Format of Bank Guarantee of Earnest Money Deposit

ANNEXURE-I

Ref. Clause No.6.9.1.1

FORMAT OF BANK GUARANTEE OF EARNEST MONEY DEPOSIT

The Kerala Medical Services Corporation Limited

(Address)

WHEREAS ______(Name and address of the Company) (Hereinafter called “the bidder”) has undertaken, in pursuance of tender no______dated ______(herein after called “the tender”) to participate in the tender of The Kerala Medical Services Corporation

Limited, (address) with ……………………………. (description of goods and supplies).

AND WHEREAS it has been stipulated by you in the said tender that the bidder shall furnish you with a bank guarantee by a scheduled commercial bank recognised by you for the sum specified therein as Earnest Money Deposit for compliance with its obligations in accordance with the tender;

AND WHEREAS we have agreed to give the bidder------(name and address) such a bank guarantee;

NOW THEREFORE we hereby affirm that we are guarantors and responsible to you, on behalf of the bidder, up to a total amount of ______(Amount of the guarantee in words and figures), and we undertake to pay you, upon your first written demand declaring the bidder to be in default under the tender conditions and without cavil or argument, any sum or sums within the limits of (amount of guarantee) as aforesaid, without your needing to prove or to show grounds or reasons for your demand or the sum specified therein.

We hereby waive the necessity of your demanding the said debt from the bidder before presenting us with the demand.

We undertake to pay you any money so demanded notwithstanding any dispute or disputes raised by the bidder(s) in any suit or proceeding pending before any Court or Tribunal relating thereto our liability under these presents being absolute and unequivocal.

We agree that no change or addition to or other modification of the terms of the tender to be performed there under or of any of the tender documents which may be made between you and the supplier shall in any way release us from any liability under this guarantee and we hereby waive notice of any such change, addition or modification.

No action, event, or condition that by any applicable law should operate to discharge us from liability, hereunder shall have any effect and we hereby waive any right we may have to apply such law, so that in all respects our liability hereunder shall be irrevocable and except as stated herein, unconditional in all respects.

This guarantee will not be discharged due to the change in the constitution of the Bank or the bidder(s).

We, ______(indicate the name of bank) lastly undertake not to revoke this guarantee during its currency except with the previous consent, in writing, of The Kerala Medical Services Corporation Limited.

This Guarantee will remain in force up to ------(Date). Unless a claim or a demand in writing is made against the bank in terms of this guarantee on or before the expiry of ------(Date) all your rights in the said guarantee shall be forfeited and we shall be relieved and discharged from all the liability there under irrespective of whether the original guarantee is received by us or not.

(Signature with date of the authorised officer of the Bank)

………………………………………………………….

Name and designation of the officer

………………………………………………………….

Seal, name & address of the Bank and address of the Branch

ANNEXURE-II

Ref. Clause No. 6.9.1.11

FORM OR CERTIFICATE OF SALES TAX VERIFICATION TO BE

PRODUCED BY AN APPLICANT FROM THE CONTRACT OR OTHER

PATRONAGE AT THE DISPOSAL OF THE GOVERNMENT OF

KERALA.

(To be filled up by the applicant)

01.Name or style in which the applicant is assessed or assessable to Sales Tax Addresses or assessment.

02.a.Name and address of all companies, firms or associations or persons in which the applicant is interested in his individual or fiduciary capacity.

b.Places of business of the applicant (All places of business should be mentioned).

03.The Districts, Taluks and divisions in which the applicant is assessed to Sales Tax (All the places of business should be furnished).

04.a.Total contract amount or value of patronage received in the preceding three years.

2007- 2008

2008- 2009

2009 - 2010

b.Particulars of Sales - Tax for the preceding three years.

Year / Total T.O. be assessed Rs. / Total Tax assessed Rs. / Total Tax paid Rs. / Balance due Rs. / Reasons for balance Rs.

2007- 2008

2008- 2009

2009 - 2010

c.If there has been no assessment in any year, whether returns were submitted any, if there were, the division in which the returns were sent.

d.Whether any penal action or proceeding for the recovery of Sales Tax is pending.

e.The name and address of Branches if any:

I declare that the above information is correct and complete to the best of my knowledge and belief.

