pre-bid clarification s / amendments in response to...

PRE-BID CLARIFICATIONS / AMENDMENTS IN RESPONSE TO THE QUERIES RAISED BY PROSPECTIVE BIDDERS IN THE PRE-BID MEETING HELD ON 17.08.2017, 11.00 A.M. IN THE CONFERENCE HALL, OSMCL FOR THE TENDER OF DRUGS AND MEDICAL CONSUMABLES 2016-17, Bid Ref. No.: OSMCL/2017-18/DRUGS-DHS/02 and OSMCL/2017-18/DRUGS-DHS/03.

Total No. of prospective bidders/ representatives present in the pre-bid meeting are: 43(Forty Three).

The queries raised by the prospective bidders in the meeting and through e-mail on the above mentioned tender references were discussed thread barely and subsequently the recommendations mentioned at Annexure-I were made for approval. The detailed statement is mentioned at Annexure-I.

Sd/- Managing Director,

OSMC

Annexure-I

A) SUPPLY OF DRUGS & MEDICAL CONSUMABLES (Group-I), Bid ref No. OSMCL/2017-18/DRUGS-DHS/02:-

Sl. No.

Item Name/ Particulars

Details as mentioned in the tender document

Queries raised by the prospective bidders

Clarifications/ Amendments in response to the queries.

Queries relating to General Terms and Conditions 1 Section- III

Clause No. 3.1 Cost of Bid Document (in shape of DEMAND DRAFT) Page No. 10

Rs. 5,600/- ( including GST as applicable if any ) for any or all the item(s)

Rs. 5,600/- (including GST) for any or all the item(s)

2 Section – IV , Column 5 Page No.- 12

Regarding various queries relating to Pack Size (Primary and Secondary)

Clarification: The pack size mentioned in Column No. 6 Section IV is Preferable Pack Size. However the items listed in the tender under Schedule P1 of D & C Act 1940 & Rules 1945 as well as Govt. of India Programme items should be supplied in the primary packaging as per the prescribed norms

3 Section – IV , Item Sl No. 191, D21024 - Tab. Ondansetron (Dispersible Tablet) (Aluminium foil/Glycine Poly Foil/Blister pack), 4mg / Tab. Page No.- 28

EMD Amount :- Rs. 18,43,000 The EMD amount for the item is comparatively much higher in respect to the approx. quantity mentioned in the tender document. Hence, this may be relooked.

EMD Amount :- Rs. 19,000

4 Section- V Clause No. 5.1

Submission of Performance Security15 days

Submission of Performance Security may

No Change

Page No. 44 from the date of issue of Letter of Intent.

be amended to 21 days instead of 15 days from the date of issue of Letter of Intent

5 Section- V Clause No. 5.2.1 Page No. 44

Bidder shall be a manufacturer having valid own manufacturing license/loan license / direct importer holding valid import license with product registration certificate issued by the Drugs Controller General of India.

Loan license for blood products and life saving products may not be allowed to participate in the tender.

No Change

6 Section- V Clause No. 5.2.6

Page No. 44 - 45

Bidders shall have a minimum turnover of: Rs. 15 Crs or more in each year during last (3) three financial years in India for the items from Sl. No. 1 to Sl. No. 250, Rs. 10 Crs or more in each year during last (3) three financial years in India for the items from Sl. No. 251 to Sl. No. 333 as per Section IV. Last three financial years mean either for 2013-14, 2014-15 and 2015-16 or 2014-15, 2015-16 and 2016-17.

1) Each year may be amended to average of three financial years as mentioned.

2) Minimize the turnover criteria for importer.

No Change

7 Section- VI Clause No. 6.5.1

Page No. 50

The Bid document fee/EMD shall have to be furnished in shape of Demand Draft (DD)/Bankers Cheque(BC) from any nationalized/scheduled bank in India in favour of Odisha State Medical Corporation Ltd., payable

1. In SFMS Bank Guarantee there is no original bank guarantee generated. Hence how to submit original bank guarantee in format of Annexure IV?

No Change. Clarification:

1. Original BG as per format Annexure-IV for submission of EMD is mandatory for the bidders to submit before the opening of the online technical bid.

at Bhubaneswar. The EMD in Shape of Bank Guarantee (BG) from any of the nationalized/scheduled bank in India are also being acceptable. Bank Guarantee to be generated through Structured Financial Messaging System (SFMS) portal. The Bank Details for generating Bank Guarantee in SFMS, IFS Code: UBIN0538086 and Branch Code: 538086. The Bank Guarantee should be in Favour of Odisha State Medical Corporation Ltd. (OSMCL), payable at Bhubaneswar. Original BG as per format Annexure-IV is mandatory for the bidders to submit before the opening of the online technical bid. BG submitted in format other than Annexure- IV will be liable for rejection.

2. Can original bank Guarantee be submitted in normal way?

However, the bidders are requested to submit the original BG from banks which are covered under SFMS platform for early verification of the same.

2. Yes original bank Guarantee payable at Bhubaneswar can be submitted in normal way.


Page No. 51 Section-IV

Clause No.4.1 Page No. 11

The amount of the EMD(s) to be submitted per item is mentioned at Section III and Non- submission of EMD as mentioned in Section III shall be one of the primary reasons for rejection of the offer in the first round.

EMD amount may be fixed with a ceiling i.e. maximum up to Rs. 20 Lakhs to enable the bidders to quote in maximum no of items. As item wise EMD is restricting bidders to participate for multiple items in the tender.

No Change.


Page No. 61

However, for programme item (s) and other Bulk item(s) empanelment of other technically qualified suppliers may be asked

Bulk items may be clearly mentioned in the tender at Section-IV for better clarity for the bidders in quoting

Amended However, for programme item (s) and other Bulk item(s) (As mentioned in Annexure-A) empanelment of other technically qualified

through negotiation to match with the L1 price for supply of the item (s). Subsequently orders can be given to L1, L2 & L3 suppliers at L1 rate in the ratio of 50:30:20. In case of failure of any supplier, the non supply portion of the order can go to the suppliers who are on the panel for supplying and in the event L2 and L3 suppliers also failing, the orders can be placed on other qualified suppliers willing to supply at L1 rate. MD, OSMCL reserves all rights regarding the decision of division of the total order quantity.

their price. suppliers may be asked through negotiation to match with the L1 price for supply of the item(s). Subsequently orders can be given to L1, L2 & L3 suppliers at L1 rate in the ratio of 50:30:20. In case of failure of any supplier, NSQ declaration or emergency requirement for exigencies the order can be placed to the suppliers who are on the panel for supplying and in the event L2 and L3 suppliers also failing, the orders can be placed on other qualified suppliers willing to supply at L1rate.MD, OSMCL reserves all rights regarding the decision of division of the total order quantity.


Page No. 64

The tender inviting authority may place the supply order in a phased manner during the rate contract period.

The Minimum Order quantity for small volume items and no of phases in which the order quantity will be placed may be declared in the tender document for better clarity.

Clarification: The Approx. Quantity mentioned at column No. 6 is only an indicative quantity. The quantity will be ordered in phased manner based on the consumption pattern.


Page No. 66

However in case of imported items, small ordered items (i.e. small ordered quantity in comparison to the batch manufacturing size) and in case of vaccines, serums, immunoglobulin’s, blood products like human coagulation factors VII, VIII, IX, etc are exempted form 5/6th Shelf life, with an under taking from the supplier

In case of imported items, the item may be accepted with minimum 60% of the remaining shelf life from the date of manufacture.

No Change

that if the item expires being not utilised then the supplier shall replace the whole expired item with fresh batch(es) of supply. However at the time of supply the item should have minimum 70% of the remaining shelf life from the date of manufacture.

12 Section- VI Clause No.

6.28.15 Page No. 67 Section-IV

Clause No.4.2 Page No.11

The items requiring special cold storage conditions should either be supplied with cold chain transporting system under cold chain norms from the manufacturing unit to the warehouses of the Corporation (as per section- IV, Clause No. 4.2) complying cold chain norms.

Order for the cold chain items may be ordered to the warehouses having cold chain facilities and the list of warehouses with cold chain facility may be mentioned in the tender document.

No Change


Page No. 68

Quality testing and Handling charges: 1.5 % of the purchase order value shall be collected from the approved supplier as the quality testing charges

Testing charge may be exempted in case of imported items, vaccines, serum, immunoglobulin, blood products like human coagulation factors VII, VIII, IX, etc., which requires quality clearance of the item(s) from CRI Kasauli/ NIB Noida/ Govt. Statutory Laboratories.

