The first query is pertaining to use of Neofax and British formulary for checking dosage of various drugs used in newborn. There was no separate neonatal drug formulary available by Indian regulatory body like DCGI at the time when this study was conducted. So, we had to use Neofax and British neonatal drug formulary for bedside consultation of drug dose, route, frequency and duration, and USFDA drug list of approval for neonatal use for the particular indication. Data were cross checked randomly by an independent specialist, who was not the part of this study. Most of the units in India confirm the drug dose, route, frequency and duration from latest Neofax edition or standard text books.

Second query is regarding source/document relied upon to classify the drug as off-label. Definition of off-label used in this study was as per the definition used by Turner, et al. [1].

We deliberately did not include inotropes in the list of off-label drugs. Inotropes are used for clinical shock without functional echocardiography and without intra-arterial blood pressure monitoring. This was prospective chart audit, without interfering with practice; so we decided to use only common drugs in this audit.