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Tender Document for Empanelment of NABL Accredited Drugs Testing Laboratories of 61

TENDER DOCUMENT (NOT TRANSFERABLE)

FOR

EMPANELMENT OF NABL ACCREDITED DRUGS TESTING

LABORATORIES FOR THE ANALYSIS OF DRUGS SENT BY

NIB – NOIDA

Tender No: NIB/DS/2014-15/03

Cost of Tender Document Rs.2,500/-(inclusive of UP-VAT)

(Non-Refundable)

19th January 2015

NATIONAL INSTITUTE OF BIOLOGICALS (Ministry of Health & Family Welfare, Govt. of India)

A-32, Sector-62

Near NH-24, Noida-201 309 (U.P.)

Tel: 0120-2400022, 2400072, Fax: 0120-2400074, 2403014

E-mail: [email protected] Website: www.nib.gov.in

mailto:[email protected]

http://www.nib.gov.in/


TABLE OF CONTENTS

Sl.No. TITLE PAGE No.

1. Executive Summary for Inviting Tender 4-6

2. Introduction, General Instructions and Guidelines for the Bidder

7-12

3. Introduction 7

4. Eligibility Criteria for Empanelment 7-8

5. Guidelines for Submission of Tender 8-12

6. Cover – 1 : Technical Bid 8-10

7. Cover – 2 : Financial Bid 10-11

8. Pre-Bid Meeting 11

9. Validity of Bids 12

10. Amendment of Tender 12

11. General Conditions of Tender 12-15

12. Acceptance of Tender 13

13. Agreement 14

14. Security Deposit 14

15. Payment Terms 14

16. Penalties 14-15

17. Complete Analysis & Reporting Conditions 15-16

18. Annexure I – Performa for Performance Statement 17

19. Annexure II – Service Tax Registration and PAN Card

18

20. Annexure III (a) – Technical Personnel in Laboratory

19

21. Annexure III (b) – List of Sophisticated Equipment’s 20

22. Annexure III (c) – Facilities in the Microbiological Section

21

23. Annexure III (d) – List of Reference standards 22

24. Annexure III (e) – List of Working Standards 23

25. Annexure III (f) – List of Reference Cultures 24

26. Annexure IV – Declaration Form 25

27. Annexure V – Details of the Laboratory 26

28. Annexure VI – List of Drugs for Analysis 27-35


29. Annexure VII – Check List 36-37

30. Annexure VIII – Financial/ Price Bid 38-50

31. Annexure IX – Format of Test Report 51

32. Annexure X – Format for Performance Guarantee 52-54

33. Annexure XI – Format for Agreement 55-60

34. Annexure XII – Affidavit for No Commercial Interest 61


Dated-19th January 2015

EXECUTIVE SUMMARY FOR INVITING TENDERS Subject: Empanelment of NABL Accredited Drugs Testing Laboratories for the Analysis

of Drugs Sent by NIB, Noida. The Director NIB invites sealed tender under “Two Bid System” from eligible &

qualified bidders for “Empanelment of NABL Accredited Drugs Testing Laboratories

for the Analysis of Drugs”for a initial period of one year from the date of acceptance

of the tender in the prescribed Bid Forms and Formats enclosed with this Document.

1. The Brief Details of the Tender are as Under:

1. Tender No. NIB/DS/2014-15/03

2. Tender Name Empanelment of NABL Accredited Drugs Testing Laboratories for the Analysis of Drugs

3. Quantum of Work Refer Complete Analysis & Reporting Conditions as per Tender document.

4. Type of Tender Open Tender

5. Tender Fees Rs. 2,500/- (Rupee Twenty Five Hundred) inclusive of UP-VAT in form of Demand Draft from any Nationalized Bank drawn in favour of ‘National Institute of Biologicals – Drugs Survey’, payable at Noida/Delhi.

6. Bidding System Two Bid System

7. Place of availability of Tender Documents

Either purchase from NIB office during the working hours or Download from the NIB website www.nib.gov.in or CPP portal.

8. Sale of Tender document

From 19/01/2015 (03:00 PM onwards) to 10/02/2015

9. Date & Venue for Pre-Bid Meeting

28/01/2015 at 02:30 P.M. in National Institute of Biologicals, A-32, Sector-62, Near NH-24, Noida - 201 309

10. Last date & time for submission of Tender in NIB

On 11/02/2015 up to 03.00 P.M.

11. Tender Opening date & time(Technical Bid)

On 11/02/2015 at 03:30 P.M.

12. Correspondence Address for Issue & Submission of Bid

The Director, National Institute of Biologicals, A-32, Sector-62, Near NH-24, Noida- 201 309. Contact No- 0120-2400027

13. Bid Validity Up to 90 (Ninety) days from the date of opening of Bid.



14. Earnest Money Deposit in the form of Demand Draft (DD).

EMD amount for Rs. 25,000/- (Rupees Twenty Five thousand only) to be submitted in form of Demand Draft in the name of ‘National Institute of Biologicals – Drugs Survey’, payable at Noida/Delhi.

15.

Security Deposit / Performance Bank Guarantee / Contract Security

The successful bidder has to submit Security Deposit /Performance Bank Guarantee / Contract Security – in the form of Demand draft in favour of ‘National Institute of Biologicals’, payable at Noida/Delhi or Performance Bank Guarantee (PBG) – for Rs. 50,000 (Rupee Fifty Thousand only) or 10% (Ten Percent) of the Total Contract Value whichever is higher, within 15 (Fifteen) days from date of LOA/LOI as per prescribed format enclosed at Annexure-X.

Validity of Performance Bank Guarantee

60 (Sixty) days beyond the expiry of the contract period. The Agency will have to extend the validity of the same for extended period (If any).

2. A complete set of tender document may be purchased by any eligible tenderer on

submission of written application and upon payment of a non Refundable Fee of

Rs.2,500/- (Rupees Two Thousand five Hundred Only) Inclusive of UP-VAT in the

form of Demand draft drawn in favour of ‘Nationl Institute of Biologicals – Drugs

Survey’, payble at Noida/Delhi or alternatively, the tender document may be

downloaded from the NIB website: www.nib.gov.in or CPP portal.

3. The Bidders Downloading the tender document from the Website should ensure to

submit tender fees of Rs. 2,500/- (Rupees Two Thousand five Hundred Only)

Inclusive of UP-VAT in form of Demand Draftalong with their Bid in Cover – 1

containing the Technical Bid.

OFFERS NOT ACCOMPANIED WITH PRESCRIBED TENDER FEE AND EMD WILL

NOT BE ACCEPTED.

4. Two Bid System shall be followed and bidders should take due care to submit

tenders in accordance with the requirements given in the tender document. Financial

Bids will be evaluated on the basis of L-1 Rates quoted for Respective Products/

Dosage Forms for Complete Analysis as mentioned in Annexure- VIII.

5. The Pre-bid meeting shall be held on the date and time given above to provide

clarifications to prospective bidders regarding Technical & Financial terms and

conditions given in Tender Document.



6. All further notifications/amendments, if any shall be posted on www.nib.gov.in only.

No separate communication shall be made with individual Bidders.

For Director,

National Institute of Biologicals,

Ministry of Health & Family Welfare,

Government of India,

Noida



Tender No: NIB/DS/2014-15/03

TENDER DOCUMENT FOR EMPANELMENT OF NABL ACCREDITED DRUGS TESTING LABORATORIES

FOR THE ANALYSIS OF DRUGS SENT BY NIB.

“CONFIDENTIALITY IS THE ESSENCE OF THIS TENDER”

1. INTRODUCTION, GENERAL INSTRUCTIONS AND GUIDELINES FOR THE BIDDER:

1.1. INTRODUCTION

NATIONAL INSTITUTE OF BIOLOGICALS (NIB) is an Autonomous Institute under the

administrative control of Ministry of Health & Family Welfare, Govt. of India and engaged

in the evaluation and quality control testing of various Biological products like Vaccines,

Blood Products, Blood reagents, Sera, Immuno-diagnostic kits etc. produced and imported

in India. NIB has a state of art laboratory building having area of 15,000/Sqm. approx.

Sealed Tenders will be Accepted till 03.00 PM on 11.02.2015, in National Institute of

Biologicals (Ministry of Health & family Welfare, Govt. of India) Noida, UP, (herein referred

as Tender Inviting Authority unless the context otherwise requires) for

“EMPANELMENT OF NABL ACCREDITED DRUGS TESTING LABORATORIES FOR

THE ANALYSIS OF DRUGS SENT BY NIB” of 15 (Fifteen) therapeutic category of Drugs

under drugs survey for a Initial period of 1 (one) year from the date of Acceptance of the

Tender. The tender may be extended on same terms & conditions for further periodas per the

requirement, if mutually agreed.

1.2. ELIGIBILITY CRITERIA FOR EMPANELMENT

a) The Drug Testing Laboratories should have valid Approval for carrying out test on drugs

under the Drugs and Cosmetics Act, 1940 and Rules thereunder (Government Drugs

testing Laboratories are exempted).

b) The Drug Testing Laboratory should have valid NABL Accreditation (ISO/IEC–

17025:2005) certification at the time of submission of Tender Document or should have

applied for its renewal.

c) The laboratory should have an average annual turnover of Rs.50.00 Lakhs (Rupee Fifty

Lakhs only) towards drugs testing services for the preceding 3(three) years (2011-12,

NATIONAL INSTITUTE OF BIOLOGICALS A-32, Sector-62,

Near NH-24, Noida-201 309 (U.P.)

Tel: 0120-2400022, 2400072, Fax: 0120-2400074, 2403014 E-mail: [email protected] Website: www.nib.gov.in

mailto:[email protected]



2012-13 and 2013-14) (Government Drugs Testing Laboratories are exempted from turnover

limit) are eligible to participate in the tender.

d) The tender submitted by a laboratory which has been blacklisted in last 3 (Three) years

by any State /Central Government Organisation shall not be considered or its approval

should not be suspended / cancelled during the last 3 years.

e) The laboratory and its responsible persons should not have been convicted under the

provisions of Drugs and Cosmetic Act 1940 and Rules their under with regard to the

activities and conduct of the laboratory during last 3 years.

f) The laboratory should have all necessary instruments/equipments/machines, equipped

with all required accessories for testing of quoated drugs in this Tender.

g) The laboratory should have sufficient trained number of technical manpower to address

the need of the project.

h) Analytical Laboratory, which has manufacturing activity with the same management,

shall not be eligible to participate in the tender. Laboratory has to furnish a declaration

in this regard as per Anneexure – XII.

i) Agents are not eligible to participate in the tender.

1.3 GUIDELINE FOR SUBMISSION OF TENDER /BIDS

a) Each and every page of the tender document should be signed by Authorized signatory

in token of acceptance of the tender conditions along with the other required

documents/details. The bid can be sent by owner or owner’s representative.

