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Exports

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Exports & Clinical Trials for Medical Devices Dr. Subodh P. Adeshara Executive Director Sahajanand Medical Technologies Pvt. Ltd. & Coordinator Medical Devices ... – PowerPoint PPT presentation

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Title: Exports


1
Exports Clinical Trials for Medical Devices
  • Dr. Subodh P. Adeshara
  • Executive Director
  • Sahajanand Medical Technologies Pvt. Ltd.
  • Coordinator Medical Devices Panel - Pharmexcil

2
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Industry Segments
6
Global Clinical Trials
  • Permission is required from CDSCO for conducting
    global clinical trials in the country
  • Phase I for New Drug substance
  • developed outside India is not permitted
  • So far, approx. 500 permissions have been granted
    since 2003

7
Costs
  • Costs Macro View
  • Pre-Clinical (estimates)
  • Chemistry 30 to 60 of the cost of West
  • Other Pre-clinical
  • Toxicology 30 of the cost of the West
  • Animal Testing 30 of the Cost of the West
  • Clinical (estimates)
  • Phase I 25 of the cost of the West
  • Phase II/III 30 of the cost of the West
  • Time Equals Money
  • Patient Recruitment
  • Pre-clinical Regulations

8
Costs Cont..
  • Costs Micro View
  • Item US Cost India Cost

9
Conducting Clinical trials With Medical Devices
in India Regulatory Aspects
  • (Regulated by the DCGI office under Gazette
    Notification No.
  • S.O. 1468(E) dated 6th October 2005 and G.S.R.
    627(E) dated 7th October 2005)

10
Indian Regulatory Environment Regulatory Bodies
Governing Controlling Clinical Trials
11
Drugs Controller General India (DCGI) Role
  • Permission to conduct clinical trials with New
    Drugs/Existing Drugs/Medical devices under drugs
    category
  • Import license / Test License for clinical trial
    drug supplies concurrent with main submission
  • Approval for conducting clinical trials with
    Medical Devices under Drug Category
  • Permission/N.O.C./Notification for Protocol
    Amendments/ICF amendments/Safety reports
  • Notification for SAEs observed in ongoing
    clinical trials

12
Following Medical Devices have been considered as
Drug by DCGI as per Gazette notification no. S.O.
1468(E) dated 6th October 2005 and G.S.R. 627(E)
dated 7th October 2005
  • 1.Cardiac Stents
  • 2.Drug Eluting Stents
  • 3.Catheters
  • 4.Intra Ocular Lenses
  • 5.I.V. Cannulae
  • 6.Bone Cements
  • 7.Heart Valves
  • 8.Scalp Vein Set
  • 9.Orthopedic Implants
  • 10. Internal Prosthetic Replacements

13
Medical Devices Contd
  • A. All devices falling under the category of
    devices specified by DCGI and containing the drug
    components will
  • 1.Be reviewed and approved by the NEW
  • DRUG DIVISION of the DCGI.
  • 2.Approval timelines are 4-6 weeks for Category
    A and
  • 8-12 weeks for Category B applications.
  • a. CATEGORY A Those Protocols which are
    approved by recognized and developed
    countries viz. USA,
  • UK, Switzerland, Australia, Canada,
    Germany, South Africa, Japan, EMEA.
  • b. CATEGORY B All other applications not
    falling
  • under Category A.

14
Medical Devices Contd
  • B. All devices falling under the category of
    devices specified by DCGI and not containing the
    drug component will
  • 1.Be reviewed and approved by the
  • MEDICAL DEVICE SECTION of DCGI.
  • 2.Approval timelines are between 6-8
  • weeks.

15
Medical Devices Contd
  • C. All those devices which do not fall under the
    category of devices specified by DCGI will
  • 1.Be submitted ONLY FOR NOTIFICATION at DCGI
  • for conduct of clinical trial.
  • 2.No written approval / NOC is issued / required
  • from DCGI to conduct clinical trial in
    India.
  • 3.Ethics Committee approvals are required to
  • initiate the clinical trial at the sites.

