India finds two more toxic syrups months after poisoning deaths
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[October 05, 2023]
By Krishna N. Das and Sumit Khanna
NEW DELHI (Reuters) -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 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.
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 drug industry dominated by small players.
H.G. 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."
Norris Managing Director Vimal Shah declined to comment outside business
hours.
![](http://archives.lincolndailynews.com/2023/Oct/05/images/ads/current/werth_sda_FHG_2023.png)
The company's Trimax Expectorant contained 0.118% of EG, while allergy
drug Sylpro Plus Syrup had 0.171% of EG and 0.243% of DEG, according to
tests at a CDSCO laboratory, according to its list of "not of standard
quality/spurious/adulterated/misbranded" drugs for August uploaded on
its website. Koshia said Norris used to export the cough syrup, but did
not say where.
The World Health Organization (WHO) says the safe limit, based on
internationally accepted standards, is no more than 0.10%.
"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."
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![](../images/100523PIX/health25.jpg)
Poli Devi, whose 11-month-old daughter Janvi was among the children
who died due to kidney injury after consuming contaminated cough
syrup, holds a photo of her at their house in Ramnagar on the
outskirts of Jammu, India, March 28, 2023. REUTERS/Anushree Fadnavis/File
Photo
![](http://archives.lincolndailynews.com/2023/Oct/05/images/ads/current/peasleymemorials_lda_2022.png) 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 World Health
Organisation 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.
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."
The alerts on the toxic medicines come at a time when the
government, through pharmexcil, is organizing 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% 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.
(Reporting by Krishna N. Das; additional reporting by Jennifer
Rigby; Editing by Andrew Heavens, Nick Macfie, William Maclean)
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