New Delhi: The Union Health Ministry has proposed a significant change to India’s drug import regulations by mandating that imported medicines must have a minimum residual shelf life of 12 months at the time they enter the country. The move is aimed at ensuring patients receive medicines with adequate usable life while improving efficiency across the pharmaceutical supply chain.
The proposal, published in a draft gazette notification on June 22 for public consultation, seeks to amend the existing Drugs Rules. At present, imported medicines are required to have more than 60 per cent of their shelf life remaining at the time of import. Under the proposed amendment, this requirement would be replaced with a fixed minimum residual shelf life of 12 months.
The Health Ministry, however, clarified that biological products and radiopharmaceuticals will continue to be governed by the existing requirement of retaining more than 60 per cent of their shelf life due to their specialised nature and public health considerations.
According to the ministry, the proposed amendment is intended to strengthen the pharmaceutical supply chain by ensuring imported medicines remain suitable for distribution and consumption before their expiry dates. Officials said the change would help reduce wastage caused by restrictive shelf-life norms and improve inventory management.
The ministry believes the revised rule will optimise medicine availability, lower supply chain costs and enhance access to essential drugs across the country while continuing to safeguard the quality and safety of medicines supplied to patients.
The draft notification has been placed in the public domain for stakeholder feedback before the amendment is finalised.
