State Drug Alert: 93 Drug samples including Glenmark's TELMA AM, Alkem Health Science's Ondem-4 fail To Qualify CDSCO Test

Written By :  Susmita Roy
Published On 2025-03-01 12:30 GMT   |   Update On 2025-03-01 16:03 GMT

New Delhi: In line with the 'Not of Standard Quality' data provided by states, the apex drug regulatory body, the Central Drug Standard Control Organisation (CDSCO), in its latest drug safety alert, has flagged 93 medicine batches for failing to qualify for a random sample test for January 2025.

The list of drugs declared not of standard quality includes Aceclofenac and Drotaverine Hydrochloride Tablets (100 mg/80 mg) manufactured by Regent Ajanta Biotech, Compound Sodium Lactate Injection I.P (Ringer’s Lactate I.P) manufactured by Paschim Banga Pharmaceuticals, Paracetamol, Cetirizine Hydrochloride & Phenylephrine Hydrochloride Tablets (WINCOLDZ) manufactured by Wings Biotech, BETAHISTINE DIHYDROCHLORIDE tablets IP (Betahox8) manufactured by Jackson Laboratories and others.

In addition, popular medicines such as TELMA AM manufactured by Glenmark Pharmaceuticals and Ondem-4 [Ondansetron Tablets IP] manufactured by Alkem Health Science are on the list of Not of Standard Quality (NSQ) drugs.

The alert stated 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 about the NSQ batches identified in the market." the alert added.

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 and 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.

Furthermore, the alert mentioned that NSQ data was received as per format and in an Excel sheet from the state drug licensing authorities of Jammu and Kashmir, Chennai, West Bengal, Puducherry, Telangana, Thiruvananthapuram (Kerala), and Bangalore. Further NSQ data was received from Tripura, Ladakh, and Himachal Pradesh as NIL. However, data was not received as per format in Excel Sheet from Jharkhand (PDF Format), Delhi (PDF Format), Goa (PDF Format), and Maharashtra (PDF Format) for the Month of January 2025 as per DCG (I) Circular dated 09.02.2024.

In addition, the alert noted that State Drugs Licensing Authorities of Andhra Pradesh, Arunachal Pradesh, Assam, Bihar, Chhattisgarh, Gujarat, Haryana, Madhya Pradesh, Manipur, Meghalaya, Nagaland, Odisha, Punjab, Rajasthan, Sikkim, Uttar Pradesh, Uttarakhand, Andaman & Nicobar, Dadar and Nagar Haveli; Daman and Diu; and Lakshadweep have not submitted any data in respect of the Not of Standard Quality (NSQ) Alert for the Month of January, 2025 as per DCG (I) Circular dated 09.02.2024.

NOT OF STANDARD QUALITY ALERT FOR THE MONTH OF JANUARY– 2025

B. State Laboratories

S.No

Product/Dr ug Name

Batch No.

Manufa cturing Date

Expiry Date

Manufactured By

NSQ Result

Reported by State Laboratory

1.

PC-WIN- 650

VGT2316 99C

09/23

08/25

Mfg By: Vrindavan Global Plot No. 23-B & C , Ind. Area Lodhimajra Baddi Distt. Solan (HP) 173205

Mrk. By: In Med Therepeutics Plot No. 286, Basement Part-I,

Industrial Area , Phase I , Panchkula -134113

The sample does not conform to IP 2022 with respect to the test for Dissolution

Drug Testing Laboratory Srinagar (J&K) - Report attached as Annexure A

2.

Aceclofenac & Drotaverine Hydrochlori de Tablets (100 mg/

80 mg)

PRT2401

-01

01/2024

45992

M/s. Regent Ajanta Biotech, 86-87, Village Makhiyali Dundi, Peerpura Road, Roorkee- 247667 (U.K)

Description

Karnataka

3.

Compound Sodium Lactate Injection I.P (Ringer’s Lactate I.P)

03BF231

9

Dec/202 3

46327

M/s. Paschim Banga Pharmaceuticals, (A Unit of Farista Vanijya Pvt. Ltd), NH- 31, TIN MILE HAT, Sonapur

HAT, PS. Chopra Dist. Uttar Dinajpur-733214 (W.B)

Bacterial Endotoxins Test

Karnataka

4.

Compound Sodium

Lactate

03BF224

1

45200

09/2026

M/s. Paschim Banga Pharmaceuticals, (A Unit of

Farista Vanijya Pvt. Ltd), NH-

Test for Sterility

Karnataka

Injection I.P (Ringer’s

Lactate I.P)

31, TIN MILE HAT, Sonapur

HAT, PS. Chopra Dist. Uttar Dinajpur-733214 (W.B)

5.

Compound Sodium Lactate Injection I.P (Ringer’s Lactate I.P)

03BF226

0

Oct/202 3

46266

M/s. Paschim Banga Pharmaceuticals, (A Unit of Farista Vanijya Pvt. Ltd), NH- 31, TIN MILE HAT, Sonapur

HAT, PS. Chopra Dist. Uttar Dinajpur-733214 (W.B)

Test for Sterility

Karnataka

6.

Compound Sodium Lactate Injection I.P (Ringer’s

Lactate I.P)

03BF231

8

45261

46327

M/s. Paschim Banga Pharmaceuticals, (A Unit of Farista Vanijya Pvt. Ltd), NH- 31, TIN MILE HAT, Sonapur

HAT, PS. Chopra Dist. Uttar Dinajpur-733214 (W.B)

Bacterial Endotoxins Test” and “Test for Sterility

Karnataka

7.

