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Reporting Adverse Drug Events

Adverse Event Reporting

Patient safety is our highest priority. Continuous monitoring of medicine safety helps ensure that treatments remain safe and effective for patients.

If an adverse drug event (ADE) or any unexpected reaction is suspected with a medicine facilitated through us, it should be reported promptly. Reporting adverse events supports accurate safety monitoring and helps improve patient care.

Patients are advised to seek medical advice from their treating healthcare provider for any adverse event. Patients participating in a clinical trial should report the event directly to their coordinating study site, as per trial protocol.

End-to-End Regulatory
Support:

We provide comprehensive support for every step of the Named Patient Program process. From securing CDSCO approvals and DGFT import permits to preparing all legal documents, we make the journey seamless for healthcare providers. Our regulatory team ensures that each patient's access request is handled with precision, reducing delays and safeguarding compliance.

Adverse Event Reporting Form

1. Patient Details

1.1. Patient Name :

1.2. Date of Birth :

1.3. Age :

1.4. Gender :

Male Female Other

1.5. Weight in kg/lbs :

1.6. Height in cm/ft :

1.7. Additional Information :

2. Reporter Information

2.1. Reporter's Name :

2.2. Reporter's Address :

2.3. E-mail :

2.4. Reporter Qualification :

Physician Pharmacist Other

Please Specify :-

2.5. Country :

2.6. Phone Number :

2.7. Date :

3. Suspected Medicine

3.1. Medicine Name :

3.2. Manufacturer :

3.3. Batch :

3.4. Expiry :

3.5. Indication :

3.6. Dose :

3.7. Route :

3.8. Frequency :

3.9. Treatment :

Starting Date :

Stopped Date :

3.10. Causality Assessment :

Did AE improve after stopping or reducing drug?

Yes No N/A

Did AE reappear after reintroduction?

Yes No N/A

4. Adverse Event Description

( Action Taken After Reaction )

4.1. Symptom(s) :

4.2. Treatment :

Starting Date :

Stopped Date :

4.3. Intensity :

Mild Moderate Severe

4.4. Outcome :

5. Seriousness ( Is the Adverse Event Serious )

Death

Immediate
Life-Threatening

In-patient Hospitalization
/ Prolonging Existing

Resulting in Persistent /
Significant Disability

Congenital Abnormality /
Birth Defect

If Death, Specify Cause :

Date of Death :

Post Mortem / Autopsy Performed?

Yes No N/A

6. Please Provide Any Relevant Information About AE

7. Relevant Medical History / Concurrent Diseases

8. Concomitant Medication

8.1. Medicine Name :

8.2. Manufacturer :

8.3. Batch :

8.4. Indication :

8.5. Dose :

8.6. Route :

8.7. Frequency :

8.8. Treatment :

Starting Date :

Stopped Date :

I accept that all enquiries submitted to "Adverse Event Reporting" are sent to the Sun Pharma global pharmacovigilance team, headquartered in India. I accept that my personal data are shared with the relevant local team. I accept the Sun Pharma general Privacy Policy, described here.

If you would like to send us information by post, please download the form and mail to the following address:

Global Pharmacovigilance Department

Ikris Pharma Network 905 I-Thum Business Park Plot No. - 40, Block A, Unit No. 5,

Tower A Sector 62, Noida 201301 (INDIA)

Toll Free Number : 1-800-309-8112 (Toll free throughout India)

DrugSafety@sunpharma.com

To report adverse events, we recommend you to use the email address DrugSafety@sunpharma.com. If more information specific to your Country is required, you may also navigate to the Worldwide tab available on the website.

Frequently Asked

Questions

Here are answer to questions
we're often asked.

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Reporting Adverse Drug Events

Adverse Event Reporting

End-to-End Regulatory Support:

Adverse Event Reporting Form

1. Patient Details

2. Reporter Information

3. Suspected Medicine

Did AE improve after stopping or reducing drug?

Did AE reappear after reintroduction?

4. Adverse Event Description

5. Seriousness ( Is the Adverse Event Serious )

Post Mortem / Autopsy Performed?

6. Please Provide Any Relevant Information About AE

7. Relevant Medical History / Concurrent Diseases

8. Concomitant Medication

Frequently Asked

Questions

End-to-End Regulatory
Support: