Why India
Why run your clinical trial in India?
Patient access, a defined regulatory pathway, experienced investigators and cost efficiency make India one of the strongest locations for global studies, with the right local partner.
Large, diverse patient populations
With more than 1.4 billion people, India offers genetically diverse populations, many treatment-naive patients and a high burden of both chronic and infectious disease, which supports faster recruitment across many indications.
A defined regulatory pathway
The New Drugs and Clinical Trials Rules, 2019 set out the approval process and decision timelines for clinical trial applications to CDSCO, giving sponsors a predictable route to study start.
Experienced, English-speaking investigators
India has a large pool of medically qualified, English-speaking investigators and site staff trained in ICH-GCP, many with global trial experience.
Cost-efficient operations
Site, staff and operational costs are significantly lower than in North America and Western Europe, without lowering the standard of conduct.
Traditional medicine expertise
India has an established regulatory framework and deep clinical experience with Ayurvedic and herbal medicines, valuable for nutraceutical and botanical studies.
Data accepted globally
Studies conducted to ICH-GCP with robust data management can support regulatory submissions in other markets.
The regulatory pathway
What it takes to start a trial in India
ACRS prepares and manages each step for you, and keeps the study compliant through to close-out.
Regulatory affairs →- 1
CDSCO permission
Clinical trial application to the Central Drugs Standard Control Organisation under the New Drugs and Clinical Trials Rules, 2019.
- 2
Ethics committee approval
Approval from an ethics committee registered with CDSCO for every participating site.
- 3
CTRI registration
Registration on the Clinical Trials Registry – India before the first participant is enrolled.
- 4
Ongoing compliance
Informed consent, safety reporting, compensation and record-keeping requirements throughout the study.
This is a general overview, not legal advice. Requirements depend on the product and study type, so we confirm the pathway for each study.
Why a local partner matters
India rewards sponsors who know the ground
Site capability, ethics committee practice and patient recruitment vary widely across India. A partner who knows the sites and investigators, and who has handled the approvals before, is the difference between a study that starts on time and one that stalls.
ACRS has worked in Indian clinical research since 2010, as a training institute, a site management organisation and now a full-service CRO. That gives us relationships with sites and investigators, and a practical understanding of what it takes to deliver.
Considering India for your next study?
Tell us the indication, phase and target enrolment. We will assess feasibility and outline the pathway and timelines.