CDSCO Drug Alert: 58 Drug Samples Including Alkems’s Pyricool 500, Glenmark’s Deferasirox, Sun Pharma’s Zole F Flagged

New Delhi: In its latest drug safety alert, the apex drug regulatory body, the Central Standard Control Organisation (CDSCO) has flagged 58 medicine batches for failing to qualify for a random sample test for February 2023, while 2 drug samples have been declared as suprious.

These drugs include Acepik – P (Aceclofenac and Paracetamol Tablets) manufactured by Nexkem Biotech, Amoxycillin Oral Suspension I.P. (Medmoxil 125) manufactured by Laborate Pharmaceuticals, Calcium Carbonate and Vitamin D3 Tablets IP (Calcigiant 500 Tablets) manufactured by Nutra Life Healthcare, Ofloxacin manufactured by Concept Pharmaceutical, Calcium and Vitamin D3 Tablets manufactured by Hanuchem Laboratories, Serratiopeptidase Tablets manufactured by Arnav Research Laboratories.

Furthermore, the list contains, Paracetamol Tablets IP 500 mg (Pyricool 500) manufactured by Alkem Health Science, a unit of Alkem Laboratories Limited, Deferasirox manufactured by Glenmark Lifesciences, Miconazole Nitrate and Fluocinolone Acetonide Ointment (Zole – F) manufactured by Sun Pharmaceuticals and others.

In addition to the above, Telmisartan Tablets 40 mg and Amlodipine 5 mg Tablets IP (Telma AM) belonging batch no 05230355 and Telmisartan Tablets I.P. 40 mg (Telma 40), belonging batch no I8220890 are declared spurious as the actual manufacturer, Glenmark Pharmaceutical (as per label claim) has informed that the impugned batches of the products have not been manufactured by them and that it is a spurious drug.

“Thus, the products are purported to be spurious, however, the same is subject to outcome of further investigation.” the actual manufacturer, Glenmark Pharmaceutical added.

The list came after analysis and tests were conducted by the CDSCO, Drugs Control Departments on 1167 samples. Out of this, 1018 samples were found of standard quality while 58 were declared Not of Standard Quality (NSQ).

A few reasons why the drug samples tested failed were the failure of the assay, failure of the dissolution test, failure of the disintegration test, failure of Uniformity of Dispersion, and the presence of water content and particulate matter etc.

The samples collected were tested in CDL Kolkata, CDTL Hyderabad, CDTL Mumbai, RDTL Chandigarh and RDTL Guwahati.

List of Drugs, Medical Devices, Vaccines and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded for the Month of February– 2024.

Total no. of samples received

– 676

Total number of samples tested

– 1167

Total number of samples declared as of Standard Quality

– 1018

Total number of samples declared as Not of Standard Quality – 58

Total number of samples declared as Spurious

– 02

Total number of samples declared as Misbranded

– NIL

S.N

o

Name of Drugs/medical device/cosmetics

Batch No.

Date of Manufactu re

Date of Expiry

Manufactured By

Reason for failure

Drawn By (From

state/CDS CO Zone)

From (Name of Laboratory)

1

Acepik – P (Aceclofenac and Paracetamol Tablets)

NKT230962A

05/2023

04/2025

Nexkem Biotech Pvt. Ltd., Plot No. 64, HPSIDC, Industrial Area, Baddi, Distt. Solan (H.P.) – 173

205.

Disintegration

Drugs Inspector, Ranchi, Jharkhand

Central Drugs Laboratory, Kolkata

2

Amoxycillin Oral Suspension I.P. (Medmoxil 125)

XMSD-001

03/2023

08/2024

Laborate Pharmaceuticals India Ltd., 51, Indl, Area, Paonta Sahib

(H.P.)

Stability

Drugs Inspector, Ranchi, Jharkhand

Central Drugs Laboratory, Kolkata

3

Calcium Carbonate and Vitamin D3 Tablets IP (Calcigiant 500 Tablets)

NLT-17023

05/2023

04/2025

Nutra Life Healthcare Pvt. Ltd., Plot No. 44-45, Shiv Ganga Industrial Estate,

Lakeshwari, Bhagwanpur, Roorkee, Distt.

