Today, the Supreme Court of India will decide on a matter that has a bearing on all current and future labouring mothers in India, a country that sees 26 million births each year. It will decide whether one southern Indian company should be given sole responsibility for manufacturing and supplying oxytocin for all of India’s women and animals.

Oxytocin is a critical part of the birthing process and is recommended as a first line drug to prevent and treat excess bleeding immediately after childbirth. With stakes this high, it’s little surprise that the oxytocin injection figures in the World Health Organisation’s Model List of Essential Medicines as well as India’s National List of Essential Medicines.

But despite this, both manufacture and distribution of the drug have been severely restricted since July 2018, when the Indian government banned private companies from manufacturing oxytocin. Instead, the health ministry decreed that a public sector unit (PSU)—Karnataka Antibiotics & Pharmaceuticals Limited (KAPL)—located in Bengaluru would now single-handedly shoulder the burden of fulfilling India’s oxytocin needs.

Here’s the kicker though, KAPL’s expertise in oxytocin is limited. It only began producing oxytocin in 2018, when it was finally licensed to manufacture it. But now, its factory in Peenya, an industrial area on the outskirts of Bengaluru, is expected to produce at least 160,000 ampoules per day for 71,232 births (two ampoules per woman)—the national daily requirement of oxytocin, according to the country’s birth rate. An ampoule is a small single dosage vial with a sealed neck.

The government’s logic for this was that private players were illegally diverting the drug for other uses, such as injecting cows with it to increase milk production. However, in the months following the government’s directive, one patient activist group and three pharmaceutical companies challenged the ban in the Delhi High Court. In December 2018, they won. The court overruled the government order as it wasn’t supported by sufficient data to prove the assertion that there was “rampant abuse” of the drug. The court also saw the dangers of concentrating production for the entire country in one place.

Missing in action

The Central Drugs Standard Control Organisation started seizing oxytocin only after the government banned the private production of oxytocin. According to its submission in the Delhi HC, it seized 1.12 million oxytocin ampoules meant for veterinary use in four months, from April to August 2018, but no manufacturer’s licence was cancelled in this period

So, the government took its fight to the Supreme Court.

There are questions aplenty about KAPL’s capability to manage this incredibly important duty. Doubts about its distribution channel, which, public health activists and gynaecologists allege, is insufficient.

AUTHOR

Suraksha P

Suraksha writes on Healthcare and Pharma. She has been a journalist for five years, reporting for The New Indian Express in Bengaluru and Chennai, and The Times of India, Delhi. In her previous stints she has written on health, civic issues and education. She investigated cover up of corruption in the state health department’s think tank, narrated harrowing tales of women who underwent unwarranted hysterectomies, and wrote about how loss of biometrics came in the way of Leprosy patients getting an Aadhaar card and thereby pension. She can be reached at suraksha at the-ken dot com.

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