Ban on manufacture, sale of oxytocin by pvt co. with immediate effect

Manufacture and sale of oxytocin to be limited to the public sector, import is banned too

Private companies can no longer manufacture or sell oxytocin – neither can the hormone be imported. The ministry of health and family welfare has issued an order that will now restricts manufacture and sale of oxytocin only to the public sector. Oxytocin in any form will not be sold by a retail chemist.

The move has been taken to prevent the use of oxytocin – a female hormone involved in milk production – in the dairy industry and agriculture. It is often injected into vegetables to increase their size. Cows are injected with oxytocin to increase their milk output. All of this is done illegally, leaving consumers to deal with the health hazards of unwarranted exposure to oxytocin.

The High Court of Himachal Pradesh, Shimla, had, in its judgment dated 15.3.2016 in CWPIL No. 16 of 2014 titled ‘Court on its own motion’ versus State of Himachal Pradesh and others, 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. It had also observed that the feasibility of restricting the manufacture of Oxytocin only in public sector companies should be considered.

The manufacture of Oxytocin formulations for domestic use shall be by public sector undertakings or companies only and the label of the product shall bear barcodes

The matter was considered by the Drugs Technical Advisory Board, a statutory body constituted under the Drugs and Cosmetics Act, 1940. The Board recommended that Oxytocin formulations for human use be regulated and restricted to be supplied only to registered hospitals and clinics in public and private sector to prevent its misuse.

Accordingly, the Central Government has regulated the manufacture for sale or for distribution of Oxytocin:-

• The manufacture of Oxytocin formulations for domestic use shall be by public sector undertakings or companies only and the label of the product shall bear barcodes.
• The manufacturers of active pharmaceutical ingredient (API) of Oxytocin shall supply the API only to the public sector manufacturers for manufacture of formulations for domestic use.
• For export purpose, the API will be supplied to the manufacturers in both public and private sector
• The Oxytocin formulations meant for domestic consumption will be supplied by the manufacturers to the registered hospitals and clinics in public and private sector directly
• Oxytocin in any form or name will not be allowed to be sold through retail Chemist.