As part of its efforts to check the misuse of oxytocin by dairy operators and some farmers, the Ministry of Health has restricted its manufacture for domestic use to public sector only.
The government has also banned the import of oxytocin and its formulations, besides bringing in some more regulations on the manufacture and sale of the controversial hormone.
The regulations will come into force on July 1, while the ban on import takes immediate effect, according to an official statement.
Oxytocin is a naturally-occurring hormone that causes uterine contractions during labour and helps new mothers lactate.
But its 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 judgment 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.
Amongst others, the court had also observed that the feasibility of restricting the manufacturing of oxytocin only in public sector companies should be considered.
The matter was considered by the Drugs Technical Advisory Board, a statutory body constituted under the Drugs and Cosmetics Act, 1940, which 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 misuse.
"The central government, on the basis of the recommendations of the board and after examination of the matter, was satisfied that unregulated and illegal use of oxytocin is likely to involve risk to human beings or animals.
"It also felt that in the public interest it is necessary and expedient to regulate and restrict its manufacture, sale and distribution to prevent its misuse by unauthorised persons or otherwise," the statement said.
Accordingly, the government has regulated the manufacture for sale or for distribution of oxytocin, a life saving drug, according to which the manufacture of oxytocin formulations for domestic use shall be by public sector undertakings or companies only.
Moreover, the label of the product shall bear barcodes and in any form or name, it will not be allowed to be sold through a retail chemist.
The manufacture of oxytocin formulations for export purposes shall, however, be open to both public and private sector. The packs of such manufacture for exports shall also 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.
However, for manufacture of formulations 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.
The manufacturers can also supply the formulations to the Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) and Affordable Medicines and Reliable Implants for Treatment (AMRIT) outlets or any other government entity which may be specified by the central government for this purpose.
However, these outlets will further supply oxytocin to the registered hospitals and clinics in public and private sector, according to the statement.
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