How authentication of drugs has become a fundamental pillar of patient safety

The proliferation of falsified drugs and counterfeit medicines globally has become a pressing concern, significantly impacting patient safety. Incidences of these fraudulent products have posed grave threats to individuals relying on medications for their well-being. Counterfeit drugs, intentionally mislabeled or misrepresented, often contain substandard or harmful ingredients, incorrect dosages, or no active ingredients at all. This widespread issue has led to treatment failures, adverse reactions, and even loss of life among patients. The urgent need to address this challenge and safeguard patient safety has prompted governments, regulatory bodies, and pharma companies worldwide to take decisive action in combating the production and distribution of falsified drugs.

The issue of counterfeit drugs in India has become a major concern, primarily due to the rapid growth of the pharma market. The Indian government has acknowledged the seriousness of this problem and has taken proactive measures to strengthen the authentication and traceability of drugs. As part of these efforts, the government has implemented regulations mandating API (active pharmaceutical ingredient) manufacturers and pharma brands to incorporate barcoding on product packaging. This regulatory step is aimed at preventing falsified medicines from entering the market. The introduction of track and trace systems, facilitated by unique identification codes on drug packaging, has played a vital role in multiple ways.

Traceability safeguards a patient’s well-being in the following ways:

Counterfeit medicines and patient safety: Counterfeit medicines pose a significant threat to patient safety globally. These falsified drugs are intentionally mislabeled, often containing substandard or harmful ingredients. By implementing traceability systems, pharma companies can track and authenticate the entire journey of a drug, from manufacturing to distribution. This ensures patients receive genuine medications, reducing the risk of ineffective or harmful treatments and protecting their well-being.

Quality control and regulatory compliance: Traceability is crucial for maintaining quality control and ensuring compliance with stringent regulations in the medicine space. By accurately documenting the movement of drugs, manufacturers can identify any quality issues that may arise during production, storage, or transportation. Early detection of such issues allows for prompt corrective actions, minimising the chances of compromised drug quality. Moreover, traceability aids in complying with regulatory requirements and standards, preventing legal issues and penalties that could arise from non-compliance.

Pharmacovigilance and adverse event reporting: Traceability systems enable effective pharmacovigilance, which involves mo