Pharmaceutical major Lupin said that the United States Food and Drug Administration (USFDA) has given it an Establishment Inspection Report (EIR) for its Mumbai-based global pharmacovigilance group, Drug Safety & Risk Management (DSRM).
Pharmacovigilance, also known as drug safety, is the science relating to the collection, detection, assessment, monitoring and prevention of adverse effects with pharmaceutical products.
Lupin said that the Post-marketing Adverse Drug Experience (PADE) inspection, carried out between January 14-18, was completed with four observations.
The pharma major added that the inspection included a comprehensive scrutiny of practices and procedures for reporting of adverse events of its marketed products worldwide.
The receipt of an EIR is considered good news as it means that the company can now use the DSRM facility to audit the safety of its products.
A PADE inspection is the practice of monitoring the safety of a pharmaceutical drug or medical device after it has been released on the market and is an important part of the science of pharmacovigilance.
It uses a number of approaches to monitor drug and device safety, including spontaneous reporting databases, prescription event monitoring, electronic health records, patient registries and record linkage between health databases.
Mumbai-based Lupin is one of the world’s biggest makers of generic drugs, and sells both branded and generic formulations, biotechnology products and pharmaceutical ingredients globally.
It is the world’s biggest manufacturer of anti-TB medicines and focuses on cardiovascular, diabetology, asthma, paediatric, CNS, GI, anti-infective and NSAID segments of the pharma market.