DIRECTORATE OF MEDICAL EDUCATION & RESEARCH, MUMBAI€¦ · DIRECTORATE OF MEDICAL EDUCATION & RESEARCH, MUMBAI Tender: DMER/DPC/D&M/ ALL TENDER SCHEDULES GENERALTERMS & CONDITIONS

DMER - Drug Purchase Cell

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DRUG PURCHASE CELL, DIRECTORATE OF MEDICAL EDUCATION

& RESEARCH, MUMBAI

Tender: DMER/DPC/D&M/ ALL TENDER SCHEDULES

GENERALTERMS & CONDITIONS OF TENDER ENQUIRY (As per Govt. Resolution dated 27 March 2000 and 17 June 2009 &

04 July 2014) - 1 A. Tenders are invited for and on behalf of Governor of Maharashtra from the manufacturer/importer for fixing rate contract for supply of drugs & Pharmaceuticals, surgical items and consumables to institutions under the control of Directorate of Medical Education & Research (DMER), Mumbai, & Directorate of Ayurved (DA) under the following terms & conditions. The rate contract will be valid for a period two year or until further orders in this regard.

INSTRUCTIONS TO TENDERERS

1.1 The Tenders shall be submitted online through e- tendering process only. No tender will be accepted manually or through fax etc.

1.2 The Tender form will be available online only. No tender form will be sold/issued manually from Directorate of Medical Education & Research, Mumbai

1.3 The tender document will be uploaded / released on Govt. of Maharashtra etendering website http://dmer.maharashtra.etenders.in The tenderer is required to download the tender document from this website as per the schedule of activities for online tender document download.

1.4 The tenderer has to pay cost of the tender document Rs. 2000/- (Two Thousand only) by cash or Demand Draft in the office of Director, Medical Education & Research, Mumbai. To download the tender document from the website the tenderer is required to fill the details of the cash receipt number towards the cost of the


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tender document. Documents downloaded without filling the details of cash receipt of tender cost will not be considered as valid tender document.

1.5 The tenderer is required to pay the amount towards the cost of the tender document in cash at Directorate of Medical Education & Research, Mumbai Office on any working day excluding 2nd and 4th Saturday, Sunday and Govt. holidays between 11.00 am to 5.00 pm. before due date.

1.6 The tenderer is required to upload the cash receipt towards the cost of the tender at the time of uploading the documents required for technical bid.

1.7 The tenderer is required to download the tender document within the schedule of activity for online tender document download. After expiry of the date and time for tender document download, the Directorate of Medical Education & Research, Mumbai will not be responsible for any such failure on account of tenderer for not downloading the document within the schedule even though he has paid the cost of the tender to the Directorate of Medical Education & Research, Mumbai office. In such case the cost of the tender paid by the tenderer will not be refunded.

1.8 During the activity of bid preparation, the tenderer is required to upload all the documents mentioned in the terms & conditions of the technical bid by scanning the documents and uploading it in the PDF. This activity of uploading the documents as well as preparation of commercial bid and other Annexures enclosed with the tender shall be completed within the schedule given for bid preparation.

1.9 After bid preparation, the tenderer is required to submit the bid again during the activity of submission of bid without which the tender will not be submitted. Successful submission of bid only completes the entire tendering process.

1.10 The tenders submitted online will be opened on the schedule date before the participant. At the time of opening of technical bid(Envelop no.1) the tenderer should bring the original documents as mentioned below which have been uploaded in the technical bid so that same can be verified at the time of opening of technical bid. If the tenderer fails to produce the original documents at the time of


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opening of technical bid , the said bid will be treated as non-resposive. list of documents :-

1) Cash receipt for the purchase of the tender form(Rs.2000/-)

2) EMD-RBI Challan or Bank Guarantee 3) Power of attorny to sign the tender document. 4) Original copy of Tender Terms & condition document,

all pages signed & sealed.

1.11 As the tenders are invited online, tenderers are required to upload tender as per the schedule given. DMER is not responsible for failure on the part of tenderer to upload tender within the time schedule. In case of any help required for this purpose the tenderer shall contact to help line of e-tendering agency M/s. Sify NexTenders on telephone nos. 020- 25315555 Tenderers are requested to go carefully through the process of e-tendering given on the website of website http://dmer.maharashtra.etenders.in to avoid disqualification of their tender on any ground.

1.12 The tenderer is required to pay tender processing fee of Rs.1038 per tender to e-tendering agency, M/s. Sify Nex Tenders at the time of on line submission stage through e-payment (through credit cards/debit card/net banking). Details of different modes of online payment to e-tendering service provider are given in the flow chart of the web site. Non payment of fees will result in non submission of the tender and Directorate of Medical Education & Research, Mumbai will not be responsible if the tenderer is not able to submit their offer due to non payment of processing fees to the e-tendering agency.

1.13 Any amendment to the tender will be placed on the e-tendering website of the Govt. of Maharashtra DMER. The tenderer will not be communicated separately regarding the amendment. The tenderer should download the amendment. However if the tenderer fails to download any of these amendments then it will be presumed that the tenderer has quoted his/ her rates by taking the note of these amendments.


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1.14 MANNER OF SUBMISSSION OF TENDER The tender is divided in two parts i.e. Technical Bid Env No 1 & Commercial Bid Env No 2 and required to be submitted online only

1.15 Technical Bid Env N0.1 - Contains technical information such as technical specifications, terms & conditions of the tender, qualification criteria, documents required to be submitted to become qualify for opening of commercial bid, general terms & conditions of the tender, instructions to the tenderer for submission of the tender, other Annexures required to be submitted by the tenderer along with the technical bid, confirmation to tender terms & conditions

1.16 Commercial Bid Env No. 2 - contains price bid to be filled in by the tenderer along with necessary Annexures.

1 B Turnover Clause - Pre-qualification Condition The Manufacturer/Importer having annual turnover for formulations (not including bulk drugs) as shown below will be only eligible for participation in the tender.

Table No. 1.

Sr.No.

Tender Schedule Turnover EMD

1 Injection 10Crores

1,00,000 2 Surgical sutures 10 Crores

3 I.V. Fluid 10 Crores

4 Anti cancer 10 Crores

5 Super speciality 10 Crores

6 X ray films 10 Crores

7 Tablet Capsule 5 Crores 50,000

8 Inj ARV & Inj ASVS 5 Crores

9 Liquid

Oral,ointment,Drops

5 Crores

10 Antiseptic &

Disinfectant

10 Crores


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2)Documents in Technical Bid : It will contain following documents in following serial order:- 2.1 Cash receipt of purchase of Tender form 2.2 Forwarding letter in prescribed Proforma (Annexure No. I) 2.3 E.M.D. (Earnest Money Deposit) Challan. Every tenderer will have to

deposit “Schedule-wise “ amount as mentioned Above Table No. 1 either in the form of challan, credited in the “Reserve Bank of India” Mumbai, under the head, (as mentioned below) Or in the form of Bank Guarantee from nationalized/Scheduled Banks valid for at least for six months. Bank Guarantee to be submitted in the name of Director, Directorate of Medical Education and Research, Mumbai.

2.4 Head-“K” Deposit & advance, 8443, Civil Deposit (Not bearing

interest) 800, OTHER RECEIPT (E.M.D./S.D.) Code No. 8443 532 300. The same Challan in original or Bank guarantee should be enclosed along with Tender in Envelop No.1. However S.S.I units registered with Directorate of Industries & N.S.I.C. are exempted from paying EMD if their Units are located in Maharashtra State. The attested Photostat copy of the Said Registration must be attached with the tender in the Technical Bid.

11 Surgical Drugs 50 lakh 25,000

12 Orthopedic Implants 50 lakh

13 Diagnostic

Kits/Repacking Items

50 lakh

14 Surgical Dressing 50 lakh

15 Ayurvedic Propritery 50 lakh

16 Ayurvedic Classical 50 lakh

17 Surgical Non Drug 50 lakh

18 X ray related material 50 lakh

19 Dental material,phenyl 25 lakh


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2.5 EMD of Non Responsive Bidders will be refunded immediately after opening of Commercial Bid of Responsive Bidders.