Signature of applicant:

Address:

Date:

(To be filled up by the Assessing authority)

In my opinion, the applicant mentioned above has been/ has not been/ doing everything possible to pay the tax demands promptly and regularly and to facilitate the completion of pending proceedings.

Date Seal:Deputy / Asst. Commercial Tax - Officer

Deputy Asst.

NOTE:A separate certificate should be obtained in respect of each of the place of business of the applicant from the Deputy Commercial Tax Officer or Assistant Commercial Tax Officer having jurisdiction over that place.

ANNEXURE-III

Ref. Clause No. 6.9.1.12

DECLARATION

I/We M/s.______represented by its Proprietor / Managing Partner / Managing Director having its Registered Office at ______and its Factory Premises at ______do hereby declare that I/We have carefully read all the conditions of tender No…………………………………….. dated………………………. for supply of Blood Diagnostic Kits and Reagents for the period from 01.04.2011 to 31.03.2012 floated by the Kerala Medical Services Corporation Ltd., Thiruvananthapuram and accepts all conditions of Tender.

I/We declare that we possess the valid license and GMP Certificate as per revised Schedule-‘M’ issued by the Competent Authority and complies and continue to comply with the conditions laid in Schedule M of Drugs & Cosmetics Act, 1940 and the Rules made there under. I/We furnish the particulars in this regard in enclosure to this declaration.

I/We agree that the Tender Inviting Authority forfeiting the Earnest Money Deposit and or Security Deposit and blacklisting me/us if, any information furnished by us proved to be false at the time of inspection and not complying the conditions as per Schedule M of the said Act.

Signature:

Seal

Name & Address:

To be attested by the Notary.

Enclosure to Annexure – III

Refer Clause 6.9.1.12

Declaration for Compliance of cG.M.P

01.Name and Address of the Firm:

02. Name of Proprietor / Partner / Director:

03. Name and Designation of Person Present:

04.GMP Certificate As per Revised Schedule “M”

05. Details of Licenses Held With Validity :

06. Number of Workers Employed:female:

male:

07.Whether Workers Provided with Uniform:Yes / No

08. Whether Medical Examination done

for the Workers : Yes / No

09. Hygienic Condition

(I)Surrounding :Satisfactory / Not Satisfactory

(II) Production Areas: Satisfactory / Not Satisfactory

(III) Other Areas: Satisfactory / Not Satisfactory

10.Provision for Disposal of Waste:Yes / No

11.Heating System:Yes / No

12. Whether Benches provided in all :Yes / No

Working Area

13.Water Supply

(A)Source:

(B) Storage Condition: Satisfactory / Not Satisfactory

(C)Testing

(With reference to Pathogenic Organisms):Yes / No

(D)Cleaning Schedule in Water Supply

System with Proper Records :Yes / No

(E)Type of Machinery installed as to

Semi-automatic or Fully Automatic plant for

water purification system along with cost and

whether this is working, and if so the flow rate

of Pharmaceutical water to meet the

requirements of preparation :

14.Air handling system along with list of machine

and cost of the unit, separately for sterile and

non sterile preparation:

15.Whether the pollution control clearance is valid for

Air and Water and if so the period upto which valid

(copy of the certificate to be enclosed) :

16. Raw Material Storage Area

(I) Quarantine : Provided / Not Provided

(II) Passed Materials: Provided / Not Provided

(III) Rejected Materials: Provided / Not Provided

17. Finished Product Storage Area

(I ) Quarantine: Provided / Not Provided

(II) Released Material: Provided / Not Provided

18. Details of Technical Staff

Name QualificationExperience

For Manufacturing:

For Testing:

19. Testing Facilities (List of Equipments to be furnished separately in the format to meet the bench mark vide Annexure)

Chemical Method:Yes / No

Instrumental:Yes / No

(Type of Instrument provided as indicated

in Annexure)

Biological:Yes / No

Micro Biological:Yes / No

Animal Testing:Yes / No

20. Remarks

(A) Whether Products Quoted to KMSCL

are Endorsed in the License:Yes / No

(B)Whether the Blood Diagnostic Kits and Reagents quoted to

KMSCL have been Manufactured

Earlier (Last 3 Years) :Yes / No

If Yes, Details Like

Sl.No / Date of Manufacture / Name of the Drug / Batch No. / Batch Size / Date of Release

