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DISTRICTWISE DETAILS OF WORKDONE OF JAMMU DIVISION (DRUG SIDE) FOR THE MONTH OF DECEMBER, 2013
Achivements
Doda / Kishtwar
Udhampur
a. Sales Establishmentsb. Manufacturing Units Amount of License Fee deposited in the Treasury 2,37,700
4,38,966
No of premises existing at the end of the Month c. Manufacturing Units(Allopathic + Ayurvedic) (including Loan licensee) , Blood Banks & Blood Violation detected in regard to DPCO under Qualified Person / Not maintaining Sale / Purchase Records.
Any other information related to Drug side Total Revenue Collected = Rs. 2,37,700 + Rs. 1,52,800 (Revenue from Head Office) = Rs. 3,90,500
DISTRICTWISE DETAILS OF WORK DONE OF KASHMIR DIVISION (DRUG SIDE) FOR THE MONTH OF DECEMBER, 2013
Achivements
Srinagar
Anantnag
Baramulla
Ganderbal
Bandipora
No of premises existing at the end of the Month Blood Storage CentreViolation detected in regard Commodities Act. No of shops detected being Shifting
01 Shifting
Shifting
DISTRICTWISE WORKDONE OF DRUG TESTING LABORATORY, KASHMIR DIVISION FOR THE MONTH OF DECEMBER, 2013
Achievements
Srinagar
Ganderbal
Anantnag
Baramulla
Bandipora
DISTRICTWISE WORKDONE OF COMBINED FOOD AND DRUG LABORATORY, JAMMU DIVISION FOR THE MONTH OF DECEMBER, 2013
Achievements
anderbal
rincipal
andipora
Srinagar
The samples have been tested on the request by Principal GMC with respect to procurement by State Government.
Total Drug Samples Tested
Formal Drug Samples Tested
Informal Samples Tested
Hospital Supply Sample Tested
: 70 (out of 205)
Jan-Aushadhi
: 02 (out of 205)
Maharashtra Government Supply
: 01 (out of 205)
Market Samples
: 132 (out of 205)
CUMULATIVE WORK DONE OF DRUGS WING OF JAMMU & KASHMIR TILL THE MONTH OF DECEMBER, 2013
ACHIEVEMENTS
JAMMU DIVISION
KASHMIR DIVISION
TOTAL JAMMU & KASHMIR
Previous
Cumulative Till
Previous
Cumulative Till
December
Cumulative Till
December 2013
December 2013
Previous Cumulative
Cumulative
December, 2013
Cumulative
December, 2013
December, 2013
2,37,700 +
25,77,900 +
1,52,800 (RHO)
28,15,600 + 8,47,150
3,43,700
32,04,960
35,48,660
7,34,200
64,77,210
72,11,410
= 3,90,500
6,94,350 (RHO) =
(RHO) = 36,62,750
32,72,250
4,38,966
16,55,541
20,94,507
62,13,703
4,87,014
78,69,245
83,56,259
No of premises existing at the end of the Month under Essential Commodities Act. No. of Shops detected being run without Qualified Person / Not maintaining Sale / Purchase Records.
Any other information related to Drug side 357 / 20 Shifting
380 / 22 Shifting
701 / 20 Shifting
740 / 22 Shifting
02 Shifting
Shifting
1. DETAILS OF PROSECUTION LAUNCHED
District
State through DI v/s Ms/ A.K. Biotech Pvt. Ltd., Bari Brahmana Jammu in CJM, Jammu 1. DI v/s M/s Sundaram Surgicals Chatrapatti in JM, Pulwama (Rolled Bandage B. No.: 30) 2. DI v/s M/s Sundaram Surgicals Chatrapatti in JM, Pulwama (Rolled Bandage B. No.: 33) 3. DI v/s M/s Aron Weaving Moradabad in JM, Pulwama (Rolled Guaze B. No.: 11) DI v/s M/s Eaton Laboratories in CJM Srinagar (Emlo A B. No.: 9159) 2. DETAILS OF SEIZURE UNDERTAKEN
District
Piperacillin and Tazobactam for Injection USP 4.5g, Batch No.: 3600313, M/D: 07/2013, E/D: 06/2015, Mfg By: M/s Karnataka Antibiotics & Pharmaceuticals Limited, (a Government of India Enterprises) Plot No.: 14, II Phase, Peenya Bangalore – 560 058 seized from: 1. Directorate of Health Services, Jammu (1990 vials of Rs. 2,38,800)
2. Stores of GMC, Jammu (1446 vials of Rs. 1,63,976)
3. New India Medical House, Gandhi Nagar, Jammu (50 vials of Rs. 6000)
Total: (3486 vials of Rs. 4,08,776)
Dolcin-500 Tablet IP, Batch No.: ULT-4418, M/D: 01/2013, E/D: 12/2014, Mfg By: Not Mentioned (Seized Value: Rs.
Piperacillin and Tazobactam for Injection USP 4.5g, Batch No.: 3600313, M/D: 07/2013, E/D: 06/2015, Mfg By: M/s Karnataka Antibiotics & Pharmaceuticals Limited, (a Government of India Enterprises) Plot No.: 14, II Phase, Peenya
Bangalore – 560 058 (Seized Value: Rs. 4920)
1. Amoxycillin & Potassium Clavulanate Injection (Jan Aushadhi Product) Batch 3400812, M/D: 12/2012, E/D:11/2014,
Mfg By: M/s Karnataka Antibiotic &Pharmaceuticals Limited (Government of India Enterprise), Plot No.: 14, II Phase,
Peenya, Bangalore – 560 058 (Seized Value: Rs. 5680)
2. Absorbent Cotton Wool (JKH Supply), Batch No.: 83, M/D: 10/2013, E/D: After 5 years, Mfg By: M/s Samrat
Surgicals Pvt. Ltd., SIDCO Industrial Complex, Bari Brahmana, Jammu (Seized Value: Rs. 10746)
Total Seized: Value: 16426
Panteva Injection, Batch No. PZ-25, M/D: 07/2012, E/D: 06/2014, Mfg By: M/s Tanacia Pharmaceuticals Naiwala Road, Barnala 148 101 (Seized Value: Rs. 9030)
Panteva Injection, Batch No. PZ-25, M/D: 07/2012, E/D: 06/2014, Mfg By: M/s Tanacia Pharmaceuticals Naiwala Road,
Barnala 148 101 (Seized Value: Rs. 16168)
Total Seized Value: Rs. 6424
CUMULATIVE WORKDONE OF DRUG TESTING LABORATORY JAMMU / KASHMIR TILL THE MONTH OF DECEMBER 2013
Achievements
COMBINED FOOD AND DRUG LABORATORY, JAMMU
DRUG TESTING LABORATORY, KASHMIR
Previous
Cumulative Till
December
Previous
Cumulative Till
December
Previous
Cumulative Till
December 2013
Cumulative
December, 2013
Cumulative
December, 2013
Cumulative
December, 2013
COMPARATIVE WORK DONE, JAMMU & KASHMIR (DRUG WING)
JAMMU & KASHMIR
ACHIEVEMENTS
NOVEMBER, 2013
DECEMBER, 2013
DECEMBER, 2012
a. Sales Establishmentsb. Manufacturing Units Amount of License Fee deposited in the Treasury (Rs.) 4,95,600
7,34,200
3,51,856
4,87,014
No of premises existing at the end of the Month c. Manufacturing Units(Allopathic + Ayurvedic) (including Loan licensee) , Blood Banks & Blood Storage Violation detected in regard to DPCO under Essential Commodities Act. No. of Shops detected being run without Qualified Person / Not maintaining Sale / Purchase Records.
Any other information related to Drug side (License 58 / 03 Shifting
39 / 02 Shifting
COMPARATIVE WORK DONE, JAMMU DIVISION (DRUG WING)
JAMMU DIVISION
ACHIEVEMENTS
NOVEMBER, 2013
DECEMBER, 2013
DECEMBER, 2012
a. Sales Establishmentsb. Manufacturing Units 2,43,000 + 15,300 (RHO) =
2,37,700 + 1,52,800 (RHO) =
284900 + 29200 (RHO) =
Amount of License Fee deposited in the Treasury (Rs.) 2,58,300
3,90,500
3,14,100
2,57,852
4,38,966
No of premises existing at the end of the Month a. Retail c. Manufacturing Units(Allopathic + Ayurvedic) (including Loan licensee) , Blood Banks & Blood Storage Violation detected in regard to DPCO under Essential Commodities Act. No. of Shops detected being run without Qualified Person / Not maintaining Sale / Purchase Records.
