Centre proposes minimum 12-month shelf life rule for imported drugs
New Delhi, June 26 -- The Union ministry of health and family welfare has proposed easing the shelf-life requirement for imported drugs by replacing the current rule mandating a residual shelf life of more than 60% with a minimum remaining shelf life of 12 months at the time of import.
The draft amendment to Rule 31 of the Drugs Rules, 1945, aimed at rationalising the residual shelf-life requirement for imported drugs and further promoting ease of doing business in the country's pharmaceutical sector, was published on June 22 for public consultation.
Currently, under the Drugs and Cosmetics Rules, 1945, a drug cannot be imported or distributed in India unless it has more than 60% of its usable shelf life remaining.
According to the hea...
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