2.6 EMD of Responsive Bidders will be refunded immediately after award

of Rate Contract. 2.7 Certified copy of VAT/CST Registration Certificate & VAT/CST

Clearance Certificate up to last financial year and up to date VAT deposit receipts (Challans)

2.8 Certified copy of “Drug License of manufacturer” valid on the day of

submission of tender from Food & Drugs Administration along with list of product Licensed to be manufactured. If quoted item is manufactured at different places, manufacturing License & Performance certificate from all such places from respective F.D.A. should be enclosed. In case of items imported & in case of items covered under drug category the tenderer have to abide by notification of Govt. of India. Ministry of Health & Family Welfare notification SO No. 1468 (E) on 6th Oct. 2005 & G.S.R. 627 (E) Dt. 7th Oct. 2005 for various categories of sterile medical devices for internal & external use as mentioned in the notification, namely Intra ocular lenses, IV Cannula, Bone cements, internal prosthetic replacement, Heart Valve, I.V. Sets, B.T. Sets, Scalp vein set & Orthopedic implants and all catheters etc. as drugs and any notifications issued by Govt. in this regard from time to time.

a) For all the above-referred medical devices which are manufactured by

manufacturers in India should have license under Drug & Cosmetic Act 1940 & rules there under valid on the day of submission of tender form.

b) The dealer/agents for drugs & above imported/domestic medical

devices also should hold license for sale of these medical device under Drug & Cosmetic Act 1940 & rules there under.

In case of product being imported the importer has to submit.

i) Latest & Last three years old item-wise bills of entry (Notarized).


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ii) Notarized certified copy of country of origin for items/drugs devices being used in country of origin or COPP.

iii) Notarized copy of valid Drug selling License of the Importer. iv) C.E./.U.S. FDA certificate (Notarized) wherever applicable. v) Bankers certificate showing bank account no of

importer(original). vi) Valid notarized import license Form 10 along with list of imported

items/device/drugs. vii) Import Export certificate.(IEC) viii) Affidavit of importer regarding items being imported in India for

last three years.

ix) Authority letter issued by foreign manufacturer for importing the

product for which bid is offered OR Contract agreement between

foreign manufacturer and Importer

c) Notarized/certified copy of Drug Controller General of India, New Delhi, permission for items coming under , "New Drug and Fixed Dose Combinations" in form 45/46 as per Drugs and Cosmetic Act and Rules 122.

2.9 Performance Certificate from concerned Food & Drugs Administration

in enclosed proforma Annexure II. If the tenderer is manufacturing the same items for which tender is filled in, at various locations/ places either in, Maharashtra or outside Maharashtra, he should obtain performance certificate from the respective Food & Drugs Administration Authority for such locations where the manufacturing activities are carried out.

2.10 Notarized Valid Certificate from concerned Food & Drugs

Administration in stating that the drugs quoted in the tender are manufactured by using WHO Good Manufacturing practice, The condition of WHO-GMP is however relaxed for the schedules of Laboratory Chemicals, glassware and diagnostics, Phenyl, Surgical Dressings and all domestic surgical items like I.V. Set, B.T. Set, I. V. canula and for all domestic medical devices attracting drug license as per the letter from Drugs Controller


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General of India (Letter No. 81-5/WZ-2008/960,dt.25-4-2009 & No.29/Misc/5/2008-DC dt.6-8-2008) However for all domestic surgical items and medical devices items coming under Drugs & Cosmetics Act/medical devices notarized valid Schedule M-GMP certificate from the concerned FDA should be submitted.

2.11 Authority letter for appointment of bonafide Distributor Certificate in

proforma Annexure III, wherever applicable.

Tenders will be accepted from manufacturers and importers only, however a he can appoint distributor (which should not be more than four agents) for supply of goods or can supply directly. Manufacturing firm desires of appointing distributor should mention their names, address, contact no & email ID in the authority letter of distributor in given proforma as Annexure III. No change of distributor within the tender period will normally be allowed.

2.12 A manufacturer can/may authorize Distributor/Agent/ Dealer for supply of goods. Such authorized Distributor/Agent/Dealer should submit following documents in technical Bid.

a) Certified copy of VAT/CST Registration Certificate & VAT/CST

Clearance Certificate up to last financial year and up to date VAT deposit receipts (Challans)

b) valid FDA Drug License for sale of Drugs. c) No conviction certificate from local FDA. 2.13 Certified copy of valid registration made under Directorate General of

Supplies & Disposal (D.G.S. & D.), Small Scale Industries (S.S.I.) & National Small Scale Industries Corporation (N.S.I.C.) should be attached if applicable.

2.14 The Sample Receipt in Proforma Annexure IV for all the Ayurvedic

Drugs, surgical drugs, medical devices, surgical non drug items , Diagnostic Kits, Dental material & in case of other items wherever / whenever asked should be enclosed.


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2.15 Information in respect of products for which Quality Control Data should be furnished in proforma Annexure V & should be submitted in Technical Bid.

2.16 The tenderer need to fill the complete details of manufacturers and

importers in Annexure VI & need to enclose in Technical Bid. 2.17 The products for which tender is filled should be in the market

minimum for 3 years and in case of "New Drugs and new medical devices", it should be in the market for minimum 2 years. The product market standing experience should be substantiated by giving Item wise quantity of manufacture/ import & sales of previous three financial years in Annexure VII certified by Chartered Accountant.

2.18 Statement as per Annexure VIII showing installed capacity of the

products quoted & quantity which tenderer will be able to supply in event of selection, duly signed and sealed by authorized signatory should be submitted in Technical Bid.

2.19 The tenderer should submit Product-wise details of the "product

offered" by the tenderer along with its composition, date of product permission received from respective F.D.A. in given Proforma Annexure IX, duly signed and sealed by authorized signatory. Product offered column should not simply repeat the tender specification rather it must give actual details of the product manufactured by the manufacturer.

2.20 All the copies of certificates/documents attached with the tender

should be either original or dully attested by Gazetted Officer/Public Notary. Tenderer needs to submit original documents for verification whenever asked by the department.

2.21 Complete Audit report with relevant certificates & schedules for the

last three financial years from date of publication of the tender along with annual turnover statement for formulations for the above three


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years - certified by the Registered Chartered Accountant should be submitted in Technical Bid.

2.22 The tenderers having their factory outside the State of Maharashtra

must give an undertaking ( in Technical Bid) that whenever necessary the representative of FDA Maharashtra State or other Government officials is allowed to visit their factory for inspection.

2.23 Power of Attorney duly notarized on stamp paper to sign the tender.

2.24 All individual pages of these terms & conditions of tender form should

be signed by the authorized signatory of the firm. The signing of each page of tender form is essential as the tenderer has to abide by all the terms & conditions of tender. The signature should be accompanied by the stamp of the firm. Terms & Conditions duly signed should be enclosed in Technical Bid, failing which tender is liable for rejection.

3) Documents in Commercial Bid 3.1 Item wise remarks, if any worth mentioning regarding the product

specification. 3.2 Any assumption, condition, deviation etc., different than the in the tender invited & condition thereof.

3.3. Tender schedule with rate in Rupees (Rs) should be written both in figures & words duly signed & sealed and uploaded in the appropriate place/field.(* wherever applicable) 3.4 Product wise costing – (Annexure X)

(a) Product wise costing certificate as submitted to Bureau of Industrial cost & Production (B.I.C.P.) certificate by Registered Chartered Accountant wherever applicable. (Annexure X, Annexure XI)

(b) Product wise costing certificate as submitted to National

Pharmaceutical Pricing Authority (NPPA) certified by Registered


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Chartered Accountant wherever applicable. (Annexure X, Annexure XI)

(c) Product wise costing statement as per Drug Price Control Order

(D.P.C.O.). wherever applicable (Annexure X, XI)

(d) Statement showing brief break up of taxes & costing as regards rates offered in the tender (Annexure XI)

(e) Annexure X, XI and XII are also compulsory for all the categories

when BICP or DPCO is not applicable.

(f) Statement showing comparative prices as regards rates offered in the other tenders shall be submitted in enclosed proforma (Annexure XII)

3.5 Any false statement made by the tenderer will make the tender

invalid & contract awarded will stand terminated. Such tenderer shall also be liable for penal action, including blacklisting.

3.6 If the rate quoted is unreasonably low as compared to production cost,

the tender for that item is liable to be rejected. 3.7 Costing should be submitted as per Drug Price Control Order (DPCO)

or as submitted to National Pharmaceutical pricing authority (NPPA) and in any case price should not be more than that DPCO/NPPA price (Annexure X, Annexure XI and Annexure. XII) and undertaking to that effect should be submitted separately in Commercial Bid.

4) Price / Rate Clauses 4.1 Rate should be quoted for the Packing & Specifications such as

length, breadth strength as mentioned in tender form.

