Скачать или смотреть 💊⚙️ NDCT Rules amended: faster drug trials to boost pharma R&D | 30 Jan 2026

💊🚀 India is fast-tracking pharma innovation!
The Union Ministry of Health & Family Welfare has notified amendments to the New Drugs and Clinical Trials (NDCT) Rules, 2019 to reduce regulatory delays and strengthen India’s clinical research + R&D ecosystem ✅

⚡ What changed first? (Big Relief for Research!)
Earlier, even small quantities of new drugs made for research needed a test licence 🧾
Now, for non-commercial manufacture of small quantities, the test licence is replaced by a prior intimation mechanism—less paperwork, faster research 🧪✅

⚠️ Safety still comes first!
This waiver does NOT apply to high-risk categories:
☣️ Cytotoxic drugs
🚫 Narcotic substances
🧠 Psychotropic substances
These will still need formal licensing due to safety concerns.

⏱️ Approval timelines cut sharply
Where licences are still required, the statutory approval deadline is now:
🕒 90 days → 45 days
That’s a major push for quicker decisions and faster innovation 📈

🌐 Clinical research gets lighter + more digital
✅ Low-risk BA/BE (Bioavailability/Bioequivalence) studies will not need prior approval—only online intimation.
💻 Submissions will be streamlined via NSWS (National Single Window System) and the SUGAM portal for paperless processing—aligned with Jan Vishwas (trust-based governance) 🧾➡️📲

🎯 Why it matters (UPSC Angle):
✅ Ease of Doing Business + regulatory reforms
✅ Public health + innovation ecosystem
✅ Digital governance + single window clearances
✅ Science & Tech policy + pharma sector growth

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