India implements new medicine import rules amid regulatory scrutiny

The Indian Ministry of Health and Family Welfare has issued a new notification barring the import of medicines with less than one year of remaining shelf life. This amendment to the Drugs Rules, 1945, aims to ensure product longevity upon entry into the country. However, a separate provision allows biological drugs and radiopharmaceuticals to be imported with at least 60 percent of their labeled shelf life remaining.

Separately, the Supreme Court of India has questioned the Union government and the Drug Controller General of India (DCGI) regarding alleged regulatory delays. The court expressed concern over the continued sale of Liposomal Amphotericin B, an antifungal medicine, which reportedly utilized expired emergency permissions granted during the Covid-19 pandemic. The bench questioned why action against manufacturers was only initiated in early 2026, following judicial intervention, after the drugs had allegedly been sold without required clinical trials and oversight for several years.