Representative will have to enclose the Letter of Authority / the Power of Attorney along

with this Bid Document, otherwise the offer may be considered null and void at any

stage as per the decision of NIB.

b) All the corrections/cutting made anywhere in the tender form will have to be

authenticated with full signature. The corrections without authentication may be liable

to be rejected.

c) The Sealed bids are to be submitted in two separate envelopes

Cover – 1, Containing Technical Bid: The following is the list of documents to be

enclosed with the Technical Bid in the Cover – 1:

i. The Earnest Money Deposit (EMD) shall be Rs. 25,000/- (Twenty Five Thousand

Rupee Only). The EMD shall be paid in the form of Demand Draft in favour of

‘National Institute of Biologicals – Drugs Survey’ payable at Noida/Delhi. The

EMD should be sent along with the tender document. EMD in the form of Cheque

/ Cash / Postal Order will not be accepted. The EMD will not earn any interest.

ii. In Case the Tender Document downloaded online, Tender Fees of Rs. 2,500/-

(Rupee Twenty Five hundred Only) in form of DD in favour of ‘National Institute


of Biologicals – Drugs Survey’, Payable at Noida/ Delhi has to be submitted

along with the Technical Bid.

iii. Self Attested copy of valid Approval in ‘Form-37’ of Drugs and Cosmetics Act,

1940 and Rules made thereunder duly renewed up to date, issued by the Drug

Controller of the state. In case they have applied for renewal a letter from Drug

Licensing Authority should be provided.

iv. Documentary evidence of having analyzed Drugs for the last 3 (three) years with

a statement in the proforma given in Annexure - I.

v. Self attested copy of Service Tax Registration and PAN Card should be enclosed

Annexure - II.

vi. Self attested documents of the following should be furnished in the formats given

in Annexure III.

a. The list of Technicaly qualified personnel employed in the laboratory along

with their educational qualification and practical experience.

b. The list of sophisticated instruments installed in the laboratory along with its

date of installation, number of instruments, make & model no., status of

calibration etc.

c. Microbiological facilities available in the laboratory along with their list of

instruments/ qualification of HVAC system and clean room facility.

d. List of Reference Standards for Assay, related substance & impurities

available in the laboratory with date of purchase, source & valid up to.

e. List of Working Standards for Assay, related substance & impurities available

in the laboratory with date of purchase, source & valid up to.

f. List of Microbiologicals Reference Cultures with Date & Source of

Procurement.

vii. A declaration in the proforma given in Annexure-IV duly signed and sealed to be

enclosed.

viii. Details of Laboratory to be provided as per Annexure - V.

ix. The details of Drugs for Analysis are given in Annexure-VI

x. Copy of Documents certifying that the analytical laboratory has been accredited

by NABL.

xi. Documentary evidence for the constitution of the company / Laboratory i.e.

Incorporation Certificate / Partnership deed etc. with details of the Name, Address,


Telephone Number, Fax Number, e-mail address of the firm and the Managing

Director / Partners / Proprietor.

xii. The instruments such as power of attorney, resolution of board etc., authorizing

an officer of the tenderer should be enclosed with the tender in Cover- 1 duly

signed by the Authorized signatory of the Laboratory / Firm and such authorized

officer of the tenderer should sign in bottom of all pages of the tender documents.

xiii. Other Documents to be enclosed:

a. Self attested Non Conviction Certificate for the last 3 (three) years, i.e., 2011-

12, 2012-13 and 2013-14 to be submitted.

b. Annual turnover statement duly certified by the Chartered Accountant for last

3 (three) years i.e., 2011-12, 2012-13 and 2013-14.

c. Copy of Balance Sheet and Profit & Loss Account duly certified by the

Auditors for the last 3(three) years i.e., 2011-12, 2012-13 and 2013-14, If

Financial Statements for the F.Y. 2013-14 are not Audited till the last date for

submission of Tender, a certificate from Chartered Accountant in this regard

to be submitted.

d. Documentary evidence, if any, for having undertaken testing of products for

Exports & Govt. Departments.

e. The tenderer shall submit a checklist of documents enclosed with the tender

document as per enclosed proforma in Annexure –VII.

f. Testing capacity of the laboratory for dosage form quoted in the tender

submitted within 60 (Sixty) days.

Cover – 2 Containing Financial/Price Bid: The Following is the list of Documents to be

enclosed with the Financial/ Price Bid in the Cover – 2:

I. Financial / Price Bid of Tender Document duly filled in giving the Rates of Testing

charges for the complete analysis of each sample as per Indian Pharmacopoeia

and signed on each page with official seal of the tenderer affixed, should be sent

in a separate Sealed cover, Super Scribing Cover - 2 hereafter called “Financial /

Price Bid”. (Annexure- VIII of the tender document to be used for quoting the

rates of testing charges and this should be submitted in both Hard copy & Soft

Copy in excel format in Pen Drive with marking of name of the Laboratory for

proper Identification).


II. Cover - 2 shall consist of the rates quoted by the tenderer only. It shall not consist

of any other documents. No condition shall be indicated in the Financial /

Price Bid. All terms and condition shall be indicated only in Technical bid.

The tender documents and certificates must be submitted in a separate sealed cover

as COVER - 1 called “Technical Bid” and Financial / Price Bid shall be kept in a

separate sealed cover as COVER - 2 called “Financial Bid”. Both cover - 1 and Cover

- 2 shall be kept in single sealed in another cover on which it shall be Super Scribed

as “Tender for Empanelment of NABL Accredited Drugs Testing Laboratories

for the Analysis of Drugs Sent by NIB” with the Date of opening of Tender this

should be sent on the below mentioned address:

The Director,

National Institute of Biologicals,

A-32, Sector-62,

Near NH-24, Noida – 201 309

d) Last date for submission of tender: 11/02/2015 at 03.00 P.M.

I. The Tender document should reach NIB office within the date and time as

specified as above.

II. If, the last date for submission of Tender is declared holiday, the tenders may be

submitted on the next working day up to 03.00 P.M.

III. The Tenders received after the specified time on the specified date by whatsoever

reason will not be considered.

e) Pre-Bid Meeting:

I. The Bidder(s) or his official representative, are invited to attend a pre-bid meeting

on date, time and venue specified above. The person should carry authorization

letter along with an original photo ID proof.

II. The bidder is requested to submit clarifications/questions by e-mail/courier / fax

so as to reach NIB at least 2 (Two) days before the scheduled pre-bid meeting.

These questions shall be replied during the pre-bid meeting.

III. Corrigendum(s) and Record Notes of pre-bid discussions, if any, shall also be

available on NIB web site.

IV. Non-attendence of the pre-bid meeting will not be a cause for disqualification of a

bidder.


f) Validity of Bids:

I. Bids submitted shall remain valid for 90 (Ninety) days after the date of opening of

Technical Bids prescribed in the Tender Document. A bid valid for a shorter period

may be rejected as non-responsive. However, the prices finalized after opening

the tenders shall not increase throughout the period of implementation and

operation.

II. In exceptional circumstances, the NIB may request the Bidder(s) for an extension

of the period of bid validity. The request and the responses thereto shall be made

in writing (or by fax).

g) Amendment of Tender:

I. At any time prior to the last date for receipt of Bids, the NIB, may, for any reason,

whether at its own initiative or in response to a clarification requested by the

Bidders, modify the Tender by issuing an addendum/corrigendum. Any such

amendment issued along with the original Tender document will constitute

Revised Tender.

II. The addendum/corrigendum will be uploaded on the NIB website. The Bidders are

requested to visit the website frequently to check for any amendments.

III. The NIB may at any time during the Tendering process but before opening the

technical bid request the Bidders to submit revised Technical / Commercial Bids

and/or Supplementary Commercial Bids, in case of change in Scope of Work,

without thereby incurring any liability to the affected Bidder or Bidders

2. GENERAL CONDITIONS OF TENDER:

2.1 Forms in all annexures wherever to be filled should be filled up by type written and every

correction should invariably be attested with full signature by the tenderer.

2.2 The Tenderer should quote the rates for complete analysis as per Pharmacopoeial

requirements i.e. IP/as per label claim (as the case may be) for each product and not for

Individual test.

2.3 The rates quoted should be inclusive of all Taxes& Duties except Service Tax and the

Taxes& Duties as applicable should be clearly mentioned in the Price Bid.

2.4 Rates should be specific and should be furnished both in figures and words. In case of any

discrepancy between figures and words, the rates quoted in words will be considered.

2.5 The Rates quoted and accepted will be binding on the tenderer for the stipulated period

and on no account any revision will be entertained till the completion of contract period.


2.6 The Empanelled Laboratory has to depute one technical person, who is well versed with

the computer applications for one day training at NIB to understand Designated Software

at their own cost. Institute will not pay any TA / DA for the same.

2.7 The tender submitted by a laboratory which has been black listed in last 3 (three) years by

any State /Central Government Organisation shall not be considered or its approval should

not be suspended / cancelled during the last 3 years.

ACCEPTANCE OF TENDER:

2.8 Out of the two covers submitted by each tenderer, Cover – 1 will be opened first, at

National Institute of Biologicals, Noida, UP at 3.30 P.M. on 11/02/2015 in the presence of

Tenderers/Authorized representatives of the tenderers who chooses to be present. After

scrutiny of the documents and the information furnished in Cover–1 and confirmation of

details stated therein, a list of eligible laboratories will be shortlisted subject to satisfactory

audit report.

2.9 All the tenderers /Authorized representatives of the tenderers are entitled to be present

at the time of opening of Technical- Bid Cover- 1, of the tender submitted by them. Only

one person carrying authorization letter from the bidder will be allowed to attend the Bid

opening.

2.10 The short listed tenderer after opening the Cover-1 are subject to Audit by team of officials

to evaluate the documents submitted and laboratory status. If the Audit team found any

deficiency or false informations, the tenderer will not be considered.

2.11 Thereafter, Cover–2 of tenderer, found eligible on the basis of the examination of Cover–

1 and subsequent satisfactory Audit report, will be opened in the presence of

representative of the responsive bidders. The acceptable rates for analysis will be

decided on the basis of L-1 rates and will be communicated. The Empanelled Laboratory

may be audited by the team of officials authorized by Director, NIB, if necessary.

2.12 If capacity of successful L-1 bidder is lesser than the number of sample to be tested within

given time period, L-2 and L-3 may be called for negotiation to match the L-1 rates

respectively.

2.13 The Financial / Price Bid will be evaluated on the basis of L-1 Rates quoted for

Respective Products/ Dosage Forms for Complete Analysis as mentioned in

Annexure- VIII.

2.14 The Tender inviting authority reserves the right to accept or reject any tender for any one

or more of the items tendered for, without assigning any reason.

2.15 The Director, National Institute of Biologicals, Noida, UP will reject the tenders of

blacklisted Laboratories and reserve the right to reject those whose past performance

with any Govt. Organization for the purpose was not satisfactory.


