Haryana Medical Services Corporation Limited, (A

159 Suture Absorbable Surgical Suture (Synthetic) Polyglactin 910 Braided Coated with Antibacterial 90cm x 40 mm, size -1, ½ Circle Tapper point/ R.B...

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Haryana Medical Services Corporation Limited, (A Government of Haryana Undertaking) Bays No 59-62, Sector 2, Panchkula. Phone: 0172-575578 Dated CORRIGENDUM MEDICINES & MEDICAL CONSUMABLES Revised Specifications w.r.t. to Tender Reference No. HMSCL/Tend./2015-16/3/4-A-01 dated 08.10.2015 bid submission date 04.11.2015 onwards and ref. now be read as. Group-A DNIT Sr. No. 21

Existing Technical Specifications as per DNIT Tramadol Hydrochloride Capsule IP 50 mg

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Amoxicillin Trihydrate Capsules IP 250 mg

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Ciprofloxacin Injection IP 2mg/ ml, 100ml bottle for infusion

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Metronidazole I.V infusion IP 5 mg/ml, 100 ml bottle for infusion

86

Iron Sucrose Injection IP/BP/USP 20mg/ml

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Hydroxy Ethyl Starch 3% preferably Plasma Volume Expander 3.5% w/v for intravenous infusion each 100 ml contain polymer from D-graded gelatin 3.5 gm. Equivalent to a nitrogen control of 0.63 gm water for injection q.s

100

Mannitol Intravenous infusion IP 20 % w/v, 350 ml Mannitol Intravenous infusion IP 20 % w/v, 100ml Biphasic Isophane (R-DNA origin 30/70) Injection IP40 I.U/ml, 5ml vial

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Insulin Injection soluble Insulin Neutral IP 40 IU/ml, 5 ml vial

Technical Specifications now be Read as Tramadol Hydrochloride Capsule IP 50 mg, 10x10 Amoxicillin Trihydrate Capsules IP 250 mg, 10x10 Ciprofloxacin Injection IP 2mg/ ml, 100ml bottle for infusion (FFS technology) Metronidazole I.V infusion IP 5 mg/ml, 100 ml bottle for infusion (FFS technology) Iron Sucrose Injection IP/BP/USP 20mg/ml, 5ml Hydroxy Ethyl Starch 3% preferably Plasma Volume Expander 3.5% w/v for intravenous infusion each 100 ml contain polymer from D-graded gelatin 3.5 gm. Equivalent to a nitrogen control of 0.63 gm water for injection q.s (FFS Technology), 500ml. Mannitol Intravenous infusion IP 20 % w/v, 350 ml (FFS Technology) Mannitol Intravenous infusion IP 20 % w/v, 100ml (FFS technology ) Biphasic Isophane (R-DNA origin 30/70) Injection IP40 I.U/ml, 10ml vial Insulin Injection soluble Insulin Neutral IP 40 IU/ml, 10 ml vial

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Isophane insulin NPH Injection IP 40 IU/ml, 5 ml vial Human Anti-D immunoglobulin BP 50 mcg /vial- as Monoclonal/ Polyclonal 1 ml vial

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Human Anti-D immunoglobulin BP 150 mcg/Vial as Monoclonal/ Polyclonal 1 ml vial

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Human Anti-D immunoglobulin BP 300mcg/Vial-V/s Monoclonal/ Polyclonal 1 ml vial Suture Absorbable Surgical Suture (Synthetic) Polyglactin 910 Braided Coated with Antibacterial 90cm x 40 mm, size -1, ½ Circle Tapper point/ R.B. heavy needle

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156 to 172

Length of Sutures as mentioned in DNIT against each item

Isophane insulin NPH Injection IP 40 IU/ml, 10 ml vial Human Anti-D immunoglobulin BP/IP/EP 50 mcg /vial as Monoclonal/ Polyclonal per vial Human Anti-D immunoglobulin BP/IP/EP 150 mcg/Vial as Monoclonal/ Polyclonal per vial Human Anti-D immunoglobulin BP/IP/EP 300mcg/Vial as Monoclonal/ Polyclonal per vial Suture Absorbable Surgical Suture (Synthetic) Polyglactin 910 Braided Coated with Antibacterial 90cm x 40 mm, size -1, ½ Circle Tapper point/ R.B. heavy needle, pack of 12 Sutures The length of the suture can be more than the length mentioned in DNIT and will be considered at par for financial evaluation.

The following items at Sr. Nos. of DNIT have been dropped for the purchase:-.     

