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Substandard Drugs Flagged Across Multiple States, Over 130 Batches Fail Quality Tests In April

Farhat NasimWritten by Farhat Nasim Published On 2025-05-22T18:45:44+05:30  |  Updated On 22 May 2025 6:45 PM IST
Substandard Drugs Flagged Across Multiple States, Over 130 Batches Fail Quality Tests In April
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New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has flagged 136 batches of pharmaceutical products as Not of Standard Quality (NSQ) in its April 2025 alert, based on reports submitted by multiple state drug control laboratories across India.

The alert was compiled from test results submitted by state drug testing labs in Karnataka, Telangana, Tamil Nadu, Tripura, Punjab, Delhi, Maharashtra, and others. As per CDSCO, such monthly alerts are part of the continuous regulatory surveillance, wherein, Drugs /Cosmetics/Medical Devices samples are picked from sales/distribution point, analyzed and list of Not of Standard Quality (NSQ) drugs is displayed on CDSCO portal on monthly basis.

The list for the month of April includes common formulations such as paracetamol, antibiotics like amoxicillin and cefixime, antihypertensives such as telmisartan, and dermatological products including ketoconazole soap and face washes. Several veterinary formulations were also flagged, with repeated violations by manufacturers of albendazole and ivermectin-based bolus.

Among the most frequent issues cited were, Dissolution test failures, particularly in batches of paracetamol, telmisartan, and albendazole tablets; Assay failures involving incorrect active pharmaceutical ingredient (API) content in drugs such as amoxicillin and gabapentin-based products; Sterility failures in injectables including sodium chloride and gentamicin; Labeling and misbranding violations under Rule 127(2) of the Drugs and Cosmetics Rules, 1945, where some products failed to mention the common name of added colors or the “IP” designation for official monographs.

For example, Ambroxol Hydrochloride Syrup manufactured by Syndicate Pharma, was deemed misbranded as the product label did not indicate the specific name of the color used, violating Rule 127(2). Similarly, Lulimark Cream by Forever Lifescience Pvt. Ltd. failed to mention “IP” on its label, despite being an official monograph drug in the Indian Pharmacopoeia.

Veterinary drugs came under the scanner as well, with multiple batches of Oxfendazole & Ivermectin Bolus (marketed as “WELLMOX-1”) manufactured by Argon Remedies Pvt. Ltd. being flagged for containing significantly lower levels of Ivermectin than claimed on the label.

NOT OF STANDARD QUALITY ALERT FOR THE MONTH OF APRIL– 2025 – (State Laboratories)

S.No

Product/Drug Name

Batch No.

Manufactu ring Date

Expiry Date

Manufactured By

NSQ Result

Reported by

State

Laboratory

1.

Nimesulide &

Paracetamol Bolus

(Vet.) (Nip-UP Bolus)

NPB-23221

Feb-24

Jan-26

M/s. Akme Biotec, Plot No. 24,

Sector-5, I.I.E., Sidcul, Haridwar (U.K.)

Disintegration Test

Karnataka

2.

WORMKILL-PLUS

(Albendazole & Ivermectin Oral

Suspension)

SRVL-24003

Jun-24

May-26

M/s. SPAS Remedies, VillBersan, P.O-Lodhi Majra, Tehsil-

Baddi Distt. Solan (H.P) 173205

Assay for Albendazole and Ivermectin

Karnataka

3.

Paracetamol Tablets IP 650 mg

PCT24034

Feb-24

Jan-26

M/s. Vivek Pharmachem (India)

Ltd., NH-8, Chimanpura, Amer, Jaipur-303102

Test for Dissolution” and “Description

Karnataka

4.

Glimepiride 1 mg &

Metformin HCl 500mg

(Sustained Release)

Tablets IP

SPT40298

Sep-24

Aug-26

M/s. Surge Pharmaceuticals Pvt.

Ltd., Plot No. C-78 & 79,

Additional M.I.D.C., Jejuri412303, Taluka Purandhar

District, Pune, Maharashtra, India

Test for Dissolution” and “Assay for Glimeperide

Karnataka

5.

Spoorthi Aloegramflour Soap

6

Jun-24

May-27

M/s. Spoorthi Herbals No.:299,

SH1 Kalakupi, Airport Road,

Belagavi, Karnataka-591121

Test for Matter insoluble in Alcohol only

Karnataka

6.

Acremox-500

(Amoxycillin Trihydrate

& Lactic Acid Bacillus

Capsules)

ABC24002

Apr-24

Mar-26

M/s. Alexa Pharmaceuticals, Plot. No. 20, Ext, HPSIDC, Ind, Area,

Baddi, Distt. Solan (H.P) 173205

Assay for Amoxycillin

Karnataka

7.

Ketoconazole Tablets I.P. 200mg

GT301737

Mar-24

Feb-26

M/s. Gnosis Pharmaceuticals Pvt. Ltd., Nahan Road, Village Moginand, Kala-Amb, Distt.

Sirmour (H.P)-173030

Description only

Karnataka

8.

Compound Sodium

Lactate Injection I.P (Ringer Lactate Solution for injection I.P) (RL)

4D40168

Oct-24

Sep-27

M/s. IHL Lifesciences Pvt. Ltd., At village: Panwa, Tehsil: Kasrawad,

Dist: Khargone 451228 (M.P) India

Test for Sterility

Karnataka

9.

Amitriptyline HCl &

Chlordiazepoxide

Tablets USP

(AMTOPIC-PLUS)

N2402062

Feb-24

Jan-26

M/s. Talent Healthcare, 66-67,

Sector-6A, Sidcul, Iie, Haridwar249403 (Uttarakhand)

Assay for Amitriptyline only

Karnataka

10.

Sodium Chloride

Injection IP (0.9% W/v)

NS

4HB01401

May-24

Apr-27

M/s. Aishwarya Lifesciences, plot no 11, Ind. Area VPO-Lodhimajra,

Baddi, Distt-Solan (H.P)-174101 (India)

Test for Sterility

Karnataka

11.

Ofloxacin & Ornidazole

Tablets IP (200 mg

+500 mg) (Floxo OZ)

TAH-231704

Sep-23

Aug-25

M/s. Prochem Pharmaceuticals Pvt. Ltd., 140-141, Makkanpur, Bhagawanpur, Roorkee, Dist.

Haridwar (UK)-247661

Description

Karnataka

12.

Infusion Set (BMD)

BIV-020

Aug-24

Jul-27

M/s. Bhgwati Medicare Devices, 8, Maruti Industrial Estste, Nr.

Sindhvai Mata Temple, C.T.M-

Ramol Road, Amraiwadi,

Ahmedabad-380026. Gujarat

(India)

Test for Sterility

Karnataka

13.

Albendazole Tablet IP 400 mg,

T24/007A

Dec-24

Nov-26

M/s. Samkem 15-B & 10-B,

A.K.V.N Industrial Area,

Rangwasa, Rao, Indore - 453331, Madhya Predesh.

Dissolution does not comply as per IP.

State Lab,

Drugs Control

Laboratory,

Telangana.

14.

Albendazole Tablet IP 400 mg,

T24/020A

Dec-24

Nov-26

M/s. Samkem 15-B & 10-B,

A.K.V.N Industrial Area,

Rangwasa, Rao, Indore - 453331, Madhya Predesh.

Dissolution does not comply as per IP.

State Lab,

Drugs Control

Laboratory,

Telangana.

15.

Albendazole Tablet IP 400 mg,

T24/016A

Dec-24

Nov-26

M/s. Samkem 15-B & 10-B,

A.K.V.N Industrial Area,

Rangwasa, Rao, Indore - 453331, Madhya Predesh.

Dissolution does not comply as per IP.

State Lab,

Drugs Control

Laboratory,

Telangana.

16.

Albendazole Tablets IP 400 mg

T24/011A

Dec-24

Nov-26

M/s. Samkem 15-B & 10B,A.K.V.N.Industrial Area,

Rangwasa, Rao,Indore-

453331.(M.P.)(WHO-GMP & GLP

Certifled Company) (AN ISO

9001:2015 Certifled Company)

MADHYA PRADESH

Sample Does not comply in respect of Dissolution Test as per IP.

