directorate of health services, 4th floor, satpura … of health services, 4th floor, satpura...

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Directorate of Health Services, 4 th Floor, Satpura Bhawan, Bhopal – 462 004. Ref.No.001/DRUG/GOMP/2009-10 16.04.2010 To All tenderers, (as per list) Sirs, Sub: GOMP – Tender for the Supply of Drugs and Medicines to various Medical Health Institutions of Govt. of Madhya Pradesh for the year 2010-2011 - Cover “B” Opening - Reg. Ref: Tend. Ref.No.001/DRUG/GOMP/2009-10, Dated.20.01.2010 ----- The Cover “B” (Commercial Bid) of the tender for the supply of Drugs and Medicines to various Medical Health Institutions of Govt. of Madhya Pradesh for the year 2010-2011 will be opened on 20.04.2010 (11.00 A.M.) at Director Medical Services, 3 rd Floor, 417, Pantheon Road, Egmore, Chennai – 600 008. You are requested to attend the above meeting with 66 copies of the rates quoted by you in A4 Size Sheets. Joint Director (Procurement) Drug Cell, DHS, MP.

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Page 1: Directorate of Health Services, 4th Floor, Satpura … of Health Services, 4th Floor, Satpura Bhawan, Bhopal – 462 004. Ref.No.001/DRUG/GOMP/2009-10 16.04.2010 To All tenderers,

Directorate of Health Services, 4th Floor, Satpura Bhawan,

Bhopal – 462 004.

Ref.No.001/DRUG/GOMP/2009-10 16.04.2010 To All tenderers, (as per list) Sirs,

Sub: GOMP – Tender for the Supply of Drugs and Medicines to various

Medical Health Institutions of Govt. of Madhya Pradesh for the year 2010-2011 - Cover “B” Opening - Reg.

Ref: Tend. Ref.No.001/DRUG/GOMP/2009-10, Dated.20.01.2010

-----

The Cover “B” (Commercial Bid) of the tender for the supply of Drugs and

Medicines to various Medical Health Institutions of Govt. of Madhya Pradesh for

the year 2010-2011 will be opened on 20.04.2010 (11.00 A.M.) at Director Medical

Services, 3rd Floor, 417, Pantheon Road, Egmore, Chennai – 600 008.

You are requested to attend the above meeting with 66 copies of the

rates quoted by you in A4 Size Sheets.

Joint Director (Procurement)

Drug Cell, DHS, MP.

Page 2: Directorate of Health Services, 4th Floor, Satpura … of Health Services, 4th Floor, Satpura Bhawan, Bhopal – 462 004. Ref.No.001/DRUG/GOMP/2009-10 16.04.2010 To All tenderers,

List of tenderers were eligible for cover ‘B’ opening 1 Abbott India Limited 3-4, Corporate Park, Sion-Trombay Road, Mumbai-400 071. Ph: Fax: 2 Adroit Pharmaceuticals Pvt. Ltd., 46, Garoba Maindsn, Basti Precinct, Nagpur - 440 008 Ph: 0712-2766731 Fax: 0712-2730529 3 Agappe Diagnostics Ltd. Agappe Hills, Pattimattom PO, Ernakulam Dist. Kerala - 683 562. Ph: 0484-2689992 Fax: 0484-2689666 4 Anglo-French Drugs & Industries Ltd. Plot No.4, Phase-II, Peenya Industrial Area, Peenya, Bangalore - 560 058. Ph: 080-23156757 Fax: 080-23389963 5 Arbro Pharmaceuticals Ltd., 6/14, Kirti Nagar, Industrial Area, New Delhi - 110 015 Ph: 011-45854585 Fax: 011-45854500

Page 3: Directorate of Health Services, 4th Floor, Satpura … of Health Services, 4th Floor, Satpura Bhawan, Bhopal – 462 004. Ref.No.001/DRUG/GOMP/2009-10 16.04.2010 To All tenderers,

6 AstraZeneca Pharma India Limited 12th Mile on Bellary Road, Venkatala, Kattigenahalli Village, Bangalore - 560 063. Ph: 080-28563070 Fax: 080-28462208 7 Aventis Pharma Ltd., Aventis House, 54-A, Sir Mathuradas, Vasanji Road, Andher (East), Mumbai - 400 093 Ph: 022-28278000 Fax: 022-28370939 8 Bal Pharma Ltd., 21 & 22, Bommasandra Industiral Area, Bangalore - 560 099. Ph: 080-41570813 Fax: 080-41570820 9 Bharat Biotech International Ltd., Genome Valley, Shameerpet, Hyderabad - 500 078 Ph: 040-23480567 Fax: 040-23480560 10 Bharat Serum & Vaccines Ltd., Plot.No.A-371-372, Road-27 Wagle Industrial Estate, Thane - 400 064 Ph: 022-25821399 Fax: 022-25823640 11 Biocon Limited 20th KM Hosur Road, Electronics City,

Page 4: Directorate of Health Services, 4th Floor, Satpura … of Health Services, 4th Floor, Satpura Bhawan, Bhopal – 462 004. Ref.No.001/DRUG/GOMP/2009-10 16.04.2010 To All tenderers,

Bangalore - 560 100. Ph: 080-28082808 Fax: 080-28523423 12 Biological E. Ltd., 18/1 & 3, Azamabad, Hyderabad - 500 020 Ph: 040-30213999 Fax: 040-27615309 13 Chiron Behring Vaccines Pvt. Ltd. 501, Shree Amba Shanti Chambers, Andheri Kurla Road, Andheri(East), Mumbai-400 059. Ph: 022-66930820 Fax: 022-66930823 14 Ciron Drugs & Pharmaceuticals (P) Ltd., N-118, M.I.D.C., Boisar, Tarapur, Dist., Thane - 401 506 Ph: 02525-270408 Fax: 02525-261396 15 D.J.Laboratories Pvt. Ltd., 255, Sector I, Industrial Area, Pithampur, Dist. - Dhar Ph: 07292-329310 Fax: 0731-4042429 16 Daffodills Pharmaceuticals Ltd Jawahar Nagar, Rohta Road Meerut. Ph: 0121-2681270 Fax: 0121-2661108 17 Emil Pharmaceutical Indu. Pvt. Ltd. N-49,50 & 51, MIDC, Tarapur,

