I read with interest the perspective on the emerging role of Sildenafil in neonatology [1]. I was disappointed with the authors’ statement, "We could not find any Indian data or case report on use of sildenafil in PPHN". I have published my use of sildenafil in two term neonates with PPHN which was missed by authors [2]. I also feel disappointed by the lack of studies emerging from Indian subcontinent on use of sildenafil in neonates (especially with PPHN) as my belief is that developing countries are in a unique situation to conduct such research [3]. In developed countries, ethical dilemmas will arise as inhaled nitric oxide has become standard treatment for PPHN in term neonates.

I completely agree with Malik and Nagpal that all experiences with sildenafil in neonates must continue to be monitored and reported. However, it reads like a wishful superficial statement with no suggestions of who is going to monitor and report and how. In India, almost three-quarters of pediatricians are in private practice and it is very likely that this cohort is more likely to use this drug as an off label use. Doctors using it will be highly uncomfortable reporting it if they meet out with adverse events or mortality. This would be because of lack of access to Institutional ethics committees or ethicists for consultations, reliance on their conscience and potential for causing controversy. The journals will be critical and hesitant to publish due to lack of evidence and ethical concerns.

Sildenafil is a Schedule 4 drug in Australia meaning it is a prescription only drug. However, for indications other than where it is approved, hospitals seek approval of drug committees comprising experts in field and consultation with ethicists if such dilemmas arise. For medications not available in Australia, provisions exist using Special Access Scheme of Therapeutic Good Administration, for procuring and using off-lable drugs [4]. This results in monitoring of the drug and outcomes.

Off label use of drugs including sildenafil is an unfortunate reality in neonatology [5]. Mechanisms and regulatory bodies on regional basis for monitoring this needs to be developed to ensure safe neonates in myriad neonatal units mushrooming in India, especially in the private sector.