Special Operation Launched Foroxytocin by CDSCO

by Divya S. Content Writer

Oxytocin, which is a neurotransmitter and a peptide hormone is being greatly misused in the diary and the horticulture industry. Oxytocin is also called love hormone which is often released when people cuddle or make bonds socially.

It causes a contraction in uterine that induces labour and also keeps control of post-delivery bleeding. Making it a very important hormone for the human body.

But nowadays most operators and farmers in the dairy industry are injecting their livestock with oxytocin, forcing them to artificially release milk as and when required.

Most farmers are also using it to plump up vegetables. If its misuse continues at such alarming rates, it will result in huge hormonal imbalance among humans and will also reduce the lifespan of animals subsequently.

This is the reason why Central Drugs Standard Control Organization (CDSCO) introduced a special operation to minimize the illegal production and import of this hormone. The Drugs Controller General of India issued a notification on 21 May 2018, regarding this special operation to all the zonal, sub-zonal and the port offices of CDSCO.

What are the important measures have been taken for these special operations by CDSCO?

●       Under the special operation launched by CDSCO, the officials are directed to perform raid wherever necessary with the help of the local police. This decision to perform inspections was taken by the higher authority of Government and is given top-level priority because it has been found that oxytocin misuse is being done at various places very frequently. This is leading to several kinds of problems. This was mentioned by DGCI in his letter. The zonal offices have been directed to do inspections frequently and keep DGCI updated about all actions that are taken against these rule flouters.

●       Central governed has already imposed strict rules and restrictions on the manufacture of this hormone for domestic purposes which came into force on July 1, 2019. But the ban on import of oxytocin has already been imposed and all custom officials have been asked to enhance vigilance against those people who are trying to illegally smuggle this drug into the country. This measure depicts that government is inexorable in all its steps taken to crack down on the illegal manufacturing of oxytocin irrespective of all the discontent that is prevailing among the manufacturers.

●       As per the new rule imposed by CDSCO, the active pharmaceutical ingredient (API) of oxytocin is allowed for supply to PSUs, with the only intention for domestic use. The product label should have barcodes and it can't be sold through a retail chemist in any name. There are over 60 units, spread evenly across Maharashtra, Punjab, Andhra Pradesh and Gujarat that manufactures oxytocin injections. However, with the new rule to ban the injections has put a big question mark on the future of these companies.

●       The federation which is in charge of making inspections and tightening the supply chain and stop all illegal manufacturers is still unsuccessful in stopping the private companies in producing the hormone.

●       According to the special lunch by CDSCO, the PSU producers of oxytocin can only supply the product to registered hospitals and clinics either directly or through the Pradhan Mantri Bhartiya Janaushadhi Pariyojana

 

What’s the Manufacturers Opinion on this New Rule?

Manufacturers across the country are complaining about the huge shortage of this drug in the whole market after the new rule came into effect. According to them, it will create big logistic problems as the PSU doesn't have the calibre to make this drug available in the country.

Oxytocin can both be a life-saving or life-decimating hormone for the human body. Especially for the female demographic. The recent operations for enforcing strict measures and spreading awareness about this issue can be seen as a commendable step by the authorities. 

Medical Device Regulation India

 

 

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Created on Sep 26th 2019 01:52. Viewed 231 times.

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