Government Scraps Mandatory Test Licences for Small-Scale Drug Research
The Union government has amended the New Drugs and Clinical Trials Rules, 2019, to replace mandatory licence requirements for non-commercial drug manufacture with a prior-intimation mechanism. This move aims to facilitate 'ease of doing business' and fast-track drug development by up to three months. Developers can now manufacture small quantities for research after notifying the Central Drugs Standard Control Organisation (CDSCO) via the SUGAM portal. While the industry welcomes the reduction in 'licence raj,' experts caution that the removal of regulations must not compromise quality control, citing recent fatal incidents involving substandard cough syrups as a warning against poor pharmaceutical oversight.
Key Points
- Mandatory test licences for small-scale research drugs are replaced by a prior-intimation mechanism.
- The move aligns with the goal of improving ease of doing business in the pharmaceutical sector.
- Statutory processing time for high-risk psychotropic or narcotic drugs is reduced from 90 days to 45 days.
- Manufacturers must still meticulously document processes and adhere to Good Manufacturing Practices (GMP).
- The amendment is expected to fast-track the timeline of drug development by at least three months.
Exam Facts
- Amendment to New Drugs and Clinical Trials Rules, 2019.
- Portal for intimation: SUGAM.
- Processing time reduction for high-risk drugs: 90 to 45 days.
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