The World Health Organization (WHO) has issued an alert regarding a batch of common cold syrup discovered in Iraq that has been contaminated with toxic substances. These chemicals have resulted in the deaths of numerous children worldwide. This marks at least the fourth instance in the last year where harmful tainted syrups have been linked back to Indian manufacturers.
The troublesome medication, named Cold Out, was discovered in Iraq and determined by the WHO to have higher than normal amounts of diethylene glycol (DEG) and ethylene glycol (EG). Testing revealed that the batch had over 20 times the acceptable level of ethylene glycol.
According to the WHO, this batch was produced by Fourrts (India) Laboratories Pvt. Ltd for Dabilife Pharma Pvt. Ltd. The WHO emphasized that using this substandard batch, especially in children, could lead to severe injury or even death. The toxic effects encompass symptoms like abdominal pain, vomiting, diarrhea, altered mental state, headache, inability to pass urine, and acute kidney injury that could potentially be fatal.
Similar chemicals-contaminated cough syrups, also made in India, were associated with the deaths of children in Gambia and Uzbekistan last year. Recently, another cough syrup brand connected to child deaths in Cameroon was revealed to have the same Indian origin. The different manufacturers involved in producing these contaminated medicines have raised concerns about the regulation of India’s pharmaceutical industry.
Despite these recurrent controversies, the pharmaceutical sector in India seems financially robust. The country’s drug exports are predicted to grow almost twice as fast this fiscal year, reaching sales of $27 billion, as stated by the Pharmaceuticals Export Promotion Council of India.
The WHO did not report any casualties linked to the latest contaminated batch. An executive from Fourrts denied the company’s involvement in producing the drug, stating that the manufacturing process was subcontracted. He highlighted that the testing was based on products made in early 2022, and the test limits were only introduced in May 2023.
He emphasized that they obtained samples for testing after the WHO alert and found minimal levels of DEG and EG within permissible limits, deeming the drugs safe. The regulatory manager at Sharun Pharmaceuticals Private Ltd confirmed that they manufactured Cold Out for Fourrts last year but have ceased production.
The manufacturing unit and office of Sharun Pharmaceuticals Private Ltd were inspected by Chennai drug officials recently, and all documents related to the Cold Out drug were taken.
Source: World Health Organization – WHO
