⚠️ SERIOUS ADVERSE EVENTS
If you are experiencing a serious or life-threatening adverse event, please seek immediate medical attention by calling emergency services or visiting the nearest hospital.
After receiving medical care, please report the event to us using the methods below.
What is Pharmacovigilance?
Pharmacovigilance is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine-related problems. At Pacific BioEngineering, we maintain a robust pharmacovigilance system to:
- Monitor the safety of our products throughout their lifecycle
- Collect and analyze adverse event reports
- Identify previously unknown safety concerns
- Assess the benefit-risk profile of our medications
- Communicate safety information to healthcare professionals and patients
- Comply with regulatory requirements
What Should You Report?
Adverse Events (Side Effects)
An adverse event is any undesirable experience associated with the use of a medical product. Please report:
- Serious adverse events: Death, life-threatening events, hospitalization, disability, birth defects
- Unexpected side effects: Effects not listed in the product information
- Known side effects: Even if listed, especially if severe or unusual
- Medication errors: Wrong dose, wrong product, administration errors
- Lack of efficacy: Product not working as expected
- Drug interactions: Unexpected interactions with other medications
Product Quality Complaints
Report any concerns about product quality, including:
- Defective packaging or labeling
- Damaged or broken tablets/capsules
- Unusual appearance, color, or odor
- Foreign particles or contamination
- Suspected counterfeit products
- Storage or handling issues
Important: You do not need to be certain that the product caused the adverse event. If you suspect a connection, please report it. We will evaluate all reports professionally and confidentially.
Who Can Report?
We welcome reports from:
- Healthcare Professionals: Doctors, pharmacists, nurses, and other medical practitioners
- Patients: Individuals who have experienced adverse events
- Caregivers: Family members or caregivers of patients
- Consumers: Anyone who has used our products
How to Report
Online Reporting Form
Use the form below to submit your report online. This is the fastest way to reach our pharmacovigilance team.
Alternative Reporting Methods
What Happens After You Report?
- Acknowledgment: You will receive confirmation of your report within 24-48 hours
- Evaluation: Our pharmacovigilance team will review and assess the report
- Follow-up: We may contact you for additional information if needed
- Regulatory Reporting: Serious events are reported to regulatory authorities as required
- Safety Assessment: Information is used to monitor product safety
- Action: If necessary, safety measures or product updates may be implemented
Confidentiality
We respect your privacy and handle all reports confidentially:
- Personal information is protected and used only for pharmacovigilance purposes
- Patient identity is kept confidential in regulatory reports
- Information is stored securely and accessed only by authorized personnel
- Data is retained as required by pharmaceutical regulations
Reporting to Regulatory Authorities
You may also report adverse events directly to regulatory authorities:
India - Central Drugs Standard Control Organization (CDSCO)
Pharmacovigilance Programme of India (PvPI)
Website: www.ipc.gov.in
Email: pvpi.ipc@gov.in
Our Commitment to Safety
At Pacific BioEngineering, patient safety is our top priority. We are committed to:
- Maintaining a robust pharmacovigilance system
- Promptly investigating all safety reports
- Complying with all regulatory requirements
- Continuously monitoring product safety
- Taking appropriate action when safety concerns arise
- Communicating safety information transparently
Thank You for Reporting
Your report helps us ensure the safety of our products and protect public health. Every report is valuable and contributes to our understanding of product safety.