Amended Quality testing and Handling charges: 1.5 % of the purchase order value shall be collected from the approved supplier as the quality testing charges. The items (as mentioned at Annexure -B) are exempted from testing charges i.e. at the rate of 1.5 %. However in event of any product complaints MD OSMCL reserves to test the same and the actual testing cost may be recovered from the supplier from applicable dues.

14 T7 Format Column 9

Page No. 86

Have the items supplied Satisfactorily (attach documentary proof)**

Satisfactory supply certificate is mandatory to attach in the technical bid may be clarified

Clarification: The bidder is requested to attach item wise documentary proof towards its supply proof, the documentary proof may be a purchase

order/payment received against any P.O/ copy of original invoice raised against the P.O/ satisfactory supply proof certificate etc.

Technical Queries 15 Section – IV ,

Item Sl No. 9, D23015 Inj. Hepatitis B Immunoglobulin (HBIG) Page No. 10

100 IU/ 1ml Each unit packet shall contain the following : i) 1 Vial (1 ml./Vial) ii) 1 Eclipse Needle (21G) All blood products should be “Test Negative for HBsAg, HIV I & II, HCV Antibodies” which will be printed on each unit packet.

Specification may be changed to 100 IU/0.5 ml instead of 100 IU/1ml Option for PFS, and if PFS no need of Eclipse needle (21G)

Amended The item at Sl No.9, D23015- Inj. Hepatitis B Immunoglobulin (HBIG) to be supplied in 100 IU/0.5 ml or 1 ml Each unit packet shall contain the following : i) 1 Vial/ (0.5 ml or 1 ml./Vial) ii) 1 Eclipse Needle (21G). All blood products should be “Test Negative for HBsAg, HIV I & II, HCV Antibodies” which will be printed on each unit packet. 0.5ml or 1ml Vial 20 Vials/Box

16 Section – IV , Item Sl No. 10, D23016- Inj. Hepatitis B Immunoglobulin (HBIG) Page No. 10

200 IU/ 1ml Each unit packet (200 IU/1ml) shall contain the following: i) 1 Vial or PFS (1 ml./Vial or PFS) ii) 1 Eclipse Needle (21G) All blood products should be “Test Negative for HBsAg, HIV I & II, HCV Antibodies” which will be printed on each unit packet.

Specification to be changed to 200 IU/0.5 ml instead of 200 IU/1ml Option for PFS, and if PFS no need of Eclipse needle (21G)

Amended The item at Sl No. 10, D23016- Inj. Hepatitis B Immunoglobulin (HBIG) to be supplied in 200 IU/0.5 ml or 1 ml Each unit packet shall contain the following : i) 1 Vial (0.5 ml or 1 ml./Vial) ii) 1 Eclipse Needle (21G)

All blood products should be “Test Negative for HBsAg, HIV I & II, HCV Antibodies” which will be printed on each unit packet.

0.5ml or 1ml Vial 20 Vials/Box

17 Section – IV , Inj. Human Albumin IV In preferable pack size also Amended

Item Sl No. 26, D40002- Inj. Human Albumin IV Page No. 15

100m1/Bottle 20 Bottles/Box

Bag may be added. The item at Sl No. 26, D40002- Inj. Human Albumin IV to be supplied in 100ml/Bottle/Bag 20 Bottles or Bag/Box

18 Section – IV , Item Sl No. 63, D07005- Tab. Sodium Valproate (Aluminium foil/Glycine Poly Foil/ Blister pack) Page No. 18

200 mg/Tab (Controlled Release)

Specifications may be amended to Sodium Valproate- 133 mg and Valproic acid- 58 mg

No change

19 Section – IV , Item Sl No. 69, D07022- Tab. Sodium Valproate (Aluminium foil/Glycine Poly Foil/ Blister pack) Page No. 10

500 mg/Tab (Controlled Release)

Specifications may be amended to Sodium Valproate- 333 mg and Valproic acid- 145 mg

No change

20 Section – IV , Item Sl No. 89, D09051- Tab. Cefadroxil (Dispersible Tablet) Page No. 20

Tab. Cefadroxil (Dispersible Tablet)(Aluminium foil/Glycine Poly Foil/Blister pack)

Dispersible tablet may be changed to uncoated tablet

No Change

21 Section – IV , Item Sl No. 191, D21024- Tab. Ondansetron (Dispersible Tablet) (Aluminium

Dispersible Tablet License for mouth dissolving Tablet can be accepted.

Amended The specification of the item D21024- Tab. Ondansetron (Dispersible Tablet/ Mouth Dissolving Tablet) (Aluminium foil/Glycine Poly Foil/Blister pack) License for mouth dissolving Tablet may also

foil/Glycine Poly Foil/Blister pack) Page No. 28

be accepted.

22 Section – IV, Item Sl. No. 149, D16032- Factor VIII (with diluents in plastic container) Page No. 24

D16032- Factor VIII (with diluents in plastic container) 250 IU / vial

Diluents in glass container may be accepted

Amended The item at Item Sl. No. 149, D16032- Factor VIII to be supplied (with diluents in plastic or glass container) 250 IU/ vial Diluents in both glass & Plastic containers are accepted.

23 Section – IV, Item Sl. No. 150, D16033- Factor VIII (with diluents in plastic container) Page No. 24

D16033- Factor VIII (with diluents in plastic container) 500 IU / vial

Diluents in glass container may be accepted

Amended The item at Item Sl. No. 150, D16033- Factor VIII to be supplied ((with diluents in plastic or glass container) 500 IU / vial Diluents in both glass & Plastic containers are also accepted.

24 Section – IV, Item Sl. No. 151, D16034- Factor IX (with diluents in plastic container) Page No. 24

D16034- Factor IX (with diluents in plastic container) 600 IU / vial

1) Diluents in glass container may also be accepted.

2) Additional strength of 500

IU/Vial may be added to the specification and price may be asked to quote on IU basis

Amended 1) The item at Item Sl. No. 151, D16034-

Factor IX to be supplied ((with diluents in plastic or glass container) 600 IU / vial

2) No Change

25 Section – IV, Item Sl. No. 235, 236, 237, 238 D28013- Salbutamol Inhaler, 200metered doses and other types of inhalers Page No. 31

D28013- Salbutamol Inhaler, 200 metered doses and other types of inhalers

Metered Doses with dose counter may be added in the specification of the inhalers.

No Change Clarification:

The supplier may participate with additional features on the inhaler with mandatory specification as mentioned.

26 Section – IV, Item Sl. No. 306,

Vitamin A Solution (Concentrated)

Specification may be changed as mentioned in IP

No change Clarification:

D30017- Vitamin A Solution Page No. 37

(Orange Flavour, palatable with plastic container as per I.P, measuring spoon of 2ml with 1ml marking and measuring cap)

Both measuring spoon and cap is to be provided.

The plastic container in which the item is to be supplied should be as IP grade. Further both measuring spoon and cap is to be provided during supply.

26 Section – IV , Item Sl No. 331, S02113 - Whole Blood Finger Prick Test Kit

Detailed Technical Specification of the mentioned items are mentioned at Annexure-C

27 Section – IV , Item Sl No. 332, S02053 - VDRL Rapid Test Kit, (RPR) Rapid Plasma Regime

Detailed Technical Specification of the mentioned items are mentioned at Annexure-D

28 Section – IV , Item Sl No. 333, S02135 - Point of Care Test Kit (Rapid Whole Blood Syphilis Test Kit)

Detailed Technical Specification of the mentioned items are mentioned at Annexure-E

B) SUPPLY OF DRUGS & MEDICAL CONSUMABLES (Group-I), Bid ref No. OSMCL/2017-18/DRUGS-DHS/03:-

Sl. No.

Item Name/ Particulars

Details as mentioned in the tender document

Queries raised by the prospective bidders

Clarifications/ Amendments in response to the queries.

Queries relating to General Terms and Conditions1 Section- III

Clause No. 3.1 Bid Reference No.

Bid Reference No. OSMCL/2017-18/DRUGS-DHS-TENDER/02

Amended Bid Reference No. OSMCL/2017-18/DRUGS-DHS-TENDER/03

2 Section- III Clause No. 3.1 Cost of Bid Document (in

Rs. 5,600/- ( including GST as applicable if any ) for any or all

Rs. 5,600/- ( including GST) for any or all the item(s)

shape of DEMAND DRAFT) Page No. 11

the item(s)

3 Section – IV , Column 5

Page No.- 12

Regarding various queries relating to Pack Size (Primary and Secondary)

The pack size mentioned in Column No. 6 Section IV is Preferable Pack Size.

4 Section- V Clause No. 5.1 Page No. 44

Submission of Performance Security15 days from the date of issue of Letter of Intent.