Compound Sodium Lactate Injection I.P (Ringer’s

Lactate I.P)

03BF225

6

45200

46266

M/s. Paschim Banga Pharmaceuticals, (A Unit of Farista Vanijya Pvt. Ltd), NH- 31, TIN MILE HAT, Sonapur

HAT, PS. Chopra Dist. Uttar Dinajpur-733214 (W.B)

Test for Sterility

Karnataka

8.

Compound Sodium Lactate Injection I.P

(Ringer’s Lactate I.P)

03BF238

9

45323

46388

M/s. Paschim Banga Pharmaceuticals, (A Unit of Farista Vanijya Pvt. Ltd), NH- 31, TIN MILE HAT, Sonapur

HAT, PS. Chopra Dist. Uttar Dinajpur-733214 (W.B)

Test for Sterility

Karnataka

9.

Compound Sodium Lactate Injection I.P (Ringer’s

Lactate I.P)

03BP005

7

Sep/202 3

46235

M/s. Paschim Banga Pharmaceuticals, (A Unit of Farista Vanijya Pvt. Ltd), NH- 31, TIN MILE HAT, Sonapur

HAT, PS. Chopra Dist. Uttar Dinajpur-733214 (W.B)

Test for Sterility

Karnataka

10.

Compound Sodium Lactate Injection I.P

03BF232

8

45261

46327

M/s. Paschim Banga Pharmaceuticals, (A Unit of Farista Vanijya Pvt. Ltd), NH- 31, TIN MILE HAT, Sonapur

Bacterial Endotoxin Test” and “Test for Sterility

Karnataka

(Ringer’s

Lactate I.P)

HAT, PS. Chopra Dist. Uttar

Dinajpur-733214 (W.B)

11.

Compound Sodium Lactate Injection I.P

(Ringer’s Lactate I.P)

03BP006

0

09/2023

46235

M/s. Paschim Banga Pharmaceuticals, (A Unit of Farista Vanijya Pvt. Ltd), NH- 31, TIN MILE HAT, Sonapur

HAT, PS. Chopra Dist. Uttar Dinajpur-733214 (W.B)

Test for Sterility

Karnataka

12.

Compound Sodium Lactate Injection I.P (Ringer’s

Lactate I.P)

03BF232

9

45261

46327

M/s. Paschim Banga Pharmaceuticals, (A Unit of Farista Vanijya Pvt. Ltd), NH- 31, TIN MILE HAT, Sonapur

HAT, PS. Chopra Dist. Uttar Dinajpur-733214 (W.B)

Bacterial Endotoxin Test” and “Test for Sterility

Karnataka

13.

Compound Sodium Lactate Injection I.P (Ringer’s Lactate I.P)

03BF221

0

Sep/202 3

46235

M/s. Paschim Banga Pharmaceuticals, (A Unit of Farista Vanijya Pvt. Ltd), NH- 31, TIN MILE HAT, Sonapur

HAT, PS. Chopra Dist. Uttar Dinajpur-733214 (W.B)

Test for Sterility

Karnataka

14.

Compound Sodium Lactate Injection I.P (Ringer’s Lactate I.P)

03BP012

0

Jan/202 4

46357

M/s. Paschim Banga Pharmaceuticals, (A Unit of Farista Vanijya Pvt. Ltd), NH- 31, TIN MILE HAT, Sonapur

HAT, PS. Chopra Dist. Uttar Dinajpur-733214 (W.B)

Test for Sterility

Karnataka

15.

Compound Sodium Lactate Injection I.P (Ringer’s

Lactate I.P)

03BF234

2

45261

46327

M/s. Paschim Banga Pharmaceuticals, (A Unit of Farista Vanijya Pvt. Ltd), NH- 31, TIN MILE HAT, Sonapur

HAT, PS. Chopra Dist. Uttar Dinajpur-733214 (W.B)

Sterility Test”

Karnataka

16.

Compound Sodium Lactate Injection I.P (Ringer’s

Lactate I.P)

03BF225

4

45200

46266

M/s. Paschim Banga Pharmaceuticals, (A Unit of Farista Vanijya Pvt. Ltd), NH- 31, TIN MILE HAT, Sonapur

HAT, PS. Chopra Dist. Uttar Dinajpur-733214 (W.B)

Sterility Test

Karnataka

17.

Compound Sodium Lactate Injection I.P (Ringer’s

Lactate I.P)

03BF236

9

Dec/202 3

46327

M/s. Paschim Banga Pharmaceuticals, (A Unit of Farista Vanijya Pvt. Ltd), NH- 31, TIN MILE HAT, Sonapur

HAT, PS. Chopra Dist. Uttar Dinajpur-733214 (W.B)

Bacterial Endotoxin Test

Karnataka

18.

Compound Sodium Lactate Injection I.P (Ringer’s Lactate I.P)

03BP011

5

45261

46327

M/s. Paschim Banga Pharmaceuticals, (A Unit of Farista Vanijya Pvt. Ltd), NH- 31, TIN MILE HAT, Sonapur

HAT, PS. Chopra Dist. Uttar Dinajpur-733214 (W.B)

Test for Sterility and Bacterial Endotoxins Test

Karnataka

19.

