India’s drug regulator has made a troubling discovery regarding cough syrup and an anti-allergy syrup produced by Norris Medicines. According to a government report, these medicines have been found to be toxic, months after Indian-made cough syrups were linked to the deaths of 141 children worldwide.
The contaminated medicines were found to contain either diethylene glycol (DEG) or ethylene glycol (EG), the same contaminants that were present in the cough syrups associated with deaths in Gambia, Uzbekistan, and Cameroon since the middle of the previous year.
H.G. Koshia, the commissioner of Gujarat state’s Food and Drug Control Administration, revealed that an inspection of Norris’s factory was conducted last month, resulting in an order to suspend production. Koshia stated, “The company failed miserably on compliance parameters of good manufacturing practices. Adequate water systems were not in place, and the air-handling unit was also subpar. In the larger interest of public health, we ordered the unit to stop production.”
Norris Medicines did not respond to an email seeking comment, and its office phone numbers were unresponsive.
The federal drug regulator, the Central Drugs Standard Control Organisation (CDSCO), also identified three batches of COLD OUT syrup made by Fourrts (India) Laboratories as contaminated with DEG and EG. This information was included in the CDSCO’s list of “not of standard quality/spurious/adulterated/misbranded” drugs for August, which was uploaded to its website.
In August, the World Health Organization (WHO) reported that a batch of COLD OUT syrup sold in Iraq contained unacceptable levels of DEG and EG.
S.V. Veeramani, Chairman of Fourrts, did not respond to a request for comment. However, in August, Veeramani mentioned that a recent analysis of retention samples of COLD OUT showed no contamination or toxins. He stated, “There is no report of any adverse effect or death due to the product,” adding that the product had been voluntarily recalled in the Iraqi market as a precaution.
This discovery of toxic contaminants in cough syrups raises significant concerns about product safety and adherence to manufacturing standards in India’s pharmaceutical industry. The authorities are taking steps to address these issues and protect public health.
