The drug regulator of India discovered that an anti-allergy syrup and a cough syrup, which were being produced by Norris Medicines, are toxic, as per a government report. The syrups were declared toxic months after Indian-made cough syrups were said to be the cause of death of 141 children worldwide.
The medicines were contaminated either with ethylene glycol (EG) or diethylene glycol (DEG), the same contaminants which were discovered in the cough syrups which led to deaths in Gambia, Uzbekistan and Cameroon since last year.
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For the first time in around two years, any DEG and EG contamination has been flagged by the Central Drugs Standard Control Organisation (CDSCO) in its monthly reports as the country makes an attempt to crack down on its drug industry which is worth $42 billion and is dominated by small players.
Speaking to Reuters on Wednesday (October 4), commissioner of Gujarat state’s Food and Drug Control Administration HG Koshia said that it had inspected the Norris factory last month and gave orders for suspending its production and recalling the drugs.
“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,” Koshia said.
The CDSCO uploaded a list of “not of standard quality/spurious/adulterated/misbranded” drugs for August on its website, as per which in the tests carried out at a CDSCO laboratory, the Trimax Expectorant of the company 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.
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Koshia stated that the cough syrup was being exported by Norris. The World Health Organization (WHO) stated that the safe limit is not beyond 0.10 per cent, which is based on internationally accepted standards.
“We are aware of the CDSCO report and have communicated with that agency to ascertain where the products… have been exported,” stated a WHO spokeswoman. “This information is pivotal when we consider whether – or not – to issue a medical product alert,” she added.
The CDSCO also discovered that DEG and EG had contaminated three batches of COLD OUT syrup made by Fourrts (India) Laboratories. In August, the World Health Organization said that there were unacceptable levels of DEG and EG in the batch of COLD OUT sold in Iraq.
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Speaking to Reuters, chairman of the government-backed Pharmaceuticals Export Promotion Council of India (Pharmexcil) Fourrts Chairman S.V. Veeramani said that in August a recent “analysis of retention samples” of COLD OUT showed there was “no contamination or toxins”.
“There is no report of any adverse effect or death due to the product,” he stated in a WhatsApp message. “As a matter of abundant caution, we have voluntarily recalled the product in Iraq market,” he added.
The alerts over the toxic syrups come at a time when through Pharmexcil the government is organising workshops for drugmakers across the country to emphasise on the importance of patient safety and drug quality.
(With inputs from agencies)
