New Delhi: The government has waived off the requirement of mandatory testing of cough syrups in case manufacturers are exporting it to USA, UK, Canada, EU, Japan, Australia, Singapore, Republic of Korea and Switzerland in view of approval been granted by the regulatory authority of these countries for plants engaged in manufacturing and export of cough syrups, the new notification said.
Last year the government had made testing of cough syrups mandatory before export due to the alleged link of India-made cough syrups to the deaths of children in Gambia and Uzbekistan. According to the recent amendment in the export policy by the Directorate General of Foreign Trade (DGFT) if the cough syrups are manufactured in the plant or section approved by the regulatory agencies of these developed countries for any product, such cough syrup shall also be permitted to be exported to any country without testing as mandated earlier, the revised requirement suggested.
“The mandatory testing of the export sample of cough syrup under HSN 3004 is exempted in certain situations as mentioned above in accordance with the required GMP benchmarks/standards,” it said. ET has seen a copy of the notification.
Last year in May the DGFT had also notified that the exporters will have to also produce the certificate of analysis (CoA) from the government laboratory to be able to export cough syrups effective June 1.
“The export of cough syrup under ITC (HS) Codes falling under the heading 3004 shall be permitted subject to the export sample being tested and production of CoA issued by any of the laboratories with effect from June 1, 2023,” the earlier notification had said.
The intervention by the DGFT followed past incidents where India-made cough syrups imported into Gambia were allegedly found to be contaminated with diethylene glycol (DEG) and ethylene glycol (EG) resulting in Acute Kidney Injury (AKI) cluster among children.
An investigation led by the United States Center for Disease Control and Prevention and Gambian scientists in March “strongly suggested” that medications contaminated with DEG or EG imported into the Gambia led to this AKI cluster among children.
“A large cluster of acute kidney injury cases affecting children in The Gambia in 2022 was associated with case fatality rates of more than 80%,” it said.
The WHO had announced that the deaths of dozens of children in Gambia from acute kidney injuries might be linked to contaminated cough and cold syrups made by an Indian drug manufacturer-Maiden pharmaceuticals.
The ‘Morbidity and Mortality weekly report’ published by the CDC, reached its conclusions by reviewing the medical records of 52 (67%) of the 78 identified patients with suspected AKI.
