NEW DELHI (Reuters) – India’s government said on Tuesday it would require pre-export inspections of cough syrups after they were linked to the deaths of dozens of children in The Gambia and Uzbekistan.
The government said in a May 22 notice shared with the Ministry of Health on Tuesday that the cough syrup will require a certificate of analysis issued by a state laboratory before being exported, and will be issued from June 1.
India’s $41 billion pharmaceutical industry is one of the world’s largest, but the World Health Organization (WHO) found toxins in cough syrups made by three Indian companies. Reputation wavered.
Syrup produced by two of these companies was linked to the deaths of 70 children in Gambia and 19 of her children in Uzbekistan last year.
“Cough syrup can be exported if the export sample is tested and a certificate of analysis is presented,” the Department of Commerce said in a statement. The Ministry of Health did not immediately respond to inquiries about whether cough syrups sold in the domestic market required testing.
The notice lists seven federal laboratories to which samples can be sent for testing, along with other state laboratories that have been accredited by national accreditation agencies.
An Indian test of Maiden Pharmaceuticals’ cough syrup linked to child deaths in Gambia found no toxins, while the syrup was linked to deaths in Uzbekistan. Toxins were detected in many.
Reuters reported last week that India was considering changes to its pharmaceutical industry policy, including increased inspections of cough syrups and pharmaceutical raw materials. Both companies deny any wrongdoing. According to a May 15 Prime Minister’s office document, the health minister and federal and state regulators launched a campaign earlier this year in the southern city of Hyderabad to “find a solution to the exported cough syrups that are killing children”. A brainstorming session was held.