Aceclofenac

,

Paracetamo l and Chlorzoxazo ne Tablets (Megaceclo MR)

AMT2407 160

45474

46174

M/s. Marine Medicare Pvt. Ltd., Vill. Kulhariwala & P.O. Mandhala, Tehsil-baddi, Distt.

Solan (H.P) 174 103

On the received sample presence of spots observed which should not be present As per DCC Guidelines on Not Of Standard Quality (NSQ) Drugs Approved in 1993 (Annexure A) Tablets vide serial No.(i) Presence of

Spot/discoloration- NSQ

puducherry

20.

Paracetamo l, Cetirizine Hydrochlori de & Phenylephri ne Hydrochlori de Tablets (WINCOLD Z)

WNZT- 3240

45231

46296

M/s Wings Biotech LLP., 43 & 44, HPSIDC, Industrial Area, Baddi-173 205 (H.P)

On the received sample presence of spots were observed which should not be present As per DCC Guidelines on Not Of Standard Quality (NSQ) Drugs Approved in 1993 (Annexure A) Tablets

vide serial No.(i) Presence of

puducherry

Spot/discoloration -

NSQ

21.

Cefpodoxim e Proxetil Tablets IP 200 MG (RIZDOX- 200)

VCT/129

45139

45839

M/s Vats Biotech Pvt Ltd,(An ISO 9001:2015 GMP,GLP

Certified co) Vill.Kailar, P.O. Saproon, Teh & Distt Solan- 173 211 (H.P)

On the received sample Discoloration,rough surface and picking defects were observed which should not be present As per DCC Guidelines on Not Of Standard Quality (NSQ) Drugs Approved in 1993 (Annexure A) Tablets vide serial No.(i) Presence of Spot/discoloration (iv)Picking and

(vii)Rough surface. - NSQ

puducherry

22.

Calcium Carbonate & Vitamin D3 Tablets (VICTOCAL – D3)

MDP - 746

45536

46235

M/s. MEDINOK HEALTHCARE PVT LTD., R.S.No. 2/1, Plot

No. 87,88,89, Vazhudhavur Main Road, Kurumbapet, Puducherry – 605 009.

The sample received is labelled as CALCIUM CARBONATE & VITAMIN D3

TABLETS, however CALCIUM CARBONATE & VITAMIN D3

TABLETS is an official IP monograph (2022) hence should be labelled as CALCIUM AND VITAMIN D3 TABLETS IP. - Label

issue

puducherry

23.

Pregabalin (SR) &

MP - 240724

45566

46266

M/s. Medistark Biotech Pvt.

Ltd., R.S.

The label of the container in the drug is

puducherry

Methylcobal amin Tablet (Mecoben – PG)

No. 68/4, 68/10, Sri

Srinivasapuram, Agasampattu, Vanur Tk, Tamilnadu – 605 111.

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. -

Misbranded

24.

Thiamine Hydrochlori de Tablets IP 100mg (KTHAMINE

-100)

ZRST- 1361

45505

46023

M/s. ZRS PHARMACEUTICALS INDIA

PVT LTD., Khasra No 48, 490/3,562/489/1, Opposite Sector-6, Tehsil Kasauli, Parwanoo, Solan, HP-173220

(i) On the received sample, Presence of

Spot defect was observed which should not be present as per DCC Guidelines on Not Of Standard Quality (NSQ) Drugs Approved in 1993 (Annexure A) Tablets vide serial No.(i) Presence of Spot/discoloration. (ii)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.

(iii) The label claim of the drug states

'Thiamin hydrochloride IP 100mg' instead of '

puducherry

Thiamine Hydrochoride IP 100mg' but the proper name of the drug should be written as prescribed under 96(1),(i)(A) of The

Drugs and Cosmetics Act.

(iv) The label claim of the received sample

states Thiamin Hydrochloride IP 100mg whereas in the IP monograph, The usual strength of the thiamine tablet is stated as 5mg, 10mg, 50mg. Hence,the Strength of the sample received does not match the usual strength as mentioned in the IP monograph.

- NSQ

25.

Paracetamo l, Phenylephri ne HCl, Caffeine & Diphenhydr amine HCl Tablets (CINKOLD)

SG034B0 3

44958

45658

M/s. Sharun Pharmaceuticals Pvt Ltd.,R.S. NO: 195/9 &

197/4, Pangoor, Ariyur Revenue Village, Villianur, Puducherry-605102

NOTE:(i) On the received sample, Presence of Spot defect was observed which should not be present as per DCC Guidelines on Not Of Standard Quality (NSQ) Drugs Approved in 1993 (Annexure A) Tablets

vide serial No.(i) Presence of

puducherry

Spot/discoloration. (ii)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. vel - NSQ

26.

BETAHISTI NE DIHYDROC HLORIDE TABLETS

IP (Betahox- 8)

T-18946

44958

45658

M/s Jackson Laboratories Pvt Ltd., Plot No . 56 & 61, Industrial Area, Phase- III, Sansarpur Terrace, Distt.

Kangra (H.P)-176501

On the received sample presence of spots were observed which should not be present As per DCC Guidelines on Not Of Standard Quality (NSQ) Drugs Approved in 1993 (Annexure A) Tablets vide serial No.(i) Presence of

Spot/discolouration. - NSQ

puducherry

27.

