Adverse Event Reporting

Precise Group has a strong commitment to manufacturing quality products. We at Precise are firmly committed towards the efficacy and safety of our products. Any medicine may cause side effects in some patients. "Some information" on side effects and related risks may be known only after a drug is consumed in large numbers of patients across a wider population. We want to make sure that the therapeutic benefits of the medicine outweigh the risks.

We would like to know about every adverse event that occurs in patients after taking our medication. Reporting any issue related to the safety or quality of our medicines is mandatory for every Precise Group employee if she/he becomes aware of such instances. Every adverse event report is entered into a database and assessed, thus ensuring compliance with applicable regulations.

What is an adverse event?

An adverse event is any undesirable experience associated with the use of a medicinal product in a patient. It is commonly referred to as a “side effect”.

It includes:

Undesirable symptoms and signs e.g. headache, vomiting, abnormal ECG
Medication errors e.g. wrong dose, intravenous administration instead of intramuscular
Overdose
Misuse and Abuse
Use in pregnancy and breastfeeding
Product technical complaints e.g. discolored or deteriorated products, improper labelling

Why should I report an adverse event?

We don’t want to miss out on important data which could help us use our medicines more effectively and safely. If you report an adverse event It would also help us identify rare adverse effects, unexpected/unknown adverse effects, drug/food interactions with medications, unknown risk factors and long-term safety profile of the medications

What to report? (Necessary minimum information)

1. Patient particulars

This identifies the person who experienced the Adverse Event.
The particulars include initials, age, gender etc.

2. Event particulars

These describe the symptom/sign. Additional data include: onset, course and outcome of the event.

3. Reporter details

You should provide your name, address and phone number as you may need to be contacted for further information.

If you are not a healthcare professional, provide details of the prescribing doctor too.

4. Drug details

These include name, batch number, dosage etc. of the medicinal product suspected to cause the adverse event.

Who can report?

All Healthcare Professionals (including Doctors, Dentists, Pharmacists, Nurses etc.) and Consumers can report adverse events/drug reactions.

How do I report?

If you wish to report a suspected adverse reaction/side effect that occurred with our drug, you can report it by choosing any of the following options:

Call our Phone No. +91- 22-67828600, Monday to Friday, between 9:30 am to 6.00 pm.
Complete and submit the Adverse Event Reporting (AER) form online available on this website.

You may contact the pharmacovigilance unit of Precise Biopharma Pvt. Ltd. at
E-mail: pvglobal@precisegroup.co.in

Address: Precise Biopharma Pvt. Ltd.

E-311/312, 3rd Floor, Eastern Business District, Neptune Mall, L.B.S. Road, Bhandup (W), Mumbai - 400078, INDIA.

Confidentiality : The patient's identity is held in strict confidence and protected to the fullest extent. The company shall not disclose the reporter’s identity in response to a request from the public.