Active pharmaceutical ingredients
are those components present in drugs due to which medications work. Though it
is far from being such a simple thing and process as it sounds. There are a
series of regulations and laws that surround everything regarding API and
license laws are just the beginning. Read on to know more of these laws related
to the license requirements. There are certain documents that should be
submitted for Import and Registration of API or Bulk Drugs in India.
An application has to be
submitted in three or more files along with
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Covering letter- It would include your intention
of application. Specify clearly your requirement. Whether you are applying for
registration of manufacturing site, for license, renewal or re-registration
etc- it should be mentioned along with proper papers to support your intent.
The documents list should be mentioned in form of index along with page
numbers. If you need to provide the authorities with some more information, it
has to be here in the covering letter. Also, if you are not providing any
document, it should be mentioned here. Finally, this letter must be signed and
stamped by proper authorities on the firm’s letterhead, along with its name and
designation.
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Authorizing letter- According to Rule 122 A, an
original letter has to be submitted, issued by the Company Secretary, Director
or partner which will carry name, signature and designation of the person who
is authorized to sign in the legal papers like Power of Attorney, Form 40 etc. Validity
of this document will be as per the policies of the company. When submitting
subsequent applications within this valid period, self-attested photocopies of
the Authorization Letter should be attached.
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Drugs and Cosmetic Rules have a format and it
should be followed when filling up Form 40. It must be stamped and signed by the
local agent or manufacturer whoever is authorized and has valid license to do
business in India.
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Power of Attorney- When a foreign based company
wishes to register and apply for license in India, it has to authorize an agent
here in this country. This authorization is done by the means of a document of
Power of Attorney, which is executed as well as authenticated in two ways- in
front of a first class Magistrate in India or in front of a similar authority
in the origin country. In later case, the document has to be attested by the
Indian Embassy in that country. The original copy of this document has to be
attached along with the application form. This authorized person would be the
sole responsible one for any activity undertaken by the company in India. The
performa for the Power of Attorney can be obtained from Annexure III.
Before applying, documents should be kept ready
and up to date. For any kind of license and registration certificate, it is
very important to maintain the standard of API because it is the ultimate
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