Aceclofenac and Thiocolchico side Tablets (Speronac - MR)

P240502

45413

46113

M/s.– Prosilio Pharmaceuticals Pvt. Ltd., R.S.No. 35/6,

Uruvaiyar Main Road, Uruvaiyar, Villianur Commune, Puducherry – 605 110.

On the received sample presence of spots were observed which should not be present As per DCC Guidelines on Not Of Standard Quality (NSQ) Drugs Approved in 1993 (Annexure A) Tablets

vide serial No.(i) Presence of

puducherry

Spot/discoloration. -

NSQ

28.

Clopidogrel Tablet I.P 75 mg (Maxgrel - 75)

MDP - 309

45444

46143

M/s. Medinok Healthcare Pvt. Ltd., (A GMP & ISO 9001:2015

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

Vazhudhavur Main Road, Kurumbapet, Puducherry – 605 009

(i) On the received sample, Presence of Spot and discoloration defects were observed

which should not be present as per DCC Guidelines on Not Of Standard Quality (NSQ) Drugs Approved in 1993 (Annexure A) Tablets vide serial No.(i) Presence of Spot/discoloration. (ii)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.

(iii) On the received sample, The name of the manufacturer and

the address of the premises of the manufacturer appears in an inconspicuous manner on the label whereas they should appear in a conspicuous manner

puducherry

as prescribed under 96 (1) (iv) of the Drugs and Cosmetics Act.

(iv) On the received sample,the label

details of the primary packing does not match with that of the secondary packing (Excipients …q.s is not mentioned in primary packing)- NSQ

29.

Mecobalami n Sublingual Tablets 1500 mcg (Re- Xite BTX)

D240601 9

45444

46143

M/s LINUX LIFE SCIENCES PVT LTD., R.S. No.241/1 &

241/5, Kalitheerthalkuppam, Madagadipet Post, Mannadipet commune,Puducherry- 605

107, India.

On the received sample, Presence of Spot defect was observed which should not be present as per DCC Guidelines on Not Of Standard Quality (NSQ) Drugs Approved in 1993 (Annexure A) Tablets vide serial No.(i) Presence of

Spot/discoloration.- NSQ

puducherry

30.

Amoxycillin Trihydrate Capsules (RIMOXIN)

RIX-040

45292

45992

M/s RIPPON LABORATORIES

No.44,45, Pazaniyappa Nagar, Othiyampet, Villianur, Puducherry-605 110

The sample received is labelled as AMOXYCILLIN TRIHYDRATE

CAPSULES , however AMOXYCILLIN TRIHYDRATE

CAPSULES is an official IP monograph (2022) hence should be labelled as

AMOXYCILLIN

puducherry

TRIHYDRATE CAPSULES IP.- Label

issue

31.

Metoprolol Succinate Extended Release & Telmisartan Tablets (Leaftel Beta – 25)

MP - 231584

45352

46054

M/s. Medistark Biotech Pvt. Ltd., R.S.No. 68/4, 68/10, Sri

Srinivasapuram, Agasampattu, Vanur (TK), Tamilnadu – 605 111

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. -

Misbranded

puducherry

32.

Lucos-LM kid suspension

AMS2341 6

12/2023

11/2025

Alop Med-Sciences Pvt Ltd, Shamti, Solan-173212.H.P

Sample does not conform to Label claim with respect to the content of Levocetirizine Hydrochloride and

Montelukast in Montelukast Sodium.

Drugs Testing Laboratory, Chennai - 6

33.

Spironolacto ne Tablets IP

T- 2403993

03/2024

02/2026

Oscar Remedies Pvt. Ltd, Oscar House, Badi Majra, Yamuna Nagar(HR) - 135001

Sample does not conform to IP specification for Spironolactone Tablets with respect to

Dissolution

Drugs Testing Laboratory, Chennai - 6

34.

Nozal Cream

3447

03/2024

02/2026

Olcare Laboratories, 505/A, G.I,D.C, Estate, Wadhwancity- 363035. Dist. Surendranagar- (GUJ)

Sample does not conform to BP Specification for Ketoconazole Cream with respect to the content of Ketoconazole.

Drugs Testing Laboratory, Chennai - 6

35.

Gentamicin Injection IP- 2ml

24BUE74

05/2024

04/2026

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

36.

Sucralfate and Oxetacain Suspension

SEL2401

01/2024

12/2025

CU-V-Kar Genetic Medicines Pvt Ltd, 14, Pharmacity, Selaqui, Distt. Dehradun, Uttarakhand-248011.

Sample does not conform to Label claim with respect to content of Oxetacaine.

Drugs Testing Laboratory, Madurai -19.

37.

Aspirin Tablets

TAS2301 0AL

10/2023

09/2025

Hindustan Laboratories Limited, Plot No, 5-9, Survey NO.38/2, Aliyali, Palghar (W), Dist. Palghar 4041404(MS)

Sample does not conform to IP Specification for Aspirin Tablets with respect to the content

of Aspirin.

Drugs Testing Laboratory, Madurai -19.

38.

Nozal

4246

10/2024

09/2026

Olcare Laboratories, 505/A, G.I,D.C, Estate, Wadhwancity- 363035. Dist. Surendranagar- (GUJ)

Sample does not conform to BP Specification for Ketoconazole cream with respect to the content of

Ketoconazole

Drugs Testing Laboratory, chennai - 6

39.

