56 Formulations declared Not of standard quality as per data provided by states: CDSCO Drug Alert

Written By :  Dr. Divya Colin
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2025-04-06 12:30 GMT   |   Update On 2025-04-06 12:30 GMT
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New Delhi: In line with the 'Not of Standard Quality' data provided by states, the apex drug regulatory body, the Central Drug Standard Control Organization (CDSCO), in its latest drug safety alert, has flagged 56 medicine batches for failing to qualify for a random sample test for February 2025.

The list of drugs declared not of standard quality includes Calcium & Vitamin D3 Tablets manufactured by Affy Parenterals Vill, Para 500 manufactured by Laborate Pharmaceuticals, Phenytoin Tablets manufactured by Jackson Labratories, Telfine -CT manufactured by Cosmas Pharmacls, Xorcid-O Suspension manufactured by Spen Formulations, Cloprostenol Injection IP (Vet) (M Promate Injection) manufactured by Monatt Biotech and others.

This came as part of the continuous regulatory surveillance, where drug samples are picked from sales/distribution point, analyzed and list of Not of Standard Quality (NSQ) drugs are displayed on CDSCO portal on monthly basis. The purpose of displaying the NSQ list is to make stakeholders aware about the NSQ batches identified in the market.

The alert mentioned that NSQ data received in EXCEL SHEET from State Drugs Licensing Authorities of Puducherry, Kerala, West Bengal, Tripura, Telangana, Jammu Kashmir and Goa (PDF Format), Ladakh (PDF Format), Jharkhand (PDF Format), Himachal Pradesh (PDF Format), Assam(PDF Format), Karnataka (PDF Format), Rajasthan (PDF Format)for the month of February, 2025 as per DCG(I) Circular dated 09.02.2024.

Further, it added that State Drugs Licensing Authorities of Andhra Pradesh, Arunachal Pradesh, Bihar, Chhattisgarh, Chandigarh, Gujarat, Haryana, Manipur, Madhya Pradesh, Maharashtra, Meghalaya, Mizoram, Nagaland, Odisha, Punjab, Sikkim, Tamil Nadu, Delhi, Uttarakhand, Uttar Pradesh, Andaman &Nicobar, Dadar and Nagar Haveli, Daman and Diu, Lakshadweep have not submitted any data in respect of the Not of Standard Quality (NSQ) Alert for the Month of February, 2025 as per DCG(I) Circular dated 09.02.2024.

The alert furter highlighted that 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.

Explaining Misbranded Drugs, the alert noted that drugs shall be deemed to be misbranded:

a) if it is so coloured, coated, powdered or polished that damage is concealed or if it is made to appear of better or greater therapeutic value than it really is; or

b) if it is not labelled in the prescribed manner; or

c) if its label or container or anything accompanying the drug bears any statement, design or device which makes any false claim for the drug or which is false or misleading in any particular.

The term “Misbranded Drug” has been defined under Section 17 of the Drugs and Cosmetics Act, 1940.

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

B. State Laboratories

S.No

Product/Drug Name

Batch No.

Manufact uring Date

Expiry Date

Manufactured By

NSQ Result

Reported by State Laboratory

1.

Calcium & Vitamin D3 Tablets IP

PGT246 72

09/24

08/26

Affy Parenterals Vill. Gullawala P.O Baddi Distt. Solan 173205 (HP)

The sample does not conform to the IP 2022

requirement with respect to uniformity of weights

Drug Testing Laboratory Srinagar (J&K)

2.

Para 500

NBRT- 018

05/23

04/26

Laborate Pharmaceuticals India Ltd (Unit II) 31, Rajban Road Nariwala Paota Sahib (HP)

Mfg For : GPP Axalade 101, Kohand –Assandh Road V.P.O Salwan Haryana -132046

The sample does not conforms to the IP 2022 requirement w.r.t dissolution test

Drug Testing Laboratory Srinagar (J&K)

3.

Phenytoin Tablets IP 100 mg

T-1150

04/24

03/26

Jackson Laboratories Pvt Ltd 22-24, Majitha Road Bye Pass Amritsar – 143001 (India)

The sample does not conforms w.r.t the test for description

Modern Drug Testing Laboratory Kathua (J&K)

4.

