Safety reporting
How to report a side effect
If a medicine, device or health product may have caused a problem, please tell us. No detail is too small. Here is how to report, and what to include.
Is it an emergency?
If someone is very unwell, do not wait for us. Call a doctor or go to the nearest hospital now.
Two ways to report to us
Email or call our drug safety team
Email us
Tell us what you can, using the list below. We will ask for anything else we need.
safetyreporting@trialguna.comWho we are
You can also report to the government
TrialGuna is a private company. We are not a government body. We pass every report we receive to the company that makes the product, and to the authorities where the law requires.
You can always report straight to India's national drug safety programme, PvPI (Pharmacovigilance Programme of India). It is free.
- PvPI helpline: 1800-180-3024 (free). Mon – Fri, 9:00 am – 5:30 pm. Medicines, vaccines and medical devices, in 10 languages.
- Online and by app: report on the PvPI website (opens in a new tab), or use the ADR PvPI app on Google Play.
What to include
What to tell us
Answer what you can. It is fine to leave things out.
- Who you are: patient, carer, pharmacist, doctor or other
- How we can contact you
- The patient's initials (not their full name)
- The patient's age and sex
- The product's name
- The batch number, printed on the pack
- The dose, and how it was taken
- What happened
- When it started
- How serious it was
- How the patient is now
Please do not send photos of the body. We do not need them to start.
What happens next
After you report
We read your report
A member of our drug safety team reviews it.
We may contact you
If we need more detail, we will get in touch using the contact details you gave.
We pass it on, as the law requires
We share the report with the company that holds the product's licence, and with India's drug safety programme (PvPI) or CDSCO where needed.
Your privacy
How we use your details
We use your report only to monitor product safety. We ask for the patient's initials, not their full name. Only our drug safety team and the people the law requires can see it.
We keep reports for as long as drug safety law requires.