The story so far: Five women who underwent Caesarean section (C-section) surgeries died across two government hospitals in Rajasthan’s Kota earlier this year, reportedly days after they were administered oxytocin injections.
Laboratory tests revealed that vials from a specific batch contained no active medicine, merely water, thus offering no protection from postpartum haemorrhage or bleeding that it is purposed for.
After the deaths in May, the World Health Organization (WHO) sought information from the Government of India on the alleged supply of spurious oxytocin injections to government hospitals in Kota by a pharma distributor.
Meanwhile, the manufacturing licences of the pharma units of Jackson Laboratories in Punjab and Himachal Pradesh were cancelled following joint inspections by the Central Drugs Standard Control Organisation (CDSCO) and the respective State drug regulators.
Pharma firm licence revoked over Kota post-partum deaths; WHO seeks report What is oxytocin?
Oxytocin is a natural hormone that stimulates uterine contractions in childbirth and lactation after childbirth.
It is also known as the love hormone, thanks to its role as a chemical messenger in the brain that influences many human behaviors and social interactions, including romantic attachments, parent-infant bonding, sexual arousal, recognition and trust, the Cleveland Clinic lists.
Let’s examine the role of oxytocin during childbirth.
During a vaginal birth, as the baby pushes against the cervix, the nerve impulses from this stimulus travel to the brain and stimulate the pituitary gland to release oxytocin into the bloodstream, which travels to the uterus and stimulates contractions.
The hormone is secreted until the baby is born.
Once the baby is born, the suckling causes contractions of the myoepithelial cells in the alveolar ducts of the breasts, thanks to the role of oxytocin.
These contractions move milk through breast tissue.
Why is synthetic oxytocin used?
Healthcare providers also use synthetic (manufactured) forms of oxytocin — Syntocinon and Pitocin— to induce labour in childbirth if it has not started naturally or to strengthen contractions.
During a C-section, where the uterus is surgically opened, the abrupt removal of the placenta can cause the uterine muscles to relax too much (uterine atony).
Injecting synthetic oxytocin safely mimics this natural process, ensuring the uterus quickly clamps down firmly, acting like a natural tourniquet which closes off the open blood vessels left behind where the placenta was attached.
This dramatically limits blood loss, and helps the healing process begin.
Synthetic oxytocin is also used to speed up delivery of the placenta (the third stage of labour) and reduce the risk of life- threatening heavy bleeding (postpartum haemorrhage).
In the Kota case, criminally bereft of the active ingredient in the injection, oxytocin, mere water failed to provide the protection that the oxytocin was meant to, and the mothers bled to death over a period of time.
India’s drug quality problem The discovery of the fake oxytocin injections has once again highlight India’s very critical problem of drug quality and safety.
Recent inspections by the CDSCO have also found several batches of drugs being produced in the country wanting, substandard or even toxic.
The recent case of toxic cough syrups contaminated with diethyl gylcol resulted in the deaths of children reignited the question of safety of drugs and the need for stringent quality control.
As the country nurtures ambitions of being the pharmacy of the world, frequent lapses in quality erode trust and make the products unpopular.
In response to the recent crisis, media reports said the Rajasthan State government had ordered the immediate implementation of a three-layer drug testing system to verify the quality of medicines and surgical materials.
A better system that can be universally implemented with compulsory sample testing of adequate number of batches and regular monitoring, and supervision will ensure that good laboratory practices are being followed, and in the event they are not, then the licences must be cancelled forthwith, industry watchers have highlighted.
ALSO WATCH Explained: What led to deaths after C-sections in Kota hospitals?
