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India - Drugs Master File Notarisation for UK based Manufacturer

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  Post Number #1  
Old 8th March 2008, 12:08 PM
jampot

 
 
Total Posts: 61
Question India - Drugs Master File Notarisation for UK based Manufacturer

I was wanting some advice regarding notarisation of paperwork in relation to registration of a UK based Medical Device manufacturer who wants to sell their device in India.

I have prepared a number of documents as requested by our Indian distributor - including a Drugs Master File and Power or Attorney. According to the regs in the Drug and Cosmetics Act http://www.cdsco.nic.in/html/Drugs&CosmeticAct.pdf the documents require notarising. This is easily done by a local notary but I have been advised by our Indian distributor that the notarisation needs to be undertaken by someone from the Indian Consulate here in the UK. Having visited the Indian Consulate yesterday I was informed that before they could sign the documents they needed signing by the UK Foreign and Commonwealth Office!


If anyone could provide any advice it would be greatly appreciated.

Many thanks

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  Post Number #2  
Old 8th March 2008, 08:18 PM
Ajit Basrur's Avatar
Ajit Basrur

 
 
Total Posts: 5,874
Re: India - Drugs Master File notarisation

I suggest you / Indian distributir to contact them directly and ask queries -

Central Drugs Standard Control Organization
Directorate General of Health Services
Ministry of Health and Family Welfare
Government of India
Nirman Bhavan, New Delhi -110011
Phone: 91-11-23061806
Fax: 91-11-23062648

Probably a visit to them would help clarify too.
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  Post Number #3  
Old 10th March 2008, 05:56 PM
jampot

 
 
Total Posts: 61
Re: India - Drugs Master File Notarisation for UK based Manufacturer

Many thanks for this - appreciated.

For future reference, here is what is needed.

Device Master File and Plant Master file (the later being incorporated into the DMF) need to be signed by a company representative and also by a public notary to witness the company signature.

The Power of Attorney needs to be:

a) signed by a company representative and also by a public notary to witness the company signature.

then

b) sent to the Foreign and Commonwealth Office to legalise;

then

c) taken to an Indian Consulate for the final signature.
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