Pharma cough syrup plant linked to Uzbek deaths to reopen

The authorities in India’s Uttar Pradesh state have cleared the re-opening of a manufacturing plant which made cough syrup linked to dozens of deaths in Uzbekistan last year.

The facility, operated by Marion Biotech, has been given the green light to resume production of most of its medicines, according to a Reuters report citing the drug regulatory authority for the state. Marion Biotech is one of three manufacturers linked by the World Health Organisation (WHO) to an estimated 141 deaths among children in Uzbekistan, Gambia and Cameroon.

“There is no known case of a lack of quality in other medicines manufactured by the firm,” according to an update on Marion Biotech obtained by the newswire. Which adds that the company’s appeal against the shutdown has been “partially accepted.”

The production of products based on the excipient propylene glycol remains banned at the plant. Propylene glycol thought to be adulterated with diethylene glycol (DEG) or ethylene glycol (EG) is thought to have been responsible for the fatalities seen with the cough syrup products.

The contaminants are unsafe and their use, especially in children, may result in serious injury or death. Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state and acute kidney injury.

Earlier this year, the WHO said two products manufactured by Marion Biotech – Ambronol syrup and Dok-1 Max syrup – were suspected of being substandard, and that the firm had failed to provide guarantees about their safety and quality.

Other deaths linked to contaminated excipients have also been linked to syrup-based medicines manufactured by India’s Maiden Pharmaceuticals and Riemann, as well as Indonesian drugmaker PT Alfi.