Haridwar, Uttarakhand

Assay of Vitamin D3

Drugs Inspector, Ranchi, Jharkhand

Central Drugs Laboratory, Kolkata

4

Ofloxacin Dispersible Tablets IP 100 mg (Oflab 100 DT)

C21O062001

05/2022

04/2024

Concept Pharmaceuticals Ltd., A-28/3 MIDC,

Chikalthana, Aurangabad-431006

Uniformity of Dispersion

Drugs Inspector, Ranchi, Jharkhand

Central Drugs Laboratory, Kolkata

5

Calcium and Vitamin D3 Tablets IP (MAHACAL -500)

KSWAC014

05/2023

04/2025

Hanuchem Laboratories, Plot No. 16-17, Sector – 5, Indl. Area, Parwanoo, Dist.

Solan 173 220 (H.P.)

Assay of Vitamin D3

Drugs Inspector, Ranchi, Jharkhand

Central Drugs Laboratory, Kolkata

6

Serratiopeptidase Tablets (Serrizym Tablet)

AT035M

07/2023

06/2025

Arnav Research Laboratories, 435,

G.I.D.C. 2, Dediyasan, Mehsana,

Gujarat 384002

Assay

Drugs Inspector, Ranchi, Jharkhand

Central Drugs Laboratory, Kolkata

7

Montelukast Sodium and Levocetirizine Hydrochloride Tablet IP (XL-Mont)

TXL012007

11/2022

10/2024

DWD

Pharmaceuticals Ltd., 308/5, Village & Post: Poicha (Rania), Tal Savli, Dist.

Vadodara 391780, Gujarat, India

Desription

Drugs Inspector, Ranchi, Jharkhand

Central Drugs Laboratory, Kolkata

8

Propofol Injection IP 500 mg/50 ml

(Hyprovan 500 Injection)

L3352301A

06/2023

05/2025

Protech Telelinks, Mauza Ogli, Suketi Road, Kala Amb. Dist. Sirmour – 173030 (H.P.)

Assay of Propofol

Drugs Inspector, Bilaspur, Himachal Pradesh

Central Drugs Laboratory, Kolkata

9

Heparin Sodium Injection IP 25000 IU/5ml

22HE16

10/2022

09/2024

SAI Parenterals Limited, D1 & D4, Survey No. 280, Phase-V, IDA, Jeedimetla,

Hyderabad 500 055, Telangana, India

Description, Extractable Volume, Particulate Matter and Assay

Drugs Inspector, Bikaner, Rajasthan

Central Drugs Laboratory, Kolkata

10

Metformin HCl (SR) with Glimepiride & Voglibose Tablets (Metaglim-V2)

T-230859

08/2023

07/2025

Vilin Bio Med Ltd., Unit-II, Khasra No.

85, Madhopur Hazarathpur, Roorkee -247667,

Uttarakhand

Assay of Glimepiride

CDSCO,

Rishikesh

Central Drugs Laboratory, Kolkata

11

Clarithromycin Tablets IP 250 mg

OT-231393

10/2023

09/2025

Orchid Bio-Tech Limited, 65, Peerpura-Delhi Highway, Roorkee- 247667 (U.K.)

Dissolution

CDSCO,

Rishikesh

Central Drugs Laboratory, Kolkata

12

Rabeprazole Sodium & Domperidone Capsules (Deep SR Capsules)

OC-23349

11/2023

10/2025

Orchid Bio-Tech Limited, 65, Peerpura-Delhi

Highway, Roorkee – 247667 (U.K.)

Dissolution of Rabeprazole & Domperidone

CDSCO,

Rishikesh

Central Drugs Laboratory, Kolkata

13

Glimepiride & Meftormin Hydrochloride Prolonged Release Tablets IP (Glimsid-

2MF)

T-231020

10/2023

09/2025

Vilin Bio Med Ltd., Unit-II, Khasra No.85, Madhopur, Hazarathpur, Roorkee-247667,

Uttarakhand.

Dissolution & Assay of Glimepiride

CDSCO,

Rishikesh

Central Drugs Laboratory, Kolkata

14

Liquid Formaldehyde 40% w/v (Formallin)

FS-228A

08/2022

07/2025

Pharm Asia Drug, 20-21, Panchal Compound, Survey

No. 78/1, PH No. 17,

New 45, Gram Lasudia Mori, Indore

– 452 010 (M.P.)

