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First step need to take For Starting a Pharmaceutical Company

Query: I am a veterinarian by profession. Have been going through your website from past 1 year and have planned now to give a start to my own pharma company. Please let me know what will be the first step I need to take.  Answer: First Step you need to prepare yourself for Pharmaceutical Company:  Preparation means Choose marketing type, Choose molecules want to launch, Location where you want to launch product, Choose Company, Products Name, Budget available...  Choose marketing type: As number of marketing and selling types present in pharmaceutical market. i.e. Branded Marketing , Generic Marketing , OTC Marketing, Franchise Marketing etc. You need to select any one from above.  Choose Molecule: Once you have selected which marketing type is best suitable for you then you need to select at which segment and molecules you want to work. Check out: How to choose products/service for business? Location: You can't launch your pharmaceutical company all over India or at broad area.

Important Definitions related to Import of Pharmaceutical Products

Import licence:
means either a licence in Form 10 to import drugs ;excluding those specified in Schedule X, or a licence in Form 10-A to import drugs specified in Schedule X

Licensing authority:
means the authority appointed by the Central Government to perform the duties of the licensing authority under these Rules and includes any person to whom the powers of a licensing authority may be delegated under Rule 22 of Drug and Cosmetic Act & Rules/.

Licence for examination, test or analysis: means a licence in Form 11 to import small quantities of drugs the import of which is otherwise prohibited, for the purpose of examination, test or analysis

Manufacturer: includes a manufacturer of drugs, who may be a Company or a unit or a body corporate or any other establishment in a country other than India, having its drugs manufacturing facilities duly approved by the National Regulatory Authority of that country, and who also has a free sale approval of the drugs approved by the said authority in the concerned country, and /or in other major countries

Registration Certificate: means a certificate issued under Rule 27A of Drug and Cosmetic Act & Rules by the licensing authority in Form 41 for registration of the premises and the drugs manufactured by the manufacturer meant for import into and use in India.

Form of application for import licence: An application for an import licence shall be made to the licensing authority in Form 8 for drugs excluding those specified in Schedule X, and in Form 8A for drugs specified in Schedule X.

Form of application for Registration Certificate: An application for issue of a Registration Certificate shall be made to the licensing authority in Form 40. 

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