Pharmacovigilance
Home / PharmacovigilanceDrug Safety – Adverse Event Reporting
At Saphnix Lifesciences, patient safety comes first. We continuously monitor the safety of every product we manufacture and market. If you have experienced, or know of, a side effect or any other problem after using one of our medicines, please tell us.
Download the Adverse Event Reporting Form, fill in the details, and send it to our Pharmacovigilance team. Patients, caregivers, doctors, pharmacists and distributors can all report.
Your report matters
Every report is reviewed by our Pharmacovigilance team and helps make our medicines safer for everyone.
Call +91 81466 61517What is an Adverse Event?
An adverse event is any unwanted or unexpected medical occurrence in a person who has taken a medicine – whether or not it is believed to be caused by that medicine. It is commonly known as a side effect or adverse drug reaction (ADR).
Problems such as lack of effect, medication errors, misuse, overdose, use during pregnancy or breastfeeding, and suspected quality defects should also be reported.
Why Should You Report?
Clinical trials cannot detect every possible side effect. Reports from real-world use help us and the regulatory authorities to:
- Identify rare or previously unknown side effects
- Detect interactions with other medicines or food
- Recognise risk factors in specific patient groups
- Understand the long-term safety profile of a product
What to Report
- Any unexpected or unusual side effect
- Reactions due to interaction with other medicines or food
- Known side effects that are more severe or frequent than expected
- Delayed or long-term reactions
- Lack of expected effect or suspected product quality issues
- Serious events – hospitalisation, disability, life-threatening reactions or death
Information Helpful in a Report
- Patient details – initials, age, gender, weight
- Product name, batch number and expiry date
- Dose, route and dates of use
- Description of the reaction and its outcome
- Other medicines taken and relevant medical history
- Your contact details for follow-up
Don’t worry if you don’t have every detail – an incomplete report is still valuable.
Report in 4 Simple Steps
Download
Download the Adverse Event Reporting Form.
Fill In
Complete as many details as you can.
Send
Email a scan or photo of the form to our team.
Follow-up
Our team may contact you for more information.
Contact Our Pharmacovigilance Team
Send the completed form by email, or call us and we will record the details with you.
You may also report directly to the Pharmacovigilance Programme of India (PvPI) via the toll-free helpline 1800-180-3024. In a medical emergency, contact your doctor or nearest hospital immediately.
Confidentiality
All information you share is treated in strict confidence. The patient’s identity is protected, and the reporter’s personal details are used only for follow-up on the report and are never disclosed in response to public requests. Information may be shared with regulatory authorities in anonymised form, as required by law.
