Voluntary Recall of Digene Gel manufactured by M/s Abbott India Limited, L-18/19, Verna Industrial Estate, Salcette, Goa-403722

## Policy Analysis Report: Voluntary Recall of Digene Gel (EDComplaint2232023) **1. Executive Summary:** This report analyzes the Government of India's directive (EDComplaint2232023) regarding the voluntary recall of Digene Gel manufactured by Ms. Abbott India Limited. The core purpose is to address potential quality concerns with the product. The key finding is that all batch numbers of Digene Gel manufactured at the Goa facility are subject to the recall, requiring distributors and retailers to remove the product from the market. The recall is based on adverse reaction reports and aims to mitigate potential health risks associated with the consumption of the affected product. **2. Introduction:** This report provides an informative overview of Government of India directive EDComplaint2232023 concerning the voluntary recall of Digene Gel manufactured by Ms. Abbott India Limited. The analysis is based solely on the content of the provided policy text. **3. Policy Overview:** This is a *New Policy* regarding a specific product recall. * **Core Objective(s):** The core objective, as inferred from the text, is to ensure public safety by removing potentially compromised batches of Digene Gel from the market, responding to reports of adverse reactions. **4. Background and Rationale:** Since this is a new policy specifically concerning a product recall, the problem being addressed appears to be quality or safety issues with Digene Gel manufactured by Abbott India Limited. The text mentions "reaction" which infers adverse events led to investigation and product recall . The policy likely stems from reports indicating that the Digene Gel may pose a health risk to consumers. **5. Key Provisions / Changes:** As a New Policy, the key provisions and actions mandated are as follows: * **Voluntary Recall:** Ms. Abbott India Limited is undertaking a voluntary recall of Digene Gel. * **Scope:** The recall applies to *all* batch numbers of Digene Gel manufactured at the Goa facility. * **Action Required:** Retailers and distributors are required to remove the impacted product from the market. * **Manufacturing Location:** The Goa facility (location details provided) is specifically identified as the source of the affected product. * **Communication:** This directive serves as a communication to all relevant stakeholders, including Drugs Controllers, associations of chemists and druggists (AIOCD), and the CDSCO IT Cell for website publication. **6. Target Audience and Stakeholders:** Based on the text, the directly affected audience and stakeholders include: * Ms. Abbott India Limited (the manufacturer) * Distributors of Digene Gel * Retailers (chemists and druggists) selling Digene Gel * Consumers of Digene Gel * Drugs Controllers and regulatory bodies * All India Organization of Chemists and Druggists (AIOCD) **7. Implementation Aspects (Inferred):** * **Responsible Agency/Bodies:** The Drugs Controller General of India (DCGI), Dr. Rajeev Singh Raghuvanshi is the mentioned controlling authority. CDSCO IT Cell is responsible for website publication. State Drug Controllers are also implied in the distribution of this directive. * **Timelines/Procedures:** While a specific timeline is not explicitly stated in this text, the urgency implied by a product recall suggests immediate action is expected from distributors and retailers to remove the product. * The policy outlines actions required from Drug Inspectors, the Zonal and Sub-Zonal offices, and port offices. **8. Expected Outcomes / Impact of Changes:** The likely intended outcomes of this voluntary recall are: * **Reduced Health Risks:** Mitigating potential adverse health effects associated with the consumption of the affected Digene Gel. * **Restoration of Consumer Confidence:** Addressing quality concerns and restoring trust in the Digene Gel brand (after the issues are resolved and new unaffected products are available) and pharmaceutical product safety. * **Compliance and Enforcement:** Ensuring compliance with drug safety regulations and demonstrating the government's commitment to consumer protection. **9. Conclusion:** The Government of India directive EDComplaint2232023 outlines the voluntary recall of Digene Gel manufactured by Ms. Abbott India Limited at its Goa facility. This policy is a significant step to ensure public safety by addressing potential risks associated with the product. The directive mandates immediate action from distributors and retailers to remove the affected product from the market. This action highlights the importance of stringent quality control measures within the pharmaceutical industry and the government's vigilance in safeguarding public health.

Key Entities Referenced