Submission of Performance Security may be amended to 21 days instead of 15 days from the date of issue of Letter of Intent

No Change

5 Section- V Clause No. 5.2.1

Page No. 44

Bidder shall be a manufacturer having valid own manufacturing license/loan license / direct importer holding valid import license with product registration certificate issued by the Drugs Controller General of India. Can only Marketing Authorization Holder can participate?

Not to allow loan license for blood products and life saving products.

No Change

Clarification: Only Marketing Authorization holders cannot participate.

6 Section- V Clause No. 5.2.6 Page No. 44 - 45

Bidders shall have a minimum turnover of: Rs. 15 Crs or more in each year during last (3) three financial years in India for the items from Sl. No. 1 to Sl. No. 250, Rs. 10 Crs or more in each year during last (3) three financial years in India for the items from Sl. No. 251 to

Each year may be amended to average of three financial years as mentioned Minimize the turnover criteria for importer.

No Change

Sl. No. 333 as per Section IV. Last three financial years mean either for 2013-14, 2014-15 and 2015-16 or 2014-15, 2015-16 and 2016-17.


Page No. 50

The Bid document fee/EMD shall have to be furnished in shape of Demand Draft (DD)/Bankers Cheque(BC) from any Nationalized /scheduled bank in India in favour of Odisha State Medical Corporation Ltd., payable at Bhubaneswar. The EMD in Shape of Bank Guarantee (BG) from any of the nationalized/scheduled bank in India are also being acceptable. Bank Guarantee to be generated through Structured Financial Messaging System (SFMS) portal. The Bank Details for generating Bank Guarantee in SFMS, IFS Code: UBIN0538086 and Branch Code: 538086. The Bank Guarantee should be in Favour of Odisha State Medical Corporation Ltd. (OSMCL), payable at Bhubaneswar. Original BG as per format Annexure-IV is mandatory for the bidders to submit before the opening

1. In SFMS Bank Guarantee there is no original bank guarantee generated. Hence how to submit original bank guarantee in format of Annexure IV?

2. Can original bank Guarantee be submitted in normal way?

No Change. Clarification:

1. Original BG as per format Annexure-IV for submission of EMD is mandatory for the bidders to submit before the opening of the online technical bid.

However, the bidders are requested to submit the original BG from banks which are covered under SFMS platform for early verification of the same.

2. Yes original bank Guarantee payable at Bhubaneswar can be submitted in normal way.

of the online technical bid. BG submitted in format other than Annexure- IV will be liable for rejection.


Page No. 51

The amount of the EMD(s) to be submitted per item is mentioned at Section III and Non- submission of EMD as mentioned in Section III shall be one of the primary reasons for rejection of the offer in the first round.

EMD amount may be fixed with a ceiling i.e. maximum up to Rs. 20 Lakhs to enable the bidders to quote in maximum no of items. As item wise EMD is restricting bidders to participate for multiple items in the tender.

No Change


Page No. 61

However, for programme item (s) and other Bulk item(s) empanelment of other technically qualified suppliers may be asked through negotiation to match with the L1 price for supply of the item (s). Subsequently orders can be given to L1, L2 & L3 suppliers at L1 rate in the ratio of 50:30:20. In case of failure of any supplier, the non supply portion of the order can go to the suppliers who are on the panel for supplying and in the event L2 and L3 suppliers also failing, the orders can be placed on other qualified suppliers willing to supply at L1 rate. MD, OSMCL reserves all rights regarding the decision of

Bulk items may be clearly mentioned in the tender at Section-IV for better clarity for the bidders in quoting their price.

Amended However, for programme item (s) and other Bulk item(s) (As mentioned in Annexure-F) empanelment of other technically qualified suppliers may be asked through negotiation to match with the L1 price for supply of the item(s). Subsequently orders can be given to L1, L2 & L3 suppliers at L1 rate in the ratio of 50:30:20. In case of failure of any supplier, NSQ declaration or emergency requirement for exigencies the order can be placed to the suppliers who are on the panel for supplying and in the event L2 and L3 suppliers also failing, the orders can be placed on other qualified suppliers willing to supply at L1rate.MD, OSMCL reserves all rights regarding the decision of division of the total order quantity.

division of the total order quantity.


Page No. 64

The tender inviting authority may place the supply order in a phased manner during the rate contract period.

What is the Minimum quantity of Order to be placed and in how many phases

Clarification: The Approx. Quantity mentioned at column No. 6 is only an indicative quantity.

The quantity will be ordered in phased manner based on the consumption pattern.


Page No. 66

However in case of imported items, small ordered items (i.e. small ordered quantity in comparison to the batch manufacturing size) and in case of vaccines, serums, immunoglobulin’s, blood products like human coagulation factors VII, VIII, IX, etc are exempted form 5/6th Shelf life, with an under taking from the supplier that if the item expires being not utilised then the supplier shall replace the whole expired item with fresh batch(es) of supply. However at the time of supply the item should have minimum 70% of the remaining shelf life from the date of manufacture.

In case of imported items, the item should have minimum 60% of the remaining shelf life from the date of manufacture.

No Change


Page No. 67

The items requiring special cold storage conditions should either be supplied with cold chain transporting system under cold chain norms from the manufacturing unit to the warehouses of the Corporation

Order for the cold chain items may be ordered to the warehouses having cold chain facilities and the list of warehouses with cold chain facility may be mentioned in the tender document.

No Change

(as per section- IV, Clause No. 4.2) complying cold chain norms.


Page No. 68

Quality testing and Handling charges: 1.5 % of the purchase order value shall be collected from the approved supplier as the quality testing charges

Testing charge may be exempted in case of imported items, vaccines, serum, immunoglobulin, blood products like human coagulation factors VII, VIII, IX, etc., which requires quality clearance of the item(s) from CRI Kasauli/ NIB Noida/ Govt. Statutory Laboratories.

Amended Quality testing and Handling charges: 1.5 % of the purchase order value shall be collected from the approved supplier as the quality testing charges. The items (as mentioned at Annexure -G) are exempted from testing charges i.e. at the rate of 1.5 %. However in event of any product complaints MD OSMCL reserves to test the same and the actual testing cost may be recovered from the supplier from applicable dues.

13 Section – IV , Item Sl No. 41, D33137- Inj. Leucovorin Calcium Page No. 15

15mg / 2ml 2ml / Vial 20 Vials/Box

Also Ampoule to be added in Pack size

Amended The item at Item Sl. No. 41, D33137- Inj. Leucovorin Calcium to be supplied 15mg / 2ml 2ml / Vial/Ampoule 20 Vials or Amp/Box

14 Section – IV , Item Sl No. 48, D33079-Inj.Paclitaxel (with transfusion set (PVC and DEHP free) and NS Glass Bottle of 500ml/Polyethylene (PVC and DEH free) 500 ml bottle ) Page No. 16

260 mg/250mg /vial Both strengths to be separately tendered

No Change

15 Section – IV , Item Sl No. 62, D33075- Tab. Imatinib(Aluminium foil/Glycine Poly Foil/ Blister pack)

100 mg/Tab Also Capsule to be added in Pack size

Amended The item at Item Sl. No. 62, D33075- Tab. Imatinib to be supplied 100 mg/Tab/ Cap

Page No. 17 16 Section – IV , Item

Sl No. 81, D33186- Tab. Nilotinib(Aluminium foil/Blister pack) Page No. 18

200 mg/Tab Also Capsule to be added in Pack size

Amended The item at Item Sl. No. 81, D33186- Tab. Nilotinib to be supplied 200 mg/Tab/ Cap

17 Section – IV , Item Sl No. 92, D33199- Tab. Eltromopag Page No. 19

D33199- Tab. Eltromopag

D33199- Tab. Eltrombopag

18 Section – IV , Item Sl No. 98, D16004- Inj. Heparin Sodium Page No. 19

Inj. Heparin Sodium 5000 IU/ml 1ml/Amp 20 Amps/Box

In preferable pack size also Vial may be added

Amended The item at Item Sl. No. 98, D16004- Inj. Heparin Sodium to be supplied 5000 IU/ml 1ml/Amp or Vial 20 Amps or Vial/Box

General Clarification on Price Bid

The bidders have to quote the prices as per the Format mentioned in Price BOQ in the e—tender portal. The prices (Rates) are to be quoted per tab/ caps /bottle/amp./vial/PFS/tube/Kit/cylinder/jar/film/piece/lit./ kg./gm/test. etc( as the case may be) and not in unit pack, the quoted price includes excise duty, packing, forwarding / transportation & Door Delivery and excludes SALES TAX/ VAT & ENTRY TAX.

N:B:- 1. The amendments mentioned above are to be treated as amendments in the technical specification(s) and term(s) and condition(s) of the above tender references. All other technical specifications and terms conditions remain unchanged.

