JAKARTA, Indonesia – Indonesia’s food and drug agency said on Wednesday, November 9, it had suspended the licenses of two more local drug companies producing syrup-type medications, as authorities investigate the deaths of nearly 200 children due to acute kidney injury.
The Southeast Asian country temporarily banned sales of some syrup-based medications in October after it identified the presence in some products of ethylene glycol and diethylene glycol as possible factors for causing the illness.
The two ingredients are used in antifreeze and brake fluids and other industrial applications but also as a cheaper alternative in some pharmaceutical products to glycerine, a solvent or thickening agent in many cough syrups. They can be toxic and lead to acute kidney injury.
Penny K. Lukito, chief of the food and drugs agency (BPOM), told reporters the companies – PT Samco Farma and PT Ciubros Farma – used high levels of ethylene glycol and diethylene glycol in their products.
The companies had been ordered to pull the products and destroy remaining batches, she said, adding it also temporarily revoked their production licences.
Samco Farma and Ciubros Farma did not immediately respond to requests for comment.
Indonesian authorities were investigating raw material supply chains and screening processes to understand how an excess amount of the ingredients got into products, said Penny.
“The distribution line is long, from importers to some chemical product distributors and big traders until the raw ingredients reach the pharmaceutical industries,” she said.
Earlier this week, BPOM suspended the distribution licenses of three other companies making products that it said contained a high-level of ethylene glycol and diethylene glycol.
Indonesia has been investigating the deaths in consultation with the World Health Organization (WHO) after a similar incident in Gambia this year, which has seen at least 70 deaths related to syrup medications made by India’s Maiden Pharmaceuticals. – Rappler.com