Import Of Oxytocin To Be Regulated With Tighter Rules

The Union Health Ministry has relieved the import of active pharmaceutical ingredients of the peptide hormone Oxytocin to our country to manufacture formulations for exporting. On April 24, 2018, the Government put restrictions on oxytocin formulation manufacture for domestic use to only public use and restricted the oxytocin import and its formulations to the country.

When its import was restricted, the Ministry, through the notification GSR 52E, presented that Oxytocin and its formulations in any name have some risk to human beings and animals and prevented the drug import in the public interest. But the Central Government is getting representation from several stakeholders for allowing the import of drug reference standards for examination, test and analysis.

After the request, the Ministry said that it is contended that oxytocin import reference standard is required extensively for examination, test or analysis before undertaking the commercial manufacture of the drug. The Ministry, through a notification, made an amendment for the table of restricted drugs for changing the entrance of Oxytocin as "Oxytocin and its formulation in any name or manner other than oxytocin reference standards imported extensively for testing and analysis.

Then again, on October 27, the Ministry made a further amendment for entry of Oxytocin, making an addition after the word "test and analysis" and adding the exclusion to "oxytocin active pharmaceutical products imported extensively for manufacture formulations for export only.

All these steps were taken because of large scale misuse of drug oxytocin before these restrictions. It is quite harmful to human beings and animals. Then the whole matter was taken into consideration by the Drugs Technical Advisory Board that recommended that oxytocin formulations for use by human beings should be regulated, and it should only be supplied to registered hospitals and clinics both in public and private sectors prohibition of its misuse.

Based on the recommendation of the Board, Central Government after examining the matter was convinced that unregulated and improper use of Oxytocin is risky to human beings or animals and in the public interest, it is important and beneficial for regulating and restricting manufacture, sale and distribution for preventing the misuse by any unauthorized persons or otherwise.

So, accordingly, the central Government controlled the manufacture of sale or distribution of drug oxytocin under section 26A of the Drugs and Cosmetics Act to the effect that the manufacture of oxytocin formulations for domestic use shall by public sector undertakings only and the product label contain barcodes.

The manufacturers of Oxytocin must supply the API to public sector manufacturers of formulations for domestic purposes only. But for the manufacture of the formulation for export purposes, API is supplied to manufacturers of both public and private sectors.

The manufacturers can also supply these formulations to Pradhan Mantri Bhartiya Janaushadhi Pariyojana and Affordable Medicines and Reliable Implants for Treatment outlets or other Governmental entities, which the Central Government specifies for the purpose. No matter in which form, Oxytocin should not be allowed for getting sold through the retail chemist.

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Created on Nov 28th 2021 20:26. Viewed 214 times.

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