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.
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Gambia will make it mandatory for all pharmaceutical products from India to be inspected and tested prior to shipment from July 1, according to Gambian government documents reviewed by Reuters, the first known restrictions on national exports following the deaths of dozens of children linked to Indian-made cough syrups.
Gambia has hired a U.S. law firm to explore legal action after a government-backed investigation found that contaminated medicines from India were “very likely” to have caused the deaths of children last year, the justice minister told Reuters.
Any cough syrup must have a certificate of analysis issued by a government laboratory before it is exported, effective June 1, the government said in a notice dated May 22 and shared by the health ministry.
Contaminated cough syrup made by an Indian company has been found in the Marshall Islands and Micronesia, the World Health Organization (WHO) said on Tuesday, after a spate of child deaths linked to other syrups in some countries last year.
Indian officials are in contact with foreign authorities and have held meetings in Africa to ensure its drug exports do not suffer, the government said on Wednesday, after Indian-made cough syrups were linked to deaths in Gambia and Uzbekistan.
India directed drug manufacturers to stop using propylene glycol sourced from the Delhi-based firm that supplied the ingredient to Marion Biotech, whose cough syrups were linked to deaths of 19 children in Uzbekistan, according to a government document seen by Reuters.
India may issue an alert on cough syrup exported by Marion Biotech, whose products have been linked to deaths in Uzbekistan, after tests showed many of the company’s drug samples contained toxins, a drug inspector said on Saturday.
Contaminated cough and paracetamol syrups imported into Gambia almost certainly caused the deaths of 66 children due to acute kidney injury, according to an investigation led by the United States Center for Disease Control and Prevention and Gambian scientists.
India will spend $79.6 million on strengthening its drug regulatory system, the health minister said on Friday, after the World Health Organization raised concerns about domestically produced cough syrups being linked to the death of 89 children in two countries.