Pharma export
Amid quality concerns, Centre plans to test drugs in govt labs before exporting
New Delhi: The government is actively reviewing a plan to conduct drug testing at government laboratories prior to their shipment to other countries after global concerns about the quality of cough syrups exported by Indian companies, media reports said.
The Central Drugs Standard Control Organisation (CDSCO), the regulatory authority for drugs, has recommended that the drugs (finished products) undergo testing at government labs before they are exported, a report in the media said.
As per the proposal, exporters will be required to present certificates of analysis for each batch issued by authorized laboratories.
Only after obtaining clearance from the Directorate General of Foreign Trade (DGFT) will the consignment be approved for export.
The proposal suggests that the sample analysis of the export consignment will be conducted at various government laboratories, including the Indian Pharmacopoeia Commission and Central Drugs Standard Control Organization (CDSCO) labs such as RDTL (Chandigarh), CDL (Kolkata), CDTI (Chennai), CDTI (Hyderabad), CDTL (Mumbai), RDTI (Guwahati), as well as drug testing labs accredited by the National Accreditation Board for Testing and Calibration Laboratories (NABL) under state governments.
Concerns have been raised regarding the quality of cough syrups exported by Indian firms, as indicated by references and media reports.
Several incidents were reported where cough syrups manufactured by Indian companies and exported have failed quality control tests in other countries.
Further, the World Health Organization (WHO), Ministry of External Affairs (MEA), Department of Commerce (DoC), and other relevant organizations and departments have communicated regarding these reports and their findings.
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