State Lab,

Drugs Control

Laboratory,

Telangana.

17.

Albendazole Tablet IP 400 mg,

T24/015A

Dec-24

Nov-25

M/s. Samkem15-B & 10-B,

A.K.V.N. INDUSTRIAL AREA,

RANGWASA RAO, INDORE – 453 331 (M.P.) MADHYA

PRADESH

Dissolution does not comply as per IP.

State Lab,

Drugs Control

Laboratory,

Telangana.

18.

Albendazole Tablets IP 400 mg

T24/018A

Dec-24

Nov-26

M/s. Samkem15-B & 10-B,

A.K.V.N. INDUSTRIAL AREA,

RANGWASA RAO, INDORE – 453 331 (M.P.) MADHYA

PRADESH

Dissolution dose not complies as per IP.

State Lab,

Drugs Control

Laboratory,

Telangana.

19.

Albendazole Tablet IP 400 mg,

C25F944019

Jun-24

May-26

M/s. Concept Pharmaceuticals Ltdm Khasra No. 104, Asaf

Dissolution dose not complies as per IP.

State Lab,

Drugs Control

Nagar, Roorkee - 247 667. Uttarakhand.

Laboratory,

Telangana.

20.

Albendazole Tablet IP 400 mg,

C25F944019

Jun-24

May-26

M/s. Concept Pharmaceuticals Ltdm Khasra No. 104, Asaf Nagar, Roorkee - 247 667.

Uttarakhand.

Dissolution dose not complies as per IP.

State Lab,

Drugs Control

Laboratory,

Telangana.

21.

Emiral OD Tablets, Ondansetron orally disintegrating Tablets IP

HT24565

Jul-24

Jun-26

M/s Habitare Pharma Pvt Ltd Plot no. 43-44, Industrial Estate, HSIIDC, Alipur, Barwala, DisttPanchakula (HR) - 134118

HARYANA

Disintegration dose not complies as per IP.

State Lab,

Drugs Control

Laboratory,

Telangana.

22.

Ambroxol Hydrochloride Syrup 30 mg/5 ml

724559

Dec-24

Nov-26

M/s.Syndicate Pharma 185/B,

185/B-1, 187/A & 188, Sector-F,

Sanwer Road, Indore-452015

Madhya Pradesh

Misbranded The drug failed to indicate the common name of the colour, used in the drug, on the product label, as required under Rule 127(2) of the Drugs Rules, 1945. The label merely states Approved Colour Used. Hence, the drug is deemed to be Misbranded under Section 17 of the Drugs and Cosmetics Act,

1940, as it is not labeled in the prescribed manner.

State Lab, Drugs Control

Laboratory,

Telangana.

23.

Lulimark Creams,

Luliconazole Cream 1%

92447

Sep-24

Aug-26

M/s. Forever LifeScience Pvt.Ltd.

74/D, Sopan Kesar Industrial Hub,

Moraiya, Dist. Ahmedabad - 382213 GUJARAT

Misbranded

The drug Product

Luliconazole Cream is

official, i.e., it is included in the current edition of the Indian

Pharamacopoeia (IP2022). As required under the Second Schedule of the Drugs and Cosmetics Act,

1940, the said drug Product shall

mandatorily comply with the standards set out in the Indian

Pharmacopoeia.

State Lab, Drugs Control

Laboratory,

Telangana.

However, the designation "IP"in conjunction with the

official title Luliconazole Cream was not mentioned on the label of the drug product as an indication that it purports to comply with IP standards. Hence, drug under Section 17 of the Drugs and

Cosmetics Act, 1940 as it is not labeled in the prescribed manner.

24.

Ambroxol Hydrochloride Syrup

724543

Nov-24

Oct-26

M/s By: Syndicate Pharma 185/B,

185/B-1, 187/A & 188, Sector-F,

Sanwer Road, Indore - 452015

MADHYA PRADESH

Misbranded The drug failed to indicate the common name of the colour, used in the drug, on the product label, as required under Rule 127(2) of the Drugs Rules, 1945. The label merely states Approved Colour Used. Hence, the drug is deemed to be Misbranded under Section 17 of the Drugs and Cosmetics Act,

1940, as it is not labeled in the prescribed manner.

State Lab, Drugs Control

Laboratory,

Telangana.

25.

Winocin 500

(Paracetamol tablets IP

500 mg)

JT-2405719

May-24

Oct-26

M/s.Jineka Healthcare Pvt. Ltd,

Plot No. 15, Sector- 6B, IIE,

Ranipur, Haridwar (UK) 249403

The sample does not conform to standard quality in respect of the test for "Dissolution" performed.

State Drugs Testing

Laboratory,

Agartala, Tripura.

26.

Fevimed (Paracetamol tablets IP 500 mg)

T-23204

Sep-23

Aug-25

M/s.Kshipra Drugs Pvt. Ltd. 40-

41/22B, Industrial Area No. 1, Dewas (MP) 455001.

The sample does not conform to standard quality in respect of the test for "Dissolution" performed.

State Drugs Testing

Laboratory,

Agartala, Tripura.

27.

Sucrapolis-O Suspension

CSDL24368

Oct-24

Sep-26

M/s.CSD Lifesciences,

Village:Malkumajra, Morepen

sample does not conform to label claim

Drugs Testing

Laboratory,

Chennai - 6

Road, Baddi, Distt, Solan (HP)173205

with respect to the content of Oxetacaine

28.

Gentamicin Injection I.P2ml

24BUH83

Aug-24

Jul-26

M/s.SVP Life Sciences, C/10-1,

Sara Industrial Estate, Selequi, Dehradun.

Sample does not conform to the requirement for pH.

King Institute of

Preventive

Medicine &

Research, Guindy,

Chennai-32

29.

Gentamicin Injection I.P2ml

YGN4102

Jul-24

Jun-26

M/s.Yeluri formulations Pvt Ltd, Sy.296/7/6, I.D.A Bollaram, Samgareddy, District-502 325.

Telangana-India.

Sample does not conform to the requirement for pH.

King Institute of

Preventive

Medicine &

Research, Guindy,

Chennai-32

30.

Cefixime Tablets IP 400 mg

HTB404G

Jul-24

Jun-26

M/s.Himalaya Meditek Pvt Ltd,

Plot No.35&36 Pharmacity,

Selaqui Industrial Area, Dehradun

- 248 197

Sample does not conform to IP Specification for Cefixime Tablets with respect to the content of Anhydrous Cefixime in Cefixime Trihydrate.

Drugs Testing

Laboratory,

Madurai-19

31.

L-Histact-M Tablets

24DT122A

Jun-26

May-27

M/s.Kashmik Formuation Pvt Ltd,

PF-13, Opp procter & Gamble,

Bol GIDC-2, Sanand, Ahmedabad

- 382 170, Gurarat, India

Sample does not conform to IP Specification for

Levocetrizine

Hydrocloride and Montelukast Tablets with respect to the contect of Levocetrizine

Hydrochloride and

Montelukast in

Montelukast in

Montelukast sodium.

Drugs Testing

Laboratory,

Madurai-19

32.

Kelan

Soap(Ketoconazole

Meidcated Soap)

8091

Oct-26

Sep-26

M/s.Vimson Derma, 816/3,

Kothari Estate, Santej-382 721

(Gujarat)

sample does not conform to label claim with respect to the content of Ketoconazole

Drugs Testing

Laboratory,

Madurai-19

33.

Cefixime & Potassium

Clavulanate Tablets

(Alfix-CV)

CT24117D

Aug-24

Jan-26

M/s.Curehealth Pharmaceticals

Pvt Ltd, Vill Ranupur, P.O Deothi ,

Tehsil & District Solan (HP)

173211

Sample does not conform to label claim with respect to the content of Clavulanic Acid in Potassium Clavulanate.

Drugs Testing

Laboratory,

Madurai-19

34.

Lelet-M Syrup

(Montelukast Sodium and levocetirizine hydrochloride syrup)

LLMS-063

Apr-24

Mar-26

M/s.IOSIS Remedies pvt ltd, Rajpura road, village-khera nihla, Tehsil-Nalagarh, District-solan.

