The Government of India has banned the import of the oxytocin and its formulations for human use and also to regulate and restricted the oxytocin formulations for human use.
Its manufacture will also be stringently control and will be allowed only by public sector companies or undertakings licensed under the Drugs and Cosmetics Rules, 1945 for domestic use.
Central Drugs Standard Control Organisation and Ministry of Health and Family Welfare have taken various measures to prevent misuse of the drug.
The health ministry has also issued gazette notification dated April 27, which will come into effect from September 01, to regulate and restrict the manufacture, sale and distribution of Oxytocin in following manner:
- 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 manufacture of Oxytocin formulations for export purposes shall be open to both public and private sector companies and the packs of such manufacture for exports shall bear barcodes.
- The manufactures of active pharmaceutical ingredient (API) of Oxytocin shall supply the API only to the public sector manufacturers licensed under the Drugs and Cosmetics Rules, 1945 for manufacture of formulations of the said drug for domestic use.
- The manufacturers of active pharmaceutical ingredient of Oxytocin shall supply the said active pharmaceutical ingredient to the manufacturers in public and private sector licensed under the Drugs and Cosmetics Rules, 1945 for manufacture of formulations of the said drug for export purpose.
- The oxytocin formulations manufactured by the public sector companies or undertakings licensed under the Drugs and Cosmetics Rules, 1945 for domestic use shall supply the formulations meant for human and veterinary use only, to the registered hospitals and clinics in public and private sector directly; or 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 in the country which shall further supply the drug to the registered hospitals and clinics in public and private sector.
- The oxytocin in any form or name shall not be allowed to be sold through retail chemist.
This issue is being discussed and monitored at the highest level of government from time to time for proper implementation of various measures taken to prevent misuse of the drug in the country.