This is a high stakes case that Women and Child Development Minister Maneka Gandhi is close to. As an animal rights activist, she has advocated for the regulation of oxytocin for two decades now. She has attended every hearing even though she’s not a party to the case, claims the petitioners in the Delhi High Court case. The Solicitor General, India’s second-most senior law officer, was even brought in to lead the Centre’s case. What gives?
Federation of Obstetric and Gynaecological Societies of India
Dr. Hema Divakar makes no bones about it—oxytocin, she says matter-of-factly, is “life-saving”. Dr. Divakar is the ambassador of the Federation of Obstetric and Gynaecological Societies of India (FOGSI), which counts 33,000 Indian gynecologists and obstetricians as members. She also represents FOGSI at the International Federation of Gynecology and Obstetrics (FIGO).
“26 million women deliver in India every year. It is recommended that after each delivery, irrespective of the mode of delivery and the number of delivery, [the patient] is given 10 units of oxytocin within one minute after delivery to prevent excessive bleeding after birth,” says Dr. Divakar.
Postpartum hemorrhage (PPH)—the excessive post-childbirth bleeding that Divakar is referring to—affects eight million of the 136 million women worldwide who give birth each year. Of the total 279,000 maternal deaths worldwide each year, 69,000 deaths are due to PPH.
Apart from this, oxytocin is also used to induce labor.
Inducing the artificial ripening
And then, of course, there’s the reason the government set these events in motion in the first place. The alleged illicit use of oxytocin in cattle, which is meant to facilitate easier lactation. It was also claimed that oxytocin could induce artificial ripening in fruits and vegetables. The government’s failure to check and curb this alleged misuse is what finally resulted in the “no private players” notification.
The notification came on the heels of a March 2016 ruling of the Himachal Pradesh High Court. It directed the state and central government to coordinate better to regulate the manufacture, distribution, and import of drugs like oxytocin.
The court recognized that the misuse was not because it was being manufactured in India but because it was being illegally diverted, smuggled, imported or sold and that there was not enough that the state and central machinery was doing to prevent it.
But while the court wanted better, more effective regulation and oversight, the government opted to clamp down on oxytocin production altogether.
Delivering the goods
Considering the importance of the drug, KAPL has been producing oxytocin on a war-footing ever since it was made the sole manufacturer of the drug last year. At that time, there were 133 licensed manufacturers of the drug, though only 80 were actively involved in the production.
Currently, KAPL has a single production line for oxytocin ampoules. A second production line will be completed by the end of April. This, claims KAPL, will take its total oxytocin production capacity from 170,000 ampoules per day to 320,000 ampoules per day. Double the national requirement. But KAPL’s claims don’t quite add up.
“We produce 1 ml ampoules for human use and 10 ml ampoules for veterinary use,” says Nirja Saraf, Managing Director of KAPL. The vast majority of this—95%—she says, is for human use. KAPL began production and distribution of oxytocin in July 2018. However, to date, claims Saraf, the company has distributed 21 million ampoules worth Rs 28 crore ($4.06 million). Another 1.65 million ampoules, she says, are currently under testing. One batch takes 15-16 days to test. However, back of the envelope calculations shows that, across its eight months of oxytocin production, KAPL has dispatched far fewer ampoules than the country requires. Requests for clarification on this only elicited vague responses. “There are many factors because of which there’s a disparity between production and dispatch,” Saraf said. However, she refused to name any of these factors.
But even if we are to take KAPL’s numbers at face value, Malini Aisola, convener of the All India Drug Action Network (AIDAN), raises another problem. KAPL has no backup. “It is not just about capacity, they are confining production to one city. What happens if they are not able to sustain production in case of a breakdown?” she questions. AIDAN, a patient activist group, is one of the petitioners in the Delhi High Court case. Dr. Divakar concurs. She raises a pertinent concern: what happens to distribution if there is a strike—a common occurrence in India—which brings transport to a standstill?