In a significant development, India’s drug regulator has identified anti-allergy and cough syrups manufactured by Norris Medicines as toxic, according to a government report. This revelation comes months after Indian-made cough syrups were linked to the tragic deaths of 141 children globally.
The affected medications were discovered to contain ethylene glycol (EG) or diethylene glycol (DEG), the very same harmful substances that led to fatal incidents in countries like Gambia, Uzbekistan, and Cameroon the previous year due to tainted cough syrups.
India’s foremost drug regulatory authority, the Central Drugs Standard Control Organisation (CDSCO), has expressed significant concerns after uncovering elevated levels of these toxic contaminants in five batches of cough and allergic rhinitis syrups produced by two Indian manufacturers.
Both diethylene glycol and ethylene glycol were detected at levels surpassing the safety thresholds established by the World Health Organisation (WHO).
Gujarat state’s Food and Drug Control Administration Commissioner HG Koshia confirmed the inspection of Norris factory last month. Subsequently, orders were issued to halt production and recall the drugs due to severe compliance failures.
Koshia stated, “The company failed miserably on compliance parameters of good manufacturing practices. The adequate water system was not there. The air-handling unit was also not up to the mark. In the larger interest of public health, we ordered the unit to stop production.”
CDSCO Discovers Unsafe Levels in Indian Cough and Allergy Medications
Central Drugs Standard Control Organisation (CDSCO), in its monthly reports, highlighted DEG and EG contamination for the first time in nearly two years. This move signifies India’s efforts to crack down on its $42 billion drug industry, primarily dominated by smaller players.
A company based in Gujarat came under scrutiny in August when its cough syrup was discovered to contain 0.118 percent ethylene glycol. Additionally, their allergic rhinitis syrup was found to have 0.171 percent ethylene glycol and 0.243 percent diethylene glycol, surpassing the WHO’s safety limit of 0.10 percent. Meanwhile, a Tamil Nadu-based company faced similar issues, with two batches of its paracetamol syrup showing exceptionally high levels of ethylene glycol—1.9 percent and 2.23 percent as per CDSCO’s report.
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CDSCO’s August list of “not of standard quality/spurious/adulterated/misbranded” drugs, available on its website, revealed alarming findings. Tests conducted at a CDSCO laboratory unveiled that Trimax Expectorant contained 0.118 percent EG, while Sylpro Plus Syrup, an allergy medication, contained 0.171 percent EG and 0.243 percent DEG. This development underscores the pressing need for stringent measures to ensure the safety and quality of medications within the Indian pharmaceutical sector.
According to Christian Lindmeier, a WHO spokesperson, over 20 products from India and Indonesia, involving more than 15 different manufacturers, have been affected. These products, including cough syrup, paracetamol syrup, and vitamin syrup, have a common factor: the use of propylene glycol as a solvent. This similarity suggests that propylene glycol might be the source of diethylene glycol or ethylene glycol contamination.
While investigations are ongoing, the WHO has issued alerts about these contaminated products, emphasizing the potential risk they pose to public health. Tragically, instances of India-manufactured syrups contaminated with diethylene glycol or ethylene glycol have resulted in fatalities in countries like the Gambia and Uzbekistan, raising significant concerns about the quality and safety of these medications.