Telfine -CT

T-1150

01/24

12/25

Cosmas Pharmacls Ltd. Buranwala Road Village Kotla P.O Barotiwala Solan (H.P) 174103

Mrk. By: NemaSis kabee Vakil Sahab

Haveli Near Ansal Mall Bamba Mohalla Jodhpur India - 342001

The sample does not conform w.r.t the Assay contents of Telmisartan and Chlorthalidone

Modern Drug Testing Laboratory Kathua (J&K)

5.

Xorcid-O Suspension

LSF- B0656

07/23

06/25

Spen Formulations Pvt Ltd Plot No. 123, Industrial Area , Mehatpur, Distt. Una-174315 (H.P)

Under Investigation / The sample is found spurious as the Assay contents of Sucralfate and Oxetacaine are found to be NIL and

also fails in the test for Description

Modern Drug Testing Laboratory Kathua (J&K)

6.

Cloprostenol Injection IP (Vet) (M Promate Injection)

I241020

10/24

09/26

Monatt Biotech E-31, New Focal Point Bathinda - 151005

Sheep Husbandry Supply / The sample is found spurious as the Assay contents of Cloprostenol Sodium I.P is found to be

Modern Drug Testing Laboratory Kathua (J&K)

Nil and also fails in the Test for Sterility

7.

MIDAZOLAM

Injection IP

24257

08/2024.

07/2026.

M/s. T Walkers Pharmaceuticals Pvt Ltd, Gta No 285-B, Viii-Kasaramboli, Po Ambedvet, Tal- Mulshi, Dist Pune 411004 Maharashtra

NOT OF STANDARD QUALITY

The sample Midazolam Injection I.P does not comply for Assay and pH

parameters as per IP 2022.

State Lab, Drugs Control Laboratory,Telangana.

8.

Zinc Sulphate 20mg Dispersible Tablets

IP

T-15192

03/2023.

02-2025.

Karnal Pharmaceuticals Pvt Ltd 38, Pharmacity, Selaqui, Dehradun,Uttarakhand-248 011 Uttarakhand

NOT OF STANDARD QUALITY

The sample Zinc Sulphate 20 mg Dispersible Tablets IP does not comply disintegration test as per

I.P 2022.

State Lab, Drugs Control Laboratory,Telangana.

9.

Cefdoxi-CV-50 dry syrup Cefpodoxime & Potassium Clavulanate for Oral Suspension

CD0724 002F

02/2024.

07/2025.

Alencure Biotech Pvt Ltd Village: Nagal, Suketi road, P.O. Moginand, Kala Amb, Distt. Sirmour-173030 (HP) HIMACHAL PRADESH

NOT OF STANDARD QUALITY

  1. Description Dose Not complies- Orange -colored suspension, that is not uniformly resuspendable after reconstitution with the sterile water ampoule provided in the pack A clear phase separation is observed immediately after reconstitution. Additionally, the reconstituted suspension exhibits an obnoxious/ unacceptable odour.
  2. Assay Does Not Complies: The Assay content found is not within the prescribed limit.

State Lab, Drugs Control Laboratory,Telangana.

10.

Amoxyheal-CV tablets Amoxycillin & Potassium Clavulanate Tablets

I.P

TB2403 78A

10/2024.

09/2026.

Polestar power industries(Pharma division) Damuwala, Haripur road, Barotiwala, Baddi, Distt: Solan (H.P.)- 174 103 HIMACHAL PRADESH

NOT OF STANDARD QUALITY

The sample failed with respect to the test for Unifarmity of Weight for tablets, as 6 out of twenty tablets fall outside the

prescribed limit of 5 percent.

State Lab, Drugs Control Laboratory,Telangana.

11.

Diclofenac Sodium tablets IP 50mg.

DT23- 38

12/2023.

11/2025.

