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Newsletter ISSN:23207760PHARMACOVIGILANCE Program OF INDIA (PPI)VOL 6 l ISSUE 14 l 2016Pharmacovigilance in Drugs & Cosmetics Act 1940 & Rules 1945Govt of India Launched BedaquilineNew Anti TB drug

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How to fill out pharmacovigilance programme of india

01

Step 1: Collect all the necessary information about the drug or medical product to be included in the Pharmacovigilance Programme of India (PvPI). This includes details such as brand name, generic name, manufacturer details, therapeutic indication, dosage form, etc.

02

Step 2: Prepare a comprehensive adverse drug reaction (ADR) reporting form that includes all the required fields for reporting ADRs. The form should capture information such as patient details, drug details, suspected adverse reaction, concomitant medications, etc.

03

Step 3: Train the healthcare professionals involved in the PvPI on the process of identifying and reporting adverse drug reactions. This includes training them on how to fill out the ADR reporting form accurately.

04

Step 4: Establish a system for collecting, collating, and analyzing the reported ADRs. This may involve setting up a dedicated database or using existing reporting systems.

05

Step 5: Ensure regular and timely reporting of ADRs to the National Coordination Centre (NCC) for PvPI. The NCC serves as the central coordinating unit and repository for all ADR reports.

06

Step 6: Monitor and review the collected ADR data to identify any potential safety concerns or trends. This helps in early detection and prevention of adverse drug events.

07

Step 7: Take necessary actions based on the findings of the ADR analysis. This may include updating product labels, issuing safety alerts or advisories, conducting further investigations, etc.

08

Step 8: Maintain accurate and updated records of all ADR reports and actions taken. This information is crucial for future reference and for ensuring compliance with regulatory requirements.

Who needs pharmacovigilance programme of india?

01

Pharmaceutical companies manufacturing and marketing drugs in India need to implement the Pharmacovigilance Programme of India in order to monitor the safety of their products and comply with regulatory requirements.

02

Healthcare professionals including doctors, nurses, and pharmacists play a crucial role in pharmacovigilance. They need to actively participate in the programme to report adverse drug reactions and contribute to the overall safety monitoring.

03

Patients and consumers of medications also benefit from the Pharmacovigilance Programme of India as it helps in ensuring the safety and effectiveness of drugs available in the market. Reporting any observed adverse reactions can contribute to improving patient care and preventing harm.

04

Regulatory authorities, such as the Central Drugs Standard Control Organization (CDSCO), need the data collected through the programme to assess the safety profiles of drugs and take appropriate regulatory actions if necessary.

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What is pharmacovigilance programme of india?

The Pharmacovigilance Programme of India (PvPI) is a nationwide programme for monitoring, collection, analysis, and reporting of adverse drug reactions.

Who is required to file pharmacovigilance programme of india?

All pharmaceutical companies, clinical research organizations, and marketing authorization holders are required to file the Pharmacovigilance Programme of India.

How to fill out pharmacovigilance programme of india?

The Pharmacovigilance Programme of India can be filled out online through the PvPI website by providing the necessary information and documentation.

What is the purpose of pharmacovigilance programme of india?

The purpose of the Pharmacovigilance Programme of India is to ensure the safety of drugs and protect public health by monitoring and reporting adverse drug reactions.

What information must be reported on pharmacovigilance programme of india?

Information such as suspected adverse drug reactions, patient information, drug details, and causality assessment must be reported on the Pharmacovigilance Programme of India.

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