Drug Safety Reporting

Immediate Medical Emergency Notice: If you or someone in your care is experiencing a life-threatening medical emergency or severe allergic reaction, please contact your local emergency number immediately (112 in India, 911 in the US, or local emergency medical helpline). This form is dedicated to pharmacovigilance safety surveillance and cannot replace urgent medical intervention.

24x7 Safety Helpline

Pharmacovigilance Active Desk

Our global drug safety team is available 24 hours a day, 7 days a week to receive adverse reaction reports concerning any RPG Life Sciences formulation.

Toll-Free Phone+91 (022) 2498 1234 / 1800-266-7745

Dedicated Safety Emailpharmacovigilance@rpgls.com

Pharmacovigilance Unit

RPG Life Sciences Ltd, RPG House, 463 Dr. Annie Besant Road, Worli, Mumbai — 400 030, India.

What Constitutes an Adverse Event?

Under CDSCO, WHO GVP, and ICH guidelines, an Adverse Event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with the treatment.

Unintended side effects or unexpected physical reactions
Lack of anticipated therapeutic efficacy
Medication errors, overdose, misuse, or accidental exposure
Drug interactions with concomitant therapies or food
Adverse pregnancy outcomes or fetal exposure during gestation

Confidentiality & Data Privacy

Information provided on Form F-08 is strictly protected under the Digital Personal Data Protection (DPDP) Act 2023 and global Good Pharmacovigilance Practices.

De-identified patient recording (initials only)
Zero persistence in public databases or commercial CRMs
Secure end-to-end TLS dispatch directly to safety officers

Download Offline Form F-08 (PDF)

CDSCO / WHO GVP Standard

Form F-08: Adverse Event Submission

Encrypted Protocol

Reporter Identification

You are reporting as *

Reporter Full Name *

Email Address *

Contact Phone Number *

Hospital / Clinic / Organization

Patient Demographics (De-Identified)

To preserve patient privacy under statutory regulations, please do not enter full names or identity records.

Patient Initials *

Age / Age Unit *

Gender *

Suspected RPGLS Product

Product / Brand Name *

Batch / Lot Number (if available on packaging)

Daily Dosage & Frequency

Therapy Start Date

Therapy Stop Date (or ongoing)

Adverse Reaction & Event Details

Onset Date of Reaction *

Description of the Adverse Event / Symptoms *

Seriousness Criteria (Check all that apply)

Inpatient Hospitalization / Prolonged Hospital StayLife-Threatening EventSignificant Disability or IncapacityCongenital Anomaly / Birth DefectRequired Intervention to Prevent Permanent DamageOther Medically Significant Condition

Outcome of the Event *

Other Concomitant Medications Taken

I confirm that the information submitted above is true to the best of my knowledge and understand that it will be utilized solely for scientific drug safety surveillance, pharmacovigilance evaluation, and regulatory reporting in compliance with CDSCO and international Good Pharmacovigilance Practices (GVP).

Submissions are processed by RPG Life Sciences Global Pharmacovigilance Unit under strict regulatory audit trails.