AGREEMENT:

2.16 All tenderers, who have been selected for empanelment will have to execute an

agreement in a non-judicial stamp paper of value Rs.100/- (Rupee One Hundred Only)

(Stamp duty to be paid by the tenderer), with the Director, National Institute of Biologicals,

Noida, UP within 15 (Fifteen) days from the date of receipt of the Letter of Award. The

form of agreement is enclosed in the tender document (Annexure XI).

SECURITY DEPOSIT:

2.17 The successful tenderers shall be required to pay a security deposit of Rs. 50,000/-

(Rupee Fifty Thousand only) or 10% (Ten percent) of the awarded value whichever is

higher at the time of execution of the agreement reference in clause (2.14) above by way

of Demand Draft in favour of ‘National Institute of Biologicals’, payable at Noida/Delhi

or In form of Performance Bank Guarantee which should be valid for 60 (Sixty) days

beyond the entire contract period (Including Extended Period, if any) as per the format

attached with the Tender Document (Annexure-X).

PAYMENT TERMS:

2.18 No advance payment towards any analysis will be made to the empaneled tenderer.

2.19 The Pre-Receipt bills in duplicate should be submitted along with the copy of test reports

on monthly basis.

2.20 No payment will be made for the incomplete analysis or incomplete report.

2.21 Payments will be made within 45 (forty five) days from the date of receipt of bill in NIB

towards the Analysis of Drugs as per the agreed rates after deduction of TDS/ Taxes as

applicable.

PENALTIES:

2.22 If the successful tenderer fails to execute the agreement or payment of Security Deposit

within the time specified or withdraws the tender after intimation of the acceptance of the

tender has been sent or owing to any other reasons, the tenderer is unable to undertake

the contract, the empanelment will be cancelled and the EMD submitted by the tenderer

shall stand forfeited by the Director, National Institute of Biologicals, Noida, UP. Such

tenderer(s) will also be liable for all damages sustained by the Director, National Institute

of Biologicals, Noida, UP by reasons of breach of tender conditions. Such damages shall

be assessed by the Competent Authority whose decision shall be final.

2.23 Non performance of any tender or empanelment conditions will disqualify a laboratory to

participate in the tender for the next 2 (two) Years.

2.24 To assess the Accuracy and Precision of the test results being given by the Empanelled

Laboratories, at random, samples would also be sent simultaneously to the Government


Analyst for testing and if any, variation is found in the analytical reports furnished by the

empaneled laboratories (either pass or fail) with the result of Government Laboratory, the

empaneled laboratory will be blacklisted for a period of 2 (Two) years besides forfeiture

of the security deposit after following the due process.

2.25 If, it is revealed that the analytical Laboratory is involved in any form of fraud and collusion

with the manufacturer of the sample (drugs) under testing, the Analytical Laboratory will

be black listed for a period of 5 (Five) years. The tenderers shall also be liable for action

under criminal law and the matter will be notified to the concerned State Drug Control

Authorities for penal action.

2.26 The Tender inviting authority will be at liberty to terminate the empanelment without

assigning any reasons. The tenderer will not be entitled for any compensation whatsoever

in respect of such termination.

2.27 In all matters pertaining to the tender, the decision of the Tender Inviting Authority shall

be final and binding.

2.28 In the event of any dispute arising out of the tender such dispute would be subject to the

jurisdiction of the civil courts within the city of Noida/Delhi.

2.29 In case of a dispute or difference arising between the Tender Inviting Authority and an

empaneled Analytical laboratory relating to any matter arising out of or connected with

this tender agreement, such dispute or difference shall be settled in accordance with the

Arbitration and Conciliation Act, 1996. The Jurisdiction of arbitration shall be in

Noida/Delhi.

3. COMPLETE ANALYSIS & REPORTING CONDITIONS:

3.1 On empanelment and entrustment of the work, the Analytical Laboratory should Furnish

the test reports on the format at Annexure-IX within:

3.1.1 60 (sixty) days of receipt of the samples.

3.1.2 Within 24 hrs. of the receipt of the samples, the information of receipt in appropriate

format should be acknowledged via Designated Software

3.2 All the tests mentioned in IP/as per label claim (as the case may be) should be carried

out for each and every sample.The results obtained in the test should be mentioned in

figure (wherever possible).

3.3 If Dissolution profile / Manufacturers specification for extended / Prolonged / Sustained

release for any dosage form is required, the same should be demanded with in 10 days

from the receipt of sample with returned request by email from NIB.

3.4 If Placebo for related substance test is reuired for any dosage form, the same should be

demanded with in 10 days from the receipt of sample with returned request by email from

NIB.


3.5 “COMPLIES” or “PASSES” in the result column of the report is treated as incomplete

report, if the result has some specific Value/Limits.

3.6 Every test report must have specific remarks i.e. Standard Quality or Not of Standard

Quality. In case of Standard Quality, test report should be printed on white paper and Not

of Standard Quality on Pink Colour paper.

3.7 Reports should be in A4 size (8.27” X 11.69”) paper of good quality.

3.8 The Reports should be on format given in Annexure-IX.

3.9 Records like Raw data of calculations, chromatographs, spectra etc should be preserved

by the laboratory for the period of one year from the date of issue of test report for audit,

if required.

3.10 Certificate of analysis (Test Reports) should be uploaded to the designated software of

NIB on weekly basis.

3.11 Hard copy of Certificate of analysis (Test Reports) along with copy of raw data/

chromatographs, spectra etc. should be submitted to the Director, National Institute of

Biologicals, Noida, UP by post every fortnightly.

3.12 The Director, National Institute of Biologicals, Noida, UP or his authorised

representative(s) have the right to audit before and after empanelment of the Laboratory,

at any point of time during the continuance of the tender and terminate / cancel its

empanelment or any orders issued to the laboratory or not to entrust any further testing

work to the laboratory based on facts brought out during such audits.

3.13 The Laboratory shall co-operate to the Audit Team to enable them to inspect Sample and

& Standard storage, Reagents, Instruments, all other related records/ Raw data of

analysis etc., in the laboratory.


ANNEXURE- I

PROFORMA FOR PERFORMANCE STATEMENT

Name of the Laboratory : ____________________________________ Address : ____________________________________

____________________________________

Sl.No. Types of Samples No. of Samples Tested

Remarks F.Y. 2011-12 F.Y. 2012-13 F.Y. 2013-14

1 Tablets / Capsules / Pessaries

2 Injectables

3 Liquid Orals

4 Ointment / Creams / Gels

5 Others (Drugs)

Signature : Date : Name of the Lab : Office Seal :


ANNEXURE – II

COPY OF SERVICE TAX REGISTRATION AND PAN CARD SHOULD BE ENCLOSED


ANNEXURE – III (a)

TECHNICAL PERSONNEL IN LABORATORY

S.No. Name of the Staff Designation Qualification Experience (in years)

(revelant to analysis of drugs



ANNEXURE – III (b)

LIST OF SOPHISTICATED EQUIPMENT / APPARATUS AVAILABLE IN THE LABORATORY

S.No. Name of the Equipment

Instruments / Apparatus

Number of

Instruments

Make & Model

No.

Date of

installation

Date of Last

calibration

Working Condition



ANNEXURE – III(c)

FACILITIES IN THE MICROBIOLOGICAL SECTION

1. List of Equipment / Apparatus available with Date of Installation (e. g. Incubators/Bio Safety/Laminar Flow Bench/HVAC system etc.)

2. Qualification status of HVAC system and Clean room.

Signature : Name of the Lab : Date : Office Seal :


ANNEXURE – III(d)

LIST OF REFERENCE STANDARDS AVAILABLE IN THE LABORATORY

S.No. Name of Reference Standard for Assay, Related Substances and Impurities

Source of Procurement

Date of Procurement

Date of Expiry/Validity



ANNEXURE – III(e)

LIST OF WORKING STANDARDS AVAILABLE IN THE LABORATORY

S.No. Name of Working Standard for Assay, Related Substances and Impurities

Date of Prepration




ANNEXURE – III (f)

LIST OF REFERENCE CULTURES AVAILABLE IN THE LABORATORY

S.No. Name of Reference Cultures Source of Procurement

Date of Procurement




ANNEXURE- IV

DECLARATION FORM

I / We _________________________________________________ (Name of the

tenderer) having our office at ______________________________________________ Lab

at____________________________________________do declare that I/We have carefully

read all the Terms & Conditions of Tender Document of National Institute of Biologicals, Noida,

UP for the tender floated, for empanelment of NABL Accredited analytical testing laboratories

for the analysis of drugs for the period of one year from the date of acceptance and abide by all

conditions set forth therein.

I / We further declare that I / We possess valid Approval in Form-37 of Drugs & Cosmetics Rules bearing No._______________________ valid upto____________________.



ANNEXURE – V

DETAILS OF LABORATORY

Name of the Laboratory & Full Address : Phone No : Fax : E-mail : Date of Inception : Approval No. & Date : Issued by : Valid up to : Details of manufacturing activity under : the same Management, if any (Enclose an affidavit of no commercial Interest as per Annexure - XII) Name of the Person In-charge : Specimen Signature of the Person In-charge :


ANNEXURE -VI.