Leostar Healthcare Pvt. Ltd Sy No. 321, Plot No. 10, Biotect park phase- III, Genome valley, Karlapatla (V), Markook(M), Siddipet(Sist)502281,

NOT OF STANDARD QUALITY

  1. While opening the strip, it is found that the tablets are not in intact condition. Hence sample is of Not of Standard Quality with respect to Description test parameter.
  2. Disintegration test does not complies since the tablets disintegrated in acid medium completely. But as per IP the coating of the enteric coated should be in intact condition in acid medium. Hence sample is of Not of Standerd Quality with respect to Disintegration test

parameter.

State Lab, Drugs Control Laboratory,Telangana.

12.

RABISAP tablets Rabeprazole Gastro Resistant Tablets IP 20

mg

AST 24524

10/2024.

09/2026.

AASSK Pharmaceuticals Pvt Ltd Plot NO.9 Dr .Ambedkar Street, Kozhumanivakkam, Mangadu,Chennai-600122. TAMIL

NADU

NOT OF STANDARD QUALITY

Sample does not complies in respect of Dissolution test as per IP

State Lab, Drugs Control Laboratory,Telangana.

13.

Rabicy-20 Tablets Rabeprazole Tablets IP 20 mg

AT2403 4149

03/2024.

02/2026.

Accura Care Pharmaceuticals Pvt Ltd ( A Venture of Biochemix grop (Agmp& ISO Certified Co) Vill. Mogin and Nahan Road Kala Amb.Dist Sirmour (H.P)173030 HIMACHAL PRADESH

NOT OF STANDARD QUALITY &MISBRADED

  1. Sample does not complies in respect of Dissolution test as per IP
  2. The drug Rabeprazole Sodium is official in IP. But the product titile Rabeprazole Sodium IP is not mentioned on the product label. Hence the subject drug is Misbranded as per section 17 of Drugs & Cosmetics Act 1940, as it

is not labeled in the prescribed manner

State Lab, Drugs Control Laboratory,Telangana.

14.

ACEGLO tablets Aceclofenac and

ATG4I7 87

09/2024.

08/2026.

Anrose pharma 147,Mauza Sansiwala ,Post :Barotiwala ,Tehsil -

MISBRANDED DRUG

The drug product

Aceclofenac and

State Lab, Drugs Control Laboratory,Telangana.

Paracetamol Tablets

Kasauli ,Dist .Solan(H.P.)-173205 HIMACHAL PRADESH

Paracetamol Tablets is official i.e. included in the Addendum 2024 to Indian Pharmacopoeia 2022 effective from 1st July, 2024-current edition of IP and as required as per Second Schesule of the Drugs and Cosmetics Act, 1940. The said drug product shall comply with the standards set out in the Indian Pharmacopoeia .But the designation IP in conjunction with the official title Aceclofenac and Paracetamol tablets on the label of the drug product was not menttioned as an indication that the drug product purports to comply with IP standards. Hence the drug product shall be deemed to be Misbranded Drug as per Secton 17 of Drugs and Cosmetics Act,

as it is not labeled in the prescribed manner.

15.

Amrox-LS syrup Levosalbutamol Sulphate, Amborxol Hydrochloride & Guaipenesin syrup

AJLH24 051

06/2024.

05/2026.

M/s. Leeford Healthcare Ltd. Plot No. 88-B, EPIP, Phase – II, Village- Thana, Baddi, Distt. Solan (H.P) 173205 HIMACHAL PRADESH

MISBRANDED DRUG

In the composition the label should be mentioned as Levosalbutamol Sulphate IP equivalent to Levosalbutamol. But the label is mentioned as only Levosalbutamol Sulphate IP, equivalent to Levosalbutamol as not mentioned. Hence it is a Misbranded drug as per section 17 of Drugs and Cosmetics Act, as it is not labeled in the prescribed

manner.

State Lab, Drugs Control Laboratory,Telangana.

16.

Cefixime Dispersible Tablets IP 100 mg

oo84

10/2024.

03/2026.

Stride Organics Private Limited SY.No.265/P,Kondapur(Vill.),Ghatkes ar,Medchal District(T.S.) Telangana

MISBRANDED DRUG

  1. The sample is deemed to be misbranded as it is labeled only with the words approved colours used but fails to include the common name of the color on the label, as required by Rule 127(2) of the Drugs Rules, 1945.
  2. Additionally, the label does not state that the tablets should be dispersed in water immediately before use, as required by the IP 2022 monograph for Cefixime Dispersible tablets. Hence, the drug is deemed Misbranded under section 17 of the Drug and Cosmetics Act, 1940 as it is not labeled in the prescribed

manner.

