Govt's ban on import, production and sale of life-saving drug oxytocin will negatively impact healthcare
Three months ago, the government created a monopoly of the drug oxytocin that prevents women from bleeding to death during labour.
By Aashika Ravi
Three months ago, the government created a monopoly of a drug that prevents women from bleeding to death during labour. It did this in an alarming response to a passing suggestion from a Himachal Pradesh court's ruling in the case of malpractice in the dairy industry. Sounds random? It is, and unfortunately, likely to contribute to the deaths of lakhs of women.
First, some good news. In early June, data released by the Registrar General of India suggested a significant decline in the country’s Maternal Mortality Rate (MMR). From 167 (per 100,000 live births) in 2011-2013, it had dropped to 130 in 2014-16. Since 1990, the MMR has dropped by over 69 percent, in part due to interventions by the health ministry like the National Rural Health Mission in 2005, and the Reproductive, Maternal, Newborn, Child, and Adolescent Health (RMNCH+A) approach which addresses major causes of mortality among women and children.
But in April this year, the government seems to have thrown a wrench in the work in progress that is our healthcare system by banning the import and commercial production and sale of the life-saving drug oxytocin.
A judgment by the Himachal Pradesh High Court in March 2016 observed that oxytocin was being misused in the dairy industry, and that feasibility of restricting the manufacture of the drug should be considered. This was then taken up suo moto by the government, which introduced a ban from 1 July 2018, which has since been deferred to 1 September without citing any reason. As per regulations, the only company authorised to manufacture and sell the drug is a PSU, the Karnataka Antibiotic Private Ltd (KAPL), which has started production for the first time on 2 July.
To understand the various repercussions of a move like this on maternal healthcare, we need to know why doctors need oxytocin.
Dr Mira Shiva, co-ordinator of the Initiative for Health and Equity in Society and one of the founders of the All India Drug Action Network, explains three main uses.
“The first use is the induction of labour for women who are overdue. The second use is what they call the active management of third stage of labour, which is recommended routinely to prevent bleeding, and this is a protocol. And what we have been taught, is that little bit of bleeding takes place, normally. But if there is more, then it (oxytocin) is used for the management of PPH.”
Post-Partum Haemorrhaging (PPH) is medically defined as the loss of more than 500 ml or 1,000 ml of blood within the first 24 hours following childbirth. As suggested in the study, Postpartum Hemorrhage; a Major Killer of Woman: Review of Current Scenario by Associate Professor of Obstetrics and Gynaecology Naina Kumar, latest figures dating to reports in 2006 report Post-Partum Haemorrhaging as the contributory cause of 19.9 percent of maternal mortality in India. The National Health Portal also reported that of the five most common direct causes of pregnancy-related mortality in the world, haemorrhaging accounted for a whopping 35 percent.
Shiva contextualises these statistics. “Most women in rural areas are anaemic or malnourished, so they need to lose much less blood to die.” (At another point in the conversation, she also talked about some of the myths that contribute to poor blood donations. “Culturally, the thing in the head of the men is that 100 drops of semen is equal to 1 drop of blood. So they think they'll become impotent. So you have these hatta-katta six footers and they are not willing to donate.”)
Owing to its use in prevention and management of PPH, the indispensable nature of the drug has been recognised formally too. Oxytocin, Shiva says, is included in the National List of Essential Medicines 2015, a list of medicines prepared by the Ministry of Health and Family Welfare that are considered essential in India.
Dr Subha Sri of the Coalition for Maternal-Neonatal Health and Safe Abortion or CommonHealth says quite simply, “I can’t imagine running a labour room without oxytocin.”
The KAPL, on its part, is confident of meeting the requirements of oxytocin across the country, which it estimates to be 25 lakh ampoules a month. However, the medical community is unconvinced for many reasons.
Primary among them is the question of accessibility. “From Jharkhand to Chhattisgarh to the North-East, access to medicine is a problem. When someone is about to deliver, a prescription is written and a relative goes to the chemist shop and gets the medicine. So they rely on that. Now they’re saying that the maternity homes and the clinics will have to write to KAPL in Karnataka and place an order,” says Dr Shiva.
Dr Rakhal Gaitonde, community health researcher activist, also asks some important questions of the KAPL. “Do they have the logistical capacity? Will a hospital, in say some small little village in Jharkhand, be able to access the required amount of oxytocin at the price that they were getting it at earlier? Without these questions being squarely engaged with, merely rushing through a ban on oxytocin is extremely problematic.”
The logistics of distribution is further in jeopardy because of the monsoons. “The monsoons have come. For smaller hospitals and maternity homes, nobody is going to bother to ensure the delivery of oxytocin.” Dr Shiva points out.
For hospitals or healthcare facilities that are easily accessible, estimation of their requirements is another struggle.
“Is there a foolproof mechanism of estimating how much oxytocin one needs? If we have X number of deliveries and we need 2 ampoules per delivery, 2X is the amount of oxytocin we require. But in case of emergency, it can be 5 times more. Pre-delivery you need some more. There is no robust estimate of all of this. How are we going to make a proper estimate, and get it to all of the people who need it?” asks Dr Gaitonde.
What about the price of the drug? The Times of India reported that “KAPL will be selling it at Rs 15.58 plus 12% GST, which is Rs 17.78 per vial, more than three times the cost of the generic versions.”
The Hindu adds to the grim picture. “According to the KAPL, the new price of Oxytocin will be Rs 17.78/vial, which is unacceptably high and could seriously upset the budgets of small hospitals. Also, KAPL says that the minimum order quantity should be 1,000 ampoules, which might be difficult for small nursing homes,” gynaecologists who spoke to The Hindu said.
When it comes to alternatives, there are few real substitutes. One of them is Misoprostol, which according to Dr Shiva, can be used for PPH but is not available in the periphery and is costlier than oxytocin.
Another drug called carbetocin is being endorsed as an alternative for oxytocin, but it is still not proven to be as effective for severe bleeding and might even be costlier, according to this Tech2 article.
The healthcare community is equally concerned about the manner in which the government has gone about this ban. It has resulted in a lack of proper awareness in all tiers of the healthcare and pharmaceutical industries and opens up avenues for hoarding and other means of misuse.
When asked about how CommonHealth was responding to the ban, Dr Subha Sri said, “There is lots of concern around the issue from different groups – both from people working on an activist front on maternal health, and from professional associations like Federation of Obstetrics and Gynaecological Societies (FOGSI). Several letters have been sent to the Ministry of Health and the Prime Minister’s Office (PMO) to reconsider this. We have put out statements and talked to professional journals. And our local media has covered it quite widely but in spite of all of that, it seems that the order on restriction of manufacture and sale is going to be enforced from September 1st as planned. The Ministry of Health is making a lot of efforts to try and see what best they can do out of the situation by co-ordinating with KAPL to link them up and set up distribution points, etc.”
Activists are also worried because the order (which is widely rumoured and has recently been reported by The Wire to have come from the PMO) and the intervention would have to be at that level.
As of 24 July 2018, US generic drugs major Mylan has approached the Delhi High Court to challenge the ban, according to BusinessLine.
It's not clear if the government's hasty and hare-brained decision is due to a complete lack of effort in understanding the crucial role played by oxytocin in saving women's lives or if they simply revere cattle more. Unfortunately, we live in a country at a time when the latter is entirely plausible.
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