New Delhi, 29 Oct 2021: The Union health ministry has exempted import of active pharmaceutical ingredient (API) of peptide hormone oxytocin to the country for the purpose of manufacturing formulations exclusively for exports. The government, on April 24, 2018, had restricted the manufacture of oxytocin formulations for domestic use to the public sector only and also banned the import of oxytocin and its formulations to the country.
In a latest notification, the Ministry said that it is amending the earlier notification regarding the restriction, to allow import of oxytocin API exclusively to manufacture formulations for the purpose of export only.
After banning the import of the drug in 2018, the Ministry, in its notification GSR 52(E), said that while the use of the drug oxytocin and its formulations in any name or manner is likely to involve certain risk to human beings and animals and prohibited import of the drug in public interest, the Central Government has received representations from various stakeholders to allow import of the drug reference standards for the purpose of examination, test and analysis.
Following the request, the Ministry said that it is satisfied that import of oxytocin reference standards is necessary exclusively for the purpose of examination, test or analysis before carrying out commercial manufacturing of the said drug. The Ministry through the notification, amended the table of restricted drugs to change the entry of oxytocin as – “Oxytocin and its formulation in any name or manner except oxytocin reference standards imported exclusively for the purpose of test and analysis”.
Now, through a notification issued on October 27, the Ministry has further amended the entry of oxytocin, adding after the word “test and analysis”, adding the exception to “Oxytocin active pharmaceutical ingredient (API) imported exclusively to manufacture formulations for the purpose of exports only”.
The issue of oxytocin misuse has been a matter of concern for the authorities prior to the restrictions. The High Court of Himachal Pradesh, Shimla, had, in its judgment dated March 15, 2016, 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.
Amongst others, it had also observed that the feasibility of restricting the manufacture of oxytocin only in public sector companies should be considered.
The matter was considered by the Drugs Technical Advisory Board (DTAB), which recommended that oxytocin formulations for human use be regulated and restricted to be supplied only to registered hospitals and clinics in the public and private sector to prevent its 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 and 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.
Accordingly, the Central Government has regulated the manufacture for sale or for distribution of oxytocin under section 26A of the Drugs and Cosmetics Act to the effect that 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, 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 ingredients 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 purposes, the API will be supplied to the manufacturers in both the public and private sector.
The oxytocin formulations meant for domestic consumption will be supplied by the manufacturers to the registered hospitals and clinics in the 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 the drug to the registered hospitals and clinics in the public and private sector. Oxytocin in any form or name will not be allowed to be sold through retail chemist, added the government while announcing the ban on import of oxytocin in India in 2018.