BID EVALUATION REPORT FOR THE LEFTOVER ITEMS OF GOVT: MCC FOR THE YEAR 2017-18
S.NO / COMPANY NAME / REMARKS / STATUS / TECHNICAL SCOREM/S Abbott / NOT RECOMMENDEDfor Ibuprofen 120 ml, Calcium carbonate, / Recommended for Ascorbic acid / 27
N Acetyl Cystein / 27
SodiumValporate / 27
SodiumValporate / 27
M/S ACP System / NOT RECOMMENDED for integrity Cardiac stents (Bare metal) Chromium cobalt size 24 and integrity resolute
Cardiac Stents (Drug Eluting, Zotarolimus) size 24, 28 and 40 due to non-availibility of stock at the time of inspection. / Cardiac stents (Bare metal) Chromium cobalt Integrity
Size 20, 22 and 30. / 64
Cardiac Stents (Drug Eluting, Zotarolimus)
Integrity resolute size 20,22 and 36. / 64
M/S Akram Brothers / NOTRECOMMENDEDCatgut Chromic / NOT RECOMENDED
by the panel of MCC for physical examination at the time of examination. / 0
M/S Allmed Lab Karachi / RECOMMENDED / RECOMMENDEDfor Iron isomaltoside / 63
M/S Amroz Pharma / NOT RECOMMENDED
The inspection team at the time of inspection observed that:-
- Raw Material Store
- Weighing machine was not calibrated
- Oxytocin & Phenaremine raw material were placed at room temperature whereas required was 10-15 C.
- Dexamethasone was placed in passed area without knowing the status i.e. either it’s passed or not.
- Quality Control Department
- Stability Chamber was out of order and stability data was not provided to inspection team at the time of inspection.
- The quoted products were not found in stability chamber at the time of inspection.
- Finished Goods Store
- Racks/Pellets were not seen in FGS and stock was placed on floor.
- Temperature log sheet was not maintained in FGS which is non adherence to Good storage practices.
M/S Anwar & Sons / Recommended for catgut
And not recommended for Surgical Blades due to non-adherence to the specification of formulary. / RECOMMENDEDfor Catgut 4/0, 2 and 0 / 40
M/S Atlantic / Recommend for
Anti-Rabies Vaccine (Vero Cells) / RECOMMENDED / 43
M/S Bajwa Pharma / The inspection team at the time of inspection observed that
1. Theaccelerated Stability Chamber was not present.
2. The Stability studies of the quoted products was not present.
3. High performance Liquid Chromatography (HPLC-UV) was not functional.
4. Raw Material of the quoted product i-e Naxolone is not present.
5. Finished products were lying on corridor of the manufacturing area.
Valid cGMP of the firm was not present.
NOT RECOMMENDED / NOTRECOMMENDED / 0
M/S Bajwa Sons Importer / The inspection team at the time of inspection observed that
1. Free sale Certificate of the quoted products was expired
The decision was placed at the disposal of the committee for its fate
NOT RECOMMENDED / NOTRECOMMENDED / 0
M/S Barret Hadgson, Karachi / NOT RECOMMENDEDdue to submission of old CDR i.e. dated 20.03.2017. / NOT RECOMMENDED / 0
M/S B. Braun / NOT RECOMMENDEDby the panel of inspection at the time of inspection due to non-availability of valid mandatory embassy attested documents / NOT RECOMMENDED / 0
M/SCirin / RECOMMENDEDfor
Anti-rabies vaccine / RECOMMENDED / 45
M/S Digital Imaging System, Rawalpindi / NOT RECOMMENDED.
The inspection team at the time of inspection observed that
The firm did not show original documents i-e Free sale certificate (FSC) & cGMP/Quality Assurance certificate etc to the committee at the time of inspection. / NOT RECOMMENDED / 0
M/S Elite Pharma / The inspection team at the time of inspectionobserved that:
1. The cGMP of the firm was expired.
2. External Calibration of the equipment’s was not done.
3. Real time stability chamber is not available.
4. The stability data for the quoted items was not produced at the time of inspection.
5. HPLC was not used regularly for life saving quoted items.
NOT RECOMMENDED / NOT RECOMMENDED / 0
M/S Feroz & Sons / The inspection team observed at the time of inspection
- The Original Mandatory documents cGMP, FSC etc was not produced at the time of inspection.
- The mandatory Documents cGMP & FSC was not embassy attested.