State Lab, Drugs Control Laboratory,Telangana.

17.

Moovrun tablets Diclofenac Sodium and Paracetamol tablets

DFP- 2403

01/2024.

12/2025.

Concord Drugs Ltd . Sy no.249

,Brahmanapally

,R.R.(DT),T.S.501505 Telangana

MISBRANDED DRUG

The drug product Diclofenac sodium and Paracetamol tablets is offcially included in the current edition of Indian Pharmacopoeia IP 2022 and as required as per second schedule of the Drugs and Cosmetics Act, 1940 the said Product shall comply with the standards set out in the Indian Pharmacopoeia. But the designation IP in conjunction with the offcial title Diclofenac sodium and Paracetamol tablets on the label of the drug product

was not mentioned as an indication that the drug

State Lab, Drugs Control Laboratory,Telangana.

product purports to comply with the IP satadards.

Hence the drug product shall deemed to be MISBRANDED DRUG as

per section 17 of Drugs and Cosmetics Act, 1940 as it is not labelled in the prescribed Manner.

18.

Sodium Hypochlorite 5% (NaOCL)

NSSH1 0

01/2024.

12/2025.

Neucleus Scientific,

Azara, Guwahati – 781017 (Assam)

The Sample does not conform to standard

in respect of the test “Assay” performed.

State Drugs Testing Laboratory, Agartala, Tripura.

19.

URINIF-SR

(Nitrofurantoin Sustained Release

Tablets I.P. 100 mg

USR- 186

11/2024.

10/2026.

Overseas Health Care Pvt. Ltd., 335 km, Milestone, National Highway No. 1,

P.O. Box No. 25, Philaur – 144410, Punjab.

The sample does not conform to standard

in respect of the test for “Dissolution” test performed.

State Drugs Testing Laboratory, Agartala, Tripura.

20.

Glitel M1 (Glimepride & Metformin Hydrochloride Prolonged Releasre

Tablets IP)

LGN05/ 186/08

05/2024.

04/2026.

Logos Pharma, Village MaissaTibba, Tehsil Nalagarh, Dist. Solan (H.P) - 174101.

The sample does not conform to Standard

in respect of the tests for “Assay, Dissolution & Uniformity of content for Glimepiride” performed.

State Drugs Testing Laboratory, Agartala, Tripura.

21.

Glitel M2 (Glimepride & Metformin Hydrochloride Prolonged

Releasre Tablets IP)

LGM09/ 237/11

09/2024.

08/2025.

Logos Pharma, Village MaissaTibba, Tehsil Nalagarh, Dist. Solan (H.P) - 174101.

The sample does not conform to Standard

in respect of the tests for “Assay, Dissolution & Uniformity of content for Glimepiride” performed.

State Drugs Testing Laboratory, Agartala, Tripura.

22.

Amoxycillin & Potassium Clavulanate Tab I.P.

APTD- 002

12/2024.

05/2026.

M/s. Standard Pharmaceuticals Ltd., Serampore-712203, West Bengal

Does not conform to I.P.

State Drugs Testing Laboratory, Kolkata, West Bengal.

23.

Telmisartan Tab IP 40 mg [Telmasil-40]

TBS 034

45352

02/26

RTN Pharma, Sy. No. 675/2, Plot No.15, 17, 18 & 19 Bharathiyar

Nagar, Avalapalli Road, Hosur- 635 109 , Tamil Nadu

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

Drugs Testing Laboratory Thiruvananthapuram

24.

Paracetamol Tab IP 500 mg

PAK 551

06/23

05/26

Healer’s Lab Unit II, Plot No. 33, H.P.S.I.D.C, Extn. Baddi, Distt-Solan (H.P)

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

Drugs Testing Laboratory Thiruvananthapuram

25.

