The Central Drugs Standard Control Organisation (CDSCO) has registered the child-friendly HIV drug in oral pellet form, ending months of uncertainty for the HIV community. This has opened up crucial supplies from Cipla Pharmaceuticals, a market leader in the HIV segment, to the National AIDS Control Programme (NACO), which had been struggling to source quality assured paediatric formulations of the drug.
India ran out of Lopinavir syrup, a child-friendly HIV drug, in March after Cipla — the sole manufacturer of the drug — stopped production consequent to non-payment by the Health Ministry. The drug’s adult version has to be swallowed whole and thus cannot be administered to infants and young children.
In March, over 600 children had written a letter to Prime Minister Narendra Modi, asking for a quick resolution to the matter.
On May 25, an expert committee of the CDSCO had permitted the child-friendly and heat-stable pellet formulation of the HIV drug lopinavir/ritonavir (LPV/r) to be registered.
The pellets, which come in capsules and are dosed by weight, can be sprinkled (but not stirred or crushed) over a small amount of soft food. For infants — who must be able to swallow them — the pellets can be added to a spoonful of breast milk or put on the infant’s tongue.
“The lack of child-friendly HIV formulations is one of the major reasons why there is such a large treatment gap between adults and children, and is also why we consider paediatric HIV to be a ‘neglected disease’,” said Dr. Suman Rijal, Head, Drugs for Neglected Diseases (DNDi) India.
“The registration of the pellets is a positive sign as the needs of children are being addressed. Children are some of the most vulnerable HIV patients, and we cannot forget their special R&D needs,” Dr. Rijal added.
