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Drug Alert: CDSCO flags 56 formulations as Not of Standard Quality

Farhat NasimWritten by Farhat Nasim Published On 2024-11-30T17:58:20+05:30  |  Updated On 30 Nov 2024 5:58 PM IST
Drug Alert: CDSCO flags 56 formulations as Not of Standard Quality
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New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has declared 56 drug samples as "Not of Standard Quality" (NSQ) in its latest alert for October 2024. Among these, Trypsin & Chymotrypsin Tablets (Lysoflam Forte), Chlorhexidine Gluconate Solution 4% w/v, Diclofenac Sodium, Paracetamol & Chlorzoxazone Tablets, Hydroquinone, Tretinoin & Allantoin Cream (Lumadip), Liposomal Amphotericin B Injection 50mg (Ambilip) are some of the most widely used drugs listed.

As part of its ongoing regulatory oversight, the CDSCO collects drug samples from various sales and distribution points across the country. These samples are then analyzed to identify any batches that fail to meet the required quality standards.

The list of Not of Standard Quality (NSQ) drugs is published monthly on the CDSCO portal. The goal of this initiative is to inform stakeholders, including healthcare professionals, distributors, and consumers, about the presence of substandard or counterfeit drugs in the market, thereby enhancing public safety and promoting greater transparency.

Lately, the drugs samples collected in the month of October failed to meet the prescribed regulatory standards and were found in various tests to have deficiencies like dissolution, assay, disintegration, bacterial endotoxins, and particulate matter.

The tests on the collected drug samples were conducted at different CDSCO drug laboratories including Central Drugs Laboratory, Kolkata; RDTL, Guwahati; CDTL-Mumba; CDTL, Hyderabad; CDTL, Chennai and RDTL, Chandigarh.

Below is the detailed list of drugs flagged as NSQ:

A. CDSCO/Central Laboratories

S.No

Product/Drug Name

Batch No.

Manufacturin g Date

Expiry Date

Manufactured By

NSQ Result

Reported by

CDSCO

Laboratory

1.

Absorbent Cotton Wool IP

2013

02/2024

01/2027

M/s. Jind Surgicals 24-

27, HSIIDC Industrial

Area, New Hansi Road,

Jind-126 102, Haryana

Surface active

Substances,

Sulphated ash,

Fluorescence, Water Soluble

Substances

Central Drugs

Laboratory, Kolkata

2.

Trypsin &

Chymotrypsin

Tablets (Lysoflam

Forte)

LFTF24002C

06/2024

05/2026

M/s. Cachet

Pharmaceuticals Private Limited, Village - Thana,

Baddi, Distt. Solan,

Himachal Pradesh

173205

Assay of Trypsin & Chymotrypsin

Central Drugs

Laboratory, Kolkata

3.

Chlorhexidine

Gluconate

Solution 4% w/v

012

07/2024

06/2026

M/s. OVERSEAS CHEMICALS, Vill.

Bonderbill (Sukanta Pally), Hooghly 712 247, W.B.

Assay

Central Drugs

Laboratory, Kolkata

4.

Diclofenac

Sodium,

Paracetamol &

Chlorzoxazone

Tablets

DCPT3310

09/2023

08/2025

M/s. MODERN

LABORATORIES, 45-47,

Sector D-2, Industrial

Area, Sanwar Road,

Indore (M.P.) - 452 015.

Disintegration

Central Drugs

Laboratory, Kolkata

5.

Hydroquinone,

Tretinoin &

Allantoin Cream

(Lumadip)

LD-18

12/2023

11/2025

M/s. Tosc International

Pvt. Ltd.,

(Pharmaceutical

Division), Plot No. 47,

Sector-3, SIDCUL, Pantnagar-263153

(Rudrapur), Distt. Udham

Singh Nagar,

Description & pH

Central Drugs

Laboratory, Kolkata

(Uttarakhand)

6.

