Recall & Product Safety Alerts Policy

Effective Date: April 30th, 2025

1. Introduction

Shretan Solutions Private Limited is committed to the health and safety of animals and the integrity of the veterinary products we manufacture, distribute, and market. As a responsible veterinary company, we have established a robust Recall & Product Safety Alerts Policy to ensure swift, transparent, and effective actions are taken in the event that a product poses a risk to animal health, human handlers, or the environment.

2. Purpose

The purpose of this policy is to outline the procedures and responsibilities for:

  • Identifying and assessing risks associated with veterinary products.
  • Initiating recalls or issuing safety alerts when required.
  • Informing stakeholders and regulatory bodies in a timely manner.
  • Minimizing potential harm to animals, humans, and the environment.
  • Ensuring compliance with national and international regulatory requirements.

3. Scope

This policy applies to all veterinary pharmaceutical and non-pharmaceutical products manufactured, imported, distributed, or sold by Shretan Solutions Private Limited. It covers:

  • Adverse events reported by veterinarians, animal handlers, distributors, or regulatory agencies.
  • Defective products due to manufacturing, labeling, packaging, or contamination.
  • Products with unauthorized or misrepresented ingredients or claims.
  • Issues involving supply chain or storage conditions that may compromise safety or efficacy.

4. Definitions

  • Product Recall: The process of retrieving a product from the market that poses a potential or actual health risk.
  • Safety Alert: A formal notification regarding potential risks or side effects associated with the product.
  • Adverse Event: Any undesirable experience associated with the use of a veterinary product.
  • Batch or Lot Number: Identification code used to trace and track production batches.

5. Responsibilities

  • Quality Assurance Team: Leads the investigation, coordinates with manufacturing, and ensures root cause analysis.
  • Regulatory Affairs: Notifies relevant authorities such as the CDSCO (Central Drugs Standard Control Organization) and ensures compliance with Indian and international laws.
  • Customer Relations: Communicates with veterinarians, wholesalers, and customers.
  • Recall Coordinator: Appointed to oversee the recall process and documentation.

6. Recall Classification

Recalls are classified based on the seriousness of the risk:

  • Class I Recall: Involves products that pose a serious or life-threatening risk to animals or humans.
  • Class II Recall: Involves products that may cause temporary health issues or pose slight risk.
  • Class III Recall: Involves products unlikely to cause harm but which violate regulations (e.g., labeling errors).

7. Recall Procedure

  • Detection of Issue: Through internal audits, customer complaints, regulatory inspection, or pharmacovigilance reports.
  • Preliminary Risk Assessment: Initial analysis of the issue’s severity and potential impact.
  • Internal Notification: Management and relevant teams are alerted.
  • Recall Decision: Based on risk level, batch history, and potential impact.
  • Regulatory Notification: CDSCO and any other relevant bodies are informed.
  • Public Communication:
  • Issue of press release if applicable.
  • Direct communication to veterinary professionals, distributors, and clients.
  • Product Retrieval: Coordination with supply chain partners to recover affected products.
  • Corrective Actions: Investigate root causes and implement changes to prevent recurrence.
  • Documentation and Reporting: Detailed records of investigation, communication, and follow-ups are maintained.

8. Post-Recall Activities

  • Effectiveness Check: Confirm the reach and success of the recall.
  • Reconciliation Report: Comparison between units produced, distributed, and retrieved.
  • Regulatory Report: Submission of final reports to authorities with full traceability and corrective action plans.
  • Stakeholder Feedback: Engage with customers and veterinarians for feedback on handling and resolution.

9. Communication Strategy

Use of official channels including email, registered post, website updates, and direct phone calls.

Multilingual communication materials where necessary, especially for field workers or rural markets.

Designated helpline for recall-related queries.

10. Training and Review

  • Regular staff training on recall protocols, reporting mechanisms, and documentation.
  • Annual mock recalls to test preparedness and response.
  • Periodic policy review to align with regulatory updates and business changes.

11. Regulatory Framework

Shretan Solutions Private Limited complies with:

  • Drugs and Cosmetics Act & Rules (India)
  • CDSCO Guidelines
  • World Health Organization (WHO) guidelines for veterinary products
  • Any applicable state-level or international regulations

12. Contact Information

Recall Coordinator
Shretan Solutions Private Limited
Email: info@shretan.com
📞 Phone: +91 99017 80270