Dr Shivanand K Mutta
Dr Shivanand K Mutta is Professor and Head of the Department of Pharmaceutical Regulatory Affairs, at Acharya & BM Reddy College of Pharmacy, India
JournalFrom regulation to implementation: Medical device serialisation and traceability in India
This article critically examines the regulatory evolution of medical advice traceability and structured device identification in India, the implementation challenges encountered and the role of GS1 in advancing standardisation.
JournalModernising India’s drug submissions: Embracing eCTD 4.0 for international regulatory alignment
This article examines India’s regulatory modernisation initiatives and its eCTD 4.0 adoption roadmap. It considers the challenges involved and makes evidence-based recommendations to stakeholders planning a similar transition.