The Serious Adverse Event (SAE) Division of the Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India, is responsible for the regulatory oversight of Serious Adverse Events (SAEs) reported during clinical trials & Bioavailability & Bioequivalence studies conducted under the provisions of the New Drugs and Clinical Trials (NDCT) Rules, 2019.

The Division receives, scrutinizes, and processes SAE reports submitted by the Investigators, Sponsors, and Ethics Committees in accordance with the prescribed timelines under the NDCT Rules, 2019. The reports are evaluated for regulatory compliance, completeness of documentation, causality assessment and recommendations of the Ethics Committee. An Independent Expert Committee is constituted by the CLA before which the SAE cases are presented for deliberation and final recommendations are received from the IEC members. (Where required, the cases are placed before the Subject Expert Committee (SEC) for expert opinion).

Based on the recommendations of the Independent Expert Committee and the provisions of the NDCT Rules, 2019, the Central Licensing Authority (CLA) takes appropriate decisions regarding the relatedness of the SAE(s) to the Clinical Trials & Bioavailability & Bioequivalence Studies, compensation to trial participants or their legal heirs, and other necessary regulatory actions.

The SAE Division is also responsible for:

• Monitoring compliance with statutory timelines for SAE reporting.
• Processing compensation-related cases under the NDCT Rules, 2019.
• Coordinating with Sponsors, Investigators, Ethics Committees, Expert Committees, and other stakeholders for timely submission of information and clarifications.
• Coordinating with other divisions of CDSCO for matters pertaining to clinical trials/ bioavailability & bioequivalence studies, wherein SAE(s) are reported, as well as for other miscellaneous works as assigned for execution.
• Addressing Parliament Questions, Public Grievances, RTI & Court matters and other regulatory communications related to SAEs.
• Maintaining transparency, consistency, and regulatory oversight in the management of SAEs reported during clinical trials & bioavailability & bioequivalence studies.

The Division is committed to protecting the rights, safety, well-being, and dignity of clinical trial participants while ensuring that clinical trials & bioavailability & bioequivalence studies in India are conducted in compliance with the applicable regulatory requirements and ethical standards.

• Review of SAE Reports as per Annexure A
• Constitution & Functions of Independent Expert Committee (IEC)-

  As per Rule 42 of New Drugs and Clinical trials (NDCT) Rules, 2019, the Central Licencing Authority (CLA) shall constitute an Independent Expert Committee (IEC) to examine the Serious Adverse Event (SAE) cases.

  This IEC comprises of group of experts with specialisation in relevant fields, with the approval of the CLA, for evaluation of scientific and technical matters relating to drugs. It provides recommendations to the said authority on matters referred to it within a period of sixty days from the receipt of the report of the SAE(s) for arriving at the cause of occurrence of such events and calculation of quantum of compensation to be paid to the subject/ legal heirs.

• Conduct of Independent Expert Committee-

  Once the IEC has been constituted by the CLA, the proposals pertaining to the SAE cases are forwarded to the IEC members for their review and the same are deliberated in the meeting held between the officials of this Directorate with the IEC members.

• Issuance of Order-

  The CLA shall consider the recommendations of the expert committee and shall determine the cause of SAE with regards to the relatedness of the SAE to the clinical trial or the bioavailability or bioequivalence study, as the case may be and accordingly, by order, decide the quantum of compensation, determined as per the formula specified in the Seventh Schedule, to be paid by the sponsor or its representative and shall pass orders as deemed necessary within ninety days of the receipt of the report of the SAE.

• Verification of Compensation Paid or Not-

  For the SAE related cases, the Orders are issued to the Sponsors of the concerned CT/ BA-BE study with a direction to pay the amount calculated as per the formulae prescribed under Seventh Schedule of NDCT Rules, 2019, to the subject/ legal heirs/ nominee of the subject. The said amount shall be paid within 30 days from the date of receipt of the issued order as per sub-rule 2(ix) of Rule 42 of NDCT Rules, 2019, under intimation to this Directorate.

  The details of the compensation paid along with acknowledgment copy of cheque/draft from the subject/nominee is to be submitted to this Directorate within 30 days of the receipt of the order. Further, the sponsor is also directed to submit the details of free medical management provided to the subject.

Process Work Flow Chart of the SAE division

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