The Central Drugs Standard Control Organization (CDSCO) has issued comprehensive guidance for the identification and verification of spurious drugs in India. This guidance, based on the Drugs and Cosmetics Act, 1940, provides a clear legal framework for identifying counterfeit and spurious drugs, while mandating QR code and Bar code implementation for tracking and authentication.
Spurious drugs pose a significant threat to public health, causing treatment failures, adverse reactions, and in severe cases, fatalities. The CDSCO's guidance document outlines the legal definition of spurious drugs and establishes mandatory tracking mechanisms through QR codes and Bar codes for Active Pharmaceutical Ingredients (APIs) and Top 300 drug formulations.
Reference: Official CDSCO Guidance Document
Legal Definition of Spurious Drugs
According to the Drugs and Cosmetics Act, 1940, a drug shall be deemed to be spurious if it meets any of the following criteria:
Name Misappropriation
A drug manufactured under a name that belongs to another drug, or an imitation/substitute that resembles another drug in a manner likely to deceive, unless it is plainly and conspicuously marked to reveal its true character.
Fictitious Manufacturer
A drug whose label or container bears the name of an individual or company purporting to be the manufacturer, but such individual or company is fictitious or does not exist.
Substitution
A drug that has been substituted wholly or in part by another drug or substance, compromising its intended composition and therapeutic effect.
False Origin
A drug that purports to be the product of a manufacturer of whom it is not truly a product, misrepresenting its origin and authenticity.
These legal definitions provide a comprehensive framework for identifying spurious drugs and enable regulatory authorities to take appropriate action against manufacturers and distributors of counterfeit products.
QR Code Mandate for Active Pharmaceutical Ingredients (APIs)
On January 18, 2022, the Drugs Rules, 1945 were amended vide G.S.R. 20 (E), mandating QR code implementation for all Active Pharmaceutical Ingredients (bulk drugs) manufactured or imported in India.
Effective Date
January 1, 2023
Scope
All APIs manufactured or imported in India
Packaging Level
Each level of packaging
Requirements
- QR Code Placement: Every API must bear a Quick Response Code on its label at each level of packaging.
- Data Storage: The QR code must store data or information readable with software applications to facilitate tracking and tracing.
- Minimum Particulars: The stored data must include:
- Unique product identification code
- Batch Number
- Manufacturing Date (MFG Date)
- Expiry Date (Exp. Date)
- Other relevant tracking information
This mandate ensures complete traceability of APIs from manufacturing to distribution, enabling authorities to track the movement of bulk drugs and identify any spurious or counterfeit products in the supply chain.
QR Code/Bar Code Mandate for Top 300 Drug Formulations
On November 17, 2022, the Drugs Rules, 1945 were further amended vide G.S.R. 823(E), mandating QR code or Bar code implementation for the Top 300 brands of drug formulation products specified in Schedule H2.
Effective Date
August 1, 2023
Scope
Top 300 drug formulation brands (Schedule H2)
Code Type
Bar Code or Quick Response Code
Requirements
Primary Packaging
Manufacturers must print or affix Bar Code or Quick Response Code on the primary packaging label of drug formulations.
Secondary Packaging
In cases where there is inadequate space on the primary package label, the code may be placed on the secondary package label.
Authentication Data
The code must store data or information legible with software applications to facilitate authentication of the drug product.
Schedule H2 Compliance
The list of Top 300 brands is specified in Schedule H2 of the Drugs Rules, 1945, as detailed in G.S.R. 823(E).
This mandate focuses on high-volume, high-risk drug formulations that are most susceptible to counterfeiting, ensuring that consumers can verify the authenticity of these critical medications.
Process Flow for Drug Authentication
The CDSCO guidance document outlines a clear process flow for verifying the authenticity of drugs by reading Bar Codes or Quick Response Codes. This process enables stakeholders across the supply chain to verify drug authenticity.
Step 1: Code Scanning
Use a smartphone or dedicated scanner to scan the QR code or Bar code printed on the drug packaging label (primary or secondary, as applicable).
Step 2: Data Extraction
The software application reads the stored data from the code, extracting information such as unique product identification code, batch number, manufacturing date, and expiry date.
Step 3: Database Verification
The extracted data is verified against manufacturer databases or regulatory databases to confirm product authenticity, registration status, and batch validity.
Step 4: Authentication Result
The verification system provides an authentication result, indicating whether the drug is genuine, spurious, or requires further investigation.
This process flow enables multiple stakeholders—including consumers, pharmacists, healthcare providers, and regulatory authorities—to verify drug authenticity at any point in the supply chain.
Impact on Pharmaceutical Industry
The CDSCO's guidance and mandatory QR code/Bar code requirements have significant implications for pharmaceutical manufacturers, distributors, and consumers:
For Manufacturers
- Compliance Obligations: Manufacturers must implement QR code/Bar code systems for APIs and Top 300 formulations, ensuring all required data fields are included.
