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Q: umiat-ga hummer-ga kapilr-ga czh-ga pafalafa-ga ( Answered 5 out of 5 stars,   5 Comments )
Question  
Subject: umiat-ga hummer-ga kapilr-ga czh-ga pafalafa-ga
Category: Business and Money > Small Businesses
Asked by: johnterryjr-ga
List Price: $45.00
Posted: 02 Aug 2004 18:44 PDT
Expires: 01 Sep 2004 18:44 PDT
Question ID: 382705
Kindly let me know the requirements in order to get a drug license for
retail sale in India (issued by the Indian FDA - Food and Drug
Administration in Mumbai). All questions can be directed to the FDA.
  I am thinking about these things in particular:

1.1) Are there any special requirements/minimum regarding how big the
leased area should be such as minimum XX squarememters

1.2) Should the leased office be for a minimum of time such as minimum
3 years in the contract?

1.3) Does there need to be a pharmacist present and/or employed in
order to get/keep the drug license?

1.4) can the drugs be stored in a different location than where the
drug license is registered to? (like, a distribution warehouse)?

1.5) How much does the drug license cost and how much time does it
take to get it issued?

1.6) if a company is based in United Kingdom but has a liasson/branch
office in Mumbai - can a branch office then have such drug license (or
does it need to be a normal "limited liability" company"

1.7.1) is it legal for a drug store to send prescription drugs outside India?

1.7.2) Does prescription drugs need to have a prescription from a
pharmacist or pysician in india in order to be sent out of India
legally?

Best regards,
Johnterryjr
Answer  
Subject: Re: umiat-ga hummer-ga kapilr-ga czh-ga pafalafa-ga
Answered By: hummer-ga on 04 Aug 2004 15:57 PDT
Rated:5 out of 5 stars
 
Hi johnterryjr,

Given that I have found several references connecting Mambai-based
businesses to the FDCA of Gujarat state (see the following link for an
example), I'm assuming that the Gujarat state office is the one you
will need to contact to make your application for a license.

"In a case of Drug Price Control Order (DPCO) violation that was
investigated by the Food and Drug Control Administration (FDCA) of
Gujarat state, the Mumbai-based, Themis Chemicals Limited has been
found liable for breaching MRP to the tune of Rs 39."
http://www.pharmabiz.com/article/detnews.asp?articleid=8793&sectionid=19

>>>Food And Drug Control Administration, Gujarat, State, FDCA

SALE OF DRUGS REQUIREMENTS LINKS

Introduction:
http://www.gujhealth.gov.in/FDCA/sale_of_drugs/sale_of_drugs.htm

Drugs Licences/ Application Forms & Licence Fee 
http://www.gujhealth.gov.in/FDCA/sale_of_drugs/application_form.htm

Requirements of Sales premises
http://www.gujhealth.gov.in/FDCA/sale_of_drugs/requirements.htm

Qualifications and Documents Required
http://www.gujhealth.gov.in/FDCA/sale_of_drugs/qualification.htm

Chalan 
http://www.gujhealth.gov.in/FDCA/sale_of_drugs/chalan.htm

Contact
http://www.gujhealth.gov.in/FDCA/GeneralInformation/OfficeAddressOfFDCA.htm

>>>YOUR SPECIFIC QUESTIONS AND WHERE TO FIND THE ANSWERS

1.1) Are there any special requirements/minimum regarding how big the
leased area should be such as minimum XX squarememters
http://www.gujhealth.gov.in/FDCA/sale_of_drugs/requirements.htm

1.2) Should the leased office be for a minimum of time such as minimum
3 years in the contract?
http://www.gujhealth.gov.in/FDCA/sale_of_drugs/qualification.htm

1.3) Does there need to be a pharmacist present and/or employed in
order to get/keep the drug license?
>Qualification of Competent Person
http://www.gujhealth.gov.in/FDCA/sale_of_drugs/qualification.htm