Paracetamol Tab IP [Parayes -500 )

423-

1582

09/23

08/26

Zee Laboratories Ltd, behind 47, Industrial Area, Paonta Sahib- 173 025

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

Drugs Testing Laboratory Thiruvananthapuram

26.

Fevanex Rapid -

650[ Paracetamol Tab IP 650 mg]

SRGT- 24471

08/24

07/26

SPAS REMEDISE Vill, bersan P.O,

Lodhi Majra, Tehsil Baddi, Dist.Solan (HP) 173 205

It fails the test ‘Dissolution’

Specified in the laboratory protocol as per IP

Drugs Testing Laboratory Thiruvananthapuram

27.

Vitamin B Complex Tablets N.F.I

VBT241 6

03/24

02/26

Modern Laboratories 45-47, Sector D- 2, Industrial area, Sanwer Road, Indore (MP) 452 015

The sample does not conform to IP standards to Descriptive part for tablets As per IP, the tablets should have sufficient hardness to withstand handling without crumbling or breaking. The tablets are soft and in powdered form and cannot be removed from strip in intact form and further tests cannot be performed for the reason specified in the

laboratory protocol.

Drugs Testing Laboratory Thiruvananthapuram

28.

Liquid Paraffin IP

163

03/24

08/26

Medi smith Pharma Lab, #20A 1 st phase, KIADB, Mysore Road Kumbalagodu, Bangalore- 560074

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

Drugs Testing Laboratory Thiruvananthapuram

29.

Vitamin B Complex Tablets N.F.I

VBT 2468

05/24

04/26

Modern Laboratories 45-47, Sector D- 2, Industrial area, Sanwer Road, Indore (MP) 452 015

The sample does not conform to IP standards to Descriptive part for tablets As per IP, the tablets should have sufficient hardness to withstand handling without crumbling or breaking. The tablets are soft and in powdered form and cannot be removed from strip in intact form and further tests cannot be performed for the reason specified in the

laboratory protocol.

Drugs Testing Laboratory Thiruvananthapuram

30.

Isosorbide Dinitrate Tablets IP [ISOMIC 10]

PT- 42968

08/24

07/26

Pharmaroots Healthcare, Khasra No. 411, Village Tipra.P.O, Barotiwala, Tehsil ,dist. Soaln (HP)

The sample does not conform to identification test for Isosorbide Dinitrate

as per IP. Hence the sample is spurious and

Drugs Testing Laboratory Thiruvananthapuram

declared as Not of Standard Quality

31.

Vitamin B Complex Tablets N.F.I

VBT 2415

03/24

02/26

Modern Laboratories 45-47, Sector D- 2, Industrial area, Sanwer Road, Indore (MP) 452 015

The sample does not conform to IP standards to Descriptive part for tablets As per IP, the tablets should have sufficient hardness to withstand handling without crumbling or breaking. The tablets are soft and in powdered form and cannot be removed from strip in intact form and further tests cannot be performed for the reason specified in the

laboratory protocol.

Drugs Testing Laboratory Thiruvananthapuram

32.

Vitamin B Complex Tablets N.F.I

VBT 2417

03/24

02/26

Modern Laboratories 45-47, Sector D- 2, Industrial area, Sanwer Road, Indore (MP) 452 015

The sample does not conform to IP standards to Descriptive part for tablets As per IP, the tablets should have sufficient hardness to withstand handling without crumbling or breaking. The tablets are soft and in powdered form and cannot be removed from strip in intact form and further tests cannot be performed for the reason specified in the

laboratory protocol.

Drugs Testing Laboratory Thiruvananthapuram

33.

Vitamin B Complex Tablets N.F.I

VBT 2414

03/24

02/26

Modern Laboratories 45-47, Sector D- 2, Industrial area, Sanwer Road, Indore (MP) 452 015

The sample does not conform to IP standards to Descriptive part for tablets As per IP, the tablets should have sufficient hardness to withstand handling without crumbling or breaking. The tablets are soft and in powdered form and cannot be removed from strip in intact

form and further tests cannot be performed for

Drugs Testing Laboratory Thiruvananthapuram

the reason specified in the laboratory protocol.

34.

