Gambia deaths: Syrup contaminants fatal, errors likely at Sonepat firm’s end: World Health Organisation

Aditi Tandon &

Bhartesh Singh Thakur

Tribune News Service

New Delhi/Chandigarh, Oct 11

With India awaiting the World Health Organisation’s report on direct causal link between the deaths of 66 Gambian children and the drugs manufactured by Sonepat-based Maiden Pharmaceuticals, the global body has said it was difficult to establish a firm link, but the contaminants flagged by it on October 5 were known toxins and could prove fatal.

The WHO, however, said it had shared with India the lab analysis results of the contaminated cough syrups manufactured by the firm in question.

After the WHO’s October 5 alert, India had said, “The exact one-to-one causal relation of deaths with the medical products in question had not yet been provided. The WHO has been requested to share at the earliest the report with the Central Drug Standard Control Organisation.”

Responding to The Tribune queries on whether the causal link report had been shared with India, a WHO spokesperson said, “The contamination of the four products in question was discovered during the investigation into the deaths of children. While it is hard to establish a firm causal link, and the investigations are still going on, we know that these contaminants (diethylene glycol and ethylene glycol) are toxic and can prove fatal. This is why it’s important that these products are taken off the market as soon as possible.”

The WHO said there was no set timeline for reporting on causal link. “The WHO continues to be in touch with India on this issue and has shared lab analysis confirming the presence of contaminants with the Drugs Controller General of India,” it said.

In tentative results, the WHO received from Gambia, four out of 23 syrup samples were found contaminated.

On the source of contamination, the WHO spokesperson, in an email to The Tribune, said, “The cause of contamination is still under investigation. Failure to observe good manufacturing practices (GMP) may be a contributory factor. Previous cases of DEG and EG contamination have been due to errors at the end of the manufacturer, including poor practices at the manufacturing facility.”

Commenting on the genesis of the Gambian tragedy, the WHO said at the end of July, Gambia received information on increase in acute kidney injuries (AKI) among children from the country’s Edward Francis Small Teaching Hospital.

“As of September 30, about 78 cases of AKI had been reported, including 66 deaths, a case fatality rate of 85 per cent. About 72 per cent cases were under the age of two years. The children displayed symptoms like fever (81 per cent of cases), vomiting (61 per cent), diarrhoea (51 per cent) and cough (10 per cent),” the WHO spokesperson said, adding the world body was supporting Gambia with investigations, looking at both infectious and non-infectious causes.

“Some samples of medicines used by children turned positive for DEG and EG. The products concerned were paracetamol, promethazine, and cough syrups. The country began recalling the products on October 2,” said the WHO, which is now aiding recall/withdrawal of the contaminated products from across the world.

Meanwhile, Gambian President Adama Barrow has authorised the national drug regulator to suspend the licence of the suspected pharmacy and importer behind the contaminated drugs from India and those involved are being interrogated by the police.

An October 8 statement said President Barrow had directed the Foreign Minister to reach out to the Indian Ambassador to Gambia for consultation on his government’s “most profound concern over the issue”. “The Barrow administration is also reviewing the entire drug and medical licensing regime to inform other causes of action,” the statement added.

PGI files report on shot-linked deaths

The PGI, Chandigarh, has filed a report on propofol injection deaths with UT admn. It hasn’t recommended FIR against manufacturing firm as of now.

Haryana Govt halts ops at Maiden Pharma

• Haryana has ordered the suspension of manufacturing at Sonepat’s Maiden Pharma
• Action comes after a team of Central, state officials detected violations
• Sources say the firm is likely to be sealed, its licence suspended inside

#sonepat