2. Since any text in the price BOQ can’t be changed in the e-tender portal, the amendments mentioned in the specifications above are to be treated as amendments in the price bid/ BOQ also.

Annexure - A List of Items for which order to be divided in between L1 : L2 : L3

as per Tender Clause No. 6.24.1.

Bid Reference No. OSMCL/2017-18/DRUGS-DHS/02

Sl No. Item Sl No.

Item Code Name of the Item Specification

1 1 D23002 Inj. Snake Venom AntiSerum (Polyvalent) with diluents

10 ml/Vial (Lyphillised, Powder form)

2 4 D23009 Inj. Anti Rabies Vaccine for Human Use with diluents

1 ml (ID),AS PER TENDER SPECIFICATION

3 5 D23011 Inj. Human Anti-D Immunoglobuline 300mcg/ 2ml Amp/Vial

4 6 D23012 Inj. Antitetanus Human Immunoglobulin / Tetanus Immunoglobulin

250 IU/Vial

5 12 D20004 I.V Mannitol 20% w/v (FFS Plastic container)

6 13 D20002 Inj. Frusemide 10 mg/ 1 ml

7 14 D29001 I.V Sodium Chloride (Normal Saline) 0.9% w/v (FFS Plastic Container)

8 15 D29002 I.V Dextrose and Sodium Chloride (DNS) 5% w/v Dextrose, 0.9% w/v Sodium Chloride (FFS Plastic Container)

9 16 D29003 I.V Compound Sodium Lactate (RingerS Lactate) RL

Lactic Acid-0.24w/v equivalent to 0.32% w/v of sodium lactate sodium chloride-0.6% w/v, potassium chloride-0.04% w/v, calcium chloride-0.027% w/v (FFS Plastic Container)

10 17 D29004 I.V Dextrose 5% (5D) 5% w/v (FFS Plastic Container)

11 29 D04003 Syp. Paracetamol (Palatable, with measuring cap and plastic container/ Glass Bottle as per I.P)

125 mg/5 ml

12 32 D04008 Inj. Pentazocine Lactate 30 mg/ml (equivalent of 30 mg of pentazocine) /ml

13 33 D04010 Inj. Diclofenac Sodium 25 mg/ml

14 35 D04025 Tab. Aceclofenac(Aluminium foil/Glycine Poly Foil/ Blister pack)

100mg/Tab.

15 51 D05001 Inj. Dexamethasone Sodium Phosphate 4 mg/ml (4.4 mg of Dexamethas one sodium phospate is equivalent to 4 mg. of Dexamethasone Phosphate)

16 54 D05011 Syp. Cetrizine Dihydrochloride (Palatable, with measuring cap and plastic container/ Glass Bottle as per I.P)

5 mg/ 5 ml

17 56 D05021 Tab. Levocetirizine Dihydrochloride(Aluminium foil/Glycine Poly Foil/ Blister pack)

5 mg/Tab

18 73 D09007 Inj. Ciprofloxacin I.V. 200mg/100ml (FFS Plastic Container)

19 74 D09073 Inj. Ofloxacin I.V 200mg/100ml Bottle (FFS Plastic Container)

20 75 D09121 Inj. Linezolid I.V 200 mg/100 ml

21 76 D09003 Susp. Cotrimoxazole (Palatable, with measuring cap and plastic container/ Glass Bottle as per I.P)

(Trimethoprim 40mg + Sulphamethoxazole 200mg)/5 ml

22 77 D09009 Inj. Gentamycin Sulphate Equiv. to Gentamicin 40 mg/ml

23 78 D09010 Inj. Gentamycin Sulphate Equiv. to Gentamicin 10 mg/ml

24 79 D09012 Tab. Amoxycillin Trihydrate(Dispersible) (Aluminium Foil/Glycine Poly Foil/Blister Pack)

Equivalent to 250 mg/Tab of Amoxicillin (Dispersible Tablet)

25 80 D09017 Tab. Norfloxacin (Aluminium Foil/GlycinePoly Foil/Blister Pack)

400 mg/Tab

26 81 D09019 Inj. Amikacin Sulphate 500 mg/2ml equivalent of Amikacin

27 82 D09020 Tab. Ciprofloxacin HCl (Aluminium Foil/Glycine Poly Foil/Blister Pack)

500 mg/Tab

28 83 D09026 Tab. Cefadroxil (Aluminium Foil/Glycine Poly Foil/Blister Pack)

500 mg/Tab

29 84 D09033 Tab. Ofloxacin (Aluminium Foil/Glycine Poly Foil/Blister Pack)

200 mg/Tab

30 85 D09046 Inj. Amikacin Sulphate 100 mg/2ml equivalent of Amikacin 31 86 D09049 Tab. Ciprofloxacin HCl (Aluminium

Foil/Glycine Poly Foil/Blister Pack) 250 mg/Tab

32 87 D09050 Cap. Amoxycillin Trihydrate (Aluminium Foil/Glycine Poly Foil/Blister Pack)

500 mg/Cap

33 88 D09051 Tab. Cefadroxil (Dispersible Tablet)(Aluminium foil/Glycine Poly Foil/Blister pack)

Equiv. to Anhydrous Cefadroxil 250 mg/Tab. (DT)

34 89 D09053 Inj. Cefotaxime Sodium (with diluents in plastic container)

Equiv. to Cefotaxime 250 mg/Vial

35 90 D09054 Inj. Cefotaxime Sodium(with diluents in plastic container)

1 gm/Vial

36 91 D09060 Susp. Amoxycillin(Palatable, with measuring cap and plastic container/ Glass Bottle as per I.P)

125 mg / 5ml

37 92 D09077 Tab. Azithromycin (Aluminium Foil/Glycine Poly Foil/Blister pack)

500 mg/Tab

38 93 D09084 Tab. Ofloxacin (Aluminium foil/Glycine Poly Foil/Blister pack)

400 mg/Tab

39 94 D09086 Inj. Cefoperazone & Sulbactam (with diluents in plastic container)

250mg Cefoperazone + 250mg Sulbactam/vial

40 95 D09087 Inj. Piperacillin + Tazobactam (with diluents in plastic container)

Piperacillin 4gm + Tazobactam 500mg/vial



42 97 D09089 Susp. Azithromycin (Palatable, with measuring cap and plastic container/ Glass Bottle as per I.P)

100mg / 5ml

43 98 D09091 Tab. Cefixime (Aluminium Foil/Glycine Poly Foil/Blister pack)

200mg/Tab

44 99 D09093 Inj. Ceftriaxone (with diluents in plastic container)

Equiv. to Ceftriaxone 250mg /vial

45 100 D09094 Inj. Ceftriaxone (with diluents in plastic container)

Equiv. to Ceftriaxone 1gm / vial

46 101 D09095 Azithromycin Oral Suspension (Palatable, with measuring cap and plastic container/ Glass Bottle as per I.P)

200mg / 5ml

47 102 D09096 Tab. Cefixime (Scored and Dispersible) (Aluminium Foil/Glycine Poly Foil/Blister pack)

100mg/Tab



49 104 D09104 Cefadroxil Drop(Palatable, with dropper and plastic container as per I.P)

100mg/ml

50 105 D09110 Tab. Cotrimoxazole Paediatric (Aluminium foil/Blister pack)

TMP 40mg + SMZ 200mg / Tab

51 106 D09122 Tab. Linezolid(Aluminium foil/Glycine Poly Foil/Blister pack)

600mg / Tab.

52 107 D09124 Tab. Levofloxacin(Aluminium foil/Glycine Poly Foil/Blister pack)

500mg / Tab.

