What is Oxytocin- Uses and Misuses: Regulation of Manufacture, Sale and Import of Oxytocin (Download PDF)

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To check misuse of Oxytocin, Ministry of Health & Family Welfare has restricted manufacture of Oxytocin formulation for domestic use to public sector and banned import of Oxytocin & its formulations.

 Image of Oxytocin

Image of Oxytocin

Image of Oxytocin

  • Govt. regulations w/regard to manufacturing of Oxytocin for domestic use will come into force on 1st July 2018.

  • Some people for their own benefits misuse drug, which causes extreme pain to animals, shorten their lives & make them barren w/time.

  • Govt. ’s decision to regulate drug will save animal’s health.

  • Effects of Oxytocin are known for centuries. It is used in various treatments & remedies.

What is Oxytocin?

  • Oxytocin or cuddle hormone is naturally-occurring hormone, which causes uterine contraction during labour & helps new mother to lactate. It is widely misused by farmers & dairy industry.

  • It is often called love hormone, which is released naturally human bonding activities like sex, childbirth, & breastfeeding.

  • It is used to help abort foetus in cases of incomplete abortion or miscarriage, & control bleeding after childbirth.

  • It may be used for breast engorgement.

Misuse of Oxytocin:

  • Dairy Industry: Livestock is injected w/Oxytocin to make them release milk at time convenient to farmers, which is painful for animals.

  • Farmers: Hormone is misused by farmers to increase size of vegetables such as pumpkins, watermelons, brinjals, gourds, & cucumbers.

When it is misused for long time, it causes symptoms of dizziness, nausea, early puberty, mood swings, erratic heart rate & fetal damage among others.

Background: Reason of the Ban

  • High Court Ruling (Himachal Pradesh)

    High Court of Himachal Pradesh in its judgment in 2016 observed that there is large-scale clandestine manufacture & sale of drug Oxytocin; leading to its grave misuse, harmful to both animals & humans.

  • Drug Technical Advisory Board

    • Matter was considered by Drug Technical Advisory Board, statutory body constituted under Drugs & Cosmetics Act, 1940.

    • To prevent its misuse, Board recommended that formulation of Oxytocin for human use should be regulated & restricted to be supplied only to registered hospitals & clinics in public & private sector.

  • Consideration of recommendation

    • Central Govt. , on basis of recommendation of Board & after proper examining of matter, was satisfied that unregulated & illegal use of Oxytocin is to involve risk to human beings & animals.

    • That in public interest is necessary & expedient to regulate & restrict its manufacture, sale, & distribution to prevent its misuse by unauthorized persons or otherwise.

Details on Regulation of Govt.

Central Govt. has regulated manufacture for sale or for distribution of Oxytocin under section 26A of said Act, in some manner:

  • Manufacture of Oxytocin formulations for domestic use shall be by public sector undertakings or companies only & label of product shall bear barcodes.

  • Manufacture of Oxytocin formulations for export purposes shall, be open to both public & private sector. Packs of such manufacture for exports shall bear barcodes.

  • Manufacturers of Active Pharmaceutical Ingredient (API) of Oxytocin shall supply API only to public sector manufacturers for manufacture of formulations for domestic use.

  • For manufacture of formulations for export purpose, API will be supplied to manufacturers in both public & private sector.

  • Oxytocin formulations meant for domestic consumption will be supplied by manufacturers to registered hospitals & clinics in public & private sector directly.

  • Manufacturers can supply formulations to Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) & Affordable Medicines & Reliable Implants for Treatment (AMRIT) outlets or any other Govt. entity which may be specified by Central Govt. for this purpose.

  • These outlets will further supply drug to registered hospitals & clinics in public & private sector.

  • Oxytocin in any form or name will not be allowed to be sold thru retail Chemist.

Benefits of Regulations:

  • Regulation of Oxytocin will check misuse of drug by farmers & dairy industry.

  • Limited sale of hormone, only in registered govt. hospitals & clinics, & using barcode system on all forms of drug will ensure tracking & prevent abuse.

- Published/Last Modified on: July 12, 2018

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