Clinical Trial Regulatory Services in India
Conducting clinical trials in India requires navigating a complex regulatory framework involving CDSCO, the Drug Controller General of India (DCGI), ethics committees, and ICMR guidelines. India offers a compelling proposition for clinical research — a large, diverse patient population, world-class medical infrastructure, and competitive costs — but success depends on rigorous regulatory compliance.
The New Drugs and Clinical Trials (Amendment) Rules, 2026, effective March 7, 2026, represent the most significant reform in years, cutting review timelines from 90 to 45 working days and introducing prior-intimation pathways for lower-risk studies. ACPL helps sponsors and CROs capitalize on these improvements while maintaining full compliance.
Our Clinical Trial Services
- Clinical Trial Application (CTA) preparation and submission to DCGI
- DCGI approval for Phase I–IV clinical trials
- Ethics Committee (EC) liaison, documentation, and coordination
- ICMR guideline compliance advisory
- Bioavailability and Bioequivalence (BA/BE) study approvals
- Clinical Trials Registry – India (CTRI) registration
- Post-trial access and compassionate use applications
- Serious Adverse Event (SAE) reporting to CDSCO
- CRO registration support with DCGI
Key 2026 Regulatory Reforms
- 45-day review timeline — Reduced from 90 working days for clinical trial applications
- Prior-intimation pathway — Rule 52 allows Form CT-10 submission for lower-risk BA/BE studies; manufacturing can begin upon acknowledgment
- CRO registration mandatory — Since April 2025, all CROs conducting human trials must register with DCGI
- Simplified non-commercial manufacturing — Testing license requirement replaced with prior-intimation for lower-risk drugs
Why India for Clinical Trials
India is among the world’s most attractive clinical trial destinations due to:
- Large, treatment-naive patient population across diverse therapeutic areas
- Over 40,000 NABH-accredited hospitals and 250+ medical colleges
- Cost advantages of 40–60% compared to Western markets
- English-speaking medical professionals and investigators
- Streamlined regulatory pathways under the 2026 amendments
Related Services
- CDSCO Registration — New drug registration following successful clinical trials
- Pharmacovigilance — Post-trial and post-market safety monitoring
- Field Safety Trials — Bio-efficacy studies for agrochemical products
- India Entry Strategy — Complete market entry support including clinical development