53 108 D09128 Tab. Azithromycin(Aluminium Foil/Glycine Poly Foil/Blister pack)

250 mg/ Tab

54 109 D09130 Inj. Cefepime(with diluents in plastic container)

1000mg/vial

55 110 D09131 Inj. Cefoperazone & Sulbactam (with 10ml diluents in plastic container)

1000mg Cefoperazone + 500mg Sulbactam / vial

56 111 D09134 Tab. Cotrimoxazole TMP 160mg + SMZ 800mg / Tab 57 112 D09138 Susp. Ofloxacin (Palatable, with measuring

cap and plastic container/ Glass Bottle as per I.P)

50mg / 5ml

58 113 D09139 Tab. Ofloxacin 100 mg/ Tab

59 114 D09004 Inj. Ampicillin Sodium (with diluents in plastic container)

Equivalent to 500 mg of anhydrous Ampicillin/Vial

60 115 D09111 Tab. Amoxycillin Trihydrate (Dispersible Tablet) (Aluminium foil/Glycine Poly Foil/Blister pack)

Equivalent to 125 mg/Tab of Amoxicillin

61 116 D09129 Inj. Cefepime (with diluents in plastic container)

500mg/vial

62 117 D09136 Inj. Meropenem (with 10ml diluents in plastic container)

1gm

63 118 D09132 Inj. Cefoperazone(with 10ml diluents in plastic container)

1000mg Cefoperazone / vial

64 119 D09137 Tab. Moxifloxacin(Aluminium foil/Blister pack)

400mg / Tab.Scored

65 120 D09119 Inj. Ceftazidime(with diluents in plastic container)

1gm/vial

66 121 D09135 Susp. Linezolid (Palatable, plastic container as per I.P with Dropper)

100mg/5ml

67 122 D09106 Inj. Vancomycin(with diluents in plastic container)

500 mg/Vial

68 123 D09141 Inj. Teicoplanin (with diluents in plast ic container)

400mg/vial

69 124 D09133 Tab. Clarithromycin(Aluminium foil/Blister pack)

500mg / Tab.Scored

70 125 D09142 Inj. Vancomycin(with 10ml diluents in plastic container)

1000mg/vial

71 126 D09101 Inj. Amoxycillin Trihydrate (with diluents in plastic container)

500mg / vial

72 127 D09070 Cap. Tetracycline (Aluminium foil/Blister pack)

500 mg/Cap

73 128 D09016 Tab. Erythromycin Stearate (Equiv.to Erythromycin 250 mg)

250 mg/Tab

74 136 D13007 Susp. Metronidazole (Oral Susp.) (Palatable, with measuring cap and plastic container/ Glass Bottel as per I.P)

200 mg/5 ml(100 mg of Metronidazole Benzoate is equivalent of 62.5 mg of Metronidazole)

75 140 D13003 Inj. Metronidazole I.V 500 mg/100 ml Bottle (FFS Plastic Container)

76 145 D16012 Inj. Tranexamic Acid 500mg/5ml

77 146 D16013 Tab. Tranexamic Acid (Aluminium foil/Glycine Poly Foil/Blister pack)

500mg/Tab.

78 147 D16015 Cap. Hydroxyurea (Aluminium foil/Glycine Poly Foil/Blister pack)

500mg/Cap.

79 148 D16017 Tab. Doxylamine Succinate + Pyridoxine (Aluminium foil/Glycine Poly Foil/Blister pack)

Doxylamine Succinate 10 mg + Pyridoxine 10 mg / Tab.

80 149 D16032 Factor VIII (with diluents in plastic container)

250 IU / vial

81 150 D16033 Factor VIII (with diluents in plastic container)

500 IU / Vial

82 151 D16034 Factor IX (with diluents in plastic container) 600 IU / Vial

83 152 D16022 Tab. Deferasirox (Aluminium foil/Glycine Poly Foil/Blister pack)

100 mg/Tab

84 153 D16023 Tab. Deferasirox (Aluminium foil/Glycine Poly Foil/Blister pack)

400 mg/Tab

85 154 D16038 Tab. Ferrous Sulphate + Folic Acid(Enter ic Coated, Red Colour)(Aluminium foil/Glycine Poly Foil/Blister pack)

Equivalent to 100 mg of Elemental Iron + Folic Acid 0.5mg (500mcg) / Enteric Coated Tablet

86 155 D16045 Syp. Ferrous Sulphate + Folic Acid (Palatable with dropper and plastic container as per I.P, Auto-dispensing bottle)

Each 1ml contains 20mg of Elemental Iron and 0.1 mg (100mcg)of Folic Acid (Auto-dispensing bottle so that only 1ml canbe dispensed at a time)

87 156 D30021 Inj. Vitamin K1 1mg/0.5ml 88 158 D16029 Tab. Ferrous Sulphate + Folic Acid (Larg e)

(Enteric Coated and blue coloured-Indigo caramine) (The thickness of Aluminium foil: 40micron with LDPE 25 micron coating/ heat seal

Each Tblet Contains:Equivalentto 100 mg of Elemental Iron +Folic Acid 0.5mg (500mcg)

89 159 D16044 Tab. Ferrous Sulphate + Folic Acid (Smal l) (Sugar Coated and Pink coloured) (The thickness of Aluminium foil: 40micron with LDPE 25 micron coating/ heat seal la cquer) IFA (Sma

Each Tblet Contains:Equivalentto 45 mg of Elemental Iron +Folic Acid 0.4mg (400mcg)

90 166 D16018 Inj Iron Sucrose 50 mg/ 2.5 ml

91 167 D17006 Tab. Atenolol (Alluminium Foil/Glycine Poly Foil/ Blister Pack)

50 mg/Tab

92 168 D17015 Tab. Amlodipine Besylate (Alluminium Foil/ Glycine Poly Foil/Blister Pack)

5 mg/Tab

93 170 D17032 Tab. Telmisartan (Aluminium foil/Glycine Poly Foil/Blister pack)

40mg/Tab.

94 180 D21001 Inj. Ranitidine HCl 50 mg / 2 ml 95 189 D21018 Tab. Pantoprazole (Scored) (Aluminium

foil/Glycine Poly Foil/Blister pack) 40 mg/Tab

96 191 D21024 Tab. Ondansetron (Dispersible Tablet) (Aluminium foil/Glycine Poly Foil/Blister pack)

4mg / Tab.

97 195 D21030 Inj. Pantoprazole (with diluents in plastic container)

40 mg/vial

98 196 D21032 Tab. Drotaverine HCl(Aluminium foil/Glycine Poly Foil/Blister pack)

40 mg/Tab

99 198 D21036 Inj. Drotaverine 20 mg/ml

100 199 D21038 Syp. Ondansetron (Palatable, with measuring cap and plastic container / Glass Bottelas per I.P)

2 mg/5ml

101 200 D21039 Inj. Ondansetron 2 mg/ml 102 204 D22003 Tab. Metformin HCl (coated)(Aluminium

foil/Glycine Poly Foil/Blister pack) 500 mg/Tab

103 205 D22014 Tab. Glimepiride 2 mg/Tab 104 209 D26002 Inj. Oxytocin 5 IU/1ml 105 212 D26006 Inj. Magnesium Sulphate 500 mg/ml 106 213 D26007 Tab. Misoprostol (Aluminium foil/Glycine

Poly Foil/Blister pack) 200mcg/ Tab

107 214 D26012 Tab. Mifepristone (Aluminium Foil/Glycine Poly Foil/Blister pack)

200mg/Tab.

108 230 D28001 Inj. Theophylline & Etophylline (Theophylline 50.6 mg + Etophylline 169.4 mg)/2ml

109 232 D28011 Syp. Salbutamol Sulphate (Palatable, with measuring cap and plastic container/ Glass Bottel as per I.P)

2.41mg Salbutamol Sulphate equivalent to 2mg of Salbutamol/ 5ml

110 233 D28017 Tab. Doxofylline (Aluminium foil/GlycinePoly Foil/Blister pack)

400mg/Tab.

111 245 D14018 Inj. Artesunate 60 mg/Vial (with Sodium Bi-carbonate 1 ml+5ml NaCl)

112 246 D14006 Tab. Primaquin Phosphate (Coated) (Aluminium foil/Glycine Poly Foil/Blister pack)

7.5 mg/Tab,13 mg of primaquin phosphate equivalent to 7.5 mg of primaquin

113 247 D14035 Tab. Primaquin Phosphate (coated) (Aluminium foil/Glycine Poly Foil/Blister pack)

2.5mg/Tab.