Himachal Pradesh - 174 101 India

sample does not conform to label claim with respect to content of Montelukast in Montelukast sodium

Drugs Testing

Laboratory,

Madurai-19

35.

Amoxycillin and potassium clavulanate tablets IP (AUGMONT CV 625 DUP Coamoxiclav)

BT408244A

Aug-24

Apr-26

M/s.Nikvin Healthcare (I) Pvt Ltd, Baddi-Barotiwala Road, Behind Govt, Toimber Depot Vill, Katha.

Baddi(HP)-173 205

Sample does not conform to IP specification for amoxycillin and potassium clavulanate tablets with respect to the content of Clavulanic acid in potassium clavulanate.

Drugs Testing

Laboratory,

Madurai-19

36.

Amoxycillin and potassium clavulanate tablets IP 625 mg

BT240491

May-24

Apr-26

M/s.Hindustan Antibiotics Ltd, at:

Village Saini Majra, Tehsil

Nalagarh Dist. Solan (HP) - 174 101

Sample does not conform to IP specification for amoxycillin and potassium clavulanate tablets with respect to the content of Clavulanic acid in potassium clavulanate.

Drugs Testing

Laboratory,

Madurai-19

37.

Lidocaine Hydrochloride and Gabapentin Gel (Gabaneuron Gel)

PWBBO7

Jun-24

Nov-25

M/s.Pure & Cure Healthcare Pvt

Ltd,(A Subsidiary of Akums Drugs & Pharmaceuticals Ltd) Plot No.

26A, 27-30,Sectir-8A, I.I.E,

SIDCUL, Raniput, Haridwar-249

403, Uttarakhand

Sample does not conform to lebel claim with respect to the content of Gabapentin

Drugs Testing

Laboratory,

Madurai-19

38.

Petben (Benzoyl peroxide shampoo

2.5%)

0000678585

Mar-24

Feb-26

M/s.Hidustan Antibitics Ltd, at

Village Saini Majra, Tehsil

Nalagarh Dist. Solan (HP) - 174 101

Sample does not conform to lebel claim with respect to description of shampoo

Drugs Testing

Laboratory,

Madurai-19

39.

Omeprazole Capsules IP 20mg

HCN423F

Jun-24

May-26

M/s.Himalaya Meditek Pvt Ltd,

Plot No.35&36 Pharmacity,

Selaqui Industrial Area, Dehradun

- 248 197

Sample does not conform to IP specification with respect to Uniformity of

weight

Drugs Testing

Laboratory,

Madurai-19

40.

Clotrimazole and Selenium Sulfide

Suspension, candid tv

46230305

Dec-23

Nov-25

M/s.Glenmark Pharmaceuticals

Ltd, At, Plot No. 38939 Sector-II,

I.I.E, Sidcul, Haridwar, Uttarakhand-249 403.

Sample does not conform to label claim with respect to identification and the

content of clotrimazole (Deemed to be spurious)

Drugs Testing

Laboratory,

Madurai-19

41.

Bisacodyl Tablets Ip 5mg

TA24366

Jun-42

Apr-26

M/s. Saintlife Pharmaceuticals

Ltd, 323, Central Hope Town, Industrial Area, Selaqui,

Dehradun-248011, Uttarakhand.

Sample does not conform to IP specification for Bisacodyl Tablets with respect to Dissolution

Drugs Testing

Laboratory,

Chennai-06

42.

Amoxycillin & Potassium Calvulanate Tablets

BT406210A

Jun-24

May-26

M/s.Nikvin Healthcare (I) Pvt Ltd, Baddi-Barotiwala Road, Behind Govt, Toimber Depot Vill, Katha.

Baddi(HP)-173 205

Sample does not conform to IP specification for Amoxycillin and

Potassium Clavulanate

Tablets with respect to

Dissolution for

Clavulanic Acid and to the content of Clavulanic

Acid in Potassium

Clavulanate Diluted

Drugs Testing

Laboratory,

Chennai-06

43.

Nitrobi-CR

2.6(Nitroglycerin

Controlled Release

Tablets 2.6mg)

JT-2312229

Dec-23

Nov-25

M/s.Jeneka Healthcaere Pvt Ltd,

Khasra No.507-525, Bedpur

Crossing Bhagwanpur By Pass, Roorkee, Distt, Haridwar, Uttarakhand.

Sample does not conform to Label Claim with respect to the content of Nitroglycerine in Diluted

Drugs Testing

Laboratory,

Madurai-19

44.

Bisacodyl Tablets IP 5mg

TA24688

Aug-24

Jul-26

M/s.Saintlife Pharmaceuticals Ltd,

323, Central Hope Town, Industrial Area, Selaqui,

Dehradun-248011, Uttarakhand.

Sample does not conform to IP specification for Bisacodyl Tablets with respect to Dissolution

(Acid medium and

Buffer medium)

Drugs Testing

Laboratory,

Chennai-06

45.

Moxivin-CV 625

(Amoxycillin and

Potassium Calvulnate

Tablets IP)

VMIT2404

Oct-24

Sep-26

M/s.Vertex Pharma Chemicals,

Plot No.60-A,61-A, PIPDIC

Electronic Park, Thirubhuvanai,

Puducherry-605107

The Sample does not

conform to IP specification for Amoxycillin and

Potassium Clavulanate

Tablets with respect to

Identification of

Potassium Clavulanate, Uniformity of weight and content of Amoxycillin in Amoxycillin Trihydrate and Clavulanic Acid in Potassium Clavulanate (Deemed to be spurious).

Drugs Testing

Laboratory,

Madurai-19

46.

Burmoxicla+V(Amoxycill in & Potassium Clavulanate Oral

Suspension IP)

ABD-187C

Jun-24

Nov-25

M/s.Azot Life Sciences,

Vill.Chewa, P.O, Kumarhatti,

Distt. Solan - 173229(H.P)

Sample does not conform to IP specification for Amoxycillin and Potassium Clavulanate oral suspension with respect to the content of

Drugs Testing

Laboratory,

Madurai-19

Clavulanic Acid in

Potassium Clavulanate

47.

Z&D Syrup (Zinc

Gluconate Oral Solution

20mg)

XSZE24005

Aug-24

Jan-26

M/s.Hema Laboratories Pvt Ltd,

Plot No.29, Pharma City, Selaqui Industrial, Area, Dehradun 248011, Uttarakhand.

Sample does not conform to Label Claim with respect to content of Elemental Zinc in Zinc Gluconate

Drugs Testing

Laboratory,

Madurai-19

48.

Softuss-D

(Dextromethorphan

Hydrobromide,

Phenylephrine

Hydrochloride &

Chlorpheniramine

Maleate Syrup)

DL2501013B

Jan-25

Dec-26

M/s.Indorama Health Care Pvt

Ltd, 204-205, HSIIDC, Manakpur,

Industrial Area, Jagadhri, Distt,

Yamuna Nagar (Haryana),

135003

Sample does not conform to IP specification for label claim with respect to the

content of Phenylephrine

Hydrochloride

Drugs Testing

Laboratory,

Chennai-06

49.

Chlorpheniramine

Maleate IP & Noscapine

IP Oral Syrup

(Coscopin Linctus)

VTL4006

Mar-24

Feb-26

M/s.Biological E Limited, Plot

47B/2, Street No.04, Phase-1,

IDA Cherlapally Village, Kapra

Mandal, Medchal-Malkajgiri District-500052, Telangana State, India.

Sample does not conform to Label claim with respect to the content of Noscapine

Drugs Testing

Laboratory,

Madurai-19

50.

Betamethasone

Valerate Ointment IP

0.1% w/w

B75

Aug-24

Jul-26

M/s.Syndicate Pharma, 185/B,

185/B-1, 187/A & 188 Sector - F, Sanwer Road, Indore-452015.

Sample does not conform to IP specification for

Betamethasone

Valerate Ointment with respect to the content of

Betamethasone in

Betamethasone

Valerate

Drugs Testing

Laboratory,

Madurai-19

51.

