CDSCO Releases Draft Guidance on Pharmacovigilance for Vaccines

The latest draft outlines the safety monitoring protocols for vaccines and calls for suggestions, objections, and comments to be submitted within 15 days.

The Central Drugs Standard Control Organisation (CDSCO) has published a draft guidance document on pharmacovigilance requirements for human vaccines, inviting feedback from stakeholders. 

The latest draft outlines the safety monitoring protocols for vaccines and calls for suggestions, objections, and comments to be submitted within 15 days.

The draft guidance, titled "Guidance for Industry on Pharmacovigilance Requirements for Human Vaccines, Version 2.0," was prepared in consultation with the Adverse Events Following Immunization (AEFI) Secretariat and the Indian Pharmacopoeia Commission's (IPC) Pharmacovigilance Programme of India (PvPI). 

The aim is to align with the New Drugs and Clinical Trial Rules (NDCTR), 2019, and provide comprehensive guidelines for stakeholders involved in vaccine safety monitoring.

About the Latest Draft

The guidance document targets Marketing Authorization Holders (MAHs) and other stakeholders, outlining requirements for vaccine safety monitoring, audits, and inspections. 

It emphasizes the need for a Risk Management Plan (RMP) and the periodic submission of Risk-Benefit Evaluation Reports, known as Periodic Safety Update Reports (PSUR), to the Licensing Authority.

The document further aims to help MAHs and stakeholders implement effective pharmacovigilance systems to ensure patient safety. 

Key elements include identifying risks, formulating risk profiles for vaccines and their administration programs, and designing appropriate pharmacovigilance plans to mitigate risks. It also focuses on uncovering critical information not identified during pre-market phase I, II, and III trials.

The guidance outlines the roles and responsibilities of various authorities, including the CDSCO, PvPI at IPC, the AEFI Secretariat, and the Immunization Division of the Ministry of Health and Family Welfare. 

It includes aspects such as signal detection and management for vaccines, strengthening safety surveillance for new vaccine introductions or pandemic preparedness, and developing pharmacovigilance plans and reporting models.

Important Highlights from the New Guideline

The guidance mandates that all MAHs of human vaccines, whether importers or manufacturers, establish and implement effective pharmacovigilance systems. 

These systems should have qualified, trained, and experienced personnel to collect, collate, and analyze all AEFI cases as per the New Drugs and Clinical Trial Rules, 2019. 

Moreover, companies must conduct decisive causality assessments of AEFI cases, prepare case closure reports, and include this information in comprehensive PSURs submitted to the Licensing Authority.

Additionally, the CDSCO will review the submitted PSURs and convene meetings of the PSUR committee to allow MAHs to present their cases. Based on the committee's recommendations, the Vaccine Licensing Authority will take appropriate regulatory action in accordance with the Drugs & Cosmetics Act and associated rules to monitor the safety and effectiveness of vaccines in the market.

The guidance specifies that MAHs must report all serious adverse events following immunization via email within 15 calendar days of receipt of information to the National Regulatory Authority (NRA), CDSCO. 

According to the latest release, non-serious adverse events must be reported within 30 calendar days. Adverse events due to lack of efficacy or medication errors must also be reported to the NRA.

The PSUR must detail procedures for reporting cumulative and interval patient exposure from marketing experiences in India and globally, post-approval use in special populations, ongoing clinical studies, long-term follow-ups, and other relevant data.

Stakeholder feedback will be crucial in refining and finalizing these guidelines to ensure robust pharmacovigilance systems that protect public health.