In a recent development, every active pharmaceutical ingredient (API) manufactured or imported in India will have a quick response or QR code on its label to help identify the authenticity of the API and help facilitate tracking.
According to the notification, “Every active pharmaceutical ingredient (bulk drug) manufactured or imported in India shall bear QR code on its label at each level packaging that stores data or information readable with software applications to facilitate tracking and tracing. The stored data or information shall include the unique product identification code, the name of the API, brand name (if any), name and address of the manufacturer, batch number, batch size, date of manufacture, date of expiry or retesting, serial shipping container code, manufacturing licence number or import license number, and special storage conditions required (if any).
There is also a proposal to amend the Drugs and Cosmetics (D&C) Rules, 1945, to implement the newly proposed system.
PharmaSecure is a global brand protection, track-and-trace, and patient engagement company that has helped protect close to 4 billion packages through its technology-enabled solutions for more than a decade. Our proven serialization capabilities have enabled large pharmaceutical companies to meet different traceability requirements. Our Solutions are ready for your brand’s compliance with the API requirement.