All drugs and pharmaceuticals exported from India will be required to add barcodes to packaging labels to enable tracing and tracking of their products across the supply chain.
The move is in response to quality concerns raised against Indian drugs by some African countries, according to local media reports.
In a public notice the Directorate General of Foreign Trade (DGFT) has issued a change in export regulations, stating that primary packaging should incorporate 2D barcodes on blister strips, vials and bottles, encoding a unique product identification code, batch number, expiry date and serial number.
Secondary packaging will be encoded with the same information using either 2D or 1D barcodes, while tertiary packaging (shipper or carton) must use 1D barcodes to encode the same information.
The track and trace technology used by exporters should conform to the GS-1 standards at all levels of packaging, the DGFT said.
The DGFT said it would give ‘adequate time’ to enable exporters to add this technology to their products. Manufacturers have until 1 July to comply with the new regulation.
The DGFT also requires exporters to include with their shipments a copy of the Certificate of Analysis issued by the manufacturer, or by the approved laboratory of the importing country, or issued by a laboratory approved by the Indian Drugs Controller under the Drugs & Cosmetics Act, 1940.
Furthermore, officials of the Drug Control Department can, when required, retain a sample of the shipment for reference and tracking purposes.
The move is in response to quality concerns raised against Indian drugs by some African countries, according to local media reports.
In a public notice the Directorate General of Foreign Trade (DGFT) has issued a change in export regulations, stating that primary packaging should incorporate 2D barcodes on blister strips, vials and bottles, encoding a unique product identification code, batch number, expiry date and serial number.
Secondary packaging will be encoded with the same information using either 2D or 1D barcodes, while tertiary packaging (shipper or carton) must use 1D barcodes to encode the same information.
The track and trace technology used by exporters should conform to the GS-1 standards at all levels of packaging, the DGFT said.
The DGFT said it would give ‘adequate time’ to enable exporters to add this technology to their products. Manufacturers have until 1 July to comply with the new regulation.
The DGFT also requires exporters to include with their shipments a copy of the Certificate of Analysis issued by the manufacturer, or by the approved laboratory of the importing country, or issued by a laboratory approved by the Indian Drugs Controller under the Drugs & Cosmetics Act, 1940.
Furthermore, officials of the Drug Control Department can, when required, retain a sample of the shipment for reference and tracking purposes.
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