Folic Acid Tablets IP 5 mg [Foldivit]

FTV240 04

06/24

05/26

Danish Healthcare (p) Ltd, 76/27-28, Industrial Estate, Maxi Road, Ujjain,

456010, MP

It fails the test ‘Dissolution’ Specified in the laboratory

protocol as per IP

Drugs Testing Laboratory Thiruvananthapuram

35.

Mydew Ultra Syndet Bar

2387

01/24

Best before 36 months from the date of Mfg.

Jain Soap, 39/A, Devam Estate, Gandhi Nagar, Gujarat

The sample does not conform to the test pH as per manufacturer’s specification for Mydew Ultra Syndet Bar as specified in the Laboratory

Protocol

Drugs Testing Laboratory Thiruvananthapuram

36.

Acetazolamide Tablets IP 250 mg

T 240840

08/24

07/27

Micron Pharmaceuticals, 2117, A-2, PhaseIII, GIDC, Vapi- 396 195

It fails the test ‘Dissolution’

Specified in the laboratory protocol as per IP

Drugs Testing Laboratory Thiruvananthapuram

37.

Clopidogrel Tab IP 75 mg

D 2720/24

-25

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

It fails the test ‘Dissolution’, ‘Assay’ and descriptive part for tablets specified above as per IP

Drugs Testing Laboratory Thiruvananthapuram

38.

Cefixime Oral Suspension IP 100 mg/5ml

D2852/2 4-25

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

It fails the test ‘Assay’ and ‘Descriptive part’ for

oral powders specified above as per IP

Drugs Testing Laboratory Thiruvananthapuram

39.

Vitamin B Complex Tablets N.F.I

S0018/2 4-25

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

The sample does not conform to IP standards to Descriptive part for tablets As per IP, the tablets should have sufficient hardness to withstand handling without crumbling or breaking. The tablets are soft and in powdered form and cannot be removed from strip in intact form and further tests cannot be performed for the reason specified in the

laboratory protocol.

Drugs Testing Laboratory Thiruvananthapuram

40.

Vitamin B Complex Tablets N.F.I

S0017/2 4-25

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

The sample does not conform to IP standards to Descriptive part for tablets As per IP, the tablets should have sufficient hardness to withstand handling without crumbling

or breaking. The tablets

Drugs Testing Laboratory ThiruvananthapuramH20

are soft and in powdered form and cannot be removed from strip in intact form and further tests cannot be performed for the reason specified in the

laboratory protocol.

41.

Asokarishtam

56

09/24

Within 3 Yrs from the date of Mfg.

Sakthi Ayurveda Pharmaceuticals, Ottasekharamangalam, Neyyattinkara, Thiruvananthapuram

It fails the test ‘Total Solids’

, ‘Specific Gravity’, ‘Reducing Sugar’ and ‘Alcohol Content’ as

specified in the Laboratory protocol as per API

Drugs Testing Laboratory Thiruvananthapuram

42.

Amrutharishtam

58

09/24

3 Yrs from the date of Mfg.

Sakthi Ayurveda Pharmaceuticals, Ottasekharamangalam, Neyyattinkara, Thiruvananthapuram

It fails the test ‘Total Solids’

, ‘Specific Gravity’, ‘Reducing Sugar’ and ‘Alcohol Content’ as

specified in the Laboratory protocol as per API

Drugs Testing Laboratory Thiruvananthapuram

43.

Balarishtam

57

09/24

NO EXPIRY

Sakthi Ayurveda Pharmaceuticals, Ottasekharamangalam, Neyyattinkara, Thiruvananthapuram

It fails the test ‘Total Solids’

, ‘Specific Gravity’, ‘Reducing Sugar’ and ‘Alcohol Content’ as specified in the Laboratory protocol as per API

Drugs Testing Laboratory Thiruvananthapuram

44.

CEFIXIME & LACTIC ACID BACILLUS TABLETS (AFIX- L 200)

MDP - 785

Oct-24

Sep-26

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

87,88,89, Vazhudhavur Main Road, Kurumbapet, Puducherry – 605 009.