DNIT Sr. No. 4: Lignocaine Hydrochloride Injection (Heavy) 2%, 2ml vial DNIT Sr. No. 7: Atropine (sulphate) Injection IP 0.5 mg/ml, 20 ml ampoule DNIT Sr. No. 91: Dilitazem 50mg/5ml packing. DNIT Sr. No. 150: Chloroquine Phosphate Injection IP 40 mg/ml, 2 ml ampoule DNIT Sr. No. 155: Partially absorbable light weight meshes Polypropylene Non absorbable Synthetic Surgical Mesh size 15 cm X 15 cm.

Managing Director Haryana Medical Service Corporation Ltd.

Haryana Medical Services Corporation Limited, (A Government of Haryana Undertaking) Bays No 59-62, Sector 2, Panchkula. Phone: 0172-575578 Dated CORRIGENDUM Clarifications Regarding Terms & Conditions of Medicines & Medical Consumables w.r.t to TENDER REFERENCE NO. HMSCL/TEND./2015-16/3/4-A-01 DATED 08.10.2015 last bid submission date 30.12.2015. Regarding representation of the firms. Tender Reference No. HMSCL/Tend./2015-16/3/4-A-01 (Group-A) Sr. Name of the Representation by the firm HMSCL reply No Firm 1 IDPL Requested to extend the date of your The last date has been extended tender because a festival season is ahead. 2 Hab Pharma Annexure 8.4 This letter is in reference No Sale tax clearance certificate with the tender ref. no HMSCL /Tend required /2015-16/3/4-A-02 in which we are keen interested to participate. We have gone through with all the terms and condition of the tender and we found OK but we are unable to submit sale tax verification as per annexure 8.4 as our excise and taxation department is unable to give the same in the format given in the tender. In lieu of this we can submit sale tax clearance certificate duly signed by the concerned authorities. 3 Plasma Gen We would like to participate in the tender Bio Sciences for the supply of imported Blood Plasma Pvt. Ltd. Products called in the above tender. Hence please find enclosed our representations for changes in the tender conditions. Requested for change as under:4.4 Turnover:- Importer shall have a No change minimum annual average turnover of Rs. 10 crores for last three Financial Years will be eligible 5.12 (h) Market standing certificates in No change case importer the principal manufacturer

of the drug should have three years marketing standing in India and the importer should have three years marking standing in the pharmaceutical filed. 5.30 The performance security shall have No change and upper limit of Rs. 15 Lacs to be deposited by a bidder at the time of signing of agreement ( For one or many items however, when the actual purchase orders cross a threshold for requiring additional security, the same will be required to be deposited by the supplier.

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Indian Immunologi cal Ltd.

Suture India

7.12 Quality Testing Since blood products No change are supplied after testing the approval of Government accredited labs., we request you to kindly remove testing deduction of 1.5% for blood products. Page no 66 to 68 and annexure 8.4 format No sales tax for sale tax verification period differ in certificate required. annexure and sale tax particulars.

clearance

Page No. 33 clause 5.23 Bid Evaluation vaccines and immunoglobulin undergo testing at CDL Kasauli and on approved of vaccine CDL issue the batch clearance. Therefore the sample testing of vaccine need not to be mandatory requirement during the technical bid evaluation. Clause 4.3.4 Quantity manufactured and supplied of the items quoted in last three along with batch size document by CA are required. Please clarified is this only required only from CA or from Drug Controller also it is required.

No change Sample testing is the discretion of Bid Evaluation Committee wherever it requires as Para5.23

Clause 5.2. (A) The bid fee should be submitted for each bid and separate bids should be submitted each item listed in the schedule of requirement.

Separate Bid fee is required for separate tender. For multiple bids in same tender bid fees is required only once

Clause 4.3.4 Quantity manufactured and supplied will be acceptable either from CA or Drug controller

Affidavit: - Required on letter head or on Self attested documents only stamp paper? are required except where If stamp paper than of what value? mentioned explicitly as per the Notary is required are not? Indian Stamp Act, 1899

Undertaking:- :- Required on letter head Self attested documents only or on stamp paper? are required on letter head If stamp paper than of what value? except where mentioned Notary is required are not? explicitly as per the Indian Stamp Act, 1899 Tender document affidavit:- Format is not provided for the affidavit. Can be provide our own format? If stamp paper than of what value? Notary is required are not?