Liposomal

Amphotericinn B

Injection 50mg

(Ambilip)

ALLC4A1

03/2024

02/2026

M/s. UNITED BIOTECH (P) LIMITED, Bagbania,

Baddi-Nalagarh Road, Distt. Solan (HP) 174 101.

Bacterial endotoxins and Assay of

Amphotericin B

Central Drugs

Laboratory, Kolkata

7.

Ornidazole &

Ofloxacin Tablets

IP

HOOA07

08/2023

07/2025

M/s. Hindustan

Antibiotics Ltd., At 11, W.E.A. Faridabad 121 001 (Haryana).

Description

Central Drugs Laboratory, Kolkata

8.

Amlodipine and

Perindopril

Tablets (Amtas

PRP)

K2201310

06/2022

05/2025

M/s. Intas

Pharmaceuticals Ltd.,

Bhagey Khola Rangpo,

East Sikkim 737 132, India.

Assay of

Perindopril

Erbumine

Central Drugs

Laboratory, Kolkata

9.

Decitabine for Injection 50 mg / vial

H230266

03/2023

02/2025

M/s. Dr. Reddys

Laboratories,

Formulation Unit-7, Plot

Nos. P1 to P9, Phase-III, VSEZ, Duvvada visakhapatnam

Water Content

Central Drugs Laboratory, Kolkata

10.

Natamycin

Ophthalmic

Suspension IP

(Nataprime Eye

Drops)

PE062308

06/2023

05/2025

M/s. Primus

Pharmaceuticals,

Sadhoura Road, Mouza

Ogli Khari, Vill. Asgarpur Majra, Kala Amb. Dist,

Sirmour (H.P.)- 173030.

Sterility

Central Drugs Laboratory, Kolkata

11.

Iron Sucrose Injection USP 5 ml

IRA12320

08/2023

07/2025

M/s. Nandani Medical Laboratories Pvt. Ltd.,

221/5, Bicholi Hapsi, Kanadia Road, Indore, M.P.

Specific Gravity, Particulate matter, Assay of Sucrose & Assay of Ferric

Hydroxide with sucrose calculated as elemental Iron

Central Drugs

Laboratory, Kolkata

12.

Paclitaxel Injection IP

OI220089A

11/2022

10/2024

M/s. Cosmas Research

Lab Ltd., Village:

Gaunspura, P.O.

Noorpur Bet, Hambram,

Description &

Particulate Matter

Central Drugs

Laboratory, Kolkata

Ludhiana-141008

13.

Glucosamine

Sulfate

Potassium Chloride MSM and Diacerein Tablets (Orcerin

GM )

KOO2207A

05/2022

04/2025

M/s. MACLEODS

PHARMACEUTICAL

LTD., Khasra No. 21, 22,

66, 67 & 68, Aho-

Yangtam, Namchepung, PO: Ranipool, Sikkim - 737 135.

Description

Central Drugs Laboratory, Kolkata

14.

Iron Sucrose Injection USP 5 ml

MA24B129

02/2024

01/2026

M/s. MARTIN & BROWN BIO-SCIENCES PVT. LTD., K. No. 918/419,

Malkumajra, Nalagarh

Road, Baddi, Dist-Solan

(H.P) -173205

Particulate Matter

Central Drugs

Laboratory, Kolkata

15.

SUCRALFATE USP

LSU2404015

04/2024

03/2029

M/s. Legend Industries, (Unit-II) C1/200, 201/4, Phase-II, GIDC, Opp. Encore Ltd., Naroda,

Ahmedabad-382330,

Gujarat

Spurious,

Identification &

Assay

Central Drugs

Laboratory, Kolkata

16.

SUCRALFATE USP

SCF/24/0049

05/2024

04/2029

M/s. Par Drugs &

Chemicals Limited,

333/1, 333/2, 334, 335,

336/A & B, 337, 338

GIDC Ind. Estate,

Phase-2, Chitra,

Bhavnagar-364004,

Gujarat

Spurious,

Identification &

Assay

Central Drugs

Laboratory, Kolkata

17.