Any other information related to Drug side (License COMPARATIVE WORK DONE, COMBINED FOOD AND DRUG LABORATORY, JAMMU
ACHIEVEMENTS
NOVEMBER, 2013
DECEMBER, 2013
DECEMBER, 2012
COMPARATIVE WORK DONE, DRUG TESTING LABORATORY, KASHMIR
ACHIEVEMENTS
NOVEMBER, 2013
DECEMBER, 2013
DECEMBER, 2012
LIST OF SAMPLES DECLARED NOT OF STANDARD QUALITY / MISBRANDED DURING THE YEAR 2013- 2014
Name of the Drug
Manufacturer
Sample Lifted By
Batch No.
Test Report No. & Date
APRIL, 2013
M/s Ratchet Laboratories Ltd., Baghbania, Baddi – 174 101, District Solan (HP)M/s Orchid Biotech (P) Limited, (A Division of SRF India (P) Ltd, an ISO Sample fails in the Assay of Amoxycillin (70.52% of the claim made) and in Description.
Certified Co) 65, Peerpura – Delhi Highway, Roorkee – 247 667 (UK)M/s Cyano Pharma (P) Sample fails in Uniformity of Weight.
Sample fails in 1. Description 2. Absorbency (Sinking Time) 3. Fluorescence and 4. Packaging MAY, 2013
Sample fails in Threads/dm, Width and Weight in Sample fails in Threads/dm, Width and Weight in Sample fails in Threads/dm, Width and Weight in Sample fails in Threads/dm, Width and Weight in Nagar, Meerut- 250002M/s Protech Biopharma Pvt 3. Due to sticky nature of the Tablets, Assay could LIST OF SAMPLES DECLARED NOT OF STANDARD QUALITY / MISBRANDED DURING THE YEAR 2013- 2014
Name of the Drug
Manufacturer
Sample Lifted By
Batch No.
Test Report No. & Date
3. Due to sticky nature of the Tablets, Assay could ointment” the ointment should be water soluble, Hence, due to insolubility in water, the above Sample fails in the Assay of Paracetamol (75.18% Sample fails in test of Particulate Matter Sirmour – 173 030 (HP)M/s Jackson Laboratories Sample fails in test of Uniformity of Weights Ceftriaxone Injection M/s Vivek Pharmachem The Sample fails the test Clarity of Solution The Sample fails in Description and in Particulate As per the USP monograph of ‘Povidone Iodine Ointment’ the Ointment should be water soluble. Hence due to its insolubility in water, the above LIST OF SAMPLES DECLARED NOT OF STANDARD QUALITY / MISBRANDED DURING THE YEAR 2013- 2014
Name of the Drug
Manufacturer
Sample Lifted By
Batch No.
Test Report No. & Date
2. Description as (Pantoprazole Sodium should be in Industrial Estate, Zainakote, DI, Mfg, Kashmir the form of Enteric Coated Granules in the Capsule Shell) also Domperidone Maleate has not been shown Official”.
Absorbent Cotton Wool M/s Samrat Surgicals Pvt. As per the USP monograph of ‘Povidone Iodine Ointment’ the Ointment should be water soluble. Hence due to its insolubility in water, the above The Sample fails in the Assay of Amlodipine Industrial Estate, Zainakote, DI, Bijbehera Besylate (70.90% of the claim made)”.
The Sample fails in the Assay of Amlodipine Industrial Estate, Zainakote, DI, Srinagar Besylate (70.18% of the claim made)”.
JUNE, 2013
The Sample is not labeled in the prescribed manner, The Sample fails in the Assay of Hydrogen Peroxide The Sample fails in the Assay of Hydrogen Peroxide LIST OF SAMPLES DECLARED NOT OF STANDARD QUALITY / MISBRANDED DURING THE YEAR 2013- 2014
Name of the Drug
Manufacturer
Sample Lifted By
Batch No.
