Instructions to fill the Adverse Event/Product Complaint Reporting Form

Dear Consumer/Healthcare professional,

You have been provided here with instructions to fill all the sections of the form. Apart from this, there is a ready access to
specific instructions in different sections of the form when you fill the form online. It is compulsory to fill all the information
marked with an asterix (*).

Reporter’s Details


Please provide your name since you are reporting the event.

Patient Information

Name or Initials:

Enter name or initials accurately. This is essential to facilitate identification and to locate the patient if needed.

Age or Date of Birth:

Provide the most precise information available. Enter the birth date, if known or age in years.


Select appropriate option of gender.

Suspect Products’ Information
  • You can provide information on suspectBiocon product.
  • Please provide accurate names of the suspected medicinal product (brand name and generic name), the dosage form it is available for use (tablet/injection/liquid/syrup/solution etc.), and strength in mg or mg/ml or as appropriate (example 500mg or 25 mg/ml).
  • Provide accurate lot no / batch no
  • If accurate dates of use are not known please provide the approximate duration of use in hours/days/weeks/months or years.
Adverse Event/Side Effect Information

Enter the date and time of the onset of the adverse event/side effect, date and time of the end of adverse event (if the adverse event has stopped). If accurate dates are not known, please provide the approximate duration of the event.

Event Description or product complaint description
  • If you are lodging a product complaint explain here in detail the same.
  • Indicate clearly the adverse event name or diagnosis of the event (if you are health care professional).
  • Describe the event with detailed description of what happened and a summary of all relevant clinical information
Outcome of the event
  • Check the appropriate block to indicate the outcome of the event - whether recovered completely, not recovered, recovered with sequelae or fatal and provide dates where ever they are required to be filled in the form.
  • If the information for all of the above is not available, check in the block for unknown.
  • Check in the appropriate block to indicate whether the event appeared again after stopping the therapy and whether the events reappear again after rechallenge of the drug.
  • If it reappeared, how long the treatment lasted until reappearance.