Drugs and Food Control Organization (J&K) - PowerPoint Presentation

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Drugs and Food Control Organization (J&K) - PPT Presentation

CONTROLLER DRUGS amp FOOD CONTROL ORGANIZATION JampK JAMMU S No Particulars JAMMU DIVISION KASHMIR DIVISION TOTAL 1 Inspections conducted 1054 886 1940 2 Samples lifted 118 ID: 796301

dated 2013 amp sample 2013 dated sample amp jammu fails 2012 samples drug district drugs work june tablet 2014

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Slide1

Drugs and Food Control Organization (J&K)

CONTROLLER

DRUGS & FOOD CONTROL ORGANIZATION,

J&K, JAMMU

Slide2

S. No.ParticularsJAMMU DIVISIONKASHMIR DIVISIONTOTAL1Inspections conducted105488619402Samples lifted1181913093Samples Tested201134

3354Samples Found Standard

187

1193065Samples Found Sub-Standard1415296Prosecutions Launched0104057Cases Decided by Court 01*001

WORK DONE

JUNE 2013 (DRUG WING)

*State Through Drugs Inspector V/s Gupta Medico Surgicals,

Bhalla

, Doda

( NSQ : Kold

Plus,B.No

: KB20,Mfd By : Laborate Labs )

Slide3

WORK DONEJUNE 2013 (DRUG WING)S. No.ParticularsJAMMU DIVISIONKASHMIR DIVISIONTOTAL8Licenses Granted64791439Licenses Renewed6565 / 03 Shifting130 / 03 Shifting10

Show Cause Issued1806

11Licenses Suspended08021012Licenses Cancelled23042713Value of Drugs Seized Rs. 4,40,591Rs. 2,44,985Rs. 68557614

Revenue Collected

Rs. 4,21,900

Rs. 5,86,500Rs. 100840015

Unlicensed

Shops Detected

02002

Slide4

Unlicensed Shops Detected /Seizure Undertaken worth Rs 5000/=1. Belonging to Prem ji Koat Banu S/o Raj Kumar R/o Hiranagar at Koat Banu,Hiranagar.2. Belonging to Joginder Paul S/o Mangat ram R/oGurdaspur at Maharjpur, Hiranagar.Prosecutions Launched :Drugs Inspector V/s Farmers Cooperative Fair Price Shop,R.S Pura ( NSQ, Lelock-20 Tablet, Batch No.: T-9609, Mfg Date: 09/2011, Exp Date: 08/2013 Manufactured in India By: M/s Jackson Laboratories (P) Ltd., Majitha Road, Bye Pass, Amritsar )Drugs Inspector V/s Riaz Medicate,Pullwama ( Non Furnishing of Records of habit Forming Drugs)Drugs Inspector V/s Fair Price Medical Shop, Pampore ( Unlicensed).Drugs Inspector V/s M/s Standard Surgical Dressing Co., Dhampur Road, Kanth ( NSQ, Standard Handloom Rolled Bandage, Batch No.: 034, Mfg Date: 08/2011, Exp Date: 3 years from the Date of Mfg, Manufactured By: M/s Standard Surgical Dressing Co., Dhampur Road, Kanth – 244 501 )Drugs Inspector V/s Khursheed Medicate, Baramulla ( Unlicensed). Court Case Decided 4

Slide5

COMPARATIVE WORK DONE, JAMMU & KASHMIR (DRUG WING)S.No.ParticularsJUNE, 2012JUNE, 20131Inspections conducted261819402Samples lifted3683093Samples Tested1763354

Samples Found Standard169306

Samples Found Sub-Standard07296Prosecutions Launched02057Cases Decided by Court0015

Slide6

S.No.ParticularsJUNE, 2012JUNE, 20138Licenses Granted1191439Licenses Renewed85130 / 03 Shifting10Show Cause Issued282411Licenses Suspended1510

