ClinRegs has updated its regulatory information for India to reflect changes described in the 5th and 6th Amendments to India’s Drugs and Cosmetics Rules, which took effect in summer 2015.
Salient changes include:
- Initial investigator reporting timeline is now 24 hours for all Serious Adverse Events (SAEs) and not just serious and unexpected adverse events
- Reporting timeline for SAEs has changed from 10 days to 14 days for additional reporting from the sponsor and the investigator
- Sponsor and investigator no longer need to send SAE reports to the Chairman of the Expert Committee
- In the case of injury, medical treatment should be provided for as long as necessary unless it is established that the injury is not trial-related
- In the case of non-permanent injury, compensation should be commensurate with the nature of the injury and loss of wages
- Informed Consent documents must indicate that the drug being tested may not have the intended therapeutic effect and that a placebo shall not have a therapeutic effect
- Audio-visual recording of the informed consent process is required for vulnerable populations; in the case of human immunodeficiency virus (HIV) and leprosy drug trials, only audio recording is required
Details can be found in the following topics/subtopics:
- Clinical Trial Lifecycle – Safety Reporting
- Sponsorship – Safety Reporting, Subject Compensation
- Informed Consent – Documentation Requirements, Compensation, Informed Consent Form (ICF) Requirements/Elements