16
Timelines
  • Approval Time Frame
  • Export NOC 2 Weeks
  • Dual use, Rule 37
  • Neutral code 3 Weeks
  • Additional indication etc. 4 Weeks
  • Form 10 4 Weeks
  • Test License 4 Weeks
  • First response to New Drug 6 Weeks
  • FDC first response 6 Weeks
  • Endorsement of additional 8 Weeks
  • products on registration
  • Registration 12 weeks

17
Checklist of documents for seeking permission to
conduct Clinical Trial with Medical Devices under
Drug category (With Drug / Without Drug) and
Device category
  • 1.Name of the Applicant
  • 2.Transfer of Responsibility letter from the
    sponsor
  • 3.Name of the Device
  • 4.Regulatory status of the device in other
    countries (US FDA clearance/approval)
  • 5.Objective of the Study
  • 6.Phase of study
  • 7.Names of the Participating Countries/Investigato
    r sites
  • 8.No. of patients to be included in India
  • 9.Country / IRB approvals from participating
    countries
  • 10.ISO/CN/CE certification for the manufacturing
    facility and the list of countries where the
    device is being marketed.

18
Checklist of documents contd.
  • 11. Status of the study in other countries
  • 12. Affidavit from the sponsor regarding non-
  • discontinuation of the study
  • 13. CE certificate from European authority
    approval
  • from Australia / Canada / Japan, if
    available
  • 14. Undertaking of conformity w.r.t product
    standards,
  • safety effectiveness requirements and
    quality
  • systems in the country of origin.
  • 15. Clinical data and published literature on the
    safety,
  • quality usefulness of the medical
    substance used
  • in the medical device (Only for devices
    containing
  • drug component).

19
Checklist of documents contd.
  • 16.Data submitted
  • Chemical Pharmaceutical data
  • Generic name and chemical name
  • Dosage Form
  • Composition
  • Animal Pharmacology Data
  • Animal Toxicology data
  • Clinical data
  • 17.Documents submitted
  • Form 44 Fee Receipt
  • Form 12 and Fee Receipt
  • Details of Biological specimens to be exported
  • Protocol
  • Informed Consent Form
  • Case Report Form
  • Investigators Brochure
  • Undertakings CVs by Investigators
  • Ethics Committee approvals (For Category B)

20
Directorate General of Foreign Trade Role
  • 1.Issuing Export Permission for exporting Human
    biological samples for study related analysis to
    Central Lab
  • Export Permission valid for a period of 1
  • year
  • 2.Revalidation of Export Permission

21
Approval Timelines -Export Permission
  • 1.Devices Containing Drug component
  • 4-6 Weeks
  • 2.Devices not containing Drug Component
  • 4-6 Weeks
  • 3.Devices Under notification category
  • Export Permission not issued by DGFT

22
Joint Directorate General of Foreign Trade Role
  • 1.Issuing Export License for exporting Human
    biological samples for study related analysis to
    central lab
  • The export license is valid for a period of
  • 2 years
  • 2.Revalidation of Export License

23
Checklist of documents to be submitted for
Export License
  • 1.Cover letter
  • 2.Copy of DCGI approval letter
  • 3.Letters from the Labs
  • 4.Aayat Niryaat Form
  • 5.Copy of IEC Certificate
  • 6.Copy of PAN Number
  • 7.Copy of Registration cum Membership certificate
  • 8.List of Directors
  • 9.Copy of Certificate of Incorporation
  • 10.Copy of Study Protocol
  • 11.Copy of Export Permission

24
Approval Timelines -Export Licence
  • 1.Devices Containing Drug Component
  • 2 Weeks
  • 2.Devices Not Containing Drug Component
  • 2 Weeks
  • 3.Devices Under Notification Category
  • Export Licence not issued by Jt. DGFT

25
Role of Pharmaceutical Export Promotion Council -
PHARMEXCIL
  • Promote Activity related to export of Medical
    Devices
  • Conduit for financial assistance by GOI
  • Up gradation of medical Device Industry in the
    country
  • Vital link between India Buyer Countries
  • Conducts buyer seller meets

26
Activity by Pharmexcil
  • 50 of expense on Registration of Medical Device
    in any country for the purpose of Export is
    Reimbursed by GOI thro Pharmexcil upto Rs 50
    lacs pa per company. Such registration costs
    several thousands of USD
  • Helps exporters to get exposed to buyers marke
  • Promotes export by helping industry to fulfill
    export procedures
  • Provides Technical support wherever possible
  • Activities like seminars, training, cluster
    development for modernization