12Licenses Cancelled19

13Value of Drugs Seized Rs. 83,057Rs. 68557614RevenueRs. 7,66,800Rs. 100840015Unlicensed Shops Detected01026

COMPARATIVE WORK DONE,

JAMMU & KASHMIR (DRUG WING)

Slide7

Slide8

District Wise Work Done (Drug Wing) Jammu Division June 2013JammuSambaKathuaRajouriPoonchDoda / KishtwarUdhampurReasiRambanTotal

Samples Lifted48

12060514110308118No. of Inspections Conducteda. Sales Establishments33484

161

7141227

7120

1039

b. Manufacturing Units

No. of Prosecution Launched

0000001No. of Cases decided by the Court000000100001a. With Quantum of Imprisonment0000000000b. Amount of Fine (Rs) imposed0000000000c. Acquittal 000000100001d. Convicted0000000000No. of Cases of pending in the Court1021956051306100408223

Slide9

JammuSambaKathuaRajouriPoonchDoda / KishtwarUdhampurReasiRambanTotalNo. of Licenses Issued

a. Retail22

060404140402058b. Whole

c. Restricted

d. Homeopathic

0000000000Amount of License Fee deposited in the Treasury (Rs.) 1,36,90019,00030,00039,00047,00073,30016,00012,00003,73,200Value of the Seized Drug (Rs.)3,93,502300033,1250075962501977704,40,591No. of Complaintsa. Received010000000001b. Investigated01001020000004c. Pending for investigation0

0100000001No. of Un-licensed Shops Detected000200000002No. of Show Cause Notice Issued05012000001018No. of Licenses a. Suspended04003000001008b. Cancelled0901030008020023

Slide10

10JammuSambaKathuaRajouriPoonchDoda / KishtwarUdhampurReasiRambanTotalNo of premises existing at the end of the Month

a. Retail

2467

3205043152384973292181965084

b. Whole .

146921

1669

c. Manufacturing Units(Allopathic + Ayurvedic) (including Loan licensee) , Blood Banks & Blood Storage Centre

18/06(BB)/02(BSC)

45/01 (BB)/01(BSC)

01(BB)/03(BSC)

01(BB) /

02 (BSC)

02 (BB)

02/02(BB)/04(BSC)

65 / 13 (BB) / 12(BSC)

Violation detected in regard to DPCO under Essential Commodities Act.

000000000No. of Shops detected being run without Qualified Person / Not maintaining / Purchase Records.0200000001003Any other information related to Drug side (License Renewed)3003040710070202065

Slide11

Slide12

District Wise Work Done (Drug Wing) Kashmir Division June 201312SrinagarBudgamAnantnagKulgamBaramullaKupwaraGanderbalBandiporaPulwama

ShopianLeh

Kargil

MfgTotalSamples Lifted471430082012

1609

191

No. of Inspections Conducted a. Sales Establishments

219

174

882b. Manufacturing Units------------0404No. of Prosecution Launched010000100002000004No. of Cases decided by the Court00000000000000a. With Quantum of Imprisonment00000000000

00b. Amount of Fine (Rs) imposed00000000000000c. Acquittal 00000000000000d. Convicted00000000000000No. of Cases of pending in the Court900811021108

187

No. of Licenses Issued

a. Retail

Slide13

SrinagarBudgamAnantnagKulgamBaramullaKupwaraGanderbalBandiporaPulwamaShopianLeh

KargilMfg

Total

b. Whole Sale1105080010010

c. Restricted/Mfg.

d. Homeopathic

00000000000000Amount of License Fee deposited in the Treasury (Rs.)2,16,50049,0001,61,00044,00062,000600015,00018,00090003000300005,86,500Value of the Seized Drugs (Rs.)223435063007080000702001150002,44,985No. of Complaints a. Received0100001010010000004

b. Investigated

000001010010000003c. Pending for Investigation0100000000000001No. of Un-Licensed Shops detected 00000000000000No. of Show Cause Notice issued040010000010

