The Indian drug controller’s Subject Expert Committee (SEC) has rejected fast-track registration of the Lopinavir and Ritonavir pellets, a child-friendly HIV drug which is currently not available in India.
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The National AIDS Control Organization (NACO) had requested for the drug to be fast-tracked in March, after The Hindu reported that India had run out off paediatric formulations, leaving hapless parents to break down adult tablets and administer to children, raising questions about dosages, said Loon Gangte, patient activist with International Treatment Preparedness Coalition, South Asia.
Meanwhile, the Drug Controller General of India (DCGI), Dr GN Singh confirmed that the SEC did not have HIV experts or paediatricians in the committee, resulting in the decision. “I am not pleased by the outcome. None of our officials attended the meeting. I will overrule the SEC’s decision if I must because our priority is to ensure children living with HIV get these medicines,” said Dr GN Singh, DCGI, Central Drug Standard Control Organization (CDSCO).
On March 6, The Hindu reported that India had run out of paediatric formulations of the syrup after Cipla Pharmaceutical, the sole manufacturer of the Lopinavir syrup, stopped manufacturing it over the issue of non-payment from the Health Ministry. As a stop-gap arrangement, NACO had placed an emergency order for Lopinavir syrup and write to the DCGI, requesting that registration of lopinavir and ritonavir pellets be fast tracked.
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“Besides being foul tasting, the syrup is not recommended anymore because a better and safer medicine is available. But the SEC’s decision to not fast track registration of oral pellets is a severe blow to us. We are breaking adult formulations (tablets) into pieces and giving it to children. We are routinely under dosing or overdosing our kids. The syrup contains 40 per cent alcohol. We are being forced to make our children consume alcohol and the government is showing no urgency in procuring the new drug, available everywhere else in the world,” said Mr Gangte.
In March, 637 children, between the ages of 3 to 19 years, wrote to Prime Minister Narendra Modi, requesting him to intervene and ensure that the life saving drug was not withdrawn. The letter, signed by guardian of the HIV infected children, states, “we humbly request you to look into the matter of HIV drug stock out, in general, and in particular paediatric HIV medicines to ensure that they are not merely exported but also actually available to the children in this country.”
Considering the urgency of making HIV drugs available, Dr Soumya Swaminathan, Director General of Indian Council of Medical Research (ICMR) said that the decision required to be relooked. “This decision needs to be relooked. There is a need for the drug and the committee should include someone from the programme, perhaps from NACO."
Meanwhile, India is also running out of the substitute drug, Lopinavir in syrup form, currently being used instead of the oral pellets.