18 formulations declared Not of Standard Quality as per data provided by states: CDSCO Drug Alert

B. State Laboratories

S.No

Product/Drug

Name

Batch No.

Manufacturing

Date

Expiry

Date

Manufactured By

NSQ Result

Reported by

CDSCO Laboratory

1.

Neurotem-NT

CPT-2698

Mar-24

Feb-26

Catasta Pharmaceuticals Plot No. 113, DIC,

Industrial Area, Baddi Distt. Solan (H.P)

Mrk. By : Cosway Biosciences Coprporate Office : Khasra No.

2054/1724, 1725 SCO No.

11 Baddi Barotiwala Road The. Baddi Distt. Solan H.P 173205

The given Drug Sample does not comply to the contents of Assay with respect to Pregabalin ( 23.26% of

claim)

Drug Testing Laboratory Srinagar (J&K) vide report on Form 13 bearing No. L/DA/2024- 25/1191

Dated: 05.09.2024.

(Report attached as Annexure A)

2.

Cefuroxime Axetil Tablets IP 500 mg (JKMSCL Supply)

JAK-23

Jul-23

Jun-25

Agron Remedies Pvt Ltd Sarverkhera Moradabad Road Kashipur 244 713 (Uttarakhand)

The sample fails in the Description, Dissolution and Assay of Cefuroxime Axetil w.r.t the sample portion received as

above

Combined Food & Drug Testing Laboratory Jammu (J&K) vide report on Form 13 bearing No.

CFDL/J/2024-25/1120 Dated: 26.09.2024.

(Report attached as Annexure B)

3.

Loperamide Hydrochloride Tablets IP (JKMSCL Hospital Supply)

T-16201

May-24

Apr-26

Karnani Pharmaceuticals Pvt. Ltd , 38 Pharma City , Selaqui Dehradun -248011

The sample does not conform to IP with respect to the test for Dissolution & Assay

Drug Testing Laboratory Srinagar (J&K) vide report on Form 13 bearing No. L/DA/2024-25/1311 Dated: 27.09.2024.

(Report attached as Annexure C)

4.

Floxages-OZ (Ofloxacin and Ornidazole Tablets IP)

SPY41223

12/23

11/26

Suraksha Pharma pvt.Ltd, 410, Karondi, Roorkee-247

667, Uttarakhand

It fails the test ‘Dissolution’ as per IP

Drugs Testing Laboratory Thiruvananthapuram

5.

Wintel 40 Tablets

HTN257D

04/24

03/26

Himalaya Meditek pvt.Ltd, Plot No. 35 & 36, Pharmacity, Selaqui, Industrial Area, Dehradun -

248 197

It fails the test ‘Dissolution’ as per IP

Drugs Testing Laboratory Thiruvananthapuram

6.

Moxica -250 [Amoxicillin Dispersible Tablets IP 250 mg]

SD 243

08/23

07/25

Indica Pharmaceuticals (P) Ltd, Bapunagar, Ahmedabad- 382 345

It fails the test ‘Disintegration’ and ‘Uniformity of Dispersion’ specified in the Laboratory Protocol as per

IP

Drugs Testing Laboratory Thiruvananthapuram

7.

Frusemide Injection IP 20 mg

FRIB-03

01/24

12/25

Nestor Pharmaceuticals

Ltd, 11, Western Extension Area, Faridabad -121001

It fails the test

‘Sterility’ as per IP

Drugs Testing

Laboratory Thiruvananthapuram

8.

Cloxacillin Sodium Capsules IP 250 mg

CLCA-04

04/23

03/25

Nestor Pharmaceuticals Ltd, 11, Western Extension Area, Faridabad -121001

The sample does not conform to IP Standards with respect to ‘Descriptive part’ of hard gelatin capsules and further tests cannot be performed due to reasons secified in the

laboratory protocol

Drugs Testing Laboratory Thiruvananthapuram

9.

Fluorometholone Eye Drops IP

CHE-3044

05/23

04/25

Cotec Healthcare pvt.Ltd, K.H.No.593/1, Roorkee, Dehradun Highway, Kishanpur, Roorkee- 247

667, UK

It fails the test ‘Uniformity of Volume’ and ‘Assay’ as per IP

Drugs Testing Laboratory Thiruvananthapuram

10.

Panlib 40 Tablets

HTN 102A

01/24

12/25

Himalaya Meditek pvt.Ltd, Plot No. 35 & 36,

Pharmacity, Selaqui, Industrial Area, Dehradun

It fails the test Dissolution’ and

‘Assay’ as per IP

Drugs Testing Laboratory Thiruvananthapuram

11.

B - Cidal 625

UT232859

03/24

08/25

VADSP Pharmaceuticals, Plot No. 124, EPIP

Indl.Area, Phase 1, Jharmajri, Baddi (HP)- 174103

The content of Clavulanic acid is not with in the limit of ‘Schedule V’ of Drugs and Cosmetics Act & Rules

thereunder

Drugs Testing Laboratory Thiruvananthapuram

12.

Trypsin, Bromelain & Rutoside Trihydrate Tablets [Flavoshine]

TTF24065

06/24

11/25

Tiruvision Medcare, Plot No. 177, HPSIDC,

Indl.Area, Baddi, Dist Solan HP 173 205

The sample fails the test ‘Disintegration’ specified in the Laboratory protocol as per

IP

Drugs Testing Laboratory Thiruvananthapuram

13.

C Mont LC Kid 60 ml (Montelukast & Leveocetirizine Dihydrochloride syrup)

AL 23206

11/23

10/25

Cian Healthcare Ltd, kh No.248, Village sisonia, Bhagwanpur, Roorkee, Haridwar, Uttarakhand- 247

661

The content of montelukast is not within the limits of Schedule ‘V’ of Drugs & Cosmetics Act &

Rules

Drugs Testing Laboratory Thiruvananthapuram

14.

Yogaraja Guggulu Tablet

P 592324

10/23

09/26

Oushadhi, The Pharmaceutical corporation (IM) , Kerala Ltd, Kuttanellur, Thrissur- 68

0014

The sample does not conform to API Standards. It fails the tests ‘Total Ash’ as

per API Standards.

Drugs Testing Laboratory Thiruvananthapuram

15.

Telmisartan Tab IP 40 mg

D1153/24-25

Kerala Medical Services Corporation Ltd, Thycaud P.O, Thiruvananthapuram- 14

The sample does not conform to IP Standards with respective to ‘Descriptive part’ of tablets and further tests cannot be performed due

to above reasons.

Drugs Testing Laboratory Thiruvananthapuram

16.

Pantoprazole Inj.BP 40 mg

D 0923/24- 25

Kerala Medical Services Corporation Ltd, Thycaud P.O, Thiruvananthapuram- 14

It fails the test ‘Sterility’ specified in the laboratory

protocol as per IP

Drugs Testing Laboratory Thiruvananthapuram

17.

Glimepiride Tab IP

D1272/24-25

Kerala Medical Services Corporation Ltd, Thycaud P.O, Thiruvananthapuram- 14

The sample fails the descriptive part for tablets as they are not sufficiently hard to withstand handling without crumbling or breaking and further tests cannot be performed due

to above reason

Drugs Testing Laboratory Thiruvananthapuram

18.

Cough Syrup

D 1278/24- 25

Kerala Medical Services Corporation Ltd, Thycaud P.O, Thiruvananthapuram- 14

The sample fails the ‘Descriptive part’ for oral dosage forms of Schedule V of drugs and cosmetics Act

and Rules, as the syrup contains red coloured

suspended paticles

Drugs Testing Laboratory Thiruvananthapuram