No. of Licenses

a. Suspended

0010000001000002b. Cancelled010020000100000004No of premises existing at the end of the Month a. Retail12324521176437723538202214551294453405898b. Whole Sale.13081388169127591263631359070203162

Slide14

SrinagarBudgamAnantnagKulgamBaramullaKupwaraGanderbalBandiporaPulwamaShopianLeh

KargilMfg

Total

c. Manufacturing Units(Allopathic +Ayurvedic) (including Loan licensee) , Blood Banks & Blood Storage Centre--------

16 BB / 12Mfg / 04 BSC

Violation detected in regard to DPCO under Essential Commodities Act.

No of shops detected being run without Qualified Person.

00000000000000No of Chemists shops not maintaining Sale / Purchase Record.0000000020000002Any other information related to drug side (License Renewed).29 / 03 Shifting0808040504000302020065 / 03 Shifting14

Slide15

District wise Work Done of Drug Testing Laboratory, Kashmir (June 2013)15S.No.ItemACHIEVEMENTS

Srinagar

Ganderbal

BudgamAnantnagKulgamPulwamaShopian

Baramulla

Bandipora

KupwaraLeh

Kargil

Total

Samples Received

156

Samples Tested[Pending (P) + New (N) ]3208072316151306030205041343.Sample Found Standard2907062316101006030203041194.Samples Found Sub Standard03010100050300002015

Slide16

District wise Work Done of Combined Food and Drug Laboratory, Jammu(June 2013)16S.No.ItemACHIEVEMENTS

Anantnag

Budgam

BandiporaBaramullaDodaGanderbalJammu

Kathua

Kargil

KishtwarKupwara

Leh

Poonch

Samples Received

Samples Tested[Pending (P) + New (N) ]0200302306613002020103.Sample Found Standard000302206112002020084.Samples Found Sub Standard020000100501000002S.No.ItemACHIEVEMENTS

Pulwama

RajouriRambanReasiSambaShopianSrinagarUdhampurPolice/CBPrincipal GMC (Informal Samples)Total1.Samples Received 01060808110006001152.Samples Tested[Pending (P) + New (N) ]018100909022110102013.Sample Found Standard018090909020110101874.Samples Found

Sub Standard

00014

Slide17

CUMULATIVE WORKDONE OF DRUG TESTING LABORATORY JAMMU / KASHMIR TILL THE MONTH OF JUNE, 2013S.NoItemAchievementsCOMBINED FOOD AND DRUG LABORATORY, JAMMUDRUG TESTING LABORATORY, KASHMIRTotalApril,2013April,2013

May 2013June 2013

Cumulative Till June, 2013

April,2013May,2013June 2013Cumulative Till June, 2013Till June, 20131.Samples Received

209 P +176 N

= 385216

115

507

178P +

234N

= 412

111

156

501

1008

Samples Tested

[Pending (P) + New (N) ]

135

207

201

543

131

204

134

46910123.Sample Found Standard1332001875201281871194349544.Samples Found Sub Standard02071423031715355817

Slide18

List of Sub-Standard Drugs June 2013S. No.Name of the DrugManufacturerSample Lifted ByBatch No.Test Report No. & DateReasons1.Primolut - N Tablet M/s Zydus Healthcare, N.H. No.: 31A, Majhitar, Rangpo, East Sikkim - 737132DI, Srinagar Zone IV

Nil M/D: Nil, E/D: Nil,

L/DA/2013-14/372,

Dated: 12.06.2013 The Sample is not labeled in the prescribed manner, hence Misbranded2.Hydrogen Peroxide Solution IP(JKH Supply)M/s Biotic Pharma 64, Phase III, Industrial Extension Area, Gangyal, Jammu – 180 010DI, Kangan / LarL215, M/D: 01/2012, E/D: 06/2014,L/DA/2013-14/339, Dated: 10.06.2013The Sample fails in the Assay of Hydrogen Peroxide (3.112% against 6% of the claim made)3.

