Lopinavir syrup for children with HIV now available across India – Govt

NACO ran out of Lopinavir stock in February

Minister of health and family welfare Anupriya Patel said Lopinavir syrup, the life-saving drug given to infants and toddlers with HIV has been restocked by the National Aids Control Organization.

“NACO has done an emergency procurement from a registered manufacturer — McNeil and Argus. The drug has already been supplied and is available throughout the country,” Patel said today.

Lopinavir syrup is used in children with weight below 10 kg, and was being manufactured by Cipla.

Although media reports said Cipla stopped the production of the drug in 2015 due to delays in payment by the government, the company clarified that production of the syrup was stopped in 2015 as a pellet format of the same formulation was introduced in its place.

However, the company said, the pharma regulator in India is yet to approve the new drug, unlike in many other countries where it is available. The US FDA approved the drug in 2015.

The National Aids Control Organization or NACO last procured the drug in 2014. It again called for tenders last last year to replenish its stock, but nobody bid for it. The organization ran out of the drug early this year, endangering condition of 650 children that depended on the drug in India.

The government had to get the drug made by McNeil and Argus, a Haryana-based Pharmaceutical manufacturer.

Patel said the scarcity happened because Cipla did not inform NACO that it was stopping the manufacture of the drug. The Central Drugs Standard Control Organization (CDSCO) has expressed its willingness to waive off requirements for clinical trials and expedite the approval process for the pellets if Cipla provides the required safety data.