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Indian pharma underscores the need to stand united, to innovate, and to reinforce public trust in medicine safety. There is a need to enhance transparency and responsiveness in safety reporting to drive ahead in the global market, said Chakravarthi AVPS, sr vice president (national), chairman - AP & Telangana, Federation of Pharma Entrepreneurs (FOPE).
Drug safety is far more than just a compliance issue but a global health mission. With counterfeit medicines on the rise and supply chains becoming increasingly complex, our responsibility begins with making sure every medicine is genuine, traceable, and tamper-proof. With serialization and digital verification, we can collectively protect lives, he added.
Global drug safety is a priority. Counterfeit medicines are a silent pandemic, especially in low-and middle-income countries. WHO estimates that around 10 per cent of medicines in these regions are fake or sub-standard. This means a lot for patient safety and healthcare credibility as lives are at a risk. We need an urgent action: stronger regulations, awareness campaigns, and robust authentication technologies, said Chakravarthi at PHARMAP 2025, Europe’s premier pharmaceutical congress held in Berlin recently.
Regulatory gaps are seen to lead towards market exploitation. Counterfeiters thrive in the shadows of weak regulation. Both developed and emerging markets are vulnerable when regulatory frameworks are not aligned or enforced. These gaps allow fake drugs to enter legitimate supply chains, endangering lives and causing economic damage. It is clear that strengthening global regulatory coordination is no longer optional; it’s essential, Chakravarthi noted.
The 1982 tragic Tylenol case in Chicago, where cyanide-laced capsules led to the loss of seven lives, became a wake-up call. It exposed major flaws in product safety and shook public confidence. While the case remains unsolved, its legacy is undeniable. It led to tamper-evident packaging and global safety standards. This moment reshaped our industry, proving that crisis can also drive reform. It is a powerful reminder of why we must never let our guard down, he said.
Reflecting on historic tragedies like the 1982 Chicago Tylenol case and today’s fragmented global supply chains, Chakravarthi underlined the urgent need for traceability, regulatory harmonization, and packaging innovation. “Every medicine must be genuine, traceable, and safe,” he emphasized, spotlighting the role of advanced technologies like RFID, blockchain, and serialization.
Chakravarthi outlined two critical pathways. One is enabling digital traceability in developing nations through scalable tech and public-private partnerships. Second is accelerating Global Harmonization by aligning around GS1, ICH standards, and fostering mutual recognition agreements without undermining national priorities.
Technology is our strongest ally in this fight. Advanced packaging tools like RFID, blockchain, and serialization are transforming how we secure our medicines. Globally, we are seeing promising moves. In Africa, mobile-based drug verification is making an impact. Europe’s Falsified Medicines Directive and the US Drug Supply Chain Security Act are excellent examples of how regulatory muscle can make a difference. These initiatives demonstrate how coordinated, technology-driven policies can enhance security and transparency across borders, he said.
But there is the challenge with regulatory fragmentation. We need effective collaboration between governments, pharma companies, and regulators. Harmonizing standards and aligning efforts can drastically improve safety. By working together, we can outpace counterfeiters and ensure authentic, safe medications reach every corner of the globe. The future of safe medicines depends on three pillars: innovation, regulatory harmonization, and international cooperation. With the right strategies in place, we can build a world where patients, no matter where they live, can trust the medicine in their hands, said Chakravarthi.
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