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Union Health Ministry Drafts Drugs Rules, 1945
Draft amendments to the Drugs Rules, 1945 provide for a simplified procedure to obtain permission for the import of drugs for examination, testing, or analysis. The draft provides for an online prior intimation system in place of a physical licence, and it also provides for changes to Rule 31 on minimum residual shelf life for imported drugs.
Draft amendments to Drugs Rules, 1945 :
| Dimension | Key Details |
|---|---|
| Rule/Instrument | The draft provides for amendments to the Drugs Rules, 1945. |
| Competent authority | The Union Health Ministry provides for the draft amendments. |
| Coverage (type of imports) | The draft applies to import of drugs for examination, testing, or analysis. |
| Import permission mechanism | The draft provides for submission of an online prior intimation form, and it removes the requirement of a prior physical license for such imports. |
| Digital clearance | The digital system instantly generates an acknowledgement, and it authorises the acknowledgement as valid legal clearance to execute the import. |
| Safety exclusions | The draft explicitly excludes: sex hormones; cytotoxic drugs; beta-lactam drugs; biologics containing live microorganisms; narcotic and psychotropic substances. |
| Domestic alignment reference | New Drugs and Clinical Trials Rules, 2019 have been amended in January 2026 for domestic manufacturing test licenses. |
| Rule 31 | Rule 31 mandates that any imported drug possesses a minimum residual shelf life of more than 60% of its original lifetime upon arrival in India. |
| Rule 31 (proposed change) | The draft provides for a flat minimum residual shelf life of 12 months at the time of import. |
| Categories retaining the 60% rule | The draft mandates that the more than 60% residual shelf life requirement remains mandatory for: biological products, and radiopharmaceuticals. |
| Quality standards status | The draft provides for a modification limited to the timeline threshold at port entry, and it does not relax statutory quality, safety, or efficacy standards under the Drugs and Cosmetics Act, 1940. |