Bharat Serums and Vaccines Limited is committed to ensure the safety of all patients who receive our products. Every medicine has potential benefits and risks. Whenever any medicine is used, the possible risks are weighed against the expected benefits. The full safety profile of any medicine is established only after years of research and clinical use. Continuous monitoring of the risks associated with any medicine is necessary to ensure that the benefits outweigh possible risks.
For this purpose, ‘Report any suspected adverse event to Bharat Serums and Vaccines Limited medication’ as described below.
What is an adverse event?
An adverse event is any undesirable experience associated with the use of a medicinal product in a patient. It is commonly referred to as ‘side effect’.
Why report adverse events?
It ensures that we don’t miss out on important data which could help us use our medicines more effectively and safely.
It helps in identifying rare adverse effects, unexpected/unknown adverse effects, drug/food interactions with medications, unknown risk factors and long-term safety profile of the medications
What to report? (Necessary minimum information)
1. Patient particulars
This identifies the person who experienced the Adverse Event.
The particulars include initials, age, sex etc.
2. Event particulars
These describe the symptom/sign. Additional data include: onset, course and outcome of the event.
3. Reporter details
You should provide your name, address and phone number as you may need to be contacted for further information
If you are not a healthcare professional, provide details of the prescribing doctor too.
4. Drug details
These include name, batch number, dosage etc. of the medicinal product suspected to cause the adverse event
How to report?
You can report the Adverse Event by downloading the Adverse Event Report Form and sending it to pharmacovigilance unit of Bharat Serums and Vaccines Limited through one of the modes provided further below
You may contact the pharmacovigilance unit of Bharat Serums and Vaccines Limited at
Fax: +91- 22-45043355
Phone: +91- 22-45043347
Address: Clinical Research & Pharmacovigilance,
Bharat Serums and Vaccines Ltd.,
3rd Floor, Liberty Tower, Plot No. K-10, Behind Reliable Plaza,
Kalwa Industrial Estate, Airoli, Navi Mumbai, India – 400708.