Cardiac Stents (Drug Eluting, Everolimus) Promus element plus sizes 20,24,28,36 and 40, Cardiac Stents Drug Eluting, Everolimus Synergy size 40 with Guide wire for JJ Stent 0.25mma nd 0.32mm / 0
M/S Genus Karachi / NOT RECOMMENDED by the panel of MCC for physical examination at the time of examination. / NOT RECOMMENDED / 0
M/S Geofman / RECOMMENDED for awarding the specified marks for the items mentioned in the scrutiny proforma for physical evaluation. / RECOMMENDED / 63
M/S Global Pharma / The inspection team at the time of inspection observed that
1. MCC formulary contain Rifampicintablet whereas the firm manufacturedcapsule dosage form.
- Tigecycline quoted by the firm was registered by the name of vision pharma not by the applicant firm. The said product come in the preview of TOLL manufacturing.
M/S GSK / The Firm Quoted Non-Formulary Item, Hence Not Recommended. / NOT RECOMMENDED / 0
M/S Hakimson / The inspection team at the time of inspection observed that:-
- For products quoted by M/S Foyomed China
- Suction catheter don’t have valid registration of DRAP.
- CGMP/Quality Assurance certificate was not embassy attested.
- Free Sale certificate of Foyomed doesn’t have names of quoted items.
- For products quoted by M/S Hospetech China
- Chest Tube don’t have valid registration of DRAP.
- CGMP/Quality Assurance certificate was not embassy attested.
- Free Sale certificate doesn’t have names of quoted items.
- For products quoted by M/S Life Vascular
- CGMP/Quality Assurance and Free sale certificate not available at time of inspection and submitted to DRAP.
- For products quoted by M/S Swormed or Nesseler
- CGMP/Quality Assurance and Free sale certificate not provided to inspection team at time of inspection.
M/S Hashir Surgical / RECOMMENDEDfor Suction catheter only and Not Recommended for Surgical Blades because not according to specification of Govt MCC Formulary. / Suction catheter Sterilized Sizes 6,8,10,12,14,16 & 18 FR / 60
Surgical Blades / 0
M/S Hospital Service & Sales
Biological Importer / Recommended / indirab
Antirabies vaccine / 50
M/S Hospital Service & Sales
Medical Device Importer / NotRecommended by the MCC Panel of expert/s at the time of Physical evaluation. / NOT RECOMMENDED / 0
M/S Linker Asia Medical / The inspection team at the time of inspection observed that
Free sale certificate was expired
NOT RECOMMENDED / NOT RECOMMENDED / 0
M/S Majeed Sons / The inspection team at the time of inspection observed that
- The Original Mandatory documents cGMP, FSC etc was not produced at the time of inspection.
- Cold storage and stock condition was satisfactory.
M/S Medwell Pharma / The inspection team at the time of inspection observed that
1. Manufacturing License Expired.
2. cGMP of firm expired.
3. Real time Stability chamber was not present.
The stability data of the quoted items not present.
4. No Production was carry on at the time of inspection.
5. Raw Material for the quoted items was not present at raw material store.
6. HVAC was not functional.
NOTRECOMMENDED / NOT RECOMMENDED / 0
M/S Nabi Qasim / Recommended by the Inspection team but the firm submitted Old CDR whereas required is new, Hence NOT RECOMMENDED / NOTRECOMMENDED / 0
M/S Nenza Pharma / The inspection team at the time of inspection observed that
1. cGMP of the manufacturing unit is expired.
2. HVAC was not functional at the time of inspection in RMS & Finished goods store.
3. HPLC was not functional.
4. Stability data of the quoted items was not present.
NOTRECOMMENDED / NOTRECOMMENDED / 0
M/S Paktex / RECOMMENDED / Guaze Cloth
Ortho guaze
Sizes 100cmx20m
100cmx40m / 60
M/S Popular / The inspection team at the time of inspection observed that:-
- For The Products quoted by M/S Kadrion Italy
2. For The Products quoted by M/SGrifols USA
RECOMMENDED / Hep B immunoglobulin / 55
Salt free Albumin 20% / 55
Salt free Albumin 20% / 55
Rabies Immunoglobulin / 55
M/S Premier Agency / RECOMMENDEDExcept Visipaque for which free sale certificate was not provided in original to inspection team at the time of inspection. / lohexol 50ml / 48
lohexol 100ml / 48
lohexol 500ml / 48
Omniscan / 48
M/S Renacon Pharma / RECOMMENDED / Renocarb concentrate 4000 ml
Hemodialysis Solution / 60
M/S Roche Pharma / RECOMMENDED / Epoetin-β 2000 i.u/vialRecormon / 57
Epoetin-β 5000 i.u/vialRecormon / 57
M/S Saru International / The inspection team at the time of inspection observed that:-
- Free sale certificate embassy attested and valid cGMP certificate embassy attested was not provided to inspection team at the time of inspection and upon telephonic conversation it was shared with the inspection team that owner in not available and will provide document to the inspection team but till date not provided.
- Physical stock of Foley catheter was not available at the time of inspection.
M/S Uniferoze / NOTRECOMMENDED due to non-provision of embassy attested documents to the inspection team at the time of inspection. / NOT RECOMENDED / 0