4.2 Rates should be written both in figures & words should be clearly specified and the said tender form should be uploaded in the commercial envelope in the given spaces as "financial offer


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document". The figures and words quoted must be without any corrections/ overwritting. This douments should be duly signed and sealed.

4.3 In quoting rates where there is no numerical figure preceding point

decimal it is to be preceded by cipher “O”. Eg Product Z- price Rs. 0.62 per unit.

4.4 The offer of the tenderer must be firm. Conditional offer will not be

considered for the specifications and packs in the tender. 4.5 Price/Rate quoted should be Door Delivery, anywhere in

Maharashtra State inclusive of all taxes, duties, levies & anyother charges, but excluding octroi / LBT, wherever applicable Octroi /LBT Exemption certificate will be provided. Rates should be valid for 120 days after opening of Tender.

4.6 Sales Tax, Custom Duty and Excise duty if not applicable/ exempted it

should be clearly indicated in costing sheet Annexure X and Annexure XI.

5) Procedure of Tender Opening A) Opening of Technical Bid and Commercial Bid

5.A1. Only following documents to be submitted personally, in original to this office at the time of opening of Technical Bid.

1) Cash receipt for the purchase of the tender form(Rs.2000/-) 2) EMD-RBI Challan or Bank Guarantee 3) Power of attorny to sign the tender document. 4) Original copy of Tender Terms & condition document, all pages

signed & sealed.


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5.A 2. The tenderer should note that following documents enlisted under A must be submitted in Technical Bid & under B must be submitted under Commercial Bid while submitting the tender.

List A – Technical Bid

1) Fee receipt of Tender form

2) EMD ( In case of exemption in EMD, valid certificate) in the form

of RBI Challan or Bank Guarantee.

3) Copy of valid registration made under DGS &D/ SSI / NSIC if

applicable

4) Valid certificate issued by competent authority District Industries

Officer in case of SSI units claiming 20% reservation in quantity

for units Located in backward areas in State of Maharashtra

5) Annexure I - Forwarding letter

6) Annexure II -Original copy of the Performance Certificate issued

by respective State F.D.A.

7) Annexure III- Original Copy of authority letter for appointing

Distributor (wherever applicable)

8) Annexure IV- Copies of the "Sample Receipt form" (wherever

applicable)

9) Annexure V - Copies of the Quality Control Data in case of New

Drugs, New Surgical Drugs & Medical Devices (wherever

applicable)

10) Annexure VI- Statement of particulars of drug

manufacturer/Importer


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11) Annexure VII - Statement showing item wise quantities

manufactured / imported and sold in India during last three

financial years issued by C A

12) Annexure VIII - Statement showing installed capacity

13) Annexure IX – detail composition of Product offered.

14) Undertaking for factory inspection by FDA officials /other

Government officials (wherever applicable)

15) Valid Drug Manufacturing License.

16) FDA approved valid Drug List

17) Valid WHO GMP certificate/COPP , (schedule M/ T GMP, ISI,CE

certificate wherever applicable)

18) copy of permission from the Drug Controller General of India,

New Delhi, for items coming under , "New Drug and Fixed Dose

Combinations”.

19) Latest & Last three years old item-wise bills of entry (Notarized). 20) Notarized certified copy of country of origin for items/drugs

devices being used in country of origin or COPP.

21) Notarized copy of valid Drug selling License of the Importer. 22) C.E./.U.S. FDA certificate (Notarized) wherever applicable. 23) Bankers certificate in original showing bank account number of

importer.

24) Valid notarized import license Form 10 along with list of imported items/device/drugs.

25) Import Export certificate.(IEC)


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26) Affidavit of importer regarding items being imported in India for

last three years.

27) Authority letter issued by foreign manufacturer for importing the

product for which bid is offered OR Contract agreement between

foreign manufacturer and Importer.

28) C A certified complete audit reports with all schedules & balance

sheet and Profit & Loss a/c statement of last three financial years

29)Last three years Turnover certificate issued by Chartered

Accountant

30) Copy of Ownership certificate in respect of manufacturing unit &

equipments issued by chartered accountant.

31) Manufacturer‟s/ Importer‟s Valid Notarized copy of VAT/CST Registration Certificate & VAT/CST Clearance Certificate up to last financial year and up to date VAT deposit receipts (Challans)

32) Distributor‟s Valid drug selling license (wherever applicable)

33) Distributor‟s Valid Notarized copy of VAT/CST Registration

Certificate & VAT/CST Clearance Certificate up to last

financial year and up to date VAT deposit receipts (Challans)

34) No conviction certificate from FDA for distributor

35) Notarised Power of Attorney for signing the Tender Documents

36) Notarised Power of Attorney /Authority letter to attend Tender

meetings & negotiation of rates.

37) Signed & sealed copy of Tender Terms & conditions documents.


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38) If any of the documents mentioned above, of the Technical Bid is

not applicable then tenderer should upload duly signed copy of

letter stating that the said documents is " Not Applicable " .

List B – Commercial Bid

1. Annexure X - Product wise costing in respect of drugs not covered under B.I.C.P OR D.P.C.O.

2. Annexure XI - Statement showing brief break up of taxes & costing as regards rates offered in the tender

3. Annexure XII - Statement showing comparative prices as regards rates offered in the other tenders.

4. Copy of Tender Form with item wise Commercial offers (wherever applicable)

B) Penalty for submission of documents.

5.B1. If some minor discrepancies are noticed regarding the documents in the Technical Bid and Commercial Bid except 4 documents mentioned in the 5A1 then the tenderer will be allowed to submit/ comply the said documents within 6 days, with penalty/ fee of Rs. 2000/- per document per day. If tenderer fails to submit the documents in Technical Bid within stipulated period, then the said bid will be treated as non responsive and its Commercial bid will not be opened.

5.B2. Further the tenderer fails to submit documents in Commercial

Bid within stipulated period, then its bid will be treated as non responsive & tenderer's EMD will be forfeited.

5.B3. Any conditional offer of the tender will be summarily rejected.


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C) Negotiations and Matching with lowest Rates

Tender Approval Committee or Sub-committee appointed by Tender Approval Committee shall negotiate with the tenderer to reduce the rates offered by them. These negotiations will be made with two acceptable lowest tenderers. (L1 & L2). The lowest rate received after negotiations for a particular item will be treated as rate for „Rate Contract”. The final rate contract will be awarded to these lowest negotiated rates as L1 & L2 and the purchase quantity will be divided 80% & 20% between L1 & L2, two successful tenderers.

D) TIE BREAK PROCEDURE .

(Procedure to be followed in case of more tenderers quoting same, identical rate same, identical items)

1) If one or more same offers for L1 & / or L2 are received, then new

commercial offer for the said items from the said tenderers will be invited in sealed envelope.

2) If in the above process again same offer are received then L1 & L2

will be decided through lottery system and Rate Contract will be awarded accordingly.

E) After opening Commercial Bid, if for any particular item less than 3

acceptable offers are received even then the Tender Approval Committee may take decision to accept it by recording reason thereof.

6) General

6.1 The decision of the Director, Directorate of Medical Education &

Research, Mumbai, is final & binding & Director, Directorate of Medical Education & Research, Mumbai, do not pledge himself to accept the lowest or any tender & to relax any of the conditions of this tender. The Director, Directorate of Medical Education & Research, Mumbai, reserves the right to make any change in the tender terms & conditions & schedules of the tender and reject any or all tender without assigning any reason.


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6.2 Pre-bid meeting for tender schedule will be called and the date of

the pre-bid meeting tender schedule wise will be intimated on the Govt. of Maharashtra etendering website http://dmer.maharashtra.etenders.in in due course. Subsequently minutes of the said pre-bid meeting will be published on the website.

7) Other Terms & Conditions

7.1 No assistance in obtaining import license or any license/permit etc. in respect of raw material or finished goods of accepted items will be provided form Government of Maharashtra.

7.2 In case of items or drugs not manufactured in India, the tenderer

will have to import directly & if any repacking after import items is required, repacking work will have to be got done through Haffkine Bio-Pharmaceuticals Corporation Ltd., Mumbai for which importer will pay fee directly according to the rates fixed from time to time.

7.3 As mentioned above the tenderer will have to get the repacking of

imported items done from Hakkfkine Bio-Pharmaceuticals Corporation Ltd., Mumbai. The charges for repacking will be done by the tenderer. The tenderer will have to give a repacking certificate from Haffkine Bio-Pharmaceuticals Corporation Limited as per Government Resolution No. DPR/1088/1515/Cr-230/Med-4B, dated 31st August 1990.

7.4 Preference for the purchase of surgical dressing will be given to

different institutions like Leprosy Institute, Jail Authorities & other such institutions declared by Government for manufacturing surgical dressing.

7.5 The quantities mentioned in the tender form stated under heading

“Approximate Annual Requirement” are only approximate estimated quantities mentioned for estimation of Security Deposit only & the Directorate of Medical Education & Research, Mumbai,


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is not bound to purchase the same quantities. The Directorate of Medical Education & Research, Mumbai, also reserves the right to increase or decrease the quantities by plus/minus +/- 25% as per requirement during the tenure of the tender.

7.6 Tenderers must distinctly understand that they will not be allowed

any increase over the rates quoted by them during the contract period. The rates revision may be considered only in case of imposition of duty or removal of duty or increase/decrease in tax by Government, either Central or State & only after necessary legal documentary evidence is produced by the firm in support thereof. However, no supply of drugs/surgical items shall be stopped because of this during contract period & if supply is stopped, the tenderer will be liable for risk purchase & penalty there under.

7.7 The successful tenderer will be required to supply the items at the

rate contract rate during the extension of contract period.

7.8 In the event of tender being accepted, the contract must be signed by the authorized signatory. The authorized signatory must produce power of attorney on notarized stamp paper, authorizing him to sign the contract on behalf of the tenderer.

7.9 In case the rates quoted in the tender are accepted and thereafter if the firm on rate contract sells the items, on the rate contract of

other government institutes in Maharashtra during the validity of DMER rate contract period, below the rates accepted by the Directorate of Medical Education & Research, Mumbai & if such supply is made to other Government Institution, he will promptly inform the Directorate of Medical Education & Research, Mumbai accordingly. Rate contract holder must match the rate & supply at the same rate to DMER for which the tenderer is required to give an undertaking to that effect. If he fails to inform DMER in case of default action to recover the difference in cost will be taken. /or action appropriate action deemed fit will initiated against the rate contract holder.


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7.10 In the event of the prices going down below the rate contracts, the rate contract holder shall promptly furnish such information to

the Directorate of Medical Education & Research, Mumbai, to enable him to revise the rate for subsequent supplies, for which the

tenderer is required to give an undertaking to that effect. 7.11 No supply of items shall be stopped because of reasons like hike in

raw materials and or fuel prices etc. or shortages of raw materials or delay in payments by DDO's during the contract period & if supply is stopped the tenderer will be liable for risk purchase & penalty there under.

7.12 If any tenderer wish to lodge any complaint against the other

tenderer regarding submission of false documents, information etc. the tenderer has to deposit Rs.1,00,000 in form of Demand Draft drawn in favor of Director, Medical Education & Research, Mumbai as a deposit.

7.13 If the complaint after scrutiny is found true the amount deposited will

be refunded. However, if the complaint found to be false and malafide, the deposit will be forfeited and appropriate action will be taken on the complainant.

7.14 If tenderer has any dispute /complaint regarding specification of

items then tenderer can file an appeal before Secretary, Medical Education & Drugs Department, Mumbai, within 5 days from the date of publication of the pre-bid minutes.

7.15 Other than specification of items issue if tenderer has any dispute /

complaints regarding award of tender and / or any specific action taken by the department during the rate contract period, he can file an appeal before Secretary, Medical Education & Drugs Department, Mumbai, within 30 days from the date of award of rate contract and/ or date of issue of such order.


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7.16 All notices intended to be served on the tenderers shall be deemed to have duly served, if sent by registered post & Under certificate of posting/fax/email and received in person to the address mentioned in the tender.

7.17 The successful tenderer have to inform their E-mail address to

all DDO‟s and all correspondence done through E-mail shall be treated as an official correspondence.

8) Security Deposit 8.1 In the event of tender being accepted & intimation being given by

Directorate of Medical Education & Research, Mumbai, the tenderer will have to furnish Security Deposit at the rate of 5 percent of the estimated approximate annual value of quantity. ( Validity 30 months) Security Deposit should be in the form of Bank Guarantee. The minimum limit for Security Deposit will be Rs. 50,000 /- only.

8.2 Provisions for submission of Security Deposit made under

Government Resolution of Department of Industries, Energy & Labour No. BhaKhaS/1088/2512/Udyog-6,dated 2nd January,1992, Para-10.7 Annex. 12- Para- 'Security Deposit', will be applicable to SSI Units/NSIC Registered Small Scale Units in Maharashtra only.

8.3 The Security Deposit in the form of Bank Guarantee should be

submitted within 30 days from the date of issue of acceptance letter, failing which the following action will be taken -

1) Acceptance of tender will be cancelled. 2) EMD will be forfeited. 3) Director reserves the right to take decision on merits to give extension of 15 days for submission of Security Deposit. 4) Inspite of above extention noted in point 3 the tenderer fails to submit the Security Deposit, the tenderer will be debarred from participating in the next tender for said items.


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8.4 When the contract ceases, the pledge will be cancelled & the Security Deposit will be returned to the contractor after recovery of the penalties due, if any from the tenderer. The tenderer need to submit Warranty Indemnity Bond valid for 1 year as mentioned in Government Resolution of Department of Industries, Energy & Labour No. BhaKhaS/1088/2512/Udyog-6,dated 2nd January,1992, Para-10.7 Annex. 12- Para- 'Security Deposit' - Para-2 .

8.5 The security Deposit will be forfeited in the event of breach of any of

the terms & Conditions of the contract . 9) Supplies

9.1 As regards labeling & packing, the provisions of Drugs & Cosmetics Act, 1940 & the rules there under with latest amendments should be distinctively specified on each unit of label.

a) Name of Drug. b) Specification under which the drug is manufactured viz.

I.P./B.P./USP/NFI & its year etc. c) Name of manufacturer with address. d) Name of the importer, License No. e) Drug License number under which the drug has been

manufactured f) Batch number. g) Date of expiry of potency. h) Date of manufacture. i) Net Contents j) Formula with ingredients, its strength as per pharmacopoeia

(year of pharmacopoeia also should be mentioned) k) Specific storage condition. l) Every batch supplied to Government of Maharashtra must have

in printed on its label "For Government of Maharashtra and not for Sale"

m) Specific doses for pediatric and geriatric patients. n) Specific dose measuring droppers/measuring devices should be

provided in case pediatric dosage forms.


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9.2 No product marked with “For Government of Maharashtra and not

for Sale” marking meant for supply under the rate contract should be sold to public.

9.3 In case of Drugs & surgical items/medical device governed by

specification & rules under pharmacopoeias “Drugs & Cosmetic Act 1940” with latest amendments, the Directorate of Medical Education & Research, Mumbai, shall have a right to get samples analyzed by Food & Drugs Administration or F.D.A. approved laboratories at the cost of tenderer. If the tenderer fails to pay the said expenses when called upon to do so, the Directorate of Medical Education & Research, Mumbai, shall without prejudice to his other rights be entitled to recover the same from the tenderer‟s deposits or outstanding dues of the tenderer.

9.4 The maximum time period permitted between the date of

manufacture & date of supply of drugs shall not be more than ¼ of the whole life period of such drugs.

9.5 In case of vaccine & sera the date of supply of these drugs should

not be more than 1/6th of the whole life period. 9.6 All the drugs should be packed & supplied in the prescribed

packing only and as per the standard guidelines & FDA/ISI. 9.7 Active ingredients used in formulation of items quoted shall be of

Pharmacopoeia quality & specifications. 9.8 All vaccines and Biological products should be tested by Central

Drug Lab, Kasauli, Himachal Pradesh and batch wise test report to that effect should be attached with supplies.

9.9 The Rate Contract Holder shall also be responsible for free

replacement of Drugs/items for which there is no expiry date & which are found deteriorated.


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9.10 The ampoules used should be used as per standards laid down under latest Indian Pharmacopoeia, machine made, & long enough to prevent slipping of glass pieces in injection. One cutter should be provided per box of Hundred ampoules. The vials used should also be as per standard laid down in latest Indian Pharmacopoeia.

9.11 The oral liquids supplied in small bottle should be accompanied

by plastic measure correctly marked for desired doses. and leaflet mentioning dose regimen should be inserted with each container. The bottles not accompanying plastic measures will be rejected at the time of supply by D.D.O.

9.12 All the supplies made by a successful tenderer shall bear

following certificate on every Challan & every bill/invoice duly signed.

“The products supplied under this Challan invoice are

manufactured as per standards mentioned in pharmacopoeia/I.S.I. standard, & the product is of standard quality. We are solely responsible for the defect/deviation from the standards, if found any time in future.”

9.13 All supplies of Drugs Items should accompany a quality test

certificate in respect of each batch, mentioning all the tests carried from a laboratory / chemist approved by FDA. The said certificate must be signed by FDA approved laboratory/chemist. The full name, Qualification of FDA- approved laboratory/chemist must be mentioned and the supply without batch wise test report should not be accepted by the concern DDOs.

10) Final Packing 10.1 Final packing shall be done in corrugated fiber boxes, confirming

to IS-1503 & supplementary schedule No. CIGS 121. These shall be suitable & strong enough to bear rail/road transit hazard.


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10.2 Goods should be dispatched at carrier‟s risk failing which they should be properly covered by transit insurance with Government Insurance fund, Mantralaya, Foreshore Road, Mumbai 400 032. However, the supplier will be responsible until the entire store contracted for arrival in good condition at destination.

10.3 The actual quantity of different items which may be required to

be supplied for purchase under this tender shall be informed by respective Direct Demanding Officer (D.D.O.) situated in the State of Maharashtra from time to time as per requirement during the tenure of the Rate Contract.

11 Procedure of Supply & Risk purchase :

11.1 The D.D.O. under the two directorates DMER & Directorate of

Ayush will send the order for drug/surgical items by Registered Post/Under certificate of posting/fax/email to the tenderer. The Rate Contract holder should acknowledge the receipt of the order to the D.D.O. by letter sent by Register post A.D./Under certificate of posting/fax/email within 15 days stating the exact delivery period required & quantities he will be supplying to the D.D.O. Which should not be more than Thirty days from the date of receipt of order. If Rate Contract holder is not in a position to supply the entire quantity indented, he will inform the D.D.O. & also communicate same to Directorate of Medical Education & Research, Mumbai, under registered post letter/Under certificate of posting/fax/email.

11.2 If the Rate Contract holder fails to supply the stores within the

stipulated delivery period of thirty days from the date of receipt of order by Registered Post/Under certificate of posting/fax/email, penalty at the rate of 0.5% of the cost of ordered quantity per week or part thereof supplied late by him will be charged by concerned D.D.O. & deducted from the bill of the contract holder. The maximum limit for the penalty will be 10% of the cost of ordered quantity.


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11.3 If the Rate Contract holder fails to supply the stores within the

stipulated period & according to terms & conditions of this tender or fails to replace rejected store by the concerned D.D.O., within such time as may be stipulated by D.D.O., the concerned D.D.O., shall be entitled to purchase such stores from any other source after confirmation of the Directorate of Medical Education & Research, Mumbai, at such price which ordinarily should not be more than 10% of rate contract price, unless otherwise properly satisfied by concerned D.D.O. The extra expenditure in such cases shall be immediately recovered by the D.D.O., from the outstanding bill of the rate contract holder. If no bills of Rate Contract holder are outstanding with concerned D.D.O. the tenderer should be asked to deposit the amount in form of DD, drawn in favour of DDO. If the rate contract holder fails to deposit the said amount the extra expenditure shall be immediately informed to the Directorate of Medical Education & Research, Mumbai, for further necessary action & recovery from Security Deposit .

11.4 Any other recoveries to be recovered from the contract holder, the

details to be submitted to DMER immediately after expiry of the contract period.

12) Terms of Payment

12.1 80% of payment will be made by D.D.O. within 90 days of the

receipt of store & balance amount after receipt of quality control report from the manufacturer & verification of supplied quantity.

12.2 In any case remaining 20% payment will be made within 120

days from the date of receipt of stores. The supplier may be paid interest at the prevalent rate of interest for any delayed payment, if there is delay in payment without adequate reason. The decision in this case of charging interest for delayed payment will be final and at the discretion of Government.


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12.3 If the rate contract holder submit goods in full quantity along with batch wise test report (wherever applicable e.g for the all items claimed under drug category) the full payment may be made by DDO.

13. Cancellation of contract and debarring of Tenderer The quality of particular batch of drugs supplied to any of the D.D.O. should not be declared substandard in any of the following category.

A) Drugs declared “Misbranded” „Adulterated’ & Spurious‟ as per

Drugs & Cosmetics Act” 1940 amended from time to time. a) The contract of the firm for the said item will be cancelled. b) The extra expenditure incurred if any because of risk purchase

shall be recovered from the contract holder. c) EMD and Security Deposit of the contract holder will be

forfeited. d) Purchase cost of full order irrespective of its consumed

quantity shall be recovered from rate contract holder from the outstanding bills or Security Deposit.

e) The goods which are not used, but belong to the said substandard batch shall be destroyed by the concerned DDO in the presence of/or under intimation to Food and Drug Administration officials. The necessary expenditure incurred for this shall be recovered from the rate contract holder.

f) The rate contract firm will be debarred from participating in tender for next three years.

B) Drugs declared “Not of Standard Quality” as per drugs &

Cosmetics Act, 1940 amended from time to time.

a) The cancellation of contract for the specified item shall be decided by the Directorate of Medical Education & Research, Mumbai, after reviewing the severity of sub-standard quality of item with the FDA Maharashtra. The testing report issued by


28

Food & Drug Administration or F.D.A. approved laboratory regarding quality shall be final & binding on the contract holder.

b) The extra expenditure incurred if any because of risk purchase shall be recovered from the contract holder.

c) Purchase cost of full order irrespective of its consumed quantity shall be recovered from rate contract holder from the outstanding bills or Security Deposit.

d) The goods which are not used, but belong to the said substandard batch shall be destroyed by the concerned DDO in the presence of/or under intimation to Food and Drug Administration officials. The necessary expenditure incurred for this shall be recovered from the rate contract holder.

C ) In case the tenderer quotes prices higher than allowed as per

DPCO, NPPA or higher than MRP or/and fails to supply the goods consistently the tenderers will be declared as a Fraudulent and defaulters

a) The extra expenditure incurred because of extra cost and

because of risk purchase shall be recovered from the contract holder.

b) The Contract holder's EMD, Security Deposit will be forfeited. c) The contract holder will be debarred from participating in the

tender for next three years.

D) In case if found that the tenderer has submitted forged documents the following actions will be taken against the tenders.

a) The police case will be filed against the tenderer. b) The tenderer's EMD, Security Deposit will be forfeited. c) The tenderer will be debarred from participating in the tender

for next three years.

E) In case if found that the goods supplied by the tenderer have been declared "Not of Standard Quality" by FDA in case of more than three items the following actions will be taken


29

a) The extra expenditure incurred if any because of risk purchase

shall be recovered from the contract holder. b) The all rate contracts of the tenderer's will be cancelled. c) The contract holder's EMD, Security Deposit will be forfeited. d) The contract holder will be debarred from participating in the

tender for next three years.

14. All matters of dispute/litigations shall be subject to the jurisdiction of Mumbai.

---------------------------------------------x--------------------------------------------------


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ANNEXURE I (Document of Technical Bid) Forwarding Letter of the Firm From To, The Director, Medical Education & Research, 4th Floor, Govt. Dental College Building, Near C.S.T. Rly. Stn. Mumbai – 400 001.

Sub :- Supply of drugs/surgical items/ medical device,/Ayurvedic Formulations/ consumable at the quoted rate to Government of Maharashtra Institution for the period of two years from the date of finalization of Tender

Sir, I/We am/are Mr.______________________________________________________ working as ___________________________________having authorized signatories of M/s._______________________________________________________________and I/We hereby undertake as follows :- 1) I/We hereby undertake to supply drugs/surgical items/ medical device,/Ayurvedic

Formulations/consumable in areas specified by Directorate of Medical Education & Research, Mumbai, for the period of two years and extension period from the date of finalization of Tender at the rates quoted by me/us & in packing specified in the prescribed tender form which is submitted herewith according to the instruction & the terms & conditions. The duration of the said contract may be extended for a period of three / six months if the Directorate of Medical Education & Research, Mumbai, so desires.

2) The rates quoted against each item of drugs/surgical items/ medical

device,/Ayurvedic Formulations/ consumable by me/us in the tender are inclusive of all taxes, packing, freight charges & duties payable during the contract period.


31

Insurance of the goods, whenever required will be done with the Government Insurance Fund.

3) Necessary documents as required are enclosed herewith in the order in which

they are mentioned. 4) Samples of the drugs/surgical items/ medical device,/Ayurvedic Formulations/

consumable quoted for will be submitted on or before due date or whenever asked for in suitable sealed packing

5) I/We understand that security deposit submitted on entering in contract, is likely

to be forfeited in the event of lapse on my/our part to comply with the terms & conditions of the tender as also on supplying drugs/items of substandard quality or if found to have followed unscrupulous practices apart from the liability of penal action for violating the law of the land.

6) I/We have carefully read & understood the terms & condition of the tender. I/We

shall abide by these conditions. I/We will follow them very scrupulously. I/We have not been black listed/debarred for supply default/ quality defect by Govt. of India or any State Government or any other local self Govt. Institutions at the time of said tender.

7) I/We also take cognizance of the fact that failure to furnish the information called

for by the Directorate of Medical Education & Research, Mumbai, or to comply with any requirement laid down under the conditions will be considered as disqualification & the tender be rejected on that account.

8) I/We undertake to abide by the instructions issued by the Directorate of Medical

Education & Research, Mumbai, from time to time. 9) I/We undertake to bear the cost of Bio-availability testing/testing for quality of the

product supplied whenever the Directorate of Medical Education & Research, Mumbai, or any other authority acting on their behalf decides to do the testing during the contract period.

10) I/We hereby undertake to abide by the terms & conditions of the contract

modified from time, & I/We have signed all the papers of terms & conditions & submitted necessary annexures in prescribed proforma given along with the tender..

11) I/We hereby undertake that all the documents enclosed in Technical bid

(envelope no. one) & commercial bid (envelope no. two ) are true and correct to the best of my knowledge.


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12) I/We hereby undertake to inform immediate any reduction in price of the items for

which contract is awarded and any change in and validity of licenses their location address, constitution of firm etc.

13) I/We have not quoted prices higher than permitted as per DPCO, NPPA or higher

than the market prices and MRP. 14) I/We hereby undertake that all matters of dispute/litigations shall be subject to the

jurisdiction of Mumbai.

Yours Faithfully,

(Signature & stamp of the Tenderer)


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ANNEXURE II (Document of Technical Bid)

PROFORMANCE CERTIFICATE FOR TENDER

FOOD & DRUGS ADMINISTRATION No. Office of the Joint Commissioner Division Date:

PROFORMANCE CERTIFICATE This is to certify that M/s. having Manufacturing premises at and holding license (s) No _________________valid upto in form No. under the Drugs & Cosmetics Act, 1940 & Rules thereunder, on the said address & that the performance of the aforesaid manufacturer of preceding three (3) years is satisfactory, & that I) The drugs/device in respect of which this certificate is issued is/are manufactured on the own licence of the manufacturer & not on the loan licence. II) The manufacturer has his own quality control section. III) During the preceding three (3) years there is no instance of suspension or

cancellation of a part of a licence, issued to the manufacturer, in respect of any of the drugs, surgical items, medical device which are offered by the manufacturer in the tender mentioned in Para 2 below on account of drugs & cosmetic act under tender being not of standard quality.

IV) During the preceding three (3) years there is no instance of suspension or

cancellation of factory licence (full licence) on any account. V) There is no instance wherein any of the drugs, surgical items , medical devices

manufactured by the manufacturer is reported to be spurious or adulterated. VI) No administrative action or prosecution is contemplated or launched against the

manufacturer under the Drugs & Cosmetics Act, 1940 & Rules there under in respect of any of the drugs, surgical items, medical device offered by him in the tender mentioned in paragraph 2 below.


34

VII) During the period of three (3) preceding years, the manufacturer has not been convicted under the Drugs & Cosmetics Act, 1940 & Rules thereunder to undergo imprisonment for more than one day.

VIII) The manufacturer has submitted year wise (April to March) three year's

statement of production & sale of the concerned drugs, surgical items, medical device duly certified by Chartered Accountant, this annual sale is found at least 20 per cent of the quantity of total requirement specified in the tender.

2) This certificate is issued for the purpose of Directorate of Medical Education &

Research, Mumbai, tender for rate contract in respect of the drug mentioned below.

List of items (1) (2) Joint Commissioner, Division. Food & Drugs Administration. *(Vide Government Resolution, Medical Education & Drugs Department, No.DPR.1088/1515/Cr.230/88/MED-4, dt. 31st August 1990 & the Government Resolution of even number. Part – III, dt. 25th February, 1993 & the Government Resolution No. Dpr.1097/538/45/97/Upkram,dt. 26th May 1997)


35

ANNEXURE III (Document of Technical Bid)

AUTHORITY LETTER (On original letter head)

(Authority Letter to be issued by the Manufacturer/Importer for appointing Distributor/Dealer/Agent/importer etc.) I/we undersigned who is/are authorized signatory/signatories of the manufacturing firm M/s. . Address Tal do hereby authorize M/s. to quote the rates/collect the orders/raise the bill for the good manufactured by me/us under the tender published in the Government Gazette No./Tender schedule No. Dated I/We have not authorized any other distributors/agents/dealers/importer etc. for this purpose. I/We have gone through all the terms & conditions of the tender & will be binding on me/us & also on the Distributors/Dealers/Agent/importer M/s. appointed by me/us, during the Whole contract period including extension period of the said contract. Authorised Signatory of the firm for whom Power of Attorney is issued. Seal and Signature with Rubber Stamp Date :


36

ANNEXURE IV (Document of Technical Bid) SAMPLE RECEIPT (To be submitted in TRIPLICATE whenever samples are asked) DIRECTORATE OF MEDICAL EDUCATION & RESEARCH, MUMBAI. Received following samples of drugs/surgical items/ medical device,/Ayurvedic Formulations/consumable from M/s. _ Address ______ __________ ______ For the Tender Enquiry No. Date _

(1) Item No. (2) Name of the Item (3) Batch No. (4) (a) Total No. of Units submitted

(b) Packing offered. (5) Name of Manufacturer. (6) Manufacturing Date. (7) Manufacturing Licence No. (8) Expiry Date. (9) Specific storage condition. (10) Type of Container used. (11) Remarks (12) Import Licence No.

Tenderers Signature & Stamp Receivers Signature & Date. Place : Place : Date : Date : Seal :


37

ANNEXURE – V (Document of Technical Bid)

PROFORMA FOR QUALITY CONTROL DATA (In case of new drugs and new Surgical Drugs, Medical Devices, Ayurvedic Drugs) or In house quality control reports for regular items. (I) Name & address of Tenderer :- 1) Company's standing & experience of formulation --

(a) Year of establishment of the firm. (b) Year of introduction of the product. (c) Literature/Product details.

2) Information of the product :-

(a) Description of the product. (b) Tests -

(i) Dissolution & Disintegration. (ii) Chemical composition.

3) Quality control facilities within the manufacturing unit : 4) Raw Material -- Basic Manufacturer : Yes/No. If no, source of Raw Material. (5) I/We undertake to bear the cost of Bio-availability testing/testing for the quality of

the product whenever the Directorate of Medical Education & Research, Mumbai, or any other Authority acting on their behalf decides to do this Testing.

(6) Date of DCGI approval/Form 10. Signature & Stamp of Tenderer Date :


38

ANNEXURE VI (Document of Technical Bid) PARTICULARS OF THE MANUFACTURERS/IMPORTERS. (Statement of particulars of Drug Manufacturers / Importer etc.) (Put a tick mark -/ where applicable, write N.A. where not applicable) 1) Name & address of the firm :

(a) Places of manufacture: (b) Registered Head Office, Postal Address & Tel. No. (c) Mumbai Office address with Phone No. (If any) email Add. (d) Total Annual Sales turnover in the last financial year :

2) a) Is the firm registered under the Indian Companies Act : Yes/No. 1913 Companies Act I of 1956 or any other Act, in Force if so, furnish certified Photostat copy of certificate of registration.

b) In case of Limited Companies, furnish a copy of the : Yes/No. Memorandum articles of Association. c) In Case of Proprietorship/Partnership firms names of :

1 .Proprietors/Partners/Directors with address (two in Order of % of share) 2._________________

3) Ownership status of the firm (Maharashtra Govt./Other State Govt/Cent. Govt./ Joint Sector/Co-Operative/SSI/Private.) 4) Whether Tendering as a Manufacturer/Agent/Importerr/Repacked/etc. (State your

category.) 5) Details of contact person for any communication regarding Tender :

Name :______________________ Post of the Officer______________ Phone No:_____________________ Mobile no:______________________ Official Email ID:________________

6) Location of other drugs, surgical items, medical device manufacturing

works/factory/factories owned by the firm (if any) 7) a) Details of arrangements for quality control.


