On August 2, the central drug regulator ordered a “strict vigil” to stop oxytocin imports, and to ensure imported stocks were not used “in any form or name”. The government has banned production of oxytocin for domestic use by private companies, and its sale by private chemists from September 1. Why?
Drug and its uses
Oxytocin is naturally secreted by the pituitary glands of mammals during sex, childbirth, lactation or social bonding, and is sometimes called “love hormone”. It is chemically synthesised and sold by pharmaceutical companies across the world. It is used as a drug during childbirth because it can contract the uterus and induce delivery, control bleeding, and promote the release of breast milk. Oxytocin can be administered to humans as an injection or a nasal solution. An oxytocin injection is generally available for Rs 3-20 at any chemist.
In October 2014, Union Women and Child Development Minister Maneka Gandhi wrote to the Health Ministry to flag the “loss of livestock in the country” due to illegal use of oxytocin. On March 15, 2016, Himachal Pradesh High Court passed an order listing the grave dangers oxytocin posed to humans. This judgment forms the basis of the Centre’s clampdown on oxytocin production, import, and sale.
“…There is a grave misuse of Oxytocin by farmers and diary owners… It is not only the health of the animals, which is a matter of concern, but a greater concern lies in the fact that it is this very milk and vegetables which have been injected with Oxytocin to increase its size, that is being consumed by all of us… Oxytocin filters into the milk and… has been held responsible for breast and uterine cancers, male impotence… Its use is also considered harmful for eyes, especially in children. The hormone affects the reproductive ability of woman… Consumption of Oxytocin infected milk by pregnant woman increases risk of haemorrhage. It is also responsible for high spike in tuberculosis cases…,” the court said.
It directed the government “to consider the feasibility of restricting the manufacture of Oxytocin only in public sector companies and also restricting and limiting (its) manufacture by companies to whom license have already been granted”.
A study commissioned by the central government and published in the June 2014 issue of the Indian Journal of Medical Research, reported that “exogenous OT (Oxytocin) injections do not influence its content in milk”, and that “OT present in milk is rapidly degraded during intestinal digestion, ruling out its intestinal absorption and associated adverse health consequences, if any”.
On December 22, 2015, Agriculture Minister Radha Mohan Singh told Lok Sabha: “The National Dairy Research Institute has informed that there is no scientific evidence that artificial use of Oxytocin has adversely affected progeny of cattle and buffaloes resulting in dwindling of livestock. However, continuous Oxytocin use could lead to a progressive addiction and lack of response to normal let down of milk.”
Several gynaecologists told The Indian Express that no international study has so far definitively demonstrated the harmful effects of oxytocin on humans when consumed through vegetables or milk. It has uses as a drug, and regulators elsewhere have not felt it necessary to put restrictions on its production by private firms or sale by private chemists.
At its meeting on February 12 this year, the Drugs Technical Advisory Board (DTAB) — a Health Ministry body that advises central and state governments on technical matters related to the provisions of The Drugs and Cosmetics Act, 1940 — “agreed on a draft notification for regulating, restricting the Oxytocin formulations for human use to be supplied only to registered hospitals and clinics in public and private sector”. On April 27, the central government in a gazette notification said that from July 1, private companies would not be allowed to manufacture oxytocin for domestic use, and private retail chemists would not be allowed to sell it.
The government subsequently pushed the deadline back to September 1. The import of oxytocin was banned by a separate notification on April 24.
Monopoly and supply
The April 27 notification did not say which PSUs could manufacture oxytocin for domestic use after September 1; it emerged only later that the public sector Karnataka Antibiotics & Pharmaceuticals Limited (KAPL) would have a monopoly. While the central government has given no reason for choosing KAPL, a senior official said it believes KAPL “is the only pharmaceutical PSU that has the capacity to manufacture and supply oxytocin across the length and breadth of India”. However, according to a Health Ministry guidance note to state governments, KAPL will have just 17 distribution centres across the country for oxytocin, and none at all in 19 states and UTs, including all of the Northeast, Jammu and Kashmir, Himachal, Haryana, Punjab, and Goa. A “nodal centre in the vicinity” will distribute oxytocin formulations to these states, the note said.