Betamethasone

Sodium

Phosphate

Injection I.P.

(Betalone )

IBT-11189

06/2024

05/2026

M/s. E.G.

Pharmaceuticals, Vill. Mandhala, Teh. Baddi, Dist. Solan, H.P.

Description &

Particulate matter

Central Drugs

Laboratory, Kolkata

18.

Amoxycillin and

Potassium

Clavulanate for Injection IP 1.2

gm

23AP10

10/2023

09/2025

M/s. SAI Parenterals

Limited, D1 & D4, Survey

No. 280, Phase-V, IDA,

Jeedimetla, Hyderabad -

500 055, Telangana,

India

Particulate matter

& Clarity of

Solution

Central Drugs

Laboratory, Kolkata

19.

Ciprofloxacin Injection IP 100 ml

09AF0061

12/2022

11/2025

M/s. Paschim Banga Pharmaceuticals (A Unit of Farista Vanijya Pvt. Ltd), NH-31, Tin Mile

Hat, P.S. Chopra, DistUttar Dinajpur-733214

(WB)

Extractable

Volume

Central Drugs

Laboratory, Kolkata

20.

Rosuvastatin

Tablets IP

(ROZUTIN- 10)

VDT-23531

06/2023

05/2025

M/s.Vidhyasha Pharmaceuticals, 28,

Industrial Area, Johron, Trilokpur Road, Kala Amb, Distt-Sirmour, H.P.

173 030.

Related

Substances

Central Drugs

Laboratory, Kolkata

21.

Rabeprazole

Sodium &

Domperidone SR

Capsules

(RABALKEMDSR)

RKBC22064

S

12/2022

11/2024

M/s. Shiva Biogenetic Laboratories Pvt. Ltd.,

Vill-Manpura, Baddi, Dist. Solan, (H.P.) -174 101.

Assay of

Rabeprazole

Central Drugs

Laboratory, Kolkata

22.

Aceclofenac,

Paracetamol and

Serratiopeptidase

Tablets

(Megaceclo SP)

AMT2302037

02/2023

01/2025

M/s. MARINE

MEDICARE PVT. LTD.,

Village - Kulhariwala &

P.O. Mandhala, Tehsil Baddi, Distt-Solan (H.P.), Pin-174103, India.

Description and

Assay of

Serratiopeptidase

Central Drugs

Laboratory, Kolkata

23.

Enrofloxacin Injection I.P. (Vet.)

(ENROXACIN

VET Injection)

LV326

01/2023

12/2024

M/s. Lavista Ideal

Pharmacy Pvt. Ltd.,

Lavista Ideal Pharmacy

Pvt. Ltd., Back side of

Tata Motor Vill-Nalka,

PO - Manpura, Tehsil

Baddi, Dist. Solan (HP) 173205

pH

Central Drugs Laboratory, Kolkata

24.

Rabeprazole

Sodium (Enteric

Coated) And

Domperidone

(Sustained

Release)

Capsules (ZABIL-

UD2C-

23469E

06/2023

05/2025

M/s. Ultra Drugs Pvt.

Ltd., (Unit-II), HS No.

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

Vill. Katha, Baddi, Distt.

Solan (H.P.) - 173 205.

Dissolution of

Rabeprazole &

Domperidone,

Assay of

Domperidone

Central Drugs

Laboratory, Kolkata

DSR)

25.

Calcium 500 mg with Vitamin D3 250 IU Tablets IP

LMT240377

03/2024

02/2026

Life Max Cancer

Laboratories, Plot No.

106 & 106 A, Sector6A,

IIE, SIDCUL, Haridwar-

249403 (U.K)

Dissolution of

Calcium and

Assay of Vitamin

D3

RDTL, Guwahati

26.

Glimepiride

Tablets IP 2 mg

LMT240333

03/2024

02/2026

Life Max Cancer

Laboratories, Plot No.

106 & 106 A, Sector-6A,

IIE, SIDCUL, Haridwar-

249403 (U.K)

Dissolution

RDTL, Guwahati

27.

Adrenaline

Injection IP

1.8mg/ml

(Adrenascot)

GA3A020

01/2023

12/2024

M/s. Scott-Edil

Pharmacia Ltd., 56,

EPIP., Phase-I,

Jharmajri, Baddi, Distt.

Solan - 173 205,

(H.P.),INDIA

Appearance of

Solution and

Description

RDTL, Guwahati

28.

Buprenorphine

Injection I.P.

(LUPIGESIC)

1470 ASG

01/2024

12/2025

M/s. S.M.G.

PHARMACEUTICALS

(Pvt) Ltd., Plot No-K.B

Complex Opp. Mahavir

Nagar, N.H. No-I, Vitpl- 306185 Gujarat

Assay" of

Buprenorphine

RDTL, Guwahati

29.

Telmisartan Tablets I.P.

(Telesky-40

Tablet)

CMT23-1658

03/2024

02/2026

M/s. Cortex Medical Inc.,

Plot No. -3F, Apperal

Park, Katha, Industrial

Area Baddi, Distt.- Solan

(H.P.)

Dissolution

RDTL, Guwahati

30.

Telmisartan Tablets I.P. 40 mg

LMT240611

05/2024

04/2026

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

106 & 106 A, Sector6A,

IIE, SIDCUL,

Haridwar249403 (U.K)

Description

RDTL, Guwahati

31.

Telmisartan

Tablets IP 40 mg

LMT240536

05/2024

04/2026

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

106 & 106 A, Sector6A,

IIE, SIDCUL,

Haridwar249403 (U.K)

Description

RDTL, Guwahati

32.

Buprenorphine

Injection I.P.

1470 ASG

09/2023

08/2025

M/s. S.M.G.

PHARMACEUTICALS

Assay/Content of Buprenorphine

RDTL, Guwahati

(LUPIGESIC)

(Pvt) Ltd., Plot No-K.B Complex Opp. Mahavir

Nagar, N.H. No-I, Vitpl- 306185. AT-75/1GI.DC

Vipl-306185

33.

Ciprofloxcin Tablets IP 250

mg

CT23241818

02/2024

01/2026

M/s. CMG BIOTECH

PVT.LTD. ( A WHO-

GMP Certified Co.), 58,

Industrial Area, PhaseIII, Sansarpur Terrace,

Jaswan Dist. Kangra

H.P. 176501

Dissolution of Ciprofloxcin

RDTL, Guwahati

34.

Esomeprazole

Tablets IP 40 mg

(Essokynt-40)

TT23-505

07/2023

06/2025

Tanishka

Pharmaceuticals Pvt. Ltd., Vill. Nandpur,

Kharuni-Lodhi Majra Road, Baddi Teh.

Nalagarh (H.P.)

Dissolution

(Buffer Stage)

RDTL, Guwahati

35.

Fexofenadine Hydrochloride Tablets I.P.

T-2403971

03/2023

02/2026

M/s. Oscar Remedies

Pvt. Ltd., OSCAR

HOUSE, BADI MAJRA,

YAMUNA NAGAR-

135001 (HR)

Dissolution of

Fexofenadine

Hydrochloride.

RDTL, Guwahati

36.

Paracetamol Tablets IP 500 mg (Pararex-500

CT-7129

09/2023

08/2026

CHEMETAC

PHARMACEUTICALS

42, MAINA PUR,

MEERUT ROAD,

GHAZIABAD-201003

Dissolution

RDTL, Guwahati

37.

Ciprofloxacin Tablets U.S.P. 500 mg

T-2401066

01/2024

12/2025

M/s. Rivpra Formulation

Pvt. Ltd. ., Plot No.8,

Sector-6A, IIE SIDCUL,

Haridwar-249 403

(U.K.)..

