New Delhi: In the month of July, Joint DCGI has issued letter to most of the FDC applicant (FDC already approved by state licensing authority) to submit protocol for Phase IV Clinical Trial. Most of the companies are not aware about the definition of Phase IV Clinical Trial. Vague information is given in Y-Schedule for Phase IV Clinical Trial on website. Interestingly our officer visited personally CDSCO office with the same query as how to write protocol for Phase IV Clinical Trial, executive on front desk replied, visit CDSCO site.
Studies or trials conducted after a medicine is marketed to provide additional details about the medicine’s efficacy or safety profile. Different formulations, dosages, durations of treatment, drug-drug interaction(s), dose-response or safety studies and trials designed to support use under the approved indication(s), e.g. mortality/morbidity studies, epidemiological studies etc and other medicine comparisons may be evaluated. New age groups, races, and other types of patients can be studied. Detection and definition of previously unknown or inadequately quantified adverse reactions and related risk factors are an important aspect of many Phase IV studies. These trials may not be considered necessary at the time of new drug approval but may be required by the Licensing Authority for optimizing the drug’s use
If a marketed medicine is to be evaluated for another (i.e., new) indication, then those clinical trials are considered Phase II clinical trials. The term post-marketing surveillance is frequently used to describe those clinical studies in Phase IV (i.e., the period following marketing) that are primarily observational or non-experimental in nature, to distinguish them from well controlled Phase IV clinical trials or marketing studies.
Small scale manufacturers are not financially sound enough to hire highly paid trained managers who can handle all queries. It would be kind enough if Joint DCGI upload on website a master protocol for Phase IV Clinical Trial and organise workshop for stake holders such as manufacturers and consultants. Modi ji advocates for EASE OF BUSINESS. Manufacturers should be treated as client by government servants and offcourse client is a God. Please make client happy, Tabhi Achhe Din aaynge.