Methyl Alcohol & Assay of Formaldehyde 40%w/v

CDSCO,

North Zone

Central Drugs Laboratory, Kolkata

15

Piroxicam Capsules IP (Piroxicam-20)

KCC-03

11/2023

10/2025

SGS Pharmaceutical (P) Ltd., E-13/1,

Kavi Nagar Indl. Area, Sector – 17, Ghaziabad 201002

(U.P.)

Water content

CDSCO,

North Zone

Central Drugs Laboratory, Kolkata

16

Hydrogen Peroxide Topical Solution IP 6% w/v (20 Volume)

HP23-021

02/2023

01/2025

Pharm Asia Drug, 20-21, Panchal Compound, Survey

No. 78/1, PH No. 17,

New 45, Gram Lasudia Mori, Indore

– 452 010 (M.P.)

Identification, Acidity, Non-volatile matter and Assay

(Spurious)

CDSCO,

North Zone

Central Drugs Laboratory, Kolkata

17

L-Asparaginase 10000 IU (L-ASGEN)

BASL2205Y A

03/2022

02/2024

Beta Drugs Ltd., Kharuni Lodhimajra Road, Vill. Nandpur, Baddi, Dist. Solan, Himachal Pradesh

173205

Particulate Matter (subvisible)

O/o. The Drugs Inspector, Cuttack, Odisha.

Central Drugs Laboratory, Kolkata

18

Amikacin Injection IP 500 mg (Amikatas 500 mg)

RV3044

08/2023

07/2025

Ronam Healthcare Pvt. Ltd. Village- Kalujhanda, Tehsil- Baddi, Distt. Slolan (H.P.) 174103

Description & Particulate Matter

O/o. The Drugs Inspector, Cuttack, Odisha.

Central Drugs Laboratory, Kolkata

19

Neostigmine Injection IP 0.5 mg/ml

V23034

01/02/2023

31/01/2025

Vital Healthcare Pvt. Ltd., Plot No. H10 and H10/1, MIDC Satpur, Nashik.

pH and Assay of Neostigmine

CDSCO,

West Zone, Mumbai

Central Drugs Laboratory, Kolkata

20

Tranexamic Acid Injection I.P. (Tranexica)

SAI-14764

03/2022

02/2024

Sunvet Healthcare, Vill. Shambhuwala, Paonta Road, Distt. Sirmour (H.P.) –

173001

pH

DCA,

Vijayawada

, Andhra Pradesh

Central Drugs Laboratory, Kolkata

21

Paracetamol Tablets IP 500 mg (Pyricool 500)

23444042

11/2023

10/2026

Alkem Health Science, A unit of Alkem Laboratories Limited, Unit – 2,

Samardung, Karek

Dissolution

CDSCO,

East Zone, Kolkata

Central Drugs Laboratory, Kolkata

Block, P.O. Namthan, Dist. Namchi, Sikkim –

737137

22

Ciprofloxacin Hydrochloride Tablets IP 500 mg

2331044

07/2023

06/2026

Aurio Pharma Laboratories Pvt. Ltd., 26/1/1, S.H.K.B

Sarani (Jawpur Road), Dumdum,

Kolkata- 700 074

Dissolution

CDSCO,

East Zone, Kolkata

Central Drugs Laboratory, Kolkata

23

Oseltamivir Oral Suspension I.P. 12 mg

URDP1153

05/2023

10/2024

Unicure India Ltd., Plot No. 46(B) / 49B,

Vill. Raipur, Bhagwanpur, Roorkee, Distt.

Haridwar, Uttarakhand

Description

CDSCO,

East Zone, Kolkata

Central Drugs Laboratory, Kolkata

24

Ambroxol,Guaiphenes in & Terbutaline Syrup (Bromex Expectorant)

BXE064

01/09/2023

31/05/2026

Hygeia Pharmaceuticals MFG (P) Ltd., 608,

Dwarir Road, Dhamaitala Dakshin Jagaddal, Pin – 700

151

Assay of Ambroxol Hydrochloride and Terbutaline Sulphate

CDSCO,

East Zone, Kolkata

Central Drugs Laboratory, Kolkata

25

Paracetamol, Phenylephrine Hydrochloride, Chlorpheniramine Maleate, Sodium Citrate and Menthol

Syrup (SUNGESIC-C)

002

01/09/2023

31/08/2025

Sunny Industries Private Limited, 23/3/1B, R.N.

