Restoring Oxytocin Sale - Delhi High Court Order

Why in news?

The Delhi High Court has quashed a government ban on the retail sale and private manufacture of oxytocin. Click here to know more on the ban.

Why was the ban challenged?

• Union Ministry of Health and Family Welfare earlier notified the ban of oxytocin.
• This was after widespread concerns with the misuse of the drug in dairy cattle, fruits and vegetables.
• But the ban was opposed as oxytocin is a life-saving drug used to stop post-partum bleeding among new mothers.
• Around 45,000 women die from post-partum complications in India each year, and in 38% of the cases, haemorrhaging is the reason.
• Without the easy availability of inexpensive oxytocin, addressing the maternal mortality epidemic could have been difficult.
• In fact, oxytocin had been listed by both the World Health Organization and the Health Ministry as an essential medicine.
• So the All India Drug Action Network (AIDAN), a patient-rights group, challenged the government ban in the Delhi High Court.

What is the Delhi High Court's rationale?

• The ban came despite the fact that all statutory bodies, including the Drugs Technical Advisory Board, had advised against a ban.
• There was no scientific basis to the conclusion that oxytocin's existing availability/manner of distribution posed a risk to human life.
• So in response to AIDAN’s and drug manufacturers’ petitions, the court struck down the ban, calling it “unreasonable and arbitrary”.
• It thus restored the retail sale and private manufacture of a life-saving drug, oxytocin.
• The government failed to weigh the adverse effect, to the public in general and women in particular, of possible restricted supply if manufacture is confined to one unit.
• The scarcity or even a restricted availability can cause increase in maternal fatalities, during childbirth.
• Notably, the Karnataka Antibiotics & Pharmaceuticals Limited (the only authorised producer after the ban) did not have the capability to manufacture it until mid-2017.
• The Centre has put down licensed manufacturers with a proven track record, while roping in this state firm with no real experience.
• It had also failed to show that the drug was widely misused for veterinary purposes, the actual reason behind the ban.
• Also, though the Centre claims to have made 25 illegal drug seizures across India in a 3-year period, 12 of them did not actually find oxytocin.
• Among those that did, none involved licensed drugmakers.

What lies ahead?

• The whole oxytocin episode calls for the policy-makers to reflect on the process that led to the ill-conceived order.
• The basis for the Centre to overrule the advice of multiple statutory bodies should be investigated.
• The reason for the government to accept the reports of the drug’s misuse without any valid proofs should be looked into.
• The country needs a relook on the mechanism for health policy-making, for it to safeguard the right to health of Indian citizens.

Source: The Hindu