The Union health ministry is likely to come out with pharmacovigilance guidelines very soon after due deliberations with the stakeholders. The guidelines will feature pertinent areas like signal detection for risk-benefit evaluation and risk management programmes.

“We have received feedback on the draft guidelines released recently and will be released soon after due deliberations. Post-release, market authorisation holders (MAH) will be given six months time to implement the guidelines,” according to an official associated with the development.

Indian Pharmacopoeia Commission (IPC), Ghaziabad had released the much awaited revised draft guidelines on post marketing surveillance of pharmaceutical products in India recently.

Signal management is not compulsory in the present set of guidelines. Risk benefit of the product can be measured properly through signal detection.

MAH has been mandated to set up pharmacovigilance (PV) cell in their companies in accordance with the Drugs and Cosmetics Rules, 1945 to collect, process and forward the report to the licensing authority for information on 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 company can meet their pharmacovigilance obligations either by setting up in-house systems for pharmacovigilance or can enter into contractual arrangements with contract research organizations (CROs) specializing in pharmacovigilance function.

The SOPs are expected to cover all pharmacovigilance functions and should be structured comprehensively detailing the necessary steps. Since pharmacovigilance involves global operations, clearly written SOPs ensures consistency, compliance, and quality, clear assignment of roles and responsibilities, uniform performance over multiple users to avoid errors of oral communication.

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.