NEW DELHI: 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 (Oct 6), 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 per cent of EG, while allergy drug Sylpro Plus Syrup, made in May, had 0.171 per cent of EG and 0.243 per cent 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 per cent. 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.
Source: CNA