LIST OF DRUGS FOR ANALYSIS

S.NO. Code No. Products / Dosage Forms Protocol to be used for Analysis

1 M076A Diclofenac Injection Indian Pharmacopoeia (IP)

2 M076B Diclofenac Gastro-resistant Tablets Indian Pharmacopoeia (IP)

3 M076C Diclofenac Prolonged-release Tablets Indian Pharmacopoeia (IP)

4 M123A Ibuprofen Cream Indian Pharmacopoeia (IP)

5 M123B Ibuprofen Gel Indian Pharmacopoeia (IP)

6 M123C Ibuprofen Tablets Indian Pharmacopoeia (IP)

7 M178A Paracetamol Infusion Indian Pharmacopoeia (IP)

8 M178B Paracetamol Oral Suspension Indian Pharmacopoeia (IP)

9 M178C Paracetamol Paediatric Oral Suspension Indian Pharmacopoeia (IP)

10 M178D Paracetamol Syrup Indian Pharmacopoeia (IP)

11 M178E Paracetamol Tablets Indian Pharmacopoeia (IP)

12 M216 Tramadol Capsules Indian Pharmacopoeia (IP)

13 M010 Allopurinol Tablets Indian Pharmacopoeia (IP)

14 M058 Colchicine Tablets Indian Pharmacopoeia (IP)

15 M027 Azathioprine Tablets Indian Pharmacopoeia (IP)

16 M155A Methotrexate Injection, Indian Pharmacopoeia (IP)

17 M155B Methotrexate Tablets Indian Pharmacopoeia (IP)

18 M008 Adrenaline Injection Indian Pharmacopoeia (IP)

19 M226 Procaine and Adrenaline Injection Indian Pharmacopoeia (IP)

20 M227 Lignocaine and Adrenaline Injection Indian Pharmacopoeia (IP)

21 M045A Chlorpheniramine Injection Indian Pharmacopoeia (IP)

22 M045B Chlorpheniramine Tablets Indian Pharmacopoeia (IP)

23 M068 Dexchlorpheniramine Oral Solution Indian Pharmacopoeia (IP)

24 M067 Dexamethasone Tablets Indian Pharmacopoeia (IP)

25 M120 Hydrocortisone Sodium Succinate Injection Indian Pharmacopoeia (IP)

26 M180A Pheniramine Injection Indian Pharmacopoeia (IP)

27 M180B Pheniramine Tablets Indian Pharmacopoeia (IP)

28 M186 Prednisolone Tablets Indian Pharmacopoeia (IP)

29 M190A Promethazine Injection Indian Pharmacopoeia (IP)

30 M190B Promethazine Syrup Indian Pharmacopoeia (IP)

31 M190C Promethazine Tablets Indian Pharmacopoeia (IP)

32 M190D Promethazine Theoclate Tablets Indian Pharmacopoeia (IP)



33 M042A Cetirizine Syrup Indian Pharmacopoeia (IP)

34 M042B Cetirizine Tablets Indian Pharmacopoeia (IP)

35 M009A Albendazole Oral Suspension Indian Pharmacopoeia (IP)

36 M009B Albendazole Tablets Indian Pharmacopoeia (IP)

37 M183A Piperazine Adipate Tablets Indian Pharmacopoeia (IP)

38 M183B Piperazine Citrate Syrup Indian Pharmacopoeia (IP)

39 M183C Piperazine Phosphate Tablets Indian Pharmacopoeia (IP)

40 M079A Diethylcarbamazine Injection Indian Pharmacopoeia (IP)

41 M079B Diethylcarbamazine Tablets Indian Pharmacopoeia (IP)

42 M185 Praziquantel Tablets Indian Pharmacopoeia (IP)

43 M018A Amoxycillin Injection Indian Pharmacopoeia (IP)

44 M018B Amoxycillin Capsules Indian Pharmacopoeia (IP)

45 M018C Amoxycillin Dispersible Tablets Indian Pharmacopoeia (IP)

46 M018D Amoxycillin Oral Suspension Indian Pharmacopoeia (IP)

47 M020A Ampicillin Capsules Indian Pharmacopoeia (IP)

48 M020B Ampicillin Oral Suspension Indian Pharmacopoeia (IP)

49 M020C Ampicillin Dispersible Tablet Indian Pharmacopoeia (IP)

50 M020D Ampicillin Injection Indian Pharmacopoeia (IP)

51 M038A Cefotaxime Sodium Injection Indian Pharmacopoeia (IP)

52 M038B Ceftazidime for Injection Indian Pharmacopoeia (IP)

53 M038C Ceftazidime Injection Indian Pharmacopoeia (IP)

54 M040 Ceftriaxone Injection Indian Pharmacopoeia (IP)

55 M041A Cephalexin Capsules Indian Pharmacopoeia (IP)

56 M041B Cephalexin Oral Suspension Indian Pharmacopoeia (IP)

57 M041C Cephalexin Tablets Indian Pharmacopoeia (IP)

58 M056A Cloxacillin Capsules Indian Pharmacopoeia (IP)

59 M056B Cloxacillin Injection Indian Pharmacopoeia (IP)

60 M056C Cloxacillin Syrup Indian Pharmacopoeia (IP)

61 M037A Cefixime Oral Suspension Indian Pharmacopoeia (IP)

62 M037B Cefixime Tablets Indian Pharmacopoeia (IP)

63 M013 Amikacin Injection Indian Pharmacopoeia (IP)

64 M028A Azithromycin Capsules Indian Pharmacopoeia (IP)

65 M028B Azithromycin Oral Suspension Indian Pharmacopoeia (IP)

66 M028C Azithromycin Tablets Indian Pharmacopoeia (IP)

67 M048A Ciprofloxacin Eye Drops Indian Pharmacopoeia (IP)

68 M048B Ciprofloxacin Tablets Indian Pharmacopoeia (IP)



69 M214A Trimethoprim and Sulphamethoxazole Oral

Suspension Indian Pharmacopoeia (IP)

