Draft Drugs Rules change residual shelf-life requirement
01 Jun, 2026

Draft Drugs Rules change residual shelf-life requirement

Unit 9 — People, Development and Environment Unit 10 — Higher Education System

What Happened?

The Ministry of Health and Family Welfare released draft amendments to the Drugs Rules, 1945. The proposal would replace the general requirement that imported drugs have more than 60% shelf life remaining with a minimum residual shelf life of one year, while retaining the 60% standard for biologicals and radiopharmaceuticals.

Premium Content Locked

Unlock this explanation, Paper 1 mapping, and MCQs by upgrading your plan.

Unlock Premium