Nandan Lane, Kolkata 700 025

Description & Assay of Paracetamol

CDSCO,

East Zone, Kolkata

Central Drugs Laboratory, Kolkata

26

Deferasirox

82231480

02/07/2023

01/07/2027

Glenmark Lifesciences Ltd., Plot No. Z-103/I, Sez Phase II, Dahej, Dist.

Bharuch – 392130, Gujarat, India.

4 Hydrazino benzoic acid

CDSCO,

Ahmedabad

Central Drugs Laboratory, Kolkata

27

Miconazole Nitrate and Fluocinolone Acetonide Ointment (Zole – F)

SXE1800A

08/2023

07/2026

Sun Pharmaceuticals Ind. Ltd., Kh. No. 1335-1340, Near

EPIP- I, Vill- Bhatoli

Kalan, Baddi, Distt. Solan, H.P. 173205

Assay

CDSCO,

Ahmedabad

Central Drugs Laboratory, Kolkata

28

Trihexyphenidyl Hydrochloride Tablets IP 2 mg (Ridyl)

AR-132

06/2023

05/2025

Apex Formulations Pvt. Ltd., 1276,

Rajpur, Ahmedabad- Mehsana Highway, Dist. Mehsana,

Gujarat.

Assay

CDSCO,

Ahmedabad

Central Drugs Laboratory, Kolkata

29

Levosalbutamol Sulphate, Ambroxol Hydrochloride, Guaiphenesin and Menthol Syrup 60 ml Syrup (HISTARED- LS)

L23K015

11/2023

10/2025

Fanal Pharmaceuticals LLP, 67, Surbhi Radhe Industrial Zone, Survey No. 251, At. Khambha,

360311, Gujarat, India

Description & Assay of Levosalbutamol

CDSCO,

Ahmedabad

Central Drugs Laboratory, Kolkata

30

TERBUTALINE SULPHATE, BROMHEXINE HCl & GUAIPHENESIN SYRUP (NEFDYL-X)

WHL-01715

Nov-2023

Oct-2025

Warner Hindusthan Pvt. Ltd.,. 24-85/7, Sy.No.548 & 551,

Laxmi Narayana Nagar Colony, New

IDA, Uppal, Hyderabad-39 (TS)

Assay of Bromhexine Hydrochloride

CDSCO

Hyderabad

CDTL,

Hyderabad

31

BROMHEXINE HYDROCHLORIDE

SYRUP 4mg/5ml

31413

01-Aug-

2023

31-Jul-2025

Zenith Drugs Pvt.

Ltd., 72/5, Muradpura (Orangpura) Dhar Road, Near Kalaria, Indore 453001 (MP) India

pH and Assay

CDSCO,

Sub Zone, Indore

CDTL,

Hyderabad

32

POVIDONE-IODINE SOLUTION BP (VIDON)

EVO310

01-Jun-

2023

31-May-

2026

US PHARMA (I) PVT.LTD

Plot No. 4, Gut No. 66, H.No. 827-830,

Khupi Village, Near Kudus, Tal. Wada, Dist. Palghar, 421312, Maharashtra,

India.

pH

CDSCO,

West Zone, Mumbai

CDTL,

Hyderabad

33

Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride & Chlorpheniramine

Maleate Syrup (Zist- D)

HRL-070

Oct-23

Sep-25

Household Remedies Pvt. Ltd., Plot No.6/35, Dewan And Sons Aliyali,

Palghar- 401 404.

Microbial Limit test

CDSCO,

West Zone, Mumbai

CDTL,

Mumbai

34

Pantoprazole Gastro- resistant Tablets IP (Pantojohn – 20)

T-2210131

Oct-22

Sep-25

Johnlee Pharmaceuticals Pvt Ltd., By Aagya Biotech Pvt. Ltd., 1.5, Manglour- saharanpur road, Manglour- 247656,

Roorkee, Haridwar.

