Central Government Amends Import Regulations for Pharmaceutical Products

Key facts

• The Central Government brought the Drugs (Thirteenth Amendment) Rules, 2026 into force on 28 October 2026.
• The Ministry of Health and Family Welfare (MoHFW) issued the amendment to Rule 31 of the Drugs Rules, 1945.
• Most imported drugs now require a minimum of 12 months of residual shelf life on the date of import.
• Biological drugs and radiopharmaceuticals are permitted for import if at least 60% of their labelled shelf life remains.
• The final amendment was formulated following consultation with the Drugs Technical Advisory Board (DTAB) and public feedback.