If we talk about steps for starting pharma marketing company so, Step 1. You need to take experience in pharmaceutical industry that how you can sell your pharmaceutical products. Step 2. You need to choose your company name. Step 3. After that select your products, choose brand names for your products Step 4. You can also go for trademark registration if you want to. Step 5: After finishing these works you can go for company registration if you want to.other wise you can work as a firm Step 6. Apply for licenses - wholesale drug license, GST number. Step7. If you also have food products then you can take fssai registration or license. Step 8. Next step is to find out a good manufacturer who will manufacture your products. Step 9. Next steps is to get manufactured your products from that manufacturer. Step 10. Receiving of products. After receiving products, you can selling and marketing of your products. So, like that you can start your pharma marketing company step by step.
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 Y describes the requirements and guidelines for permission to import and / or manufacture of new drugs for sale or to undertake clinical trials.
1.
Application for Permission
2.
Clinical Trial
I.
Approval for clinical trial
II.
Responsibilities of Sponsor
III.
Responsibilities of the Investigator(s)
IV.
Informed Consent
V.
Responsibilities of the Ethics Committee
VI.
Human Pharmacology (Phase I)
VII.
Therapeutic exploratory trials (Phase II)
VIII.
Therapeutic confirmatory trials (Phase III)
IX.
Post Marketing Trials (Phase IV)
3.
Studies in special populations
I.
Geriatrics
II.
Paediatrics
III.
Pregnant or nursing women
IV.
Post Marketing Surveillance
V.
Special studies: Bioavailability /
Bioequivalence Studies
Appendix I: Data to be submitted along with the application to conduct clinical trials/import/manufacture of new drugs for marketing in the country
Appendix IA: Data required to be submitted by an applicant for grant of permission to import and / or manufacture a new drug already approved in the country
Appendix IB: Data to be submitted along with application to conduct clinical trial or import or manufacture of a phytopharmaceutical drug in the country
Appendix II: Structure, contents and format for clinical study reports
Appendix III: Animal toxicology (non-clinical toxicity studies)
Appendix IV: Animal Pharmacology
Appendix V: Informed Consent
Appendix VI: Fix Dose Combinations (FDCs)
Appendix VII: Undertaking by Investigator
Appendix VIII: Ethics Committee
Appendix IX: Stability Testing of New Drugs
Appendix X: Contents of the proposed protocol for conducting clinical trials
Appendix XI: Data Elements for reporting serious adverse events occuring in a clinical trial
Appendix XII: Compensation in case of injury or death during clinical trial
For more detail refer Drug and Cosmetic Act
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