Government simplifies drug import rules for testing and R&D purposes
The Union Health Ministry has proposed amendments to the Drugs Rules, 1945, to simplify the procedure for importing drugs for examination, test, or analysis. An acknowledgement-based system will replace licensing for importing small quantities of drugs for analytical and non-clinical testing, except for certain sensitive categories. This deregulation aims to boost the R&D sector and promote ease of doing business in the pharma sector. Additionally, the Ministry proposes revising the minimum residual shelf-life norm for imported drugs to 12 months, ensuring sufficient time for distribution and consumption, though biological products and radiopharmaceuticals retain the 60% norm due to their specialized nature.
Key Points
- The Union Health Ministry proposes amendments to the Drugs Rules, 1945, to simplify drug import procedures for testing and R&D.
- An acknowledgement-based system will be introduced for importing small quantities of drugs, replacing the need for licenses, except for specific sensitive drug categories.
- This deregulation is intended to boost the pharmaceutical R&D sector and improve ease of doing business.
- The minimum residual shelf-life norm for imported drugs is proposed to be revised to 12 months.
- The existing 60% shelf-life norm will continue for biological products and radiopharmaceuticals due to their specialized nature.
Exam Facts
- Drugs Rules, 1945, are being amended.
- New Drugs and Clinical Trials Rules, 2019, were amended in January 2026.
- Proposed minimum residual shelf life: 12 months (general) and 60% (biological products, radiopharmaceuticals).
- The changes aim to cut compliance burden and promote ease of doing business.
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