70 M214B Trimethoprim and Sulphamethoxazole Tablets Indian Pharmacopoeia (IP)

71 M086 Doxycycline Capsules Indian Pharmacopoeia (IP)

72 M092 Erythromycin Gastro-resistant Tablets Indian Pharmacopoeia (IP)

73 M109A Gentamicin Eye Drops Indian Pharmacopoeia (IP)

74 M109B Gentamicin Injection Indian Pharmacopoeia (IP)

75 M161A Metronidazole Benzoate Oral Suspension Indian Pharmacopoeia (IP)

76 M161B Metronidazole Injection Indian Pharmacopoeia (IP)

77 M161C Metronidazole Sterile Suspension Indian Pharmacopoeia (IP)

78 M161D Metronidazole Tablets Indian Pharmacopoeia (IP)

79 M168 Nitrofurantoin Tablets Indian Pharmacopoeia (IP)

80 M213 Sulphadiazine Tablets Indian Pharmacopoeia (IP)

81 M052 Clofazimine Capsules Indian Pharmacopoeia (IP)

82 M065 Dapsone Tablets Indian Pharmacopoeia (IP)

83 M198A Rifampicin Capsules Indian Pharmacopoeia (IP)

84 M198B Rifampicin Oral Suspension Indian Pharmacopoeia (IP)

85 M198C Rifampicin Tablets Indian Pharmacopoeia (IP)

86 M093A Ethambutol Injection Indian Pharmacopoeia (IP)

87 M093B Ethambutol Tablets Indian Pharmacopoeia (IP)

88 M130 Isoniazid Tablets Indian Pharmacopoeia (IP)

89 M171A Ofloxacin Infusion Indian Pharmacopoeia (IP)

90 M171B Ofloxacin Opthalmic Solution Indian Pharmacopoeia (IP)

91 M171C Ofloxacin Oral Suspension Indian Pharmacopoeia (IP)

92 M171D Ofloxacin Tablets Indian Pharmacopoeia (IP)

93 M191 Pyrazinamide Tablets Indian Pharmacopoeia (IP)

94 M210A Streptomycin Injection Indian Pharmacopoeia (IP)

95 M210B Streptomycin Tablets Indian Pharmacopoeia (IP)

96 M055A Clotrimazole Cream Indian Pharmacopoeia (IP)

97 M055B Clotrimazole Pessaries Indian Pharmacopoeia (IP)

98 M103A Fluconazole Capsules Indian Pharmacopoeia (IP)

99 M103B Fluconazole Tablets Indian Pharmacopoeia (IP)

100 M112 Griseofulvin Tablets Indian Pharmacopoeia (IP)

101 M170A Nystatin Ointment Indian Pharmacopoeia (IP)

102 M170B Nystatin Pessaries Indian Pharmacopoeia (IP)

103 M170C Nystatin Tablets Indian Pharmacopoeia (IP)



104 M007A Aciclovir Cream Indian Pharmacopoeia (IP)

105 M007B Aciclovir Dispersible Tablets Indian Pharmacopoeia (IP)

106 M007C Aciclovir Eye Ointment Indian Pharmacopoeia (IP)

107 M007D Aciclovir Intravenous Infusion Indian Pharmacopoeia (IP)

108 M007E Aciclovir Oral Suspension Indian Pharmacopoeia (IP)

109 M007F Aciclovir Tablets Indian Pharmacopoeia (IP)

110 M078A Didanosine Gastro-resistant Capsules Indian Pharmacopoeia (IP)

111 M078B Didanosine Tablets Indian Pharmacopoeia (IP)

112 M135A Lamivudine Oral Solution Indian Pharmacopoeia (IP)

113 M135B Lamivudine Tablets Indian Pharmacopoeia (IP)

114 M209A Stavudine Capsules Indian Pharmacopoeia (IP)

115 M209B Stavudine Oral Solution Indian Pharmacopoeia (IP)

116 M224A Zidovudine Capsules Indian Pharmacopoeia (IP)

117 M224B Zidovudine Injection Indian Pharmacopoeia (IP)

118 M224C Zidovudine Oral Solution Indian Pharmacopoeia (IP)

119 M224D Zidovudine Tablets Indian Pharmacopoeia (IP)

120 M087A Efavirenz Capsules Indian Pharmacopoeia (IP)

121 M087B Efavirenz Tablets Indian Pharmacopoeia (IP)

122 M166A Nevirapine Oral Suspension Indian Pharmacopoeia (IP)

123 M166B Nevirapine Tablets Indian Pharmacopoeia (IP)

124 M126 Indinavir Capsules Indian Pharmacopoeia (IP)

125 M164A Nelfinavir Mesylate Oral Powder Indian Pharmacopoeia (IP)

126 M164B Nelfinavir Tablets Indian Pharmacopoeia (IP)

127 M200A Ritonavir Capsules Indian Pharmacopoeia (IP)

128 M200B Ritonavir Tablets Indian Pharmacopoeia (IP)

129 M203A Saquinavir Capsules Indian Pharmacopoeia (IP)

130 M203B Saquinavir Mesylate Tablets Indian Pharmacopoeia (IP)

131 M081 Diloxanide Tablets Indian Pharmacopoeia (IP)

132 M179 Pentamidine Injection Indian Pharmacopoeia (IP)

133 M044A Chloroquine Phosphate Injection Indian Pharmacopoeia (IP)

134 M044B Chloroquine Phosphate Suspension Indian Pharmacopoeia (IP)

135 M044C Chloroquine Phosphate Tablets Indian Pharmacopoeia (IP)

136 M188 Primaquine Tablets Indian Pharmacopoeia (IP)

137 M193 Pyrimethamine Tablets Indian Pharmacopoeia (IP)

138 M195 Quinine Tablets Indian Pharmacopoeia (IP)

139 M051A Clindamycin Capsules Indian Pharmacopoeia (IP)



140 M051B Clindamycin Injection Indian Pharmacopoeia (IP)

141 M150 Mefloquine Tablets Indian Pharmacopoeia (IP)

142 M032 Busulphan Tablets Indian Pharmacopoeia (IP)

143 M049 Cisplatin Injection Indian Pharmacopoeia (IP)

144 M063A Cyclophosphamide Injection Indian Pharmacopoeia (IP)

145 M063B Cyclophosphamide Tablets Indian Pharmacopoeia (IP)

146 M064 Danazol Capsules Indian Pharmacopoeia (IP)

147 M101A Etoposide Capsules Indian Pharmacopoeia (IP)

148 M101B Etoposide Injection Indian Pharmacopoeia (IP)

149 M105A Flutamide Capsules Indian Pharmacopoeia (IP)

150 M105B Flutamide Tablets Indian Pharmacopoeia (IP)

151 M003 Fluorouracil Injection Indian Pharmacopoeia (IP)

152 M151 Melphalan Tablets Indian Pharmacopoeia (IP)

153 M152 Mercaptopurine Tablets Indian Pharmacopoeia (IP)

154 M221 Vinblastine Sulphate Indian Pharmacopoeia (IP)

155 M222 Vincristine Injection Indian Pharmacopoeia (IP)

156 M066 Daunorubicin Injection Indian Pharmacopoeia (IP)

157 M124 Imatinib Tablets Indian Pharmacopoeia (IP)

158 M043 Chlorambucil Tablets Indian Pharmacopoeia (IP)

159 M196 Raloxifene Hydrochloride Tablets Indian Pharmacopoeia (IP)

160 M215 Tamoxifen Tablets Indian Pharmacopoeia (IP)

161 M174A Ondansetron Injection Indian Pharmacopoeia (IP)

162 M174B Ondansetron Orally Disintegrating Tablets Indian Pharmacopoeia (IP)

163 M174C Ondansetron Oral Solution Indian Pharmacopoeia (IP)

164 M174D Ondansetron Tablets Indian Pharmacopoeia (IP)

165 M034A Carbamazepine Prolonged-release Tablets Indian Pharmacopoeia (IP)

166 M034B Carbamazepine Tablets Indian Pharmacopoeia (IP)

167 M075A Diazepam Capsules Indian Pharmacopoeia (IP)

168 M075B Diazepam Injection Indian Pharmacopoeia (IP)

169 M075C Diazepam Tablets Indian Pharmacopoeia (IP)

170 M147 Magnesium Sulphate Injection Indian Pharmacopoeia (IP)

171 M181A Phenobarbitone Tablets Indian Pharmacopoeia (IP)

172 M181B Phenobarbitone Injection Indian Pharmacopoeia (IP)

173 M181C Phenobarbitone Sodium Tablets Indian Pharmacopoeia (IP)

174 M182A Phenytoin Injection Indian Pharmacopoeia (IP)

175 M182B Phenytoin Capsules Indian Pharmacopoeia (IP)



176 M182C Phenytoin Tablets Indian Pharmacopoeia (IP)

177 M207A Sodium Valproate Injection Indian Pharmacopoeia (IP)

178 M207B Sodium Valproate Oral Solution Indian Pharmacopoeia (IP)

179 M207C Sodium Valproate Gastro-resistant Tablets Indian Pharmacopoeia (IP)

180 M207D Sodium Valproate Tablets Indian Pharmacopoeia (IP)

181 M145A Lorazepam Injection Indian Pharmacopoeia (IP)

182 M145B Lorazepam Tablets Indian Pharmacopoeia (IP)

183 M082A Diltiazem Injection Indian Pharmacopoeia (IP)

184 M082B Diltiazem Tablets Indian Pharmacopoeia (IP)

185 M111 Glyceryl Trinitrate Tablets Indian Pharmacopoeia (IP)

186 M134A Isosorbide Mononitrate Tablets Indian Pharmacopoeia (IP)

187 M134B Isosorbide Dinitrate Tablets Indian Pharmacopoeia (IP)

188 M160A Metoprolol Injection Indian Pharmacopoeia (IP)

189 M160B Metoprolol Tablets Indian Pharmacopoeia (IP)

190 M054 Clopidogrel Tablets Indian Pharmacopoeia (IP)

191 M014A Amiodarone Intravenous Infusion Indian Pharmacopoeia (IP)

192 M014B Amiodarone Tablets Indian Pharmacopoeia (IP)

193 M142A Lignocaine Gel Indian Pharmacopoeia (IP)

194 M142B Lignocaine Injection Indian Pharmacopoeia (IP)

195 M142C Lignocaine Injection Indian Pharmacopoeia (IP)

196 M189A Procainamide Injection Indian Pharmacopoeia (IP)

197 M189B Procainamide Tablets Indian Pharmacopoeia (IP)

198 M220A Verapamil Injection Indian Pharmacopoeia (IP)

199 M220B Verapamil Tablets Indian Pharmacopoeia (IP)

200 M016A Amlodipine Tablets Indian Pharmacopoeia (IP)

201 M016B S-Amlodipine Tablets Indian Pharmacopoeia (IP)

202 M023 Atenolol Tablets Indian Pharmacopoeia (IP)

203 M091 Enalapril Maleate Tablets Indian Pharmacopoeia (IP)

204 M146 Losartan Tablets Indian Pharmacopoeia (IP)

205 M157 Methyldopa Tablets Indian Pharmacopoeia (IP)

206 M167A Nifedipine Capsules Indian Pharmacopoeia (IP)

207 M167B Nifedipine Prolonged-release Tablets Indian Pharmacopoeia (IP)

208 M167C Nifedipine Tablets Indian Pharmacopoeia (IP)

209 M206 Sodium Nitroprusside Injection Indian Pharmacopoeia (IP)

210 M118 Hydrochlorothiazide Tablets Indian Pharmacopoeia (IP)

211 M080A Digoxin Injection Indian Pharmacopoeia (IP)



212 M080B Digoxin Paediatric Solution Indian Pharmacopoeia (IP)

213 M080C Digoxin Tablets Indian Pharmacopoeia (IP)

214 M083 Dobutamine Injection Indian Pharmacopoeia (IP)

215 M085 Dopamine Injection Indian Pharmacopoeia (IP)

216 M024 Atorvastatin Tablets Indian Pharmacopoeia (IP)

217 M108A Frusemide Injection Indian Pharmacopoeia (IP)

218 M108B Frusemide Tablets Indian Pharmacopoeia (IP)

219 M148 Mannitol injection Indian Pharmacopoeia (IP)

220 M208 Spironolactone Tablets Indian Pharmacopoeia (IP)

221 M173 Omeprazole Gastro-resistant Capsules Indian Pharmacopoeia (IP)

222 M197A Ranitidine Injection Indian Pharmacopoeia (IP)

223 M197B Ranitidine Tablets Indian Pharmacopoeia (IP)

224 M177 Pantoprazole Gastro-resistant Tablets Indian Pharmacopoeia (IP)

225 M102 Famotidine Tablets Indian Pharmacopoeia (IP)

226 M084A Domperidone Suspension Indian Pharmacopoeia (IP)

227 M084B Domperidone Tablets Indian Pharmacopoeia (IP)

228 M159A Metoclopramide Injection Indian Pharmacopoeia (IP)

229 M159B Metoclopramide Syrup Indian Pharmacopoeia (IP)

230 M159C Metoclopramide Tablets Indian Pharmacopoeia (IP)

231 M077A Dicyclomine Injection Indian Pharmacopoeia (IP)

232 M077B Dicyclomine Oral Solution Indian Pharmacopoeia (IP)

233 M077C Dicyclomine Tablets Indian Pharmacopoeia (IP)

234 M122A Hyoscine Butylbromide Injection Indian Pharmacopoeia (IP)

235 M122B Hyoscine Butylbromide Tablets Indian Pharmacopoeia (IP)

236 M031A Bisacodyl Gastro-resistant Tablets Indian Pharmacopoeia (IP)

237 M031B Bisacodyl Suppositories Indian Pharmacopoeia (IP)

238 M225A Zinc Sulphate Eye Drops Indian Pharmacopoeia (IP)

239 M225B Zinc Sulphate Oral Solution Indian Pharmacopoeia (IP)

240 M225C Zinc Sulphate Dispersible Tablets Indian Pharmacopoeia (IP)

241 M156A Methylprednisolone Tablets Indian Pharmacopoeia (IP)

242 M156B Methylprednisolone Acetate Injection Indian Pharmacopoeia (IP)

243 M217 Testosterone Propionate Injection Indian Pharmacopoeia (IP)

244 M110 Glibenclamide Tablets Indian Pharmacopoeia (IP)

245 M127A Insulin Aspart Injection Indian Pharmacopoeia (IP)

246 M127B Insulin Lispro Injection Indian Pharmacopoeia (IP)

247 M127C Biphasic Insulin Aspart Injection Indian Pharmacopoeia (IP)



248 M127D Biphasic Insulin Lispro Injection Indian Pharmacopoeia (IP)

249 M127E Biphasic Isophane Insulin Injection Indian Pharmacopoeia (IP)

250 M127F Isophane Insulin Injection Indian Pharmacopoeia (IP)

251 M154A Metformin Tablets Indian Pharmacopoeia (IP)

252 M154B Metformin Hydrochloride Prolonged-release

Tablets Indian Pharmacopoeia (IP)

253 M154C Metformin Oral Solution Indian Pharmacopoeia (IP)

254 M169 Norethisterone Tablets Indian Pharmacopoeia (IP)

255 M036 Carbimazole Tablets Indian Pharmacopoeia (IP)

256 M129 Povidone-Iodine Solution Indian Pharmacopoeia (IP)

257 M025 Atracurium Besylate Injection Indian Pharmacopoeia (IP)

258 M165A Neostigmine Tablets Indian Pharmacopoeia (IP)

259 M165B Neostigmine Injection Indian Pharmacopoeia (IP)

260 M192A Pyridostigmine Injection Indian Pharmacopoeia (IP)

261 M192B Pyridostigmine Tablets Indian Pharmacopoeia (IP)

262 M211 Succinylcholine Injection Indian Pharmacopoeia (IP)

263 M219 Vecuronium Bromide Injection Indian Pharmacopoeia (IP)

264 M046A Chlorpromazine Injection Indian Pharmacopoeia (IP)

265 M046B Chlorpromazine Tablets Indian Pharmacopoeia (IP)

266 M113A Haloperidol Injection Indian Pharmacopoeia (IP)

267 M113B Haloperidol Oral Solution Indian Pharmacopoeia (IP)

268 M113C Haloperidol Tablets Indian Pharmacopoeia (IP)

269 M172 Olanzapine Tablets Indian Pharmacopoeia (IP)

270 M015 Amitriptyline Tablets Indian Pharmacopoeia (IP)

271 M104A Fluoxetine Capsules Indian Pharmacopoeia (IP)

272 M104B Fluoxetine Oral Solution Indian Pharmacopoeia (IP)

273 M104C Fluoxetine Tablets Indian Pharmacopoeia (IP)

274 M125 Imipramine Tablets Indian Pharmacopoeia (IP)

275 M143A Lithium Carbonate Prolonged-release Tablets Indian Pharmacopoeia (IP)

276 M143B Lithium Carbonate Tablets Indian Pharmacopoeia (IP)

277 M011A Alprazolam Prolonged-release Tablets Indian Pharmacopoeia (IP)

278 M011B Alprazolam Tablets Indian Pharmacopoeia (IP)

279 M029 Beclomethasone Inhalation Indian Pharmacopoeia (IP)

280 M201A Salbutamol Syrup Indian Pharmacopoeia (IP)

281 M201B Salbutamol Tablets Indian Pharmacopoeia (IP)

282 M057A Codeine Syrup Indian Pharmacopoeia (IP)



283 M057B Codeine Tablets Indian Pharmacopoeia (IP)

284 M069 Dextromethorphan Hydrobromide Syrup Indian Pharmacopoeia (IP)

285 M176A Oxytocin Injection Indian Pharmacopoeia (IP)

286 M176B Oxytocin Nasal Solution Indian Pharmacopoeia (IP)

287 M184 Potassium Chloride for injection Indian Pharmacopoeia (IP)

288 M204 Sodium Bicarbonate Injection Indian Pharmacopoeia (IP)

289 M022A Aspirin Gastro-resistant Tablets Indian Pharmacopoeia (IP)

290 M022B Aspirin Tablets Indian Pharmacopoeia (IP)

291 M022C Soluble Aspirin Tablets Indian Pharmacopoeia (IP)


ANNEXURE – VII

CHECKLIST OF DOCUMENTS REQUIRED

FOR TECHNICAL SCRUTINY

The list of documents required to be enclosed with Technical Bid and Financial Bid: -

