India relaxes drug import shelf-life rules to boost trade

The Health Ministry has overhauled its import regulations for pharmaceutical products, establishing a fixed 12-month residual shelf-life requirement to replace the previous 60 per cent minimum shelf-life criterion. The policy change applies to the majority of imported drugs entering the Indian market and is expected to facilitate smoother trade flows while reducing the volume of pharmaceutical waste.

Under the earlier framework, importers were required to ensure that medicines retained at least 60 per cent of their total shelf life upon arrival in India. This percentage-based approach created variable timelines depending on individual drug formulations and manufacturing dates, often complicating logistics and inventory management for trading partners.

The new uniform standard establishes a more transparent and predictable import environment. By fixing the minimum residual shelf life at one year, the ministry aims to provide clarity to pharmaceutical suppliers and reduce the incidence of product rejections or destruction due to shelf-life expiry during transit or storage.

Industry observers note the revision could enhance India's attractiveness as a market for international pharmaceutical manufacturers while reducing supply-chain friction. The modification reflects the government's broader effort to balance regulatory oversight with practical trade considerations.