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    Iboxime 100mg Suspension B.No. C-225

    Uploaded by

    Muhammad Imran
    This letter responds to a show cause notice regarding a drug product. It provides details of the case history, including that sample collection procedures were not followed, results of their own testing, multiple requests to challenge results that went unanswered, and the product has now expired. They request the case be closed as time barred since they were deprived of their legal right to challenge results and the product is expired.

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    © All Rights Reserved
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    Iboxime 100mg Suspension B.No. C-225

    Uploaded by

    Muhammad Imran
    35 views6 pages
    This letter responds to a show cause notice regarding a drug product. It provides details of the case history, including that sample collection procedures were not followed, results of their own testing, multiple requests to challenge results that went unanswered, and the product has now expired. They request the case be closed as time barred since they were deprived of their legal right to challenge results and the product is expired.

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    This letter responds to a show cause notice regarding a drug product. It provides details of the case history, including that sample collection procedures were not followed, results of their own testing, multiple requests to challenge results that went unanswered, and the product has now expired. They request the case be closed as time barred since they were deprived of their legal right to challenge results and the product is expired.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    35 views6 pages

    Iboxime 100mg Suspension B.No. C-225

    Uploaded by

    Muhammad Imran
    This letter responds to a show cause notice regarding a drug product. It provides details of the case history, including that sample collection procedures were not followed, results of their own testing, multiple requests to challenge results that went unanswered, and the product has now expired. They request the case be closed as time barred since they were deprived of their legal right to challenge results and the product is expired.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
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    You are on page 1of 6

    Date : 11-10-2023

    To,
    The Secretary,
    Provincial Quality Control Board,
    Primary & Secondary Health Care Department,
    Office 492, R-II, Johar Town, Lahore,
    Punjab - Pakistan

    Subject: Show Cause Notice w.r.t. Product Iboxime 100mg Suspension B. No. C-225
    Respected Sir,
    Reference to your letter # PQCB/R-644/2021 Dated 18.09.23 received at our office on 06.10.23
    regarding Subject matter, It is to bring into your kind notice that we have tested the subject Product in
    our Lab and results found satisfactory. We are attaching herewith all requested document along with
    complete history of communication to relevant drug inspector for your kind perusal.

    Copies of claimed documents are enclosed with the letter mentioned below.
    1. All Communication made with Drug Inspector and with PQCB (Copies of letters attached)
    2. Names of CEO, QCM and PM
    3. Testing Result of said Product in our Lab

    As the product is now expired and we are unable to challenge the result in NIH or any other approved
    Lab. It is requested herewith by keeping our prompted response with PQCB to give a chance by kindly
    revoking the show cause notice.

    For Wenovo Pharmaceuticals


    `NAME OF TECHNICALL STAFF

    No Name Designation

    01 Mr. Muhammad Arshad Managing Director

    02 Mr. Muhammad Imran Quality Control Manager

    03 Mr. Saqib Yaqub Awan Production Manager


    Date : 11-10-2023
    To,
    The Secretary,
    Provincial Quality Control Board,
    Primary & Secondary Health Care Department,
    Office 492, R-II, Johar Town, Lahore,
    Punjab - Pakistan

    Subject: Show Cause Notice w.r.t. Product Iboxime 100mg Suspension B. No. C-225 Mfg. Date 06-19
    Exp. date 05.21
    Respected Sir,
    Reference to your letter # PQCB/R-644/2021 Dated 18.09.23 received at our office on 06.10.23
    regarding Subject matter, It crucial & important information are herewith bring into your kind notice the
    complete case history as
    1. Sample of subject matter product were taken from M/S Baloch Enterprises, Vehari for
    Analysis at DTL however we didn’t received Sample Intimation Letter & no sealed warrantor
    portion of subject mentioned samples were provided to Wenovo Pharmaceuticals,
    Manufacturer of the Drug, which were already communicated to Inspector of Drug, Vehari
    via Letter dated 05.03.21 (Copy of Letter attached).
    2. The product was tested at our Lab and results were found satisfactory so we challenged the
    DTL-Multan Results of the Sample for retesting at our expense along with Warrantor Sealed
    portion via Letter dated 20.03.21 & again on 28.03.21.
    3. No information regarding challenging DTL-Results and retesting of our product from NIH
    received.
    4. Our Product expired on 05.21.
    5. On dated 27.08.22, after 1.5 years, we received a letter from Inspector of Drugs, Vehari
    request to provide information regarding verification of warranty, provision of DML, Sales
    Statements etc
    6. Reply via Letter dated 15.09.22 to Inspector of Drugs, Vehari, we have presented our
    standing and factual position.
    7. On dated 30.09.22, we received a letter from to Inspector of Drugs, Vehari requiring Name
    of Technical Staff and Address of the Company.
    8. Reply via Letter dated 17.10.22 to Inspector of Drugs, Vehari, we again presented our
    standing and factual position regarding subject Product along with required information.
    9. A personal Hearing Notice via Letter CDC-P&S/TN/01-97/2022 Dated 08.11.22 received from
    PQCB for Personal Hearing of the said case in PQCB on dated 22.11.22.
    10. Our Plant Manager appears in PQCB along with all requested/required documents and
    successfully attends the Personnel Hearing Meeting.
    11. On Dated 18-09-23 Via Letter PQCB/R-644/2021, we now received Show Cause Notice.

