New Delhi: There is some relief on the cards for the millions of children living with HIV (CLHIV) in India as the central drug authority has approved the registration of a child friendly pellet formulation, from pharmaceutical company Cipla. The approval, crucially, opens up supplies from Cipla to the National AIDS Control Organisation (NACO), after months of unavailability of medicines for children.
Cipla had stopped selling the previous syrup formulation for children to the NACO, saying it had not received payment from the government. This came to light when, on March 3, the Delhi Network of Positive People (DNP+) sent a letter signed by over 600 children, aged 3 to 19, to Prime Minister Narendra Modi and Union health minister JP Nadda, asking for help as they ran out of the lifesaving drug. As Cipla is the only manufacturer of the syrup, it had disappeared from the market.
The letter read, “Cipla has in various forums cited delay in payments by the national programme for the HIV medicines by several years and even non-payment of its dues in many cases.”
On-time treatment of children is crucial. As a statement by Médecins Sans Frontières (MSF) points out, “HIV infection progresses more quickly in children than adults. The younger the children are, the higher is the risk of dying of HIV. Globally, one in every 10 HIV related death is of a child which can be easily prevented if the children are started early on treatment.”
Even adults cannot miss their anti retroviral treatment (ART), as it leads to the body building a resistance to the medicine, soon rendering it ineffective.
Figures from as far back as 2007 say that there are 2.1 million children in India living with HIV. Paediatric HIV treatments are globally neglected, however, Cipla is manufacturing and supplying pellet drugs in countries across Africa, with tentative approval from the US Food and Drug Administration.
On May 25, an expert committee of the Central Drugs Standard Control Organization (CDSCO) finally granted approval in India, to the pellet formulation of the HIV drug lopinavir/ritonavir (LPV/r), seen as heat stable and easy to administer, especially compared to the previous formulation of a syrup, which children reportedly found to distasteful to swallow or would spit out. Its 40% alcohol content also needed careful cold-chain transport.
Lopinavir is an essential first line medicine for infants, as recommended by the World Health Organisation in 2013. Adults consume it in the form of a whole pill, which children cannot take. This pellet can be sprinkled over food, making it simpler to ensure that children take their ART on time.
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