Dissolution

RDTL, Guwahati

38.

Metronidazole

400 mg Tablets

(Metagyl - 400)

B22-275

12/2022

05/2025

Saint Michael Biotech,

Plot No. 130, Village

Kurdi, Manglore,

Jharbrera Road,

Roorkee- 247656

(Haridwar) (U.K.)

Dissolution of Metronidazole.

RDTL, Guwahati

39.

Aceclofenac &

Paracetamol

Tablets

(Eldigesic-P)

AGT305144

05/2023

04/2026

Alventa Pharma Limited.,

Vill. Kishanpura, Baddi-

Nalagarh Road, Tehsil Baddi, Distt. Solan (H.P.) -174101.

Assay of

Aceclofenac

CDTL-Mumbai

40.

Sodium Fusidate Cream 2 %

344

11/2023

10/2025

Bharat Parenterals Limited., Survey No.

144-A, Jarod- Samlaya

Road, Vill. Haripura, Tal.

Savli, Dist. Vadodara -

391250, Gujarat, India

Assay

CDTL-Mumbai

41.

Enalapril Maleate

Tablets IP 5 mg

(Opioril- 5)

23HT1771

11/2023

10/2025

Orison Pharma

International, Vill. Khari,

Mauza Ogli, Kala Amb,

Distt. Sirmour - 173030

(H.P.)

Dissolution and

Assay of Enalapril

Maleate

CDTL-Mumbai

42.

Bupropion

Hydrochloride

Extended

Release Tablets U.S.P. 150 mg

(Brudel SR-150)

T23169

09/2023

08/2026

Rebase Lifescience Pvt.

Ltd., Block No.6, Plot No. 11 & 12, Nr. Amrut Dairy,

Lalpur, Daskroi,

Ahmedabad, Gujarat -

382 430

Assay of

Bupropion

Hydrochloride

CDTL-Mumbai

43.

Propylene Glycol USP / IP

BT1205B251 22023

12/2023

12/2025

Balaji Amines Limited., Unit IV, F - 104, Chincholi, MIDC, Tq.

Mohol Dist. Solapur -

413255 Maharashtra

Water

CDTL-Mumbai

44.

Racecadotril &

Oflozacin

Suspension

(Combact-O +

Suspension)

L23J003A

10/2023

09/2025

Bajaj Formulations,

Khasra No. 161, Village-

Lakeshwary,

Bhagwanpur, Roorkee,

Distt. Haridwar- 247661

(U.K.)

Assay of

Racecadotril &

Ofloxacin

CDTL-Mumbai

45.

Pantoprazole

Sodium (Enteric

Coated and

Domperidone

(Sustained

Release)

Capsules

C582

01/2024

12/2025

Stalion Laboratories Pvt.

Ltd, c-1B, 305/2,3,4 & 5, G.I.D.C., Kerala (Bavla),

Dist. Ahmedabad-

382220, Gujarat

Dissolution of Domperidone

CDTL-Mumbai

(Penstal-DSR)

46.

Terbinafine

Hydrochloride

Tablets IP

(TERBONATE-

250)

NT-7900

03/2024

02/2026

M/s. Neptune Life

Sciences Pvt. Ltd., 100-

B, EPIP, Phase-II,

Thana, Baddi- 173205

(H.P.)

Test for

Dissolution

CDTL, Hyderabad

47.

Ondansetron

Injection IP

2mg/ml

OT-5411

08/2024

07/2026

M/s. Alchemist

Remedies Pvt. Ltd.,138139, Industrial Area 2,AB

Road Dewas , Madhya

Pradesh

The sample does not Conform to IP Standards with respect to TEST FOR STERILITY

CDTL,Chennai

48.

Single use

Syringe (EDGEX)

5DSB27

11/2023

10/2028

NOBLE PHARMACARE

LTD., A/24, C.I.N.

