The final decision on whether the government can block private pharmaceutical companies from manufacturing and selling vital pregnancy drug oxytocin in India has been deferred, with the Supreme Court deciding the issue needs further deliberation. While the apex court, hearing the government’s appeal on the issue for several months, was expected to pronounce its judgment on the issue on August 22, a bench comprising Justices Abhay Manohar Sapre and Indu Malhotra has instead formulated seven “points” for consideration by a larger bench.
What is oxytocin?
Oxytocin, also known as the ‘love hormone’, is a hormone secreted by the pituitary glands of mammals during sex, childbirth, lactation or social bonding. However, it can also be chemically manufactured and is sold by pharma companies for use during childbirth. It is administered either as an injection or a nasal solution.
Why is it vital?
Oxytocin helps contract the uterus and induce delivery, control bleeding, and promote the release of breast milk. Its use is especially crucial to prevent new mothers from excessively bleeding after giving birth—a common cause of maternal deaths. According to an India sample registration scheme survey conducted in 2001-2003, postpartum hemorrhage accounted for 38 per cent of maternal deaths.
What is the case?
The health ministry in April 2018 notified a ban on private firms from manufacturing and selling oxytocin, stating that it wanted to restrict the responsibility of supplying the drug to a Karnataka-based public sector manufacturer to avoid its misuse in the veterinary field.
Following a case by drug makers like Mylan and Neon Laboratories and patient activist group All India Drug Action Network (AIDAN), the Delhi High Court in December quashed the ban on various grounds, including that it lacked scientific basis.
The government has appealed the decision at the Supreme Court, arguing that the Karnataka PSU, Karnataka Antibiotics and Pharmaceuticals Ltd (KAPL), has built up the capacity to manufacture and supply the required quantity of the drug here.
What happens now?
The government and other parties in the case will have to place their arguments in front of the new bench on the seven points that the two judges have listed. These points are yet to be made public, as the court’s latest order on this matter is not available yet.