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New drug approval in India
- 2. CONTENTS • GOVT. OF INDIA • RECENTLY APPROVED DRUGS • STEPS FOR CLINICAL TRIALS • REQUIREMENTS AND GUIDELINES • FEES FOR CLINICAL TRIAL/APPROVAL OF NEW DRUGS • OVERVIEW OF DRUG APPROVAL • REQUIREMENTS FOR INDIA By -Rohit Bhatia
- 3. GOVT. OF INDIA MOHFW DGHS CDSCO DCGI Ministry of Chemicals & Fertilizers Dept. of Pharmaceuticals NPPA Ministry of Commerce Patent Office Ministry of Science & Technology ICMR DBT CSIR Labs By Rohit Bhatia
- 4. Recently approved new drugs in IndiaSALT NAME BRAND NAME CLASS Date of Approval Trientine Hydrochloride bulk & 250mg capsule SYPRINE (Merck) Chelating agent 11.06.2018 Netupitant 300 mg + Palonosetron 0.5 mg Capsule AKYNZEO 300mg/0.56mg Capsule ( Glenmark) Antiemetic 20.02.2018 Clofarabine Bulk & Injection 20 mg/20ml vial CLOLAR (Sanofi) Anticancer 16.01.2018 Gadoteridol - 279.3mg/ml for injection PROHANCE (Bra cco Diagnostics ) Gadolinium- based contrast agent. 25.06.2018 Emtricitabine 200mg and tenofovir alafenamide 25mg tablets TAFERO-EM ( Hetro ) Antiretroviral 25.06.2018 By Rohit Bhatia
- 5. APPLICANT IND application filling to CDSCO Application to Ethical committee Report to ethical commitee Examination by new drug division Detail review by IND committee Recommendation to DCGI IND application approved Clinical trail started Application for new drug registration CDSCO Review by DCGI Drug Approval By Rohit Bhatia
- 6. Legal Provisions for permission to Import / Manufacture of New Drugs • Requirements and Guidelines - Schedule Y • Rule 122 A Permission to import new drug • Rule 122 B Permission to manufacture new drug • Rule 122 D Permission to import/manufacture of FDC • Rule 122 DB Suspension / Cancellation of permissions • Rule 122 E Definition of New Drugs By Rohit Bhatia
- 7. • 122-B. Application for approval to manufacture New Drug other than the drugs classifiable under Schedules C and C(1) • Form 44 • Application received after one year of the grant of approval . • Drug if approved to be manufactured (Form 46 and/or Form 46 A) • When applying for approval to manufacture of a new drug under sub-rule (1) or its preparations to the State licensing authority(Rule 21). By Rohit Bhatia
- 8. • Permission to import or manufacture fixed dose combination (122-D): • Defined in clause (c) of rule 122 E • Form 44, accompanied by a fee of fifteen thousand rupees and shall be accompanied by such information and data as is required in Appendix VI of Schedule Y. • The Licensing Authority after being satisfied that the fixed dose combination, if approved to be imported or manufactured as finished formulation shall be effective and safe for use in the country, shall issue permission in Form 45 or Form 46, as the case may be, subject to the conditions stated therein; Provided that the Licensing Authority shall where the data provided or generated on the fixed dose combination is inadequate, intimate the applicant in writing, and the conditions which shall be satisfied before grant of approval/permission could be considered. By Rohit Bhatia
- 9. Fees for Clinical Trial/Approval of New Drugs • Phase I (IND) -Rs. 50000 • Phase II (IND) -Rs.25000 • Phase III(IND) -Rs.25000 • Approval of New Molecule -Rs.50000 • Approved New Drug:- Within1 yr of approval -Rs.50000 After 1yr of approval -Rs.15000 • Approval of New claim, New Dosage form etc.- Rs.15000 By Rohit Bhatia
- 10. FORM • Form 44: Application for Permission to undertake clinical trial/Manufacture/Import of New Drugs with details of documents to be submitted along with prescribed fees • Data required to be submitted – As per Appendix- I(For unapproved new molecules) – As per Appendix- IA (For approved new drugs) By Rohit Bhatia
- 11. By Rohit Bhatia