Self attested documents only are required on letter head except where mentioned explicitly as per the Indian Stamp Act, 1899

Annexure 8.4:- Sale tax clearance Sales tax clearance certificate certificate to be signed by Deputy/Ass. not required Commercial Tax Officer. Specific format certificate will not be issued by the sale tax clearance authority

Regarding Uploading:- documents 40 to 50 MB space is required to upload is the adequate space by the respective authority in the e-portal?

10 MB space is available bidder is advised to reduced the coloured pages and submit essential documents. All brochures of the non essential documents can be submitted in hard copy.

Marketing standing: - If the product The point is already explained in quoted new and is in market for two DNIT in clause 4.3.2 years, can be participate for this product? Kindly confirm the following certificates/Affidavits /Declerations are

required on letteer head or on stamp paper? If it has to be submitted on stamp paper then stamp paper of what value is required? Also confirmed any of the documents/affidavit /Declerations has to be notarized? a. Affidavit-stating the bidder comply with a. Self attested documents only WHO GMP certification with regards to are required on letter head the items quoted except where mentioned explicitly as per the Indian Stamp Act, 1899

b.Undertaking that bidder will own b. Self attested documents only responsibility of any damage arising are required on letter head. because of dealy in supply, non supply or supply of poor quality items.

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c. Affidavit regarding blacklisting /debarring and non-conviction certificate is required. A specific format is not given for the same therefore can be providing in our own format? Medicamen The fairness of things that vial the Biotech Ltd. corporation expects lowest possible rates, it should follow the norms that are now given by the other procurement agencies who now state that the rates quoted should be the lowest for supplies within the state. State trust the corporation would look into this aspect seriously to ensure that party is brought in its procurement system in line with the system followed by other major procurement agencies in the country. Crystal The Hon'ble Supreme court of India has Pharmaceuti already ordered not to imposed WHOcals GMP certificate with COPP item wise as WHO-GMP is meant only for export purpose supported by documentation of Drug control general of India and further

c. Agreed.

No change

After Hon’ble Supreme Court orders, there are three orders in different Hon’ble High Courts of India i.e. Aurangabad bench of Bombay High Court order Case No. 7823/ 2009, Indore bench of

decision taken by the State drug controller in the last meeting of Drug advisory board as well as in the minutes of Principal Secretary/Commissioner health Haryana .You are requested to either make necessary amendment with relaxation of WHO -GMP otherwise it will be contempt of Hon'ble supreme Court of India which will be dealt by over Hon'ble Senior Advocates. In the end of once again we strongly protest the condition laid Down at page no-17 of paragraph 4.2 to remove the WHO-GMP condition It should be only GMP certificate According to New revised scheduled -M which has the same Identity for the purchase in India.

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Johnson Johnson



Bhopal High Court order Case No. 7049 & 6165 of 2013 and Jaipur High Court order Case No. 3211/2015 dated 2-9-2015 and the Honourable courts have given decision in favour of WHO-GMP. Two of these courts have considered the decision of the Hon’ble Supreme Court. Therefore this would not be the contempt of the Hon’ble Supreme Court. The inclusion of WHO-GMP inspection certificates in line with the WHO-GMP certification scheme and certificate of Pharmaceutical Products (COPP) has been laid down as a policy by the Government of Haryana vide its notification. & d) Also we suggest getting the Sample testing is the discretion Antibacterial/Triclosan sutures tested at a of Bid Evaluation Committee Microbiology lab along with Sample wherever it requires as Para5.23 testing with the technical experts as a parameter to check the efficacy properties of the sutures.

The rates in BOQ be quoted as per packing mentioned against each item in DNIT. E.g. if the packing is 10X10 the rates be quoted for 100 tablets, if the pack is 10 the rate be quoted for 10 only, if it is mentioned as I ampoule or 60 ml bottle the rate be quoted for single bottle or ampule or vial.

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Annexure 8.4 is only suggestive the No sales tax clearance certificate required. Documents Self attested documents only are required on letter head except where mentioned explicitly. Uploaded 10 MB space is available bidder is advised to reduced the colored pages and submit essential documents as Paraclause 5.12.1. All broachers of the non essential documents can be submitted in hard copy. Bar Coding is required as per DNIT clause 7.11 on secondary and tertiary packing. BID Fee and processing charges are clubbed together only single DD of Rs 2500/to be made against bid fee and processing charges. WHO-GMP is mandatory for the Product WHO GMP along with COPP is compulsory wherever applicable. Quantity manufactured and supplied as par 4.3.4 Either from CA or Drug controller will be acceptable

All others terms & conditions are remain the same.

Managing Director Haryana Medical Service Corporation Ltd.