SL.NO. PARTICULARS PAGE NO. YES NO

Technical Bid : Cover - 1

1. Tender Fees and EMD in form of DD shall be kept in an Envelop.

2. Self attested copy of Analytical approval for Analytical Laboratory renewed upto date issued by State Drug Conroller.

3. Annexure-I – Documentary evidence of having analyzed Drugs for the last 3 (Three) years.

4. Annexure-II – Self attested copy of Service Tax Registration and PAN Card

5. Annexure- III (a) – List of Qualified personal employed in the laboratory

6. Annexure-III (b) – List of Sophisticated instruments.

7. Annexure-III € - Micro biological Facilities

8. Annexure-III (d) - List of Reference Standards

9. Annexure-III (e) - List of Working Standards

10. Annexure-III (f) - List of Reference Cultures

11. Annexure-IV - Declaration form duly signed & Stamped

12. Annexure-V - Details of Laboratory.

13. Self attested NABL Certificate

14. Any other Certificate

15. Documentary evidence, for the constitution of the company / laboratory i.e., Memorandum and articles of Association or partnership etc.,

16. Self attested Non Conviction Certificate for the last three years.

17. Annual Turn over for the last 3 (Three) years Certified by the Chartered Accountant.

18. Balance Sheet and Profit & Loss Account for the last 3 (Three) years.


19. Documentary evidence, if any for having testing of products for exports.

20. The tender document signed by the tenderer in all pages with official seal

21. Annexure-XII – Declaration Form for having No Commercial Interest.

Financial Bid : Cover - 2

22. Annexure-VIII – Financial Bid


Annexure VIII

FINANCIAL / PRICE BID

Sub: - Financial Bid for Empanelment of NABL Accredited Drugs Testing

Laboratories for the Analysis of Drugs Sent by NIB, Noida Dear Sir,

I/We have carefully read your Tender No- NIB/DS/2014-15/03 Dated 19th January 2015 on the above subject and agree to the terms and conditions stated therein and hereby quote my/our rates as under:-

