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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Swara Bhasker: Sharp objects has to be on the radar of every woman who is tired of being “nice”

The actress weighs in on what she loves about the show.

This article has been written by award-winning actor Swara Bhasker.

All women growing up in India, South Asia, or anywhere in the world frankly; will remember in some form or the other that gentle girlhood admonishing, “Nice girls don’t do that.” I kept recalling that gently reasoned reproach as I watched Sharp Objects (you can catch it on Hotstar Premium). Adapted from the author of Gone Girl, Gillian Flynn’s debut novel Sharp Objects has been directed by Jean-Marc Vallée, who has my heart since he gave us Big Little Lies. It stars the multiple-Oscar nominee Amy Adams, who delivers a searing performance as Camille Preaker; and Patricia Clarkson, who is magnetic as the dominating and dark Adora Crellin. As an actress myself, it felt great to watch a show driven by its female performers.

The series is woven around a troubled, alcohol-dependent, self-harming, female journalist Camille (single and in her thirties incidentally) who returns to the small town of her birth and childhood, Wind Gap, Missouri, to report on two similarly gruesome murders of teenage girls. While the series is a murder mystery, it equally delves into the psychology, not just of the principal characters, but also of the town, and thus a culture as a whole.

There is a lot that impresses in Sharp Objects — the manner in which the storytelling gently unwraps a plot that is dark, disturbing and shocking, the stellar and crafty control that Jean-Marc Vallée exercises on his narrative, the cinematography that is fluid and still manages to suggest that something sinister lurks within Wind Gap, the editing which keeps this narrative languid yet sharp and consistently evokes a haunting sensation.

Sharp Objects is also liberating (apart from its positive performance on Bechdel parameters) as content — for female actors and for audiences in giving us female centric and female driven shows that do not bear the burden of providing either role-models or even uplifting messages. 

Instead, it presents a world where women are dangerous and dysfunctional but very real — a world where women are neither pure victims, nor pure aggressors. A world where they occupy the grey areas, complex and contradictory as agents in a power play, in which they control some reigns too.

But to me personally, and perhaps to many young women viewers across the world, what makes Sharp Objects particularly impactful, perhaps almost poignant, is the manner in which it unravels the whole idea, the culture, the entire psychology of that childhood admonishment “Nice girls don’t do that.” Sharp Objects explores the sinister and dark possibilities of what the corollary of that thinking could be.

“Nice girls don’t do that.”

“Who does?”

“Bad girls.”

“So I’m a bad girl.”

“You shouldn’t be a bad girl.”

“Why not?”

“Bad girls get in trouble.”

“What trouble? What happens to bad girls?”

“Bad things.”

“What bad things?”

“Very bad things.”

“How bad?”

“Terrible!!!”

“Like what?”

“Like….”

A point the show makes early on is that both the victims of the introductory brutal murders were not your typically nice girly-girls. Camille, the traumatised protagonist carrying a burden from her past was herself not a nice girl. Amma, her deceptive half-sister manipulates the nice girl act to defy her controlling mother. But perhaps the most incisive critique on the whole ‘Be a nice girl’ culture, in fact the whole ‘nice’ culture — nice folks, nice manners, nice homes, nice towns — comes in the form of Adora’s character and the manner in which beneath the whole veneer of nice, a whole town is complicit in damning secrets and not-so-nice acts. At one point early on in the show, Adora tells her firstborn Camille, with whom she has a strained relationship (to put it mildly), “I just want things to be nice with us but maybe I don’t know how..” Interestingly it is this very notion of ‘nice’ that becomes the most oppressive and deceptive experience of young Camille, and later Amma’s growing years.

This ‘Culture of Nice’ is in fact the pervasive ‘Culture of Silence’ that women all over the world, particularly in India, are all too familiar with. 

It takes different forms, but always towards the same goal — to silence the not-so-nice details of what the experiences; sometimes intimate experiences of women might be. This Culture of Silence is propagated from the child’s earliest experience of being parented by society in general. Amongst the values that girls receive in our early years — apart from those of being obedient, dutiful, respectful, homely — we also receive the twin headed Chimera in the form of shame and guilt.

“Have some shame!”

“Oh for shame!”

“Shameless!”

“Shameful!”

“Ashamed.”

“Do not bring shame upon…”

Different phrases in different languages, but always with the same implication. Shameful things happen to girls who are not nice and that brings ‘shame’ on the family or everyone associated with the girl. And nice folks do not talk about these things. Nice folks go on as if nothing has happened.

It is this culture of silence that women across the world today, are calling out in many different ways. Whether it is the #MeToo movement or a show like Sharp Objects; or on a lighter and happier note, even a film like Veere Di Wedding punctures this culture of silence, quite simply by refusing to be silenced and saying the not-nice things, or depicting the so called ‘unspeakable’ things that could happen to girls. By talking about the unspeakable, you rob it of the power to shame you; you disallow the ‘Culture of Nice’ to erase your experience. You stand up for yourself and you build your own identity.

And this to me is the most liberating aspect of being an actor, and even just a girl at a time when shows like Sharp Objects and Big Little Lies (another great show on Hotstar Premium), and films like Veere Di Wedding and Anaarkali Of Aarah are being made.

The next time I hear someone say, “Nice girls don’t do that!”, I know what I’m going to say — I don’t give a shit about nice. I’m just a girl! And that’s okay!

Swara is a an award winning actor of the Hindi film industry. Her last few films, including Veere Di Wedding, Anaarkali of Aaraah and Nil Battey Sannata have earned her both critical and commercial success. Swara is an occasional writer of articles and opinion pieces. The occasions are frequent :).

Watch the trailer of Sharp Objects here:

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This article was published by the Scroll marketing team with Swara Bhasker on behalf of Hotstar Premium and not by the Scroll editorial team.