Union Health Ministry allows import of Oxytocin API to manufacture drugs exclusively for export

New Delhi: Through a recent gazette notification, the Ministry of Health and Family Welfare has allowed the import of oxytocin as an Active Pharmaceutical Ingredient (API) for manufacturing exclusively for the purpose of export.

Oxytocin is a recombinant hormone used to induce or strengthen uterine contractions in pregnant women to aid in labor and delivery or to control postpartum bleeding.

Oxytocin plays a vital role in labour and delivery. The hormone is produced in the hypothalamus and is secreted from the paraventricular nucleus to the posterior pituitary where it is stored. It is then released in pulses during childbirth to induce uterine contractions.

Earlier, the Medical Dialogues Team had reported that the Ministry of Health and Family Welfare had restricted the manufacture of oxytocin formulations for domestic use to the public sector only from 1st July 2018. It had also banned the import of oxytocin and its formulations.

Also Read: Import Banned, Only Public Sector To Manufacture Oxytocin

It was reported that from 1st July 2018, no private manufacturer will be allowed to manufacture the drug for domestic use. Only Karnataka Antibiotics & Pharmaceuticals Ltd (KAPL), a public sector company, would be manufacturing this drug for domestic use from that date.

Oxytocin misuse is widespread in the dairy industry where livestock are injected with oxytocin to make them release milk at a time convenient to farmers. The hormone is also used to increase the size of vegetables such as pumpkins, watermelons, brinjals, gourds, and cucumbers.

The High Court of Himachal Pradesh had in its judgement dated March 15, 2016, observed a large scale clandestine manufacturing and sale of oxytocin, leading to its grave misuse, which is harmful to animals and humans.

Now, through a recent gazette notification, in exercise of the powers conferred by section 10A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby makes the amendment further to amend the notification of the Government of India in the Ministry of Health and Family Welfare, number G.S.R. 577 (E), dated July 23rd, 1983.

As per the recent amendment,

"Oxytocin and its formulation in any name or manner except Oxytocin reference standards imported exclusively for the purpose of test and analysis and Oxytocin Active Pharmaceutical Ingredient (API) imported exclusively to manufacture formulations for the purpose of export only."