This file photograph shows collected cough syrups in Banjul, The Gambia on Oct 6, 2022. The Indian government has made laboratory testing of cough syrups mandatory prior to their export, officials said May 23, 2023. (PHOTO / AFP)
NEW DELHI – The Indian government has made laboratory testing of cough syrups mandatory prior to their export, officials said Tuesday.
According to a notification issued by the Directorate General of Foreign Trade (DGFT) on Monday evening, an amendment in the export policy of cough syrup has been made.
The US Food and Drug Administration has said India-made eye drops were linked to at least three deaths and a deadly outbreak of drug-resistant infections in the United States
The revised policy which will come into effect from June 1 states that companies will have to get a certificate of analysis from a government-approved laboratory.
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"Cough syrup shall be permitted to be exported subject to the export sample being tested and production of a certificate of analysis," read the notification.
The amendment has come after some India-made cough syrups were linked to deaths in The Gambia and Uzbekistan.
Since then many Indian pharma companies have come under the scanner for the quality of their drugs.
Last month the World Health Organization (WHO) issued an alert for made-in-India cough syrup – Guaifenesin Syrup TG Syrup – noting it contains "unacceptable amounts of diethylene glycol and ethylene glycol".
The batch of the contaminated India-made cough syrup was found in the Marshall Islands and Micronesia.
Last October, the WHO sounded a global alert and linked four cough syrups made by Maiden Pharmaceuticals Limited based in India to the deaths of 66 children from kidney injuries in The Gambia.
In March this year, authorities in the northern Indian state of Uttar Pradesh cancelled the manufacturing license of the pharmaceutical firm, Marion Biotech, whose cough syrup Doc-1 Max was alleged to have caused the death of 19 children in Uzbekistan.
In another development, the US Food and Drug Administration has said India-made eye drops were linked to at least three deaths and a deadly outbreak of drug-resistant infections in the United States.