27
Current Trials being Conducted in India NIH
Registered
  • Overall Clinical Trials 870/68811 1.3
  • Device based Trials 25/3544 0.7
  • Biotechnology based Trials 3/140 2.1
  • Stent based Trials 13/409 3.2
  • ClinicalTrials.gov

28
Global Trials in India
Based on The Boston Consulting Group and Business
Communications Co.
29
Trials in India
Based on The Boston Consulting Group and Business
Communications Co.
30
Why India ?
  • Genetically diverse population Western disease
    distribution
  • Low Cost 40-60 reduction
  • Large and quick pt. recruitment
  • Over 600 ICH/GCP compatible sites
  • Large number of medical specialists
  • Well developed IT and other infrastructure
    available
  • English as spoken and technical language
  • Increase in number of CROs National and
    International

31
On-going Device Based Trials in India
32
Interventional Cardiology Device based Trials
  • Indian Trials
  • Multi-national Trials

33
Indian Stent Trials - Completed
  • SIMPLE I Infinnium stent, FIM, completed (SMT)
  • NOVA FIM Pronova stent, FIM, completed
    (Vascular Concepts)
  • RELEASE T Relisys stent, FIM, completed
    (Relisys Medical Devices)
  • SIMPLE II III Infinnium stent, Pre-market,
    completed (SMT)
  • EMPIRE Propass stent, Pre-market, completed
    (Vascular Concepts)
  • PROSES INNOVA Propass stent, Post-market,
    completed (Vascular Concepts)
  • SERIES I Supralimus stent, FIM, Completed (SMT)
  • MAXIMUS Supralimus-Core stent, FIM, Completed
    (SMT)

34
Multinational Device based Trials -Completed
  • COSTAR I Costar stent, FIM (Conor Medsystems)
  • WISDOM Taxus stent, Pre-market (Boston
    Scientific)
  • SPIRIT II Xience V vs. Taxus stent, Pre-market
    (Abbott Vascular)
  • TAXUS OLYMPIA Taxus stent, Post-market (Boston
    Scientific)
  • E Cypher Cypher stent, Post-market (Cordis, J
    J)
  • VIVE Vision stent, Post-market (Abbott
    Vascular)
  • REALITY Cypher vs. Taxus stent, Post-market
    (Cordis, J J)
  • DECODE Cypher vs. Bx Velocity stent,
    Post-market (Cordis, J J)
  • SPIRIT V Xience V stent, Post-market (Abbott
    Vascular)

35
Multinational Device based Trials -On-going
  • FRONTIER Frontier Bifurcation stent,
    Post-market (Abbott Vascular)
  • PROTECT Endeavor vs. Cypher stent, Post-market
    (Medtronic)
  • E SELECT Cypher stent, Post-market (Cordis, J
    J)
  • CC Flex CC Flex stent, Post-market (eucatech )
  • FREEDOM Cypher vs. CABG, Post-market (Boston)
  • ENDEAVOR 5 Endeavor stent, Post-market
    (Medtronic)
  • EXPORT Export Aspiration Catheter, Post-market
    (Medtronic)
  • PANORAMA CRDM Device, Post-market (Medtronic)
  • Bone Marrow aspiration for CLI, Post-market
  • CiTopTM Guidewire for CTO, Post-market (Ovalum)

36
Issues in India
  • Informed Consent Issues
  • Truly Independent IRBs
  • Proper documentation
  • Under-reporting by pts., physicians etc.
  • Proper Follow-up
  • Change in study co-coordinators
  • Regulatory Apparatus

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Market Implications
  • adapted from Sumner K. Attitude Adjustment.
    Available on www.devicelink.com

40
WW Combination Product Market
  • 2009 (est)
  • 10 billion
  •  
  • 88 all Cardiovascular applications
  • 12 Wound Care, Orthopedics and all other
    applications
  • DES will account for 70 of total market
  • Combination Products An Impact Analysis on the
    Convergence of Medical Devices and Therapeutics.
    Navigant Consulting/Front Line Strategic Market
    Reports

41
Conclusions
  • Clinical trial industry in India accounts for
    1 of global trials but is likely to increase
    up to 15
  • Lower cost and faster recruitment potential is
    most important reason for it
  • Several Indian and prestigious Multi-national devi
    ce based trials have already been conducted and
    many more are in pipeline
  • Some regulatory and local IRB Accreditation
    issues need still to be addressed

42
Thank You
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