India finds 2 more toxic cough syrups: What we know about them

The Central Drugs Standard Control Organisation (CDSCO) has identified an unsafe level of diethylene glycol and ethylene glycol in cough and allergic rhinitis syrups manufactured by two Indian companies, one from Gujarat and the other from Tamil Nadu. It comes months after Indian-made cough syrups were linked to 141 children’s deaths worldwide. Contamination was discovered in 48 of the 1,166 drug samples tested in August, which were designated “not of standard quality” and “spurious” by the CDSCO. Previously, the World Health Organisation (WHO) issued warnings about contamination in cold-cough syrups sold by India, stating that these two contaminants (diethylene glycol and ethylene glycol) were discovered in the medicine. Same contaminants found According to a government report, India’s medicines authority discovered that Norris Medicines’ cough syrup and anti-allergy syrup are harmful. The medicines were contaminated either with diethylene glycol (DEG) or ethylene glycol (EG), the same contaminants found in the cough syrups that caused the deaths in Gambia, Uzbekistan and Cameroon since the middle of last year. Samples from a batch of cough syrup and one batch of anti-allergy syrup prepared by the Gujarat-based firm were discovered to contain 0.118 per cent ethylene glycol, 0.171 per cent ethylene glycol, and 0.243 per cent diethylene glycol, respectively, and were not of standard grade. [caption id=“attachment_13204412” align=“alignnone” width=“640”] The medicines were contaminated either with diethylene glycol (DEG) or ethylene glycol (EG), the same contaminants found in the cough syrups that caused the deaths in Gambia, Uzbekistan and Cameroon since the middle of last year. Reuters[/caption] 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 $42 billion (Rs 3,49,574 crore) drug industry dominated by small players. HG Koshia, commissioner of Gujarat state’s Food and Drug Control Administration, told Reuters on Wednesday that it had inspected Norris’s factory last month and ordered it to suspend production and recall the drugs. “The company failed miserably on compliance parameters of good manufacturing practices,” Koshia said. “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 added that Norris used to export the cough syrup, but did not say where. Norris Managing Director Vimal Shah declined to comment outside business hours. Contaminated cough syrups in circulation The World Health Organisation (WHO) says the safe limit, based on internationally accepted standards, is no more than 0.10 per cent. “We are aware of the CDSCO report and have communicated with that agency to ascertain where the products… have been exported,” said a WHO spokeswoman. “This information is pivotal when we consider whether — or not — to issue a medical product alert.” 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. [caption id=“attachment_13204432” align=“alignnone” width=“640”] The alerts on the toxic medicines come at a time when the government, through pharmexcil, is organising workshops for drugmakers across the country to stress the importance of drug quality and patient safety. Image used for representational purpose/Pixabay[/caption] The CDSCO also found three batches of COLD OUT syrup made by Fourrts (India) Laboratories, Tamil Nadu-based company, contaminated with DEG and EG. The syrup containing Paracetamol, Phenylephrine, and Chlorpheniramine and used to relieve nasal congestion, runny nose, and fever, among other things, was found to contain both contaminants — ethylene glycol 1.9 per cent and diethylene glycol 0.14 per cent. The World Health Organisation said in August that a batch of COLD OUT sold in Iraq had unacceptable levels of DEG and EG. Fourrts Chairman SV Veeramani did not respond to a request for comment. 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 there was “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 Iraq market.” Focus on drug quality amidst toxic medicine alerts The alerts on the toxic medicines come at a time when the government, through pharmexcil, is organising workshops for drugmakers across the country to stress the importance of drug quality and patient safety. The CDSCO list also named a glycerine batch made by Adani Wilmar, despite it containing 0.025 per cent EG, within the WHO safety limit. Adani Wilmar did not immediately respond to a request for comment outside business hours. Indian pharmaceutical executives and regulators have told Reuters that it is common practice among some manufacturers in the country to substitute cheaper, commercial-grade ingredients when making cough syrups. With inputs from Reuters