Voluntary
Reporting Form

For reporting adverse events, side effects,
and/or product quality complaints for
Biocon Biologics’ products.

Biocon Biologics Limited (BBL) is highly committed and vigilant in collecting adverse events/side effects and/or product quality complaints. 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’ product that is in question.

  • The patient taking Biocon Biologics’ medicinal product was pregnant.
  • The patient has overdosed on Biocon Biologics’ medicinal product.
  • The product quality complaints, e.g., discolored or damaged products.
  • Abuse/misuse, Lack of effect, Medication and administration errors Occupational exposure or Suspected transmission of infectious agents via a medicinal product (STIAMP).
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Who can report

Health care
professionals

Doctors, Dentists, Nurses, Pharmacists

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

Non-Healthcare
professionals

Patients, Relatives, Friends, 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 a 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.

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.

How to report Adverse events/side effects and/or product complaint

Adverse events/side effects and/or product complaint reporting form

Email

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 our email ID : DrugSafety@biocon.com. We request you to please provide the 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 above mentioned email ID for smooth processing of your complaint at Biocon Biologics.

Call/Fax

You can also call the toll-free numbers and report the adverse events/side effects and/or product quality complaints related with the use of Biocon Biologics Products telephonically.You can also fax filled AE reporting form via fax no: +91 80 6775 5323

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ONLINE
FORM

Online Form: You can report the adverse events/side effects and/or product quality complaints for of Biocon Biologics products by filling AE reporting from online. You can follow the instructions onfor 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 acknowledgment on your email address.

Online Form >>
OFFLINE
FORM

You can download the AE reporting form, fill it out offline and can send this filled form via email (which is mentioned on the package insert / Biocon Biologics website), fax or post. The details are as mentioned below:

Download Form >>