ADVERSE EVENT REPORTING

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’.


It includes:

  • Undesirable symptoms and signs e.g. headache, vomiting, abnormal ECG
  • Medication errors e.g. wrong dose, intravenous administration instead of intramuscular
  • Overdose
  • Misuse and Abuse
  • Use in pregnancy and breastfeeding
  • Product technical complaints e.g. discolored or deteriorated products, improper labeling


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
E-mail: pv@bharatserums.com


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.