Page 5: Directorate of Health Services, 4th Floor, Satpura … of Health Services, 4th Floor, Satpura Bhawan, Bhopal – 462 004. Ref.No.001/DRUG/GOMP/2009-10 16.04.2010 To All tenderers,

Village Kumbhavali, Taluka-Palghar, Dist. Thane, Boisar-401 506. Ph: 02525-270286 Fax: 02525-273358 18 Erica Niramaya Ethicals Pvt. Ltd. F-1/2, MIDC, Jejuri, Pune - 412 303. Ph: 02115-254790 Fax: 02115-254790 19 Fresenius Kabi India Pvt. Ltd. A-3, MIDC, Ranjangaon, Tal. Shirur, Dist. Pune - 412 209. Ph: 02138-232283-85 Fax: 02138-232282 20 Galpha Laboratories Limited. A1-6104-3, G.I.D.C. Industrial Estate, Ankaleshwar - 393 002 Ph: 02646-20223 Fax: 02646-38751 21 Glenmark Pharmaceuticals Ltd., B/2, Mahalaxmi Chambers, 22, Bhulabhai Desai Road, Mumbai - 400 026. Ph: Fax: 22 Haseeb Pharmaceuticals Pvt. Ltd., Plot.No.F 9/15, M.I.D.C., Nagpur - 440 016 Ph: 07104-36530 Fax: 07104-36156 23 Health Biotech Ltd. Nalagarh Road, Baddi - 173 205.

Page 6: Directorate of Health Services, 4th Floor, Satpura … of Health Services, 4th Floor, Satpura Bhawan, Bhopal – 462 004. Ref.No.001/DRUG/GOMP/2009-10 16.04.2010 To All tenderers,

Distt. Solan Ph: 01795-245526 Fax: 24 Hindustan Antibiotics Ltd., Mumbai Pune Road, PIMPRI Pune - 411 018 Ph: 020-7245331 Fax: 020-7425327 25 Hindustan Institute of Pharmakon Ltd. 96-A, Industrial Area, Mandideep Distt., Raisen (M.P.) Ph: Fax: 26 IPCA Laboratories Limited P.O. Sejvata, District Ratlam. Ph: Fax: 27 Ind-Swift Limited 781, Industrial area, Phase-II, Chandigarh - 160 002 Ph: 0172-2638781 Fax: 0172-2652242 28 Indian Immunologicals Limited 'Rakshapuram', Gachibowli Post, Hyderabad - 500 032. Ph: 040-23000211 Fax: 040-23000213

Page 7: Directorate of Health Services, 4th Floor, Satpura … of Health Services, 4th Floor, Satpura Bhawan, Bhopal – 462 004. Ref.No.001/DRUG/GOMP/2009-10 16.04.2010 To All tenderers,

29 Indoco Remedies Limited Village Katha, Baddi, Distt. Solan Ph: Fax: 30 Innova Captab 81-B, E.P.I.P., Phase-I, Jharmajri, Baddi, Dist. Solan. Ph: 9218452184 Fax: 01795-271850 31 Inven Pharmaceuticals Pvt. Ltd. Village Kalsada Khurd, Distt. Dhar. M.P. Ph: 32 Ives Drugs (India) Pvt. Ltd., 504, Chetak Centre, 12/2, R.N.T.Marg, Indore - 1 Ph: 0731-2518604, 2518605 Fax: 0731-2510887 33 J.Mitra & Co. Pvt. Ltd. A-180-181, Okhla Ind. Area, Phase-I, New Delhi - 110 020. Ph: 011-26818971 Fax: 011-26810945 34 Jackson Laboratories (P) Ltd., Majitha Road, Bye Pass, P.O.Khanna Nagar, Amritsar - 143 004 Ph: 0183-2423310, 2422228, 2571871 Fax: 0183-2423072

Page 8: Directorate of Health Services, 4th Floor, Satpura … of Health Services, 4th Floor, Satpura Bhawan, Bhopal – 462 004. Ref.No.001/DRUG/GOMP/2009-10 16.04.2010 To All tenderers,

35 Kwality Pharmaceuticals (P) Ltd. 6th Mile Stone, Village Nag Kalan, Majitha Road, Amristar - 143 601. Ph: 0183-2774321 Fax: 0183-2774477 36 La-Chemico Pvt. Ltd. Taki Road, P.O.Kadambagachi, P.S.Barasat, Dist.24-Parganas(N), West Bengal-743 221. Ph: 033-25524980 Fax: 37 Legend Drugs & Formulations Pvt. Ltd., Plot No. 53, III Phase, Jeedimetla, Hyderabad - 500 054 Ph: 040-23095939 Fax: 040-23713602 38 Medibios Laboratories Pvt. Ltd. J-76, M.I.D.C. Tarapur, Taluka-Palghar, Boisar-401 506., Thane. Ph: 02525-271339 Fax: 02525-279574 39 Medicamen Biotech Limited. SP-1192 A & B, Phase-IV, Industrial Area, Distt. Alwar, Bhiwadi - 301 019. Ph: 01493-221291 Fax: 01493-221948 40 Medico Remedies Pvt. Ltd., 8-9, Dewan & Sons Udyog Nagar, Palghar (West), Dist. Thane, Maharashtra Ph: 02525-327113 Fax: 02525-255287

Page 9: Directorate of Health Services, 4th Floor, Satpura … of Health Services, 4th Floor, Satpura Bhawan, Bhopal – 462 004. Ref.No.001/DRUG/GOMP/2009-10 16.04.2010 To All tenderers,

41 Medipol Pharmaceuticals India Pvt. Ltd., 1199/3, Bhud, Baddi, Distt. Solan. Ph: 01795-202593 Fax: 42 Meyer Organics Pvt. Ltd. A-177, Road No.16-Z, Wagle Estate, Thane - 400 604. Ph: 022-25817000 Fax: 022-25817002 43 Moraceae Pharmaceuticals Pvt. Ltd. A-66, Eldeco Sidcul Industrial Park, Sitarganj, Udham Singh Nagar, Uttrakhand. Ph: Fax: 44 Olive Healthcare 197/2, Athiawad, Dabhel Village, Nani Daman, Daman. Ph: 0260-2244370 Fax: 0260-2244375 45 Osmed Formulations (P) Ltd. 56,57, Industrial Area, Maxi Road, Ujjain, M.P.-456 010. Ph: Fax: 46 Parentral Drugs (India) Ltd., Village Asarawad, Post Dudhia Dist, Indore - 453 331 Ph: 0731-2863359

Page 10: Directorate of Health Services, 4th Floor, Satpura … of Health Services, 4th Floor, Satpura Bhawan, Bhopal – 462 004. Ref.No.001/DRUG/GOMP/2009-10 16.04.2010 To All tenderers,

Fax: 47 Pentagon Labs Ltd., 16C - 16D, Industrial Area No.1, AB Road, Dewas, M.P.-455 001. Ph: 07272-403261 Fax: 07272-403261 48 Poddar Pharmaceuticals Pvt. Ltd., E-35, Industrial Area, Hardwar - 249 401 Ph: 01334-227975 Fax: 01334-222026 49 Prem Pharmaceuticals Osan Bag, P.O., Palda Indore - 452 003. Ph: 0731-2461241 Fax: 0731-2492180 50 Priest Pharmaceuticals W-24, (A) M.I.D.C., Amravati - 444 607. Ph: 0721-2566008 Fax: 0721-2566008 51 Raman & Weil (P) Ltd Gala No.4, Chirag Industrial Complex, Somnath Road, Dabhel, Daman. Ph: 0260-2242677 Fax: 022-22023042 52 S.P.M.Drugs Pvt. Ltd., S.F.52/1, Main Road, K.R.Palayam, Bhavani - 638 301 (TamilNadu) Ph: 0424-2230517

Page 11: Directorate of Health Services, 4th Floor, Satpura … of Health Services, 4th Floor, Satpura Bhawan, Bhopal – 462 004. Ref.No.001/DRUG/GOMP/2009-10 16.04.2010 To All tenderers,

Fax: 0424-2230517 53 Salus Pharmaceuticals 480/211, Vill. Harripur, P.O. Gurumajra, Nalagarh Road, Baddi-173 205, Dist. Solan. Ph: 01795-645795 Fax: 54 Sanjivani Parentral Ltd. R-40, TTC, Rabale, Thane-Belapur Road, Navi, Mumbai - 400 701. Ph: 022-67290900 Fax: 022-67290930 55 Sanofi Synthelabo (India) Ltd. 54/A, Sir Mathuradas Vasanji Road, Andheri (E), Mumbai - 400 093. Ph: 022-28278000 Fax: 022-28370939 56 Sara Pharmaceuticals 4, Industrial Estate, Konam, Nagercoil - 629 004 Ph: 04652-261527 Fax: 04652-264846 57 Serum Institute of India Ltd., 212/2, Hadapsar, Pune - 411 028. Ph: Fax: 58 Soft Medicaps Ltd. 50-B, 52-A, 53-C, 53-D,

Page 12: Directorate of Health Services, 4th Floor, Satpura … of Health Services, 4th Floor, Satpura Bhawan, Bhopal – 462 004. Ref.No.001/DRUG/GOMP/2009-10 16.04.2010 To All tenderers,

Industrial Area, No.1 A.B.Road, Dewas - 455 001. Ph: 07272-258377 59 Synergy Diagnostics Pvt. Ltd., 127-128, Laxmi Market, 1st Floor, Vartak Nagar, Thane (West) - 400 606 Ph: 022-41424040 Fax: 022-25855120 60 Tam-Bran Pharmaceuticals Ltd. Plot No.212-216, Sector-1, Pithampur, Dist. Dhar. M.P. Ph: Fax: 07292-400783 61 The Swastik Pharmaceuticals 44-1-18/2, Gunadala, Vijayawada - 520 005 Ph: 0866-2450440 Fax: 0866-2450294 62 Torrent Pharmaceuticals Ltd., Ahmedabad - Mehsana Highway, Taluk Kadi, Village: Indrad, Dist. Mehsana Ph: 02764-233671 Fax: 02764-233676 63 Uni Jules Life Sciences Ltd. B-35, MIDC, Kalmeshwar, Dist. Nagpur. Ph: Fax:

Page 13: Directorate of Health Services, 4th Floor, Satpura … of Health Services, 4th Floor, Satpura Bhawan, Bhopal – 462 004. Ref.No.001/DRUG/GOMP/2009-10 16.04.2010 To All tenderers,

64 Unilab Chemicals & Pharmaceuticals (P) Ltd., W/32, M.I.D.C., Phase-II, Sagaon, Dombivli (East), Pin - 421 204 Ph: 0251-2871942 Fax: 65 United Biotech (P) Ltd. FC/B-1(Extn), Mohan Co-operative Industrial Estate, Mathura Road, New Delhi - 110 044. Ph: 011-40651100 Fax: 011-66607091 66 VINS Bioproducts Ltd., Survey No.291, Erdanur - 502 329 Andhra Pradesh Ph: 08455-220296, 220092, 040-23354550 Fax: 040-23350410 67 Vivek Pharmachem (India) Ltd., A-1, Sethi Colony, Jaipur - 302 004 Ph: 141-2602100, 2602003, 2615333 Fax: 141-2603657 68 Wallace Pharmaceuticals (P) Ltd. Nirancal Road, Curti, Ponda - 403 409. Goa. Ph: 0832-2330359 Fax: 0832-2330681 69 Zim Laboratories Limited B-21,22, MIDC Area, Kalmeshwar - 441 501. Ph: 07118-271370 Fax: 07118-271470

Page 14: Directorate of Health Services, 4th Floor, Satpura … of Health Services, 4th Floor, Satpura Bhawan, Bhopal – 462 004. Ref.No.001/DRUG/GOMP/2009-10 16.04.2010 To All tenderers,

Directorate of Health Services, 4th Floor, Satpura Bhawan,

Bhopal – 462 004. Ref.No.001/DRUG/GOMP/2009-10 16.04.2010

To All the tenderers, (as per list)

Sir,

Sub: GOMP – Tender for the Supply of Drugs and Medicines to various

Medical Health Institutions of Govt. of Madhya Pradesh for the year 2010-2011 - Inspection of manufacturing Premises – Rejection of Tender – Reg.

Ref: Tend. Ref.No.001/DRUG/GOMP/2009-10, Dated.20.01.2010

--------

Your firm had participated in the tender for the supply of Drugs and

Medicines for the year 2010-11. A team consisting of specialists had inspected

your manufacturing unit on __________ and on inspection it was observed that

your firm has not followed the GMP as per revised schedule M.

The extract of the report submitted by the team is at Annexure. Hence

your firm has been disqualified and your tender is rejected and appropriate

action will be taken to forfeiture of Earnest Money Deposit (EMD) for violation

of affidavit furnished by you in Annexure – III of tender documents.

Joint Director (Procurement) Drug Cell, DHS, MP.

Encl: Annexure

Page 15: Directorate of Health Services, 4th Floor, Satpura … of Health Services, 4th Floor, Satpura Bhawan, Bhopal – 462 004. Ref.No.001/DRUG/GOMP/2009-10 16.04.2010 To All tenderers,

List of tenderers were rejected on factory inspection:-

1. M/s. Supermax Laboratories Plot No.40, Pharma City, Selaqui Industrial Area,

Dehradun - 248 001. Ph: 0135-6526937 Fax: 0135-2698214

2. M/s. Shivam Enterprises Suketi Road, Kala Amb, Distt.Sirmour (HP). Ph: 9355023856

Fax: 3. M/s. Arvind Remidies Ltd., 38, 39 & 40, Sidco Industiral Estate, Kakkalur, Thiruvellore - 602 003. Ph:

Fax: 4. M/s. Elegant Drugs Pvt. Ltd., R.S. No 59/3A, Chalmatti Village Kalghatgi Taluk, Dharwad Dist. - 580 204.

Ph: 08370-64650 Fax: 0836-253386

5. M/s. Sterling Lab 57, Sipcot Industrial Complex, Hosur - 635 126 TamilNadu.

Ph: 04344-576071 Fax: 04344-578303

Page 16: Directorate of Health Services, 4th Floor, Satpura … of Health Services, 4th Floor, Satpura Bhawan, Bhopal – 462 004. Ref.No.001/DRUG/GOMP/2009-10 16.04.2010 To All tenderers,

6. M/s. Sudarshan Pharmaceuticals Pvt. Ltd. 17B/18A, Sanwer Road, Industrial Area, Indore-452 015.

Ph: 0731-4047243 Fax:

7. M/s. Kabra Drugs Ltd. Plot No.26, Sector 'A', Sanwer Road, (Indl.Area), Indore - 452 003.

Ph: 0731-2722222 Fax: 0731-2722756

8. M/s. Maxwell Lifescience Pvt. Ltd., T-53, M.I.D.C., Tarapur, Tal. Palghar, Dist. Thane.

Ph: 02525-275042 Fax: 02525-274895

9. M/s. Bengal Chemicals & Pharmaceuticals Ltd., 164, Maniktala Main Road, Kolkata - 700 054. Ph:

Fax: 10. M/s. Rajat Pharmachem Ltd. Plot No.307-311, G.I.D.C., At & Post. Ankleshwar - 393 002. Dist. Bharuch, Gujarat.

Ph: 02646-227886 Fax: 02646-227881

Page 17: Directorate of Health Services, 4th Floor, Satpura … of Health Services, 4th Floor, Satpura Bhawan, Bhopal – 462 004. Ref.No.001/DRUG/GOMP/2009-10 16.04.2010 To All tenderers,

Tender for the supply of Drugs & Medicines of Govt. of Madhya Pradesh for the year 2010-11

The following firms were rejected for the following reasons:- I. M/s. Supermax Laboratoires, Dehradun:-

1. The walls in all the rooms were found to be chipped in the tablet,

capsule and liquid oral sections.

2. Dampers was noted on the walls with coloured patches in the

coating, compressing and formulation section.

3. GMP not followed –Mat present at the entrance to granulator

section.

4. Quality control section:-

i) Reagent bottles are not labeled promptly.

ii) Bottles and other material stored at floor level due to want of

cabins.

iii) Tests for pathogen not being conducted on the water and

empty gelatin capsules, cultures of bacteria not shown, but

test report were produced.

a) EHG cap schedule B.No.117032010 dt. of analysis

06.02.2010 – No microbiological test done on this batch

no. capsule

b) Deionised water test on 19.01.2010 – No microbiological

test was done.

5. Medical examinations of workers is not being done.

6. Only Tab. Paracetamol (500mg) IP, Ranitidine HCL tab IP are

endorsed under generic name, all others are endorsed as brand

names.

7. No qualified microbiologist. No endorsement for Mr. Ravindra

Singh not produced.

8. Pollution control certificate, not validated beyond 31.03.08.

Page 18: Directorate of Health Services, 4th Floor, Satpura … of Health Services, 4th Floor, Satpura Bhawan, Bhopal – 462 004. Ref.No.001/DRUG/GOMP/2009-10 16.04.2010 To All tenderers,

II. M/s. Shivam Enterprises, Himachal Pradesh:-

1. The factory is situated at the foothills of a Markavdaya hills on the

banks of the Markavdaya river. The surrounding area is very

dusty.

2. Medical examination of workers is not being done.

3. Entry into injectable section does not have change room.

4. There is gab between door and door frame at all levels. AHU

functioning is questionable.

5. Reagent bottles are not labeled. Except name of reagent, no other

detail is available.

6. Only working standards are available – No reference standards are

available.

7. Microbiology cultures not available. Microbiologist left job one

month before.

8. Raw material and finished materials are kept along all the

corridors.

9. Cracks present at many places e.g. corridors and door frames.

10. Ointment manufacture area – false ceiling has gap, hole, crack and

fungal patch present, loose electrical connection.

11. All quoted products are endorsed under brand name only.

III. Aravind Remedies Ltd., Thiruvallur:-

1. Premises / Equipments:- Premises is unhygienic conditions

wall, floors are not smooth. No epoxy coating at the junction point.

2. Floor is made of kota stone. Some of the floor portion is in broken

condition in the production area of the tablets and capsules.

3. Found electric connection in open condition, machines are very old

and rusted.

Page 19: Directorate of Health Services, 4th Floor, Satpura … of Health Services, 4th Floor, Satpura Bhawan, Bhopal – 462 004. Ref.No.001/DRUG/GOMP/2009-10 16.04.2010 To All tenderers,

4. Maximum wooden wall found in the production area both in the

tablets and capsules.

5. Half portion of the door is made of wooden, Tablets, stools used in

the production area are made of wooden material.

6. Overall cooling is not found satisfactory especially in capsule area.

7. AHU are not found in the working condition.

8. No suction and aeration found in production area and found un-

hygienic.

9. Raw-materials store section some of the raw-materials are not put

on the labels.

10. Original manufacturing licence submitted in the drug control office

for further renewal as stated by the person incharge.

IV. M/s. Elegant Drugs Pvt. Ltd., Karnataka:-

1. The firm is being inspected in the presence of Plant Manager Mr.

Arun G. Pawar, B-Pharm. Manufacturing activity found not in

process due to installation of automatic liquid filling machines.

2. Premises surrounding is found unsatisfactory, cleanliness is not

maintained properly.

3. Walls are having some cracks and smooth epoxy coating is not

proper.

4. Storage of raw-materials tested / un-tested storage is not found

maintained separately.

5. Certificate of pollution GMP and the remaining records found

maintained.

6. Production area is not maintained properly found not satisfactory.

V. M/s. Sterling Labs, Dharmapuri:-

Page 20: Directorate of Health Services, 4th Floor, Satpura … of Health Services, 4th Floor, Satpura Bhawan, Bhopal – 462 004. Ref.No.001/DRUG/GOMP/2009-10 16.04.2010 To All tenderers,

1. The firm is inspected in the presence of Quality Control Manager

Mr. Badura and Production incharge Smt. K. Revathy, B-Pharm the

Proprietor of Mr. Jayanthilal Surana is the proprietor is not found

present at the time of inspection Mr. Krishanan, Administrative

Officer is also found.

2. The firm is having manufacturing licence form 25/359/110789 and

valid upto 31.12.2012 and form 28/187/110789 valid upto

31.12.2012.

3. Area surrounding the plant is constructed in the sufficient area but

overall cleanliness of the whole plant inside the production area is

not satisfactory.

4. No proper epoxy coating is done on the floor and wall junction all

are rough in surface very much chances of the position of the drugs

particles that can cause cross contamination in process. Dry syrup

section attached with the bath room is very dirty in nature and with

broken doors. So water is coming inside the section will leads to

contamination.

5. Manufacturing machine in tablet / capsule / dry syrup are very

old and rusted.

6. The raw-material storage, many of the raw-materials are not lablled

properly in case of colors / flavours maximum color labels bearing

with expiry date is over. For example banana flavour bearing

expiry date 11.12.08 and batch no. 707133, flavour butter scatch

batch no.1841204 / expiry date 01.07.08 and tartrazin 420403 /

expiry date 03.09, IDECOL red oxide of iron. 160312 / expiry 11.08

found kept stocked in the raw-material store.

7. The blister packing machine is common for packing of tablets and

capsules.

Page 21: Directorate of Health Services, 4th Floor, Satpura … of Health Services, 4th Floor, Satpura Bhawan, Bhopal – 462 004. Ref.No.001/DRUG/GOMP/2009-10 16.04.2010 To All tenderers,

8. For export quality medicines / and for loan licencee

manufacturing unit there is no separate quarantine for finished

products / raw-materials is provided.

9. AHU is not found working satisfactory suction and aeration is

found without sufficient pressure.

10. Pollution certificate validity 31.03.2008 and applied for further

renewal as stated.

VI. Sudharshan Pharmaceuticals Pvt. Ltd., Indore:-

The condition of this industry is as follows:-

1. No production activities take place presently, because the

renovation and work is going on.

VII. M/s. Kabra Drugs Ltd., Indore:-

The present situation of this industry is as follows:-

1. The renovation works is going in the premises.

2. No manufacturing activities going on.

VIII. M/s. Maxwell Life Sciences Pvt. Ltd:-

1. Surrounding of the premises were found un-hygienic.

2. Around 300 drums of compressed tablets (ready for packing) found

stored in outside of the premises.

3. Adequate space, logical arrangement of machinery, uniflow and

separate area for approved, unapproved, rejected raw-material

finished product not provided.

4. Walls, floors, ceiling of the premises are not smooth for easy to

clean.

5. Electric wiring in compression area and liquid manufacturing area

are not found concealed.

Page 22: Directorate of Health Services, 4th Floor, Satpura … of Health Services, 4th Floor, Satpura Bhawan, Bhopal – 462 004. Ref.No.001/DRUG/GOMP/2009-10 16.04.2010 To All tenderers,

6. Air curtain in the entry of workers not provided.

7. Air lock of the compression area and dispensing area are not found

in proper working.

8. Laminar Air Flow not provided is dispensing area.

9. AHU provided in manufacturing area but no manometer was

found.

10. Air control not found in microbiology area. Stability chamber not

provided.

11. Due to improper exhaust system lot of dust found accumulated in

compression area.

12. SOP not found displayed in working area.

13. Log book of weighing machine not maintained.

14. Training records of staff and workers not maintained.

15. PVC pipe found attached in purified water line of liquid

manufacturing area.

16. Status tag of machines not maintained.

17. Warehousing are not sufficient.

18. Cleaning schedule not maintained. Validation of records are not

maintained.

19. Production area workers apron were dirty. Drainage system was

not proper.

20. Control samples found stored in the Quality Control lobby.

21. They are not having sufficient space to fulfill their own

manufacturing load.

22. a) The firm is not having the adequate space in the premises.

b) The firm is not complying with the provision of GMP of

Drugs and cosmetics act 1940.

c) They are not having sufficient space for raw-material and

finished products.

Page 23: Directorate of Health Services, 4th Floor, Satpura … of Health Services, 4th Floor, Satpura Bhawan, Bhopal – 462 004. Ref.No.001/DRUG/GOMP/2009-10 16.04.2010 To All tenderers,

IX. M/s. Bengal Chemicals & Pharmaceuticals Ltd:-

1. No records provided for cleaning schedule.

2. Finished product storage tablets container were found open (before

blister / strip packing)

3. Unlabled raw-materials were found without analytical report

number. Some raw-materials (starch, sodium glycolate, aspertame.

PVP K-30, starch, Nipasal & Nipazine) containers were open in

tablet, capsule & ointment section.

4. Air curtains not provided at the man & material entries in tablet,

capsule and ointment section.

5. Granulation area:- Drainage has open, hole was made on the wall

to drain the water.

6. Fluidized Bed Drier bags are not provided product wise some

Fluidized Bed Drier bag is used for all products.

7. No calibration records for magnetic gauges for showing pressure

difference.

8. Termite on the wall in production area.

9. Printed packing material and primary packing materials are not

stored properly. Dust are found on PVC & Aluminum foil rolls.

10. Coating area – Metronidazole core tablet batch no.959601 kept

open.

11. Compression room brooms kept, paints is pealing off from the wall.

12. In capsules section workers are working without gloves in the area

of semi-automatic capsule filling machine.

13. AHU found out of order in capsule automatic filling machine area.

14. Ointment section – Silver sulphadiaoxide B.No.9388010 pending on

22.03.10 for filling the batch BMR showing filled on 12.02.10 &

packed on 12.02.10.

Page 24: Directorate of Health Services, 4th Floor, Satpura … of Health Services, 4th Floor, Satpura Bhawan, Bhopal – 462 004. Ref.No.001/DRUG/GOMP/2009-10 16.04.2010 To All tenderers,

15. Ointment section:- In process report sheet not filled in BMR of SSD

Batch no.9388010.

16. Log book not maintained for all machineries.

X. M/s. Rajat Pharmachem Ltd., Ankelshwar:

1. M/s. Rajat Pharmachem Ltd., is having drug manufacturing licence

no.G/25/1763, G/28/1246 in form no.25 & 28 issued on 05.04.07,

valid upto 04.04.12.

2. As on today three years of manufacturing licence and quoted items

has not completed.

Page 25: Directorate of Health Services, 4th Floor, Satpura … of Health Services, 4th Floor, Satpura Bhawan, Bhopal – 462 004. Ref.No.001/DRUG/GOMP/2009-10 16.04.2010 To All tenderers,

Directorate of Health Services, 4th Floor, Satpura Bhawan,

Bhopal – 462 004. Ref.No.001/DRUG/GOMP/2009-10 16.04.2010

To All the tenderers, (as per list)

Sir,

Sub: GOMP – Tender for the Supply of Drugs and Medicines to

various Medical Health Institutions of Govt. of Madhya Pradesh for the year 2010-2011 – Scrutiny of the documents – Rejection of certain items – Reg.

Ref: 1) Tender Ref.No.001/DRUG/GOMP/2009-10, Dt.20.01.10.

2) This office Lr. ref.no.001/DRUG/GOMP/2009-10, dt.26.03.2010. --------

Government of Madhya Pradesh invited tenders for the supply of Drugs

and Medicines for the year 2010-11 to various Medical Health Institutions of

Govt. of Madhya Pradesh and on scrutiny of the documents submitted by your

firm, we have noticed certain discrepancies/deficiencies.

In the reference 2nd cited, you are requested to submit clarification for the

discrepancies/deficiencies and after verification of the documents submitted by

your firm, the drugs indicated in the Annexure are rejected for the reasons

indicated against.

Joint Director (Procurement) Drug Cell, DHS, MP.

Encl: Annexure.

Page 26: Directorate of Health Services, 4th Floor, Satpura … of Health Services, 4th Floor, Satpura Bhawan, Bhopal – 462 004. Ref.No.001/DRUG/GOMP/2009-10 16.04.2010 To All tenderers,

The following firms were rejected for certain items:- 1. M/s. Daffodills Pharmaceuticals Ltd Jawahar Nagar, Rohta Road Meerut. Ph: 0121-2681270

Fax: 0121-2661108 2. M/s. Glenmark Pharmaceuticals Ltd., B/2, Mahalaxmi Chambers, 22, Bhulabhai Desai Road, Mumbai - 400 026.

Ph: Fax:

3. M/s. Health Biotech Ltd. Nalagarh Road, Baddi - 173 205. Distt. Solan

Ph: 01795-245526 Fax:

4. M/s. Medicamen Biotech Limited. SP-1192 A & B, Phase-IV, Industrial Area, Distt. Alwar, Bhiwadi - 301 019.

Ph: 01493-221291 Fax: 01493-221948

5. M/s. Meyer Organics Pvt. Ltd. A-177, Road No.16-Z, Wagle Estate, Thane - 400 604.

Ph: 022-25817000 Fax: 022-25817002

Page 27: Directorate of Health Services, 4th Floor, Satpura … of Health Services, 4th Floor, Satpura Bhawan, Bhopal – 462 004. Ref.No.001/DRUG/GOMP/2009-10 16.04.2010 To All tenderers,

Discrepancy / Deficiency not clarified by the tenderers. Following discrepancies noticed as further scrutiny of the documents:- 1. M/s. Daffodills Pharmaceuticals Ltd

Sl. No.

Drug Code

Name of the Drug Remarks

1. MP172 Magnesium suplhate inj. BP - 50 % w/v

No licence

2. MP186 Phenytoin sodium Inj. - 50 mg/ml

No licence

2. M/s. Glenmark Pharmaceuticals Ltd.,

Sl. No.

Drug Code

Name of the Drug Remarks

1. MP080 Ofloxacin Suspension - 50mg

No licence

2. MP176 Micronised Progestron inj. - 200mg

Loan licence

3. MP232 Ceftriaxone+Tazobactum - 1.125 Inj.

Loan licence

3. M/s.Health Biotech Ltd.

Sl. No.

Drug Code Name of the Drug Remarks

1. MP007 Amoxicillin Cap. - 250 mg. No Licence

2. MP008 Amoxicillin Cap. - 500mg No License

3. MP011 Amoxycilline and Clavulanic Acid No License

4. MP015 Atropine Eye drops - 1% No License

5. MP017 Azithromycin suspension - 200mg/5ml No License

6. MP020 Bromhexine hydrochloride Syrup. No License

Page 28: Directorate of Health Services, 4th Floor, Satpura … of Health Services, 4th Floor, Satpura Bhawan, Bhopal – 462 004. Ref.No.001/DRUG/GOMP/2009-10 16.04.2010 To All tenderers,

Sl. No.

Drug Code Name of the Drug Remarks

7. MP022 Cephalexine Cap. - 500mg No License

8. MP023 Cephalexine Syp. No License

9. MP025 Chloramphenicol Ear drop - 5% No License

10. MP027 Chloramphenicol Eye drops - 1% No License

11. MP028 Chloroquine phosphate Syrup. No License

12. MP036 Clotrimazole cream - 1% No License

13. MP038 Dextromethorphan Syrup. No License

14. MP042 Domperidone Suspension. No License

15. MP080 Ofloxacin Suspension No License

16. MP082 Omeprazole Cap. - 20mg No License

17. MP084 Paracetamol Syp. - 125 mg/5ml No License

18. MP095 Povidone iodine Solution. - 5% No License

19. MP096 Povidone iodine surgical scrub Solution.

No License

20. MP102 Promethazine Syrup. - 5 mg/5ml No License

21. MP106 Sulfacetamide Eye drops - 20% No License

22. MP124 Adrenochrome Monosemicarbazone Inj -

No License

23. MP127 Amiodarone inj. - 50mg/ml No License

24. MP133 Azithromycin inj - 100mg/5ml No License

25. MP134 Azithromycin inj - 200mg/5ml No License

26. MP139 Calcium gluconate Inj. - 10% No License

27. MP152 Dobutamine inj. - 50gm/ml 5ml Amp No License

28. MP162 Hyaluronidase inj. - 1500 IU No License

29. MP176 Micronised Progestron inj. - 200mg No License

30. MP182 Pancuronium Inj. - 2mg/ml No License

31. MP188 Potassium chloride inj. - 150 mg/ 10ml No License

32. MP192 Quinine Sulphate Inj. - 300mg/ml . No License

Page 29: Directorate of Health Services, 4th Floor, Satpura … of Health Services, 4th Floor, Satpura Bhawan, Bhopal – 462 004. Ref.No.001/DRUG/GOMP/2009-10 16.04.2010 To All tenderers,

Sl. No.

Drug Code Name of the Drug Remarks

33. MP198 Sodium bicarbonate Inj. - 7.5% w/v No License

34. MP209 Valethamate Bromide inj. - 8mg/ml No License

35. MP215 Calcium Chloride Inj. No License

36. MP222 Lidocaine 2% Inj. No License

4. M/s. Medicamen Biotec Ltd:-

Sl. No.

Drug Code Name of the Drug Remarks

1 MP077 Multivitamin Drops Not as per specification

2. MP058 Iron and folic acid entric coated Tab. Licence valid upto 2008

3. MP059 Iron and folic acid entric coated Tab. Licence valid upto 2008

5. M/s. Meyer Organics Pvt. Ltd

Sl. No.

Drug Code Name of the Drug Remarks

1. MP059 Iron and folic acid entric coated Tab.

Not as per specification

Page 30: Directorate of Health Services, 4th Floor, Satpura … of Health Services, 4th Floor, Satpura Bhawan, Bhopal – 462 004. Ref.No.001/DRUG/GOMP/2009-10 16.04.2010 To All tenderers,

Directorate of Health Services, 4th Floor, Satpura Bhawan,

Bhopal – 462 004. Ref.No.001/DRUG/GOMP/2009-10 16.04.2010 To All the tenderers, (as per list)

Sir,

Sub: GOMP – Tender for the Supply of Drugs and Medicines to various

Medical Health Institutions of Govt. of Madhya Pradesh for the year 2010-2011 – Scrutiny of the documents – Rejection – Reg.

Ref: 1) Tender Ref.No.001/DRUG/GOMP/2009-10, Dt.20.01.10.

2) This office Lr. ref.no.001/DRUG/GOMP/2009-10, dt.26.03.2010. -------

Government of Madhya Pradesh invited tenders for the supply of Drugs

and Medicines for the year 2010-11 to various Medical Health Institutions of

Govt. of Madhya Pradesh and on scrutiny of the documents submitted by your

firm, we have noticed certain discrepancies/deficiencies.

In the reference 2nd cited, you are requested to submit clarification for the

discrepancies/deficiencies within the stipulated time.

Since your firm did not submit the documents indicated in the Annexure,

therefore the tender submitted by your firm in the reference 1st cited is rejected.

Joint Director (Procurement) Drug Cell, DHS, MP.

Encl: Annexure.

Page 31: Directorate of Health Services, 4th Floor, Satpura … of Health Services, 4th Floor, Satpura Bhawan, Bhopal – 462 004. Ref.No.001/DRUG/GOMP/2009-10 16.04.2010 To All tenderers,

The following firms were rejected for certain items:- 1. M/s. Beryl Drugs Limited 123, Sector-1, Industrial Estate, Pithampur, Dist. Dhar, M.P. Ph: 07292-403295

Fax: 0731-3046366 2. M/s. Glaxosmithkline Pharmaceuticals Ltd., 252, Dr.Annie Besant Road, Worli, Mumbai - 400 025. Ph: 022-24953308 Fax: 022-24975155 3. M/s. Novartis Healthcare Pvt. Ltd. Sandoz House, 7th Floor, Shivsagar Estate, Worli, Dr.Annie Besant Road, Mumbai. Ph: 022-24958773 Fax: 022-24970362 4. M/s. Novartis India Ltd. Arihant Compound, Bldg. No.28 & 27, Gala No. 1 to 11, & 1 to 11, Purna Village, Bhivandi Ph:

Fax:

Page 32: Directorate of Health Services, 4th Floor, Satpura … of Health Services, 4th Floor, Satpura Bhawan, Bhopal – 462 004. Ref.No.001/DRUG/GOMP/2009-10 16.04.2010 To All tenderers,

Discrepancy / Deficiency not clarified by the tenderers. Following discrepancies noticed as further scrutiny of the documents:- 1. M/s.Beryl Drugs Limited

a. Market Standing Certificate issued by Licencing Authority as a

Manufacturer for each drug quoted

2. M/s.Glaxosmithkline Pharmaceuticals Ltd.

a. True Copy of Record of Manufacture / Import to establish three years

Market standing

b. Balance Sheet and Profit and Loss Account for Last 3 years

3. M/s. Novartis Healthcare Pvt. Ltd

a. Market Standing Certificate issued by Licencing Authority as a

Manufacturer for each drug quoted

4. M/s. Novartis India Ltd

a. Copy of Manufacturing Licence for the products quoted by them

duly renewed upto date

b. Good Manufacturing Practices Certificate issued by Licencing

Authority

Page 33: Directorate of Health Services, 4th Floor, Satpura … of Health Services, 4th Floor, Satpura Bhawan, Bhopal – 462 004. Ref.No.001/DRUG/GOMP/2009-10 16.04.2010 To All tenderers,

c. Details of Technical Personnel Involved in the Manufacturing and

Testing of Drugs

Page 34: Directorate of Health Services, 4th Floor, Satpura … of Health Services, 4th Floor, Satpura Bhawan, Bhopal – 462 004. Ref.No.001/DRUG/GOMP/2009-10 16.04.2010 To All tenderers,

Directorate of Health Services, 4th Floor, Satpura Bhawan,

Bhopal – 462 004. ------------------------------------------------------------------------------------------------------------ Ref.No.001/DRUG/GOMP/2009-10 16.04.2010 To M/s. SD Bio Standard Diagnostics Pvt. Ltd. Plot No.266, Sector-6, IMT Manesar, Gurgaon - 122 050. Ph: 0124-4130300, Fax: 0124-4130301

Sir,

Sub: GOMP – Tender for the Supply of Drugs and Medicines to various Medical Health Institutions of Govt. of Madhya Pradesh for the

year 2010-2011 – Not having market standing – Rejection of Tender – Reg.

Ref: Tend. Ref.No.001/DRUG/GOMP/2009-10, Dated.20.01.2010

----------- In the reference cited, you have participated in the tender for the Supply

of Drugs and Medicines to various Medical Health Institutions of Govt. of

Madhya Pradesh for the year 2010-2011, since you have got the drug licence only

from 01.07.2009 and hence you are not having 3 years market standing for the

products quoted. Therefore your tender is rejected as per tender condition.

Joint Director (Procurement) Drug Cell, DHS, MP.

Page 35: Directorate of Health Services, 4th Floor, Satpura … of Health Services, 4th Floor, Satpura Bhawan, Bhopal – 462 004. Ref.No.001/DRUG/GOMP/2009-10 16.04.2010 To All tenderers,

Directorate of Health Services, 4th Floor, Satpura Bhawan,

Bhopal – 462 004. ------------------------------------------------------------------------------------------------------------ Ref.No.001/DRUG/GOMP/2009-10 16.04.2010

To M/s. Shreya Life Sciences (P) Ltd. B-9/2, M.I.D.C. Waluj, Aurangabad - 431 136.

Sir,

Sub: GOMP – Tender for the Supply of Drugs and Medicines to various Medical Health Institutions of Govt. of Madhya Pradesh for the year 2010-2011 - submission of fake certificate – case not cleared – Rejection of tender – Reg. Ref: Tend. Ref.No.001/DRUG/GOMP/2009-10, Dated.20.01.2010

-------- Your firm have submitted the tender for the supply of Drugs and

Medicines for the year 2010-11 and on scrutiny of the documents, it is found that

the Joint Commissioner, Food & Drugs Administration (M.S.) Aurangabad have

issued a certificate that a case has been filed by Kranti Chouk Police against the

Director of your firm for production of fake certificate of the administration and

the case is under investigation.

Since your firm was not cleared by the police dept., and FDA

administration of MS and hence the tender submitted by your firm in the above

reference is rejected.

Joint Director (Procurement) Drug Cell, DHS, MP.

Page 36: Directorate of Health Services, 4th Floor, Satpura … of Health Services, 4th Floor, Satpura Bhawan, Bhopal – 462 004. Ref.No.001/DRUG/GOMP/2009-10 16.04.2010 To All tenderers,

Directorate of Health Services, 4th Floor, Satpura Bhawan,

Bhopal – 462 004. ------------------------------------------------------------------------------------------------------------ Ref.No.001/DRUG/GOMP/2009-10 16.04.2010 To

M/s. VHB Life Sciences Ltd., No.40, B/2, Shankar Smruti, Sir Balachandra Road, Dedar (E), Mumbai—400 014, Maharastra State. Ph: 022-24161006, Fax: 022-24108346

Sir, Sub: GOMP – Tender for the Supply of Drugs and Medicines to various Medical Health Institutions of Govt. of Madhya Pradesh for the year 2010-2011 - Blacklisted by the Central Medical Stores Organisation, Gujarat and M/s. Kerala Medical Services Corporation Ltd. Thiruvananthapuram –Rejection of tender– Reg.

Ref: Tend. Ref.No.001/DRUG/GOMP/2009-10, Dated.20.01.2010. ---------

You have participated in the tender for the supply of Drugs and

Medicines for the year 2010-11. We came to know that your firm was blacklisted

by the Central Medical Stores Organisation, Gujarat from 08.05.2006 to 07-05-

2011 and based on the above your tender has also rejected by M/s. Kerala

Medical Services Corporation Ltd., Thiruvananthapuram for the supply of drugs

for the year 2009-10 and by TNMSC, Chennai for the year 2010-11.

As per clause 2(e) of the tender condition i.e., “The Company / Firm which has been blacklisted either by Tender

Inviting Authority or by any State Government or Central Government

Organization should not participate in the tender during the period of

blacklisting”.

As per the above condition, the tender submitted by your firm for the

supply of drugs and medicines for the year 2010-11 is rejected.

Joint Director (Procurement) Drug Cell, DHS, MP.

Page 37: Directorate of Health Services, 4th Floor, Satpura … of Health Services, 4th Floor, Satpura Bhawan, Bhopal – 462 004. Ref.No.001/DRUG/GOMP/2009-10 16.04.2010 To All tenderers,