Amoxycillin Dispersible Tablets IP 125 mg

PGA24- 001

01/2024

12/2025

Pondchy Pharmaceuticals, R.S.No.218/4, 218/5,

Odiaampet, Manaveli Road, Villianur Commune, Puducherry, 605110.

Sample does not conform to IP Specification for Dispersible Tablets with respect to uniformity of

Dispersion and Disintegration

Drugs Testing Laboratory, chennai - 6

40.

Povinanz Gargle

ES40030

03/2024

02/2026

Nanz med Science Pharma Pvt Ltd, Rampur Ghat, Paonta Sahib, District Sirmour (H.P) India - 173 025

sample does not conform to label with respect to the content of available iodine in povidone-iodine

Drugs Testing Laboratory, chennai - 6

41.

Amoxycillin Dispersible Tablets IP

125 mg

PGA24- 006

08/2024

07/2026

Pondchy Pharmaceuticals, R.S.No.218/4, 218/5,

Odiaampet, Manaveli Road,

Sample does not conform to IP Specification for

Dispersible Tablets

Drugs Testing Laboratory, chennai - 6

Villianur Commune, Puducherry, 605110.

with respect to uniformity of Dispersion and

Disintegration

42.

Ttocin Ointment, Mupirocin with Tea Tree Oil Ointment

MVO-070

10/2024

09/2026

Bonn Schetering Bio Sciences, Plot No.64 & 65, 1st Floor, Electronic park, Thirubuvanai, Mannadipet Commune, Puducherry, 605107.

Sample does not conform to label claim with respect to the content of mupirocin.

Drugs Testing Laboratory, chennai - 6

43.

Flumethrin 1% Porur- On Solution

EE- 240906

09/2024

08/2026

Ethicare Laboratories, 15, Industrial Estate, Digiana, Jammu-180010

Sample does not conform to Lablel Claim with respect to

the content of Flumethrin.

Drugs Testing Laboratory, Madurai -19.

44.

Sucnol-O Suspension

SCI-2305

11/2023

10/2025

Apple Formulations Pvt Ltd, Plot No.208, Kidhsnpur, Roorkee-247667(U.K)

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

Oxetacaine

Drugs Testing Laboratory, Madurai -19.

45.

Betamethas one Valerate Ointment IP 0.1% w/w

B76

08/2024

07/2026

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, chennai - 6

46.

Co- Trimoxazole Tablets IP 480mg

MT402

01/2024

12/2026

Maxwell Lifescience Pvt Ltd, T- 53 & T-81, M.I.D.C, Tarapur,

Boisar, Dist, Palghar, 401506.

Sample does not conform to IP Specification for Co- Trimoxazole Tablets with respect to Dissolution for Trimethoprim and Sulphamethoxazole

Drugs Testing Laboratory, chennai - 6

47.

N-Clin Gel

M030

07/2024

06/2026

Elegant Cosmed Pvt Ltd, Plot No.32&33, G.I.D.C, Rajkot,

Gujarat, Kuvadva - 360023

Sample does not conform to label claim with respect to the content Clindamycin in Clindamycin

Phosphate

Drugs Testing Laboratory, chennai - 6

48.

Gentamicin Injection IP- 2ml

24BUF83

06/2024

05/2026

SVP Life science, C/10-1, Sara industrial Estate, Selequri, Dehradun

sample does not Conform to the requirement for PH

King Institute of Preventive Medicine & Research, Guindy, Chennai-32

49.

Gentamicin Injection IP- 2ml

HLI620F

06/2024

05/2026

Himalaya Meditek Private Ltd, Plot.No 35&36 Pharmacity, Selaquri Industrial Ara,

Dehradun - 248 197

sample does not Conform to the requirement for PH

King Institute of Preventive Medicine & Research, Guindy,

Chennai-32

50.

Gentamicin Injection IP- 2ml

HLI615F

06/2024

05/2026

Himalaya Meditek Private Ltd, Plot.No 35&36 Pharmacity, Selaquri Industrial Ara, Dehradun - 248 197

sample does not Conform to the requirement for PH

King Institute of Preventive Medicine & Research, Guindy, Chennai-32

51.

Gentamicin Injection IP- 2ml

HLI623F

06/2024

05/2026

Himalaya Meditek Private Ltd, Plot.No 35&36 Pharmacity, Selaquri Industrial Ara,

Dehradun - 248 197

sample does not Conform to the requirement for PH

King Institute of Preventive Medicine & Research, Guindy,

Chennai-32

52.

Gentamicin Injection IP- 2ml

23BUH50

08/2023

07/2025

SVP Life science, C/10-1, Sara industrial Estate, Selequri, Dehradun

sample does not Conform to the requirement for PH

King Institute of Preventive Medicine &

Research, Guindy, Chennai-32

53.

Gentamicin Injection IP- 2ml

HLI628F

06/2024

05/2026

Himalaya Meditek Private Ltd, Plot.No 35&36 Pharmacity, Selaquri Industrial Ara,

Dehradun - 248 197

sample does not Conform to the requirement for PH

King Institute of Preventive Medicine & Research, Guindy,

Chennai-32

54.

Ketoya Soap

MO26

08/2024

07/2026

Elegant Cosmed Pvt Ltd, Plot No.32&33, G.I.D.C, Rajkot,

Kuvadva - 360023,Gujarat,

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

Drugs Testing Laboratory, chennai - 6

55.

Betamethas one

Valerate

BO6

05/2024

04/2026

Syndicate Pharma, 185/B, 185/B-1, 187/A & 188, sector -

Sample does not conform to IP

specification for

Drugs Testing Laboratory,

chennai - 6

Oilment IP 0.1% w/w

F, Sanwer Road, Indore- 452015.

Betamethasone Valerate Ointment with respect to the content of Betamethasone in Betamethasone

Valerate.

56.

Mupirocin Ointment IP

SO-033

03/2024

02/2026

SB Lifesciences pvt ltd, At.Plot No.45, EPIP, Phase-I,

Jharmajri Baddi, Dist Solan (HP)-173205

Sample does not conform to IP specification for Mupirocin Ointment with respect to the content of Mupirocin

Drugs Testing Laboratory, Madurai -19.

57.

Mupirocin Ointment IP

ME-41

02/2024

01/2026

Maxwell pharma, Plot No.6&7, Sector-5, Parwanoo, Solan,

H.P PIN-173220, India

Sample does not conform to IP specification for Mupirocin Ointment with respect to identification and

content of mupirocin

Drugs Testing Laboratory, Madurai -19.

58.

Lukus

G198

06/2024

05/2026

INDKUS Biotech India, Vill manuja rampur jattan, Moginand, Kala amb, Sist.sirmour (HP) - 173001

Sample does not conform to IP specification for Luliconazole Cream with respect to the

content of Luliconazole

Drugs Testing Laboratory, Madurai -19.

59.

Coscopin Cold Plus

CSP2300 1

06/2023

05/2025

Windlas Biotech Limited (Plant- 2) Khasra No.141 to 143 & 145, Mohabewala, Indl. Area, Dehradun-248110.

Uttarakhand.

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

Hydrochloride

Drugs Testing Laboratory, Madurai -19.

60.

Mobicool TM-S

Suspenion

RL- 231203

02/2024

01/2026

Rednex pharmaceuticals,LS No-142, NR, HBS,

Chancharvadi Vasna, Ta: sanand Di: Ahmedabad

Sample does not conform to Label claim with respect to content Oxetacaine

Drugs Testing Laboratory, Madurai -19.

61.

Mupirocin Ointment IP 2% w/w

NO33015 6

11/2023

10/2025

Nanz med Science Pharma Pvt Ltd, Rampur Ghat, Paonta Sahib, District Sirmour (H.P) India - 173 025

Sample does not conform to IP specification for Mupirocin Ointment with respect to the

content of mupirocin

Drugs Testing Laboratory, Madurai -19.

62.

Luliconazole Cream IP 1% w/w

2946

05/2024

04/2026

Regent Ajanta Biotech, 86-87, Village Makhiyali Dundi, Peerpura Road, Roorkee - 247667 (UK)

sample does not Conform to IP Specification for Luliconazole Cream with respect to the PH of 10% w/v solution.

Drugs Testing Laboratory, Madurai -19.

63.

Cefixime & Lactic Acid Bacillus Dispersible Tablets

MLS- 24506

07/2024

06/2026

Maskon Life sciences pvt ltd, Kh.No.69/70, Khatakheri, Bhagwanpur, Roorkee 247667 (UK) India

Sample does not conform to label claim with respect to the content of Anhydrous

Cefixime in Cefixime Trihydrate

Drugs Testing Laboratory, Madurai -19.

64.

VIP Hair Colour Shampoo

B107C

06/2024

05/2026

VIMAC, #18/C. Noombal Village, SF.No.125/1A, 1B, Ambattur, Taluk, Tiruvallur District, Chennai-600077.

Sample does not conform to BIS specification for oxidation hair dye with respect to the content of phenyl methyl

pyrazolone and Resorcinol

Drugs Testing Laboratory, Chennai - 6

65.

B&B Beaute Blanc Hair Colour Conditioner Natural Black

2201202

4

22.01.2

024

21.01.2

027

Gabt Co Ltd, Guanzhou, China.

The sample is found to contain m- phenylenediamine which must not form part of the conposition of cosmetics products as per BIS specification 4707

(Part 2): 2017, under Annex A (clauses 1,2 and 3.1), serial No.1198.

Drugs Testing Laboratory, Chennai - 6

66.

Nyomi Fruit Vinegar Black Hair Gel Colour

2024071

2

12.07.2

024

11.07.2

027

Guangzhou Aocai Bio- Technology Co. Ltd, Address.

Building D.No.10, Shi Longgang Industry, Chang Yaoling Village, Zhong Luotan Town, Guangzhou, China.

Sample does not conform to BIS Specification for Oxidation Hair dye with respect to the content of Phenyl

Methyl Pyrazole.

Drugs Testing Laboratory, Chennai - 6

67.

Xputum-LS Syrup

24-XLS-

010

02/2024

07/2025

Stedman Pharmaceuticals Pvt Ltd, C-4, SIDCO

Pharmaceuticals Complex, Alathur, Thiruporur-603 110, Tamilnadu.

Sample does not conform to Label Claim With respect to content of Levosalbutamol in Levosalbutamol

Sulphate.

Drugs Testing Laboratory, Madurai -19.

68.

