MoU for effective implementation of Pharmacovigilance system in India

The Training Programme was intended to provide a platform for the NABH-Accredited Hospitals to understand the systems and procedures involved in ADR-reporting and relevant practices.

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Last Updated on March 27, 2021 by The Health Master

The Pharmacovigilance Programme of India (PvPI) has signed a Memorandum of Understanding (MoU) with the National Accreditation Board for Hospitals and Healthcare Providers (NABH) for effective implementation of pharmacovigilance system in the country.

For implementing the same, the Ghaziabad-based Indian Pharmacopoeia Commission (IPC), which is the National Coordination Centre (NCC) for PvPI recently organised a Virtual Training on Pharmacovigilance for NABH Accredited Hospitals in India.

IPC
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The Training Programme was intended to provide a platform for the NABH-Accredited Hospitals to understand the systems and procedures involved in ADR-reporting and relevant practices.

The resource persons for virtual training included experts from NABH, IPC, PvPI and ADR Monitoring Centre who trained the participants during the training.

A total of 131 participants from across the country attended the training programme. The training programme was aimed to enhance the involvement of NABH Hospitals in monitoring and reporting of ADRs to PvPI.


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The virtual training programme is expected to strengthen the pharmacovigilance activity at their respective organizations in order to protect the safety and well-being of the patients.

During the training programme, Dr Rajeev Singh Raghuvanshi Secretary-cum-Scientific Director, IPC, motivated the participants to report Adverse ADRs and enroll their organization as ADR Monitoring Centres (AMC) under PvPI.

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He emphasized that pharmacovigilance part of drug intervention is important not only during the drug development process but also after marketing authorization.

The NABH has also granted further extension of validity of accreditation or certification till March 31, 2021 under accreditation, certification and empanelment programmes considering the ongoing pandemic situation.


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This is in continuation to the earlier NABH notification dated June 25, 2020 regarding extension of validity of accreditation/certification.

NABH is a constituent board of Quality Council of India (QCI), set up to establish and operate accreditation programme for healthcare organisations.

NABH had resumed assessments of health care organisations (HCOs) from July, 2020 onwards against the applications received under accreditation, certification and empanelment programs. It has now decided to grant further extension of validity of accreditation/certification till March 31, 2021 or till the decision on the renewal application is taken by NABH, whichever is earlier.

NABH secretariat has also started approaching HCOs which have already submitted the applications for renewal for the dates for scheduling of re-assessments.

Further, all the terms and conditions for eligibility of extension of validity mentioned in earlier issued notification dated June, 2020 will apply and are as under for ready reference.

The HCOs which have already applied for re-accreditation/re-certification shall be eligible for further extension of validity of accreditation till March 31, 2021 or till the decision on the renewal application is taken by NABH, whichever is earlier.

The HCOs seeking extension of validity will be required to ensure compliance to the applicable NABH standards during the extended period of validity and submit declaration to this effect.

The HCOs will also be required to update the C-19 status along with the number of beds dedicated for C-19 patients.

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