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  • 48 Drug Samples...

48 Drug Samples Including Alkem's PAN 40, Cadila's ACILOC 150 Fail To Qualify CDSCO Test, 1 Declared spurious

Susmita RoyWritten by Susmita Roy Published On 2023-07-22T18:00:56+05:30  |  Updated On 7 Oct 2023 3:52 PM IST
48 Drug Samples Including Alkems PAN 40, Cadilas ACILOC 150 Fail To Qualify CDSCO Test, 1 Declared spurious
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New Delhi: In its latest drug safety alert, the apex drug regulatory body, the Central Drugs Standard Control Organization (CDSCO), flagged 48 medicine batches for failing to qualify for a random drug sample test for the month of June, while one drug sample has been declared spurious.

The list of Drugs declared as Not of Standard Quality includes Rosuvastatin and Vitamin D3 Tablets manufactured by Synokem Pharmaceuticals (Batch No.22S1GTA576), Prednisolone Tablets manufactured by Unicure India (Batch No.PDT1009), Paracetamol Tablets I.P. 650 mg manufactured by Hindustan Antibiotics(Batch No.0019), Acenomac 1 (Nicoumalone Tablets IP) manufactured by Macleods Pharmaceuticals(Batch No.FNU02202A), Aciclovir Tablets IP 400 mg manufactured by Nestor pharmaceuticals(Batch No.YCTZ-01), Cetirizine tablets manufactured by Hindustan Antibiotics (Batch No.0051) and others.

Apart from the above, popular medicines such as PAN 40 (Pantoprazole Gastro-Resistant Tablets I.P.) manufactured by Alkem health science (Batch No.22441073), and ACILOC 150 (Ranitidine tablets I.P. 150mg) manufactured by Cadila Pharmaceuticals (Batch No.LD21512) are also on the list of drugs declared as Not of Standard Quality.

Also Read:Drug Alert: 27 drug samples fail to clear CDSCO test, 1 declared spurious

Furthermore, FLAGORIN, Heparin Inj. I.P. 1000 IU/ml manufactured by Divine Laboratories has been declared as Spurious.

This came after analysis and tests conducted by the CDSCO Drugs Control Department on 1273 samples. Out of these, 1225 samples were found to be of standard quality, while 48 of them were declared as not of standard quality (NSQ), and 1 drug was declared Spurious.

A few of the reasons why the drug samples tested failed were the failure of the assay, the failure of the dissolution test, the failure of disintegration, and the failure of the identification test.

The samples collected were tested in five laboratories, namely CDL Kolkata, CDTL Mumbai, RDTL Chandigarh, RDTL Guwahati, and CDTL Hyderabad.

List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded for the Month of June– 2023:

Total number of samples tested: 1273

Total number of samples declared as of Standard Quality: 1225

Total number of samples declared as Not of Standard Quality: 48

Total number of samples declared as Spurious: 1

Total number of samples declared as Misbranded: NIL


S.No

Name of Drugs/medical

device/cosmetics

Batch No.

Date of Manufa

cture

Date of Expiry

Manufactured By

Reason for failure

Drawn By

From

1

Clorin Capsules (Aspirin & Clopidogrel Capsules)

SPC221847

Aug-22

Jul-24

Salus Pharmaceuticals, 480/211, Harraipur, P.O. Gurumajra, Teh. Baddi,

Dist. Solan (H.P.) – 173205

Assay of Aspirin & Dissolution of Aspirin

CDSCO

Hyderabad

CDL Kolkata

2

Astrifos 2 gm (Ifosfamide Injection IP with Mesna Injection)

OL220037A

Aug-22

Jul-24

Astrica Healthcare Pvt. Ltd., First Floor, Plot No. 9-18/5, Bharathi Nagar, Temple Alwal, Medchal

Hyderabad - 10, Works At: Vill: Gaunspura, P.O. Noorpur Bet, Hambran, Ludhiana – 141 008

Punjab .

Assay of Ifosfamide

CDSCO

Hyderabad

CDL Kolkata

3

Rosuvastatin & Vitamin D3 Tablets

22S1GTA576

May-22

Apr-24

Synokem Phramaceuticals Ltd., Plot No. 35-36, Sector - 6A, I.I.E. (SIDCUL), Ranipur (BHEL), Haridwar - 249 403, (Uttarakhand).

