Why more medicines will now have QR codes on their packets, Pg22

Key Highlights:

• The Union Health Ministry has mandated QR codes or barcodes on vaccines, antimicrobials, narcotics, and anti-cancer drugs to enable a track-and-trace mechanism.
• This initiative expands the scope of Schedule H2 of the Drugs Rules, 1945, which previously covered 300 top drug brands and Active Pharmaceutical Ingredients (APIs).
• The new provisions will be implemented by July 2027 for vaccines, narcotics, and anti-cancer drugs, and by July 2028 for antimicrobials.
• The primary goal is to combat counterfeiting and the distribution of spurious medicines, ensuring product authenticity from manufacturing to retail.
• This measure also aims to improve the maturity level of the Indian drug regulator, aligning with the World Health Organization (WHO) Global Benchmarking Tool (GBT) standards.

Detailed Insights:

• Each QR code will contain crucial information such as a unique identification number, brand and generic names, manufacturer details, batch number, manufacturing and expiry dates, and manufacturing license number.
• The system requires manufacturers, wholesalers, distributors, and retailers to log product data onto specialized platforms, making it difficult to re-register used codes.
• The enhanced traceability will facilitate authentication at various stages of the supply chain and improve the ability to track and recall products if necessary.
• The move is a shift from revenue-based to risk-based regulation, targeting critical therapies vulnerable to counterfeiting.
• Implementing this system presents challenges, including the cost for companies to generate unique codes and maintain tracking platforms, especially for smaller manufacturers.
• Achieving a higher Maturity Level under the WHO GBT signifies greater trustworthiness of Indian medicines in international markets, boosting pharmaceutical trade.

Key Concepts Involved:

• Drugs Rules, 1945: A subordinate legislation framework under India's drug regulatory system, amended to include new provisions.
• Schedule H2: A classification under the Drugs Rules, 1945, mandating barcodes or QR codes on specific drug products for authentication and traceability.
• Track-and-trace mechanism: A system that allows monitoring the entire journey of a product from its origin to the end-user.
• Counterfeiting: The illegal practice of producing or selling fake goods, in this context, medicines with no active ingredients or diluted drugs.
• Spurious medicines: Drugs that are falsely represented as genuine, often containing incorrect ingredients, insufficient active ingredients, or no active ingredients.
• World Health Organization (WHO) Global Benchmarking Tool (GBT): A global standard for objectively assessing and strengthening national regulatory authorities for medical products.
• Maturity Level: A scale (1 to 4) used by the WHO GBT to assess the overall maturity and performance of a regulatory system.
• Central Drugs Standard Control Organisation (CDSCO): India's national regulatory body for cosmetics, pharmaceuticals, and medical devices, operating under the Drugs and Cosmetics Act, 1940.
• Drugs and Cosmetics Act, 1940: The primary legislation governing the manufacture, sale, and distribution of drugs and cosmetics in India.