Podine-M

PM 04

04/2024

03/2026

Karlin Pharmaceuticals & Exports Private Limited, No.2/140, Indira Nagar, Valasaravakkam, Chennai - 600087

sample does not conform to label claim with respect to the content of available iodine in povidone iodine

Drugs Testing Laboratory, Chennai - 6

69.

Mupirocin Ointment IP

DC2437

03/2024

08/2025

Arius Formulation Private Limited, R.S.No.141/1, Groud floor, Navarkulam Main Road, Pattanur, Tamilnadu - 605101

Sample does not conform to IP Specification for Mupirocin Ointment

with respect to the content of Mupirocin

Drugs Testing Laboratory, Madurai-19

70.

Cumox 500

FDCX- 076

10/2024

09/2026

Firstmed Therapeuticals pvt ltd, R.S.No.31/1, Pondy- Tindivanam Main Road, Auroville (PO), Thiruchitrambalam, Tamilnadu

- 605 101

Sample does not conform to IP specification for Amoxycillin capsules with respect to Uniformity of Weight and to the content of

Amoxycillin in Amoxycillin Trihydrate.

Drugs Testing Laboratory, Chennai - 6

71.

Norfloxacin Tablets IP 400mg

RNFT- 017

10/2024

.

09/2026

.

Mfg By: Revat Laboratories Pvt.Ltd., 12-321, Opp. I.D.A,

Kurnool Road, Pernamitta,

NOT OF STANDARD QUALITY

Dissolution test does

State Lab, Drugs Control

Ongole - 523 002 Andhra Pradesh.

not complies for Norfloxacin Tablets IP at S2 Level as per IP

2022.

Laboratory, Telangana.

72.

Cefpodoxim e & Potassium Clavulanate Tablets

BPT- 3003

02/2024

.

01/2026

.

Mfg By: Geenac Pharma Plot No: 582, Raipur, Bhagwanpur, Roorkee, Uttarakhand-247667.

Uttarakhand.

.

Mrkt: Wellnow Healthcare Kanal Industrial Estate, Road No. 6, Borivali East, Mumbai - 400 066.

NOT OF STANDARD QUALITY

The sample does not meets the Specifications wrt.

Identification test - and Assay - for Cefpodoxime and Clavulanic Acid as per STP. U/S. 17 B of

Drugs and Cosmetics Act 1940. The Sample is deemed to be Spurious Drug.

State Lab, Drugs Control Laboratory, Telangana.

73.

Norfloxacin Tablets IP 400mg

RNFT- 014

12/2023

.

11/2025

.

Mfg By: Revat Laboratories Pvt.Ltd., 12-321, Opp. I.D.A,

Kurnool Road, Pernamitta, Ongole - 523 002 Andhra Pradesh.

NOT OF STANDARD QUALITY

Dissolution test does not complies for Norfloxacin Tablets IP at S2 level as per IP 2022.

State Lab, Drugs Control Laboratory, Telangana.

74.

Parenteral preparations

, Piperacillin & Tazobactam Injection I.P.

4.5 gm

24PT41

11/2024

.

10/2026

.

Mfg By: Sai parenterals limited D1&D4, Survey no. 280, Phase

- V Survey No. 280, Phase - V, IDA, Jeedimetla, Hyderabad - 500055, Telangana, India Telangana.

NOT OF STANDARD QUALITY

Test for sterility does not complies as per IP for the sample Piperacillin and

Tazobactam injection IP 4.5 gm

State Lab, Drugs Control Laboratory, Telangana.

75.

Retibak (0.2%

Retinol) Face Serum

AHO2400 48

23-07-

2024.

06/2026

.

Mfg By: M/s. Aarohee healthcare Private Ltd, Sy.No. 751 & 757 Burgula (V), Farooq Nagar (M), Rangareddy District.

NOT OF STANDARD QUALITY

Sample does not meets the specifications wrt. to

State Lab, Drugs Control Laboratory, Telangana.

Manufactured for : M/s. Origo cosmeceuticals Pvt.Ltd.,

.

Marketed By: Cosmonova Medicare Pvt. Ltd., No.

18/5(A), 1st main S.R. Nagar, Richmond Road, Bangalore - 560 027.

identification test for Retinol as per STP.

76.

Pantoprazol e tablets IP

P03524

09/2024

.

08/2026

.

Mfg By: Spansules formulations India Pvt.Ltd, Sy NO.172, Plot No. 154/A4, IDA

bollaram village Jinnaram mandal, Sangareddy dist,

Hyderabad - 502 325, Telangana.

NOT OF STANDARD QUALITY

Assay and Dissolution test does not complies for Pantoprazole tablets as per IP

2022.

State Lab, Drugs Control Laboratory, Telangana.

77.

Kaltfer Drops Iron(III)- Hydroxide Polymaltose Complex Drops.

EHL- 3532

07/2024

.

12/2025

.

Mfg By: M/s. Exotic Healthcare Plot No. 1305, Sector - 82, JLPL, Mohali, SAS Nagar, Punjab.

.

Mrkt: M/s. Curezen Pharma Pvt. Ltd, Pharmaceuticals No. 2/A/GF/FF/SF, Ground floor, Vijaynagar colony, Secunderabad, Hyd - 500025.

NOT OF STANDARD QUALITY

The sample Does not meets the Specifications wrt.

