Periodic Safety Update Reporting of Newly Launched Drugs through Hospitals–Need of the Hour: A Drug Controller General of India Initiative

Alkeshe K Lokhand

doi:10.4172/2167-1052.1000155

Abstract

A Periodic Safety Update Report (PSUR) is comprise of most complete safety experience of drug submitted to the competent drug regulatory authorities at defined period of time. In India, PSURs for all newer drugs must be submitted every six month for first two years followed by annually for next two years to the Drug Controller General of India [DCG(I)], New Delhi. So far, it’s been mandatory only to Marketing Authorization Holders (MAHs) to submit PSURs periodically to DCG(I), New Delhi. But, since 28 August 2012 DCG(I) has made it mandatory for hospitals in India to implement PSUR system for newly introduced drugs. In country like India where, lots of irregularity seen in safety surveillance of patients. We have very less active Adverse Drug Reaction (ADR) monitoring centers in function and a lot of determination is needed in order to collect drug safety data which may be carried out through active safety surveillance of therapeutic agents. Thus it has become important to comply with the requirement of DCG(I) and address the safety concern of our hospitalized patients. PSUR is the need of the hour to in our hospitals. We have to take steps for monitoring patients who are on newly introduced drugs and generate data for the reporting of PSURs to the DCG(I). This pioneering hospital based PSUR setup will create an environment for healthy safety reporting and helps the regulatory authorities for drug safety related decisions.

Highlights

Topic have been chosen to focus on the recent trend of drug safety reporting in India and latest amendment done by Indian Drug Regulatory Authority [DCG(I)] to explore the possibilities and betterment in drug safety surveillance
While drug safety directly linked to patients that’s why geneses of such drug safety surveillance system in each hospital is very much essential
It will contribute to DCG(I), to take decision on issues related to safety of newer drugs and to validate the accuracy of drug safety data (PSURs) submitted from the Marketing Authorization Holders (MAHs) side

Summary

Introduction

Topic have been chosen to focus on the recent trend of drug safety reporting in India and latest amendment done by Indian Drug Regulatory Authority [DCG(I)] to explore the possibilities and betterment in drug safety surveillance. This pioneering model hospital based PSUR setup will create an environment for healthy safety reporting and helps the regulatory authorities for drug safety related decisions Such system will provide latest drug safety information, rationale for their use, risk-benefits, cost, outcome and effective use in clinical practice. On 28th August 2012 an order from DCG(I) office has been passed to all the MAHs of newer drugs that, they must adhere to the system and report the PSURs as indicated in Schedule Y They have given additional 3 weeks period to submit previous PSURs reports [9]. The DCG(I) office was only able to produce information for 8 drugs This action referred a poor follow-up of regulatory authority over MAHs for patient safety surveillance. It will be better if risk/benefit analysis [22,23] and cost analysis will be added to interpret and conclude result in better way

Conclusion

Periodic Safety Update Reports