Introduction to Schedule Y
Schedule Y forms part of the Drugs and Cosmetics Rules, 1945 and has historically played an important role in the regulation of new drugs and clinical trials in India.
Schedule Y established requirements relating to the conduct of clinical trials, responsibilities of sponsors and investigators, protection of trial participants, informed consent, ethics committee review, safety reporting and clinical-trial data requirements.
Historical Importance of Schedule Y
Schedule Y was substantially revised over time as India’s clinical research regulatory system developed. It provided an important regulatory framework for:
- Clinical trials of new drugs
- Requirements for different phases of clinical development
- Responsibilities of sponsors and investigators
- Ethics committee oversight
- Informed consent
- Safety and adverse-event reporting
- Studies involving special populations
- Post-marketing studies
- Data required for new drug applications
Schedule Y therefore remains important for understanding the historical development of clinical-trial regulation in India.
Current Regulatory Framework
India’s regulatory framework for new drugs and clinical trials changed significantly with the introduction of the New Drugs and Clinical Trials Rules, 2019 (NDCTR 2019).
The NDCTR 2019 now provides the principal regulatory framework for areas including new drugs, investigational new drugs, clinical trials, bioavailability and bioequivalence studies and ethics committees covered by these Rules.
Therefore, Schedule Y should not be considered the sole or principal current framework for conducting clinical trials of new drugs in India.
Why Schedule Y Is Still Important
Clinical research professionals may encounter Schedule Y in older regulatory documents, training materials, clinical-trial records and discussions of the evolution of Indian clinical research regulation.
Understanding Schedule Y provides useful historical context, while professionals working with current clinical trials should refer to the New Drugs and Clinical Trials Rules, 2019, as amended, and other applicable current CDSCO requirements.
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