Assay of Rosuvastatin

CDSCO

Bangalore

CDL Kolkata

4

CGTROM-1

(Nicoumalone Tablets IP)

CT22231818

Mar-23

Feb-25

CMG Biotech Pvt. Ltd., 58, Industrial Area, Phase-III, Sansarpur Terrace, HP - 176 501.

Related substances

CDSCO

Bangalore

CDL Kolkata

5

Erythromycin Stearate Tablets IP 250 mg

AT22356

Dec-22

Nov-24

Alves Healthcare Private Limited, Village: Nangal Uperla, Swarghat Road, Tehsil: Nalagarh, Distt.

Solan – 174 101 H.P.,

India

Dissolution

CDSCO

South Zone Chennai

CDL Kolkata

6

Keraboost (Tablets of D-Biotin, N- Acetyl L-Cysteine,

Vitamins & Minerals)

GT200998

Sep-22

Aug-24

Gnosis Pharmaceuticals Pvt. Ltd., Nahan Road, Village: Moginand, Kala

Amb, Distt. Sirmour , H.P. 173030.

Description and Assay of Calcium Pantothenate

CDSCO

South Zone Chennai

CDL Kolkata

7

NUHENZ

(Methylcobalamin, Alpha Lipoic acid, Myo-Inositol, Folic Acid, Chromium Polynicotinate, Selenium Dioxide Monohydrate & Benfotaimine

Capsules)

D222427

Oct-22

Sep-24

Stanford Laboratories Private Limited, 8, Industrial Area, Mehatpur, Distt. Una, (H.P.) – 174 315, India

Assay of Alpha Lipoic acid

CDSCO

South Zone Chennai

CDL Kolkata

8

NUHENZ

(Methylcobalamin, Alpha Lipoic acid, Myo-Inositol, Folic Acid, Chromium Polynicotinate, Selenium Dioxide Monohydrate &

Benfotaimine Capsules)

D222376

Aug-22

Jul-24

Stanford Laboratories Private Limited, 8, Industrial Area, Mehatpur, Distt. Una, (H.P.) – 174 315, India

Assay of Alpha Lipoic acid

CDSCO

South Zone Chennai

CDL Kolkata

9

Maxflux 100 ml (Flucloxacillin Oral solution BP 125mg/5ml

M481001

Jul-21

Jun-23

Maxheal Pharmaceuticals (India) Ltd., 95/6, M.I.D.C.

Satpur, Nashik, Maharashtra 422 007.

Assay of Flucloxacillin

CDSCO

West Zone Mumbai

CDL Kolkata

10

Maxflux 100 ml (Flucloxacillin Oral solution BP 125mg/5ml

M481002

Jul-21

Jun-23

Maxheal Pharmaceuticals (India) Ltd., 95/6, M.I.D.C.

Satpur, Nashik, Maharashtra 422 007.

Assay of Flucloxacillin

CDSCO

West Zone Mumbai

CDL Kolkata

11

Maxflux 100 ml (Flucloxacillin Oral solution BP 125mg/5ml

M481003

Jul-21

Jun-23

Maxheal Pharmaceuticals (India) Ltd., 95/6, M.I.D.C.

Satpur, Nashik, Maharashtra 422 007.

Assay of Flucloxacillin

CDSCO

West Zone Mumbai

CDL Kolkata

12

Maxflux 100 ml (Flucloxacillin Oral solution BP 125mg/5ml

M481004

Jul-21

Jun-23

Maxheal Pharmaceuticals (India) Ltd., 95/6, M.I.D.C.

Satpur, Nashik, Maharashtra 422 007.

Assay of Flucloxacillin

CDSCO

West Zone Mumbai

CDL Kolkata

13

Anabol Syrup (Cyproheptadine Hydrochloride Syrup IP)

L22556

Mar-23

Feb-25

Aan Pharma Private Limited, 816/1, Rakanpur, Ta. Kalol Dist.

Gandhinagar – 380 060, Gujarat (India).