(C)Production Capacity (Section Wise)

PRODUCTION CAPACITY:

Tablet Section

Type of Equipments
(1) / No. of Equipments
(2) / Production Capacity of all the Equipments in column 2
per shift
(3) / No. of shift
(4) / Production Capacity allotted for KMSCL
(5)
Planetary mixer
Fluidized bed drier
Tray drier
Mechanical shifter
Multi mill
Tablet compression machine
1) With ______number of station
2) With ______number of station
3) With ______number of station
4) With ______number of station
Coating pan.
Blister Packing machine
Strip packing machine

Capsule Section

Type of Equipments
(1) / No. of Equipments
(2) / Production Capacity of all the Equipments in column 2
per shift
(3) / No of shift
(4) / Production Capacity allotted for KMSCL
(5)
Double cone blender
Automatic capsule filling machine
Semi automatic Capsule filling machine
Hand filling machine
Blister packing machine
Strip packing machine

Parenteral Section

Type of Equipments
(1) / No. of Equipments
(2) / Production Capacity of all the Equipments in column 2
per shift
(3) / No of shift
(4) / Production Capacity allotted for KMSCL
(5)
Small volume Parenteral
Mixing Vessel
Laminar Flow unit
Filtration unit
Ampoule filling machine
(with No of head)
Vial filling
Machine
(with No of head)
Vial sealing machine
Powder filling machine
Autoclave for terminal Sterilization
Ampoule labeling machine
Vials labeling machine

Large Volume Parenteral Section

Type of Equipments
(1) / No. of Equipments
(2) / Production Capacity of all the Equipments in column 2
per shift
(3) / No of shift
(4) / Production Capacity allotted for KMSCL
(5)
Mixing Vessel
Filtration unit
Filling Machine Autoclave for terminal Sterilization
Labeling
Machine

Ointment / Cream

Type of Equipments
(1) / No. of Equipments
(2) / Production Capacity of all the Equipments in column 2 per shift
(3) / No of shift
(4) / Production Capacity allotted for KMSCL
(5)
Stream jacket vessel for mixing
Ointment/cream filling machine

Liquid Section

Type of Equipments
(1) / No. of Equipments
(2) / Production Capacity of all the Equipments in column 2 per shift
(3) / No of shift
(4) / Production Capacity allotted for KMSCL
(5)
Bottle washing machine
SS tank with capacity
Filter press
Colloidal mill
Bottle Filling Machine
Labeling Machine

External Preparation

Type of Equipments
(1) / No. of Equipments
(2) / Production Capacity of all the Equipments in column 2per shift
(3) / No of shift
(4) / Production Capacity allotted for KMSCL
(5)
Mixing Vessel
Filling machine
Labeling machine

(D)Any, Not Of Standard Quality :Yes / No

Reports Of Product Quoted/

Approved By KMSCL

(If Not, Nil Statement)

(E)Any Prosecution After: Yes / No

Submission of Tender Documents.

(If Not, Nil Statement)

(F)Chances Of Cross Contamination:Yes / No

at Raw Materials/In Process/

Finished Product Stages And Steps/

Facilities

(G) Validation of Equipments done: Yes / No

(H) Cleaning Schedule

(I) For Premises:

(II) For Equipments :

(I) Adverse Reaction, If Any and :

Reported

Sl. No. / Description / Remarks
1 / Whether any drug(s) manufactured by the tenderer has / have been recalled during last five years? If yes given details
2 / What are the results of investigations on the recalled drug(s)?
3 / What action have been taken to prevent recurrence of recall of drug(s) on that particular account?

(J) Complaints Received If Any:

and Steps taken.

Signature and Seal of

Proprietor / Partner / Director

To be attested by the Notary.

