DCGI Directs Manufacturers To Submit PSURs Every Six Months

Mumbai, 5 Dec 2019:

The Drugs Controller General of India (DCGI) has directed manufacturers to submit Periodic Safety Update Reports (PSURs) every six months for the first two years for veterinary products in India as part of the Pharmacovigilance Programme of India (PvPI).

This should be followed in accordance to the conditions for grant of approval in Form 45 and Form 46 of the Drugs and Cosmetics (D&C) Act, 1940 and rules there under.

For subsequent two years, the PSURs shall be submitted annually, the DCGI further clarified.

According to DCGI, “The move comes in the wake of various stakeholders of the veterinary products having raised concern regarding the clarification with respect to Pharmacovigilance reporting for veterinary products in India.”

Typical activities in PV practices include ADR case processing and reporting (electronic or hard copy), PSURs, Periodic Benefit Risk Evaluation Report (PBRER), Periodic Adverse Drug Experience Report (PADER).

It also includes product quality complaints management, medical inquiries management, safety data exchange agreement management, signal detection for risk-benefit evaluation, risk management programmes (RMP), training of company employees on ADR reporting, global compliance monitoring, audits and inspections.

Ghaziabad based Indian Pharmacopoeia Commission (IPC) under the union health ministry have also released guidelines on post marketing surveillance of pharmaceutical products in India to ensure pharmacovigilance practices to usher in a timely manner.

As part of PvPI, Market Authorization Holders (MAHs) have been mandated to set up pharmacovigilance cell in their companies in accordance with the D&C Rules, 1945 to collect, process and forward ADRs reports to the licensing authority emerging from the use of drug manufactured or marketed by the respective MAH in the country.

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. Pharmabiz