Ban On The Life-saving Drug Oxytocin: What It Means To Us

To avoid the misuse in the livestock industry India stopped formulation of oxytocin from July 1. Oxytocin, plays a vital role during labour and delivery in humans as it promotes lactation and it also contracts uterine muscles after childbirth to control loss of blood.

The US generic drugs major Mylan has challenged the decision in the Delhi High Court. As of date, the ban has been under consideration. The final decision can be expected in September this year.

Well-known gynaecologist Dr (Prof) Sadhana Kala explained the reason for the ban to SheThePeople.TV. She said, "Oxytocin is misused in the dairy industry to make livestock release milk at a time convenient to the farmer. It is also used to increase the size of vegetables such as pumpkins, watermelons, brinjals, gourds and cucumbers. To prevent such misuse, the govt. has banned the formulation of oxytocin for domestic use by the private manufacturer. The ban is effective from 01 July 2018. For domestic use, oxytocin will be formulated by KAPL – a public sector company – only and supplied to registered hospitals and clinics. Oxytocin in any form or name will not be sold through retail chemist."

Dr Kala feels, "It is a good move by the govt. But the supply chain will have to be worked out. So that the hospitals and clinics get a regular and uninterrupted supply of oxytocin from KPCL."

Government Action

Earlier in April this year, the government had curtailed the drug from being imported but the illegal usage continued. An investigation conducted by Mid-day exposed that the oxytocin is injected in the cattle twice a day to extract more milk, a violation of the government ban.

Taking a stern action against the growing menace, the Health Ministry issued a directive that no private company will be permitted to manufacture the drug. The permission to produce this imperative drug was given to a public company, Karnataka Antibiotics and Pharmaceuticals Ltd (KAPL). The monopoly was backed by the numerous cases of misuse in the dairy industry.

Importance of Oxytocin in the Medical Industry

Oxytocin is a key element in preventing excessive bleeding after pregnancy that leads to maternal mortality. Post-Partum Hemorrhaging (PPH) is one of the common causes of maternal deaths. In medical terms, PPH is the loss of more than 500 ml of blood within the first 24 hours after childbirth.

In India, PPH contributes to 19.9 percent of maternal mortality. Considering this oxytocin is listed as a life-saving drug by the National List of Essential Medicines. It is also recommended by the WHO (World Health Organization) as the first choice drug to prevent bleeding in women after childbirth.

Oxytocin is listed as a life-saving drug by the National List of Essential Medicines. It is also recommended by the WHO (World Health Organization) as the first choice drug to prevent bleeding in women after childbirth.

A statistical data released in June this year by the Registrar of India suggested that there has been a significant decline in the Maternal Mortality Rate (MMR). In 2014-16 MMR had come down to 130 (per 1 lakh live births) that summed up to 167 in 2012-13. But will the ban keep-up to these good records?

How will the Ban affect the industries?

The ban on a drug that holds so much importance will only lead to 'shortages' and 'widespread panic', said Indian Manufacturers' Drug Association (IDMA).

According to B.R Sikri, the President of the Federation of Pharmaceutical Entrepreneurs, the drug cannot be banned due to its beneficial medical use. He asserted, "Banning is not a solution. It requires strict regulation. It is an internationally established first-line drug used for active management of third stage labour and there is no proper substitute."

Experts from the industry share their views

SheThePeople.TV spoke to Dr Shivani Chaturvedi to understand the significance of the drug in the medical sector. She explained, “Oxytocin is a very vital drug, in most cases, it is used to initiate or augment the delivery and it has been used for 50 years now. In expert hands, oxytocin is a blessing, while it can be a very deadly weapon if used without proper knowledge.”

In expert hands, oxytocin is a blessing, while it can be a very deadly weapon if used without proper knowledge. -Dr Shivani Chaturvedi

Dr (Prof) Sadhana Kala said to SheThePeople.TV, "Oxytocin has been used for active management of labour since 1969 to augment the insufficient uterine action when labour was slower than average; and to reduce the caesarean section rate. However, recent studies in the UK have shown that in more than two third of the cases oxytocin use was injudicious resulting in disciplinary action and litigation and malpractice settlement; that reduction in caesarean section rate was marginal; and labour was shorter by 1.3 hours. Oxytocin will continue to have a place in childbirth. But the question will remain whether such marginal benefits justify the risk of use of Oxytocin. Too much risk for too little benefit?"

Oxytocin will continue to have a place in childbirth. But the question will remain whether such marginal benefits justify the risk of use of Oxytocin. Too much risk for too little benefit? - Dr Sadhana Kala

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.”

Dr Chaturvedi explained the implication told SheThePeople.TV, “The ban may have two primary effects. Firstly, it will affect the cost of the drug and it will only be available at a higher cost now. The second thing which may happen is whether the government likes it or not, the rate of caesarean section will rise up. If the labour is not responding and if we do not have oxytocin to our rescue, then we will need to operate and take the baby out. This ideally should not be done."

She thinks that the government should instead of banning the vital drug, restrict and regulate its usage. “It should not be available easily at the counters. Its use should be looked upon; the ban is not the solution to it,” she concluded.

Reconsidering the Decision

In this time, the government should look into both sides of the coin and then make a final decision. It should ensure that lives are not lost and the restrictions are implemented. Until the Centre takes its final call, this ‘love hormone’ will be available in retail outlets till August 31.

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Megha Thadani is an Intern with SheThePeople.TV

Picture Credit: Medical News Today