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
·
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.
·
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.
·
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.
·
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 determining factor. Manufacturers will be asked to
submit three consecutive batches of bulk drugs for testing in a particular
laboratory designated by the National Drug Regulatory Authority, fees of which
are to be paid by the company itself. All these strict regulations have been
made so that these medicines can serve their actual purpose- alleviate the
pain.
Cadila Pharmaceuticals is
a prominent name in the pharmaceutical industry. Backed by years of experience
in manufacturing innovative products and formulations, the company has been
successful in catering to the therapeutic needs of all kinds. Till date, Cadila
Pharmaceuticals has contributed about 38 APIs and other intermediates that are
duly certified by recognized authorities like USFDA. Starting its journey in
1952, it is still serving the nation with same grace and integrity. And with
venturing in the market of USA as CPL Inc in 1997, it has made itself available
globally. Today, it has ISO 9002 AND ISO 14000 certification for offering
contract manufacturing facilities of Bulk Actives. In API, they produce
medications like anti-allergic, anti-diabetes, disinfectants and so on. From
buying raw materials to quality control, everything is done with utmost care
and professionalism. So if you are looking to buy Pharmaceuticals raw materials
and products visit Allindiayellowpage.com
to get detail information about suppliers and dealers.