Table 1.

Issues with current guidelines and suggestions for reform

Issues with current guideline	Recommended reform	Rationale for recommendation
Internal discrepancy on reportable case: SAE versus SADR	Uniform definition of reportable case	Brings about uniformity
No definition of what consists an “unexpected” event	Provide definition	Ensures that sponsors/investigators have clear understanding of regulatory expectation
No guideline on safety reporting in generic trials	Specify reporting requirements	Putting in place the system to capture safety of generic trials
Causality not an essential reporting criteria	Emphasize causality for reportability	Harmonizes with global standards plus reduces burden of uninformative cases, enhancing efficiency of regulatory review
No waiver for immediate reporting of SAEs that are protocol specified or study endpoints	Grant waivers and ensure that the protocol specifies reporting process for such exempted events	Reduces burden of uninformative cases, enhancing efficiency of regulatory review
Non-existence of expedited reporting requirements and SUSAR terminology	Incorporate expedited reporting standards and timelines	Harmonizes with global standards, clarifying SUSAR reporting from Indian sites participating in multinational trial
No provision to prioritize reporting of fatal/ life-threatening SUSARs	Incorporate stringent timelines (7 calendar days)	Harmonizes with global practice plus draws urgent attention that such reports deserve
No requirement for DSUR in clinical development phase	Incorporate DSUR requirements	Ensures that real-time data on drug’s developing safety profile reach regulatory authority
No guidelines for pregnancy reporting	Formulate detailed guideline	Clarifies pregnancy reporting process