For the received sample Cefixime & Lactic Acid Bacillus tablets (AFIX- L 200),

  • The label on the secondary packaging, name of the colour information is concealed

,whereas the primary packaging label specifies 'Red oxide of Iron' as the colour. This discrepancy indicates a mismatch between the primary and secondary packaging labels.

  • The primary packaging label claims the tablet colour is ' Red oxide of

Iron' but physical verification of the tablet

Puducherry

observed as pale yellow colour. - NSQ

45.

PREGABALIN AND METHYLCOBALA MIN CAPSULES

(Amalin Plus )

MDP- 774

Oct-24

Sep-26

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 PREGABALIN AND METHYLCOBALAMIN

CAPSULES, however PREGABALIN AND METHYLCOBALAMIN

CAPSULES is an official IP monograph (2022) hence should be labelled as PREGABALIN AND METHYLCOBALAMIN CAPSULES IP-

Misbranded

Puducherry

46.

CALCIUM WITH VITAMIN D3 TABLETS IP (S- CAL)

ST2406 09

Jun-24

Nov-25

M/s. Spycaa Life care Sciences Private Limited, No. 253/4C, Thiruvandavar Village, Sirupinayur Panchayat, Uthiramerur Taluk, Kancheepuram District, Pin-603 308

For the received sample, 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 Drug

Rule,1945 was not mentioned.-Misbranded

Puducherry

47.

RABEPRAZOLE ENTERIC COATED TABLETS IP

20mg (Rabelanz-20)

SP/T/76 2

Jun-24

May-26

M/s Signoret Pharmaceuticals Pvt.Ltd., Plot No. 556, Industrial area, Phase IX, SAS Nagar-160059

For the received sample Rabeprazole Enteric Coated Tablets IP 20mg,

  1. Chipping and Rough surface defect was observed which should not be present as per Drugs & Cosmetics (Amendment) Act, 2008 of DCC Guidelines on Not Of Standard Quality (NSQ) Drugs Approved in 1993 (Annexure A) Tablets vide serial No. (V) Chipping and (Vii) Rough

surface.

  1. Cracking of the coating defect was observed which should not be present as prescribed under rule 124B

Puducherry

of the Drugs Rules

,1945.

  1. 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.

  1. Does not comply with respect to test for Disintegration and Assay -

NSQ

48.

PANTOPROZOL E SODIUM (EC)

& DOMPERIDONE (SR) CAPSULES

(Tonixpro DSR)

MDP- 345

Jul-24

Jun-26

M/s. Medinok Healthcare Pvt. Ltd., R.S.No. 2/1, Plot No. 87, 88, 89,

Vazhudhavur Main Road, Kurumbapet, Puducherry – 605 009.

  1. The primary packaging label claims 'Each film coated tablet contains:' however, on physical observation the received sample is found to be 'Hard Gelatin

Capsules'.

  1. The received sample is labelled as 'PANTOPROZOLE SODIUM (EC) & DOMPERIDONE (SR)

CAPSULES', however Pantoprazole Gastro- resistant and Domperidone Prolonged-release Capsules is an official IP monograph (2022) hence should be labelled as PANTOPRAZOLE SODIUM (EC) & DOMPERIDONE (SR) CAPSULES

IP.

  1. The sample name and the label claim of the drug states 'PANTOPROZOLE' instead of 'PANTOPRAZOLE' but the proper name of the drug

should be written as

Puducherry

prescribed under 96(1), (i)(A) of the Drugs & Cosmetics Act.- Misbranded

49.

TELMISARTAN & HYDROCHLORO THIAZIDE TABLETS IP

(Lanztel-H)

RHT24- 401

Jul-24

Jun-26

M/s Revantis Healthcare, Plot No. 124, HPSIDC, Industrial Area, Baddi, Distt. Solan (H.P)-173205

For the received sample Telmisartan & Hydrochlorothiazide Tablets IP,

Presence of Spot and Rough Surface was observed which should not be present as per Drugs & Cosmetics (Amendment) Act, 2008 of DCC Guidelines on Not Of Standard Quality (NSQ) Drugs Approved in 1993 (Annexure A) Tablets vide serial No. (i) Presence of Spot/discoloration (vii) Rough surface and rule 124B of the Drugs

Rules,1945. -NSQ

Puducherry

50.

