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.
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. Ganesh Remedies
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.
