A brand of cough syrup linked to several deaths among children in Cameroon was manufactured within India, drug officials have confirmed, in what is the latest controversy to engulf the country’s scandal-hit pharmaceutical industry.
India’s drugs regulator and the World Health Organization (WHO) have been investigating the medicine, sold under the brand name Naturcold, after reports of its alleged involvement in the deaths of at least six Cameroonian children.
Packaging from a highly toxic batch of the medicine found in the central African nation suggested it was manufactured by a British producer called Fraken International (England), but the UK health regulator said no such company exists.
However, India’s drug regulator has since indicated that the Naturcold brand is produced by an Indian manufacturer called Riemann Private Ltd, based in Indore. It appears to be exported to global markets, including Cameroon, by a second Indian company, called Wellona Pharma.
WHO testing found that the toxic batch had more than 200 times the acceptable amount of diethylene glycol, a highly toxic solvent that can cause vomiting, diarrhoea, acute kidney injury and eventually death.
The revelations come at a time of great scrutiny for India’s pharmaceutical sector. Last month, the country recalled its typhoid vaccine from global markets due to concerns over quality. Before that, the deaths of nearly 70 children in the Gambia were linked to an Indian-made cough syrup.
An inspection of Riemann Private was carried out in June by India’s drug regulator, the Central Drugs Standard Control Organisation (CDSCO). Samples of Naturcold were subsequently found at the company’s premises and collected by officials for lab testing.
“The company has manufactured six batches of the Naturcold and exported the drug through Wellona Pharma which is based in Surat, Gujarat,” Manmohan Molasari, a senior drugs official from Indore, told The Telegraph.
“It is confirmed that the Naturcold syrup was manufactured here but it is not confirmed that the contaminated product found in Cameroon is the same. That will be established once the lab reports arrive. We are waiting for the report.”
Mr Molasari said that the CDSCO is “in [the] process” of taking disciplinary action against Riemann. A “show cause notice” has been issued against the company, “asking its owners why action should not be taken.” The drugs regulator has yet to receive a response, Mr Molasari added.
Yogesh Gupta, another official who was part of the inspection team, said the company was still operating and manufacturing drugs for now.
Contamination crisis
Riemann Pvt Ltd director Navin Bhatia has yet to respond to a request for comment. On June 20, he told local media that “this is an old matter and we have made it clear that our product was duplicated and sold … on the street.”
Riemann last produced a batch of Naturcold under contract for Fraken in early 2022 and provided it to an exporter who reported sending it to Cameroon, Mr Bhatia said.
Wellona Pharma was also approached for comment but did not respond.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has so far found no evidence to indicate that the medicine originated in the UK or was made available to British buyers.
The MHRA has been monitoring fake claims of UK origin made by overseas pharmaceutical companies, which are used to lend credibility to otherwise falsified, unlicensed, or substandard medicine.
“Over the last 12-months, we have not seen a significant increase in the number of reports of falsified medicinal products claiming to be of UK origin, however the potential for a shift in criminal behaviour means that we will always need to closely monitor this type of threat,” Dr Alison Cave, MHRA Chief Safety Officer, told the Telegraph.
Last week, the WHO said that the batch of Naturcold found in Cameroon had samples which were 28.6 per cent diethylene glycol. The acceptable limit is no more than 0.10 per cent.
Unscrupulous actors sometimes substitute propylene glycol, an ingredient used in cough syrups, with cheaper but toxic alternatives like ethylene glycol and diethylene glycol.
The toxic substances are thought to be at the centre of last year’s mass poisoning of 300 children across Uzbekistan, the Gambia and Indonesia, in what is the biggest tainted medicine scandal since contaminated cough syrup killed 365 people in Panama in 2006.
Several of the medicines linked to fatalities in Gambia and Uzbekistan have been traced to Indian firms, raising concerns about regulation of the country’s $42 billion pharmaceutical industry, which is sometimes referred to as the “pharmacy of the world”.
Despite the repeated scandals, the sector appears to remain in strong financial health. India’s drugs exports this fiscal year are set to grow nearly twice as fast as last year, to reach sales of $27 billion, according to the Pharmaceuticals Export Promotion Council of India.
