Health ministry bans import, sale of oxytocin

Move aimed to prevent dairy industry from misusing hormone to extract more milk

government on Friday banned import and over-thecounter sale of the ‘cuddle hormone’ oxytocin and restricted its manufacture to public sector units to check misuse by the dairy industry to extract milk from livestock and to promote early puberty in trafficked girls.

The hormone — released in human bodies when a couple hugs or cuddles — has medical uses, such as to induce labour and lower some childbirth-related complications in pregnant women, but its rampant misuse in the dairy industry and as a growth hormone to induce early puberty in trafficked children is a big concern.

The health ministry issued the order to regulate and restrict its manufacture, sale and distribution based on the recommendause

tions made by the Drugs Technical Advisory Board, a statutory body under the Drugs and Cosmetics Act, 1940.

The ban on import comes into effect immediately, with the manufacture regulations for domestic coming into force from July 1, 2018.

The board recommended that oxytocin formulations for human use be regulated and restricted to be supplied only to registered hospitals and clinics in the public and private sectors to prevent misuse.

“We know of cases where the drug is stocked and supplied illegally and not for its intended purpose. People tend to misuse it and control over its manufacturing, sale and distribution will ensure it is used primarily in the labour rooms for deliveries,” said a senior health ministry official.

Sudhir Kumar, joint secretary in the health ministry cited a Himachal Pradesh high court order asking to consider “regulating its use, manufacture, sale and distribution”.

“We have complied with the order,” Kumar added.

The Central Drugs Standard Control Organisation (CDSCO), which is the regulatory body for drugs and medical devices, had also issued a circular last year asking for strict regulatory control over manufacturing, sale and distribution of the hormone and its formulations.

“We asked the states to take strict action, which could even be criminal action, against people who are found to be illegally manufacturing, storing or selling the drug. It is extremely harmful to produce the medicine in a nonsterile condition,” said a senior official in CDSCO, who did not wish to be identified.

Anuradha Kapur, senior obstetrician and gynaecologist at Max Healthcare, described the restrictions as a “good move”.

“It’s good move because its dosage has to be regulated even in the labour room. It’s also miused because it leads to sexual arousal,” Kapur added.