Indian Clinical Trial and Safety Regulations: From Schedule Y to NDCTR 2019

India’s regulatory requirements for clinical trials and new drugs have evolved considerably over time. Schedule Y of the Drugs and Cosmetics Rules, 1945 historically provided important requirements relating to clinical trials, new-drug development and safety reporting.

The regulatory framework was subsequently strengthened and reorganised through the New Drugs and Clinical Trials Rules, 2019 (NDCTR 2019).

Role of Schedule Y

Schedule Y historically established requirements relating to areas such as:

• Clinical trials of new drugs
• Responsibilities of sponsors and investigators
• Ethics committee review
• Informed consent
• Protection of clinical-trial participants
• Reporting of serious adverse events
• Clinical-trial data and documentation
• Post-marketing surveillance and special studies

These requirements contributed to the development of India’s clinical-trial and pharmacovigilance regulatory system.

New Drugs and Clinical Trials Rules, 2019

The NDCTR 2019 introduced a dedicated regulatory framework covering new drugs and investigational new drugs, clinical trials, bioavailability and bioequivalence studies, ethics committees and related regulatory activities.

The Rules include requirements concerning clinical-trial permission, ethics committee registration and oversight, informed consent, medical management and compensation for trial-related injury, and reporting of serious adverse events.

The Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health and Family Welfare, performs central regulatory functions relating to new drugs and clinical trials.

Safety Reporting

Safety monitoring is an essential component of clinical research.

Sponsors, investigators and ethics committees have defined responsibilities for the management and reporting of safety information during clinical trials. Serious adverse events require assessment and reporting according to applicable regulatory requirements and timelines.

Safety information generated during clinical development contributes to the continuing evaluation of the benefit-risk profile of an investigational or new drug.

Post-Marketing Safety

Safety monitoring continues after a drug receives marketing authorisation. Post-marketing pharmacovigilance helps identify and evaluate adverse reactions and other safety information that may emerge when a medicine is used in a larger and more diverse population.

Regulatory authorities may use post-marketing safety information to determine whether additional risk-minimisation measures, changes to prescribing information or other regulatory actions are necessary.

Current Regulatory Perspective

Schedule Y remains important for understanding the historical development of clinical-trial and drug-safety regulation in India. However, professionals should not rely on Schedule Y alone when determining current requirements.

Current clinical-trial and new-drug activities should be considered under the New Drugs and Clinical Trials Rules, 2019, as amended, together with other applicable provisions of the Drugs and Cosmetics Act and Rules and current CDSCO requirements and guidance.

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