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India needs a PQCA mechanism to fortify drug regulation

Chronicle Pharmabiz

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October 30, 2025

NDIA needs a national Pharma Quality Certification & Audit (PQCA) mechanism under Quality Council of India (QCI) to fortify drug regulation, according to B Thirunavukkarasu, president, Bangalore District Chemists and Druggists Association (BDCDA).

- Nandita Vijayasimha, Bengaluru

Even as India is the Pharmacy of the World and the challenges confronting our system go beyond ethics, trust, and human life, we are witnessing an alarming rise in counterfeit medicines, untraceable PCD drugs, contaminated cough syrups, misleading advertisements, and fake generics, each posing a grave threat to public health and national credibility, he added. Compounding this crisis is the lack of accountability and transparency within certain layers of the regulatory machinery, along with the uncontrolled spread of unregulated online and quick-commerce medicine sales. These developments are eroding faith in our healthcare ecosystem and tarnishing India’s hard-earned reputation as a global leader in affordable and quality medicines.

BDCDA urges Union ministry of health, Karnataka government and QCI to jointly examine the need to set up the QCI-PQ-CA and initiate a national audit of drug testing laboratories across all states.

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