Instruments Provided in the Quality Control Lab

Sl.
(1) / Name of the Instruments
(2) / No. of Instruments
(3) / Cost of Instruments
(4) / Whether it is in working condition
(5)
1 / Analytical Balance
2 / Infra Red Spectrometer
3 / Karl Fisher Tritator
4 / Melting Point
5 / Brookfield Viscometer
6 / Polarimeter
7 / Autoclave
8 / Refractometer
9 / Sampling Booth
10 / UV-Vis Spectrometer
11 / HPLC
12 / Muffle Furnace
13 / Fuming Cupboard
14 / Micrometer
15 / Dissolution Tester
16 / Disintegration Tester
17 / Friability Tester
18 / Vernier Calipers
19 / IR Balance
20 / Hardness Tester
21 / Leak Test Apparatus
22 / Laminar Air Flow
23 / BOD Incubator
24 / Vacuum oven
25 / Bulk Density Apparatus
26 / Water Activity Meter
27 / Anaerobic System
28 / Gas Chromatograph
29 / LAL Kit
30 / Sterility Test Kit
31 / Particle Counter
32 / Air Sampler
33 / Flame Photometer
34 / Tap Density Tester

ANNEXURE-III-A

Refer clause No. 6.5.9

UNDERTAKING

I ______, S/o ______, Proprietor / Partner / Managing Director of ______(Proprietary Concern / Firm / Company Ltd.) execute this Undertaking for myself and on behalf of ______(Proprietary Concern / Firm / Company Ltd.).

2. Whereas, KMSCL (Tender Inviting Authority) has invited tender for supply of Blood Diagnostic Kits and Reagents for the year 2011-12 and in pursuant to the conditions in the tender documents, M/s.______is exempted from payment of Earnest Money Deposit.

3. And whereas, in pursuant to the conditions in Clause 6.5.9

of the tender, the Earnest Money Deposit can be forfeited by the Tender Inviting Authority in case of violation of any of the conditions and for non-performance of the obligation under tender document.

Witness: -Signature:

(1) Seal

(2) Name & Address

ANNEXURE-IV

Ref. Clause No. 6.9.1.13

PROFORMA FOR PERFORMANCE STATEMENT

(ATTACH SEPARATE SHEET FOR EACH PRODUCT QUOTED)

Name of firm …………………………………………………………………….

Name of the product …………………………………………………………………….

Tendered Quantity …………………………………………………………………......

Production Capacity: i) Annual ……………………………………………………….

ii) Monthly………………………………………………………

Offered Quantity ………………………………………………………………………

Sl No / Batch Nos and expiry date / Batch Size / BMR Reference No. / Name and full address of the purchasers* / Supply order No and date / Invoice No and date / Page Nos of the documents submitted in the Cover A
BMR / Supply order / Invoice
2008-09
1
2
3
4
5
2009-10
1
2
3
4
5
2010-11
1
2
3
4
5

Signature and seal of the Tenderer

*if there are more than one purchaser for a batch the details of each purchaser should be furnished in the respective column.

Annexure-V

Ref. Clause. 6.9.1.14

ANNUAL TURN OVER STATEMENT

The Annual Turnover of M/s______for the past three years are given below and certified that the statement is true and correct.

______

Sl. No. YearTurnover in Lakhs (Rs)

______

12007 - 2008 -

22008 - 2009 -

3 2009- 2010

______

Total -Rs. ______Lakhs.

______

Average turnover per annual- Rs.______Lakhs.

Date: Signature of Auditor/ Chartered Accountant

(Name in Capital)

Seal:

ANNEXURE-VI

Refer Clause No. 6.191.17 and 6.27.

DECLARATION

I/We …………………………………………………………………………do hereby declare that I /We will supply the Blood Diagnostic Kits and Reagents as per the designs given in enclosures to this Annexure and as per the instructions given in this regard.

Signature of the Tenderer

Name in capital letters with Designation

Attested by Notary Public.

ENCLOSURE-I TO ANNEXURE-VI

Refer Clause No. 6.9.1.17 and 6.27.

DESIGN FOR LOGOGRAM

BLOOD DIAGNOSTIC KITS AND REAGENTS

The primary, secondary packing and outer cartons of Blood Diagnostic Kits and Reagents shall bear the above logograms and the words “Kerala Government Supplies – Not for Sale” overprinted in red colour.

IMPORTED BLOOD DIAGNOSTIC KITS AND REAGENTS/ PRODUCTS

In case of imported Blood Diagnostic Kits and Reagents/ products the above logograms and wordings should be printed in indelible ink either on the label borne by the container of the Drug/ product or on a label or wrapper affixed to any package in which the container is issued.

