Karnataka Antibiotics & Pharmaceuticals Limited, Peenya, Bangalore Review

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Karnataka Antibiotics & Pharmaceuticals Limited and Oxytocin

Oxytocin is a life-saving drug used to stem post-partum bleeding among new mothers.
Because of this it had been listed by both the World Health Organization and the Health
Ministry as an essential medicine. Around 45,000 women die from post-partum
complications in India each year, and in 38% of the cases the reason is haemorrhaging.
Without the easy availability of inexpensive oxytocin, efforts to stem the maternal mortality
epidemic could have suffered a costly setback. These worries led to the All India Drug
Action Network (AIDAN), a patient-rights group, to challenge the order in the Delhi High
Court.
Details of Delhi High Court judgement
In its judgment on December 14, in response to AIDAN s and drug manufacturers petitions,
the court struck down the ban, calling it unreasonable and arbitrary . The court found that
the government had failed to weigh the danger the ban posed to thousands of young
mothers. What is more, it had failed to show that the drug was widely misused for
veterinary purposes, the purported reason behind the order.
Production of Oxytocin
Several bits of evidence cited in the judgment support this analysis. Even though the Centre
claims to have made 25 illegal drug seizures across India in a three-year period, 12 of them
didn t actually find oxytocin. Among those that did, none involved licensed drugmakers.
Karnataka Antibiotics & Pharmaceuticals Limited, the only authorised oxytocin producer
after the ban, did not have the capability to manufacture it until mid-2017.
It is mystifying why the Centre clamped down on licensed manufacturers with a proven
track record, while roping in a state firm with no real experience. The most damning
observation in the judgment is that the Centre focussed on the health of milch animals,
without considering the well-being of women. This was despite the fact that all statutory
bodies, including the Drugs Technical Advisory Board, had advised against a ban. This
episode ought to compel policy-makers to reflect on the process that led to the ill conceived order. Several questions must be answered. On what basis did the Centre
overrule the advice of multiple statutory bodies? What led to its acceptance of sporadic
reports of the drug s misuse, without clinching proof? It is time for a post-mortem of how
health policy is made, because that is the only way to safeguard the right to health of Indian
citizens.

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