Manufacture of oxytocin to be restricted, import banned

The government on Friday said it has planned to restrict manufacture of oxytocin formulations for domestic use to the public sector only and has banned its import to check wide misuse of the hormone, which is harmful to animals and humans.

"The regulations with regard to manufacture of oxytocin for domestic use will come into force on July 1, 2018. However, the ban on import takes place with immediate effect," a Health and Family Welfare Ministry statement said.

Oxytocin is a hormone that causes increased contraction of the uterus during labour and stimulates ejection of milk into the ducts of the breasts. Its misuse is widespread in the dairy industry and is also used to increase the size of vegetables.

The Central government regulated the manufacture of oxytocin under Section 26A of the Drugs and Cosmetics Act, 1940.

As per the regulations, manufacture of oxytocin formulations for domestic use will be by public sector undertakings or companies only. However, its manufacture for export purposes can be done by both public and private sector. All products will have to bear barcodes.

The manufacturers of active pharmaceutical ingredient (API), the part of the drug that produces its effect, of oxytocin will supply the API only to the public sector manufacturers in case of domestic use but also to private sector in case of export purpose, the ministry said.

The makers of oxytocin formulations will directly supply to the registered hospitals and clinics in public and private sector. "Oxytocin in any form or name will not be allowed to be sold through retail chemist," the ministry said.

The makers can also supply oxytocin to Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) and Affordable Medicines and Reliable Implants for Treatment (AMRIT) outlets. However, these outlets will further supply to public and private registered hospitals and clinics.

The ministry said the Himachal Pradesh High Court in 2016 had observed that there is large scale clandestine manufacture and sale of the drug oxytocin leading to its grave misuse, which is harmful to animals and humans. 

The court also suggested regulating its manufacture. The matter was considered by the Drugs Technical Advisory Board and recommended that oxytocin formulations for human use be regulated and restricted to prevent its misuse, which was accepted by the Central government, the statement said.