“In the first phase, the mandate for manufacturers of the top 300 brands was to have a QR Code. In the next phase, the DCGI is looking at expanding this list to a larger number of products,” said Dr. Raghuvanshi, DCGI, at the 6th CII Pharma & Life Sciences Summit on October 9, 2024.

This directive, rooted in a notification released by the Central Drugs Standard Control Organisation (CDSCO) in November 2022, is a bold step toward strengthening drug traceability and combating counterfeit medicines. But what does this mean for the pharmaceutical industry, and how does it impact consumers?

A. Decoding the Context of CDSCO’s Mandate

As per the notification released by CDSCO (Central Drugs Standard Control Organisation), Ministry of Health and Family Welfare, Government of India dated Nov 17, 2022, the manufacturers of drug formulation products specified in the notification shall print or affix Barcode or Quick Response Code (QR Code) which shall include the following particulars, namely: 

• Unique product identification code
• Proper and generic name of the drug
• Brand name
• Name and address of the manufacturer
• Batch number
• Date of manufacturing
• Date of expiry
• Manufacturing license number

This rule came into effect on August 1, 2023, and aims to safeguard public health by ensuring the authenticity of pharmaceuticals.

As of now, 300 brands fall under this mandate, but CDSCO is preparing to expand the list significantly. This regulation applies to both indigenous and foreign manufacturers marketing these brands in India.

B. Why Has CDSCO Mandated Barcodes or QR Codes on Medicines?

India’s vast drug supply chain faces increasing challenges from counterfeit drugs, which jeopardize patient safety by causing treatment failures or adverse effects. Barcodes or QR Codes offer a robust solution by:

• Enabling traceability and verification
• Providing quick access to product details
• Strengthening consumer trust in drug authenticity

Additionally, vaccines are also part of this initiative, with Barcodes or QR Codes mandated for widely used formulations such as

• Pfizer’s Prevnar 13 injection 0.5 ml
• Panacea Biotec’s Easy Six Prefilled Syringe 0.5 ml
• GlaxoSmithkline Pharma’s Varilrix injection 0.5 ml
• Synflorix injection 1
• Infanrix Hexa injection 0.5 ml
• Sanofi India’s Menactra injection 0.5 ml
• Hexaxim injection 0.5 ml

C. Possible Penalties for Non-Compliance

While specific penalties are not officially outlined, the CDSCO has demonstrated its commitment to quality by recalling products from 50 manufacturers for non-compliance with norms. With CDSCO banned drugs being a growing concern, non-adherence to this mandate may result in strict enforcement actions.

D. Barcodes vs. QR Codes: Why QR Codes Lead the Way

When it comes to drug traceability and compliance with CDSCO’s stringent requirements, QR Codes outshine traditional barcodes. Here’s why they’re the preferred choice for the pharmaceutical industry:

1. Higher Data Capacity

QR Codes can store a wealth of information, including URLs, drug specifics, batch numbers, manufacturing dates, expiration dates, and licensing details. This capability aligns perfectly with CDSCO’s mandates, ensuring all critical drug information is easily accessible in one scan.

2. Compact and Space-Efficient

QR Codes pack extensive data into a small area, making them suitable for limited label space, including primary and secondary packaging. This is especially critical for pharmaceutical products where space constraints are common.

3. Flexible Scanning

Unlike barcodes that require precise alignment for scanning, QR Codes are omnidirectional. They can be scanned from any angle, making the process faster and more reliable—a significant advantage in fast-paced medical environments.

4. Future-Ready Design

As CDSCO expands its regulatory scope, QR Codes are primed to adapt. They can accommodate additional fields, encrypted data, or new compliance requirements, ensuring long-term usability.

E. QR Codes: A Game-Changer for CDSCO Compliance

For manufacturers, adhering to the evolving CDSCO standards can seem daunting, but tools such as QR Mark simplify the journey. Here’s how:

1. Verifiable QR Code Creation

QR Mark enables manufacturers to generate verifiable QR Codes that are not only secure but also fully compliant with CDSCO’s detailed requirements. From product identifiers to expiration dates, every detail is accounted for.

2. Custom Domain for Trust and Consistency

QR Mark allows manufacturers to link QR Codes to their custom domains, creating a seamless, branded experience for consumers. When scanned, the QR Code redirects users to the brand page displaying verified product details, fostering trust and authenticity.

3. Advanced Anti-Counterfeiting Measures

Counterfeit drugs are a significant public health threat. QR Mark addresses this by providing secure QR Codes that enable instant verification of a drug’s authenticity. Scans reveal essential data, such as batch and licensing information, reducing counterfeiting risks.

4. Seamless System Integration

Adopting QR Codes doesn’t have to disrupt existing workflows. QR Mark integrates seamlessly with production processes, supporting high-volume operations without delays.

F. Paving the Way for Safer Medicines

The CDSCO’s initiative to include QR Codes on medicines is a critical step in combating counterfeit drugs and improving public health safeguards. With tools like QR Mark, pharmaceutical companies can effortlessly comply with these regulations while enhancing consumer trust.

In an era where authenticity and safety are paramount, QR Codes transcend their role as simple labels. They become a symbol of reliability and security. With QR Mark, your company can turn compliance into a competitive edge—ensuring every scan tells a story of trust and transparency.

For a seamless QR Code compliance solution, contact us at [email protected] to enable secure verifications and take the first step towards safer medicines today!