Health ministry issues circular to state drug controllers to get feedback on draft PV guidelines

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To better the prospects of pharmacovigilance practice in the country, Union health ministry has issued a circular to all the state drug controllers to give their feedback on new set of draft guidelines on pharmacovigilance (PV). The recommendations for this were recently received from the stakeholders at the centre and will be released soon after receiving comments from all the state drug controllers of the country.

“Since state drug controllers are going to play a crucial role in ushering good PV practices in the country based on a set of guidelines, feedback and comments on the new set of draft guidelines from state drug controllers will be the last and final step in consolidating PV guidelines towards drug quality and patient safety,” according to a senior health ministry official associated with the development.

Union health ministry had recently received recommendations from the concerned stakeholders to take forward pertinent aspects of PV like signal detection for risk-benefit evaluation and risk management programmes with a multi-stakeholder approach..

This is a positive development as the government has mandated market authorisation holders (MAH) to set up PV cell in their companies in accordance with the Drugs and Cosmetics Rules, 1945 to report adverse drug reactions (ADRs) emerging from the use of the drug manufactured or marketed by the respective MAH in the country through a gazette notification on March 8, 2016.

The drug exporting pharmaceutical companies can set up a PV system to fulfill its legal tasks in relation to pharmacovigilance, design to monitor the safety of authorised medicinal products and detect any change to their risk-benefit balance.

A pharmaceutical companies are expected to meet their pharmacovigilance obligations either by setting up in-house systems or can enter into contractual arrangements with contract research organizations (CROs) specializing in pharmacovigilance function.

Typical activities in PV department are ADR case processing and reporting (electronic or hard copy), Periodic Safety Update Report (PSUR), Periodic Benefit Risk Evaluation Report (PBRER), Periodic Adverse Drug Experience Report (PADER), product quality complaints management, medical inquiries management, safety data exchange agreement management, signal detection for risk-benefit evaluation, risk management programmes (RMP), literature monitoring for ADR case reports (including local literature monitoring, EU MLM search), training of company employees on ADR reporting, global compliance monitoring, audits and inspections.

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