ENCLOSURE-II TO ANNEXURE-VI

Refer Clause No. 6.9.1.17

SPECIMEN LABEL FOR OUTER CARTON

KERALA GOVT. SUPPLY
NOT FOR SALE

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
xxxxxxxx (Product Name)
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
EXP. DATE: ……….
Batch. : …………… Quantity Packed: …………..
Mfg Date: …………… Net Weight:……………….
Manufactured by: ……….

ENCLOSURE-III TO ANNEXURE-VI

Refer clause 6.28.2

BAR CODING DETAILS

BOX NO :

PO NUMBER :

SUPPLIER CODE :

SUPPLIER NAME :

DRUG CODE :

DRUG NAME :

BATCH NO :

MFG DATE :

EXPIRY DATE :

BATCH QUANTITY :

INVOICE NO :

D C NO :

ANNEXURE – VII

Refer clause No.6.9.1.18

DETAILS OF MANUFACTURING UNIT

Name of the Tenderer & Full Address:

PAN Number :

Phone Nos.:

Fax:

E-Mail:

Date of Inception:

License No. & Date:

Issued by:

Valid up to:

Details of Installed Production Capacity for 60 days / 1 year

(In Terms of Unit Packs)

Injections

Ampoules:

Vials:

Sterile Powder:

Liquids

Disinfectants:

Name & designation of the authorized signatory:

Specimen signature of the authorized Signatory:

*The details of manufacturing unit shall be for the premises where items quoted are actually manufactured

CHECK LIST

ANNEXURE – VIII

Refer clause No. 6.9.1.23

COVER- A. Page No

1. / Checklist – Annexure VIII / 1
2. / EMD in the form of DD shall be kept in an envelope. Valid SSI certificate for exemption
DD No/BG No.:
Date:
Bank & branch:
Amount:
3. / Inspection fee in the form of DD shall be kept in an envelope (Applicable only to those firms whose offer has been rejected due to failure in Inspection in the previous years)
DD No/BG No.:
Date:
Bank & branch:
Amount:
4. / Tender document cost in the form of DD shall be kept in an envelope (applicable only to those firms who has downloaded the tender document)
DD No/BG No.:
Date:
Bank & branch:
Amount:
5. / Copy of voucher receipt issued by KMSCL for the remittance of the Tender document cost (applicable only to those firms who has purchased the Tender documents)
Voucher No.
Date :
6. / Copy of voucher receipt issued by KMSCL for the remittance of fee for pre-bid meeting (applicable only to those firms who had participated in the pre-bid meeting)
Voucher No.
Date :
7. / Documentary evidence for the constitutions
of the company / concern
8. / Duly attested photocopy of License for the
product duly approved by the Licensing
Authority for each and every product quoted.
9. / Duly attested photocopy of Import License,
if imported.
10. / The instruments such as power of attorney, resolution of board etc.,
11. / Authorization letter nominating a responsible person of the tenderer to transact the business with the Tender inviting Authority.
12. / Market Standing Certificate issued
by the Licensing Authority
13. / Notary attested copy of record of manufacture / import to establish 3 years market standing.
14. / Non Conviction Certificate issued by the
Drugs Controller
15. / Good Manufacturing Practices Certificate
16. / Annual Turnover Statement for 3 Years
(Annexure-V)
17. / Copies of balance sheet & profit loss
account for three years
18. / Annexure-II
(Sales Tax clearance certificate)
19. / Annexure-VI
(Undertaking for embossment of logo)
20. / Declaration Form in Annexure-III
21. / Performa for Performance Statement
(Annexure-IV)
22. / Details of Manufacturing Unit in
Annexure-VII
23. / Notary attested copy of the license for the use of standard mark (IS) issued by Bureau of Indian Standards (BIS), in case of non drug products for which IS specification is insisted in SectionIV
24. / WHO, UNICEF, ISO certificates if any
25. / Details of Technical personnel
employed in the manufacture and testing
26. / List of items quoted without rates(2 copies).
27 / Notary attested documentary evidence to prove that the tenderer is having own cold chain transporting system/copy of the contract agreement made with transporting agent
28 / Declaration in annexure-XIII
27. / The Tender document signed by the
tenderer in all pages with office seal.

Place:Signature: