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  • Drug Alert: CDSCO...

Drug Alert: CDSCO Flags 51 Formulations As Not Of Standard Quality

Written By : Susmita Roy |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2025-01-25T18:00:46+05:30  |  Updated On 25 Jan 2025 6:00 PM IST
Drug Alert: CDSCO flags 56 formulations as Not of Standard Quality
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New Delhi: In its latest drug alert, the apex drug regulatory body, the Central Drug Standard Control Organization (CDSCO), has flagged 41 medicine batches for failing to qualify for a random drug sample test for December 2024.

These include Cefotaxime Sodium Injection IP 1 g manufactured by Bengal Chemicals and Pharmaceuticals, Aspirin Gastro resistant Tablets IP 75mg manufactured by Unicure India, Diphenhydramine Hydrochloride, Ammonium Chloride, Sodium Citrate & Menthol Syrup (Beedryl Plus) manufactured by Zenith Drugs, and Calcium with Vitamin D3 Tablets (CITCAL TABLETS) manufactured by Uniplus Biotech and others.

Furthermore, the list includes Thyroxine Sodium tablets IP (THYROX -25) manufactured by Macleods Pharmaceuticals and Pantoprazole gastro-resistant tablets IP 40 mg (PANTIN) manufactured by Hetero Healthcare.

The alert further mentioned that as part of the continuous regulatory surveillance, drug samples are picked from sales/distribution points, analyzed, and lists of Not of Standard Quality (NSQ) drugs are displayed on the CDSCO portal on a monthly basis. The purpose of displaying the NSQ list is to make stakeholders aware of the NSQ batches identified in the market.

Not of Standard Quality (NSQ) drugs are 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 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.)

A few of the reasons why the drug samples tested failed were the failure of the assay, failure of the dissolution test, failure of pH, particulate matter, and description.

The samples collected were tested in five laboratories: RDTL Chandigarh, CDL Kolkata, CDTL Mumbai, CDTL Chennai, and RDTL-Guwahati.

Also Read:Drug Alert: 41 Drug samples including Cipla's TOFAJAK tablets fail To Qualify CDSCO Test

NOT OF STANDARD QUALITY (NSQ) ALERT FOR THE MONTH OF DECEMBER – 2024

A. CDSCO/Central Laboratories

S.No

Product/Drug Name

Batch No.

Manufacturing Date

Expiry Date

Manufactured By

NSQ Result

Reported by CDSCO

Laboratory

1.

Cefotaxime Sodium Injection IP 1 g

DP24029

04/2024

03/2026

M/s. Bengal Chemicals & Pharmaceuticals Ltd., At-620, Diamond Harbour Road, Behala Indl. Estate, Kolkata-

700034.

Test of Clarity of solution, Particulate matter

Central Drugs Laboratory, Kolkata

2.

Meropenem Injection IP 500 mg (Merohuge 500 )

A4ITX004

08/2024

07/2026

M/s. Shamshree Lifesciences Limited, Plot No. 11, Industrial Area, Katha- Bhatolikalan, Baddi-

173205, H.P.

Test of Clarity of solution, Particulate matter

Central Drugs Laboratory, Kolkata

3.

AMIKACIN SULPHATE INJECTION IP

250 mg (AMIKACIN SULPHATE INJECTION IP

250 mg/ 2 ml for

IM/IV Injection)

17800124

01/2024

12/2025

M/s. Karnataka Antibiotics And Pharmaceuticals Limited, Plot No-14, Peenya II Phase, Bengaluru-560058, Karnataka.

Particulate mattter and Description

Central Drugs Laboratory, Kolkata

4.

Rabeprazole Injection IP

AGI-23216

06/2023

05/2025

M/s. Alliaance Biotech, 440/3, Vill-Katha, Badddi, Solan (H.P.) - 173205

Sterility, Clarity of Solution, Particulate matter,

Identification,

Central Drugs Laboratory, Kolkata

Assay of Rabeprazole Sodium and Description”. The sample is deemed to be spurious as per section 17B of Drugs and

Cosmetics Act

5.

Rabeprazole Injection IP

AGI-23217

06/2023

05/2025

M/s. Alliaance Biotech, 440/3, Vill-Katha, Badddi, Solan (H.P.) - 173205

pH, Clarity of Solution, Particulate matter, Assay of Rabeprazole Sodium and

Description

Central Drugs Laboratory, Kolkata

6.

