The Union Health Ministry has proposed a mandatory minimum shelf life of 12 months for all imported drugs entering India. The draft notification aims to ensure that medicines brought into the country remain safe, effective, and usable for a reasonable duration before reaching patients.
Officials explained that the move is intended to prevent the import of short‑dated stocks that risk early expiry, thereby protecting consumers and reducing wastage. The proposal also aligns with international best practices, strengthening India’s regulatory framework for pharmaceuticals.
Industry experts noted that the requirement will compel foreign manufacturers and suppliers to plan shipments more carefully, ensuring adequate shelf life for distribution across India’s vast healthcare network. The Health Ministry has invited stakeholder feedback before finalizing the regulation.