Betamethasone

Valerate Cream IP

E4062

Feb-24

Jan-26

M/s.Rhydburg Pharmaceuticals

Ltd, C2&3, S.I.E.L, Selaqui,

Dehradun, Uttarakhand (India)

Sample does not conform to IP

specification for

Betamethasone Valerate Cream with respect to the content of

Betamethasone in

Betamethasone Valerate.

Drugs Testing

Laboratory,

Madurai-19

52.

Synclov-625 Tablets

(Amoxycillin &

Potassium Clavulanate

Tablets IP)

MICTAB-2120

Jan-25

Jun-26

M/s.Micro Formulations,

Chambaghat, New Railway

Crossing, Distt, solan

(HP),173211

Sample does not conform to IP specification for Amoxycillin and

Potassium Clavulanate

Tablets with respect to

Dissolution for

Clavulanic Acid and to

Drugs Testing

Laboratory,

Chennai-06

the content of Clavulanic

Acid in Potassium

Clavulanate Diluted

53.

Frusemide Injection IP2ml

24BTC63

Mar-24

Feb-26

M/s.SVP Life Sciences, C/10-1,

Sara Industrial Estate, Selequi, Dehradun.

Sample does not

conform to requirement

for sterility

King Institute of

Preventive

Medicine &

Research, Guindy,

Chennai-32

54.

Progaba Gel (Lidocaine

Hydrochloride &

Gabapentin Gel)

PSWAB66

Jun-24

Nov-25

M/s.Pure & Cure Healthcare Pvt

Ltd,(A Subsidiary of Akums Drugs & Pharmaceuticals Ltd) Plot No.

26A, 27-30,Sector-8A, I.I.E,

SIDCUL, Haridwar-249 403,

Uttarakhand

Sample does not conform to Label claim with respect to the content of Gabapentin

Drugs Testing

Laboratory,

Madurai-19

55.

Povigin (Povidone

Iodine Ointment USP

5%w/w)

PZ-2414

Sep-24

Aug-26

M/s. GP Glister Pharmaceutical,

B-17, AKVN Industrial Area,

Rangawasa, RAU, 453331

Sample does not conform to USP specification for

Povidone- Iodine

Ointment with respect to the content of Available

Iodine in PovidoneIodine

Drugs Testing

Laboratory,

Chennai-06

56.

Pantozor Tablets

(Pantoprazole Sodium

Tablets IP)

UTBO25A

Feb-25

Jan-27

M/s.Haustus Biotech Pvt Ltd, 4445, Indl. Area, Tahliwal, Distt, Una (H.P)

Sample does not conform to IP specification for

Pantoprazole Tablets with respect to Dissolution in Buffer stage

Drugs Testing

Laboratory,

Chennai-06

57.

Frusemide Tablets IP 40mg

TA24283

Jul-24

Jun-26

M/s.Saintlife Pharmaceuticals Ltd,

323, Central Hope Town,

Industrial Area, Selaqui,

Dehradun-248011, Uttarakhand,

India.

Sample does not conform to IP specification for

Frusemide Tablets with respect to Dissolution

Drugs Testing

Laboratory,

Chennai-06

58.

Atorvastatin Tablets IP 10mg

CT240246A

Jul-24

Jun-26

M/s.Candour Pharmaceuticals,

Vill. OGLI, Suketi Road, Kala

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

Sample does not conform to IP specification for Atorvastatin Calcium

Tablets with respect to

Dissolution

Drugs Testing

Laboratory,

Chennai-06

59.

Diclofenac Sodium Tablets IP

THB24028AL

Jul-24

Jun-26

M/s. Hindustan Laboratories

Limited, Plot No. 5-9, Survey

No.382, Aliyali, Palghar (W), Dist.

Palghat 401404 (M.S)

Sample does not conform to IP specification for Enteric Coated Tablets with respect to Disintegration

Drugs Testing

Laboratory,

Chennai-06

60.

Atorvastatin Tablets IP 10mg

AT24045

Aug-24

Jan-26

M/s. Eurokem Laboratories Pvt ltd, C-25, SIDCO Pharmaceutical Complex, Alathur, Thiruporur, 603110.

Sample does not conform to IP specification for Atorvastatin Calcium

Tablets with respect to

Dissolution

Drugs Testing Laboratory,

Chennai-06.

61.

Glypro 1 (Glimepiride Tablets IP) 1mg

FGYO-1626

Dec-24

Nov-26

M/s.Firstmed Therapeutics Pvt

Ltd, R.S.No.31/1, Pondy-

Tindivanam Main Road, Auroville

(PO), Thiruchitrambalam,

Tamilnadu-605101

Sample does not conform to IP specification for

Glimepiride Tablets with respect to the content of

Glimepiride

Drugs Testing

Laboratory,

Madurai-19

62.

Merocet (Cetirizine Hydrochloride Syrup)

1124192

Nov-24

Oct-26

M/s.Kite Formulation, No.67/1, 1st

& 2st floor, 4th street, Thirunagar,

Karumandapam, Trichy-620001

Sample does not conform to IP specification with respect to the PH.

Drugs Testing

Laboratory,

Madurai-19

63.

Mupropet (Mupirocin Ointment IP 2%w/w)

DG2436

Jul-24

Dec-25

M/s.Arius Formulations Pvt Ltd,

R.S.No.141/1, Plot No.38 & 47,

Ground Floor, Navarkulam Main

Road, Pattanur, Auroville (Post),

Vanur taluk, Tamilnadu, 605101

Sample does not conform to IP specification for

Mupirocin Ointment with respect to the content of

Mupirocin

Drugs Testing Laboratory,

Chennai-06.

64.

Atorvastatin Tablets IP 10mg

A297

Jul-24

Jun-26

M/s.Rikenbik Pharma, 113,

SIDCO Industrial Estate,

Ambattur, Chennai, 600098

Sample does not conform to IP specification for Atorvastatin Calcium

Tablets with respect to

Dissolution

Drugs Testing Laboratory,

Chennai-06.

65.

Labetalol Hydrochloride Tablets IP 100 mg

UGT231341

10/2023

Sep-25

M/s Unimarck Healthcare Ltd.,

Plot No. 24,25 & 37 Sector 6A,

SIDCUL, Haridwar-249403

(Uttarakhand)

Test For Assay(Content)

of Labetalol Hydrochloride

Government of NCT of Delhi

66.

Aspirin Gastro Resistant Tab IP 75 mg

ANET1235

May-24

Apr-26

M/s. Unicure India Ltd, C21,22&23, sector-3, Noida201301, Distt.Guatam Budh

Nagar (UP)

It fails the test

‘Dissolution’ Specified in the laboratory protocol as per IP

Drugs Testing

Laboratory

Thiruvananthapura m

67.

Telmisartan &

Amlodipine Tablets IP

UGT24G06A

Oct-24

Sep-26

M/s.Unigrow Pharmaceuticals,

Vill. Katha, Baddi, Dist. Solan

(HP)

It fails the tests for

‘Assay’ of Amlodipine and ‘Dissolution’ as specified in the

Laboratory Protocol as

per IP

Drugs Testing

Laboratory

Thiruvananthapura m

68.

Ahaglow Face Wash Gel 50 gm

AHA202

May-24

Apr-26

M/s.Torrent Pharmaceuticals Ltd,

Plot No. 810, Sector III, Industrial

Area, Pithampur, Dist.Dhar, MP- 454775

The sample does not conform to Cosmetics Rules 2020 for the standards of cosmetics.

Drugs Testing

Laboratory

Thiruvananthapura m

It fails the test for the content of ‘Mercury’ in finished cosmetic products as specified in the Laboratory Protocol.

69.

Alograce Cream

(Vitamin E, Honey &

Aloevera Cream)

A2JJX048

Dec-24

Dec-26

M/s.RSH Global Pvt. Ltd, Plot

No.3 C, Industrial Area, Baddi- 173 205

The sample does not conform to IS 6608:2004 for specifications of skin cream. It fails the test for “Heavy metals (as lead) ppm” as specified in the laboratory protocol

Drugs Testing

Laboratory

Thiruvananthapura m

70.