Assay of Cyproheptadine Hydrochloride

CDSCO

Ahmedabad

CDL Kolkata

14

Glipizide Tablets

I.P. 5 mg

T3180

Mar-23

Feb-25

Stallion Laboratories Pvt. Ltd., C-1B, 305/2, 3, 4 & 5,

G.I.D.C. Kerala (Bavla), Dist. Ahmedabad - 382220, Gujarat, India

Dissolution

CDSCO

Ahmedabad

CDL Kolkata

15

IO-Pred-S Eye Drops (Prednisolone Acetate Ophthalmic Suspension USP)

N22L17

Dec-22

Nov-24

Indiana Ophthalmics LLP, 135,136,137, G.I.D.C.

Estate, Phase-II, Wadhwan City - 363035, Dist. Surendranagar, Gujarat, India

Assay of Prednisolone Acetate

CDSCO

Ahmedabad

CDL Kolkata

16

IO-Pred-S Eye Drops (Prednisolone Acetate

Ophthalmic Suspension USP)

N22L18

Dec-22

Nov-24

Indiana Ophthalmics LLP, 135,136,137, G.I.D.C.

Estate, Phase-II, Wadhwan City - 363035,

Dist. Surendranagar, Gujarat, India

Assay of Prednisolone Acetate

CDSCO

Ahmedabad

CDL Kolkata

17

Manokast 5 (Montelukast Tablets IP)

CT22230271A

May-22

Apr-24

CMG Biotech Pvt. Ltd., 58, Industrial Area, Phase- III, Sansarpur Terrace – 176501 (H.P.).

Assay of Montelukast

CDSCO

East Zone Kolkata

CDL Kolkata

18

Ofloxacin and Ornidazole Tablets IP

6001022

Jun-22

May-25

Karnataka Antibiotics & Pharmaceuticals Limited, Plot No.14, II Phase Peenya, Bengaluru – 560

058

Description

CDSCO

East Zone Kolkata

CDL Kolkata

19

Prednisolone Tablets I.P. 5 mg

PDT1009

Oct-22

Sep-24

Unicure India Ltd., C-21, 22 & 23, Sector -3 Noida

201301, Distt. Gautam Budha Nagar (U.P.)

Related Substances

CDSCO

East Zone Kolkata

CDL Kolkata

20

Flutrol 250 (Salmeterol and Fluticasone Propionate Inhalation I.P.)

NSB2206A

Apr-22

Mar-25

Oxalis Labs, Village: Theda, P.O. Lodhimajra, Tehsil: Baddi Distt. Solan, Himachal Pradesh - 174101

Assay of Salmeterol Xinafoate and Fluticasone Propionate

CDSCO

East Zone Kolkata

CDL Kolkata

21

Aceclofenac Tablets I.P. (100 mg)

MT224501

Oct-22

Sep-24

Mascot Health Series Pvt. Ltd., Plot No. 79, 80, Sector-6A, IIE, Sidcul, Haridwar- 249 403,

Uttarakhand.

Dissolution

CDSCO

East Zone Kolkata

CDL Kolkata

22

Paracetamol Tablets I.P. 650 mg

0019

Jan-23

Dec-24

Hindustan Antibiotics Ltd., Pimpri, Pune - 411 018, India

Dissolution

CDSCO

East Zone Kolkata

CDL Kolkata

23

Glimkar-4 (Glimepiride Tablets 4 mg)

GKR-2210

Apr-22

Mar-24

Apple Formulations Pvt. Ltd., Plot No. 208, Kishanpur, Roorkee – 247 667 (U.K.).

Dissolution

CDSCO

East Zone Kolkata

CDL Kolkata

24

Acenomac 1 (Nicoumalone Tablets IP)

FNU02202A

Nov-22

Oct-24

Macleods Pharmaceuticals Ltd., Plot No. 1, 2 & 3, Mahim Road, Near Kuldeep Nagar, Palghar (W) – 401 404,

Dist. Thane, Maharashtra.

Related substances

CDSCO

East Zone Kolkata

CDL Kolkata

25

Mupirocin Ointment IP 2% w/w

002

Mar-22

Feb-24

Saar Biotech, NH-21 A, Bhud, Baddi, Distt. Solan (HP) - 173205.

Assay

CDSCO

East Zone Kolkata

CDL Kolkata

26

FLAGORIN

(Heparin Inj. I.P. 1000 IU/ml)

DP2127

Jul-22

Jun-25

Divine Laboratories Pvt. Ltd., Block No. 471, Dabhasan, Tal - Padra, Distt. Vadodara – 391 440, India.