Test Report No. & Date
M/s Affy Parenterals (WHO-cGMP / ISO 9001 : (HP)M/s Hindustan Antibiotics Limited (A Government of Ceftriaxone Injection M/s Vivek Pharmachem Ceftriaxone Injection M/s Vivek Pharmachem M/s Hindustan Antibiotics Limited (A Government of The Sample fails in Threads per dm (Warp) Cetrizine Tablets are Official in IP. The label of the Phase III, Industrial Estate DI, Reasi I /C Tikri Sample doesnot show it Official, hence Misbranded Ampicillin Injection IP M/s Vivek Pharmachem The labeling on the Sample doesnot conform as per IP since it doesnot state the amount of diluent to be used to attain specific concentration of Active The label shows Pantoprazole Sodium Tablet IP which is not Official in IP 2010, hence Misbranded LIST OF SAMPLES DECLARED NOT OF STANDARD QUALITY / MISBRANDED DURING THE YEAR 2013- 2014
Name of the Drug
Manufacturer
Sample Lifted By
Batch No.
Test Report No. & Date
M/s Gag Pharmaceuticals (An ISO 9001: 2008 & Sample fails in the Assay (68.32% of the claim made) and the Label shows Cefixime Dispersible Tablet IP which is not Official in IP 2010, hence Ludhiana, Punjab – 144 025M/s Vivek Pharmachem The Sample fails in Particulate Matter.
The label of the Product shows (Pantoprazole Tablet IP) which is not Official in IP 2010, hence M/s Crescent Therapeutics Limited, Khasara No.: 597 / The label of the Product shows (Pantoprazole Tablet IP) which is not Official in IP 2010, hence District Solan (HP) 173205M/s Ramson Remedies, Mumbai – 400 006M/s Shreya Life Sciences Road Santacrnz (E), Mumbai -400 098 India) The Sample is identifies for Steroid Prednisolone.
The Sample is identifies for Steroid Prednisolone.
LIST OF SAMPLES DECLARED NOT OF STANDARD QUALITY / MISBRANDED DURING THE YEAR 2013- 2014
Name of the Drug
Manufacturer
Sample Lifted By
Batch No.
Test Report No. & Date
Pantoprazole Sodium Sesquihydrate is not shown 124, EPIP, Industrial Area, DI, Pulwama (HQ) (HP)M/s Unimark Remedies Limited, Plot No.: 13, M/s Tulbros Formulations (An ISO 9001 : 2008 & JULY, 2013
Esgipyrin – N 5ml limited, 737 Sola Santy Sample fails in the Assay of Phenylbutazone (14.80% of the claim made) and in Sterility Test Sample fails in the test Particulate Matter and Pantoprazole Sodium is not shown Official.
Ampicillin Injection IP M/s Vivek Pharmachem The labeling on the Sample doesnot state the amount of diluent to be used to attain specific concentration LIST OF SAMPLES DECLARED NOT OF STANDARD QUALITY / MISBRANDED DURING THE YEAR 2013- 2014
Name of the Drug
Manufacturer
Sample Lifted By
Batch No.
Test Report No. & Date
Ampicillin Injection IP M/s Vivek Pharmachem The content of “Available Iodine” in the Sample is not found within the specified USP Limits (25.38% Sample fails in Particulate Matter and Description 173 205 (HP)M/s All Kind Healthcare, Plot No. 88-B, export LIST OF SAMPLES DECLARED NOT OF STANDARD QUALITY / MISBRANDED DURING THE YEAR 2013- 2014
Name of the Drug
Manufacturer
Sample Lifted By
Batch No.
Test Report No. & Date
The Content of available Iodine in the sample is not found within the specified USP Limits.
The contents of Calcium Carbonate calculated as Elemental Calcium in the Sample are found more than in claim made (140.77% of the claim made) The Sample identifies for presence of Prednisolone.
AUGUST,2013
M/s Marck Biosciences Ltd., Plot No.: 876, NH Sample fails in Assay of Dextrose (20.71% of the LIST OF SAMPLES DECLARED NOT OF STANDARD QUALITY / MISBRANDED DURING THE YEAR 2013- 2014
Name of the Drug
Manufacturer
Sample Lifted By
Batch No.
