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The Union Health Ministry has published a draft notification proposing amendments to the drugs rules under which imported drugs should have a minimum residual shelf life of 12 months at the time of import. The step would ensure that patients receive medicines with adequate usable shelf life and improve utilisation of pharmaceutical inventories across the supply chain. The draft amendment published for public consultation vide gazette notification on June 22 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 considerations, the existing requirement of a minimum residual shelf life of more than 60 per cent shall continue to apply to biological products and radiopharmaceuticals. The proposed amendment seeks to facilitate greater efficiency in the pharmaceutical supply chain while ...
The government has given approval to four waitlisted firms under the Production Linked Incentive (PLI) scheme for domestic manufacturing of bulk drugs, an official statement said on Monday. The Department of Pharmaceuticals had launched the PLI scheme for promotion of domestic manufacturing of critical bulk drugs -- Key Starting Materials (KSMs)/ Drug Intermediates and Active Pharmaceutical Ingredients (APIs). It envisages setting up greenfield plants in four different target segments with a total outlay of Rs 6,940 crore for the period 2020-21 to 2029-30. All the 215 applications received for the 36 products spread across the four target segments were considered and appraised and selected participants duly informed, the Ministry of Chemicals and Fertilizers said. Now, four waitlisted applicants who are otherwise eligible have been approved against slots vacated by withdrawal by companies which had earlier been granted approvals, the ministry said. The companies which have been gi