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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

2. Reporter Information

Please Specify :-

3. Suspected Medicine

Starting Date :
Stopped Date :

Did AE improve after stopping or reducing drug?

Did AE reappear after reintroduction?

4. Adverse Event Description

( Action Taken After Reaction )
Starting Date :
Stopped Date :

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

Post Mortem / Autopsy Performed?

6. Please Provide Any Relevant Information About AE

7. Relevant Medical History / Concurrent Diseases

8. Concomitant Medication

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)

To report adverse events, we recommend you to use the email address. 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 answers to questions we're often asked.

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