114 248 D14005 Inj. Quinine Di-Hydrochloride 300 mg/ml

115 249 D14004 Tab. Quinine Sulphate (Coated) (Aluminium foil/Glycine Poly Foil/Blister pack)

300 mg/Tab

116 254 D02001 Inj. Lignocaine HCl 2% w/v 117 257 D02008 Inj. Bupivacaine (Heavy) Bupivacaine 5mg/ml + Dextrose

80mg / ml 118 261 D08003 Susp. Albendazole(Palatable, with measuring

cap(5 ml)and plastic container/ Glass Bottel as per I.P)

200 mg/5ml

119 262 D08004 Tab. Albendazole (Chewable) (Aluminium foil/Glycine Poly Foil/Blister pack)

400 MG/TAB

120 264 D12008 Tab. Fluconazole (Aluminium Foil/Glycine Poly Foil/Blister Pack)

150 mg/Tab

121 270 D18003 Silver Sulphadiazine Cream 1% w/v

122 271 D18007 Povidone Iodine Solution (Plastic container as per I.P)

5% w/v

123 280 D18024 Povidone Iodine Oint. 5 % w/v 124 284 D25001 Gentamycin Sulphate Eye/Ear Drops 0.3% w/v of Gentamicin, (FFS /

BFS Plastic Container) 125 286 D25012 Ciprofloxacin Eye /Ear Drop (Preservative

Benzalkonium Cl. Soln. 0.01%w/v) 0.3% w/v (FFS / BFS Plastic Container)

126 287 D25022 Clotrimazole & Lignocaine Ear Drop (Clotrimazole 1% w/v + Lignocaine HCl 2% w/v) (20mg/ml) (FFS/ BFS Plastic Container) As per Pack Sample Approved

127 294 D30001 Tab. Calcium and Vit. D3 (Film coated)(Aluminium foil/Glycine Poly Foil/Blister pack)

500mg Elemental Calcium + Vitamin D3 250IU /Tab

128 297 D30012 Concentrated Vitamin A Solution (Orange Flavour, palatable with plastic container/ Glass Bottel as per I.P, measuring spoon having measuring of 1 ml-2ml

1,00,000 I.U / 1ml

129 298 D30015 Tab. Zinc Acetate / Sulphate (Dispersible Tablets)

Equivalent to 20mg of Elemental Zinc

130 309 D38013 Tab. Anti-Malarial Combipack (Blister Pack) (Adults 15 year and above)

(Day 1): One tablet of Artesunate (i.e. 1 tablet of 200mg) and two tablets of Sulphadoxineand Pyrimethamine (750mg + 375mg) each Second Row (Day 2): one tablet of Artesunate 200mg Third Row (Day 3): one tablet of Artesunate 200mg

131 310 D14024 Tab. Anti-Malarial Combipack (Blister Pack) Children 1 - 4 years

(Day 1): One tablet of Artesunate (i.e. 1 tablet of 50mg) and one tablet of Sulphadoxine and Pyrimethamine (500mg + 25mg) Second Row (Day 2): one tablet of Artesunate 50mg Third Row (Day 3): one tablet of Artesunate 50mg.


(Day 1): One tablet of Artesunate (i.e. 1 tablet of 100mg) and one tablet of Sulphadoxineand Pyrimethamine (750mg + 37.5mg) Second Row (Day 2): one tablet of Artesunate 100mg Third Row (Day 3): one tablet of Artesunate 100mg.


(Day 1): One tablet of Artesunate (i.e. 1 tablet of 150mg) and two tablets of Sulphadoxine and Pyrimethamine (500mg + 25mg) each Second Row (Day 2): one tablet of Artesunate 150mg Third Row (Day 3): one tablet of Artesunate 150mg.

134 313 D14023 Tab. Anti-Malarial Combipack (Blister Pack) Infant less than 1 year

(Day 1): One tablet of Artesunate (i.e. 1 tablet of 25mg) and one tablet of Sulphadoxine and Pyrimethamine (250mg + 12.5mg) Second Row (Day 2): one tablet of Artesunate 25mg Third Row (Day 3): one tablet of Artesunate 25mg.

Annexure – B List of Items Exempted for Quality Testing Charges

Bid Reference No. OSMCL/2017-18/DRUGS-DHS/02 Sl No. Item Sl

No. Item Code Name of the Item Specification

1 1 D23002 Inj. Snake Venom AntiSerum (Polyvalent) with diluents

10 ml/Vial (Lyphillised, Powder form)

2 2 D23005 Inj. Tetanus Toxoid (Adsorbed) 0.5 ml/Amp

3 3 D23008 Inj. Snake Venom AntiSerum (Polyvalent) 10 ml/Vial (Liquid Form)

4 4 D23009 Inj. Anti Rabies Vaccine for Human Use with diluents 1 ml (ID),AS PER TENDER SPECIFICATION

5 5 D23011 Inj. Human Anti-D Immunoglobuline 300mcg/ 2ml Amp/Vial

6 6 D23012 Inj. Antitetanus Human Immunoglobulin / Tetan us Immunoglobulin

250 IU/Vial

7 7 D23013 Inj. Antitetanus Human Immunoglobulin 500 IU/Vial

8 8 D23014 Inj. Human Rabies Immunoglobuline 300 IU / 2ML

9 9 D23015 Inj. Hepatitis B Immunoglobulin (HBIG) 100 IU/ 1ML EACH UNIT PACKET SHALL CONTAIN THE FOLLOWING : I ) 1 VIAL (1 ML./VIAL) II) 1 EC LIPSE NEEDLE (21G) ALL BLOOD PRODUCTS SHOULD BE ¿TESTNEGATIVE FOR HBSAG, HIV I & II, HCV ANTIBODIES¿ WHICH WILL BE PRINTED ON EACH UNIT PACKET.

10 10 D23016 Inj. Hepatitis B Immunoglobulin (HBIG) 200 IU/ 1ml Each unit packet (200 IU/1ml) shall contain the following: i)1 Vial or PFS (1ml./Vial or PFS)ii) 1 Eclipse Needle (21G) All blood products should be ¿Test Negative for HBsAg, HIV I & II, HCV Antibodies¿ which will be printed on each unit

11 11 D23010 Equine Rabies Immunoglobulin 1500 IU / 5 ml (Rabies Immunoserum)

12 149 D16032 Factor VIII (with diluents in plastic container) 250 IU / vial

13 150 D16033 Factor VIII (with diluents in plastic container) 500 IU / Vial

14 151 D16034 Factor IX (with diluents in plastic container) 600 IU / Vial

15 239 D31008 X-Ray Photo Films 8" x 10" 8" x 10" Conforming to IS No. 15584




19 243 D31025 Dental intra oral X-Ray films 4.1cm x 3.1cm Conforming to IS No. 15584

20 331 S02113 Whole Blood Finger Prick Test Kit AS PER TENDER SPECIFICATION

Annexure - C TECHNICAL SPECIFICATION

HIV (Rapid) Whole Blood Finger Prick Test (S02113)

Kits

Bidders are required to mention “Comply”/ “Not comply” or specific information requested against each criteria of the

following Technical Specification for the items being supplied.

PART A

Sl. Specification Your Offer (Please fill-in)

Yes/No 1 The indigenous HIV antibody rapid test kits should have a valid

license issued by the competent authority defined under Drugs & Cosmetics Act, 1940 after appropriate evaluation by the centres approved by DCG(I). The imported rapid test kits should have the approval of the statutory authority in the country of Origin/manufacture and should satisfy the requirements of Drugs & Cosmetics Act in India. The imported kits should Yes/No

2. The assay should be able to detect antibodies of HIV1, HIV2 and all the subtypes by detection of antibodies by the agglutination/ Enzyme

3 The assay should have sensitivity of 99.5% or more and specificity of 98% or more as per data from an identified national reference laboratory.

Sl. Specific Requirement: Your Offer (Please fill-in)

“Comply”/Not Comply

“Not comply” 1 A „Cold Chain indicator‟ is to be supplied with the kits with

the following

i specification: A cumulative time/temperature indicator should indicate

the exposure to temperature in the range of 2-8 0C

ii The cumulative time-temperature indicator technology used should be prequalified by WHO

iii The indicator should change color uniformly, irreversibly and the rate of reaction should be predictable by appropriate

iv kinetic parameters. The color change should have a well-defined start point and end

point that can be correlated to the heat stability of the kit.

2 Bar-coding details are enclosed in tender document

4. The assay should have solid phase/ particles coated with synthetic and/ or recombination or both types of antigens of HIV1 & HIV2.

5. Total procedure time should not be more than 30 minutes.

6. The manufacturers should ensure that: d) The test kit should be packed such that there is a provision to conduct single test at a time; e) The assay components should include HIV positive and negative serum controls sufficient for conducting 20% of the tests (10% negative and 10% positive controls); and f) The pack size of HIV rapid test kits should be 30 tests per Kit.

PART B TECHNICAL SPECIFICATION – GENERAL

Sl. Minimum Requirements Your Offer (Please fill-in)

Product and Package Specifications Yes/No 1 The required packing standards and labeling must meet the

requirements given in this Technical Specification and Part. 2 Not only the Goods but also the packaging components

should also meet specifications suitable for use in a climate similar to that prevailing in the country of the Purchaser. All packaging must be properly sealed and tampered- proof.

3 All labeling and packaging inserts shall be in the language requested by the Purchaser or English if not otherwise stated

4 Goods requiring refrigeration or freezing for stability must specifically indicate storage requirements on labels and containers and be shipped in special containers to ensure stability in transit from point of shipment to port of entry.

Sl. Requirements Your Offer (Please fill-in)

Terms and Conditions Yes/No 1 Shelf life of the kits has to be defined as 83% of residual life for indigenous item and for

Imported item 70% residual life or a shelf-life of 18 months at the time of dispatch to the consignee.

