Import Of Oxytocin To Be Regulated With Tighter Rules
by Content Writer Online Content WriterThe 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.
CliniExperts provide end-to-end
solution for your Phytopharmaceutical Drugs need. It provides Drug
licence application process, Drug
licence registration process, etc. This end-to-end service offering will
help you import, manufacture, test, conduct clinical trials and distribute your
products in India efficiently.
Sponsor Ads
Created on Nov 28th 2021 20:26. Viewed 214 times.