New Drug Approval in India

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  1. 1. Accredited Consultants Pvt. Ltd.1 WELCOME Accredited Consultants Pvt. Ltd.
  2. 2. Accredited Consultants Pvt . Ltd.2 New Drug Approval [NDA]
  3. 3. Accredited Consultants Pvt. Ltd. 3 DRUG REGULATION SYSTEM IN INDIA Drug Controller General [DCG] of India is the Head of the Central Drug Standard Control Organisation [CDSCO] that Regulates Medical Devices & Drugs in India. The Objective of a Drug Regulatory Authority is to ensure that medicinal products are of acceptable Quality, Safe and Efficient. That the medicinal products are Manufactured, Approved, and Imported.
  4. 4. Accredited Consultants Pvt . Ltd.4 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/Povigilance] 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 Accredited Consultants Pvt. Ltd.5 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 of Test License, Personal License, NOCs for Export Testing of Drugs
  6. 6. Approval of Clinical Trials, Import, & Manufacture of New Drugs Accredited Consultants Pvt. Ltd.6 Requirements and Guidelines - Schedule Y 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.7 FLOW CHART FOR New Drug Approval (NDA) Common Technical documents [CTD] (Modules 1-5) Veterinary Product - CTD Modules 1-4 Biologicals Vaccines New Drugs/Devices NoC from Animal Husbandry
  8. 8. Accredited Consultants Pvt . Ltd.8 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.9 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.10 1. It generally takes about one year to scrutinize these documents by Technical Data Associates/Drug Inspectors of CDSCO. 2. During this period clarifications if any, are required by them are answered and thereafter the importer gets the Approval. 3. TR Challan of Rs 50,000 is required for the fresh application. 4. TR Challan of Rs 15,000 is required for subsequent application.
  11. 11. Accredited Consultants Pvt . Ltd.11 FLOW CHART FOR REGISTRATION Legal Documents Regulatory documents Technical Documents Form 40 POA, DI & DII PMF DMF Labels/Inserts
  12. 12. Accredited Consultants Pvt Ltd12 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
  13. 13. Accredited Consultants Pvt . Ltd.13 LEGAL DOCUMENTS Documents To be submitted by Indian agent Form 40- It should be signed and stamped by the Indian agent. Documents To be submitted by Manufacturer PoA- Power of Attorney should be Appostilised or Consularized by the Indian Embassy from the country of origin. It should be co-jointly signed by both the parties i.e The Manufacturer and the Indian Agent. Schedule DI & DII- They should be signed and stamped by Manufacturer (Need not to be notarized)
  14. 14. Accredited Consultants Pvt. Ltd.14 REGULATORY DOCUMENTS 1. Notarized Plant Registration Certificate 2. Notarized Manufacturing & Marketing License 3. Notarized Free Sale Certificate 4. GMP/COPP Certificate Notarized
  15. 15. Accredited Consultants Pvt. Ltd.15 Technical Documents A) Plant master file: Should include the following points. 1. Sketch of the Plant 2. Profile of the company 3. Organogram of the Company 4. Plant & Machinery 5. Hygienic & Sanitary measure details 6. IQPQDQOQ 7. HAVAC System 8. MEN MATERIAL MOVEMENT
  16. 16. Accredited Consultants Pvt . Ltd.16 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 Risk Assessment as per ISO 14971. Process validation/verification Stability data Biocompatibility and Toxicological data Clinical Studies & reports
  17. 17. Accredited Consultants Pvt. Ltd.17 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 Action Taken
  18. 18. Accredited Consultants Pvt. Ltd.18 C). LABELS AND INSERTS 1.Product labels should show the address of Manufacturer. 2. Product inserts should describe the brief description of the product and its intended use.
  19. 19. Accredited Consultants Pvt. Ltd.19 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 the Technical Data Associates/Drug Inspectors of CDSCO. During this period if any clarification is required by them, these are answered. Thereafter we get the Registration Certificate (RC) in Form 41.
  20. 20. Accredited Consultants Pvt . Ltd.20 IMPORT PROCESSING After getting the registration certificate from CDSCO, the Indian agent can 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 the First Product, thereafter Rs. 100 for each additional product) Form 9 Copy of Wholesale License (Indian agent)-Notarized Copy of Registration Certificate-Notarized
  21. 21. Accredited Consultants Pvt. Ltd.21 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 by Technical Data Associates/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 application TR Challan of Rs 1000 for Ist. product then Rs 100 for each additional product is required.
  22. 22. Contact Details: Accredited Consultants Private Limited, D-29, First Floor, Acharya Niketan, Mayur Vihar Phase-I, Delhi-110091. Phones: 011-22758204, (M) +91-9310040434, +91-9266665201 Fax: 011-22758994 Email: info@acplgroupindia.com, info@acplgroupindia.co.in, prasad_bhat@hotmail. Accredited Consultants Pvt. Ltd.