In a stride towards eliminating counterfeit drugs, The Drugs Control General of India (DCGI), the country’s highest drug authority, has decreed the mandatory application of barcodes or QR codes to the packaging of India’s leading 300 medicine brands. This directive will apply to popular medications like Allegra, Shelcal, Calpol, Dolo, and Meftal Spas.
The new rule demands pharmaceutical companies to strictly adhere to this unique product identification system, with non-compliance leading to hefty penalties. These barcodes or QR codes will contain crucial information including the drug’s name, brand name, the manufacturer’s details, batch number,
manufacturing and expiry dates, and the manufacturing license number.
The Central Drugs Standard Control Organization (CDSCO) stated, “Any batch of brands of the drug formulations…manufactured on or after 1 August 2023, irrespective of the location of the manufacturing site, shall have the Barcode or QR code on its label.” While this is a mandatory requirement for the top 300 brands, other manufacturers are free to voluntarily incorporate this labelling system.
The regulation applies to both local and foreign manufacturers of these brands for the Indian market. It also recommends that imported products should ideally bear the barcode or QR code on arrival. However, it permits the affixing of these codes in India post-import, following due permission from the Licensing Authority.
Previously, the absence of such regulation resulted in inconsistencies in the use of QR codes by pharmaceutical brands. The DCGI’s directive aims to standardize this process to maintain medicine quality and boost patient health and safety.
The Indian Drugs Manufacturing Association (IDMA) has also urged its member companies to follow the new guidelines. The implementation of this directive is expected to greatly enhance the traceability and authentication of drugs, effectively curbing the spread of spurious medicines. The health ministry has yet to comment on this development.
