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§ionid=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
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