ACECLOFENAC

& PARACETAMOL TABLETS (ACPON-P)

ACP- 046

Aug-24

Jul-27

M/s Rippon Laboratories No.44-45, Palaniappa Nagar, Othiyampet, Villianur commune, Puducherry-605 110

The sample received is labelled as ACECLOFENAC & PARACETAMOL TABLETS (ACPON-P),

however ACECLOFENAC & PARACETAMOL

TABLETS is an official IP monograph (Addendum 2024) hence should be labelled as ACECLOFENAC & PARACETAMOL

TABLETS IP.- Misbranded

Puducherry

51.

TELMISARTAN TABLETS IP 40

mg (Leaftel-40)

240390

Mar-24

Feb-26

M/s. Sai sarvaa Biotech Pvt. Ltd., Plot No. 8 & 9, Balaji Nagar, Pattanur, Auroville (PO), Vanur(Tk), Villupuram (Dt), Pin – 605 101.

For the received sample Telmisartan Tablets IP 40 mg (Leaftel-40),

Capping defect was observed which should not be present as per Drugs & Cosmetics (Amendment)

Act, 2008 of DCC

Puducherry

Guidelines on Not Of Standard Quality (NSQ) Drugs Approved in 1993 (Annexure A) Tablets vide serial No. (VI) Capping and rule 124B of the Drugs

Rules,1945.- NSQ

52.

SITAGLIPTIN IP 100mg TABLETS

(LanZsita 100)

SP/T/83 8

Jul-24

Jun-26

M/s Signoret Pharmaceuticals Pvt.Ltd., Plot No. 556, Industrial Area, Phase IX, SAS Nagar-160059

For the received sample Sitagliptin IP 100mg Tablets (LanZsita 100), 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.-

Misbranded

Puducherry

53.

METHYLCOBALA MIN, FOLIC ACID, ALPHA LIPOIC ACID, VITAMIN B6, CHROMIUM PICOLINATE, SODIUM SELENITE & ZINC SOFT GELATIN CAPSULES

(Mi- 6)

SOD- 2470

May-24

Apr-26

M/s. Symbiosis Pharmaceuticals Pvt. Ltd., At C/o

Ovation Remedies

Behind IITT Engg. College, Trilokpur Road, Kala Amb. Distt. Sirmour, HP - 173030

Does not comply with respect to test for Disintegration -NSQ

Puducherry

54.

SITAGLIPTIN PHOSPHATE 50

+ METFORMIN 500MG TABLETS

(LanZsita-M)

SP/T/76 1

Jun-24

May-26

M/s. SIGNORET PHARMACEUTICALS PVT.LTD.,

Plot No. 556, Industrial area, Phase IX, SAS nagar,-160059.

For the received sample SITAGLIPTIN PHOSPHATE 50 + METFORMIN 500MG TABLETS (LanZsita-M), 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.-Misbranded

Puducherry

55.

DICLOFENAC SODIUM AND PARACETAMOL TABLETS I.P

(DiCLOWiN PLUS)

DPT- 5765

Aug-24

Jul-27

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

Does not comply with respect to Assay for Diclofenac sodium -NSQ

Puducherry

56.

PIOGLITAZONE 15, GLIMEPIRIDE

2mg+ METFORMIN 500

mg (Lanzpride- PM2)

SP/T/74 3

Jun-24

May-26

M/s. SIGNORET PHARMACEUTICALS PVT.LTD.,

Plot No. 556, Industrial area, Phase IX, SAS nagar,-160059.

For the received sample PIOGLITAZONE 15, GLIMEPIRIDE 2mg+ METFORMIN 500 mg

(Lanzpride-PM2),

  1. 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. For the received sample PIOGLITAZONE 15, GLIMEPIRIDE 2mg+ METFORMIN 500 mg

(Lanzpride-PM2), On visual inspection pink coloured spots were observed on

other side (white colour) of the tablets .-Misbranded

Puducherry

Also Read:Zydus Lifesciences gets CDSCO panel nod to conduct bioequivalence study of Eltrombopag for oral suspension

To view the official notice, click the link below:

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