Tranexamic Acid Tablets IP 500 mg (Clip 500 )

054A003

01/2024

12/2025

M/s. FDC Limited L-56 & L-57, Phase-II-D Verna Industrial Estate, Verna-403722, Salcete,

Goa

Related Substances

Central Drugs Laboratory, Kolkata

7.

Fexofenadine Hydrochloride Tablets IP (MANOFEX-180 )

CT24250327 A

05/2024

04/2026

M/s.CMG BIOTECH PVT.LTD, (Unit-II)Plot

No-58, Phase-III, Industrial Area, Sasarpur Terrace, HP-

176501

Dissolution

Central Drugs Laboratory, Kolkata

8.

Rabeprazole Sodium Injection IP

MD23H20

08/2023

07/2025

M/s. Martin & Brown Bio Sciences, K.No. 918/419, Malkumajra, Nalagarh Road, Baddi, Dist. Solan (H.P.)- 173205

pH, Water, Clarity of Solution, Particulate matter, Assay of Rabeprazole Sodium and

Description

Central Drugs Laboratory, Kolkata

9.

Lignocaine Hydrochloride Gel IP 5% w/v (30 g)

G406

09/2024

08/2026

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

Amb, Distt.Sirmour,

pH

Central Drugs Laboratory, Kolkata

H.P.-173030

10.

Cold Plus Syrup (Cold Plus Syrup)

4EL02283

09/2024

08/2027

M/s. Ciron Drugs & Pharmaceuticals Pvt. Ltd., N- 118,119,113,119/1,

119/2 & 118/1,

M.I.D.C., Tarapur,

Boisar, Dist-Palghar- 401506, Maharashtra

Assay of Phenylephrine Hydrochloride

Central Drugs Laboratory, Kolkata

11.

Omeprazole Lyophilized Powder for Injection (I.V) (OMERA 40mg

Lyophilized Powder for

Injection )

0ZI2415AC

06/2024

05/2026

M/s. CELON LABORATORIES PVT. LTD., Plot No-2,

ALEAP Industrial Estate, Gajularamaram, Medchal District-500 090, Telangana State,

India

Test of Water by KF

Central Drugs Laboratory, Kolkata

12.

BUPIVACAINE HYDROCHLORI DE INJECTION

IP 0.5%

BCV22315

12/2023

11/2025

M/s. Nandani Medical Laboratories Pvt. Ltd., 221/5, Bicholi Hapsi,

Kanadia Road, Indore

Particulate mattter and Description

Central Drugs Laboratory, Kolkata

13.

AXBEX

Suspension (Multivitamin Mulltimineral & Antioxidant

Suspension)

A21410

05/2024

10/2025

M/s. Ozone Pharmaceuticals Ltd., Katha, Baddi-173205, Himachal Pradesh

Identification & Assay of Cholecalciferol

Central Drugs Laboratory, Kolkata

14.

AXBEX

Suspension (Multivitamin Mulltimineral &

Antioxidant Suspension)

A21411

05/2024

10/2025

M/s. Ozone Pharmaceuticals Ltd., Katha, Baddi-173205, Himachal Pradesh

Identification & Assay of Cholecalciferol

Central Drugs Laboratory, Kolkata

15.

Thyroxine Sodium tablets IP (THYROX-25)

16240148D

05/2024

04/2026

M/s. Macleods Pharmaceuticals Ltd., Plot No-2209, GIDC,

Sarigam, Dist-Valsad- 396155, Gujarat

Dissolution

Central Drugs Laboratory, Kolkata

16.

Dexamethasone Sodium

119

06/2024

05/2026

M/s. Hindustan Medicines Pvt. Ltd.,

Free Dexamethasone,

Central Drugs Laboratory, Kolkata

Phosphate Injection I.P.

BARAUNI-851112.

Particulate matter, Sterility, Extractable

volume and Description

17.

Amikacin Sulphate Injection

I.P. (AmikaVen- 500 Injection)

L-24A-23I

01/2024

12/2025

M/s. Inmac Laboratories, Bangsipura-142033 (Pb)

Particulate mattter, Assay/content of Amikacin and

Description

Central Drugs Laboratory, Kolkata

18.

Aspirin Gastro- resistant Tablets IP 75mg

ANET1121

08/2023

07/2025

M/s. Unicure India Ltd., C-21, 22 & 23, Sector-

3, Noida- 201301, Distt. Gautam Budh Nagar

(U.P.)

Test of Dissolution Buffer Stage

Central Drugs Laboratory, Kolkata

19.

Absorbent Cotton Wool IP

331

07/2024

06/2026

M/s. Vandana Surgi Pharma (P) Ltd., GA- 26, RIICO Industrial Area, Bijaynagar- 305624, (Raj)

Acidity or alkalinity, Absorbency Sinking Time, Absorbency Water-holding Capacity, Foreign Fibres, Fluorescence, Water soluble substances, Neps and Sulphated

ash

Central Drugs Laboratory, Kolkata

20.

Noscapine, Chlorpheniramine Maleate, Guaiphenesin & Sodium Citrate

Syrup

NGC-091

12/2023

11/2025

M/s.Medipol Pharmaceuticals India Pvt. Ltd., 1199/3, Bhud, Baddi, Dist-Solan, H.P., India

Description

Central Drugs Laboratory, Kolkata

21.

Diphenhydramine Hydrochloride, Ammonium Chloride, Sodium

Citrate & Menthol Syrup (Beedryl

40183

02/2024

01/2026

M/s. Zenith Drugs Limited 72/5 & 72/3, 72/4, 74/1/1, 75/1/1,

Muradpura (Orangpura)

Dhar Road, Near Kalaria Indore 453001

Assay of Menthol and Description

Central Drugs Laboratory, Kolkata

Plus)

(MP), India

22.

Bupivacaine Hydrochloride in Dextrose Injection USP 4 ml

17B24005

09/2024

08/2026

M/s. Radiant Parenterals Ltd., 242/4, 5 &6, G.I.D.C., Estate at & Post Waghodia,

Dist-Vadodara , Gujarat-391760

pH and Bacterial Endotoxins

Central Drugs Laboratory, Kolkata

23.

Bupivacaine Hydrochloride in Dextrose Injection USP 4 ml

17B24004

06/2024

05/2026

M/s. Radiant Parenterals Ltd., 242/4, 5 &6, G.I.D.C., Estate at & Post Waghodia, Dist-Vadodara ,

Gujarat-391760

pH, Bacterial Endotoxins and Sterility

Central Drugs Laboratory, Kolkata

24.

Diphenhydramine Hydrochloride, Ammonium Chloride, Sodium Citrate & Menthol

Syrup (Beedryl Plus)

40186

02/2024

01/2026

M/s. Zenith Drugs Limited 72/5 & 72/3, 72/4, 74/1/1, 75/1/1,

Muradpura (Orangpura) Dhar Road, Near Kalaria Indore 453001

(MP), India

Assay of Menthol and Description

Central Drugs Laboratory, Kolkata

25.

Telmisartan Tablets I.P.. (TELMOPI-40)

23I-T2003

12/2023

11/2025

M/s. Orison Pharma International, Vill. Khari, Mauza Ogli, Kala Amb, Distt. Sirmour - 173030

(H.P.)

Dissolution

RDTL, Guwahati

26.

Acyclovir Dispersible Tablets IP (Zovibact 800 mg)

SRTH230874 B

08/2023

07/2025

M/s. SYSTOLE REMEDIES PVT. LTD.,

Vill. Ogli, Kala Amb, Teh. Nahan, Distt. Sirmour (H.P.) - 173

030

Uniformity of dispersion & Disintegration

RDTL, Guwahati

27.

GLIMEPIRIDE TABLETS IP (GLIMP-1)

SPT240261

02/2024

01/2026

M/s. SALUS PHARMACEUTICALS,

480/211, Harraipur, PO Gurumajra, Teh. Baddi,

Distt. Solan (H.P.) 173205

Dissolution

RDTL, Guwahati

28.

Zinc Sulphate Dispersible

Tablets IP 20 mg

LMT240811

07/2024

06/2026

M/s.Life Max Cancer Laboratories, Plot No.

106 & 106 A, Sector6A,

Uniformity of dispersion &

Disintegration

RDTL, Guwahati

IIE, SIDCUL,

Haridwar249403 (U.K)

29.

