Safety & Compliance

Report an Adverse Event

Your safety is our top priority. If you or someone you know has experienced a side effect or adverse reaction after using one of our medicines, please report it immediately. Every report helps us monitor drug safety and protect patient health.

Why to Report?

Detection of unknown safety issues associated with medicines.
Detection of increases in frequency of known safety issues associated with medicines.
Identification of risk factors.
Quantifying risks associated with medicines.
Preventing patients from being adversely affected unnecessarily after medicine intake.
Patient safety.
Compliance / Regulatory Requirements.

When to Report?

Within 24 hours of noticing any adverse event or adverse drug reaction (AE/ADR) / product quality complaint.

Who Can Report?

Any health care professionals (such as physicians, pharmacists, dentists, nurses etc.) and consumers (such as patients, family members, caregivers etc.)

How to Report?

For adverse events or product quality complaints, please fill adverse event form and email to SHLPV@Shalina.com or directly call on the PV Helpline Number 022-65384603.

Download Adverse Event Form

What to Report?

If you get to know that an adverse event has occurred, collect the below minimum information:

Details of the Patient: Characterised by initials, patient identification number, date of birth, age or gender.
Details of the Reporter: Characterised by qualification (e.g. physician, pharmacist, other healthcare professional, lawyer, consumer or other non healthcare professional), name, initials or address.
A Shalina Suspect Drug: One or more suspected substance/medicinal product, concomitant product, treatment product with indication of use.
Adverse Event (AE): One or more suspected adverse event (may or may not be related to Shalina product).

Confidentiality of the Events Reported

The patient's and reporter's identity are handled with strict confidentiality. Company shall not disclose the reporter's or patient's identity in response to a request from the public.