India’s Norris Medicines has recalled a cough syrup and an allergy syrup that the country’s federal drugs regulator had found to be toxic, its managing director said on Friday, adding that the products had only been sold in India.
Tests by India’s Central Drugs Standard Control Organisation (CDSCO) showed the medicines were contaminated either with diethylene glycol (DEG) or ethylene glycol (EG).
The same toxins found in other Indian-made cough syrups have been linked by the World Health Organization (WHO) and other health agencies to the deaths of more than 140 children in Gambia, Uzbekistan and Cameroon since the middle of last year.
Regulators have not suggested any harm has been caused by the products which Norris is recalling.
“All stocks have been recalled and data has been submitted to the CDSCO,” Norris Managing Director Vimal Shah told Reuters.
“We have never exported these products. We are investigating the issue at our end with toxicology studies. We have investigated (and) no harm has been reported,” Shah added.
The company’s Trimax Expectorant, made in January, contained 0.118% of EG, while allergy drug Sylpro Plus Syrup, made in May, had 0.171% of EG and 0.243% of DEG, according to CDSCO laboratory tests, Reuters reported last week, citing a monthly report from the regulator for August.
The WHO says the safe limit is no more than 0.10%. The WHO, which has issued several alerts about Indian medicines since last year, told Reuters the CDSCO had informed it about the Norris products.
Shah declined to say how many bottles of the two syrups Norris made in total and how many had been recalled.
“We have been manufacturing these syrups for the last 10 years without any complaint,” he said. “Of late, diethylene glycol and ethylene glycol have been brought to the list of watch by the CDSCO due to the incidents abroad.”
The drug regulator of Gujarat state, where Norris is based and has two factories near to each other, has shut all its production, citing violations of good manufacturing practices after an inspection last month, Reuters reported last week citing H.G. Koshia, commissioner of Gujarat state’s Food and Drug Control Administration. Koshia did not cite any evidence.
Shah did not respond to a request for comment on Koshia’s allegation. The cough syrup was made in one factory and the other product in another, according to the CDSCO.
The CDSCO list also named a glycerine batch it said was made by Adani Wilmar in October 2021, despite it containing 0.025% EG, which is within the WHO safety limit.
An Adani Wilmar spokesperson told Reuters in an email it believed “that the product in question (that tested by the CDSCO) is counterfeit and communicated the same to the department with a request to drop the recall notice”.
The CDSCO did not immediately respond to a request for comment on Adani Wilmar’s suspicion that the product tested was a fake and was not manufactured by the company itself.
(Reporting by Krishna N. Das; Editing by Alexander Smith)
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