Here we are going to talk about how you can do that if you want to sell Ayurvedic medicine in India. We talked a lot about: How can you start an ayush manufacturing company? How can you start a ayush marketing company? How can you do ayush products distribution? How can you start ayush retail store? But now comes the matter that if you want to sell Ayurvedic medicine , then in what way can you sell them. First, let's discuss about some regulatory requirements. Regardless of the Ayurvedic medicine that is available, then we include the entire AYUSH sector. Let's talk about the entire Ayush sector (Ayurvedic, Yoga & Naturopathy, Unani, Siddha and Homeopathy) . But keeping homeopathic medicine on the side, because license is required for homeopathic medicine. When it comes to manufacturing Ayurvedic medicine, Unani medicine, Siddha medicine, , it is regulated within the Drug and Cosmetic Act. The section of Ayurvedic Medicine is covered under this Act . Manufacturing of ayurve
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
Comments
Post a Comment