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New drug approval ppt

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ACCREDITED CONSULTANTS PVT LTD
info@acplgroupindia.co.in
+919310040434

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New drug approval ppt

  1. 1. WELCOME Accredited Consultants Pvt Ltd D-29, First Floor, Acharya Niketan, Mayur Vihar Phase-I, Delhi-110091 Ph: 011-22758204, Fax: 011-22758994 (M) +91-9310040434:+91- 9266665201 Email: info@acplgroupindia.com, info@acplgroupindia.co.in; prasad_bhat@hotmail.com; Web: www.acplgroupindia.co.in
  2. 2. New Drug Approval [NDA] Accredited Consultants Pvt Ltd
  3. 3. Accredited Consultants Pvt Ltd DRUG REGULATION SYSTEM IN INDIA The Objective of a Drug Regulatory Authority is to ensure that of medicinal products are of acceptable Quality, Safety and Efficacy which are Approved, Manufactured and Imported. Drug Controller General of India is the head of Central Drug Standard Control Organization , which regulates Devices & Drugs in India.
  4. 4. Accredited Consultants Pvt Ltd Drug Controller General of India Deputy Drug Deputy Drug Deputy Drug Deputy Drug Controller Controller Controller Controller [New Drug/GCT [Medical Device] [Biologicals &Vaccines] [Drugs] /FDC/P’ovigilance] Asst Drug Controller Asst Drug Controller Asst Drug Controller Asst Drug Controller T.O/D.I (5-15) T.O/D.I (5-15) T.O/D.I (5-15) T.O/D.I (5-15) TDA (0-10) TDA (0-10) TDA (0-10) TDA (0-10)
  5. 5. Functions of CDSCO  Approval of new drugs and clinical trials  Import Registration and Licensing  Licensing of Blood Banks, LVPs,Vaccines, r-DNA  products & some Medical Devices  Amendment to D &C Act and Rules  Banning of drugs and cosmetics  Grant ofTest License, Personal License, NOCs for Export  Testing of Drugs Accredited Consultants Pvt Ltd
  6. 6. Approval of Clinical Trials, Import, & Manufacture of New Drugs Accredited Consultants Pvt Ltd Requirements and Guidelines - ScheduleY  Rule 122 A -: Permission to import and market new drug  Rule 122 B -: Permission to manufacture new drug  Rule 122 DA -: Permission of Clinical trials/IND  Rule 122 E -: Definition of New Drugs* • New substance having therapeutic indication • Modified or new claims, new route of administration for already approved drug • Fixed Dose Combination
  7. 7. Accredited Consultants Pvt Ltd FLOW CHART FOR New Drug Approval (NDA) Biologicals Vaccines New drugs/Devices Common Technical documents [CTD] (Modules 1-5) • Veterinary Product - CTD Modules 1-4 - Noc from Animal Husbandry
  8. 8. Accredited Consultants Pvt Ltd Common Technical Documents MODULE-1: Administrative Information MODULE- 2: Quality Overall Summary MODULE-3: Quality MODULE-4: Non- Clinical Studies MODULE-5: Clinical Studies
  9. 9. Accredited Consultants Pvt Ltd New Drug Approval Form 45 Form 45 A Form 46 (Finished Formulation) (Bulk Substance) (Manufacturing) Registration Form 41 Import License Form 10
  10. 10. TIME LINE & FEES FOR NDA Accredited Consultants Pvt Ltd It generally takes about one year to scrutinize these documents byTechnical DataAssociates/Drug inspectors of CDSCO and during this period clarification if any, are required by them are answered and thereafter the importer gets theApproval. TR Challan of Rs 50,000 is required for the fresh application. TR Challan of Rs 15,000 is required for subsequent application.
  11. 11. Accredited Consultants Pvt Ltd FLOW CHART FOR REGISTRATION Legal Documents Regulatory documents Technical Documents Form 40 POA, DI & DII PMF DMF Labels/Inserts
  12. 12. LEGAL DOCUMENTS DocumentsTo be submitted by Indian agent  Form 40- It should be signed and stamped by Indian agent. DocumentsTo be submitted by Manufacturer  POA- Power of attorney should beAppostilised or Consularized from Indian embassy of the country of origin, and should be co- jointly signed by both the parties i.e Manufacturer and Indian Agent.  Schedule DI & DII- They should be signed and stamped by Manufacturer (Need not to be notarized) Accredited Consultants Pvt Ltd
  13. 13. REGULATORY DOCUMENTS  Notarized Plant Registration Certificate  Notarized Manufacturing & Marketing License  Notarized Free Sale Certificate  GMP/COPPCertificate Notarized Accredited Consultants Pvt Ltd
  14. 14. Accredited Consultants Pvt Ltd Technical Documents A) Plant master file: Should include the following points.  Sketch of the Plant  Profile of the company  Organogram of the Company  Plant & Machinery  Hygienic & Sanitary measure details  IQPQDQOQ  HAVAC System  MEN MATERIAL MOVEMENT
  15. 15. Accredited Consultants Pvt Ltd B). Drug master file: Should include the following points.  Manufacturing process/Flow Chart  Quality Assurance procedures/process controls  The provision to control contamination & cross contamination in the final product  Process control, control of critical steps and intermediates.  Container Closure System  RiskAssessment as per ISO 14971.  Process validation/verification  Stability data  Biocompatibility andToxicological data  Clinical Studies & reports
  16. 16. Accredited Consultants Pvt Ltd Post marketing Surveillance- It is the part of Device Master File, should include following points:  Procedures for distribution of records  Complaint handling.  Adverse incident reporting  Procedure for product recall  Corrective ActionTaken
  17. 17. Accredited Consultants Pvt Ltd C). LABELS AND INSERTS  Product labels should show the address of Manufacturer.  Product inserts should describe the brief description of the product and its intended use.
  18. 18. Accredited Consultants Pvt Ltd PROCESSING PROCEDURE After ensuring all documents correctly as per the requirements of FDA, they are submitted. It generally takes about 2-3 months to scrutinize these documents by Technical DataAssociates/Drug inspectors of CDSCO and during this period clarification if any, required by them are answered and thereafter we get the Registration Certificate (RC) in Form 41.
  19. 19. Accredited Consultants Pvt Ltd IMPORT PROCESSING After getting the registration certificate from CDSCO, the Indian agent is now import the products from the manufacturer. Following documents are further required to get Form 10 (Import license).  Form 8  TR Challan- (Rs 1000 for Ist product then Rs 100 for each additional product)  Form 9  Copy ofWholesale License (Indian agent)-Notarized  Copy of Registration Certificate-Notarized
  20. 20. Accredited Consultants Pvt Ltd TIME LINE FOR IMPORT LICENSE The Importer (Indian agent) is not authorized to import the products from foreign manufacturer unless he obtains Import license (Form 10) form CDSCO. It generally takes about one month to scrutinize these documents byTechnical DataAssociates/Drug inspectors of CDSCO and during this period clarification if any, are required by them are answered and thereafter the importer gets the Import license. For Import license applicationTR Challan of Rs 1000 for Ist product then Rs 100 for each additional product is required.
  21. 21. THANK YOU Accredited Consultants Pvt Ltd OUR HEARTFUL THANKS WE BELIEVE OUR CLIENTS ARE OUR KINGS!!! D-29, First Floor, Acharya Niketan, Mayur Vihar Phase-I, Delhi-110091 Ph: 011-22758204, Fax: 011-22758994 (M) +91-9310040434:+91- 9266665201 Email: info@acplgroupindia.com, info@acplgroupindia.co.in; prasad_bhat@hotmail.com; Web: www.acplgroupindia.co.in

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