India CDSCO: Guidance for Industry on Pharmacovigilance Requirements for Human Vaccines

The Central Drugs Standard Control Organisation (CDSCO) has issued comprehensive guidance on (29 May, 2024) "Guidance for Industry on Pharmacovigilance Requirements for Human Vaccines". This guidance outlines the roles and responsibilities of various authorities, the pharmacovigilance plan, specific chapters on pharmacovigilance activities, and procedures for implementing an effective pharmacovigilance system.

• Pharmacovigilance: Activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem.

• Adverse Event Following Immunization (AEFI): Any untoward medical occurrence which follows immunization and which does not necessarily have a causal relationship with the usage of the vaccine.

The purpose of this guidance document is to provide guidance on pharmacovigilance activities for vaccines circulating in the market throughout their life cycle after licensure. As used in this guidance, pharmacovigilance refers to all scientific and data-gathering activities aimed at detecting, assessing, understanding and preventing adverse events.

The rationale behind this guidance is to enhance the pharmacovigilance system in India, ensuring timely and accurate reporting of AEFI and improving the overall safety profile of vaccines. This guidance applies to all stakeholders involved in the development, manufacturing, and distribution of human vaccines in India, including healthcare professionals, marketing authorization holders (MAHs), and regulatory authorities.

The Pharmacovigilance Programme of India (PvPI) under the Indian Pharmacopoeia Commission collects, collates, and analyses data on adverse events, providing critical insights for regulatory decision-making. The AEFI Secretariat oversees the national immunization program, ensuring that adverse events are promptly reported and investigated. This division within the CDSCO focuses specifically on the pharmacovigilance of human vaccines, ensuring that all regulatory requirements are met and that safety data is effectively managed.

The guidance outlines various pharmacovigilance methods, including spontaneous reporting, active surveillance, and cohort event monitoring. Post-marketing surveillance and periodic safety update reports (PSURs) are essential components of the pharmacovigilance plan, providing ongoing safety data on marketed vaccines.

Chapter 1: Pharmacovigilance System Master File: details the requirements for maintaining a comprehensive pharmacovigilance system master file, which includes all relevant safety data and documentation.

Chapter 2: Collection, Processing, and Reporting of Individual Case Safety Reports (ICSR) by Marketing Authorization Holder (MAH): MAHs are required to collect, process, and report ICSRs to ensure that any adverse events are promptly addressed.

Chapter 3: Preparation & Submission of Periodic Safety Update Report by MAH: MAHs must prepare and submit PSURs, providing a detailed analysis of the vaccine's safety profile over a specified period.

Chapter 4: Quality Management System at MAH Site: MAHs must implement a robust quality management system to ensure the integrity and reliability of pharmacovigilance data.

Chapter 5: Audits & Inspections of Pharmacovigilance System at MAH Site: Regular audits and inspections of the pharmacovigilance system at MAH sites are necessary to ensure compliance with regulatory standards.

Chapter 6: Submission of Risk Management Plan: MAHs are required to submit a risk management plan outlining strategies to identify, assess, and mitigate risks associated with the vaccine.

The guidance provides detailed procedures for establishing and maintaining an effective pharmacovigilance system, including staff training, data management, and continuous monitoring.

The revised pharmacovigilance guidance by CDSCO is a significant step towards ensuring the safety of human vaccines in India. By outlining clear roles, responsibilities, and procedures, this guidance aims to enhance the monitoring and reporting of adverse events, thereby protecting public health. For detailed information, refer to the full guidance document available here.