Identification (A) and Potency of Heparin The sample is

deemed to be Spurious

CDSCO

East Zone Kolkata

CDL Kolkata

27

Telmisartan Tablets IP 40 mg (TLS-40 TABLETS)

DT0862B

Jul-22

Jun-24

DM PHARMA PRIVATE LIMITED, Vill. Bhud, NH-

21A, Baddi, Distt. Solan (H.P.)-173205.

Dissolution

CDSCO

SubZone Bangalore

RDTL

Chandigarh

28

Aciclovir Tablets IP 400 mg

YCTZ-01

Jun-22

May-24

Nestor pharmaceuticals

LIMITED, 11, Western Extension Area, Faridabad-121001, INDIA

Assay of Aciclovir

CDSCO

North Zone Ghaziabad

RDTL

Chandigarh

29

Telmisartan Tablets IP 40 mg (Telwin-40 Tablets)

TT230416

Mar-23

Feb-25

Trugen Pharmaceuticals Pvt. Ltd., Vill. Tejjupur, Near Chodiala Rly.

Station, Roorkee, Distt. Haridwar, Uttarakhand-

247661

Dissolution

CDSCO

North Zone Ghaziabad

RDTL

Chandigarh

30

Zinc Sulphate Dispersible Tablets IP

ZST22015

Feb-22

Jan-24

LA-CHEMICO PRIVATE

LIMITED, Taki Road, Kadambagachi, Barasat, North 24-Paraganas, Kolkata-700125, W.B.

Disintegration Test

CDSCO

North Zone Ghaziabad

RDTL

Chandigarh

31

Aluminium Hydroxide (0.291 gm), Magnesium Hydroxide (98 mg) and Oxetacaine (10 mg ) Gel

ML220582

Oct-22

Sep-24

Mascot Health Series Pvt. Ltd., Plot No. 79, 80, Sector-6A, IIE, Sidcul, Haridwar-249403

Assay of Oxetacaine

CDSCO

North Zone Ghaziabad

RDTL

Chandigarh

32

Acetazolamide Tablets IP 250 mg

423-27

Jan-23

Dec-25

ZEE LABORATORIES

LTD., Behind 47, Industrial Area, Paonta Sahib-

173025

Uniformity of weight

CDSCO

North Zone Ghaziabad

RDTL

Chandigarh

33

Cetirizine tablets IP 10

mg

0051

May-22

Apr-24

Hindustan Antibiotics Ltd., (A Govt. Of India Enterpriese), Pimpri, Pune

- 411018.

Related substances

CDSCO

West Zone Mumbai

CDTL

Mumbai

34

NOOPHIN (BUPRENORPHIN E INJECTION I.P.

2ml)

LM18920

Aug-21

Jul-27

Cooper Pharma Ltd.C3 Industrial area Selaque,Dehradun – 248197

Related Substances

Drug Control Department Bihar

RDTL

Guwahati

35

Diclofenac Sodium Injection IP DOLOMAX

25mg/ml

FDF1-098

Sep-21

Aug-23

BITECH LABORATORY INDORE-452015 (M.P.)

Assay

Drug Controller

Department Gaya

RDTL

Guwahati

36

Ranitidine tablets ip

150mg (ACILOC 150)

LD21512

OCT.20 21

MAR.2 024

Cadila pharmaceuticals LIMITED,

1389, DHOLKA – 382225,

Dist.: Ahmedabad

Description

Drug Controller Department Sikkim

RDTL

Guwahati

37

Chlorpheniramine Maleate & Codeine Phosphate Syrup ONEREXâ„¢ COUGH SYRUP

ONCS 1713

MAR.2 022

FEB.20 24

Wings biotech LLP 43 & 44, HPSIDC

Industrial Area, Baddi- 17205 (H.P.)

Identification and Assay of Codeine phosphate

Drug Controller Department Bihar

RDTL

Guwahati

38

Pantoprazole Gastro- Resistant Tablets IP (PAN*40)

22440483

Feb-22

Jul-24

ALKEM HEALTH SCIENCE,

A unit of Alkem Laboratories Limited, Unit- 2, Samardung Karek Block,

P.O.: Namthang, South Sikkim- 737137

Assay of Pantoprazole

Drug Controller Department Bhagalpur

RDTL

Guwahati

39

Panqubâ„¢ DSR Capsules (Pantoprazole Sodium (GR) & Domperidone (PR)

Capsules I.P.)