Pantonis-40

(Pantoprazole Sodium

Gastro Resistant Tab

IP)

JMT-2407371

Jul-24

Jun-26

M/s. JMM Laboratories, Vill- Khari,Kala amb, Tehsil, Nahan

Sirmour- 173030

It fails the test

‘Dissolution’ as per IP, as Specified in the laboratory protocol

Drugs Testing

Laboratory

Thiruvananthapura m

71.

Nebivolol Tablets IP

KMNB 24002

Oct-24

Sep-26

M/s.Ravian Life Sciences Pvt Ltd,

Plot No. 34, sector-8A, IIE,

SIDCUL, Haridwar- 249 403,

Uttarakhand

It fails the test for ‘Dissolution’ as per IP, as Specified in the laboratory protocol

Drugs Testing

Laboratory

Thiruvananthapura m

72.

Mamaearth Vitamin C daily glow light moisturising cream

AM4J160

Oct-24

Use before 24 Months from the date Mfg.

M/s.VA Life sciences, LLP, Plot

NO. 9D, sector-2, Parvanoo, HP 173 220

The sample does not conform to Cosmetics Rules 2020 for the standards of cosmetics.

It fails the test for the content of ‘Mercury’ in finished cosmetic products as specified in the Laboratoty Protocol.

Drugs Testing

Laboratory

Thiruvananthapura m

73.

Ondansetron Tablets IP 4 mg

ONTB-06

Sep-24

Aug-26

M/s.Nestor Pharmaceuticals

Limited,

11, Western Extension Area,

Faridabad -121 001

It fails the test for ‘Dissolution’ as per IP as

Specified in the laboratory protocol

Drugs Testing

Laboratory

Thiruvananthapura m

74.

Paracetamol Tablets IP 500 mg

PAK-517

May-23

Apr-26

M/s. Healer’s Lab Unit II, Plot No.

33, HPSIDC, Extn, Baddi,

Dist.Solan HP

It fails the test for ‘Dissolution’ as per IP as

Specified in the laboratory protocol

Drugs Testing

Laboratory

Thiruvananthapura m

75.

Restomol 650

(Paracetamol Tablets IP

650 mg)

K1224079

Dec-24

Nov-27

M/s.Kaushik Therapeutics (P) Ltd,

Plot No.6 &7 , Door No. 728,

Kakkanji Cross Street,

Paraniputhur Road,

Gerugambakkam, Chennai -

600128

It fails the test for ‘Dissolution’ as per IP as

Specified in the laboratory protocol

Drugs Testing

Laboratory

Thiruvananthapura m

76.

Nicocred-10 (Nicorandil Tablets 10 mg)

SGT- 241195

Aug-24

Jul-26

M/s.SB Life Sciences Pvt Ltd, At Plot No. 45, EPIP, Phase-I,

It fails the tests

‘Dissolution’ and ‘Assay’

Drugs Testing Laboratory

Jharmajri, Baddi, Distt , Solan (HP)

as per IP , specified in the laboratory protocol

Thiruvananthapura m

77.

Cefixime Oral

Suspension IP Dry

Syrup 30 ml

CADB- 02

Jun-24

May-26

M/s.Nestor Pharmaceuticals

Limited,

11, Western Extension Area,

Faridabad -121 001

It fails the test Assay, water and descriptive part for oral liquids as per IP , as specified in the Laboratory Protocol

Drugs Testing

Laboratory

Thiruvananthapura m

78.

Paracetamol Tab IP 500 mg

PAK-558

Sep-23

Aug-26

M/s.Healer’s Lab Unit II, Plot No.

33, HPSIDC, Extn, Baddi,

Dist.Solan HP

It fails the test

‘Dissolution’ as per IP , as Specified in the laboratory protocol

Drugs Testing

Laboratory

Thiruvananthapura m

79.

Paracetamol Tab IP 500 mg

PAK-524

May-23

Apr-26

M/s.Healer’s Lab Unit II, Plot No.

33, HPSIDC, Extn, Baddi,

Dist.Solan HP

It fails the test ‘Dissolution’ as per IP specified in the laboratory protocol

Drugs Testing

Laboratory

Thiruvananthapura m

80.

Tab Telmisartan IP 40 mg

GTM18

Jun-24

May-26

M/s.Super Formulation Pvt Ltd,

16-B, 15-F, Industrial Area , Maxi

Road, Ujjain (MP) 456010

It fails the test ‘Dissolution’ as per IP, specified in the laboratory protocol

Drugs Testing

Laboratory

Thiruvananthapura m

81.

Telmisartan Tab IP 40 mg

D0004/25-26

NIL

NIL

M/s.Kerala Medical services

Corporation Limited, Thycaud

P.O, Thiruvananthapuram

The sample does not conform to IP standards

with respect to descriptive part for tablets

Drugs Testing

Laboratory

Thiruvananthapura m

82.

Paracetamol Tab IP 500 mg

D 0001/25-26

NIL

NIL

M/s.Kerala Medical services

Corporation Limited, Thycaud

P.O, Thiruvananthapuram

It fails the tests dissolution as per IP specified in the Laboratory Protocol

Drugs Testing

Laboratory

Thiruvananthapura m

83.

Gentamicin Inj. IP

D0003/25-26

NIL

NIL

M/s.Kerala Medical services

Corporation Limited, Thycaud

P.O, Thiruvananthapuram

It fails the test particulate matter and descriptive part for injections

Drugs Testing

Laboratory

Thiruvananthapura m

84.

Oxfendazole &

Ivermectin Bolus (Vet.)

WELLMOX-1

AGWT25019

Jan-25

Dec-26

M/s.Argon Remedies Pvt. Ltd.,

Sarverkhera. Moradabad Road,

Kashipur, U S Nagar,

Uttarakhand-244713

The content of

Ivermectin found to be

29.69 mg per bolus (74.225%) against labelled claim of 40 mg per bolus.

State Drugs

Laboratory, Punjab

85.

Oxfendazole &

Ivermectin Bolus (Vet.)

WELLMOX-1

AGWT25018

Jan-25

Dec-26

M/s.Argon Remedies Pvt. Ltd.,

Sarverkhera. Moradabad Road,

Kashipur, U S Nagar,

Uttarakhand-244713

The content of

Oxfendazole found to be

883.42 mg per bolus (88.342%) against labelled claim of 1000 mg per bolus.

State Drugs

Laboratory, Punjab

86.

Oxfendazole &

Ivermectin Bolus (Vet.)

WELLMOX-1

AGWT25038

Jan-25

Dec-26

M/s.Argon Remedies Pvt. Ltd.,

Sarverkhera. Moradabad Road,

Kashipur, U S Nagar,

Uttarakhand-244713

1. Description. 2. The Content of Ivermectin found to be 34.73 mg per bolus (86.825%) against labelled claim of 40 mg per bolus.

State Drugs

Laboratory, Punjab

87.

Oxfendazole &

Ivermectin Bolus (Vet.)

WELLMOX-1

AGWT25025

Jan-25

Dec-26

M/s.Argon Remedies Pvt. Ltd.,

Sarverkhera. Moradabad Road,

Kashipur, U S Nagar,

Uttarakhand-244713

The content of

Ivermectin found to be

28.57 mg per bolus (71.425%) against labelled claim of 40 mg per bolus.

State Drugs

Laboratory, Punjab

88.

Oxfendazole &

Ivermectin Bolus (Vet.)

WELLMOX-1

AGWT25034

Jan-25

Dec-26

M/s.Argon Remedies Pvt. Ltd.,

Sarverkhera. Moradabad Road,

Kashipur, U S Nagar,

Uttarakhand-244713

The content of

Ivermectin found to be

34.91 mg per bolus (87.275%) against labelled claim of 40 mg per bolus.

State Drugs

Laboratory, Punjab

89.

Oxfendazole &

Ivermectin Bolus (Vet.)

WELLMOX-1

AGWT25033

Jan-25

Dec-26

M/s.Argon Remedies Pvt. Ltd.,

Sarverkhera. Moradabad Road,

Kashipur, U S Nagar,

Uttarakhand-244713

The content of

Ivermectin found to be

26.66 mg per bolus (66.65%) against labelled claim of 40 mg per bolus.

