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.
Schedules: Schedule A, Schedule B, Schedule C, Schedule D, Schedule E1, Schedule F, Schedule G, Schedule H, Schedule H1, Schedule I, Schedule J, Schedule K, Schedule L1, Schedule M, Schedule M1, Schedule M2, Schedule M3, Schedule N, Schedule O, Schedule P, Schedule Q, Schedule R, Schedule S, Schedule T, Schedule U, Schedule V, Schedule W, Schedule X, Schedule Y
Schedule D (Rule 43) is related to import of drugs into India. Schedule D provides information about extent and condition of exemption for a class of drug in case of import.
Schedule D(I)(Rule 21D and 24A): Information and undertaking required to be submitted by the manufacturer or his authorized agent with the Application Form for a Registration Certificate. The format shall be properly filled in for each application in Form 40.
The detailed information, secret in nature, may be furnished on a Computer Floppy.
Schedule D(II) (Rule 21D and 24A): Information required to be submitted by the manufacturer or his authorized agent with the Application Form for the registration of a bulk drug/formulation/special product for its import into India.
The format shall be properly filled in and the detailed information, secret in nature, may be furnished on a Computer Floppy.
Annexure A: Information to be Submitted In Schedule D-II: Specific information required for the Blood Product
Annexure B: Information to be submitted in schedule D-II: specific information required for the diagnostic kits
Annexure C: Information to be submitted in schedule D-II: Specific information required for the vaccines
Schedule D(III)(Rule 129A): Information and undertaking required to be submitied by the manufacturer or his authorised importer/distributor/agent with the application form for a registration certificate.
For more detail refer Drug and Cosmetic Act
Schedule D (Rule 43) is related to import of drugs into India. Schedule D provides information about extent and condition of exemption for a class of drug in case of import.
Schedule D(I)(Rule 21D and 24A): Information and undertaking required to be submitted by the manufacturer or his authorized agent with the Application Form for a Registration Certificate. The format shall be properly filled in for each application in Form 40.
The detailed information, secret in nature, may be furnished on a Computer Floppy.
Schedule D(II) (Rule 21D and 24A): Information required to be submitted by the manufacturer or his authorized agent with the Application Form for the registration of a bulk drug/formulation/special product for its import into India.
The format shall be properly filled in and the detailed information, secret in nature, may be furnished on a Computer Floppy.
Annexure A: Information to be Submitted In Schedule D-II: Specific information required for the Blood Product
Annexure B: Information to be submitted in schedule D-II: specific information required for the diagnostic kits
Annexure C: Information to be submitted in schedule D-II: Specific information required for the vaccines
Schedule D(III)(Rule 129A): Information and undertaking required to be submitied by the manufacturer or his authorised importer/distributor/agent with the application form for a registration certificate.
For more detail refer Drug and Cosmetic Act
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