Identification Test - Negative, Assay - Nil as per STP. U/S. 17 B of Drugs and Cosmetics Act 1940.

The Sample deemed to be Spurious Drug.

State Lab, Drugs Control Laboratory, Telangana.

78.

Ondansetro n orally disintegratin g tablets IP 4 mg

T-15842

12/2023

.

11/2025

.

Mfg By: Karnani Pharmaceuticals Pvt.Ltd, fact:38 Pharma city, Selaqui Dehradun - 248 011.

Uttarakhand.

NOT OF STANDARD QUALITY

While opening the strip, it is found that the tablets are not in intact condition.

Received 50 tablets,

out of 50 tablets, 40 tablets are not in intact condition. Hence sample is of Not of

State Lab, Drugs Control Laboratory, Telangana.

Standard Quality with respect to Description

test parameter.

79.

TELMA AM

5240367

45352

46419

M/s. Glenmark Pharmaceuticals Ltd., Solan H.P.

Does not confirm to I.P.

State Drugs Testing Laboratory, Kolkata, West Bengal.

80.

CLAVPARK

-LB 625mg

(Amoxycillin

, Potassium Clavulanate & Lactic Acid Bacillus

Tab)

CHTJ426 0

45566

46266

M/s. Park Pharmaceuticals, Vill. Kalujhanda, Solan, H.P

Does not confirm to claim

State Drugs Testing Laboratory, Kolkata, West Bengal.

81.

Cetirizine Syrup IP

CE3010

09/23

08/25

Kerala State Drugs and Pharmaceuticals Limited, Kalavoor .P.O, Alappuzha -688 522

It fails the test ‘Assay’ as per IP

Drugs Testing Laboratory Thiruvananthapuram

82.

Paradolo 500

[Paracetam ol Tab IP 500 mg]

AGT4055 4

05/24

04/27

Alventa Pharma Ltd, Vill, Kishanpura, Baddi-Nalagarh Road, Tehsil, Baddi, Distt.

Solan (HP) 174 101

It fails the test ‘Dissolution’ as per IP

Drugs Testing Laboratory Thiruvananthapuram

83.

Cetirizine Syrup IP

CE 3008

09/23

08/25

Kerala State Drugs and Pharmaceuticals Limited, Kalavoor .P.O, Alappuzha -688 522

It fails the test Assay and content of packaged dosage forms specified in the laboratory protocol as

per IP

Drugs Testing Laboratory Thiruvananthapuram

84.

Ondem-4 [Ondansetro n Tablets

IP]

2444145

1

04/24

03/26

Alkem Health Science, Unit -2, Samardung, Karek Block, P.O Namthang District Namchi,

Sikkim – 737 137

It fails the test dissolution specified in the Laboratory

Protocol as per IP

Drugs Testing Laboratory Thiruvananthapuram

85.

Liquid Paraffin IP 400 ml

HP 24002

07/24

06/26

Multicure Pharma Private Limited,Factory 14 A, IAD, Yadadri Bhongir- 508 116,

Hyderabad

It fails the tests ‘Weight per ml and ‘Light Absortion’ as per

IP

Drugs Testing Laboratory Thiruvananthapuram

86.

Cetirizine Syrup IP

CE4019

05/24

04/26

Kerala State Drugs and Pharmaceuticals Limited, Kalavoor .P.O, Alappuzha -688 522

It fails the tests Microbial contamination in non- sterile products as per

IP

Drugs Testing Laboratory Thiruvananthapuram

87.

Tuclav -CV 625[

Amoxycillin and Potassium Clavulanate Tab IP

MYRTAB

-618

08/24

01/26

Mayer Lab, Chambaghat, Adjacent to Railway Crossing, District Solan (HP)- 173 213

It fails the test Dissolution and Assay as per IP

Drugs Testing Laboratory Thiruvananthapuram

88.

Losartan Potassium Tab IP 25

mg

D 2615/24-

25

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

It fails the ‘Descriptive Part’ for the tablets as per IP , tablets should have sufficient hardness for handling without crumbling and

breaking

Drugs Testing Laboratory Thiruvananthapuram

89.

Fexofenadin e Hydrochlori de Tab IP 180 mg

[Fexodil- 180]

T 3105

10/24

09/26

Jackson Laboratories Pvt Ltd, 22-24, Majitha Road, Byepass, Amritsar -143 001

It fails the test ‘Dissolution’ as per IP

Drugs Testing Laboratory Thiruvananthapuram

90.

Glimepiride Tablet IP 1 mg

D2505/24

-25

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

It fails the test dissolution and ‘Descriptive Part’ specified in the Laboratory Protocol as

per IP

Drugs Testing Laboratory Thiruvananthapuram

91.

Vitamin B Complex Tablets NFI

S0016/24

-25

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

The sample does not conform to IP standards with respect to ‘Descriptive Part’ for tablets.

Drugs Testing Laboratory Thiruvananthapuram

92.

Glimepiride Tablet IP 1 mg

D2721/24

-25

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

The sample does not conform to IP standards with respect to ‘Descriptive Part’ for

tablets.

Drugs Testing Laboratory Thiruvananthapuram

93.

Glimepiride Tablet IP

D2854/24

-25

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

The sample does not conform to IP standards with respect to ‘Descriptive Part’ for tablets.

Drugs Testing Laboratory Thiruvananthapuram

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