In a recent inspection of pharmaceutical manufacturing units by the Central Drugs Standard Control Organization (CDSCO), Indian drug regulator, approximately 36% of the units faced closure due to non-compliance issues. This statistic underscores the critical need for stringent compliance measures within the pharmaceutical industry.

India, home to around 10,000 pharmaceutical manufacturing units, with the majority being micro-small and medium-scale facilities, is on a trajectory of remarkable growth. Currently valued at $55 billion, the Indian pharmaceutical sector is poised to reach $130 billion by 2030 and a staggering $450 billion by 2047. With exports contributing $27.85 billion, India is reinforcing its position as the ‘Pharmacy of the World.’

Serialization, a key process within the pharmaceutical supply chain, plays a pivotal role in enhancing transparency and safeguarding product authenticity.

What is Serialization in Pharmaceutical Packaging?

Serialization involves assigning a unique identifier to individual units or batches of pharmaceutical products at various packaging levels – primary, secondary, and tertiary.

The implementation of serialization enables the tracking and tracing of products throughout the supply chain, facilitating efficient recall procedures and reducing the risk of counterfeit medicines entering the market. This process involves establishing a parent-child relationship between individual units and their respective packaging levels, ensuring accurate identification and verification.

At Utopia Digitech, part of Holostik group, we specialize in providing advanced track and trace solutions that incorporate serialization and aggregation functionalities. Our solutions, spanning from L1 to L5, empower pharmaceutical companies to comply with regulatory requirements, enhance operational efficiency, and promote consumer safety.

The Three Levels of Packaging

Understanding the different levels of packaging in the pharmaceutical industry is crucial for ensuring product safety and compliance. Here’s a simple breakdown of each level:

Why Serialization Matters?

1. Regulatory Compliance: Meeting global standards and avoiding shutdown risks
2. Counterfeit Prevention: Creating an unbreakable chain of authenticity
3. Supply Chain Visibility: Real-time tracking from manufacturer to patient
4. Quality Assurance: Instant recall capabilities and product history tracking

To ensure effective product traceability, many countries adopt serialization guidelines established by the GS1 organization. By working closely with regulatory bodies, GS1 develops frameworks that utilize serialization to enhance product tracking.

Utopia Digitech: Your One-Stop Solution for GS1 Barcode Labels and Packaging

At Holostik, we understand the complexities of the pharmaceutical industry and offer globally recognized GS1 standards serialization and track & trace solutions to help you meet regulatory requirements and protect your brand reputation.

Our solutions cover the entire supply chain, from primary packaging (individual product units) to secondary packaging (product bundles) and tertiary packaging (shipping cartons).

By leveraging advanced technologies, we ensure seamless integration with your existing systems and provide real-time insights into your supply chain.

To implement serialization, you’ll need to incorporate the following key elements:

1. Global Location Number (GLN): Identifies the country of origin.
2. Global Trade Item Number (GTIN): Specifies the product type.
3. Serial Number (SGTIN): A unique identifier for each individual product within a specific GTIN.
4. Lot Number: Indicates the manufacturer-specific batch from a particular production run.
5. Expiration Date: Specifies the product’s validity period.

By integrating these elements into your product packaging and supply chain processes, you can significantly improve product traceability, enhance quality control, and meet regulatory requirements.

Why Serialization is the Best Line of Defense Against Pharmaceutical Counterfeiting?

Serialization plays a crucial role in combating counterfeiting. It enables robust product traceability, allowing authorities and consumers to verify the authenticity of products throughout the supply chain.

Here’s how serialization works to deter counterfeiting:

1. Unique Identification: Each product is assigned a unique serial number (SGTIN), making it distinct from others of the same type.
2. Data Capture and Verification: As products move through the supply chain, their serial numbers are scanned and recorded at various checkpoints. This data is then transmitted to a centralized database.
3. Real-time Tracking: The database allows real-time tracking of product movements, identifying any deviations from the authorized supply chain.
4. Anomaly Detection: Automated systems can detect anomalies, such as products appearing in unauthorized locations or with discrepancies in their serial numbers.
5. Authentication and Verification: Consumers can use mobile apps or other tools to scan product codes and verify their authenticity against the centralized database.

By implementing serialization, regulatory authorities, manufacturers, and consumers can work together to:

• Disrupt Counterfeit Networks: Identify and dismantle counterfeit operations by tracking the movement of illegitimate products.
• Protect Public Health: Ensure that consumers receive genuine, safe, and effective products.
• Safeguard Brand Reputation: Protect brand integrity and consumer trust.

In essence, serialization provides a powerful tool to combat counterfeiting and safeguard the integrity of supply chains.

Are you ready to transform your pharmaceutical supply chain? Discover how Utopia can be your trusted partner in compliance.

Reach us at 📞 0120-4192700 and ✉ info@utopiadigitech.com or visit 🌐 www.utopiadigitech.com