Govt's ban on import, production and sale of life-saving drug oxytocin will negatively impact healthcare

Prof.Dr.Dram,profdrram@gmail.com,Gastro Intestinal,Liver Hiv,Hepatitis and sex diseases expert 7838059592,9434143550

Three months ago, the government ordered to ban import and manufacture of  life saving drug Oxytocin except  by only one company by july 18 but later extended it upto sep 18 as it is used by diary industry to increase milk production.Oxytocin  prevents women from bleeding to death during labour and abortion.                 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. 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 productionfor the first time on 2 July. “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 is a Major Killer of Woman.  Most women in rural areas are anaemic or malnourished, so they need to lose much less blood to die.If anemic they need blood transfusion but voluntary blood donation is very less in India so blood loss cannot be accepted.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 Government is  saying that the maternity homes and the clinics will have to write to KAPL in Karnataka and place an order.             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.”              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.”so,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.                   When it comes to alternatives, there are few real substitutes. One of them is Misoprostol, which 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 study.                      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.