India is set to revise rules for imported medicines, proposing a 12-month minimum residual shelf life instead of the current 60% rule. This aims to ease business and reduce wastage, particularly for drugs with longer expiry dates. However, biological and radiopharmaceutical products will retain the stricter 60% requirement due to public health concerns. Other quality and safety regulations remain unchanged.

The Union Health Ministry has published a draft notification proposing amendments to the drugs rules under which imported drugs should have a minimum residual shelf life of 12…

The Union Health Ministry is proposing to relax import rules for medicines, requiring a minimum 12-month shelf life upon arrival instead of the current 60% of total shelf life.…