In an attempt to ensure authenticity, every active pharmaceutical ingredient (API) manufactured or imported in the country will soon bear a quick response or QR code on its label to facilitate tracking.
The Central Drugs Standard Control Organisation (CDSCO) has issued a draft notification mandating this and has directed stakeholders to send their recommendations within 30 days.
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 licence number and special storage conditions required (if any), the notification states.
India’s drug regulatory authority also proposes to amend the Drugs and Cosmetics (D&C) Rules, 1945, to implement the newly proposed system.
According to the proposal, the ministry of commerce, through the Centre for Development of Advanced Computing (C-DAC), will implement the online system for tracking and authentication of pharmaceutical export packages from April 1, 2020.
According to two people aware of the matter, the proposal envisages the creation of virtual tertiary and secondary packages and generation of unique identification for manufacturers, merchant exporters (Labeler Code), products (Product Code), and Packages (Package Code- Primary, Secondary, Tertiary Packs).