Safety Reporting

Pharmacovigilance

Adverse Drug Reaction (ADR) and product quality complaint reporting for Keroli Healthcare Pvt. Ltd. products.

What is an Adverse Drug Reaction?

An Adverse Drug Reaction (ADR) is any noxious, unintended response to a medicine that occurs at doses normally used in humans for prophylaxis, diagnosis, therapy of disease, or for modification of physiological functions.

It is important to report suspected ADRs because it helps us continuously monitor the safety of our products and fulfil our obligations under the Indian Pharmacopoeia Commission's Pharmacovigilance Programme of India (PvPI) and WHO requirements.

CDSCO PvPI Portal WHO VigiFlow

Pharmacovigilance Contact — Keroli Healthcare

PV Officer

[Pharmacovigilance Officer Name]

Email (24/7)

pharmacovigilance@kerolihealthcare.com

Phone

18002152114

Postal Address

Unit No. 202, Building No. 5, Viraj Industrial Estate, HDIL, Virar East, Palghar – 401305, Maharashtra, India

Report an Adverse Event

All fields marked * are required. All reports are treated confidentially and forwarded to the PvPI programme as required.

Reporter Type *

Your Name (optional)

Your Email (optional)

Suspect Product Name *

Batch / Lot Number (if available)

Description of Adverse Event *

Date Event Occurred

Patient Age (approximate)

Outcome

I consent to Keroli Healthcare Pvt. Ltd. processing this report for safety monitoring purposes and sharing it with the CDSCO Pharmacovigilance Programme of India (PvPI) as required by law. I understand that my personal details (if provided) are optional and will be treated confidentially in accordance with the Privacy Policy.

If this is a medical emergency, please contact emergency services immediately. This form is for post-event reporting only.