Test Report No. & Date
Sirmour (HP)M/s Skymap Pharmaceuticals, B-3, Dev Pohana Iqbalpur Road, Roorkee 247 667M/s Minil Laboratories Pvt Jammu – 20M/s Ind Swift Limited, Industrial Growth Centre, Sampled fails in 1. Warf & Weft 2. Weight in g/m2 3. LabelingSampled fails in 1. Warf & Weft 2. Length3. Weight in g/m2 4. Florescence 5. Labeling & SEPTEMBER,2013
2. Sterility Test for “Water for Injection IP” ISO 9001: 2008 Company)M/s Orison Pharma Sample fails in Disintegration Test.
Sample fails in Description and Disintegration Test LIST OF SAMPLES DECLARED NOT OF STANDARD QUALITY / MISBRANDED DURING THE YEAR 2013- 2014
Name of the Drug
Manufacturer
Sample Lifted By
Batch No.
Test Report No. & Date
M/s A.K. Biotech Pvt. Ltd., Export Promotional Sample fails in Assay of Diclofenac Sodium Brahmana, Jammu – 181 133M/s zee Laboratories, 47, Sample fails in Assay of Lithium Carbonate Sahib – 173 025M/s zee Laboratories, 47, Sample fails in Uniformity of Weight.
Sahib – 173 025M/s Talent Healthcare, 66- Product not shown Official in USP on the label, Product not shown Official in USP on the label, 249 403M/s Terrace Pharmaceuticals (P) Ltd., 3- Sample fails in Disintegration Test.
OCTOBER,2013
Sample shows positive for Marijuana, Hashish, Sample shows positive for Marijuana, Hashish, Sample shows positive for Marijuana, Hashish, Sample shows positive for Marijuana, Hashish, Sample fails in Assay (28.287% of the claim made), Description and Disintegration Test.
District Haridwar.
M/s Nikvin Healthcare(India) Pvt. Ltd., Baddi, Sample fails in Disintegration Test.
Department, Village Katha, Baddi (HP) – 173 205 LIST OF SAMPLES DECLARED NOT OF STANDARD QUALITY / MISBRANDED DURING THE YEAR 2013- 2014
Name of the
Manufacturer
Sample Lifted By
Batch No.
Test Report No. & Date
Sample fails in Disintegration Test.
Pohana Iqbalpur, Roorkee247 667M/s Cacheh Sample fails in Assay of Calcium Carbonate District Solan HP 173 205M/s Dr. Kumars Pharmaceuticals (A GMP Sample fails in Disintegration Test.
17-18, Industrial Area, Bilaspur, 174 001 HP NOVEMBER,2013
Sample fails in the test Particulate Matter – 580 011M/s Karnataka Antibiotics & Pharmaceuticals Sample fails in the test Particulate Matter Manufacturing License No. and Address of the Manufacturer are not mentioned on the Label of LIST OF SAMPLES DECLARED NOT OF STANDARD QUALITY / MISBRANDED DURING THE YEAR 2013- 2014
Name of the
Manufacturer
Sample Lifted By
Batch No.
Test Report No. & Date
DECEMBER,2013
Sample fails in Assay of Diclofenac Sodium Sample fails in Assay of Diclofenac Sodium Sample fails in the Assay of Paracetamol Sample fails in the test Particulate Matter Particulate Matter and in Clarity of Solution Sample fails in the test Particulate Matter Bangalore – 560 058M/s Biosearch Organics, Sample fails in the Assay of Paracetamol (76.45% M/s Ravenbhel Healthcare Pvt. Ltd., 16-17, Export The Sample fails in Disintegration Test and LIST OF SAMPLES DECLARED NOT OF STANDARD QUALITY / MISBRANDED DURING THE YEAR 2013- 2014
Name of the
Manufacturer
Sample Lifted By
Batch No.
Test Report No. & Date
M/s Medimark Drugs and Pharmaceuticals, Plot No.: Sample Fails In Disintegration Test.
SIDCUL, Haridwar – 249 403 (UK)M/s Mac Royal Healthcare, Plot No.: 14- Sample Fails In Disintegration Test.

Source: http://www.dfcojk.org/download/December2013.pdf

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