systems failure

A crucial drug used to treat HIV in children is fast running out in many parts of India

This is the second such critical stock out of paediatric drugs in two years.

A crucial drug used to treat HIV in paediatric patients is fast running out in many parts of the country with most states currently having a less than a month’s supply in stock. Some areas of Uttar Pradesh, Assam, Maharashtra and Bihar are reporting complete stock outs, say health groups working with people living with HIV/AIDS.

The drug is a combination of abacavir and lamivudine used for antiretroviral therapy. Multinational generic pharmaceutical company Mylan, which has its headquarters in Bengaluru, is the only manufacturer of this paediatric formulation. The drug is given as therapy to about 16,500 children across India and, like other antiretroviral medication, is supposed to be taken by the patient at a fixed time every day.

Officials with the National Aids Control Organisation, which funds the national HIV prevention, control and treatment programme and distributes antiretroviral drugs across the country, said that it was supposed to receive fresh stocks of the drug in February, but delivery has been delayed.

“States AIDS societies told me that they have less than a month’s supply left,” said Dr RS Gupta, joint director, National Aids Control Organisation. “It is critical in bigger states such as Uttar Pradesh, Bihar, Andhra Pradesh and Karnataka. The smaller states such as Meghalaya, Goa and Nagaland have about one to two months stock left.”

To prevent stock outs, the ideal buffer time to start replenishing drugs at antiretroviral therapy centres is three months. The National Aids Control Organisation first sends the stock to warehouses of the state AIDS control societies in the state capital cities, and the drugs are then further distributed.

When asked about areas reporting complete stock outs, Gupta said, “A stock that will last three to four months will reach in five to seven days.”

Mylan said that it has already dispatched the drugs to the centres. A company spokesperson said that the stock will reach the centres in a couple of days.

The delay appears to be over two batches of drugs set to expire in 19 months that Mylan wanted to dispatch with the latest round of drugs. The National Aids Control Organisation usually renegotiates the prices of near-expiry drugs before they are redistributed.

“Because our supply levels were critical, we have told Mylan to send the stock now,” said Gupta. Mylan refused to answer Scroll.in’s query on this point. The terms of negotiation, if any, are not very clear.

“While the exact nature of the dispute between Mylan and NACO [National Aids Control Organisation] over the supply of an essential HIV medicine for children is not known, when it comes to single source pharmaceutical products (as is the case with several paediatric HIV formulations), negotiations between manufacturers and the health ministry break down over terms and pricing,” said Leena Menghaney, a HIV treatment activist. “Also, with a single-source manufacturer, the approval takes longer as it often needs a sign-off from the highest level at the health ministry, and sometimes even approval at the finance ministry.”

Irate parents

Patna resident Pooja’s 10-year-old son has not had his dose of abacavir-lamivudine for a month due to a stock out across Bihar. “You can understand how a mother feels if her child is not taking his medicines,” said Pooja, who is HIV positive herself, and works with people living with HIV in the state capital. “Till he does not take his medicines, I will not take my medicines.”

Pooja tried looking for the medicines at private health facilities, but could not find them. “If an educated and well-informed person like me is facing this problem, you can imagine what a poor, uneducated person must be facing,” she said.

Pooja knows of three children aged 3, 4 and 10 in Bihar’s Begusarai district who have been falling ill with fever after they stopped getting their medicines. “The fever medicines are not helping the children,” she said.

Vimlesh Kumar from the Uttar Pradesh Network of Positive People said that stock outs of HIV drugs are very common in the state. However, the situation seems much more critical this time with complete stock outs in at least seven centres.

In Jaunpur district of Uttar Pradesh, the father of a seven-year-old HIV positive boy complained that the antiretroviral therapy centre at the district hospital never dispensed the full month’s dose of medicines, but only enough for 10 days to 15 days at a time. “There have been so many times my child has not had medicines,” said the father, who did not want to disclose his identity. “He is sick all the time. He barely goes to school.”

Mylan's abacavir-lamivudine formulation to treat HIV. (Photo: @nostrumimpex/Twitter)
Mylan's abacavir-lamivudine formulation to treat HIV. (Photo: @nostrumimpex/Twitter)

In Assam, National Aids Control Organisation officials have asked parents to cut the abacavir-lamivudine tablets meant for adults into two or three pieces, depending on the age and weight of the child and administer it to them. But activists point out that this is not feasible. “The parents are lay people,” said Jhanabi Goswami, from the Assam Network of Positive People. “How will they cut the tablet into three parts?”

Ideally, a pharmacist should divide the drug accurately using an electronic weighing scale to ensure that the dose is suitable for a child. If parents try cutting the tablet, there is a chance of underdosing or overdosing, as senior paediatrician Mamta Manglani told Scroll.in earlier.

Repeated stock outs

While the Ministry of Health and Family Welfare assures free treatment for all people with HIV, repeated stock outs across India of both paediatric and adult HIV drugs in the past few years have belied this promise.

“These drugs are not even available in the open market,” said Manoj Pardeshi, general secretary of the National Coalition of People Living with HIV in India. “We are told to take the drugs every single day. If HIV-positive children do not have their medicines, they will develop drug resistance at a very young age.”

In Chhattisgarh, some HIV-positive children have developed resistance to drugs after repeated stock outs of HIV medicines. Some children have died due to non-availability of drugs during earlier stock outs. Last year, there was a complete stock out across India of a paediatric HIV drug – a combination of lopinavir and ritonavir – meant for toddlers. Cipla, the only manufacturer of that drug – a syrup – had stopped producing it in 2015 after the company developed a pellet formulation for which the Drug Controller General of India did not give the requisite approval.

Currently, there are also stock outs of adult HIV drugs at some centres in Chhattisgarh and Andhra Pradesh, mostly due to lack of coordination between National Aids Control Organisation, state AIDS control societies and district centres. But, the stock out of abacavir-lamivudine is critical because no state has adequate supply from where stocks can be diverted to centres whose stocks are at critical levels.

Since the demand for paediatric HIV drugs is limited, very few companies supply the medicines. Only a handful of firms even apply for bids, Gupta said in a previous interview to Scroll.in.

In case of the earlier stock out of the paediatric formulation of lopinavir-ritonavir, National Aids Control Organisation officials found out that Cipla stopped manufacturing the drug only when nobody bid for a new tender.

Pardeshi pointed out that the National Aids Control Organisation’s systems should not be failing so often. “NACO knows that HIV positive people have to take their medicines every day,” he said. “Why should the community intervene each time there is a shortage of stock. Why are they not able to fix this system?”

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