The Indian drug regulator has discovered that cough syrup and anti-allergy syrup produced by Norris Medicines are toxic, containing contaminants diethylene glycol (DEG) or ethylene glycol (EG). This revelation comes months after similar Indian-made cough syrups were associated with 141 children’s deaths in Gambia, Uzbekistan, and Cameroon.
The Central Drugs Standard Control Organization (CDSCO) detected DEG and EG contamination in these medicines, marking the first time in two years that such contamination has been reported in their monthly findings. This discovery highlights India’s efforts to regulate its $42 billion drug industry, which is largely dominated by small players.
H.G. Koshia, the commissioner of Gujarat state’s Food and Drug Control Administration, disclosed that they conducted an inspection of Norris’s factory last month and ordered it to suspend production. The company was found to have serious compliance issues with good manufacturing practices, including inadequate water systems and subpar air-handling units.
Norris Medicines did not respond to an email seeking comment, and their office numbers were not in service when contacted by Reuters.
Tests conducted at a CDSCO laboratory revealed that Norris’s Trimax Expectorant contained 0.118 percent of EG, while the allergy drug Sylpro Plus Syrup contained 0.171 percent of EG and 0.243 percent of DEG. The World Health Organization (WHO) has set the safe limit for these contaminants at no more than 0.10 percent.
It remains unclear whether Norris’s drugs have been recalled or if they have caused any harm. At the time of the investigation, both medicines were still listed on online pharmacies.
Additionally, the CDSCO identified three batches of COLD OUT syrup produced by Fourrts (India) Laboratories that were contaminated with DEG and EG. In August, the WHO reported that a batch of COLD OUT sold in Iraq had unacceptable levels of these contaminants.
S.V. Veeramani, Chairman of Fourrts, did not respond to requests for comment. However, in August, he claimed that retention samples of COLD OUT showed no contamination or toxins and that there had been no reports of adverse effects or deaths due to the product. As a precaution, they voluntarily recalled the product from the Iraqi market.
These alerts regarding toxic medicines come at a time when the Indian government, through the Pharmaceuticals Export Promotion Council of India (pharmexcil), is organizing workshops to emphasize the importance of drug quality and patient safety among drug manufacturers nationwide.
The CDSCO also mentioned a glycerine batch produced by Adani Wilmar, which contained 0.025 percent EG, within the WHO safety limit. Adani Wilmar did not immediately respond to a request for comment.