- 12. Principle of India Administrative Requirements REQUIRMENT INDIA Agency One Agency DGCI Registration Process One Registration Process TSE/BSE Study data Required Braille Code Not required on labelling Post approval change Major quality changes Moderates quality changes REQUIRMENT INDIA Application MAA Required Debarment Classification Not Required Number of copies 1 Approval Timelines 12-18 Months Fees 50,000 INR Presentation Paper / Online By Rohit Bhatia
- 13. • Finished Product Control Requirement • Manufacturing & Control Requirement REQUIRMENT INDIA Justification ICH Q6A Assay 90-110% Disintegration Required Colour Identification Required Water Content Required REQUIRMENT INDIA Number of Batches 1 Packaging Not addressed Process Validation Required Batch Size Pilot scale batch By Rohit Bhatia
- 14. • Bioequivalence Requirements REQUIRMENT INDIA CRO(Audit) CDSCO Reserve Sample – Fasted/Fed As CDSCO recommendation Retention of sample 3 years from date of filing the application By Rohit Bhatia
- 15. REERENCES • Drugs Control Media Services, available from – https://www.drugscontrol.org/permission-to-market- new-drugs-in-india.php , last accessed on 14/12/18 • Central Drugs Standard Control Organization , available from- https://cdsco.gov.in/opencms/opencms/en/Approval_n ew/Approved-New-Drugs/ , last accessed on 14/12/18 • New drug approval and Post Marketing Surveillance , available from - http://www.ipa- india.org/static-files/pdf/event/New-Drug-Approval-V- G-Somani-17.pdf , last accessed on 14/12/18 By Rohit Bhatia
Editor's Notes
- (b) An application for grant of approval to manufacture the new drug and its formulations shall be made in Form 44 to the Licensing Authority as defined in clause (b) of rule 21 and shall be accompanied by a fee of fifty thousand rupees: Provided further also that any application received after one year of the grant of approval for the manufacture for sale of the new drug, shall be accompanied by a fee of fifteen thousand rupees and such information and data as required by Appendix I or Appendix I A of Schedule Y, as the case may be. (2) The manufacturer of a new drug under sub-rule (1) when applying for approval to the licensing authority mentioned in the said sub-rule, shall submit data as given in Appendix I to Schedule Y including the results of clinical trials carried out in the country in accordance with the guidelines specified in Schedule Y and submit the report of such clinical trials in the format given in Appendix II to the said Schedule. (2A) The Licensing Authority as defined in clause (b) of rule 21 after being satisfied that the drug if approved to be manufactured as raw material (bulk drug substance) or as finished formulation shall be effective and safe for use in the country, shall issue approval in Form 46 and/or Form 46 A, as the case may be, subject to the conditions stated therein: When applying for approval to manufacture of a new drug under sub-rule (1) or its preparations to the State licensing authority, an applicant shall produce along with his application, evidence that the drug for the manufacture of which application is made has already been approved by the licensing authority mentioned in Rule 21:
- (1) An application for permission to import or manufacture fixed dose combination of two or more drugs as defined in clause (c) of rule 122 E shall be made to the Licensing Authority as defined in clause (b) of rule 21 in Form 44, accompanied by a fee of fifteen thousand rupees and shall be accompanied by such information and data as is required in Appendix VI of Schedule Y. (2) The Licensing Authority after being satisfied that the fixed dose combination, if approved to be imported or manufactured as finished formulation shall be effective and safe for use in the country, shall issue permission in Form 45 or Form 46, as the case may be, subject to the conditions stated therein; Provided that the Licensing Authority shall where the data provided or generated on the fixed dose combination is inadequate, intimate the applicant in writing, and the conditions which shall be satisfied before grant of approval/permission could be considered