Advances in Pharmacoepidemiology and Drug Safety

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

Alkesh K Lokhande, M M Prabhu, M K Unnikrishnan, Girish Thunga and M Surulivel Rajan

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.