CDSCO issues restriction on import, manufacture, sale and distribution of Oxytocin to curb its misuse

Mar 06, 2018 | by Avantis RegTech Legal Research Team

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Central Drugs Standard Control Organisation (CDSCO) vide public notice dated February 27, 2018 has issued restrictions on import, manufacture, sale and distribution of Oxytocin to curb its misuseunder Section 26A of the Drugs and Cosmetics Act, 1940 providing that:-

i.             The manufacturers of bulk Oxytocin drug shall supply the active pharmaceutical ingredient only to the manufacturers licensed under the Drugs and Cosmetics Rules, 1945 for manufacture of formulations of the said drug.

ii.           The formulations meant for veterinary use shall be sold to the veterinary hospitals only.

As the whole issue of Oxytocin is of paramount importance for protection of human and animal health, following proposals are under consideration to curb its misuse.

i.             To prohibit the import of the Oxytocin and. its formulations for human use as well as animal use under section 10A of the Drugs and Cosmetics Act, 1940.

ii.           To regulate and restrict the Oxytocin formulations for human use under Section 26A of the Drugs and Cosmetics Act, 1940 so that the drug is supplied only to registered hospitals and clinics in public and private sector.

iii.         To adopt barcoding system for manufacture of Oxytocin formulations so as to ensure track and traceability of the product to avoid its misuse.

iv.          Manufacturing of Oxytocin (formulation) shall be restricted in public sector units only. However, above proposals shall not be applicable for Oxytocin meant for export purpose.

All the stakeholders are requested to forward their comments / suggestions on the above proposals through email at [email protected] or in hard copies to the 0/0 DCG(I), CDSCO, FDA Bhawan, Kotla Road, New Delhi— 110002, within 15 days of issue of this notice, so as to consider the matter further.

[File No: X-11026/40/2018-BD]

URL: http://www.cdsco.nic.in/writereaddata/Public%20Notice28.pdf


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