Pharmacovigilance

Committed to Patient Safety & Product Quality

At Life Infusion Pharmaceuticals, we are committed to monitoring the safety of our products. We encourage healthcare professionals, patients, and consumers to report any adverse events, product quality complaints, or suspected side effects associated with our products.

Report an Event

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What is Pharmacovigilance?

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine-related problems. It plays a critical role in ensuring that medicines remain safe for patients throughout their lifecycle.

At Life Infusion Pharmaceuticals Private Limited, we have established a robust pharmacovigilance system to collect, evaluate, and report safety information in compliance with national and international regulatory requirements. Your reports contribute directly to improving patient safety and product quality.

What Can Be Reported?

Adverse Drug Reactions
Leakage or Container Defects
Particulate Matter
Label Mix-up
Infusion Reactions
Sterility Concerns
Product Complaints
Medication Errors

PHARMACOVIGILANCE – IV FLUID

Adverse Drug Reaction (ADR) & Drug Safety Reporting
CDSCO / PvPI Compliant | Schedule Y

Life Infusion Pharmaceuticals Pvt. Ltd. is committed to maintaining the highest standards of patient safety, product quality, and regulatory compliance. In accordance with the guidelines of the Central Drugs Standard Control Organisation (CDSCO) and the Pharmacovigilance Programme of India (PvPI), we operate a dedicated Pharmacovigilance (PV) system for the collection, assessment, monitoring, and reporting of Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs), and product quality concerns related to our IV fluid products.

What Should Be Reported

Adverse Drug Reactions (ADR)

Any unintended, harmful, or unexpected response associated with the use of our products:

  • Unexpected side effects
  • Allergic reactions
  • Patient harm following administration

Serious Adverse Events (SAE)

Events resulting in:

  • Death
  • Life-threatening conditions
  • Hospitalisation / prolonged stay
  • Persistent disability / incapacity
  • Congenital anomaly / birth defect

Product Quality Complaints

Report issues such as:

  • Visible particulate matter
  • Discolouration
  • Leakage
  • Container / closure defects
  • Incorrect labelling / packaging

Medication Errors

Examples include:

  • Incorrect product administration
  • Dose confusion
  • Dispensing errors

Lack of Efficacy

Cases where the product does not achieve the intended clinical outcome.

Regulatory Reporting Timelines

Event Type Reporting Timeline Submission Authority
Serious ADR (Fatal / Life-threatening)Within 15 Calendar DaysCDSCO / PvPI
Serious ADR (Non-fatal)Within 90 Calendar DaysCDSCO / PvPI
Non-serious ADRQuarterly / Annual PSURCDSCO
Critical Product Quality ComplaintWithin 3 Working Days (Internal)QA Department + CDSCO
Periodic Safety Update Report (PSUR)Annual SubmissionCDSCO

How to Submit a Report

Online Submission

Use our portal. Acknowledged within 24 hours.

Email Reporting

Send details to pv@lifeinfusionpharma.com

Phone Support

+91 87141 33663 (Mon–Sat, 9 AM – 5 PM)

ADR PvPI Mobile App

Submit via official app directly to the national database.

PvPI National Reporting

Report through the national helpline.

Written Submission

Send completed CDSCO form to our office.

Frequently Asked Questions

What is an Adverse Drug Reaction (ADR)?

An ADR is a harmful or unintended reaction that occurs after using a medical product. It can be a side effect, allergic reaction, or other negative outcome linked to the medicine.

How do I report a suspected ADR?

You can report through our online portal, by email to pv@lifeinfusionpharma.com, by phone, or via the PvPI mobile app. All reports are acknowledged and handled confidentially.

Is my personal information kept confidential?

Absolutely. All personal data is protected in accordance with Indian regulations. Your identity is never disclosed without legal requirement.

What happens after I submit a report?

Our pharmacovigilance team reviews your report. You will receive a ticket number for tracking. If more information is needed, we may contact you using the details provided.

Who can report an adverse event?

Anyone: healthcare professionals, patients, caregivers, or consumers. We encourage all reports to improve product safety.

Can I report product quality issues like leakage or particles?

Yes. Product quality complaints (leakage, discolouration, particulate matter, etc.) are taken very seriously and should be reported immediately.

Pharmacovigilance Contact

Pharmacovigilance Officer

Life Infusion Pharmaceuticals Pvt. Ltd.

pv@lifeinfusionpharma.com

+91 87141 33663

Kinalur, Kozhikode, Kerala, India

Registered under CDSCO / PvPI Compliance Framework.

Patient Rights & Confidentiality

All reports are handled with strict confidentiality. Personal information is protected under Indian regulations. Reporting in good faith will not result in any penalty or disadvantage. Identity details are not disclosed except where legally required.

Regulatory References

  • Central Drugs Standard Control Organisation (CDSCO)
  • Pharmacovigilance Programme of India (PvPI)
  • WHO – Uppsala Monitoring Centre (UMC)
  • Schedule Y – Drugs & Cosmetics Rules, 1945

Aligned with CDSCO guidelines & Schedule Y provisions.