State Drugs

Laboratory, Punjab

90.

Oxfendazole &

Ivermectin Bolus (Vet.)

WELLMOX-1

AGWT25032

Jan-25

Dec-26

M/s.Argon Remedies Pvt. Ltd.,

Sarverkhera. Moradabad Road,

Kashipur, U S Nagar,

Uttarakhand-244713

The content of

Ivermectin found to be

30.19 mg per bolus (75.475%) against labelled claim of 40 mg per bolus.

State Drugs

Laboratory, Punjab

91.

Oxfendazole &

Ivermectin Bolus (Vet.)

WELLMOX-1

AGWT25031

Jan-25

Dec-26

M/s.Argon Remedies Pvt. Ltd.,

Sarverkhera. Moradabad Road,

Kashipur, U S Nagar,

Uttarakhand-244713

1. The content of

Ivermectin found to be

32.52 mg per bolus (81.30%) against labelled claim of 40 mg per bolus.2. The Content of Oxfendazole found to be 880.01 mg per bolus (88.001%) against labelled claim of 1000 mg per bolus.

State Drugs

Laboratory, Punjab

92.

Oxfendazole &

Ivermectin Bolus (Vet.)

WELLMOX-1

AGWT25037

Jan-25

Dec-26

M/s.Argon Remedies Pvt. Ltd.,

Sarverkhera. Moradabad Road,

Kashipur, U S Nagar,

Uttarakhand-244713

1. The content of

Oxfendazole found to be

877.69 mg per bolus (87.769%) against labelled claim of 1000

State Drugs

Laboratory, Punjab

mg per bolus. 2. The Content of Ivermectin found to be 28.220 mg per bolus (70.55%) against labelled claim of 40 mg per bolus.

93.

Oxfendazole &

Ivermectin Bolus (Vet.)

WELLMOX-1

AGWT25041

Jan-25

Dec-26

M/s.Argon Remedies Pvt. Ltd.,

Sarverkhera. Moradabad Road,

Kashipur, U S Nagar,

Uttarakhand-244713

The content of

Ivermectin found to be

33.19 mg per bolus (82.975%) against labelled claim of 40 mg per bolus.

State Drugs

Laboratory, Punjab

94.

Oxfendazole &

Ivermectin Bolus (Vet.)

WELLMOX-1

AGWT25035

Jan-25

Dec-26

M/s.Argon Remedies Pvt. Ltd.,

Sarverkhera. Moradabad Road,

Kashipur, U S Nagar,

Uttarakhand-244713

The content of

Ivermectin found to be

25.17 mg per bolus (62.925%) against labelled claim of 40 mg per bolus.

State Drugs

Laboratory, Punjab

95.

Oxfendazole &

Ivermectin Bolus (Vet.)

WELLMOX-1

AGWT25036

Jan-25

Dec-26

M/s.Argon Remedies Pvt. Ltd.,

Sarverkhera. Moradabad Road,

Kashipur, U S Nagar,

Uttarakhand-244713

The content of

Ivermectin found to be

28.66 mg per bolus (71.65%) against labelled claim of 40 mg per bolus.

State Drugs

Laboratory, Punjab

96.

Aceclofenac &

Paracetamol Tablets IP

GG204014

Apr-24

Mar-26

M/s.Innova Captab Limited,

1281/1, Hilltop Industrial Estate,

Near EPIP, Phase-1, Jharmajri,

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

Misbranded

Product is not official in

I.P as on its manufacturing date mentioned on its label i.e. April 2024.

State Drugs Laboratory, Punjab

97.

Oxfendazole &

Ivermectin Bolus (Vet.)

WELLMOX-1

AGWT25024

Jan-25

Dec-26

M/s.Argon Remedies Pvt. Ltd.,

Sarverkhera. Moradabad Road,

Kashipur, U S Nagar,

Uttarakhand-244713

The content of

Ivermectin found to be

33.069 mg per bolus (82.672%) against labelled claim of 40 mg per bolus.

State Drugs

Laboratory, Punjab

98.

Oxfendazole &

Ivermectin Bolus (Vet.)

WELLMOX-1

AGWT25029

Jan-25

Dec-26

M/s.Argon Remedies Pvt. Ltd.,

Sarverkhera. Moradabad Road,

Kashipur, U S Nagar,

Uttarakhand-244713

The content of

Ivermectin found to be

33.29 mg per bolus (83.225%) against labelled claim of 40 mg per bolus.

State Drugs

Laboratory, Punjab

99.

Oxfendazole &

Ivermectin Bolus (Vet.)

WELLMOX-1

AGWT25028

Jan-25

Dec-26

M/s.Argon Remedies Pvt. Ltd.,

Sarverkhera. Moradabad Road,

Kashipur, U S Nagar,

Uttarakhand-244713

The content of

Ivermectin found to be

31.82 mg per bolus

(79.55%) against

State Drugs

Laboratory, Punjab

labelled claim of 40 mg per bolus.

100.

Oxfendazole &

Ivermectin Bolus (Vet.)

WELLMOX-1

AGWT25027

Jan-25

Dec-26

M/s.Argon Remedies Pvt. Ltd.,

Sarverkhera. Moradabad Road,

Kashipur, U S Nagar,

Uttarakhand-244713

The content of

Ivermectin found to be

31.68 mg per bolus (79.20%) against labelled claim of 40 mg per bolus.

State Drugs

Laboratory, Punjab

101.

Oxfendazole &

Ivermectin Bolus (Vet.)

WELLMOX-1

AGWT25026

Jan-25

Dec-26

M/s.Argon Remedies Pvt. Ltd.,

Sarverkhera. Moradabad Road,

Kashipur, U S Nagar,

Uttarakhand-244713

The content of

Ivermectin found to be

33.055 mg per bolus (82.637%) against labelled claim of 40 mg per bolus.

State Drugs

Laboratory, Punjab

102.

Oxfendazole &

Ivermectin Bolus (Vet.)

WELLMOX-1

AGWT25030

Jan-25

Dec-26

M/s.Argon Remedies Pvt. Ltd.,

Sarverkhera. Moradabad Road,

Kashipur, U S Nagar,

Uttarakhand-244713

The content of

Ivermectin found to be

31.66 mg per bolus (79.15%) against labelled claim of 40 mg per bolus.

State Drugs

Laboratory, Punjab

103.

Clonazepam and

Paroxetine

Hydrochloride CR

Tablets (Exotine CR)

17671

Feb-24

Jan-27

M/s. Elikem Pharmaceuticals Pvt.

Ltd., 816/1, Rakanpur, Ta. Kalol,

Distt. Gandhinagar, Guj. 382721

Uniformity of Weight

State Drugs

Laboratory, Punjab

104.

Losartan Potassium

50mg &

Hydrochlorthiazide

12.5mg Tablets

LMT251666

Feb-25

Jan-27

M/s. Life Max Cancer

Laboratories, Plot No: 106 & 106

A, Sector- 6A, IIE, SIDCUL,

Haridwar-249403 (U.K)

Dissolution Test: The

Dissolution of Losartan

Potassium and

Hydrochlorthiazide does not complies within the Prescribed limit of not less than Q value i.e. 70% of labelled claim as stated in I.P 2022.

State Drugs

Laboratory, Punjab

105.

Calcium & Vitamin D3

Tablets IP (JKMSCL,

Supply)

PGT24673

Sep-24

Aug-26

M/s. Affy Parenterals Vill

Gullawala P.O. Baddi Distt Solan173205

The sample does not conform to IP 2022 w.r.t Disintegration test for the sample portion received

CDSCO Zone III Jammu

106.

Defix -AZ

DP-240754

Sep-24

Aug-26

M/s. Park Pharmaceuticals 272,

Ind. Area, Phase-II, Panchkula

134113

The sample fails in the test for Assay content of Cefixime &

Azithromycin.

CDSCO Zone III, Srinagar

107.

Proxtl 100 DT

PXT123F02

Mar-23

May-25

M/s. INDU Drugs Pvt Ltd.5-5-

35/278,279 & 281/1 (Part)

Prasanthi Nagar ida, Kutkapally,

Hyderabad-500072

The sample does not comply with IP requirements for Dissolution test.