Complex, Patia,

Bhubaneswar, Odhisa-

751024

Cleanliness and

Design of Piston/Plunger assembly

RDTL, Chandigarh

49.

Rabeprazole

Sodium (EC) and

Levosulpiride

(SR) Capsules

(RPL LS

CAPSULES)

CGC-24020

08/2024

07/2026

Calrax Healthcare

Pvt.Ltd., Plot No. 45,

EPIP, Phase-I, Jharmajri,

Baddi, Distt. Solan

(H.P.)-173205

Dissolution of Levosulpiride

RDTL, Chandigarh

50.

Amoxycillin and

Potassium

Clavulanate

Tablets IP

(Moxileb-CV 625

Tablets)

MBT23068

10/2023

09/2025

Mediwell Biotech, Plot

No. 21-22, Phase-IV,

Himuda Industrial

Township, Bhatoli Kalan,

Baddi, Distt. Solan, (HP)

173205

Assay of

Amoxycillin Trihydrate calculated as Amoxycillin

RDTL, Chandigarh

51.

Pantoprazole Tablets IP

MT-23J13

10/2023

03/2025

MARTIN & BROWN BIOSCIENCES PVT. LTD.,

K.No. 918/419,

Malkumajra, Nalagarh

Road, Baddi, Dist. Solan

(H.P.)-173205

Dissolution

(Buffer Stage)

RDTL, Chandigarh

52.

Aciclovir

Intravenous Infusion IP 250 mg (Acyclotech

D0072406B

06/2024

05/2026

M/s. Protech Telelinks,

Mauza Ogli, Suketi

Road, Kala Amb, District

Sirmour (H.P.) 173030

Assay of Aciclovir

RDTL, Chandigarh

Injection)

53.

Ceftriaxone and

Sulbactam for

Injection (TykoneS Injection)

UNI-240013

06/2024

05/2027

Unital Formulations, 114-

B, EPIP, Phase-1,

Jharmajri, Baddi, Solan

(H.P.)

Particulate matter

RDTL, Chandigarh

54.

Ampicillin 1G

Powder for

Injection 1000 mg

EXPN-24004

04/2024

03/2026

Unital Formulations, 114B, EPIP, Phase-1,

Jharmajri, Baddi, Solan,H.P.-1732025, under neutral code no. HP/DRUGS/MB/08/712

Particulate matter and Assay of Ampicillin Sodium calculated as

Ampicillin

RDTL, Chandigarh

55.

Amoxycillin and

Potassium

Clavulanate

Injection

(Manclav 300 mg)

HIAP23001A

01/2023

12/2024

Health Biotech Ltd.,

Village Sandoli, Nalagarh

Road, Baddi, Distt. Solan

(H.P.) India-173205

Particulate matter and Assay of Potassium Clavulanate calculated as Clavulanic Acid

RDTL, Chandigarh

56.

Meropenem

Injection IP

(ZENEM 1 g

INJECTION)

B240720D

07/2024

06/2026

OSCAR REMEDIES

PVT.LTD., Oscar House,

Badi Majra, Yamuna

Nagar-135001 (HR)

Particulate matter and Content of

Sodium

RDTL, Chandigarh

Under Section 16(1)(a) of the Drugs & Cosmetics Act, 1940, drugs are considered NSQ if they fail to comply with the standards of quality as prescribed in the Second Schedule of the Act. These standards ensure that drugs meet the necessary specifications for safety, potency, and efficacy.

central drugs standard control organisationcdsconot of standard qualitynsqoctober 2024lysoflam fortechlorhexidine gluconate solutiondiclofenac sodium tabletslumadip creamambilip injectiondrug samplesquality standardscounterfeit drugssubstandard drugscentral drugs laboratoryrdtl guwahaticdtl mumbaicdtl hyderabadcdtl chennairdtl chandigarh
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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