Cipla had conducted clinical trials in Uganda and Kenya and had already been supplying the drug pellets outside India.
New Delhi: India may get a new paediatric drug for treating children with HIV with the new drugs advisory committee likely to expedite the approval process for Cipla’s lopinavir-ritonavir pellets in a crucial meeting on Thursday.
Earlier, the drug regulator had rejected Cipla’s application to register an HIV drug pellet formulation, which is used for treating children with HIV below three years of age. While the company sought a waiver for clinical trials among the Indian paediatric population, the drug regulator rejected their plea, following unavailability of trials on Indian population. Cipla had conducted clinical trials in Uganda and Kenya and had already been supplying the drug pellets outside India.
However, in a meeting by the subject experts committee to be attended by oncologists, peadiatrics, gastroenterologists etc, the drug combination of lopinavir-ritonavir drug with available data will be re-examined. “If the experts are satisfied, the product will go for final testing and the Drug Controller General will approve it soon. However, if more data is needed, it will be referred to the technical advisory committee of experts,” said a senior official.
Its approval, as per experts, could be a game changer in fight against the deadly virus and will be help avoid the shortage of paediatric formulations for HIV in the country, which was witnessed by the National Aids Control Organisation recently, which ran out of stock of lopinavir and ritonavir syrup, as Cipla Ltd, the sole supplier, phased out production of the syrup in 2015 and replaced it with pellets. The pellets are yet to get approved in the country.
Following the shortage, guardians of more than 600 HIV-infected children wrote a letter to Prime Minister Narendra Modi and the ministry of health and family welfare highlighting the issue of shortage of syrup since January.