india pvpi patient report

If there is any suspicion that an adverse event or adverse reaction has occurred, the health care professional attending to the patient, can fill up the suspected ADR form or if a patient suspects that he/she has experienced an ADR can report to the nearest ADRs Monitoring Centres (AMCs) under Pharmacovigilance Programme of India (PvPI).

Full Answer

What is the vision of pvpi?

The vision of PvPI is to improve patient safety and welfare in Indian population by monitoring drug safety and thereby reducing the risk associated with use of medicines.The ultimate safety decisions on medicines may need considerations of comparative benefit/risk evaluations between products for similar indications, so the complexity is great.

What is pharmacovigilance programme of India (pvpi)?

Since safety monitoring of medicines as an integral part of clinical practice, the Ministry of Health and Family Welfare (MoHFW), Government of India launched the nationwide Pharmacovigilance Programme of India (PvPI) in the year 2010 to inspire confidence and trust among patients and healthcare professionals with respect to medicines safety.

How are ICSRs reported to NCC under pvpi?

Once the Medical institute is enrolled as an AMC under PvPI, the AMC starts reporting ICSRs to NCC via a VigiFlow. These ICSRs are then assessed at NCC for quality of data and if found valid, they are further committed to the global drug monitoring centre “Uppsala Monitoring Centre” in Sweden.

What are the different modes of Communications of pvpi?

For this PvPI is using different modes of communications as follow: It includes press release and press briefings which are primarily intended for journalists. The Secretary-Cum-Scientific Director, IPC is the only designated authority to correspond with media, related to all activities and issues of PvPI.

When did PvPI start in India?

2010Since safety monitoring of medicines as an integral part of clinical practice, the Ministry of Health and Family Welfare (MoHFW), Government of India launched the nationwide Pharmacovigilance Programme of India (PvPI) in the year 2010 to inspire confidence and trust among patients and healthcare professionals with ...

What is main purpose of PvPI?

The purpose of the Pharmacovigilance Program of India is to collect, collate and analyze data to arrive at an inference to recommend regulatory interventions, besides communicating risks to healthcare professionals and the public.

Who controls pharmacovigilance in India?

Indian Pharmacopoeia CommissionPharmacovigilance Programme of IndiaOrganisation overviewFormed2010TypeRegulatory bodyParent departmentIndian Pharmacopoeia CommissionWebsitecdsco.gov.in/opencms/opencms/en/PvPI/

Who can report an ADR adverse drug reaction under PvPI?

Facilitates ADR reporting by health-care professionals as well as consumers. Facility to report at the nearby adverse event monitoring centers across India (presently, there are 270 adverse drug reaction monitoring centers (AMCs) across different states in India)

Who can report ADR?

All healthcare professionals (clinicians, dentists, pharmacists, nurses) and patient/consumers can report ADRs to NCC or AMCs. The pharmaceutical companies can also send individual case safety reports for their product to NCC.

When did pharmacovigilance start in India?

The program, now rechristened as the Pharmacovigilance Programme of India (PVPI) was initiated by the Government of India on 14th July 2010 with the AIIMS, New Delhi as the National Coordination Centre (NCC) for monitoring ADRs in the country for safe-guarding public health.

Why does India need pharmacovigilance?

The PvPI works to safeguard the health of the Indian population by ensuring that the benefit of medicines outweighs the risks associated with their use.

What is IND and NDA?

The Investigational New Drug (IND) application falls into the first category, while the New Drug Application (NDA), Abbreviated New Drug Application (ANDA), and Biologics License Application (BLA) fall into the second category.

What is AMC in pharmacovigilance?

Under PvPI, ADRs are being identified and spontaneously reported by the healthcare professional of Adverse Drug Reaction Monitoring Centres (AMC). These AMCs are set up across the country in medical colleges approved by Medical Council of India (MCI) (Rehan, 2013).

How do we report ADRs through PvPI?

Patient or his/her representative (relative) are encouraged to report ADRs either directly to the NCC - PvPI through toll free helpline number: 1800- 180-3024 or email id: pvpi.compat@gmail.com or to their nearest AMC under PvPI by submitting 'Medicines Side Effect Reporting form for Consumers' (blue form) which can be ...

How do I report ADR in India?

➢ Dial toll free helpline number-1800 180 3024 to report ADRs. Mailing the filled ADR reporting form directly to pvpi@ipcindia. net or pvpi.ipcindia@gmail.com. Logging on to the http://www.ipc.gov.in, http://www.ipc.gov.in/ PvPI/pv_home.

Which form used in India for reporting ADR?

Council for International Organizations of Medical Sciences (CIOMS) reporting form is the only internationally recognized format, which was designed in 1990 for reporting the ADR case information to the regulatory body.

What is IPC in medicine?

The Indian Pharmacopoeia Commission (IPC), an autonomous institution under the Ministry of Health and Family Welfare, Government of India, has been instrumental in addressing the issues related to the quality of medicines since its establishment in 2009.The year 2019 was memorable for IPC as it marked one glorious decade of its foundation with a forward looking approach. With an overall objective of contributing towards public health, IPC along with its team is committed to promote the quality of drugs and pharmaceuticals through standards setting in Indian Pharmacopoeia (IP), providing Indian Pharmacopoeia Reference Substances (IPRS) to the stakeholders, rational use of medicines by bringing out National Formulary of India (NFI), to ensure safety of medicines and medical devices through Pharmacovigilance Programme of India (PvPI). The National Coordination Centres for PvPI and Materiovigilance Programme of India (MvPI) are located at IPC.

What is the Indian Pharmacopoeia Commission?

Indian Pharmacopoeia Commission through National Coordination Centre, Pharmacovigilance Programme of India is one of the active member countries in WHO-Programme of International Drug Monitoring and is also leading the thematic area of Vigilance as part of the South East Asia Regulatory Network (SEARN).

What is signal strengthened by further analysis?

A signal may be strengthened by further analysis can help the regulatory system in performing regulatory activities. Drug regulation: After approval of a medicinal product, all available domestic and international safety information is continuously monitored by the drug regulatory authority and MAH.

What is the purpose of MCI in India?

To develop and implement pharmaco-vigilance system in India. To enrol, initially, all MCI approved medical colleges in the program covering north, south, east and west of India. To encourage healthcare professionals in reporting of adverse reaction to drugs, vaccines, medical devices and biological products.

What is the pharmaceutical sector?

The pharmaceutical sector is one of the key 25 sectors identified by the Government of India under the ambitious ‘Make in India’ initiative, which is likely to provide the necessary impetus to the sector in order to achieve its true potential.

When was the National Coordination Centre launched?

The National Coordination Centre- Pharmacovigilance Programme of India, Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Government of India was launched as a WHO Collaborating Centre for Pharmacovigilance in Public Health Programmes and Regulatory Services on 30 October 2017. The event also witnessed the launch of “National ...

PvPI Performance Report

Virtual Induction-cum-Training Programme on Pharmacovigilance for Coordinators/Deputy Coordinators of Newly Recognized AMCs and Newly Recruited Pharmacovigilance Associates at AMCs held on 31st January to 2nd February 2022

News & Highlights

Virtual Induction-cum-Training Programme on Pharmacovigilance for Coordinators/Deputy Coordinators of Newly Recognized AMCs and Newly Recruited Pharmacovigilance Associates at AMCs held on 31st January to 2nd February 2022