India finds 2 more toxic syrups months after poisoning deaths
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A woman living on the outskirts of Jammu, India, holding a photo of her daughter who died after consuming contaminated cough syrup.
PHOTO: REUTERS
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NEW DELHI – India’s drug regulator has found that a cough syrup and an anti-allergy syrup made by Norris Medicines are toxic, according to a government report, months after Indian-made cough syrups were linked to 141 children’s deaths worldwide.
The medicines were contaminated with either diethylene glycol (DEG) or ethylene glycol (EG), the same contaminants found in the cough syrups that caused the deaths in Gambia, Uzbekistan and Cameroon from mid-2022.
This is the first time in at least two years that the Central Drugs Standard Control Organisation (CDSCO) has flagged any DEG and EG contamination in its monthly reports as the country tries to crack down on its US$42 billion (S$57.5 billion) drug industry dominated by small players.
Dr H.G. Koshia, commissioner of Gujarat state’s Food and Drug Control Administration, told Reuters on Wednesday that the administration inspected Norris’ factory in September and ordered it to suspend production.
“The company failed miserably on compliance parameters of good manufacturing practices,” Dr Koshia said, adding that it did not have an adequate water system. “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.”
Norris managing director Vimal Shah declined to comment outside business hours.
The company’s Trimax Expectorant contained 0.118 per cent of EG, while allergy drug Sylpro Plus Syrup had 0.171 per cent of EG and 0.243 per cent of DEG, based on tests at a CDSCO laboratory, according to its list of “not of standard quality/spurious/adulterated/misbranded” drugs for August uploaded on its website.
Dr Koshia said Norris used to export the cough syrup, but did not say where it was exported to.
The World Health Organisation (WHO) says the safe limit for DEG and EG, based on internationally accepted standards, is no more than 0.1 per cent.
It was not immediately clear if the Norris drugs had been recalled or if they caused any harm. Both medicines were listed on online pharmacies when Reuters checked.
The CDSCO also found three batches of Cold Out syrup made by Fourrts (India) Laboratories contaminated with DEG and EG. The WHO said in August that a batch of Cold Out sold in Iraq had unacceptable levels of DEG and EG.
Fourrts chairman S.V. Veeramani did not respond to a request for comment.
Mr Veeramani, who is the chairman of the government-backed Pharmaceuticals Export Promotion Council of India (Pharmexcil), told Reuters in August that a recent “analysis of retention samples” of Cold Out showed “no contamination or toxins”.
“There is no report of any adverse effect or death due to the product,” he said in a WhatsApp message. “As a matter of abundant caution, we have voluntarily recalled the product in the Iraq market.”
The alerts on the toxic medicines come at a time when the Indian government, through Pharmexcil, is organising workshops for drug-makers across the country to stress the importance of drug quality and patient safety.
The CDSCO list also named a glycerine batch made by the Adani Wilmar conglomerate although it contains 0.025 per cent EG, within the WHO safety limit. Adani Wilmar did not immediately respond to a request for comment outside business hours. REUTERS
