The Ministry of Health has released a draft to amend drug regulations. Under this proposal, it will be mandatory for imported medicines to have a remaining shelf life of at least 12 months at the time of import. However, existing rules will continue to apply to biological drugs and radiopharmaceuticals; for these, a minimum of 60 per cent of the shelf life must remain at the time of import.
According to the Ministry, this amendment will reduce the unnecessary wastage of medicines and enable better utilisation of drug stocks. The Ministry clarified that this proposal pertains solely to the remaining shelf life of medicines at the time of import.
The Ministry clarified that the current requirement of a minimum 60 per cent residual shelf life will remain unchanged for biological products and radiopharmaceuticals because of their specialised nature and public health importance.