Hydrogen Peroxide Solution IP (JKH Supply)

M/s Biotic Pharma 64, Phase III, Industrial Extension Area, Gangyal, Jammu – 180 010DI, Srinagar Zone-II

L214, M/D: 01/2012, E/D: 06/2014,

L/DA/2013-14/338,

Dated: 10.06.2013

The Sample fails in the Assay of Hydrogen Peroxide (3.112% against 6% of the claim made)

Pheniramine Maleate Injection IP

M/s SGS Pharmaceuticals Pvt. Ltd., 162/1, Pohana Iqbalpur Road, Nanhera, Roorkee – 247 667 (UK)

DI, Ramban

JPG-001

M/D: 07/2012, E/D: 06/2014

CFDL/J/2013-14/393

Dated: 14.06.2013

Sample fails in Particulate Matter

Slide19

S. No.Name of the DrugManufacturerSample Lifted ByBatch No.Test Report No. & DateReasons5.Zycal-K2 Soft Gels M/s Affy Parenterals (WHO-cGMP / ISO 9001 : 2008 certified Co), Village Gullarwala, P.O. Baddi, District Solan – 173 205 (HP)DI, Jammu (HQ)PSG-1293,

M/D: 12/2012, E/D: 11/2014,

CFDL/J/2013-14/392,

Dated: 13.06.2013 Sample fails in Uniformity of Weight6.Dynacil 500 InjectionM/s Hindustan Antibiotics Limited (A Government of India Enterprise) Pimpri, Pune 411018, At: 134-B, EPIP Phase-I, Jharmajri, Baddi District Solan HPDI, Srinagar (HQ)12012, M/D: 12/2012, E/D: 11/2014,CFDL/J/2013-14/369, Dated: 10.06.2013 Sample fails in Uniformity of Weight7.

Ceftriaxone Injection IP

(Government Supply) M/s Vivek Pharmachem (India) Ltd., EPIP, Bari Brahmana, Jammu – 181133 (J&K)

DI, Srinagar Zone VICFIJ13002, M/D: 01/2013,

E/D: 12/2014

CFDL/J/2013-14/406, Dated: 15.06.2013

The Sample fails in Clarity of Solution

Ceftriaxone Injection IP

(Government Supply)

M/s Vivek Pharmachem (India) Ltd., EPIP, Bari Brahmana, Jammu – 181133 (J&K)

DI, Anantnag

CFIJ13002,

M/D: 01/2013,

E/D

: 12/2014

CFDL/J/2013-14/405,

Dated: 15.06.2013

The Sample fails in Clarity of Solution

Dynacil 500 Injection

M/s Hindustan Antibiotics Limited (A Government of India Enterprise) Pimpri, Pune 411018, At: 134-B, EPIP Phase-I, Jharmajri, Baddi District Solan HPDI, Srinagar Zone-VI12012, M/D: 12/2012, E/D: 11/2014,L/DA/2013-14/347, Dated: 10.06.2013 Sample fails in Uniformity of Weight10Jumbo Brand Handloom Rolled Gauze M/s J.K Bandage Industries, Gangyal Jammu (J&K)DI, Pulwama / Keller84, M/D: 09/2012, E/D: After 5 yearsL/DA/2013-4/335A, Dated: 10.06.2013 The Sample fails in Threads per dm (Warp)11.Cetrizine Hydrochloride Tablet M/s Biotic Pharma, 64, Phase III, Industrial Estate Gangyal Jammu 180010DI, Reasi I /C TikriT818, M/D: 06/2012, E/D: 05/2014CFDL/J/2013-14/403, Dated: 14.06.2013 Cetrizine Tablets are Official in IP. The label of the Sample doesnot show it Official, hence Misbranded19