PHC-21252

Jan-22

Dec-23

Phytochem Healthcare, Vill- Theda, Lodhimajra Road, PO- Manpura, Kharuni, The- Nalagarh, Dist. Solan (H.P.) -

174101

Dissolution of Domperidone

Drug Controller Department Assam

RDTL

Guwahati

40

PAN 40

(Pantoprazole Gastro- Resistant Tablets I.P.)

22441073

Apr-22

Sep-24

Alkem health science,

A unit of Alkem Laboratories Limited, Unit- 2, Samardung Karek Block,

P.O.: Namthang, South Sikkim- 737137

Assay of Pantoprazole

Drug Controller Depertment Goalpara

RDTL

Guwahati

41

Ceeti-LM (Levocetirizine & Montelukast

Sodium Tablets I.P.)

ALT-0432

Dec-22

Nov-24

Anant Pharmaceuticals

G.T. Road, Uchani, Karnal

- 132001

Dissolution of Montelukast and Levocetirizine Hydrochloride

Drug Controller Depertment Mizoram

RDTL

Guwahati

42

DICLOFENAC SODIUM TABLETS I.P.50

mg

TS7464

Nov-22

Oct-24

ADROIT PHARMACEUTICALS Pvt.

Ltd at: 46 , Garoba Maidan, Nagpur -8 (M.S)

Test for Disintegration (Acid Stage)

CDSCO Zonal office Hyderabad

CDTL

Hyderabad

43

ALUMINIUM HYDROXIDE

,MAGNESIUM HYDROXIDE & ACTIVATED DIMETHICONE SUSPENSION (HICID-MPS

SUSPENSION)

HCD 2201

Feb-22

Jan-24

HIPPO LABS PVT. LTD.

Plot no. 17 ,R.G. Nagar, IDA, Prashanthi Nagar, Kukatpally,Hyderabad-72

Weight per ml

CDSCO

Visakhapatna m

CDTL

Hyderabad

44

CLOZAPINE TABLETS I.P. 100 MG

CZPT1006

Nov-22

Apr-24

UNICURE INDIA LTD, C-

21, 22 &23 Sector-3,

Noida -201301, Distt.

Gautam Budh Nagar (U.P.)

Assay

CDSCO Zonal office Hyderabad

CDTL

Hyderabad

45

ALBENDAZOLE TABLETS I.P. 400 MG (FOZY)

RD09-2202

Oct-22

Sep-24

VANCE & HEALTH PHARMACEUTICALS PVT. LTD, KHASRA

No.410 Karondi, Roorkee- 247667, Uttarakhand.

Test for Dissolution

CDSCO

Visakhapatna m

CDTL

Hyderabad

46

PANTOPRAZOLE GASTRO RESISTANT TABLETS IP 40 MG

JDT-7092

Feb-23

Jan-25

JPEE DRUGS, Plot no. - 53, Sector 6-A,SIDCUL

Haridwar (Uttarakhand).

Test for Dissolution (Buffer Stage)

CDSCO Zonal office Hyderabad

CDTL

Hyderabad

47

TELMISARTAN TABLETS IP 20

MG (TELTAN 20)

HCL2317

Nov-22

Oct-24

HANUCHEM LABORATORIES, Plot no.

16-17 , Sector-5, Indl. Area , Parwanoo, Dist. Solan -173 220 (H.P.)

Test for Dissolution

CDSCO Zonal office Hyderabad

CDTL

Hyderabad

48

PANTOPRAZOLE GASTRO RESISTANT TABLETS IP 40

MG

JDT-7132

Feb-23

Jan-25

JPEE DRUGS, Plot no. - 53, Sector 6-A,SIDCUL

Haridwar (Uttarakhand).

Test for Dissolution (Buffer Stage)

CDSCO Zonal office Hyderabad

CDTL

Hyderabad

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Susmita Roy
Susmita Roy

    Mpharm (Pharmacology)

    Susmita Roy, B pharm, M pharm Pharmacology, graduated from Gurunanak Institute of Pharmaceutical Science and Technology with a bachelor's degree in Pharmacy. She is currently working as an assistant professor at Haldia Institute of Pharmacy in West Bengal. She has been part of Medical Dialogues since March 2021.

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