The Drug Controller General of India (DCGI) on relaxed guidelines for the production of pediatric HIV drugs, whose supply was affected by regulatory issues. The regulator approved the child-friendly and thermally stable pellet formulation of Lopinavir / Ritonavir without feasibility studies, but said it would control post-marketing surveillance.
A panel of experts said it is allowing a fixed-dose combination of these drugs because of extreme difficulties in finding patients, appropriate institutions and ethical issues to carry out feasibility studies in the pediatric population in India in private settings before Of product approval. The committee recommended approval on condition that the National AIDS Control Program (NACO) carry out the post-marketing surveillance of the first 100 patients.
Organizations hope that waiver of bioequivalence studies will allow the opening of critical supplies from Cipla to NACO, which has been struggling to obtain pediatric formulations of guaranteed quality. Granules, which come in capsules and are dosed by weight, can be sprayed (but not stirred or crushed) over a small amount of soft food. For babies - who should be able to swallow them - the pellets can be added to a tablespoon of breast milk or put directly on the tongue.
"Approval of the pellet formulation by the Central Organization for Drug Control is also an important step in addressing the imminent shortage of the pediatric drug," said Médecins Sans Frontières. The World Health Organization recommends Lopinavir / Ritonavir (LPV / r), an HIV protease inhibitor, since 2013 as an essential component in first-line treatment for infants and children under three year old.