FDA Lab, Mumbai51

108.

Telivi-H 40 (Telmisartan

& Hydrochorothiazide

Tablets IP

BLT23348

Jun-23

May-25

M/s. BRIT Lifescience a GMP Certified Company) Sainwala kaula Wata, Bhood Road, kala

AMB Distt. Sirmmour (HP)

173030

1. The content of

Telmisartan and Hydrochlorothiazide in the sample is less (i.e. 83.13% and 79.44%of the labelled amount respectively) than I.P. limits. 2. The sample does not comply with I.P. Requirements for

"Dissolution Test" for

Telemisartan and

Hydrochlorothiazide.

FDA Lab, Mumbai51

109.

Koplyco Syrup

TL-6337

Jun-23

May-23

M/s. Ticoma Pharmacia E-17

Industrial Focal Point Debrabassi,

Derabassi,

1. Content of vitamin B1 in the sample is less (i.e. 71.10% of the labelled amount) than the permissible limits. 2. Content of the Vitamin

B2 in the sample is less (i.e. 72.74%) of the labelled amount) than the permissible limits.

FDA Lab, Mumbai51

110.

Ondansentron Tablets IP 4mg

PS39AB06

Jun-23

May-25

M/s. Pure & Cure Healthcare Pvt

Ltd, Plot No. 26A, 27-30, Sector8A, LLE. SIDCUL Haridwar,

Uttarakhand-249403

The sample does not comply with IP requirements for Dissolution test

FDA Lab, Mumbai51

111.

Opivas 10 tablets

23C-T465

Jun-23

May-25

M/s. Orison Pharma International

Khari, Mauza-Ogli, Kala AMB173030, HP

The sample does not comply with IP requirements for Dissolution test.

FDA Lab, Mumbai51

112.

Cetquine 5 Tablets

(Levocetirizine

Dihydrochlorine Tablets

IP

ATX060546

Jun-23

May-25

M/s. ADWIN Pharma Vill Rampur,

Jattan, Trilokpur Road, Kala,

Tehsil nahan Sirmour-173030

The sample does not comply with IP requirements for Dissolution test.

FDA Lab, Mumbai51

113.

ITRADEL-200k

SD6005C

Jun-23

May-25

M/s. Sigma Softgel & Formulation plot no. 171, HPSIDC, Industrial

Area, B. Dist. Solan HP Baddi173202

The sample does not comply with IP requirements for Dissolution test

FDA Lab, Mumbai51

114.

Phytorab-DSR Capsules

GC 41481

Jun-23

May-25

M/s. J.M. Laboratories Village

Bhanat, Po-ghatti, Subathu Road,

Solan (HP), Solan 173211

The content of rabeprazole sodium in the sample is less (i.e. 55.00% of the labelled amount) than the permissible limits

FDA Lab, Mumbai51

115.

Neem tulsi face wash

APN612

Aug-24

Aug-26

M/s. Orgello Herbal Care Vill.

Behrewala, Pantoba Sahib Distt.

Sirmour (H.P) 173025

The sample does not comply with IS 14648: 2011 (Second Revision)

Reaffirmed 2021

Requirements for

Microbiological

Examination test for

Neem Tulsi Face wash

FDA Lab, Mumbai51

116.

Adivasi Herbal

Shampoo

MASH-23-101

Jan-24

Dec-26

M/s. Beauty Birds Cosmetics

Bhatti Compound , 1/B Paik 1/1,

Plot -112TP-1, Ahmedabad

Gujarat 380022 Ahmedabad-

380022

The sample does not comply with IS

7884:2004 specification for shampoo (Third Revision) reaffirmed 2019 requirements for microbial limit

FDA Lab, Mumbai51

117.

Kivoral Forte(Trypsin and Chymotrypsin

Tablets)

SB-4242

Jul-23

Jun-25

M/s. Sano-Cito Thereapeutics Inc

Vill Loharan, PO. Ghattii, Solan173211

The enzymatic activity of trypsin chymotrypsin in the sample is less (i.e.

40.52%) of the labelled amount) than the permissible limits.

FDA Lab, Mumbai51

118.

Polergy (Levocetizine Tablets IP 5mg)

43037

Jul-23

Jun-25

M/.s Ronak Life care Pvt Ltd.,

R.S. No. 41, At and Post Rajpur,

Dist. Patan 384265

All tablets received for analysis shows light brown coloured spots all over the surface of the tablets when observed in normal daylight with unaided eyes.

FDA Lab, Mumbai51

119.

Glycical-B12 Calcium Phosphate, Vitamin D3 and Vitamin B12

Suspension

QL0606

Jun-24

May-26

M/s. Quest laboratories Pvt Ltd.

Plot Nol 45, Sector III, Dist. Dhar

(MP) Pitampur-454775

All observations are done in Normal day light conditions with unaided eyes.18 ×200 ml intact brown coloured plastic bottles received for analysis. Out of these18 ×200 ml bottles, in 14 ×200 ml bottles particles are stick around the neck of the bottle and cakes are distributed in the suspension and some cakes are floating

on the top of the suspension. During Analysis when the content from these

FDA Lab, Mumbai51

14x200 ml bottles after shaking transferred individually in clean dry glass beaker, it is observed that, out of these14 × 200ml bottles, 11x200ml bottles contains white suspension with white, pale yellow, grey and black coloured cakes with some cakes floating on the top of suspension and 3x200ml bottle contain orange coloured suspension with white cakes with some cakes floating & on the top of suspension. Remaining 4x200ml bottle contains white suspension without cake and mix uniformly after shaking

120.

Glycical-B12 Calcium Phosphate, Vitamin D3 and Vitamin B12

Suspension

QL0602

Jun-24

May-26

M/s. Quest laboratories Pvt Ltd.

Plot Nol 45, Sector III, Dist. Dhar

(MP) Pitampur-454775

All observations are done in Normal day light conditions with unaided eyes.18 ×200 ml intact brown coloured plastic bottles received for analysis. Out of these18 ×200 ml bottles, in 5 ×200 ml bottles particles are stick around the neck of the bottle and cakes are distributed in the suspension and some cakes are floating

on the top of the suspension. During Analysis when the content from these 5x200 ml bottles after shaking transferred individually in clean dry glass beaker, it is observed that, all

FDA Lab, Mumbai51

5×200ml bottles, contains white suspension with white, pale yellow, grey and black coloured cakes with some cakes floating on the top of suspension out of remaining 13x200ml bottle 12×200ml bottle contains white suspension without cake and mixes uniformly after shaking and 1×200ml bottles contains orange coloured suspension without any cake and mix uniformly after shaking

121.

Fevimed (Paracetamol tablets IP 500 mg)

451AA05

Dec-23

Nov-25

M/s. Sarv Pharmaceuticals Plot

No. 28, Sector-3A,I.I.E. Sidcul

Haridwar-2494032

The Sample does not comply for description as the tablets shows light brown coloured spots on the surface of almost all the tablets

FDA Lab,

Chhatrapati

Sambhajinagar,

Maharashtra

122.

Ronnin 500mg Tablets

(Azithromycin Tablets IP

500mg)

PPTC082

Nov-23

Oct-26

M/s. Pratima Pharmaceuticals

G.No. 56/3, Pratima Nagar, Pune-

Nagar Road, Shikrapur, Pune412208

The sample does not

give IP identification test for the presence of Azithromycin. The sample is declared as spurious vide section 17-B(d) of the Drugs and Cosmetics Act, 1940 and Rules, 1945 thereunder

FDA Lab,

Chhatrapati

Sambhajinagar,

Maharashtra

123.

Parasev 500

Tablets(Paracetamol

Tablets IP 500mg)

CHT23725

Mar-24

Feb-26

M/s. Cureza Healthcare Pvt Ltd.

A.B Road, Girwal , Gwalior474001

The tablets does not comply for description as, the tablets shows uneven light brown coloured spots on the surface of almost all the tablets.

FDA Lab,

Chhatrapati

Sambhajinagar,

Maharashtra

124.

