Panel Discussion – Packaging regulations: What’s changing and why it matters

Panellists in this video:
• Mr Praveen Kumar Narlanka, AVP-Packaging Development, Aurobindo Pharma (MODERATOR)
• Mr Tridip Mazumder, AVP, Strategic Sourcing – Packaging Material, Dr.Reddy’s Laboratories
• Mr Shivaji Chakraborty, Head- Packaging Development, Fresenius Kabi Oncology
• Mr Sailesh YHNB, Associate Director, Novo Nordisk
• Dr Srikanth Reddy Sokkula, Head – Regulatory Affairs, Jodas Expoim
• Mr Narendhar Kavide, Head – AGM – Packaging & Device development, Orbicular Pharmaceutical Technologies
• Ms Leena Padala, Sr. Scientist – II (Head), Eugia Pharma Research Centre
• Mr Nagendra Kumar Mall, Associate Manager, Global Pharma R&D, Baxter Pharmaceuticals India

Key Highlights:
[1] Packaging is now central to patient safety, sustainability, and regulatory compliance.

[2] Global regulations such as PPWR are reshaping packaging strategy, cost structures, and operational models.

[3] Traceability through QR codes, GS1, serialisation, and tamper evidence is becoming mandatory across markets.

[4] Extended Producer Responsibility and Environmental Risk Assessment are shifting lifecycle accountability to manufacturers.

[5] Compliance gaps lie in interpretation and scientific justification, not lack of regulations.

[6] Audits now focus on logic, statistical validity, sample size rationale, and complete data integrity.

[7] Advanced therapies and combination products require robust validation, reliability proof, and defensible performance data.

[8] The shift is from approval-driven documentation to risk-based, evidence-backed validation ensuring real-world patient safety.