2. The supplier should have the facility to store kits at Odisha. 3 After receipt, the consignee shall have the right to draw

samples at random from the consignment and get them retested to satisfy whether the lots conform to the laid down specifications. In the event of the product failing to conform to specifications, the consignee shall reject consignment.

5 Upon award, the successful Supplier shall, on demand, provide a translated version in the language of the bid of the prescriber‟s information for any specific goods the Purchaser may request

Product Information

6 The following information will be required for each pharmaceutical product offered by the Bidder: i) International Non-Proprietary Name (INN), if applicable; ii) Name and address of the manufacturer; iii) Country of origin; and iv) Compendia standards

7 Upon award, the supplier shall, on demand, provide a translated version in English, of the prescriber‟s information for any specific product, the Purchaser may request.

Failure to include any of this information, at the discretion

of the Purchaser, may render the bid non-responsive. Expiration Date

8 All products must indicate the dates of manufacture and expiry. In addition, unless otherwise stated in Part A of these Specifications, all products must arrive at the final consignee point with a remaining shelf life of at least five sixths (5/6ths) of the total stipulated shelf life at the time of manufacture.

Recalls

9 If products must be recalled because of problems with product quality as a result of quality check carried out during the life span of the drug or adverse reactions to the pharmaceutical, the supplier will be obligated to notify the purchaser providing full details about the reason leading to the recall and shall take steps to replace the product in question at its own cost with a fresh batch of acceptable pharmaceuticals, or withdraw and give a full refund if the product has been take off the market due to safety problems.

Labelling Instructions

10 The label for each Goods shall include: (a) the Purchaser‟s logo and code number and any specific color coding if required (b) content per pack (c) instructions for use (d) special storage requirements (e) batch number (f) date of manufacture and date of expiry (in clear language, not code)

11 The outer case or carton should also display the above Information.

Details of Packing/Cases

12 All cases should prominently indicate the following: i) The generic name of the product; ii) date of manufacture and expiry (in clear language not code); iii) batch number; and iv) quantity per case

13 No case should contain drugs from more than one batch. Unique Identifier

14 The Purchaser shall have the right to request the Supplier to imprint a logo on the containers used for packaging and in certain dosage forms such as tablets and this will be indicated in Part A of the Technical Specifications. The design of such logo shall be provided to the supplier at the time of Contract award.

Qualifications of Manufacturer

15 The bidder shall furnish a certificate from the competent FDRA that the manufacturer of the pharmaceutical or vaccine product covered by this Invitation for Bids is licensed to manufacture this product.

Standards and Quality Assurance Requirements

All products must: 16 Meet the requirements of manufacturing legislation

and regulation of pharmaceuticals or vaccines in the country of origin.

17 Conform to all the specifications contained herein 18 Must undergo strict raw material inspection, in process

checks, appropriate material handling to eliminate cross contamination (of molecules) and final product testing to ensure quality and consistency of the products.

The Bidder is required to furnish to the Purchaser:

19 With each consignment, a certificate of quality assurance test results concerning quantitative assay, chemical analysis and other tests, as applicable to the product being supplied and Part A of these Specifications.

20 Assay methodology of any or all tests if requested. 21 Evidence of basis for expiration dating and other

stability data on the offered package (as per climatic conditions prevalent in India) concerning the commercial final package upon request.

22 Package integrity test results. 23 The Bidder will also be required to provide the

purchaser with access to its manufacturing facilities to inspect its facilities, quality control procedures for raw materials, test methods, in-process tests, and finished

Goods.

THE PRODUCTS OFFERED ARE IN ACCORDANCE WITH THE SPECIFICATIONS AND REQUIREMENTS: YES NO ANY DEVIATION MUST BE LISTED BELOW: ........................................................................................................ ............................................ .......................................................................................................

PART C : SPECIAL INSTRUCTION

Sl. Minimum Requirements Your Offer (Please fill-in)

Product and Package Specifications Yes/No 1 Each packing, inner carton and nested cartons to have the

following words printed in red ink with bold letters. “GOVT. OF ODISHA SUPPLY - NOT FOR SALE”

2 Life of the product, indicating the date of manufacture and date of expiry should be printed as per Drugs & Cosmetics 1940 Act-India

3 Equivalency of Standards & Codes Wherever reference is made in the Technical Specifications to specific standards and codes to be met by the Product to be furnished or tested, the provisions of the latest current edition or revision of the relevant standards or codes in effect shall apply, unless otherwise expressly stated in the Contract. Where such standards and codes are national or authoritative standards that ensure substantial equivalence to the standards and codes specified will be acceptable

4 Packing Packing Instruction: Each unit package will be marked on two sides with proper paint/indelible ink, the following ; i)Programme : ii)Purchase Order No. : iii)Country of origin of Goods : iv)Supplier’s Name and : v)Packing list reference number :

5 Each outer packing containing the unit packing should have the following label printed in bold letters in large size. i) Purchaser’s Name : HEALTH & FAMILY WELFARE, Govt. of Odisha. ii) Programme : National Rural Health Mission, Odisha iii) Purchase Order No : iv) Country of origin Goods

6 Any other labelling requirement which the purchaser may ask at the time of approving the labelling samples

Annexure - D TECHNICAL SPECIFICATIONS

RPR TEST KITS FOR SYPHILIS DETECTION (S02053) Bidders are required to mention “Comply”/ “Not comply” or specific information requested against each criteria of the following Technical Specification

PART A

Sl. Specific Requirement: Your Offer

(Please fill-in) “Comply”/

“Not comply” 1. A “Cold Chain indicator is to be supplied with the kits with

the following specification:

i. A cumulative time/temperature indicator should indicate the exposure to temperature in the range of 2-8 0C

ii. The cumulative time-temperature indicator technology used should be prequalified by WHO

iii. The indicator should change color uniformly, irreversibly and the rate of reaction should be predictable by appropriate kinetic parameters.

iv. The color change should have a well-defined start point and end point that can be correlated to the heat stability of the kit.

2. Bar-coding details should be as mentioned in the tender document. Requirements Your Offer

(Please fill-in) RPR test kits for Syphilis detection “Comply”/

“Not comply” 1. The indigenous RPR (Rapid Plasma Reagin) kits should have been manufactured under manufacturing licence issued by the State Licensing Authority under the Drugs and Cosmetics Act. The imported kits should have been imported under Import Licence issued by the DCG(I) under the Drugs and Cosmetics Act.

2. The assay should allow for qualitative and semi quantitative determination of reagin antibodies in serum or plasma for sero-diagnosis of syphilis based on flocculation principle using non treponemal antigens.

3. The assay should be suitable to perform with either serum or plasma

4. The assay should have sensitivity of 80% or more in primary syphilis and a specificity of 90% or more

5. The assay should be calibrated to WHO reference serum and the same should be supported by statements in kit insert and certificate from manufacturer.

6. The test should be able to yield results within 20 minutes. 7. The pack size of RPR test kit should be 50 tests per kit 8. The assay components should include positive and negative serum controls sufficient for conducting 20% of the tests (10% negative and 10% positive controls)

9. The kit should have all essential accessories required for the test such as cards, droppers, applicator, etc. in adequate quantities for the number of tests to be performed.

10. The kit should have more than 60% residual shelf-life or 10 months (whichever is more) at the time of dispatch to the consignee

11. The kit should have a storage temperature of 2 0C to 8 0C and supplier/ local agent should have the facility to store kits at 2 0C to 8 0C

12. Cumulative Time Temperature Indicator should be part of the kit as per specifications defined in the terms and conditions.

13. Literature, detailing the components, methodologies, validity criteria, performance characteristics, storage conditions, manufacturing and expiry dates should be provided with each kit.

Quality Testing Sl. Our Requirements Your Offer

(Please fill-in) III Details of Quality Testing mentioned in the tender

document. “Comply”/

“Not comply” After receipt, the consignee shall draw samples at random from

the consignment and get them retested to satisfy whether the lots conform to the laid down specifications. In the event of the product failing to conform to specifications, the consignee shall reject that batch of supply and inform the supplier for arranging replacement of the rejected batches at supplier’s cost.

PART B

TECHNICAL SPECIFICATION – GENERAL

Sl. Our Minimum Requirements Your Offer (Please fill-

TECHNICAL SPECIFICATION – GENERAL “Comply”/ “Not comply”

1. Product and Package Specifications

1.1. The required packing standards and labeling must meet the requirements given in this Technical Specification and Part.

1.2. Not only the Goods but also the packaging components should also meet specifications suitable for use in a climate similar to that prevailing in the country of the Purchaser. All packaging must be properly sealed and tampered- proof.

