Both require
Shared foundations
- Independent Ethics Committee approval
- Documented informed consent
- Participant safety as the priority
- Adherence to the approved protocol
- Qualified investigators with PI oversight
- Essential documents for inspection
Every clinical trial at KG Hospital must satisfy India’s mandatory New Drugs and Clinical Trials Rules and the internationally accepted ICH Good Clinical Practice standard. Here is how the two frameworks compare, side by side.
DCGI (CDSCO), Government of India
International Council for Harmonisation
The two frameworks share the same ethical core. NDCT Rules add legally binding, India-specific requirements, while ICH GCP sets the global quality and data-integrity standard.
Shared foundations
India-specific, mandatory provisions
Global quality and data standards
| Aspect | NDCT Rules, 2019India | ICH GCP E6(R3)International |
|---|
Our Clinical Research Centre operates to both frameworks at once — meeting India’s regulatory requirements while producing data that sponsors can submit to regulators worldwide.
Successfully passed a DCGI (CDSCO) site inspection in September 2022, alongside multiple national and international sponsor audits.
Consent materials and participant-rights documents in English and Tamil, continuous Ethics Committee oversight and on-site emergency care.
Trial data maintained to ALCOA+ principles, with essential records preserved to support GCP compliance and regulatory submissions.
Download this comparison, read our ICH E6(R3) summary, or return to the Clinical Research Centre for more regulatory and participant resources.
Prepared by the Clinical Research Centre, KG Hospital. This comparison is a simplified summary for information only; refer to the official NDCT Rules, 2019 (CDSCO) and the ICH E6(R3) guideline for complete and authoritative requirements.