Slide20

S. No.Name of the DrugManufacturerSample Lifted ByBatch No.Test Report No. & DateReasons12.Ampicillin Injection IP 500mg(Government Supply) M/s Vivek Pharmachem (India) Ltd., EPIP, Bari Brahmana, Jammu – 181133 (J&K)DI, AnantnagASIJ12002,

M/D: 09/2012, E/D: 02/2014

CFDL/J/2013-14/407,

Dated: 15.06.2013 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 Ingredient in the solution13.Pade - 40 Tablet M/s Horizon Bioceuticals Pvt Ltd., Nahan Road Kala Amb, District Sirmour (HP)DI, KathuaTD-12248, M/D: 04/2012, E/D: 03/2014,CFDL/L/2013-14/428, Dated: 18.06.2013 The label shows Pantoprazole Sodium Tablet IP which is not Official in IP 2010, hence Misbranded14.

Ceflox – TZ Tablet

M/s Laborate Pharmaceuticals India Ltd., 51, Industrial Area, Paonta Sahib (HP)DI, Shopian / Zainapora

JCTIT-001, M/D: 01/2013, E/D

: 12/2015

L/DA/2013-14/371,

Dated: 12.06.2013 The Sample fails in Uniformity of Weight

15.

Diclofenac Potassium and Paracetamol Tablet

(Hospital Supply)

M/s Haustus Biotech Pvt Ltd., 44-45 Industrial Area, Tahilwal District Una, HP

DI, Leh

HBT-460,

M/D: 09/2012,

E/D

: 08/2014

L/DA/2013-14/370,

Dated: 12.06.2013

The Sample fails in Description

16.

Knox-200 DT Tablet

M/s Gag Pharmaceuticals (An ISO 9001: 2008 & GMP Certified Co.), Village Mubarkpur, Shaikhan, District Ludhiana, Punjab – 144 025

DI, PoonchGT-915, M/D: 09/2012, E/D: 08/2014CFDL/J/2013-14/429, Dated: 18.06.2013 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 Misbranded20

Slide21

S. No.Name of the DrugManufacturerSample Lifted ByBatch No.Test Report No. & DateReasons17.Vancomycin Hydrochloride Injection USP 500mg M/s Vivek Pharmachem (India) Ltd., EPIP, Bari Brahmana, Jammu – 181133 (J&K)DI, Jammu Zone I / IIIVCIJ12001M/D: 10/2012,

E/D: 09/2014CFDL/J/2013-14/457,

Dated: 22.06.2013

The Sample fails in Particulate Matter.18.Cefotaxime Sodium Injection IP 500mg M/s Vivek Pharmachem (India) Ltd., EPIP, Bari Brahmana, Jammu – 181133 (J&K)DI, Jammu Zone I / IIICTIJ12005, M/D: 06/2012, E/D: 11/2013,CFDL/J/2013-14/458, Dated: 22.06.2013 The Sample fails in Particulate Matter19.Protozole - 40 Tablet

M/s Presun Biotec, Kandwal Lodhwan Road, Tehsil: Nurpur, Kangra – 176 201 (HP)

DI, Poonch12828, M/D: 08/2012,

E/D: 07/2014

CFDL/J/2013-14/451,

Dated: 22.06.2013

The label of the Product shows (Pantoprazole Tablet IP) which is not Official in IP 2010, hence Misbranded20.

Pantosec - 40 Tablet

M/s Crescent Therapeutics Limited, Khasara No.: 597 / 588, Besides Jharmajri, Village Kunjhal Road, Baddi Tehsil, Nalagarh, District Solan (HP) 173205

DI, Doda

ACD1214,

M/D: 12/2012,

E/D

: 11/2014

CFDL/J/2013-14/450,

Dated: 22.06.2013

The label of the Product shows (Pantoprazole Tablet IP) which is not Official in IP 2010, hence Misbranded

21.