1.4) can the drugs be stored in a different location than where the
drug license is registered to? (like, a distribution warehouse)?
http://www.gujhealth.gov.in/FDCA/sale_of_drugs/requirements.htm

1.5) How much does the drug license cost and how much time does it
take to get it issued?
http://www.gujhealth.gov.in/FDCA/sale_of_drugs/application_form.htm

FORMS
http://www.gujhealth.gov.in/FDCA/GeneralInformation/form_index.htm

1.6) if a company is based in United Kingdom but has a liasson/branch
office in Mumbai - can a branch office then have such drug license (or
does it need to be a normal "limited liability" company"
To be licensed, it would need to meet all of the requirements, but
this is something you could enquire about at the FDCA office.
http://www.gujhealth.gov.in/FDCA/sale_of_drugs/qualification.htm

1.7.1) is it legal for a drug store to send prescription drugs outside India?
Yes, as long as the product is approved in the country to where it is
being shipped.
http://www.overseasrxdrugs.com/html/our_policies.asp

1.7.2) Does prescription drugs need to have a prescription from a
pharmacist or pysician in india in order to be sent out of India
legally?
"You must provide a valid prescription from a physician licensed to
practice medicine and to prescribe medications in the place where you
live."
http://www.overseasrxdrugs.com/html/faq.asp

I hope I've been able to furnish you with enough information to get
you started. If you have any questions, please post a clarification
request before closing/rating my answer and I'll be happy to reply.
I'm sure the FDCA office nearest to you (see the Contact link above)
will be happy to help you work out the remaining details.

Thank you,
hummer

Google Search Terms Used:

"UK pharmacy" limited liability india
"UK pharmacy" branch in india
india "online drug store"
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fdca Gujarat State mumbai
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fdca mumbai
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india state regulations "sale license"
india sale and distribution of Drugs
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johnterryjr-ga rated this answer:5 out of 5 stars and gave an additional tip of: $5.00
great answers

Comments  
Subject: Re: umiat-ga hummer-ga kapilr-ga czh-ga pafalafa-ga
From: pafalafa-ga on 02 Aug 2004 19:57 PDT
 
johnterryjr-ga,

Thanks for mentioning me by name.  I'll do a bit of looking into this,
but I honestly don't feel I have enough background on the systems in
India (heck...I don't have ANY background on the systems in India) to
be able to answer your question.  But if I should come up with
anything, I'll let you know.

All the best...

pafalafa-ga
Subject: Re: umiat-ga hummer-ga kapilr-ga czh-ga pafalafa-ga
From: hummer-ga on 03 Aug 2004 03:50 PDT
 
Dear johnterryjr,

Thank you for bringing your question to my attention, I appreciate it.
I'll have a look and get back to you if I have any luck.

Regards,
hummer
Subject: Re: umiat-ga hummer-ga kapilr-ga czh-ga pafalafa-ga
From: johnterryjr-ga on 03 Aug 2004 03:56 PDT
 
Great and thanks for your comments. I have written the names above
because I was advised by Google that this was th eway to find
local/india based researchers...Sorry, if a couple of names are not
based in india but i got the names from previously india related
questions.
Subject: Re: umiat-ga hummer-ga kapilr-ga czh-ga pafalafa-ga
From: czh-ga on 03 Aug 2004 11:00 PDT
 
Hello johnterryjr-ga

Thank you for thinking of me. I don't have a specific expertise in
drug licensing in India. I will do some preliminary research to
explore your question but I'm leaving it open so that other
researchers who have greater expertise may proceed with getting you
the answer you need.

~ czh ~
Subject: Re: umiat-ga hummer-ga kapilr-ga czh-ga pafalafa-ga
From: hummer-ga on 06 Aug 2004 08:10 PDT
 
Thank you, johnterryjr, for the nice rating and tip - I'm happy you
are happy. Good luck with your new business! Sincerely, hummer

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