1.3. All labeling and packaging inserts shall be in the language requested by the Purchaser or English if not otherwise stated

1.4. Goods requiring refrigeration or freezing for stability must specifically indicate storage requirements on labels and containers and be shipped in special containers to ensure stability in transit from point of shipment to port of entry.

1.5. Upon award, the successful Supplier shall, on demand, provide a translated version in the language of the bid of the prescriber’s information for any specific goods the Purchaser may request

2. Product Information 2.1. The following information will be required for each

pharmaceutical product offered by the Bidder: i) International Non-Proprietary Name (INN), if applicable; ii) Brand Name (if it appears on label); iii) Name and address of the manufacturer; iv) Country of origin; and v) Compendia standards

2.2. Upon award, the supplier shall, on demand, provide a translated version in English, of the prescriber’s information for any specific product, the Purchaser may request.

2.3. Failure to include any of this information, at the discretion of the Purchaser, may render the bid non-responsive.

3. Expiration Date 3.1. All products must indicate the dates of manufacture and expiry. In

addition, unless otherwise stated in Part A of these Specifications, all products must arrive at the final consignee point with a remaining shelf life of at least five- sixths (5/6ths) of the total stipulated shelf life at the time of manufacture.

4. Recalls

4.1. If products must be recalled because of problems with product quality as a result of quality check carried out during the life span of the drug or adverse reactions to the pharmaceutical, the supplier will be obligated to notify the purchaser providing full details about the reason leading to the recall and shall take steps to replace the product in question at its own cost with a fresh batch of acceptable pharmaceuticals, or withdraw and give a full refund if the product has been take off the market due to safety problems.

5. Labeling Instructions

5.1 The label for each Goods shall include: (a) the Purchaser s logo and code number and any specific color coding if required (b) content per pack (c) instructions for use (d) special storage requirements (e) batch number (f) date of manufacture and date of expiry (in clear language, not code) (g) name and address of manufacture with license number (h) any additional cautionary statement

5.2. The outer case or carton should also display the above information 6. Details of Packing/Cases

6.1. All cases should prominently indicate the following: i) The generic name of the product; ii) date of manufacture and expiry (in clear language not code); iii) batch number iv) quantity per case.

6.2. No case should contain drugs from more than one batch.

7. Unique Identifier

7.1. The Purchaser shall have the right to request the Supplier to imprint a logo on the containers used for packaging and in certain dosage forms such as tablets and this will be indicated in Part A of the Technical Specifications. The design of such logo shall be provided to the supplier at the time of Contract award.

Sl. Our Minimum Requirements Your Offer (Please fill-in)

TECHNICAL SPECIFICATION – GENERAL “Comply”/ “Not 8. Qualifications of Manufacturer

8.1. The bidder shall furnish a certificate from the competent FDRA that the manufacturer of the pharmaceutical or vaccine product covered by this Invitation for Bids is licensed to manufacture these products.

9. Standards and Quality Assurance Requirements 9.1. All products must: (a) Meet the requirements of manufacturing legislation and

regulation of pharmaceuticals or vaccines in the country of origin;

(b) Conform to all the specifications contained herein (c) Must undergo strict raw material inspection, in process

checks, appropriate material handling to eliminate cross contamination (of molecules) and final product testing to ensure quality and consistency of the products.

9.2. The Bidder is required to furnish to the Purchaser: (a) With each consignment, a certificate of quality assurance test

results concerning quantitative assay, chemical analysis and other tests, as applicable to the product being supplied and Part A of these Specifications.

(b) Assay methodology of any or all tests if requested. (c) Evidence of basis for expiration dating and other stability data

on the offered package (as per climatic conditions prevalent in India) concerning the commercial final package upon request.

(d) Package integrity test results.

9.3. The Bidder will also be required to provide the purchaser with access to its manufacturing facilities to inspect its facilities, quality control procedures for raw materials, test methods, in-process tests, and finished Goods.

THE PRODUCTS OFFERED ARE IN ACCORDANCE WITH THE SPECIFICATIONS AND REQUIREMENTS

YES NO ANY DEVIATION MUST BE LISTED BELOW:

PART C - SPECIAL INSTRUCTION Sl.

Our Requirements Your Offer (Please fill-in)

SPECIAL INSTRUCTIONS “Comply”/ “Not comply”

1. Each packing, inner carton and nested cartons to have the following words printed in red ink with bold letters.

“GOVT. OF ODISHA SUPPLY - NOT FOR SALE”

2. Life of the product, indicating the date of manufacture and date of expiry should be printed as per Drugs & Cosmetics Act-India

3. Equivalency of Standards & Codes

Wherever reference is made in the Technical Specifications to specific standards and codes to be met by the Product to be furnished or tested, the provisions of the latest current edition or revision of the relevant standards or codes in effect shall apply, unless otherwise expressly stated in the Contract. Where such standards and codes are national or authoritative standards that ensure substantial equivalence to the standards and codes specified will be acceptable

4. Packing Packing Instruction: Each unit package will be marked on two sides with proper paint/indelible ink, the following ; i) Programme : ii) Purchase Order No. : iii) Country of origin of Goods : iv) Supplier’s Name and : v) Packing list reference number :

5. Each outer packing containing the unit packing should have the following label printed in bold letters in large size.

i) Purchaser’s Name: HEALTH &FAMILY

WELFARE, Govt. of Odisha. ii) Programme: National Rural Health Mission, Odisha iii) Purchase Order No : iv) Country of origin of Goods v) Supplier’s Name

6. Any other labeling requirement which the purchaser may ask at the time of approving the labeling samples

Annexure - E

Technical Specifications of Treponemal-specific Rapid (Point-of-

Care) Diagnostic Test for Syphilis (S02135) The assay should have solid phase coated with synthetic or recombinant type of Treponema Pallidum antigens. The assay may be based on any of the rapid test principles:

(Immunoconcentration /Dot blot immunoassay (vertical flow), dip stick and comb assay. The assay should quantitatively detect total anti-treponemal antibody (IgG and IgM) in

whole blood, serum or plasma for serological diagnosis of syphilis in all stages of infection. The assay should have an in-built positive and negative control for testing the validity of the

test kits. The assay should have reactive and non-reactive controls with each kit in adequate volume

(minimum 10% of pack size). The kit should have 5/6th of the shelf life or 12 months before expiry (whichever is more) at

the time of receipt by the consignee. Adequate literature detailing the principle, components, methodologies, validity criteria, bio-

safety, performance characteristics, storage conditions, limitation of assay, manufacture and expiry dates and methods of disposal should be provided with each kit.

The imported rapid kit should have approval of the statutory authority in its country of origin. The imported kits should have been registered and licensed in India by the Central Drugs Standard Control Organization (CDSCO).

In case of indigenous manufacturers they should have a valid licence issued by the competent authority defined under Drugs and Cosmetics Act, 1940, after appropriate evaluation by the centres approved by the CDSCO.

The assay should have sensitivity of 90% or more and specificity of 95% or more and the same should be supported by statements in kit insert and certificate from National Institute of Biological Sciences.

The assay should be calibrated to WHO reference serum and the same should be supported by statements in kit insert and certificate from the manufacturer.

32 Screening for Syphilis During Pregnancy

The manufacturer should ensure the following: - The test should be packed such that there is a provision to conduct single test at a time. - The pack size of test kits should be in 50 (for peripheral health levels) and 100 tests per kit

(for secondary and tertiary health care level) but not more than 100 tests per kit.

The manufacturer/authorized agent should ensure maintenance of cold chain during storage and transport of kits at 2°C to 8°C.

Total procedure time should not be more than 30 minutes.

The test kit should be supplied with micro pipette of 1 micro litre voulme

Annexure - F

List of Items for which order to be divided in between L1 : L2 : L3

as per Tender Clause No. 6.24.1.


Sl No. Item Sl

No. Item Code Name of the Item Specification

1 98 D16004 Inj. Heparin Sodium 5000 IU/ml 2 101 D22012 Inj. Human Premixed Insulin

(30/70) 40 units/ml (Biphasic, 30/70)

Annexure - G List of Items Exempted for Quality Testing Charges


Sl No. Item Sl No. Item Code Name of the Item Specification

1 25 D33105 Inj. Decitabine 50mg / Vial

2 49 D33164 Inj. Rituximab 100 mg / Vial

3 50 D33165 Inj. Rituximab 500 mg / Vial

4 51 D33177 Inj. Trastuzumab 440mg

5 61 D33129 Tab. Ibandronic acid 50mg/ Tab

6 69 D33168 Cap. Sunitinib 12.5mg / Cap

7 70 D33169 Cap. Sunitinib 25mg/ Cap

8 79 D33159 Inj. Paclitaxel nanoparticle 300 mg / Vial

pre-bid clarification s / amendments in response to...

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