39

b) Whole time analytical staff with names, qualifications & residential address of two of them. (c) Equipment for quality control (Name of the important equipment)

(i) Chemical Analysis (ii) Pharmacological Analysis (Including pyrogen testing) (iii) Microbiological Analysis (Including Sterility testing) (iv) Biological Testing for Plastic. (v) Toxicological Testing.

8) In case of manufacturing units : (i) Total Number of whole time chemists (Manufacturing/ production/

Analysis/ Quality Control.) (ii) Whether covered by E.S.I. if so, state number or registration. (iii) Are you registered under the factories Act….

9) In case of repacker, have you furnished details along with Certified Photostat

copy of drug license showing names of items authorities by drug licensing authority.

10) Specify storage facilities:-

(i) Location & address (ii) Floor space available (iii) Cold storage/refrigerators facilities.

11) Specific how much quantity of products were supplied to the Government of

Maharashtra in the last tender year as shown below (use separate sheet if necessary) (including extension period).

Sr. No.

Tender Year

Name of the drug with DMER

Item no Percentage of share allocated

Quantity of orders received with dates

Quantity of supply

Name of the Stores/Institute to whom supply is made.


40

12. Please check & state whether you have submitted the following in Envelope no. One (a) Do you manufacture any product on "Loan Licence" :

Enclosed/ Not Enclosed. (b) Do you manufacture any product on "Loan Licence Basis" Give details

from where you are getting it Manufactured. Details list & addresses of the Firms.

(c) Are you manufacturing products for others firms on "Loan Licence basis" If so, Names of the firms Names of products manufactured & % Utilisation of plant capacity (d) Is the firm in technical collaboration with any foreign manufacturer: Yes/No. I/We hereby declare that particulars furnished above are true to the best of my/our knowledge & belief that if any of the particulars is found to be materially incorrect/misleading my/our tender shall be liable to be rejected & I/we liable for penal action as per terms specified in the "terms & conditions of tender". Date : Full Signature of the Tenderer official Seal & Address.


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Annexure VII (Document of Technical Bid)

Statement showing item-wise total number of units manufactured/ imported and sold during last three financial years. Name of Manufacturer/Importer and address __________________________

Sr. No

Tender item no

Tende Item Name with description

Total Number of units manufactured/ Imported in last 3 financial years from the date of publication of the Tender

Year A Year B Year C

No. of units manufactured/ imported

Sold No. of units manufactured/ imported

Sold

No. of units manufactured/ imported

Sold

Chartered Accountant Sign & Seal Date


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ANNEXURE VIII (Document of Technical Bid)

PRODUCTION / IMPORT CAPACITY NAME OF TENDERER / IMPORTER _______ ADDRESS : _______ ____________ A STATEMENT SHOWING INSTALLED CAPACITY OF EACH QUOTED ITEM PER YEAR WITH EXISTING PLANT & MACHINARY & QUANTITY/IMPORTED QUANTITIES WHICH WILL BE ABLE TO SUPPLY.

Sr. No. Product Schedule Items Installed Capacity/

Import Quantity

Quantity Offered by

the tenderer

I

II

III

IV

*The total annual Quantity imported to be mentioned in case of imported items. (SIGNATURE & STAMP OF TENDERER)

Date :


43

Annexure IX (Document of Technical Bid)

Statement showing details of Product offered with its composition .

(Product offered column should not simply repeat the tender specification rather it must give actual details of the product manufactured by the manufacturer.)

Name of Manufacturer/Importer and Address _________________________

Sr. No

Tender Item No

Item Name & Description in Tender

Product offered with composition by the tenderer

F.D.A. (for drugs)/SSI or IEM (for other) Product Permission Date

DCGI Permission Date in case of New Drugs & FDCs

1

2

3

Signature and Seal of the tenderer

Date :


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ANNEXURE X (Document of Commercial Bid) PRODUCTWISE COSTING IN RESPECT OF ALL THE ITEMS

Name of Tenderer : __ Name of the drug /surgical item/consumable __ Tender No : __ Item No. __ Strength of product Weight Batch size Pack size Name of Raw Material __ Quantity Rate Unit Amount Cost of raw material per batch : Rs. _______ Add losses % : Rs. _________________ Total cost of raw material per batch : Rs. __ Raw material cost per pack : Rs. _______ Name of packing Quantity ______________________ Unit _____Amount ____________ Cost of packing material per batch : Rs. __ Add losses % : Rs. _________________ Total cost of packing material per batch : Rs. __

SUMMARY

Raw Material Conversion cost (details of conversion cost to be submitted in detail) Packing Material Packing Charges Actual Cost Mark up Excise Duty Other Taxes, (Specify in detail if any - Octroi duty, LBT, VAT, Sales Tax etc) Total Rs. ____________________/unit A) Price offered Rs. __________________/unit B) Maximum Retail Price (MRP) Rs. ______________/unit. Price rounded to Rs. _________________________/unit price submitted ( ) NPPA/DPCO Rs. __________________/unit Signature and Seal of the tenderer Date


45

Annexure XI (Document of Commercial Bid)

Statement showing brief break up of taxes & costing as regards rates offered in the tender.

SR.NO.

Tender Item No.

Tender Item Name

UNIT PRICE as per asked in tender (e.g. Rs. Per pack of tablet/per tube/per vial/ per bottle/ per piece/ catheter etc.)

Basic Price per unit

Price including mark up / unit

Ex Factory Unit price

Price including Unit price offered in tender

Excise duty

Custom duty

Sales Tax / VAT

Octroi and other taxes

Signature & Seal of the tenderer Date : ------------------------------------------------------------------------------------ Annexure XII (Document of Commercial Bid)

Statement showing comparative prices as regards rates offered in the tender.

SR.NO. Tender Item No.

Tender Item Name

Unit price offered in tender (Rs)

MRP price per unit

Price as per DPCO NPPA per unit

Unit price offered in other Tenders

BMC Mumbai

ESIC New Delhi

DGS&D Delhi

Any other State Govt. Tender /DHS

Signature and seal of tenderer

Date :


46

POWER OF ATTORNEY

For Signing the tender document KNOW ALL MEN BY THESE PRESENTS THAT I ______________________________________________ ___________________________ (“the Grantor”), M/s ) Name of the company ___________ ___________________________________________________________________________ DO HEREBY NOMINATE APPOINT AND CONSTITUTE _______________________________________ ___________________________________________, son/daughter of _______________________________ ______________________________ („the Attorney‟ who has subscribed his/her signature hereunder in token of identification) and at present (Designation and company address) ___________________________________________________________________________ to be my lawful Attorney in my name and on my behalf to do any one or all of the following acts, deeds, matters, and things, namely: - 1. relating to the Facilities and sign such writings /letters / papers / tender documents in token of my acceptance of the terms and conditions therein contained of tender No.__________and negotiate the rates on behalf of our company…………………………….. ……………………... 2. To sign forms, documents , rate contract agreement and papers required for the purpose of all acts related to the rate contract. AND I agree to ratify all lawful acts, deeds, matters, and things done by my Attorney pursuant to the powers herein before mentioned. In Witness Whereof, I ______________________________________ have hereunto set and subscribed my hands at ____________________ on _______________________. SIGNED and DELIVERED by _________________________ in the presence of 1. _______________________ 2. _______________________ (Signature of Company Owner/Authority) I accept _________________________ Specimen signature of ________________________, the Attorney for ________________.

INSTRUCTIONS: 1. The Power of Attorney is to be executed on a non-judicial stamp paper of the requisite value as per the stamp duty prevalent in the respective state (Rs. 100 in the State of Maharashtra). 2. Power of Attorney should be notarized by a Notary Public.


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Proforma for Earnest Money Deposit (EMD) in the form of

Bank Guarantee In Rs. 100/ Stamp paper

To, Directorate of Medical Education & Research,

Drug Purchase Cell, 4th Floor, Gove. Dental Medical College building,

St. George Hospital Compound,

Mumbai - 400 001.

In Consideration of the Governor of Maharashtra (hereinafter called the Government) having

agreed to exempt, M/s --------------------------------------------------- (hereinafter called the "the

said Contractor) from the demand, under the terms and conditions of E-Tender Notice No ------

----------------- E- Tender Sr. No -----------------------/2014 Tender Name --------------------------

--- issued by the Government to the said Contractor for sr. no. 2.3 of Earnest Money Deposit for

the fulfillment by the said contractor (s) of the terms and conditions contained in the said

Tender, on production of a Bank Guarantee for Rs. ---------------- (Rupees ------------------------ )

We, -------------------------------------------- (hereinafter called the bank) do hereby undertake to

indemnify & keep indemnified the Government to the extend of Rs. ------ against any loss or

damage caused to or suffered by the Government by reason of any breach by the said contractor

of any of the terms & conditions contained in the said tender.