- Supply Chain Visibility: QR codes enable manufacturers to track products throughout the supply chain, identifying potential diversion or counterfeiting.
- Brand Protection: Authentic products can be distinguished from spurious ones, protecting brand reputation and market share.
- Regulatory Compliance: Compliance with G.S.R. 20(E) and G.S.R. 823(E) is mandatory, with penalties for non-compliance.
- Consumer Trust: Transparent authentication mechanisms build consumer confidence in product quality and safety.
For Consumers and Healthcare Providers
Patient Safety
Ability to verify drug authenticity before consumption, reducing risk of adverse effects from spurious drugs
Treatment Efficacy
Ensures patients receive genuine medications with correct active ingredients and dosages
Informed Decisions
Access to product information including batch details, expiry dates, and manufacturer information
For Regulatory Authorities
- Market Surveillance: Enhanced ability to monitor drug distribution and identify spurious products in the market.
- Rapid Response: Quick identification and recall of spurious or counterfeit drugs through traceability systems.
- Data Collection: Access to supply chain data for policy formulation and regulatory decision-making.
- Enforcement: Clear legal framework for taking action against manufacturers and distributors of spurious drugs.
Implementation Challenges and Solutions
While the QR code/Bar code mandates are crucial for drug safety, manufacturers may face several implementation challenges:
Labeling Infrastructure
Challenge: Integrating QR code/Bar code printing with existing labeling systems and production lines.
Solution: Use integrated platforms that support multiple printer types and can be seamlessly integrated with existing production infrastructure.
Data Management
Challenge: Managing unique product identification codes, batch data, and ensuring data accuracy across multiple packaging levels.
Solution: Implement cloud-based systems that automate data generation, validation, and storage with real-time synchronization.
Regulatory Compliance
Challenge: Ensuring QR codes contain all required data fields as per CDSCO guidelines and maintaining compliance across different product categories.
Solution: Use compliance-ready platforms that pre-configure all required data fields according to G.S.R. 20(E) and G.S.R. 823(E) requirements.
Timeline Pressure
Challenge: Implementing QR code systems within compliance deadlines (January 1, 2023 for APIs and August 1, 2023 for Top 300 formulations).
Solution: Rapid deployment platforms that can be implemented in weeks rather than months, with minimal disruption to production.
How Technology Solutions Enable Compliance
Modern QR code and Bar code generation platforms can help pharmaceutical manufacturers comply with CDSCO requirements efficiently:
- Automated Code Generation: Generate QR codes/Bar codes automatically with all required data fields including unique product identification code, batch number, manufacturing date, and expiry date.
- Multi-Level Packaging Support: Generate codes for each level of packaging (primary, secondary, tertiary) as required for APIs, ensuring complete traceability.
- Printer Integration: Seamless integration with existing labeling printers (Zebra, Domino, Markem-Imaj) without requiring hardware replacement.
- Verification Systems: Enable consumers, pharmacists, and healthcare providers to scan codes and verify product authenticity through mobile applications or web portals.
- Supply Chain Tracking: Track products from manufacturing to distribution, providing complete visibility and audit trails for regulatory compliance.
- Database Integration: Integrate with manufacturer databases and regulatory databases to enable real-time authentication and verification.
- Compliance Reporting: Generate automated compliance reports for regulatory audits and internal monitoring.
- Scalability: Handle high-volume production with cloud-based infrastructure that scales with business needs.
Conclusion
The CDSCO's guidance for identification and verification of spurious drugs, along with mandatory QR code/Bar code requirements, represents a significant step forward in ensuring drug safety and combating counterfeiting in India. The legal framework clearly defines spurious drugs, while the tracking mandates ensure traceability and authentication capabilities.
For pharmaceutical manufacturers, compliance with G.S.R. 20(E) and G.S.R. 823(E) is not just a regulatory requirement—it's an opportunity to protect brand reputation, ensure patient safety, and build consumer trust. The implementation of QR codes and Bar codes enables manufacturers to distinguish their authentic products from spurious ones, while providing consumers with tools to verify product authenticity.
As the pharmaceutical industry continues to evolve, manufacturers who adopt QR code/Bar code solutions early will be better positioned to navigate regulatory requirements, protect their brands, and contribute to a safer pharmaceutical ecosystem. The CDSCO's guidance provides a clear roadmap for implementation, and technology solutions make compliance achievable and efficient.
The fight against spurious drugs requires collaboration between regulatory authorities, manufacturers, distributors, and consumers. The CDSCO's guidance and mandatory tracking requirements provide the foundation for this collaborative effort, ensuring that only genuine, safe, and effective drugs reach patients.
Reference Document: For complete details, please refer to the official CDSCO guidance document.
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