Glimepiride Tablets I.P. 1 mg

LMT240339

03/2024

02/2026

M/s.Life Max Cancer Laboratories, Plot No. 106 & 106 A, Sector6A, IIE, SIDCUL,

Haridwar249403 (U.K)

Dissolution of Glimepiride

RDTL, Guwahati

30.

INFUSION SET- NV (INFUSION SET - NV)

KT-033

03/2024

02/2027

M/s.MEDIVISION HEALTHCARE, 84/4

Span Industrial complex. Second Floor, Phase-1, "F" Road, Opp. Kotak Mahindra Bank, G.I. D.C. Vatva,

Ahmedabad- 382445, Gujarat

Sterility

RDTL, Guwahati

31.

Compound Sodium Lactate Injection I.P. (RL)

03BF2472

04/2024

03/2027

M/s.Paschim Banga Pharmaceutical,, NH- 31,TIN Mile Hat, Sonapur Hat, PSChopra, Dist. Uttar

Dinajpur, PIN- 733214 (WB)

Sterility and Particulate Contamination

RDTL, Guwahati

32.

Compound Sodium Lactate Injection I.P. 500 ml (Ringers Lactate I.P.) (RL)

03BF2474

04/2024

03/2027

M/s.PASCHIM BANGA PHARMACEUTICAL (A

Unit Of FARISTA VANIJYA PVT. LTD.), NH-31, TIN MILE HAT, SONAPUR HAT, P.S. CHOPRA, DIST: UTTAR DINAJPUR,

PIN 733 214 (W.B.)

Sterility

RDTL, Guwahati

33.

Calcium with Vitamin D3 Tablets (CITCAL

TABLETS)

470823

08/2023

07/2025

M/s.Uniplus Biotech (P) Ltd., 4 km. Meerut Road, Assoda 245101

Dissolution (calcium) and Assay of Vitamin

D3

RDTL, Guwahati

34.

Calcium 500 mg with Vitamin D3 250 IU Tablets IP

LMT240346

03/2024

02/2026

M/s.Life Max Cancer Laboratories, Plot No.

106 & 106 A, Sector6A, IIE, SIDCUL, Haridwar-

Assay of Vitamin D3 and

Dissolution for calcium

RDTL, Guwahati

249403 (U.K)

35.

Co- trimoxazole Tablets I.P. (D.S.=Double Strength)

PT30119

05/2023

04/2025

M/s.Omega Pharma., Khasra No. 482, Village

- Saliyar, Roorkee - 247667. Distt-Haridwar

(Uttarakhand)

Dissolution (Trimethoprim and

Sulphamethoxazo le)

RDTL, Guwahati

36.

PRIMAQUINE PHOSPHATE TABLETS IP 2.5

mg

T-1338

07/2023

06/2025

M/s.Jackson Laboratories Pvt.Ltd, 22-24, Majitha Road, Bye Pass, Amritsar-143

001(India)

Dissolution and Assay

RDTL, Guwahati

37.

PANTOPRAZOL E GASTRO- RESISTANT TABLETS IP 40mg (PANTIN)

GT24502A

06/2024

05/2027

M/s. Hetero Healthcare limited, AIIDC Industrial Growth Centre, Changsari, Niz Sindurighopa (Village), Sila Sindurighopa

(Mouza), Kamrup (Dist) Assam-781101

Dissolution of Buffer Stage

RDTL, Guwahati

38.

Albendazole Tablets I.P.

MT-24G01

07/2024

06/2026

M/s.MARTIN & BROWN BIOSCIENCES PVT. LTD., K.No. 918/419,

Malkumajra, Nalagarh Road, Baddi, Dist.

Solan (H.P.)-173205

Dissolution

RDTL, Guwahati

39.

Calcium & Vitamin D3 Tablets IP (CALCI-D)

CDD23089

11/2023

10/2025

M/s. Danish Healthcare

(P) Ltd, 76/27-28,

Industrial Estate, Maxi Road, Ujjain-456 010

INDIA

Assay of Vitamin D3

RDTL, Guwahati

40.

Alprazolam Tablets IP 0.5 mg

BT1224

01/2024

12/2025

M/s.Brilliant Life Sciences Pvt.Ltd. , At Chuval Tagarwa, Teh Detroj Dist.

Ahmedabad(Gujarat)

The Sample does not conform to IP Standards with respect to Test

for Dissolution only

CDTL, Chennai

41.

