ADVERSE EVENT REPORTING
We at BSV are firmly committed towards the efficacy and safety of our products. Any medicine may cause side effects in some patients. "Some information" on side effects and related risks may be known only after a drug is consumed in large numbers of patients across a wider population. We want to make sure that the therapeutic benefits of the medicine outweigh the risks.
We would like to know about every adverse event that occurs in patients after taking a BSV medication. Reporting any issue related to the safety or quality of our medicines is mandatory for every BSV employee if she/he become aware of such instances. Every adverse event report is entered in a database and assessed, thus ensuring compliance with applicable regulations.
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 a “side effect”.
- Undesirable symptoms and signs e.g. headache, vomiting, abnormal ECG
- Medication errors e.g. wrong dose, intravenous administration instead of intramuscular
- Misuse and Abuse
- Use in pregnancy and breastfeeding
- Product technical complaints e.g. discolored or deteriorated products, improper labeling
Why should I report an adverse event?
We don’t want to miss out on important data which could help us use our medicines more effectively and safely. If you report an adverse event It would also help us identify 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, gender 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.
Who can I report to?
You can report to:
Any health care professional (Doctors, Dentists, Nurses, Pharmacists,Patients etc)
Non healthcare professional (Patient, relative, friend, etc)
How do I report?
If you wish to report a suspected adverse reaction/side effect that occurred with our drug, you can report it by choosing any of the following options:
Call our PV Phone No. +91- 22-45043347, Monday to Friday, between 9:00 am to 5:30 pm. (After office hours, you can keep message which will be auto recorded).
Complete and submit the Adverse Event Reporting (AER) form online available on this website.
Clinical Research & Pharmacovigilance,
Bharat Serums and Vaccines Limited (BSV).,
3rd Floor, Liberty Tower, Plot No. K-10, Behind Reliable Plaza,
Kalwa Industrial Estate, Airoli, Navi Mumbai, India – 400708.
Confidentiality : The patient's identity is held in strict confidence and protected to the fullest extent. The company shall not disclose the reporter’s identity in response to a request from the public.