We, -------------------------------- further agree that the Guarantee herein contained shall remain in

full force & effect during the period that would be taken for the finalizations of the said tender &

that it shall continue to be enforceable till the tender is finally decided or till date ------------------

-------------------------------------- certifies that the terms & condition of the said tender have been

fully & properly carried out by the said contractor (s) and accordingly discharge the guarantee,

subject, however, that the Government shall have no right under this bond after expiry of --------

--------------------from the date of its execution.

We ............................................lastly undertake not to revoke this Guarantee during its

currency except with the prior consent of the DMER, Mumbai in writing.

Notwithstanding anything to the contrary contained herein above.

a) Our liability under the Bank Guarantee shall not exceed to Rs. ------------

(Rupees -------------------------)

b) This Bank Guarantee shall be valid up to ........................

c) We are liable to pay the Guaranteed amount or any part thereof under this Bank

Guarantee only & only if you serve upon us written claim or demand on

or before dt. --------------


48

d) “Notwithstanding anything contrary contained in any law for the time being in

force or banking practice, this bank’s letter of credit shall not be assignable or

transferable by the beneficiary. Notice or invocation by any person such as assignee,

transferee or agent of beneficiary shall not be entertained by the bank. Any invocation of

guarantee can be made only by the beneficiary directly.”

DATE : SIGNATURE & STAMP OF THE BANK


49

FORMAT OF AGREEMENT

An agreement made this ---------------------------------------------------------------------

-------------------------------------------------------------------- (hereinafter called" the contractor") of

the one part Purchasing officer and the Government of Maharashtra (hereinafter called "the

Government") of the other part.

Whereas the contractor has tendered to the Government for supply to the Purchasing

officer (hereinafter called of the articles specified in the schedule (attached) as per delivery

instruction given in the acceptance of tender vide letter No.----------------- at the respective

prices or rate mentioned opposite to the said articles in the column provided for the purpose and

whereas such tender has been accepted and the contractor has deposited with the Director a sum

of Rs. ------------------- (Rs. --------------------------------------------------) and Rs ----------------------

-- (Rs. ------------------------------------------------------) for due fulfillment of this agreement.

NOW IT IS HEREBY AGREED between the parties hereto as follows :-

1) The contractor has accepted the contract on the terms and condition set out in the tender

notice No. -------------------------------------------------------- as well in the Acceptance Latter No : -

---------------------- Dt: ---------------------, which will hold good during the period of this

agreement.

2) Upon breach by the contractor of any of the condition of the agreement, the Director may

by a notice in writing resolving, determine and put an end to this agreement without prejudice to

the right of the Government to claim damages for antecedent breaches thereof on the part of the

contractor and also to responsible compensation for the loss occasioned by the failure of the

contractor to fulfill the agreement as certified in writing by the Director which certificate shall to

conclusive evidence of the amount of such compensation payable by the contractor to the

Government.

3) Upon the determination of this agreement whether by effusion of time or otherwise the said

deposit shall after the expiration of 30 months from the date of such determination be returned

to contractor but without interest and after deduction there from any sum due by the contactor

to the Government under the terms and condition of this agreement.

4) This agreement shall remain in force until the expiry of the date of delivery of material but

notwithstanding herein or in the tender and acceptance forms contained the Government shall

not be bound to take the whole or any part of the estimated quantity herein or therein mentioned

and may cancel the contract at any time upon giving one month s notice in writing without

compensating the contractor.

5) In witness whereof the said M/s -------------------------------------------------------------, Be hath

set his hand hereto and has on behalf of the of Government of Maharashtra affixed his hand

and seal hereto the day and year first above written.


50

6) Notices in connection with the contract may be given by the Director of Medical Education

& Research or any gazetted officer of the Store Purchase Organization, authorized by the

Director.

7) Except the circumstances beyond control (force majeure) the contractor fails to deliver the

store in accordance with the condition mentioned in the Acceptance of Letter, the purchasing

Officer shall, at this option be entitled either

a. to recover from the contractor as agreed liquidated damages or by way

of penalty a sum not exceeding 0.5 percent of the price of the stores which the contractor has

failed to deliver as aforesaid for each week or part of week supplied late by him will be charged

by concerned D.D.O & deducted from the bill of the contract holder. The maximum limit for

the penalty will be 10% of the cost of ordered quantity. during which the delivery of such

store may be in areas,

b. To purchase elsewhere, after giving due notice to the contractor on the account and

at the risk of the contractor the stores not delivered or other similar description

c. (where other exactly complying with the particular are not, in the

opinion of the purchasing Officer which shall be final, readily procurable) without cancelling

the contract in respect of consignment not yet due for delivery, Or

d. To cancel the Contract

8) In the event of action being taken under (a), (b), or (c) the contractor shall be liable for any

loss which the Purchasing Office, may sustain on that account. The recovery on account of

agreed liquidated damage or by way of penalty under (a) above will be made by deducting the

amount in the bills and the recovery of any loss, which the Purchasing office may sustain under

(b) and (c) should be made good by a credit not within the stipulated period for the purpose.

9) In the event of non recovery of any of the above dues the amount will be recovered from the

Security Deposit submitted to DMER as per information received from the DDO's.

10) The Contractor has fully read, understood & shall abide by all the term and conditions as

stipulated in Tender Document, failing which the Contract Agreement is liable to be terminated

at any time without assigning any reason by the DMER.

11) Any changes/ amendments if required to be incorporated in the Agreement at a later stage

shall be discussed & mutually agreed by both the parties and supplementary agreements shall be

binding on both the parties and shall form the part of this agreement.

12) This Contract Agreement shall be governed by and construed in accordance with the laws

of Republic of India.

Mumbai.

Witness with full Name and Address

1) ----------------------------

2) -------------------------- Contractor :


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Proforma for Security Deposit in the form of Bank Guarantee In Rs. 100/ Stamp paper

To, Directorate of Medical Education & Research,

Drug Purchase Cell, 4th Floor, Gove. Dental Medical College building,

St. George Hospital Compound,

Mumbai - 400 001.

In Consideration of the Governor of Maharashtra (hereinafter called the Government) having

agreed to exempt, M/s --------------------------------------------------- (hereinafter called the "the

said Contractor) from the demand, under the terms and conditions of E-Tender Notice No ------

----------------- E- Tender Sr. No -----------------------/2014 Tender Name --------------------------

---in the said Agreement issued by the Government to the said Contractor for sr. no. 9 of

Security Deposit for the fulfillment by the said contractor (s) of the terms and conditions

contained in the said Tender, on production of a Bank Guarantee for Rs. ---------------- (Rupees

-------------------------- )

We, -------------------------------------------- (hereinafter called the bank) do hereby undertake to

indemnify & keep indemnified the Government to the extend of Rs. ------ against any loss or

damage caused to or suffered by the Government by reason of any breach by the said contractor

of any of the terms & conditions contained in the said agreement.

We, -------------------------------- further agree that the Guarantee herein contained shall remain in

full force & effect during the period for the performance of the said Rate Contract Agreement,

& that it shall continue to be enforceable till all the dues of Government under or virtue of the

Rate Contract Agreement have been fully paid and it claims satisfied or discharged or till

DMER certifies that the terms & condition of the said tender have been fully & properly carried

out by the said contractor (s) and accordingly discharge the guarantee, subject, however, that the

Government shall have no right under this bond after expiry of ----------------------------from the

date of its execution.

We ............................................lastly undertake not to revoke this Guarantee during its

currency except with the prior consent of the DMER, Mumbai in writing.

Notwithstanding anything to the contrary contained herein above.

a) Our liability under the Bank Guarantee shall not exceed to Rs. ------------

(Rupees -------------------------)

b) This Bank Guarantee shall be valid up to ........................

c) We are liable to pay the Guaranteed amount or any part thereof under this

Bank Guarantee only & only if you serve upon us written claim or demand

on or before dt. --------------

d) “Notwithstanding anything contrary contained in any law for the time being in

force or banking practice, this bank’s letter of credit shall not be assignable or

transferable by the beneficiary. Notice or invocation by any person such as assignee,

transferee or agent of beneficiary shall not be entertained by the bank. Any invocation of

guarantee can be made only by the beneficiary directly.”


52

DATE : SIGNATURE & STAMP OF THE BANK