India’s drug regulator has discovered that two syrups produced by Norris Medicines, a cough syrup and an anti-allergy syrup, are toxic, according to a recent government report. This alarming finding comes several months after Indian-made cough syrups were linked to the deaths of 141 children worldwide. The contaminated medicines were found to contain either diethylene glycol (DEG) or ethylene glycol (EG), the same contaminants identified in the cough syrups responsible for the deaths in Gambia, Uzbekistan, and Cameroon last year.
Last month, H.G. Koshia, commissioner of Gujarat state’s Food and Drug Control Administration, conducted an inspection of Norris’s factory and subsequently ordered the suspension of production. Koshia declared that the company “failed miserably on compliance parameters of good manufacturing practices.” He cited the absence of an adequate water system and a subpar air-handling unit as evidence of the company’s negligence. In the interest of public health, the unit was ordered to cease production. Norris Medicines has not responded to an email seeking comment, and their office numbers were unreachable when contacted by Reuters.
In addition, the Central Drugs Standard Control Organisation (CDSCO), India’s federal drug regulator, discovered that three batches of COLD OUT syrup produced by Fourrts (India) Laboratories were also contaminated with DEG and EG. This information was included in the CDSCO’s list of drugs categorized as “not of standard quality/spurious/adulterated/misbranded” for the month of August, which was uploaded on their website. The World Health Organization had previously reported in August that a batch of COLD OUT sold in Iraq contained unacceptable levels of DEG and EG. Fourrts Chairman S.V. Veeramani has not responded to requests for comments.
Veeramani, who also serves as the chairman of the government-supported Pharmaceuticals Export Promotion Council of India, had previously assured Reuters in August that “no contamination or toxins” were present in recent “analysis of retention samples” of COLD OUT. He stated that no adverse effects or deaths had been reported due to the product. However, as a precautionary measure, the product was voluntarily recalled from the Iraqi market. The situation remains under scrutiny.
Reporting by Krishna N. Das; Editing by Andrew Heavens and Nick Macfie
Credit: The Star : News Feed
