Ethical and Regulatory Approval Process in HIV Vaccine Clinical Research India Experience HIV Vaccine Clinical Research Ethical and Regulatory Issues Brasilia, October 4-5, 2006 Dr. Sonali Kochhar Senior Medical Project Manager International - PowerPoint PPT Presentation

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Ethical and Regulatory Approval Process in HIV Vaccine Clinical Research India Experience HIV Vaccine Clinical Research Ethical and Regulatory Issues Brasilia, October 4-5, 2006 Dr. Sonali Kochhar Senior Medical Project Manager International

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Title: Ethical and Regulatory Approval Process in HIV Vaccine Clinical Research India Experience HIV Vaccine Clinical Research Ethical and Regulatory Issues Brasilia, October 4-5, 2006 Dr. Sonali Kochhar Senior Medical Project Manager International


1
Ethical and Regulatory Approval Process in
HIV Vaccine Clinical Research India Experience
HIV Vaccine Clinical Research Ethical and
Regulatory IssuesBrasilia, October 4-5, 2006
Dr. Sonali KochharSenior Medical Project
Manager International AIDS Vaccine Initiative,
India

2
Approval Process in India
  • Well-delineated pathway with published guidelines
    and forms for regulatory and ethical bodies
    available
  • Regulatory Agency - Drug Controller General of
    India (DCGI)
  • (www.cdsco.nic.in)
  • Drugs and Cosmetics Act 1940 was to prevent
    sub-standardization in drugs.
  • Drugs and Cosmetic Rule 1945 provided rules to
    Act. In latest amendment in January 2005,
    existing Schedule Y substituted.
  • Schedule Y Provides specific guidelines for
    permission to import or manufacture new drugs for
    clinical trials
  • No separate guidelines for vaccines

3
Approval Process in India
  • Phase I trials with imported product
  • Normally no Phase I with new product if not first
    tested outside India.
  • Need to submit Phase I data generated outside
    India, obtain permission to repeat Phase I trials
    and /or Phase II trials followed by Phase III
    trials concurrently with other global trials for
    product.
  • Phase III trials must be conducted in India
    before permission to market product in India is
    granted
  • Exceptions on case-by-case basis for vaccines or
    drugs targeting diseases of major public health
    threat or life threatening/serious diseases e.g.
    HIV, Malaria, TB, Cancer

4
Export Permit from USA to India
  • India is not on US FDA list for export of
    investigational products without IND
  • Two scenarios are possible
  • India is site of joint trial with countries
    where dossier was approved by European agency
    (A001 trial, Pune)
  • Obtain export approval from FDA
  • Submit abbreviated dossier and letter to FDA
    providing evidence that all steps have been taken
    to get approvals from Indian regulatory
    authorities and ethics committees (D001 trial,
    Chennai)

5
Approval Process in India
  • Mandatory, transparent
  • Institutional Scientific Committee
  • Ethics committees
  • Institutional
  • National
  • Import permit of vaccine (DCGI) MOHFW
  • National Regulatory Authority (DCGI) - MOHFW
  • Genetic Engineering Approval Committee
  • Ministry of Environment Forest
  • Health Ministrys Screening Committee

6
Regulatory Process in India
  • Preclinical Data

GEAC GEAC dossier
  • Institutional Scientific Committee
  • Protocol
  • IB
  • DCGI
  • Reviews standard clinical documents
  • Schedule Y with Form 44 (IND equivalent)
  • Form 12 (Import of test vaccine)
  • HMSC
  • TRC cover letter
  • Special HMSC form
  • All approvals

Letter Permission to use material for clinical
trial
  • Institutional Ethics Committee
  • Protocol IB
  • Toxicology Report Summary
  • Clinical documents

