Location via proxy:   [ UP ]  
[Report a bug]   [Manage cookies]                
Scribd Logo
Upload

Welcome to Scribd!

  • 11 views

    DR Prabhat Roy Kumar CT Regulatory Challnages in India 19nov14 Revised

    Uploaded by

    Saurabh Kumar Singh

    Copyright:

    © All Rights Reserved
    Download as PPT, PDF, TXT or read online from Scribd

    DR Prabhat Roy Kumar CT Regulatory Challnages in India 19nov14 Revised

    Uploaded by

    Saurabh Kumar Singh
    11 views20 pages

    Original Title

    Dr Prabhat Roy Kumar CT Regulatory Challnages in India 19Nov14 Revised

    Copyright

    © © All Rights Reserved

    Available Formats

    PPT, PDF, TXT or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    Copyright:

    © All Rights Reserved
    Download as PPT, PDF, TXT or read online from Scribd
    Download as ppt, pdf, or txt
    11 views20 pages

    DR Prabhat Roy Kumar CT Regulatory Challnages in India 19nov14 Revised

    Uploaded by

    Saurabh Kumar Singh

    Copyright:

    © All Rights Reserved
    Download as PPT, PDF, TXT or read online from Scribd
    Download as ppt, pdf, or txt
    of 20

    Current Regulatory Challenges in

    conduct of Clinical Trials –India​


    ​
    ​

    Prabhat Kumar
    November 2014
    AGENDA

    • Clinical Trial current regulatory framework


    • Current regulatory challenges
    • Background of evolution of current regulatory
    framework
    • Recommendation of the expert committee
    • Actions from the CDSCO
    • Industries expectations
    • Positive developments….!
    • Way forward
    Clinical Trials: Current Regulatory Framework 1

    • Drugs and Cosmetics Act,1940 & Rules,1945


    • ICMR Ethical guidelines,2000/2006
    • Indian GCP Guidelines, 2001
    • National Pharma.Vig. Programme, 2004
    • Revised Schedule Y (Drugs & Cosmetics Rules),
    2005
    Clinical Trials: Current Regulatory Framework 2

    • BA/BE Study Guidelines, 2005


    • Notification on Devices,2005
    • Amendment to Drugs and Cosmetic Act,2008
    • Notification on Clinical trial registration, 2009
    • Amendment to D and C Act, CRO Regn,Sch.Y-
    1,2009
    • Proposed Clinical establishment Bill,2010
    • Amendments in 2012 and 2013
    • CDSCO official order/notifications………..
    Background of evolution of current
    regulatory framework
    • NHRC orders probe into southern state drug trial scandal – several
    women were as used as human subject for breast cancer drug trial by a
    pharmaceutical company.
    • Unauthorised clinical trial of vaccine against cervical cancer were
    conducted by an NGO on 25,000 minor girls in one of the southern
    states and in western state.(HPV Vaccine Trial) A government funded
    hospital in Bhopal was conducting clinical trials on unwitting patients.
    • A Medical College in Indore enrolled children for illegal drug tests for
    nearly ten years.
    • Health activists are concerned about the way many clinical trials are
    conducted in this country.
    • There have been a series of incidences involving alleged malpractices in
    recent past, health minister in last govt. talked in Parliament about
    patient deaths during clinical trials.
    Background of evolution……framework .Cont..

    Expert Committee by MoH under Dr. Ranjit Roy choudhury


    Term of reference : To formulate policy and guidelines for
    –Approval of new drugs including biologicals
    –Approval of clinical trials including global CTs, BA/BE studies for export
    –Functioning of the 12 NDACs (now replaced with SEC and TEC)
    –To identify experts for the CDSCO
    –Any other matter related to CDSCO
    Recommendation of the expert committee
    • Total 25 recommendations were suggested by this
    committee which includes…
    • CTs can be conducted only at accredited Clinical sites by accredited PIs after
    approval by accredited ECs.
    • Roster of experts (SEC) from all over India and selection of experts by random
    tables.
    • Roster of accredited sites from which Pharma co.s can select the Sites and PIs.
    • A technical review Committee to be set up to take uniform, unbiased ,final
    decision on approvals.
    • Audio-visual recording wherever necessary in vulnerable groups.
    • Compensation (Financial) to be paid to legal nominees in case of Death or
    Disability
    • All SAEs to get equal treated whether due to test drug, placebo or Standard
    treatment.
    • Provision of Ancillary care during trial period.
    Actions from the CDSCO
    • CDSCO office released a series of orders (total 14) with
    regard to requirements for conduct/ approval of clinical
    trials and new drug approval based on the
    recommendations of R.R. Committee Report.
    Which includes mainly…….
    • CT Compensation in case of injury or death discerned at
    a later stage.
    • Providing Ancillary Care to the Clinical Trial subjects
    • Limiting Number of Clinical Trials an investigator can
    undertake at a time
    Action…… continued…
    • Requirement for filing of application to market
    new Chemical
    • Waiver of CT in Indian Population for approval of
    New Drugs
    • Requirement for filing of application to market
    new Chemical Entities
    Industries expectations