S.NO. Code No. Dosage Forms Rates in INR

In Figures In Words

1 M076A Diclofenac Injection

2 M076B Diclofenac Gastro-resistant Tablets

3 M076C Diclofenac Prolonged-release

Tablets

4 M123A Ibuprofen Cream

5 M123B Ibuprofen Gel

6 M123C Ibuprofen Tablets

7 M178A Paracetamol Infusion

8 M178B Paracetamol Oral Suspension

9 M178C Paracetamol Paediatric Oral

Suspension

10 M178D Paracetamol Syrup

11 M178E Paracetamol Tablets

12 M216 Tramadol Capsules

13 M010 Allopurinol Tablets

14 M058 Colchicine Tablets

15 M027 Azathioprine Tablets

16 M155A Methotrexate Injection,

17 M155B Methotrexate Tablets

18 M008 Adrenaline Injection



In Figures In Words

19 M226 Procaine and Adrenaline Injection

20 M227 Lignocaine and Adrenaline Injection

21 M045A Chlorpheniramine Injection

22 M045B Chlorpheniramine Tablets

23 M068 Dexchlorpheniramine Oral Solution

24 M067 Dexamethasone Tablets

25 M120 Hydrocortisone Sodium Succinate

Injection

26 M180A Pheniramine Injection

27 M180B Pheniramine Tablets

28 M186 Prednisolone Tablets

29 M190A Promethazine Injection

30 M190B Promethazine Syrup

31 M190C Promethazine Tablets

32 M190D Promethazine Theoclate Tablets

33 M042A Cetirizine Syrup

34 M042B Cetirizine Tablets

35 M009A Albendazole Oral Suspension

36 M009B Albendazole Tablets

37 M183A Piperazine Adipate Tablets

38 M183B Piperazine Citrate Syrup

39 M183C Piperazine Phosphate Tablets

40 M079A Diethylcarbamazine Injection

41 M079B Diethylcarbamazine Tablets

42 M185 Praziquantel Tablets

43 M018A Amoxycillin Injection



In Figures In Words

44 M018B Amoxycillin Capsules

45 M018C Amoxycillin Dispersible Tablets

46 M018D Amoxycillin Oral Suspension

47 M020A Ampicillin Capsules

48 M020B Ampicillin Oral Suspension

49 M020C Ampicillin Dispersible Tablet

50 M020D Ampicillin Injection

51 M038A Cefotaxime Sodium Injection

52 M038B Ceftazidime for Injection

53 M038C Ceftazidime Injection

54 M040 Ceftriaxone Injection

55 M041A Cephalexin Capsules

56 M041B Cephalexin Oral Suspension

57 M041C Cephalexin Tablets

58 M056A Cloxacillin Capsules

59 M056B Cloxacillin Injection

60 M056C Cloxacillin Syrup

61 M037A Cefixime Oral Suspension

62 M037B Cefixime Tablets

63 M013 Amikacin Injection

64 M028A Azithromycin Capsules

65 M028B Azithromycin Oral Suspension

66 M028C Azithromycin Tablets

67 M048A Ciprofloxacin Eye Drops

68 M048B Ciprofloxacin Tablets



In Figures In Words

69 M214A Trimethoprim and

Sulphamethoxazole Oral Suspension

70 M214B Trimethoprim and

Sulphamethoxazole Tablets

71 M086 Doxycycline Capsules

72 M092 Erythromycin Gastro-resistant

Tablets

73 M109A Gentamicin Eye Drops

74 M109B Gentamicin Injection

75 M161A Metronidazole Benzoate Oral

Suspension

76 M161B Metronidazole Injection

77 M161C Metronidazole Sterile Suspension

78 M161D Metronidazole Tablets

79 M168 Nitrofurantoin Tablets

80 M213 Sulphadiazine Tablets

81 M052 Clofazimine Capsules

82 M065 Dapsone Tablets

83 M198A Rifampicin Capsules

84 M198B Rifampicin Oral Suspension

85 M198C Rifampicin Tablets

86 M093A Ethambutol Injection

87 M093B Ethambutol Tablets

88 M130 Isoniazid Tablets

89 M171A Ofloxacin Infusion

90 M171B Ofloxacin Opthalmic Solution

91 M171C Ofloxacin Oral Suspension

92 M171D Ofloxacin Tablets

93 M191 Pyrazinamide Tablets



In Figures In Words

94 M210A Streptomycin Injection

95 M210B Streptomycin Tablets

96 M055A Clotrimazole Cream

97 M055B Clotrimazole Pessaries

98 M103A Fluconazole Capsules

99 M103B Fluconazole Tablets

100 M112 Griseofulvin Tablets

101 M170A Nystatin Ointment

102 M170B Nystatin Pessaries

103 M170C Nystatin Tablets

104 M007A Aciclovir Cream

105 M007B Aciclovir Dispersible Tablets

106 M007C Aciclovir Eye Ointment

107 M007D Aciclovir Intravenous Infusion

108 M007E Aciclovir Oral Suspension

109 M007F Aciclovir Tablets

110 M078A Didanosine Gastro-resistant

Capsules

111 M078B Didanosine Tablets

112 M135A Lamivudine Oral Solution

113 M135B Lamivudine Tablets

114 M209A Stavudine Capsules

115 M209B Stavudine Oral Solution

116 M224A Zidovudine Capsules

117 M224B Zidovudine Injection

118 M224C Zidovudine Oral Solution



In Figures In Words

119 M224D Zidovudine Tablets

120 M087A Efavirenz Capsules

121 M087B Efavirenz Tablets

122 M166A Nevirapine Oral Suspension

123 M166B Nevirapine Tablets

124 M126 Indinavir Capsules

125 M164A Nelfinavir Mesylate Oral Powder

126 M164B Nelfinavir Tablets

127 M200A Ritonavir Capsules

128 M200B Ritonavir Tablets

129 M203A Saquinavir Capsules

130 M203B Saquinavir Mesylate Tablets

131 M081 Diloxanide Tablets

132 M179 Pentamidine Injection

133 M044A Chloroquine Phosphate Injection

134 M044B Chloroquine Phosphate Suspension

135 M044C Chloroquine Phosphate Tablets

136 M188 Primaquine Tablets

137 M193 Pyrimethamine Tablets

138 M195 Quinine Tablets

139 M051A Clindamycin Capsules

140 M051B Clindamycin Injection

141 M150 Mefloquine Tablets

142 M032 Busulphan Tablets

143 M049 Cisplatin Injection



In Figures In Words

144 M063A Cyclophosphamide Injection

145 M063B Cyclophosphamide Tablets

146 M064 Danazol Capsules

147 M101A Etoposide Capsules

148 M101B Etoposide Injection

149 M105A Flutamide Capsules

150 M105B Flutamide Tablets

151 M003 Fluorouracil Injection

152 M151 Melphalan Tablets

153 M152 Mercaptopurine Tablets

154 M221 Vinblastine Sulphate

155 M222 Vincristine Injection

156 M066 Daunorubicin Injection

157 M124 Imatinib Tablets

158 M043 Chlorambucil Tablets

159 M196 Raloxifene Hydrochloride Tablets

160 M215 Tamoxifen Tablets

161 M174A Ondansetron Injection

162 M174B Ondansetron Orally Disintegrating

Tablets

163 M174C Ondansetron Oral Solution

164 M174D Ondansetron Tablets

165 M034A Carbamazepine Prolonged-release

Tablets

166 M034B Carbamazepine Tablets

167 M075A Diazepam Capsules



In Figures In Words

168 M075B Diazepam Injection

169 M075C Diazepam Tablets

170 M147 Magnesium Sulphate Injection

171 M181A Phenobarbitone Tablets

172 M181B Phenobarbitone Injection

173 M181C Phenobarbitone Sodium Tablets

174 M182A Phenytoin Injection

175 M182B Phenytoin Capsules

176 M182C Phenytoin Tablets

177 M207A Sodium Valproate Injection

178 M207B Sodium Valproate Oral Solution

179 M207C Sodium Valproate Gastro-resistant

Tablets

180 M207D Sodium Valproate Tablets

181 M145A Lorazepam Injection

182 M145B Lorazepam Tablets

183 M082A Diltiazem Injection

184 M082B Diltiazem Tablets

185 M111 Glyceryl Trinitrate Tablets

186 M134A Isosorbide Mononitrate Tablets

187 M134B Isosorbide Dinitrate Tablets

188 M160A Metoprolol Injection

189 M160B Metoprolol Tablets

190 M054 Clopidogrel Tablets

191 M014A Amiodarone Intravenous Infusion

192 M014B Amiodarone Tablets



In Figures In Words

193 M142A Lignocaine Gel

194 M142B Lignocaine Injection

195 M142C Lignocaine Injection

196 M189A Procainamide Injection

197 M189B Procainamide Tablets

198 M220A Verapamil Injection

199 M220B Verapamil Tablets

200 M016A Amlodipine Tablets

201 M016B S-Amlodipine Tablets

202 M023 Atenolol Tablets

203 M091 Enalapril Maleate Tablets

204 M146 Losartan Tablets

205 M157 Methyldopa Tablets

206 M167A Nifedipine Capsules

207 M167B Nifedipine Prolonged-release

Tablets

208 M167C Nifedipine Tablets

209 M206 Sodium Nitroprusside Injection

210 M118 Hydrochlorothiazide Tablets

211 M080A Digoxin Injection

212 M080B Digoxin Paediatric Solution

213 M080C Digoxin Tablets

214 M083 Dobutamine Injection

215 M085 Dopamine Injection

216 M024 Atorvastatin Tablets

217 M108A Frusemide Injection



In Figures In Words

218 M108B Frusemide Tablets

219 M148 Mannitol injection

220 M208 Spironolactone Tablets

221 M173 Omeprazole Gastro-resistant

Capsules

222 M197A Ranitidine Injection

223 M197B Ranitidine Tablets

224 M177 Pantoprazole Gastro-resistant

Tablets

225 M102 Famotidine Tablets

226 M084A Domperidone Suspension

227 M084B Domperidone Tablets

228 M159A Metoclopramide Injection

229 M159B Metoclopramide Syrup

230 M159C Metoclopramide Tablets

231 M077A Dicyclomine Injection

232 M077B Dicyclomine Oral Solution

233 M077C Dicyclomine Tablets

234 M122A Hyoscine Butylbromide Injection

235 M122B Hyoscine Butylbromide Tablets

236 M031A Bisacodyl Gastro-resistant Tablets

237 M031B Bisacodyl Suppositories

238 M225A Zinc Sulphate Eye Drops

239 M225B Zinc Sulphate Oral Solution

240 M225C Zinc Sulphate Dispersible Tablets

241 M156A Methylprednisolone Tablets

242 M156B Methylprednisolone Acetate

Injection



In Figures In Words

243 M217 Testosterone Propionate Injection

244 M110 Glibenclamide Tablets

245 M127A Insulin Aspart Injection

246 M127B Insulin Lispro Injection

247 M127C Biphasic Insulin Aspart Injection

248 M127D Biphasic Insulin Lispro Injection

249 M127E Biphasic Isophane Insulin Injection

250 M127F Isophane Insulin Injection

251 M154A Metformin Tablets

252 M154B Metformin Hydrochloride

Prolonged-release Tablets

253 M154C Metformin Oral Solution

254 M169 Norethisterone Tablets

255 M036 Carbimazole Tablets

256 M129 Povidone-Iodine Solution

257 M025 Atracurium Besylate Injection

258 M165A Neostigmine Tablets

259 M165B Neostigmine Injection

260 M192A Pyridostigmine Injection

261 M192B Pyridostigmine Tablets

262 M211 Succinylcholine Injection

263 M219 Vecuronium Bromide Injection

264 M046A Chlorpromazine Injection

265 M046B Chlorpromazine Tablets

266 M113A Haloperidol Injection

267 M113B Haloperidol Oral Solution



In Figures In Words

268 M113C Haloperidol Tablets

269 M172 Olanzapine Tablets

270 M015 Amitriptyline Tablets

271 M104A Fluoxetine Capsules

272 M104B Fluoxetine Oral Solution

273 M104C Fluoxetine Tablets

274 M125 Imipramine Tablets

275 M143A Lithium Carbonate Prolonged-

release Tablets

276 M143B Lithium Carbonate Tablets

277 M011A Alprazolam Prolonged-release

Tablets

278 M011B Alprazolam Tablets

279 M029 Beclomethasone Inhalation

280 M201A Salbutamol Syrup

281 M201B Salbutamol Tablets

282 M057A Codeine Syrup

283 M057B Codeine Tablets

284 M069 Dextromethorphan Hydrobromide

Syrup

285 M176A Oxytocin Injection

286 M176B Oxytocin Nasal Solution

287 M184 Potassium Chloride for injection

288 M204 Sodium Bicarbonate Injection

289 M022A Aspirin Gastro-resistant Tablets

290 M022B Aspirin Tablets

291 M022C Soluble Aspirin Tablets


Certified That:

1. The quoted rates must be inclusive of all taxes & duties as applicable at the

time of bidding except Service Tax.

2. The rates quoted above are valid for 90 (Ninety) days from the date of opening

of Technical Bids.

3. We will provide Services as per the time schedule prescribed by NIB.

Signature of the authorized signatory of the agency

Official seal/ stamp

Date:

Place:


ANNEXURE-IX

Format of Test Report

Laboratory Details

Lab Approval No :-

Name of Laboratory :

Test(s) Conducted :

Phone Number :

E-mail.id :

CERTIFICATE OF ANALYSIS

Sample Code No. : Lab Report No. :

Sample Name :

Brand Name :

Batch No. : Mfg. Date : Exp. Date :

Manufactured By :

Mfg. Lic. No. : Received on : Qty. Recd :

S. No. Test(s) Conducted Specification Complies/No

Complies

1

2

3

4

S.No. Test(s) Conducted Ingredients Results MAX Complies/No

Complies

5

6

7

Composition :

Protocol Applied :

Details of the Tests as per Protocol :

Conclusion

In the opinion of the under signed, the sample referred above has been analysed as per the Protocol mentioned above and found standard

quality/not of standard quality

Date: Lab : Signature of Person-in-Charge

Note: Final Draft will be provided to the Laboratory after award of the Work.


ANNEXURE –X

PERFORMANCE GUARANTEE / SECURITY DEPOSIT

IN THE FORM OF BANK GUARANTEE (On stamp paper of appropriate value from any Nationalized Bank)

Bank Guarantee No: ________________ Dated: ---------, 2015

To,

The National Institute of Biologicals

A-32, Sector-62,

Near NH-24, Noida- 201 309.

Dear Sir,

In consideration of National Institute of Biologicals (hereinafter called as the NIB) which expression

shall include his successor and assignees having awarded to ………………………….……………………

(Hereinafter referred to as the said Agency when expression shall wherever the subject of context so

permits include its successors, representatives, assignees, executors, administrators) a contract No.

…………………. In terms inter alia, of the NIB’s Letter No. …………….. Dated. ……………… and the

General Conditions of Contract and upon the condition of the Agency’s furnishing security for the

performance of the Agency’s obligations and discharge of the Agency’s liability under in connection with

the said contract up to a sum of Rs…………………. (Rupees………………………………….. only)

amounting to 10 % (Ten) percent of the total contract value.

1. We. ……………………………………………………………. (here in after called “The Bank

which expression shall include its successors and assigns) hereby jointly and severally undertake to

guarantee the payment to The NIB in rupees forthwith on demand in writing and without protest of demur

or any and all moneys anywise payable by the Agency to The NIB under in respect of or in connection

with the side contract inclusive of all The NIB’s losses and damages and costs, (inclusive between attorney

and client) charges and expenses and other moneys anywise payable in respect of the above to this

guarantee up to an aggregate limit of Rs. …………………/-

(Rupees…………………………………….only).

2. We ……………………………………………… Bank further agree that The NIB shall be sole

judge of and as to whether the said Agency has committed any breach or breaches of any of the terms and

conditions of the said contract and the extent of loss, damage, cost, charges and expenses caused to or

suffered by or that may be caused to or suffered by The NIB on account thereof and the decisions of The

NIB that the said Agency has committed such breach or breaches and as to the amount or amounts of loss,

damage, costs, charges and expenses caused to or suffered by the NIB from time to time shall be final and

binding on us.


3. The NIB shall be at liberty without reference to the bank and without affecting the full liability of

the bank hereunder to take any other security in respect of the agency’s obligations and liabilities hereunder

or to vary the contract or the work to be done thereunder vis-à-vis the agency or to grant time or indulgence

to the agency or to reduce or to increase or otherwise vary the prices of the total contract value or to release

or to forbear from enforcement of all or any of the security and/ or any other security (ies) now or hereafter

held by the NIB and no such dealing (s) reduction (s) increase (s) or other indulgence (s) or arrangements

with the Agency or release or forbearance whatsoever shall absolve the Bank of the fail liability to The

NIB hereunder or prejudice the rights of The NIB against the bank.

4. This guarantee shall not be determined or affected by the liquidation or winding up, dissolution,

or change of constitution or insolvency of the Agency but shall in all respect and for all purposes be binding

and operative until payment of all monies payable to The NIB in terms thereof.

5. The bank hereby waives all rights at any time inconsistent with the terms of this guarantee and the

obligations of the bank in terms hereof shall not be anywise affected or suspended by reason of any dispute

or dispute having been raised by the Agency stopping or preventing or purporting to stop or prevent any

payment by the bank to The NIB in terms hereof.

6. The amount stated in any notice of demand addressed by the NIB to the bank as liable to be paid

to the NIB by the Agency or as suffered or incurred by The NIB on account of any losses or damages of

cost, costs, charges and / or expenses shall be conclusive evidence of the amount so liable to be paid to

The NIB of suffered or incurred by The NIB as the case may be and shall be payable by the bank to The

NIB in terms hereof.

7. This guarantee shall be a continuing guarantee and shall remain valid and irrevocable for all claims

of the NIB and liabilities of the Agency arising up to and until midnight

of…………………………………………………………… .

8. This guarantee shall be addition to any other guarantee or security whatsoever that The NIB may

now or at any time anywise may have in relation to the Agency’s obligations/ or liabilities under and/ or

in connection with the said contract, and The NIB shall have full authority to have recourse to or enforce

this security in preference to any other guarantee or security which The NIB may have or obtain and no

forbearance on the part of The NIB in enforcing or requiring enforcement of any other security shall have

the effect or releasing the Bank from its full liability hereunder.

9. It shall not be necessary for the NIB to proceed against the said Agency before proceeding against

the Bank and the Guarantee herein contained shall be enforceable against the bank notwithstanding that

any security which the NIB may have obtained or obtain from the Agency shall at the time when

proceedings are taken against the said bank hereunder be outstanding or unrealized.

