Health ministry releases Mobile APP for ADR reporting, Pharmacovigilance guidelines,
New Delhi: The Secretary, Ministry of Health and Family Welfare, Government of India has launched a mobile app for ADR reporting and pharmacovigilance guidelines for marketing authorization holders of pharmaceutical products in order to ensure the ease of doing pharmacovigilance (PV) practices by the industry.
NCC-PvPI have developed an advanced version of the Android mobile app “ADR PvPI” which empowers all the healthcare professionals and consumers for Adverse Drugs Reaction (ADR) reporting. This new app has been developed to have administrative control of data with IPC, NCC-PvPI with the features like supporting source document and image attachment, supporting HCPs as well as consumer reporting, XML generation, and auto-filling of report details to save time
In order to ensure smooth functioning of Pharmacovigilance activities by Pharmaceutical industries, NCC-PvPI, Indian Pharmacopoeia Commission (IPC) in collaboration with Central Drugs Standard Control Organization (CDSCO) has developed Pharmacovigilance Guidance for Marketing Authorization Holders of Pharmaceutical Products.
This Pharmacovigilance guidance document is introduced for the first time by the Government of India for Pharmaceutical industries which aim to establish and ensure an effective Pharmacovigilance system at their site as per recent amendment in Drugs & Cosmetics Rules, 1945, Schedule Y vide Gazette Notification G.S.R. 32 (E) published on 08 Mar 2016.
Apart from ADR reporting, the guidelines also comprises of pharmacovigilance system master file; collection, processing and reporting of individual case safety reports; preparation and submission of periodic safety update report; quality management system at marketing authorization holder organization; audits and inspections of pharmacovigilance system at at marketing authorization holder organization; and submission of risk management plan
PV practices include ADR case processing and reporting, periodic safety update report, periodic benefit-risk evaluation report, periodic adverse drug experience report, product quality complaints management, medical inquiries management, safety data exchange agreement management, signal detection for risk-benefit evaluation, risk management programmes, literature monitoring for ADR case reports, training of company employees on ADR reporting, global compliance monitoring, audits and inspections.
Pharmacovigilance obligations of a pharmaceutical company can be met by setting up in-house systems for pharmacovigilance or the company can enter into contractual arrangements with contract research organizations (CROs) who are specialized in pharmacovigilance function.