New Delhi: The principal secretary to the Prime Minister has asked India’s drug controller to set up a “vigilance mechanism to check smuggling of oxytocin in any form,” sources in the government have told The Wire.
Until now, talks concerning the regulation of oxytocin took place at the levels of the Union health ministry and the Central Drugs Standard Control Organisation (CDSCO). That it was raised at the PMO indicates that the matter is now a policy priority.
In April, the Central Board of Excise and Customs issued a notice saying that a meeting was held in the Prime Minister’s Office on the ‘Harmful Effects of Oxytocin’ and that imports of the hormone would be stopped immediately.
Oxytocin is an important and controversial hormone, for both humans and cattle. It is misused on cattle to increase milk production. This in turn has adverse effects on the health of cattle as well as humans who consume the milk. However, oxytocin can also be lifesaving in humans, as it can prevent excessive bleeding after pregnancy, which is a leading cause for maternal mortality worldwide, including in India, where lakhs of births do not happen in institutional settings. It is often colloquially called the ‘love hormone’.
It is not clear if the Prime Minister’s office is also considering what a shortage of this hormone can mean for maternal mortality in India.
Over the last few years, safeguarding the health of cattle by regulating oxytocin has become a priority area for India’s drug controller. The Wire reported last year that the drug controller created a complaint mechanism to prevent the misuse of the hormone. The complaint system aims to tab the manufacture, sale, distribution, import and use of the hormone.
Last week the government also issued a notice banning the production of oxytocin injection for the domestic market by anyone other than Karnataka Antibiotics and Pharmaceutical Ltd. (KAPL), a public sector body. It was to be enforced from July 1, 2018. The government has reportedly immediately withdrawn that order and the matter is now under consideration again, deferred to September 2018.
Raids on 35 manufacturing units in Bihar
Union health ministry officials have conducted raids on 35 oxytocin manufacturing units in Bihar this month. Two teams of seven officials were sent on these raids along with state drug controllers, district magistrates and Bihar state police. Sources tell The Wire that the raided units were found to be “woefully bad and not fit for manufacturing of injectable preparations and the products manufactured are a hazard for humans and animals”.
FIRs have been registered against the administrators of these units. Some of them are absconding and have been found to be repeat offenders of the Drugs and Cosmetics Act, 1940.
The scale of the likely illegal operations at these manufacturing units is large. For example, at one unit alone, officials have seized 3,35,500 ampoules of oxytocin (worth Rs 57 lakh) and at another unit they seized 2,25,200 ampoules of oxytocin (worth Rs 38 lakh).
These were all found to be manufactured without their blister-packaging, which indicates to officials their “intention to divert the stocks for veterinary use”. In 2001, the government had issued directions on using blister-packing for the hormone, to ensure that it is not widely and loosely sold without any mechanism to trace its sale.
The government plans on conducting more and regular raids on manufacturing units for oxytocin.
At least five government departments are trying to regulate oxytocin
The issue of oxytocin is currently being examined by at least six different government bodies: the Prime Minister’s Office, the CDSCO in the Union health ministry, NITI Aayog, the Central Board of Excise and Customs, the women and child development ministry and various state police who are being used for law enforcement. The issue will also need to pool in resources from the Union department of animal husbandry.
In 2014, action on oxytocin gained steam when minister for women and child development Maneka Gandhi wrote to the health ministry on this. In a 2016 article on the cattle industry, she wrote: “In order to obtain milk, dairy owners inject them with an illegal drug called oxytocin twice a day. Oxytocin sends the animal into labour, so for two hours a day, the animal writhes in labour pain till the milk is squeezed out of her inflamed diseased teats.”
Following her letter to the government, an inter-ministerial committee was set up in 2014, to look into the issue.
In 2016, the Himachal Pradesh high court also issued orders to the government on the same, in two major cases at this high court.
Oxytocin is listed as a prescription-drug in Schedule H of the Drugs and Cosmetics Act, 1940. This means it can only be sold with prescriptions from registered medical practitioners and records need to be maintained for at least three years. The advertisement of Schedule H drugs is also prohibited and its manufacture and sale without a license is a cognisable and non-bailable offense. The drug is also covered under the Cruelty to Animals Act, 1960, which prohibits using oxytocin to extract milk from milch animals.