    As your office is deprived us our legal right to challenge the DTL – Multan Report at Appellant Lab / NIH-
    Islamabad and the product is already expired for more than 2 years and now we are unable to challenge
    the result in NIH or any other approved Lab. It is requested herewith by keeping our prompted
    responses with PQCB to close the case being time barred, Please.
    Thanks for your kind cooperation and consideration.

    For Wenovo Pharmaceuticals


    Date : 13-10-2023
    To,
    The Secretary,
    Provincial Quality Control Board,
    Primary & Secondary Health Care Department,
    Office 492, R-II, Johar Town, Lahore,
    Punjab - Pakistan

    Subject: Show Cause Notice - Product Iboxime 100mg Suspension B. No. C-225 Mfg. Date 06-19 Exp.
    date 05.21
    Respected Sir,
    Reference to your letter # PQCB/R-644/2021 Dated 18.09.23 received at our office on 06.10.23 (evidence
    of receiving from Post Office attached- Annexure A) regarding subject Product, We will like to submit
    factual position of the case as under

    1. Sample of subject matter product was taken from M/S Baloch Enterprises, Vehari 04.02.21
    by Mr. Qalandar Inspector of Drugs. However the Drug Inspector Vehari did not write any
    intimation letter to Wenovo Pharmaceuticals in this regards and didn’t dispatched sealed
    warrantor portion to us which was mandatory as per Drug Act 1976 Section 18 (32).
    2. On receipt of indirect information from the Distributor, we wrote letter to Drug Inspector,
    Vehari with a request to provide Sample Collection Intimation Letter along with sealed
    warrantor portion as per legal requirements.
    3. The product from the retained sample was re-tested at our Lab and results were found
    within limits therefore we requested to challenge the DTL-Multan Report results at NIH Lab
    – Islamabad and to dispatch the sealed warrantor portion of the sample to NIH – Islamabad
    for retesting at our expense vide Letter dated 20.03.21 & again on 28.03.21. (Copies
    attached- Annexure B & C).
    4. We never received any reply from the office of Drug Inspector Vehari regarding sealed
    warrantor portion & retesting of our product from NIH - Islamabad. During this period the
    said product expired on 05-2021.
    5. After 1.5 years, we received first official letter dated 27.08.22 from Office of Ms. Rubina Taj
    Drug Inspector, Vehari to provide information regarding of Product & Technical Staff. (Copy
    attached). We responded vide letter dated 15.09.22 & 17.10.22 explaining the factual
    position of the case. We requested to close the case being time barred as well as we have
    been deprived of our legal right to challenge the DTL – Multan Report at Appellant Lab of
    NIH-Islamabad and the product has expired on 05-2021. (Copies attached – Annexure D, E &
    F).
    6. We received a letter from the office of Chief Drug Controller, Punjab dated 08.11.22, for
    Personnel Hearing regarding this case. Our Plant Manager/QCM appeared before PQCB
    along with all required documents and explained in depth the factual position of the case
    with the entire satisfaction of the concerned officers during the Personnel Hearing held on
    22.11.22. A complete record file with required documents and evidences was submitted at
    the Chief Controller of Drugs, Punjab Office during the hearing. (Copy attached - Annexure
    G).
    7. After 11 months of Personnel Hearing & submission of complete record related to the case,
    we have received Show Cause Notice from Secretary PQCB, Punjab Via Letter PQCB/R-
    644/2021 Dated 18-09-23 received at our plant on 06-10-23. (Copy attached - Annexure H).

    Keeping the factual position of the case as explained above, it is requested that as we have been
    deprived of our legal right to challenge the DTL – Multan Report at Appellant Lab / NIH-Islamabad and
    the product has already expired for more than 2 years on 05.2021; the case may please be closed being
    time barred.
    The documents required by your good office are enclosed as under.
    1. All Communication made with Drug Inspector and with PQCB (Copies of letters attached)
    2. Names of CEO, QCM and PM
    3. Testing Result of said Product in our Lab

    Thanks for your kind cooperation and consideration.

    For Wenovo Pharmaceuticals

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