General information, not advice
The content on this website, including the Why India page and our Insights articles, is general information about clinical research and its regulation in India. It is not legal, regulatory or medical advice, and it is not a substitute for advice on your specific study.
Regulations change
Indian requirements, including the New Drugs and Clinical Trials Rules, 2019, CDSCO guidance and CTRI procedures, are updated from time to time. Content reflects our understanding on the date shown and may not include later changes. Confirm the requirements for your study with us or your own regulatory advisers.
Not for patients
This site is written for sponsors, research professionals and students. It does not give medical advice. If you have a health question, or are thinking of taking part in a clinical trial, please speak to a doctor.
Figures and case studies
Figures such as project, site and investigator counts are rounded and correct as of the date they were published. Case studies are anonymised to protect sponsor confidentiality, and details may be simplified.
No guarantee of outcomes
Every study is different. Past results do not guarantee regulatory approval, approval timelines, enrolment rates or any other outcome for your study.
Contact
If you spot something that is out of date, please tell us at info@alchemyclinical.in.