Pharmacovigilance Policy

Revora Healthcare Private Limited is committed to patient safety and the quality of its products. We monitor the safety of every product we market, and we take every report of a suspected adverse drug reaction (ADR) or product quality issue seriously.

This policy explains how we collect, handle and report safety information, and how you can report a side effect or quality concern to us.

Pharmacovigilance is the science and activity of detecting, assessing, understanding and preventing adverse effects or any other medicine-related problems. All pharmaceutical companies licensed in India are required by the Drugs and Cosmetics Act, 1940 (and Schedule Y and the Pharmacovigilance Programme of India) to monitor the safety of their products and report adverse events to the Central Drugs Standard Control Organisation (CDSCO).

We go beyond the legal minimum — our Drug Safety Team actively reviews every report, whether serious or non-serious.

Anyone can report a suspected side effect or product quality issue:

• Patients and carers
• Doctors, ophthalmologists, orthopaedic surgeons and other medical practitioners
• Pharmacists and chemists
• Nurses and other healthcare professionals
• Distributors, stockists and channel partners

You do not need to be certain that the product caused the problem. If you suspect a link, please report it. No report is too small.

Email: safety@revorahealthcare.com
Phone: +91 88666 44642
Hours: [Monday to Saturday, 10 am to 6 pm IST]

Postal / in-person:
Drug Safety Team — Pharmacovigilance
Revora Healthcare Private Limited
A-303, 3rd Floor, S.G. Business Hub, B/s Bhagvat Petrol Pump, Nr. Gota Over Bridge, S.G. Highway, Ahmedabad, Gujarat 382470, India

You can also report directly to the Pharmacovigilance Programme of India (PvPI) at the national coordination centre, IPC Ghaziabad. PvPI national helpline: 1800-180-4722 (toll free).

The more detail you can provide, the better we can assess the report. Even a partial report is valuable — please do not let missing information stop you from reporting.

Useful information includes:

• The product name, batch number and expiry date (printed on the pack or carton).
• A description of what happened and when it started.
• The patient's initials or “anonymous” (no full name is needed), age, and gender.
• Any other medicines the patient was taking at the same time.
• The indication the product was being used for, and the dose.
• What action was taken (e.g. product stopped, dose reduced) and the current outcome.
• Your contact details, so we can follow up if needed.

• Acknowledgement: We acknowledge every report within 5 working days.
• Assessment: Our Drug Safety Team assesses the report for causality, seriousness and expectedness, using established pharmacovigilance methods.
• Follow-up: We may contact you for additional information. You are under no obligation to provide it.
• Regulatory reporting: Serious and unexpected adverse events are reported to CDSCO within the timeframes set by Indian pharmacovigilance regulations. All ADR reports are forwarded to PvPI as required.
• Signal detection: We review reports in aggregate over time to detect any new safety signals and, where necessary, update product labelling or take other risk-minimisation measures.
• Confidentiality: Your identity and the patient's identity are kept confidential. Patient data shared with regulators is de-identified wherever possible.

If you notice a product quality issue — such as a foreign particle, incorrect colour, broken seal, suspected counterfeit, or any change in appearance — please report it to our Drug Safety Team using the same contact details in section 4.

Please keep the original pack and do not destroy it, as it may be needed for investigation.

Safety reports contain personal and health information. We handle it in accordance with our Privacy Policy. Safety records are retained for as long as drug safety regulations require, even if you subsequently ask us to delete other information about you.

As a licensed pharmaceutical company in India, we are obligated to:

• Maintain a pharmacovigilance system and appoint a qualified person responsible for pharmacovigilance.
• Collect and evaluate ADR reports and report serious ADRs to CDSCO within 15 calendar days (for fatal/life-threatening events) or 30 calendar days (for other serious events).
• Submit periodic safety update reports (PSURs) as required.
• Cooperate with any regulatory inspection or audit of our pharmacovigilance activities.

If you or the patient needs urgent medical attention, call emergency services (112) or go to the nearest hospital immediately. Do not delay emergency care to make a report. You can report the side effect to us afterwards.

We may update this policy from time to time to reflect changes in law or our practices. The “Last updated” date at the top shows the current version.

Use the form below to submit a report directly to our Drug Safety Team at safety@revorahealthcare.com. All fields marked * are required.