Opirin-75 Tablets

(Aspirin Tablets IP

75mg)

23K-T2727

Feb-24

Jan-26

M/s. Orison Pharma International

Khari, Mauza-Ogli, Kala AMB173030, HP

The sample does not comply for description as, the tablets shows

FDA Lab, Chhatrapati

uneven light brown coloured spots on the surface of almost all the tablets.

Sambhajinagar, Maharashtra

125.

Opirin-75 Tablets

(Aspirin Tablets IP

75mg)

23G-T1526

Oct-23

Sep-25

M/s. Orison Pharma International

Khari, Mauza-Ogli, Kala AMB173030, HP

The sample does not comply for description as, almost all the tablets are brittle in nature with rough surface.

FDA Lab,

Chhatrapati

Sambhajinagar,

Maharashtra

126.

Paracetamol Tablets IP (Pacel-650)

RPTC-182

Jan-25

Dec-27

M/s. Chennai Oscar Bio

Pharmaceuticals Pvt. Ltd., 3/558,

Kaveri Nagar, Pattu Mangadu,

Chennai-600 122

Does not comply with respect to test for Dissolution.

State lab, Puducherry

127.

Griseofulvin Tablets IP(GRISOVIK-250)

8563

May-24

Apr-26

M/s.Vikram Laboratories (P) Ltd.,

Behind tubewell colony, Meerut

Road, Muzaffar Nagar- 251 002 (UP)

On visual inspection, presence of spot was observed on tablets surface. The sample received does not conform with respect to the test for Description.

State lab, Puducherry

128.

Bisacodyl GastroResistant Tablets IP

(Edilax)

2418853T003

Jun-24

May-27

M/s.Scott-Edil Pharmacia Ltd., Unit-II, Plot No.21-22, E.P.I.P., Phase -I, Jharmajri, Baddi, Distt.

Solan - 173 205 (HP) , India.

Does not comply with respect to test for Disintegration

State lab, Puducherry

129.

Aceclofenac &

Paracetamol Tablets

(Aceflam P)

T-2403035

Mar-24

Feb-27

M/s. Aagya Biotech Pvt Ltd.,

1.5km, Manglour,Saharanpur Road,Manglour-247 656,

Roorkee, Distt. Haridwar (UK)

On visual inspection, presence of spot was observed on tablets surface. The sample received does not conform as per IP 2022

with respect to Description.

State lab, Puducherry

130.

Cresol With Soap

Solution (SPARK)

(LYSOL IP)

J-Ly-213

Mar-25

Feb-27

M/s. Joe's Traders, Plot No, 23

R.S. No: 258/5D, Manaveli Road,

Puthurai, Viluppuram, Tamil

Nadu-605111

The sample received does not conform to above specification as per IP 2022 with respect to description.

State lab, Puducherry

131.

Montelukast Sodium &

Levocetirizine

Hydrochloride Tablets

IP(Moncube LC)

FDMC-588

Jul-24

Jun-26

M/s. Firstmed Therapeutics Pvt

Ltd., R.S. No.31/1,PondyTindivanam Main Road,Auroville (PO),Thiruchitrambalam,Tamilnad u-605 101

For the received sample

Montelukast Sodium &

Levocetirizine

Hydrochloride Tablets IP

(Moncube LC)

,Presence of Spots was observed which should not be present

State lab, Puducherry

132.

Glimepiride Tablets (Glimilive – 4)

MDP-649

Sep-24

Aug-26

M/s. Medinok healthcare Pvt. Ltd.,

R.S.No. 2/1, Plot No. 87, 88, 89,

Vazhudhavur Main Road, Kurumbapet, Puducherry – 605 009.

Misbranded (1) For the received sample Glimepiride

Tablets (Glimilive – 4) , The label is mentioned as ‘Approved colour used’ but common name of the permitted colour used in the formulation as prescribed under rule 127(2) of the Drugs

Rules ,1945 was not

mentioned.

(2) The sample received

is labelled as Glimepiride Tablets

(Glimilive – 4) , however Glimepiride Tablets is an official IP monograph (2022) hence should be labelled as Glimepiride

Tablets IP

State lab, Puducherry

133.

Aceclofenac With

Paracetamol Tablets

(S-DOL-P)

MDP-018

Apr-24

Mar-26

M/s. Medinok Healthcare Pvt Ltd,

R.S. No: 2/1, Plot No: 87,88,89,

Vazhudhavur Main Road,

Kurumbapet, Puducherry- 605009

Misbranded The label of the container in the drug is mentioned as "Approved colour used" but the common name of the permitted colour used in the formulation as prescribed under rule 127 (2) of the drug rule was not mentioned.

State lab, Puducherry

134.

Paracetamol,

Phenylephrine HCL &

Cetrizine HCL

Suspension

OKOL-009

Jul-24

Jun-26

M/s. Laborate Pharmaceuticals India Ltd. (Unit0II) #31, Rajban road, Nariwala Poanta Sahib H.P.

The sample does not conform to claim as per Patent and Proprietary in respect of the assay of Phenylephrine Hydrochloride.

DTL Baddi

135.

Ibuprofen Tablets IP 400mg

TF240782

Jun-24

Aug-26

M/s. Orchid Medlife Pvt. Ltd., K.H- 646/513, Vill. Kaumdi, Thana,

Baddi, distt. Solan HP

Sample does not conform to claim as per I.P. 2022 w.r.t.

Dissolution of Ibuprofen.

DTL Baddi

136.

Telmisartan &

Amlodipine Tablets IP

(XTEL-AM)

BBT240427A

May-24

Apr-26

M/s. Biomax Biotechnics (P) Ltd

261,HSIIDC, Industrial Estate

Alipur, Barwala-134118 Haryana

The sample does not conform to the claim as per IP 2022 in respect to

Dissolution Test of

Amlodipine

DTL Baddi

"The purpose of displaying the NSQ list is to make stakeholders aware about the NSQ batches identified in the market," CDSCO said.

Not of Standard Quality (NSQ) drugs:

The drugs that fail to meet the quality standards or specifications are known as Not of Standard Quality (NSQ) drugs. (Further, the term ‘standards of quality’ is defined under the Section 16 (1) (a) of Drugs & Cosmetics Act, 1940, that the ‘standards of quality’ mean that the drug complies with the standards set out in the Second Schedule of the said Act.)

In its alert for the month of April, the regulatory body further provided detailed breakup as;

1.) NSQ data received from State Drugs Licensing Authorities of Assam 03 (02 NSQ already listed in CDSCO alert in the month of March-2025 and 01 listed in the CDSCO alert in the month of April-2025), Goa (Nil), Himachal Pradesh 08 (03 NSQ already listed in CDSCO alert in the month of March-2025 and 02 listed in the CDSCO alert in the month of April-2025), Jharkhand 20 (All are listed in the CDSCO alert in the month of April-2025), Karnataka, Kerala, Maharashtra, Punjab, Tamil Nadu, Telangana, Tripura , West Bengal (Nil) , Puducherry, NCT, Delhi, Jammu & Kashmir, for the month of April, 2025 as per DCG (I) Circular dated 09.02.2024.

2.) State Drugs Licensing Authorities of Andhra Pradesh, Arunachal Pradesh, Bihar, Chhattisgarh, Gujarat, Haryana, Madhya Pradesh, Manipur, Meghalaya, Mizoram, Nagaland, Odisha, Rajasthan, Sikkim, Uttar Pradesh, Uttarakhand, , Andaman & Nicobar Islands, Chandīgarh, Dadar and Nagar Haveli, Daman and Diu, Lakshadweep ,Ladakh, have not submitted any data in respect of the Not of Standard Quality (NSQ) Alert for the Month of April, 2025 as per DCG(I) Circular dated 09.02.2024.

cdsconsq drugsapril 2025 alertdrug quality testsubstandard medicinesmaharashtragujaratharyanaamoxicillinazithromycinomeprazolemetronidazolecefiximeclotrimazolefailed drug samplesdrug alert india
Farhat Nasim
Farhat Nasim

    Farhat Nasim joined Medical Dialogue an Editor for the Business Section in 2017. She Covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a graduate of St.Xavier’s College Ranchi. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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