India-manufactured syrups for cough, allergic rhinitis contaminated with toxic levels of chemicals: CDSCO

The two contaminants are known to be toxic in humans and can cause abdominal pain, vomiting, diarrhoea, inability to pass urine, and acute kidney injury that may result in death especially in children.

Written by Anonna Dutt

New Delhi | October 4, 2023 11:18 PM IST

3 min read

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At least five batches of syrups, for cough and allergic rhinitis, from two Indian manufacturers have been found to contain higher than permissible levels of contaminants – diethylene glycol and ethylene glycol, as per the report release by Central Drugs Standard Control Organisation (CDSCO), country’s apex drug controller. Earlier, the World Health Organisation had raised alerts when several syrups exported by India were found to be allegedly contaminated with these two chemicals. The two contaminants are known to be toxic in humans and can cause abdominal pain, vomiting, diarrhoea, inability to pass urine, and acute kidney injury that may result in death especially in children.

Two syrups of a Gujarat based company – one for the treatment of cough and another for allergic rhinitis – were found to be contaminated when tested in August. The cough syrup contained 0.118% ethylene glycol while the allergic rhinitis syrup contained 0.171% ethylene glycol and 0.243% diethylene glycol, according to the CDSCO’s monthly inspection report. The acceptable safety limit for both ethylene glycol and diethylene glycol is no more than 0.10%, according to the WHO. Three batches of a paracetamol syrup by a Tamil Nadu based company were also found to have the contaminants. Two of the three were found to contain high levels of both the contaminants and the third contained ethylene glycol alone. The two batches that contained both contaminants had an alarmingly high content of ethylene glycol – 1.9% and 2.23%, according to the report. The WHO had raised an alert against the same company in August after samples collected from Iraq by a news organisation were found to be contaminated. WHO spokesperson Christian Lindmeier in an email said, “To date, this situation has impacted more than 20 products with two countries of origin (India & Indonesia) and more than 15 different manufacturers.” All products have been syrups – cough syrup, paracetamol syrup, or vitamin syrup. Syrups usually use propylene glycol as a solvent, which is likely to be the source of DEG or EG contamination that has been detected in the drugs. On being asked whether the instances might be linked, the reply stated: “Our investigations with the impacted countries are ongoing. To date we cannot confirm a link.”

Several cases have been reported of India manufactured syrups with DEG/ EG contamination. In two such instances, the contaminated medicines allegedly led to 70 deaths in the Gambia and 18 in Uzbekistan. Action was initiated against the company that exported the drug to Uzbekistan after contamination was detected at its manufacturing site in India. The WHO had previously told The Indian Express that 20 such products by 15 different manufacturers had been flagged, with drugs originating from two countries — India and Indonesia.

Anonna Dutt

Anonna Dutt is a Principal Correspondent who writes primarily on health at the Indian Express. She reports on myriad topics ranging from the growing burden of non-communicable diseases such as diabetes and hypertension to the problems with pervasive infectious conditions. She reported on the government’s management of the Covid-19 pandemic and closely followed the vaccination programme. Her stories have resulted in the city government investing in high-end tests for the poor and acknowledging errors in their official reports. Dutt also takes a keen interest in the country’s space programme and has written on key missions like Chandrayaan 2 and 3, Aditya L1, and Gaganyaan. She was among the first batch of eleven media fellows with RBM Partnership to End Malaria. She was also selected to participate in the short-term programme on early childhood reporting at Columbia University’s Dart Centre. Dutt has a Bachelor’s Degree from the Symbiosis Institute of Media and Communication, Pune and a PG Diploma from the Asian College of Journalism, Chennai. She started her reporting career with the Hindustan Times. When not at work, she tries to appease the Duolingo owl with her French skills and sometimes takes to the dance floor. ... Read More

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