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    4 - Approved Regulatory Bodies and Agencies

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    Sparsh Sharma
    The document discusses India's drug regulatory system. The Drug Controller General of India heads the Central Drug Standard Control Organization and regulates drugs and medical devices in India. New drugs must be approved through a New Drug Approval process where technical documents are submitted to prove the quality, safety and efficacy of the drug. This involves forms, fees, and takes about a year to approve. Imported drugs also require an import license.

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    4 - Approved Regulatory Bodies and Agencies

    Uploaded by

    Sparsh Sharma
    59 views16 pages
    The document discusses India's drug regulatory system. The Drug Controller General of India heads the Central Drug Standard Control Organization and regulates drugs and medical devices in India. New drugs must be approved through a New Drug Approval process where technical documents are submitted to prove the quality, safety and efficacy of the drug. This involves forms, fees, and takes about a year to approve. Imported drugs also require an import license.

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    4 - Approved regulatory bodies and agencies

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    The document discusses India's drug regulatory system. The Drug Controller General of India heads the Central Drug Standard Control Organization and regulates drugs and medical devices in India. New drugs must be approved through a New Drug Approval process where technical documents are submitted to prove the quality, safety and efficacy of the drug. This involves forms, fees, and takes about a year to approve. Imported drugs also require an import license.

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    Flag for inappropriate content
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    59 views16 pages

    4 - Approved Regulatory Bodies and Agencies

    Uploaded by

    Sparsh Sharma
    The document discusses India's drug regulatory system. The Drug Controller General of India heads the Central Drug Standard Control Organization and regulates drugs and medical devices in India. New drugs must be approved through a New Drug Approval process where technical documents are submitted to prove the quality, safety and efficacy of the drug. This involves forms, fees, and takes about a year to approve. Imported drugs also require an import license.

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    of 16

    New Drug Approval

    [NDA]
    DRUG REGULATION SYSTEM IN INDIA

    The Objective of a Drug Regulatory Authority is to ensure


    that of medicinal products are of acceptable Quality, Safety
    and Efficacy which are Approved, Manufactured and
    Imported.

    Drug Controller General of India is the head of Central Drug


    Standard Control Organization , which regulates Devices &
    Drugs in India.
    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/P’ovigilance]

    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)


    Functions of CDSCO

     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
    Approval of Clinical Trials, Import, &
    Manufacture of New Drugs
    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
    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
    Common Technical Documents

    MODULE-1: Administrative Information

    MODULE- 2: Quality Overall Summary

    MODULE-3: Quality

    MODULE-4: Non- Clinical Studies

    MODULE-5: Clinical Studies


    New Drug Approval

    Form 45 Form 45 A Form 46


    (Finished Formulation) (Bulk Substance) (Manufacturing)

    Registration
    Form 41

    Import License
    Form 10
    TIME LINE & FEES FOR NDA
    It generally takes about one year 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 Approval.
    TR Challan of Rs 50,000 is required for the fresh
    application.
    TR Challan of Rs 15,000 is required for subsequent
    application.
    Technical Documents
    A) Plant master file: Should include the
    following points.
     Sketch of the Plant
     Profile of the company
     Organogram of the Company
     Plant & Machinery
     Hygienic & Sanitary measure details

     HAVAC System
     MEN MATERIAL MOVEMENT
    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
    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
    C). LABELS AND INSERTS
     Product labels should show the address of
    Manufacturer.
     Product inserts should describe the brief description
    of the product and its intended use.
    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
    Technical Data Associates/Drug inspectors of CDSCO
    and during this period clarification if any, required by
    them are answered and thereafter we get the
    Registration Certificate (RC) in Form 41.
    IMPORT PROCESSING
    After getting the registration certificate from CDSCO, the
    Indian agent is 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 Ist product then Rs 100 for each
    additional product)
     Form 9
     Copy of Wholesale License (Indian agent)-Notarized
     Copy of Registration Certificate-Notarized
    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.

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