Valsartan Tablets IP 80mg(Valsalar-

80 Tablets)

VSR1-05

04/2024

03/2026

M/s. Lark Laboratories

(I) Ltd., At, SP-1192 E,

RIICO Indl Area, Phase

The Sample does not conform to IP

Standards with

CDTL, Chennai

IV, Bhiwadi-Rajasthan

respect to Test for Dissolution

only

42.

Nutrisacc Bolus

MVNUR2403

02/2024

02/2026

M/s. Maven iLab Pvt.Ltd., No.19 Byraveshwara Industrial Area, Andrahalli Main Road Hegganahalli,

Bangalore-560091

Disintegration test and Assay of Iron, Magnesium, Calcium, Vitamin B3,Zinc and Vitamin A

RDTL, Chandigarh

43.

Duloxetine Gastro-resistant Tablets IP 20 mg

T26904

01/2024

12/2025

M/s Quest Laboratories Limited, Plot No. 45, Sector-III, Pithampur, Dist.Dhar-454775

(M.P.)

Description and Dissolution

RDTL, Chandigarh

44.

Bortezomib Injection IP (BORTEWIN 2

mg Injection)

L24BZ08A7

08/2024

07/2026

M/s. MEDION BIOTECH PVT.LTD.,

Village-Kaundi, Baddi, Solan, Himachal

Pradesh, 173205

Assay of Bortezomib

RDTL, Chandigarh

45.

Rabeprazole Gastro-resistant Tablets IP 20 mg (Robijick - 20)

T- 1047

06/2023

05/2025

M/s.Jackson Laboratories Pvt. Ltd., 22-24, Majitha Road, Bye Pass, Amritsar -

143 001 (India).

"Dissolution (Acid stage) & (Buffer stage) and Description"

CDTL, Mumbai

46.

Ramipril & Metoprolol Succinate Tablets (Ramigan -MT 2.5/ 25 Tablets)

AOT23322

06/2023

05/2025

M/s.ASTONEA LABS

PVT. LTD., Vill. Haripur Teh. Ranipur Rani, Distt. Panchkula, Haryana, India -

134204

"Assay of Ramipril"

CDTL, Mumbai

47.

Sertraline Hydrochloride (USP/ EP)

SER240002B FP

05/2024

04/2025

M/s.Exemep Pharmaceuticals., Block No. 628 (A & B), ECP Canal Road, Village : Luna, Tal : Padra, Vadodara

391440, INDIA

"Related substances"

CDTL, Mumbai

48.

Pantoprazole Gastro-resistant

UC-23001C

07/2023

06/2025

M/s.Ultra Drugs Pvt. Ltd., (Unit- II) HS No.

"Dissolution of Domperidone"

CDTL, Mumbai

and Domperidone Prolonged- release Capsules

IP (Unipraz - DSR)

211, K. No. 77/1, 78/1

Vill. Katha, Baddi, Distt. Solan (H.P.)

49.

Paracetamol Paediatric Oral Suspension IP (MYPAR)

S404115

04/2024

03/2026

M/s.ION Healthcare Pvt. Ltd., Baddi- Barotiwala Road, Baddi, Distt. Solan

(H.P.)- 173 205.

"Related substances"

CDTL, Mumbai

50.

Hydroxychloroqui ne Sulphate Tableta IP 200 mg (QUEENJAJ 200)

HCQ19K23

11/2023

10/2026

M/s. Bajaj Healthcare Ltd., R.S. No. 1818,

Manjusar - Savli Road, At & Post - Manjusar, Tal. Savli, Dist.

Vadodra - 391775,

Gujarat, India.

"Related substances"

CDTL, Mumbai

51.

DOXYCYCLINE CAPSULES IP

100 mg

HDXA08

06/2023

05/2025

M/s.Hindustan Antibiotics Ltd., At 11 W.E.A., Faridabad-

121001.

"Uniformity of weight"

CDTL, Mumbai

To view the official notice, click the link below:

https://medicaldialogues.in/pdf_upload/nsq-alert-for-the-month-of-dec-2024-1-271195.pdf
drug alertcdsco drug alertnot of standard qualityThyroxine Sodium TabletsMacleodshetero healthcare
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.

    Dr. Kamal Kant Kohli
    Dr. Kamal Kant Kohli

    Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

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