Counterfeit Medicines: Drug Quality, CDSCO & Supply-Chain Surveillance

Subject: GS 03: Security

Context: The recent counterfeit medicine racket in Bengaluru, Karnataka, highlights risks arising from the circulation of fake or falsified medicines and the need for stronger drug-quality surveillance, supply-chain monitoring and regulatory enforcement.

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About Counterfeit Medicines

• Deliberate Misrepresentation: Counterfeit medicines are products deliberately and fraudulently misrepresented regarding their identity, composition or source.
• Incorrect Composition: They may contain wrong, inadequate, excessive or no active pharmaceutical ingredient, posing risks to patients.
• Falsified Information: Counterfeit products may carry false information regarding their manufacturer, origin, composition or packaging.
• WHO Classification: The World Health Organization (WHO) recognises substandard and falsified medical products as a significant public-health and patient-safety concern.

Counterfeit vs Substandard Medicines

• Counterfeit Medicines: These involve deliberate fraud or misrepresentation regarding the identity, composition or source of a medical product.
• Substandard Medicines: These are authorised medical products that fail to meet prescribed quality standards or specifications.
• Key Distinction: Counterfeiting involves intentional deception, whereas substandard quality may result from manufacturing, storage, transportation or quality-control failures.

Drug Regulatory Framework in India

• Drugs and Cosmetics Act, 1940: It provides the core legal framework for regulating the import, manufacture, distribution and sale of drugs.
• Drugs and Cosmetics Rules, 1945: These prescribe requirements relating to licensing, standards, testing, storage and distribution of drugs.
• New Drugs and Clinical Trials Rules, 2019: These provide an updated regulatory framework for areas including new drugs and clinical trials.
• Shared Regulatory Responsibility: Drug regulation involves both Central and State authorities, with State Drug Control Organisations playing an important role in licensing and enforcement.

Global Actions & Initiatives

• WHO Global Surveillance and Monitoring System: It facilitates international reporting and monitoring of substandard and falsified medical products.
• WHO Member State Mechanism: It promotes international cooperation and information-sharing to address substandard and falsified medical products.
• INTERPOL Operations: The International Criminal Police Organization (INTERPOL) conducts coordinated operations against illicit pharmaceutical trafficking and counterfeit medicines.
• Track-and-Trace Systems: Countries increasingly use serialization and digital verification to improve pharmaceutical supply-chain traceability.

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Why is it a serious concern?

• Treatment Failure: Such medicines can lead to ineffective treatment, adverse reactions and prolonged illness.
• Antimicrobial Resistance: Poor-quality antimicrobial medicines can contribute to the development and spread of antimicrobial resistance (AMR).
• Global Supply Chains: Complex international pharmaceutical supply chains make it difficult to identify the origin and authenticity of medicines.
• Public Trust: Counterfeit medicines can undermine public confidence in the healthcare and pharmaceutical system.
• Economic Burden: Treatment failure may increase expenditure through repeated medication, additional consultations and prolonged illness.

Challenges that need to be Addressed

• Complex Distribution Networks: Multiple intermediaries make it difficult to continuously verify the origin and movement of medicines.
• Online Sales: Digital marketplaces can create additional channels for the distribution of unauthorised or counterfeit medicines.
• Sophisticated Counterfeiting: Advanced packaging and documentation can make counterfeit products increasingly difficult to distinguish from genuine ones.
• Enforcement Gaps: Effective action requires coordination among central and state regulators, manufacturers, distributors and law-enforcement agencies.
• Limited Consumer Awareness: Consumers may lack adequate awareness about authenticity verification and authorised sources.

Way Forward

• End-to-End Traceability: Strengthen digital tracking of medicines from manufacturing to dispensing.
• Risk-Based Surveillance: Prioritise testing of high-risk medicines, vulnerable supply chains and suspicious distribution channels.
• Technology-Based Verification: Expand serialization, QR-based verification and secure digital records.
• Inter-Agency Coordination: Improve coordination among CDSCO, State Drug Control Authorities, customs and law-enforcement agencies.
• Online Monitoring: Develop stronger mechanisms to detect and remove illicit pharmaceutical listings from digital platforms.
• Consumer Awareness: Encourage consumers to purchase medicines through authorised channels and report suspicious products.

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Conclusion

Counterfeit medicines represent a patient-safety and health-governance challenge. Strengthening regulatory coordination, supply-chain traceability, technology-enabled surveillance and enforcement is essential to ensure that medicines reaching patients are safe, effective and of assured quality.

News Source: The Hindu

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