “I asked myself a thousand and one questions, how could the government have let this happen,” Saidy, a 31-year-old graphic designer, said through tears.
India, which has 20 per cent of the global market for generic drugs, supplies more than 50 per cent of generic drugs sold in Africa, according to Invest India, the government’s national investment promotion and facilitation agency.
A December report by the Gambian parliament’s select committee on health showed the children who died had all been prescribed at least one of four medicines — Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup — imported into Gambia by Atlantic Pharmacy and manufactured by India’s Maiden Pharmaceuticals. This month, the US Centers for Disease Control and Prevention linked the Gambian deaths to Maiden, saying the syrups “were imported from a single Indian manufacturer”.
Maiden Pharmaceuticals, which has been in business since 1990 and also supplies Asia, Africa, eastern Europe, the Middle East and Russia, did not respond to requests for comment. Atlantic Pharmacy, which since 2019 has imported drugs from Maiden, could not be reached for comment.
The WHO in October issued an alert on the four “substandard” products made by Maiden, saying the medicines contained “unacceptable” levels of toxic chemicals used in antifreeze and lubricants.
These chemicals were also found in medicine made by India’s Marion Biotech and sold in Uzbekistan, according to Uzbekistani officials. At least 18 children have died and four people arrested. Marion Biotech, which is set to lose its license, did not respond to requests for comment.
This is not the first time Maiden has faced problems with its drugs. It was convicted in February by a court in the northern Indian state of Haryana for manufacturing substandard ranitidine, an antacid medication. The sentence is suspended pending appeal. Last month, an Indian court sentenced two executives from Maiden, blacklisted by Vietnam’s drug administration in 2014, to two and a half years in jail for their role in exporting the drugs to Vietnam.
“If the company had such a bad track record, why is it still manufacturing?” said Prashant Reddy, a lawyer and co-author of The Truth Pill, a book on India’s drug regulation framework. “Under Indian law, there is supposed to be an annual inspection to see whether drugmakers are observing GMP [good manufacturing practices]. How did they not catch this?”
In a letter to the WHO after its warning on cough syrups, Dr VG Somani, the drugs controller general of India, said a narrative promoted by the world’s media had “adversely impacted the image of India’s pharmaceutical products across the globe”. He said that the four medicines blamed for the deaths in Gambia had been tested at a government laboratory and no toxins were found in them.
For some, this response fell short. “How can you claim to be the pharmacy of the world and then refuse to take any kind of responsibility when these deaths happen?” said Reddy. “This government treats everything as a public relations issue, not a public health issue.”
At a meeting of Indian drugmakers and regulators in February, India’s health minister Mansukh Mandaviya asked participants to “steadfastly work towards making the Indian drugs regulatory system among the best in the world”.
On the Gambian side, the country’s drug regulator, the Medicine Control Agency, admitted to parliament that the country had no quality control laboratory and relied on certificates of analysis supplied by manufacturers.
The absence of sufficient checks means “we’re reliant on good faith assumptions that [Gambian] importers will buy drugs from reputable companies”, said Salieu Taal, president of the Gambia Bar Association.
“If you’re importing from the western world, you’re protected by existing regulations,” said Taal, adding that drugs shipped to the US have to meet regulatory standards there. US and European regulators, which can inspect pharmaceutical factories in India prior to granting import licences, have in the past suspended Indian companies.
“When it comes to Africa and other countries in the global south, the regime is very lax,” Taal said.
Taal alleges there are also conflicts of interest at Gambia’s Medicine Control Agency, where he says regulators also provide medical import licenses to importers for a fee.
The West African Postgraduate College of Pharmacists, a regional body, said there was a “conflict of interest of staff in regulation and having business relations in the private sector” but said those conflicts had been “addressed” without detailing how. The Medicine Control Agency did not respond to requests for comment.
The lack of regulation and Gambia’s perceived lack of an adequate response have infuriated parents.
Ebrima Sagnia, a 42-year-old banker and part-time taxi driver on the weekends, lost his three-year-old son Lamin to acute kidney injury on September 13 2022.
Sagnia showed the Financial Times a cheque for 14,285 dalasis ($234) received as a gift from the district government. He and other families have rejected the offer. “We’re fighting for justice, not money,” he said.
For Saidy, the loss of his daughter Adama is something he has to live with every day. “She was smart and intelligent and I built a jovial relationship with my kids,” he said. “We shared a very positive relationship and now her twin sister always asks where her twin is.”
Read the full article here