Important Case Laws

1. Swasthya Adhikar Manch, Indore v. Union of India, W.P. (C) No. 33 of 2012

The Supreme Court addressed concerns about clinical-trial oversight, participant safety, informed consent, and compensation. The proceedings contributed to stronger regulation of clinical trials in India. The case is relevant to failures in clinical-trial compliance, although it did not establish a single penalty for every instance of non-registration or non-reporting.

CDSCO

2. Samira Kohli v. Dr. Prabha Manchanda, (2008) 2 SCC 1

The Supreme Court held that valid informed consent is central to lawful medical treatment, subject to recognised exceptions. Although the case did not concern trial registration or adverse-event reporting, it reinforces the importance of protecting patients whose participation or treatment involves medical intervention.

Conclusion

In India, the consequences of non-registration or non-reporting depend on the specific obligation breached:

Non-registration: CTRI registration is required prospectively for applicable clinical trials, but research published in 2025 reported that no specific penalty for non-registration had been identified.

Delayed serious adverse-event reporting: Under Rule 42 of the New Drugs and Clinical Trials Rules, 2019, investigators must report serious adverse events within 24 hours and explain any delay to the satisfaction of the Central Licensing Authority. Further analysis and reporting are also required within the prescribed period.

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Therefore, non-registration and non-reporting should not be treated as identical offences. The precise consequences depend on the relevant rule, the facts, and any additional breaches involving trial permission, participant safety, consent, or compensation.