Following nationwide detection of consignments of contaminated cough syrups, the Haryana Food and Drugs Administration (FDA) on Wednesday directed pharmaceutical manufacturers across the state to ensure that warning labels are found affixed on high-risk industrial grade solvents.
The FDA had earlier banned sale, distribution and use of certain brands of cough syrups after diethylene glycol, a toxic chemical known to cause serious health complications, including acute poisoning, kidney failure, neurological disorders, and even death, particularly among children, was detected in the formulations.
State Drugs Controller Lalit Goel, in a December 31 communication to pharmaceutical manufacturers, said that the Enforcement Division of Central Drugs Standard Control Organisation, Directorate General Health Services in the central government had on December 22 issued directives to curb the sale of industrial-grade high-risk solvents and certain excipients without adequate safeguards. The directions also aimed at stopping their potential misuse and curb public health risks besides strengthening regulatory oversight and ensuring safety in the pharmaceutical supply chain.
“All traders, manufacturers, importers and distributors dealing in industrial-grade high-risk solvents must ensure that each container of such solvents bears clear, legible label stating -not for pharmaceutical use. The warning must also be printed prominently on the sale invoice, delivery challan, and any other transaction document issued during the sale of these solvents,” the state drugs controller said.
{{/usCountry}}“All traders, manufacturers, importers and distributors dealing in industrial-grade high-risk solvents must ensure that each container of such solvents bears clear, legible label stating -not for pharmaceutical use. The warning must also be printed prominently on the sale invoice, delivery challan, and any other transaction document issued during the sale of these solvents,” the state drugs controller said.
{{/usCountry}}The communication further said that sale of excipients must be done only in original tamper-proof containers and all high-risk solvents must be sold only in sealed, original tamper-proof containers with complete labelling and batch-traceability information. “Failure to comply may invite regulatory action including suspension/cancellation of licences and prosecution as applicable,” Goel said.