Neutral Code Requirement - Medical Devices Outsourced from India

Nash27

Involved In Discussions
#1
Hi All,

I hope someone could able to help me.

We are in process of outsourcing IV sets from our approved supplier from India. It has been informed by the supplier that to export the IV set they need to place the Neutral code which is their Indian FDA license number to be stated on each label/IFU (packaging), which is in the format of ABC/Drugs/X-123.

From my vague memory, it is true that Indian manufacturers are required to place the Neutral code, else the product would not be exported from India considering IV set falls in Drugs and cosmetics act.

I would like to confirm if this it is true or is there any way out, that could work between us and the supplier. We asked the supplier to provide neutral code on the outer cartons however they are persistent about the requirement to place the neutral code on individual packaging.

Thanks,
 
Last edited:
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somashekar

Staff member
Super Moderator
#3
Hi All,

I hope someone could able to help me.

We are in process of outsourcing IV sets from our approved supplier from India. It has been informed by the supplier that to export the IV set they need to place the Neutral code which is their Indian FDA license number to be stated on each label/IFU (packaging), which is in the format of ABC/Drugs/X-123.

From my vague memory, it is true that Indian manufacturers are required to place the Neutral code, else the product would not be exported from India considering IV set falls in Drugs and cosmetics act.

I would like to confirm if this it is true or is there any way out, that could work between us and the supplier. We asked the supplier to provide neutral code on the outer cartons however they are persistent about the requirement to place the neutral code on individual packaging.

Thanks,
Hi ...
It is label on the packages or containers...
There is no requirement that individual packages must have the neutral code.
See attached provision to rule 94 taken from CDSCO site.
 

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Nash27

Involved In Discussions
#4
Thanks Somshekhar for your reply, very helpful, indeed.

Its label on the packaging medical devices (IV sets). Based on the supplier information the IV sets are classified under drugs act (will confirm the section) and hence their requirement to place the code.

I will confirm and post it again.
 

QA-Man

Involved In Discussions
#5
Hi ...
It is label on the packages or containers...
There is no requirement that individual packages must have the neutral code.
See attached provision to rule 94 taken from CDSCO site.
Very helpful. I've been trying to get to the bottom of this for a few weeks.
 
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