10. We the said Bank undertake not to revoke this guarantee during its currency except with the

consent of the NIB in writing and agree that any change in the constitution of the said Agency or the said

Bank shall not discharge our liability hereunder.

11. We. …………………………………….the said Bank further that we shall pay forthwith the

amount stated in the notice of demand notwithstanding any dispute/ difference pending between the parties

before the arbitrator and/ or that any dispute is being referred to arbitration.


12. Not with standing anything contained herein above, our liability under this guarantee shall be

restricted to Rs……………/- (Rupees ……………………………… ………….only) and this guarantee

shall remain in force till ………………. and unless a claim is made on us within 3 (Three) months from

that date, that is before ……………………………. all the claims under this guarantee shall be forfeited

and we shall be relived of and discharged from our liabilities thereunder.

Dated …………day of …………2015.

For and on behalf of the Bank

-------------------------

Signature

(with rubber stamp)


ANNEXURE-XI

On Rupees 100/= non judicial stamp paper

AGREEMENT

CONTRACT AGREEMENT FOR THE

“EMPANELMENT OF NABL ACCREDITED DRUGS TESTING LABORATORIES FOR THE

ANALYSIS OF DRUGS SENT BY NIB”

Agreement made this __________ day of ____________at Noida UP, between Director,

National Institute of Biologicals, and

M/s____________________________________at__________________ (hereinafter referred

to as "The Laboratory" which term shall include its successors, representatives, heirs, executors

and administratorsunless excluded by the Contract) on one part and Director, National Institute of

Biologicals, Noida UP its Registered Office at A-32, Sector 62, Near NH-24, Noida-201309 (U.P.)

( hereinafter referred to as the Tender Inviting Authority) on the other part.

Whereas the Laboratory has agreed to undertake the analytical work to the Tender

Inviting Authority, the list of items mentioned in the Annexure- VI attached hereto at the rates

noted therein and in the manner and under the terms and conditions hereinafter mentioned.

And whereas the Laboratory has deposited with the Tender Inviting Authority a sum of

Rs. __________/- (Rupees _________________ only) as Security Deposit for the due and

faithful performance of this Agreement, to be forfeited in the event of the Laboratory failing duly

and faithfully to perform it.

Now these presents witness that for carrying out the said Agreement in this behalf into

execution, the Laboratory and the Tender Inviting Authority do hereby mutually convenient,

declare, contract and agree each of them with the other of them in the manner following, that is

to say,

1) The term “Agreement”, wherever used in this connection, shall mean and include the

terms and conditions in tender floated by the Tender Inviting Authority for Empanelment

of Drugs testing laboratories for the analysis of Drugs for the year 2014-2015 the

instructions to tenderers, the conditions of tender, acceptance of tender particulars


hereinafter defined and those general and special conditions that may be added from

time to time.

2) (a) The Agreement is for undertaking analysis of Drugs by the Laboratory to the Tender

Inviting Authority of the samples specified in the Annexure- VI attached hereto at the rates

noted against each therein on the terms and conditions set forth in the Agreement.

(b) This Agreement shall be deemed to have come into force with effect from

_____________ and it shall remain in force till completion of project and may however

be extended for a further period, on mutually agreed on existing terms& Conditions.

AUDIT OF EMPANELLED LABORATORY

3.14 In respect of the analysis of items in the Annexure-VI of the Tender Document, the

Laboratory shall allow audit by the Audit Team as authorized for the purpose by the

Director, National Institute of Biologiclas, before and after empanelment of the Laboratory

or at any point of time during the continuance of the tender. The Laboratory shall co-

operate to the Audit Team to enable them to inspect Sample & Standard storage,

Reagents, Instruments, all other related records/ raw data of analysis etc., in the

laboratory.

RECOVERY OF LOSSES/DAMAGESPAYABLE TO THE TENDER INVITING

AUTHORITY BY THE LABORATORY

3) All expenses, damages and other money payable to the Tender Inviting Authority by the

Laboratory under any provisions of this Agreement may be recovered from the amounts

due or subsequently becoming due from the Tender Inviting Authority to the Laboratory

under this or any other Agreement. In case such amounts are insufficient to fully cover

such expenses, damages or other moneys payable, it shall be lawful for the Tender

Inviting Authority to recover the balance amount from the Security Deposit of the

Laboratory and all other money held by Tender Inviting Authority and in case such

Security Deposit is insufficient, then it shall also be lawful for the Tender Inviting Authority

to recover the residue of the said expenses, damages and moneys, if necessary, by

resorting to legal proceedings against the Laboratory.


AMOUNT OF SECURITY DEPOSIT TO BE MADE BY THE LABORATORY

4) The Laboratory shall deposit with the Tender Inviting Authority an amount equivalent to

Rs 50,000/-(Rupee Fifty Thousand Only) Or 10% (Ten percent)of value of the work

awarded to them which ever is higher, The amount of Security Deposit shall be deposited

by the Laboratory to the Tender Inviting Authority by way of Demand Draft in favour

of‘National Institute of Biologicals’, payable at Noida/Delhi or In form of Performance

Bank Guarantee which should be valid for 60 (Sixty) days beyond the entire contract

period (Including Extended Period, if any) as per the format attached with the Tender

Document. This agreement comes into effect only after the laboratory has deposited the

required amount of Security Deposit, not withstanding any thing contained in clause 2(b)

of this agreement.

ASSIGNMENT OF CONTRACT PROHIBITED

5) The Laboratory shall not, at any time, assign, sub-let or make over the present contract

or the benefits thereof or any part thereof, to any person or persons whomsoever.

TERMINATION OF CONTRACT ON BREACH OF CONDITION

6) (a) In case the Laboratory falls or neglects or refuses to faithfully perform any of the

Convenants on his part herein contained or violates the condition in Tender Document, it

shall be lawful for the Tender Inviting Authority to forfeit the amountdeposited by the

Laboratory as Security Deposit and cancel the contract, apart from black listing the

Laboratory for a period of 2 (two) years.

(b) In the case the Laboratory fails, or refuses to observe, perform, fulfill and keep, all or

any one or more or any part of any one of the Convenants, stipulations and provisions

herein contained, it shall be lawful for the Tender Inviting Authority on any such failure,

neglect or refusal, to put an end to this Agreement and there upon every article, cause

and thing herein contained on the part of the Tender Inviting Authority shall cease and

be void, and in case of any damage, loss, expense, differences in cost or other moneys

than or at any time during the continuance of this Agreement becoming due or owing by

the Laboratory to the Tender Inviting Authority , it will be opened for the Tender Inviting

Authority to recover from the Laboratory, all such damages, losses, expenses,

differences in cost or other moneys as aforesaid, it shall be lawful for the Tender Inviting


Authority to appropriate the Security Deposit made by the Laboratory as herein before

mentioned to reimburse all such damages, losses, expenses, differences in cost and

other money as the Tender Inviting Authority shall have sustained, incurred or been put

to by reason of the Laboratory having been guiltyof any such failure, negligence or refusal

as aforesaid or other breach in the performance of this Contract.

(c) If at any time during the course of the contract, it is found that any information

furnished by the Laboratory to the Tender Inviting Authority, either in the Tender or

otherwise, is false, the Tender Inviting Authority may put an end to the

Contract/Agreement wholly or in part and thereupon the provisions of Clause (a) above

shall apply.

7) The Tender Inviting Authority reserves the right to terminate without assigning any

reasons thereof the Contract/Agreement either wholly or in part without any notice to the

Laboratory. The Laboratory will not be entitled for any compensation whatsoever in

respect of such termination of the Contract/Aggrement by the Tender Inviting Authority.

CERTIFICATES /NOTICES/ORDERS IN WRITING:

8) All Certificates or Notices or orders for time or for extra, varied or altered Laboratory which

are to be the subject of extra or varied charges whether so described in the Agreement

or not, shall be in writing, and unless in writing, shall not be valid, binding or be of any

effect whatsoever.

LABOARTORIES NOT TO HAVE ANY INTEREST IN THE OFFICERS CONCERNED AND

SUBORDINATES:

9) The Laboratory shall not be in any way interested in or concerned directly or indirectly

with, any of the officers, Subordinates or servants of the Tender Inviting Authority, in any

trade, business or transactions nor shall the Laboratory give or pay or promise to give or

pay any such Officer, Subordinate or Servant directly or indirectly any money or fee or

other consideration under designation of “Custom” or otherwise, nor shall the Laboratory

permit any person or persons whomsoever to interfere in the management or

performance thereof under power of attorney.


BANKRUPTCY OF THE LABORATORY

10) In case the Laboratory at any time during the continuance of the Contract becomes

bankrupt or insolvent or commits any act of bankrupcy or insolvency under the provisions

of any law in that behalf for the time being in force, or should compound with his creditors,

it shall be lawful for the Tender Inviting Authority to put an end to the Agreement, and

thereupon every article, clause and thing herein contained to be operative on the part of

the Tender Inviting Authority, shall cease and be void and the Tender Inviting Authority

shall have all the rights and remedies given to him under the precedent clauses.

SERVING OF NOTICES ON LABORATORY

11) All notices or communications relating to or arising out of this Agreement or any of the

terms thereof shall be considered duly served on or given to the Laboratory if delivered

to him or left at his premises, place of business or above.

12) And it is hereby agreed and declared between the parties hereto that in case any question

of dispute arises touching the construction or wording of any clause herein contained on

the rights, duties, liabilities of the parties hereto or any other way, touching or arising out

of the presents, the decision of the Director, National Institute of Biologicals, Noida, UP

in the matter shall be final and binding.

13) In the event of any disputes between the parties, the disputes would be subject to the

jurisdiction of the Civil Courts within the city of Noida/Delhi only.


In witness whereof the said parties have hereunto set their hands the day and

year first above written.

________________________ ___________________________

AUTHORISED SIGNATORY OF

THE LABORATORY FOR AND ON BEHALF OF THE

THE DIRECTOR,

NATIONAL INSTITUTE OF

BIOLOGICALS,

NOIDA

WITNESS WITNESS

1.______________________ 1. ________________________

________________________ ________________________

________________________ ________________________

2._______________________ 2._________________________

________________________ _________________________

________________________ _________________________


ANNEXURE –XII

DECLARATION FORM

(For no commercial interest)

I / We _______________________________(Name of the tenderer) having our office at

______________________________________________ and Lab at ----------------------------------

----------------------------------------------------------- do declare that I/We have carefully read all the

conditions of tender of National Institute of Biologicals, Noida,, for the tenders floated for

empanelment of analytical testing laboratories for the analysis of drugs etc. for the tender

period of one year from the date of acceptance and abide by all conditions set forth therein.

I/We hereby solemnly declare that our analytical laboratory is not having any

manufacturing activity of drugs directly or indirectly and not any financial interest in the

manufacturing activity of drugs.

.


ATTESTED BY NOTARY PUBLIC