Central Ethics Committee Protocol
IB Toxicology Report Summary Clinical documents
DCGI Drug Controller General of India HMSC
Health Ministry Screening Committee GEAC
Genetic Engineering Approval Committee
Approval Steps
TK-02-24-05
7
Institutional Ethics Committee
  • At least 7 members including Chairperson (from
    outside
  • institution)
  • Basic medical scientist
  • Clinician
  • Legal Expert
  • Social Scientist/ representative of NGO
  • Lay person from community
  • Sch Y requirement that committee function
    according to
  • Good Clinical Practice Guidelines issued by
    Central Drugs
  • Standard Control organization
  • Ethical Guidelines for Biomedical Research on
    Human Subjects, issued by Indian Council of
    Medical Research
  • Committee to have SOPs and maintain record of
    proceedings

8
Genetic Engineering Approval Committee
  • Genetically Engineered Products
  • If vaccine is manufactured locally by using
    recombinant DNA technology, approval of Review
    Committee for Gene Manipulation (RCGM) and GEAC
    is mandatory.
  • If vaccine is imported into country, approval
    required from GEAC.
  • Consists of members from Dept. of Biotechnology,
    Agricultural Research, Pollution Control, Food
    Technology etc.
  • Need to confirm that product is free of
    contamination
  • Measures taken to avoid release or damage of
    environment by product.

9
Heath Ministrys Screening Committee
  • Provides final approval for foreign-funded and/or
    collaborative project submitted by Indian
    collaborator.
  • Proposals are considered for review and approval
    after ICMRs technical review.
  • In the case of projects on HIV/AIDS, review by
    National AIDS Control Organization required.
  • Information collected on
  • Role/Status/Expertise of the Indian Principal
    Investigator.
  • Type of infrastructure and manpower in
    institution
  • Sources of foreign collaboration and funding.
  • If material to be sent abroad purpose/need of
    transfer nature of investigation to be conducted
  • Material Transfer Agreement (MTA)

10
AIDS Vaccine Research in India
  • First ever AIDS Vaccine trial being conducted in
    India raised lot of apprehensions amongst
    Regulatory and Ethics committees and
    investigators
  • Institutional committees required numerous
    meetings to address concerns (e.g. for first
    trial, four meetings of Institutional Scientific
    Committee held before members satisfied)
  • Committees gained confidence with experience with
    trial process (e.g. for second trial, members
    from the first trial sites Ethics Committee
    invited to attend meeting. Shared experience and
    concerns with second ethics committee members.
    Process was faster).
  • National Ethics Committee reviewed trial because
    of public significance

11
AIDS Vaccine Approval Process Timelines - India
A001 Clinical Trial, NARI, Pune
D001 Clinical Trial, TRC, Chennai
12
AIDS Vaccine Trial Approval Timelines
13
IAVIs Clinical Research in India
  • Institutional and Central Committees should have
    procedures and maintain record of proceedings as
    per GCP
  • Committees should provide approval letters
    according to GCP requirements.
  • Committees are often overworked and understaffed
  • Committee's might lack technical expertise
    amongst members. Simple and coherent
    presentations by investigators and sponsors asked
    to attend sessions to answer questions.

14
IAVIs Clinical Research in India
  • IAVI in partnership with Government of India and
    trial sites in Government institutions. Distrust
    amongst committees for private agencies (e.g.
    CROs). Need to address concerns.
  • IAVI built capacity amongst trial investigators
    and staff on GCP (via basic and advanced GCP
    courses) including on submissions and
    correspondence with committees.
  • Framework and learning's useful for future HIV
    vaccine and Vaccine research conducted in India.

15
Key Learnings from AIDS Vaccine Research in
India
  • Importance of working with local experts/ agents
  • Be aware of cultural differences and
    sensitivities
  • Deal with long approval process bureaucracy
  • Discuss development plans and dossiers with
    regulatory agencies and scientific committees
    when possible
  • Understand local concerns and address them even
    if not scientifically valid
  • Despite ICH and WHO, technical requirements and
    capacities vary
  • Global dossiers not still a reality. Need to
    prepare documents according to local requirements
  • Prepare well in advance and be prepared to be
    flexible

Acknowledgment Jim Ackland
16
IAVI India Team
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