Rasix Injection IP (2ml)

M/s Ramson Remedies, 186, Industrial Focal Point, Amritsar, A.O. 2, G, Floor, Baktawar, Malabar Hill, Mumbai – 400 006

DI, Pulwama / Keller

6644,

M/D: 06/2012, E/D: 05/2014L/DA/2013-14/418, Dated: 20.06.2013Sample fails in Particulate Matter22.Planokuf XP Expectorant Syrup 100ml M/s Shreya Life Sciences Pvt. Ltd., 13, 14, 15, Raipur P.O. Bhagwanpur Roorkee – 247 661 UKDI, Pulwama (HQ)R11028108,M/D: 11/2011, E/D: 10/2013L/DA/2013-14/385, Dated: 15.06.2013 Sample fails in Description.21

Slide22

S. No.Name of the DrugManufacturerSample Lifted ByBatch No.Test Report No. & DateReasons23.Synabron - DC 100ml M/s Concept Pharmaceuticals Ltd., A-28/3, M.I.D.C Chikalthana, Aurangabad – 431 006 (Regd. Office: 167, CST Road Santacrnz (E), Mumbai -400 098 India)DI, Pulwama (HQ)C2001, M/D: 01/2012,

E/D: 06/2014L/DA/2013-14/384,

Dated: 13.06.2013

Sample fails in Description24.Pilex Tablets 60 (Ayurvedic Medicine) M/s The Himalaya Drug Company, Makali Bangalore- 562 123 (India)DI, Jammu Zone I/III37200585B,M/D: 04/2012, E/D: 3 Years from Mfg DateCFDL/J/2013-14/516, Dated: 29.06.2013The Sample is identifies for Steroid Prednisolone.(Adulterated)25.Jumbruyog Tablets 100 Tablets (Ayurvedic Medicine)

M/s Unjha Ayurvedic Pharmacy, Station Road Unjha – 384 170, Gujarat India

DI, Jammu Zone I/IIIF119,

M/D: 07/2012, E/D: 5 Years from Mfg Date

CFDL/J/2013-14/517,

Dated: 29.06.2013

The Sample is identifies for Steroid Prednisolone.

(Adulterated)26.

Ceflox –TZ

M/s Vaishali Pharmaceuticals 7

Km, Stone Jansath Road, Muzaffar Nagar – 251 001

DI, Kashmir

T-150

L/DA/2013-14/431,

Dated: 29.06.2013

Sample fails in Description.

27.

Repzole Capsules

M/s Tulboos Formulations (An ISO 9001:2008 G.M.P Certified Company), Plot No. 91, Sector-IIDC, IIE, Pantnagar, SIDCUL, U.S. Nagar

DI, Kashmir

RPZC302

L/DA/2013-14/432,Dated: 29.06.2013Sample fails in Description.28.Markmox 250 DTM/s Unimark Remedies Limited, At Plot No. 13, Industrial Township, Bhatoli Kalan, Baddi, District Solan (HP)DI, KashmirGTB-130008L/DA/2013-14/433,Dated: 29.06.2013Sample fails in Description.29.Voligesic-5M/s Scott Edil Phatrmacia Limited, 56, EPIP Phase-I, Jharmajri – 173 205DI, KashmirS7521700L/DA/2013-14/434,Dated: 29.06.2013Sample fails in Description.30.Upanto - 40 M/s Unison Pharmaceuticals Plot No. 124, EPIP, Industrial Area, Phase-I Jharmajri Baddi (HP)DI, KashmirULTOF – 04L/DA/2013-14/435,Dated: 29.06.2013Pantoprazole Sodium is not shown Official, hence Misbranded.22

Slide23

Status of Licensed Blood-Banks in Jammu & Kashmir & Kashmir23

Slide24

Status of approved blood storage Centres in J&K24

Slide25

Status of approved blood storage centres in J&K25

Slide26

Work Done of Food wing 26

Slide27

WORK DONE OF FOOD WING OF J&K FOR THE MONTH OF JUNE,201327

Slide28

WORK DONE OF FOOD WING OF J&K FOR THE MONTH OF JUNE,201328