NSQ Vi-Conjugate Typhoid Vaccine Batch No.TC010915 and Batch No. TC010417 of M/s Bio Med Pvt Ltd dated 14-03-2018

## Report on Peda Typh Vi-Conjugate Typhoid Vaccine Batch Recall **1. Executive Summary:** This report analyzes a notification from the Drugs Controller General India (DCGI) regarding a quality issue with two batches of Peda Typh Vi-Conjugate Typhoid Vaccine One dose, manufactured by Ms Bio Med Pvt. Ltd, Ghaziabad. The batches, TC010915 and TC010417, were declared Not of Standard Quality (NSQ) due to insufficient Vi Polysaccharide content. The notification directs State/UT Drugs Controllers and CDSCO Zonal/Sub-Zonal officers to maintain strict vigilance on the movement of these specific batches in the market. **2. Introduction:** The purpose of this report is to provide a detailed analysis of a communication from the Directorate General of Health Services, Ministry of Health and Family Welfare, Central Drugs Standard Control Organization (CDSCO), Office of Drugs Controller General India (DCGI) concerning specific batches of Peda Typh Vi-Conjugate Typhoid Vaccine One dose. The analysis is based solely on the provided text of the notification. **3. Policy Overview:** This notification does not introduce a new policy. It is an action notice regarding the quality control of existing pharmaceutical products already governed by relevant drug regulations. * **Core Objective(s):** To ensure the quality and safety of a specific vaccine product (Peda Typh Vi-Conjugate Typhoid Vaccine One dose) circulating in the market by identifying and controlling potentially substandard batches. **4. Background and Rationale:** This action notice addresses a quality control issue identified through testing. Specifically, samples of the vaccine batches TC010915 and TC010417 were found to have insufficient Vi Polysaccharide content, rendering them "Not of Standard Quality" (NSQ). This deficiency potentially reduces the vaccine's efficacy and necessitates regulatory intervention to prevent its use. **5. Key Provisions / Changes:** This document serves as a directive to enforce existing quality standards and control the distribution of potentially substandard products. As such, it is an action within an existing policy framework. * **What specific part of the original policy is being changed (if discernible from the text):** This document does not change the existing policy, but it highlights its enforcement concerning specific batches of the vaccine. * **What the *new* rule/provision *is*, based *only* on the amendment text:** The communication mandates heightened vigilance on the movement of specific vaccine batches (TC010915 and TC010417). * **Explain the *difference* or the *effect* of this specific change:** This increased vigilance aims to remove the NSQ batches from the supply chain, protecting public health. **6. Target Audience and Stakeholders:** * **Directly affected:** * State/UT Drugs Controllers * CDSCO Zonal/Sub-Zonal officers * Inspectorate staffs under the control of the above * Ms Bio Med Pvt. Ltd, Ghaziabad (the manufacturer) * Pharmacies, hospitals, and other distributors of the vaccine. * Patients who may have received or may seek to receive the affected vaccine batches. **7. Implementation Aspects (Inferred):** * **Responsible agency/bodies:** * CDSCO (Central Drugs Standard Control Organization) * State/UT Drugs Controllers and their inspectorate staffs. * **Timelines or procedures:** The notification does not specify explicit timelines or procedures beyond the direction to maintain "strict vigil." It implies immediate action upon receipt of the notice. The CDL Kasauli performed the initial testing. **8. Expected Outcomes / Impact of Changes:** The likely intended outcome is to prevent the further distribution and administration of the identified substandard vaccine batches. This aims to: * Protect the public from receiving potentially ineffective typhoid vaccines. * Maintain confidence in the quality control mechanisms of the Indian drug regulatory system. * Potentially prompt Ms Bio Med Pvt. Ltd. to investigate and rectify the manufacturing issue. **9. Conclusion:** The notification from the DCGI regarding the Peda Typh Vi-Conjugate Typhoid Vaccine batches represents a proactive step in ensuring pharmaceutical quality control. By alerting relevant regulatory bodies and mandating increased vigilance, the notification aims to safeguard public health by preventing the use of potentially substandard vaccines. This action reinforces the importance of robust quality control measures within the pharmaceutical industry.

Key Entities Referenced