Dissolution in buffer stage

CDSCO,

West Zone, Mumbai

CDTL,

Mumbai

35

Atorvastatin and Clopidogrel Capsules (10mg/75mg)

MC221173

Dec-2022

Nov-2024

Mascot Health Series Pvt. Lt., Plot No. 79,80,Sector-6A, IIE,

Sidcul, Haridwar- 249403

Dissolution of Atorvastatin Calcium calculated as Atorvastatin

CDSCO,

North Zone Ghaziabad

RDTL,

Chandigarh

36

Moxonidine Tablets BP (0.3 mg)

MXDY0005

Jun-2022

May-2025

MICRO LABS LIMITED UNIT-III, R.S.No. 63/ 3 & 4,

Thiruvander Koil, Puducherry-605102

Dissolution

CDSCO,

North Zone Ghaziabad

RDTL,

Chandigarh

37

Calcium Carbonate, Vitamin D3 and L- Lysine Suspension (Oscaid Suspension)

RL22070

Aug-2022

Jul-2024

RACHIL PHARMA.., 18-19,

Phase-1, Ind.Area, Sansarpur Terrace, Distt : Kangra (HP)-

176501

Description, Identification and Assay of Vitamin D3

O/o CMO Bilaspur District- Bilaspur H.P.-

174001

RDTL,

Chandigarh

38

Cefodoxime Proxetil and Potassium Clavulanate Tablets

MBT-22012

Jun-2022

Sep-2023

Magnatek Enterprises, Plot No. 74 C (II) HPSIDC

Ind. Area Baddi, Distt. Solan (H.P.) 1732025

Assay of Potassium Clavulanate Diluted calculated as Clavulanic Acid

O/o State Drugs Controller,

H.Q. Baddi, Distt.

Solan, HP- 173205

RDTL,

Chandigarh

39

Ofloxacin and Ornidazole Tablets IP (Normal -OZ TABLETS)

122257

Dec-2022

Nov-2024

Biologics Inc., Suketi Road, Kala-Amb, Distt. Sirmour (H.P.)- 173030

Dissolution of Ofloxacin and Ornidazole

State FDA Qatilgah Kargil- 194103 (UT

Ladakh)

RDTL,

Chandigarh

40

Cefuroxime Axetil Tablets IP 500 mg

JAK-20

May-2023

Arp-2025

Agron Remedies Pvt. Ltd., Sarverkhera, Moradabad Road, Kashipur-244713

(Uttarakhand)

Dissolution and Assay of Cefuroxime Axetil calculated as Cefuroxime

CDSCO

Sub-Zone, Jammu

RDTL,

Chandigarh

41

Ambroxol, Terbutaline Sulphate, Guaiphenesin and Menthol Syrup (Tricodex A Syrup)

SRLK230054

Nov-2023

Oct-2025

SYSTOLE REMEDIES PVT.

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

173030

Assay of Terbutaline Sulphate

CDSCO ,

Baddi

RDTL,

Chandigarh

42

Ambroxol hydrochloride, Terbutaline Sulphate, Guaiphenesin and Menthol Syrup

(Bronter SYRUP)

NARL-0038

Nov-2023

Oct-2025

M Sea Pharmaceuticals (P) Ltd., Surajpur, Paonta Sahib, Sirmour Himachal

Pradesh-173001

Assay of Menthol

CDSCO ,

Baddi

RDTL,

Chandigarh

43

Ambroxol Hydrochloride, Levosalbutamol and Guaiphenesin Syrup (Saivent-LX Syrup)

MAG-S-1972

Oct-2023

Sep-2025

Magma Allianz Laboratories Ltd., Vill. Guruwala, P.O. Bhagani Sahib, Teh. Paonta Sahib, Distt.

Sirmour (H.P.)- 173025

Assay of Ambroxol Hydrochloride and Levosalbutamol Sulphate calculated as Levosalbutamol

CDSCO

Baddi

RDTL,

Chandigarh

44

Ambroxol Hydrochloride, Levosalbutamol Sulphate and Guaiphenesin Syrup (KOFVON LS Syrup)

OL-032309

Mar-2023

Feb-2025

Sickcure Pharmaceuticals, Plot No. 52A, Industiral Area, Gondpur, Tehsil-Paonta Sahib, Distt. Sirmour (H.P.)

173025

Ethylene Glycol (EG) is exceeding the permissible limit

CDSCO

Baddi

RDTL,

Chandigarh

45

Ambroxol Hydrochloride, Terbutaline Sulphate, Guaiphenesin and Menthol Syrup (AVTUS-TG SYRUP)

BL-36

Jul-2023

Jun-2025

Boffin Biotech Pvt. Ltd., Vill. Behral, Paonta Sahib, Distt. Sirmour-173025 (H.P.)