    Need of the clarity


    •Expectation to have consolidated guidance
    documents providing the current interpretation of
    the regulations related to the EC functioning,
    (similar to USFDA, EMEA etc. )
    Industries expectations Cont..
    Clinical trial liabilities
    •Recently DCGI has been instructing sponsors /CROs to include
    the wording in ICF that sponsor or CRO will provide complete
    medical care as well as compensation for the injury.
    •The injury may either arise out of the ‘study’ i.e. as specified in
    the Protocol and the ICF or may arise out of any act, omission,
    negligence or misconduct of the CRO or the investigator /
    institution.
    •Who would primarily be liable to compensate the study
    subject, whether the sponsor or the CRO or the investigator /
    institution in connection with the study?
    Industries expectations Cont..
    Access to drugs
    •Another issue that arises is the liability of the
    sponsor to provide access to drugs and treatment
    post termination of the trial. Depending upon the
    study protocol, availability of the drug and stage of
    the trial, this issue needs to be addressed.
    Positive developments….!
    In the recent(Oct14) DIA conference, where some
    of the regulatory challenges were discussed and
    thoughts from the stake holders
    There are upcoming positive changes in the near
    future in the areas of:
    Clinical trial conduct:
    • Accreditation will be required for Investigators/Study sites
    to conduct clinical trials.
    • Accreditation of Ethics Committee/Institutional Review
    Board to approve/oversee clinical trials.
    Positive developments….! Conti……
    • Compensation clause for any injury to subjects participating in
    trials: This is being re-visited (no compensation for ineffective
    therapy or adverse events not related to drug, or adverse events
    for patients in placebo arm are being discussed).
    • Audio-visual recording of informed consent (IC) is being revisited.
    – Regulatory system: Transparency and possibility of online
    tracking of regulatory application are being worked up on.
    – Changes in medical/nursing education system.
    – Affordable health: Health assurance for all patients at
    primary health centers; health insurance for
    secondary/tertiary centers.
    Way forward
    • There are encouraging sentiments of upcoming positive
    changes in the regulatory environment will lead to more
    clinical trial work in India.
    • With the advent of globalization, it is important to
    adhere to global standards and best practice respecting
    local norms and value at the same time look at
    innovative ways to provide affordable healthcare to
    patients in India.
    • Collaborative work is required between regulators,
    industry and academia to support innovation .
    • Regulatory frame work must be rational and evidence-
    based; rather mere opinion based.
    Over Regulation?
    Controlled regulation: Win-Win situation !!!
    DISCLAIMER

    The views and opinions expressed in the following PowerPoint slides are those of
    the individual presenter and should not be attributed to my organisation, its
    directors, officers, employees, volunteers, members, committee, or affiliates, or
    any organization with which the presenter is employed or affiliated.
    QUESTIONS
    Many THANKS for YOUR Attention
    Dziękuję Ďakujem dhanya-waad ధన్యవాదాలు
    bedankt ありがとう go raibh maith agat
    tesekkürle Спасибо ‫ شكًر ا‬Thank yu
    Merci köszi tack så mycket
    谢谢 Thank hvalayoufaleminderit
    Shukriyâ Danke díky kiitos
    takk Obrigada Mulţumesc nandri
    Ευχαριστώ Grazie anugurihiitosumi ‫תודה‬
    Muchas gracias dhanya-waad köszön
    köszö öm
    nöm
    tack
    너를 감사하십시요 ačiû Terima Kasih
    aitäh děkuji vam mange tak salamat

    You might also like