India, June 26 -- The Government of India has issued a release:
The Union Ministry of Health and Family Welfare has published a draft notification proposing amendments to Rule 31 of the Drugs Rules, 1945, with the objective of rationalising the residual shelf-life requirement for imported drugs and further promoting Ease of Doing Business in the pharmaceutical sector.
The draft amendment, published for public consultation vide Gazette Notification G.S.R. 505 (E) dated 22nd June 2026, proposes to revise the existing requirement of a minimum residual shelf life of more than 60 per cent for imported drugs to a minimum residual shelf life of 12 months at the time of import. However, in view of their specialised nature and public health consid...