Voluntary Reporting Form

For reporting of adverse events/side effects and/or product quality complaints for Biocon Biologic Products.

Biocon Biologics Limited (BBL) is highly committed and vigilant in collecting adverse events/side effects and/or product quality complaints. Please help us by filling the form below in the event of adverse reactions. The information generated on the basis of these reports help us to assess the safety profile of Biocon Biologics products.

What needs to be reported?

Customers/Healthcare Professionals can report ‘Any Adverse Events / Side Effects’ and/or product quality complaints experienced with Biocon Biologics Products. Besides these, there are other scenarios/situations (cited below as examples) which can be reported to Biocon Biologics Limited for any Biocon Biologics that is in question:

• Patient taking Biocon Biologics medicinal product was pregnant.
• Patient has overdosed on Biocon Biologics medicinal product.
• Product quality complaints, e.g., discoloured or damaged products.

Who can report

Health care professionals (e.g., Doctors, Dentists, Nurses, Pharmacists) and Non-healthcare professional (Patient, relative, friend, etc).

If you are a Consumer of Biocon Biologics products and you or someone in your family has experienced an adverse event/side effect to Biocon Biologics product or if you have any product complaint, you are encouraged to report it to us by using this online voluntary reporting form.

If you are a Health Care Professional you can report the product quality complaints or adverse events/side effects experienced by your patient through this online voluntary reporting form.

After submitting the form online, you will receive an acknowledgement on your email address . You will be personally contacted only if any additional information is needed. If you require any help in filling the form, you can call our executive for online support.

a. Online Form

You can report the adverse events/side effects and/or product quality complaints for Biocon Biologics products by filling AE reporting form online. You can follow the instructions for how to fill the AE reporting form. After filling the AE reporting form with all the mandatory fields, you can successfully submit the report to Biocon Biologics Pharmacovigilance department. On successful submission, you will get an acknowledgement on your email address.

b. Offline Form

You can also download the AE reporting form, fill it out offline and can send this filled form to E-mail ID: DrugSafety@biocon.com which is mentioned on the package insert / Biocon Biologics website OR you can also fax the filled AE reporting form via fax-no: +91 80 6775 5323 OR you can post the filled AE reporting form to below address.

c. E-mail

The reporter can mention/provide the details of the adverse events/side effects and/or product quality complaints experienced by the patient while using Biocon Biologics products, to email ID : DrugSafety@biocon.com. We request you to please provide these four minimum details (patient details, reporter details, Biocon Biologics drug details taken by the patient and the adverse event details experienced by the patient) through the above-mentioned email ID for smooth processing of your complaint at Biocon Biologics

d. Call/Fax 

You can also call the below toll-free numbers and report the adverse events/side effects and/or product quality complaints related to the use of Biocon Biologics Products telephonically. 1800 102 9465 (India, Toll-free), 8005 6994 7388 (UAE, Toll-free) and 00 1833 986 1468 (U.S. & Canada, Toll-Free) OR you can also fax filled AE reporting form via fax no: +91 80 6775 5323.

e. By Post

Write to us at below mentioned postal address,
BIOCON BIOLOGICS Limited
Biocon Biologics Pharmacovigilance,
Tower 3, Semicon Park,
Plot No 29-P1 & 31-P, KIADB Industrial Area,
Electronic City Phase – 2,
Bangalore, Karnataka, India – 560100

Disclaimer : Biocon Biologics is committed to hold patient’s and reporter’s personal data in strict confidence. Personal data, here, means any information by which a person is, directly or indirectly, identified or identifiable which includes but is not limited to name, address, contact number, email address, genetic data and data concerning health. Biocon Biologics strictly adheres to applicable data privacy and data integrity laws including but not limited to General Data Protection Regulations [EU] 2016/679 [“GDPR”] or its equivalent, as amended from time to time.