India plans oral nanodrug to treat severe newborn jaundice

New Delhi: India plans to expedite the development and commercial manufacturing of an oral nanodrug aimed at treating high prevalence of neonatal hyperbilirubinemia, a severe form of jaundice affecting newborns, according to two government officials and an Indian Council of Medical Research (ICMR) document reviewed by Mint.

Jaundice is extremely common in newborns, triggered by the buildup of a yellow pigment called bilirubin in the blood. While mild cases typically clear up on their own, acute jaundice allows this toxic substance to cross into an infant's brain, risking permanent neurological damage, hearing loss, severe physical disabilities, or even death. In India, severe jaundice causes 15-25% of neonatal hospital admissions, carrying a 5-10% case fatality rate.

Currently, doctors treat severe jaundice by placing infants under special blue lights, called phototherapy, or by carrying out emergency blood transfusions to quickly wash the toxins out. However, these treatments require costly hospital machinery, reliable electricity, and specially trained medical staff. For families living in smaller towns and rural areas, reaching a hospital with these facilities in time can be extremely difficult.

Delivered as a simple oral drop, the new medicine uses targeted nanoparticles to bind with bilirubin, converting the yellow pigment into a harmless compound that the infant naturally excretes through stool and urine. In preclinical animal studies, the formulation reduced brain toxin levels by nearly 85% within hours, while clinical trials showed it significantly shortened the duration babies required under phototherapy light units.

The liquid medicine works by breaking down dangerous toxin build-up in the blood so a newborn baby can pass it out naturally, reducing the need for specialized light therapy or emergency blood transfusions. Preclinical studies and early clinical trials demonstrated that the single-dose oral drug reduced neural bilirubin levels and was associated with a 94% reduction in neonatal mortality and a 92% drop in exchange transfusion requirements.

Under the proposed agreement, the selected drugmaker will secure commercialization and manufacturing rights across various dosage strengths of the nanodrug, alongside the freedom to conduct further research to bring the finished therapy to market.

Dr. Sameer Punia, a senior consultant and paediatric intensivist at Aakash healthcare superspeciality Hospital, said, "Neonatal jaundice remains a significant public health concern in India, cutting across geographies and healthcare settings. An indigenous, affordable oral nanodrug that can be administered at the point of care could be a major step forward in making timely treatment accessible to newborns who may not have access to advanced hospital infrastructure."

He added, "If clinical evidence continues to demonstrate safety and efficacy, this initiative could reduce complications, referrals and the need for invasive interventions, while strengthening newborn care at the grassroots level. It has the potential to make a meaningful difference to India's neonatal health outcomes."

Queries sent to the spokesperson of the health and family welfare ministry and ICMR on Thursday remained unanswered at the time of publishing.