Assay of Menthol

CDSCO

Baddi

RDTL,

Chandigarh

46

Chlorpheniramine Maleate, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride Syrup

(Expotus-D Syrup)

LSF-B0075

Apr-2023

Mar-2025

Spen Formulations Pvt. Ltd., Plot No- 123, Industrial Area, Mehatpur, Distt.

UNA-174315 (H.P.)

Assay of Chlorpheniramine Maleate, Dextromethorphan Hydrobromide and Phenylephrine

Hydrochloride

CDSCO

Baddi

RDTL,

Chandigarh

47

Dextromethorphan Hyhdrobromide, Phenylephrine Hydrochloride and Chlorpheniramine Maleate Syrup

(ROYCOF-DX SYRUP)

GL2301001

Jan-2023

Dec-2024

Roseate Medicare, Village Anji, PO Barog, Distt. Solan, 173211 (H.P.) INDIA

Identification and Assay of Chlorpheniramine Maleate and Assay of Dextromethorphan Hydrobromide

CDSCO

Baddi

RDTL,

Chandigarh

48

Terbutaline Sulphate, Guaiphenesin, Ambroxol Hydrochloride and Menthol Syrup (Xpert- S Syrup)

6530

Feb-2023

Jan-2025

ESTRA PHARMACEUTICA

LS, Fatehgarh Churian Road, Amritsar Br.

Assay of Ambroxol Hydrochloride and Menthol

CDSCO

Baddi

RDTL,

Chandigarh

49

LEVOCETIRIZINE HYDROCHLORIDE & MONTELUKAST SODIUM TABLETS

I.P. (Cetliv-M)

MDHMT-436

Mar-2023

Feb-2025

M Sea Pharmaceuticals (P) Ltd. (A GMP ISO 9001: 2015 CERTIFIED CO.,

Surajpur, Paonta Sahib, Sirmour

(H.P.)- 173001

Dissolution of Montelukast

Assistant Director (Food & Drugs) Mizoram

RDTL,

Guwahati

50

Levocetirizine Dihydrochloride and Montelukast Sodium Tablets IP

23112703

Mar-2023

Feb-2025

MERCURY LABORATORIES LIMITED., Unit

No.2, Halol Baroda Road, Village: Jarod. Tal: Waghodia, Dist:

Vadodara- 391510

Dissolution of Montelukast

Inspector of Drugs, Assam

RDTL,

Guwahati

51

DICLOFENAC SODIUM INJECTION I.P.

75mg/3ml

I213109

Jul-2023

Jun-2025

ANG Lifesciences India Ltd., Village Malkumajra, Nalagarh Road, Baddi, Distt. Solan- 173205 (H.P.)

Description

Inspector of Drugs, Assam

RDTL,

Guwahati

52

Montelukast Sodium and Levocetirizine Hydrochloride Tablets IP (Montas- L)

MAT22030

Jun-2022

May-2024

Tirupati Medicare Limited, Nahan Road, Paonta Sahib, Dist. Sirmour, Himachal Pradesh –

173 025, India.

Dissolution of Montelukast

Inspector of Drugs, Sikkim

RDTL,

Guwahati

53

Pheniramine Maleate Tablet I.P. (APVIL)

RT220422

May-2022

Apr-2025

Ridley Life Science Pvt. Ltd.,, D-1651, DSIDC, Indl.

Complex, Narela, Delhi- 110040

Description

Inspector of Drugs, Assam

RDTL,

Guwahati

54

Pheniramine Maleate Tablet IP (APVIL)

RT220512

Jun-2022

May-2025

RIDLEY LIFE SCIENCE PVT. LTD., D-1651, DSIDC Indl.

Complex, Narela, Delhi-110040

Description

Inspector of Drugs, Assam

RDTL,

Guwahati

55

Levocetirizine Hydrochloride & Montelukast Sodium

IP Tablets (Raremont- LC)

TSF-B1689

Apr-2023

Mar-2025

Spen Formulations Pvt. Ltd., Plot No- 123, Industrial Area, Mehatpur, Distt.

UNA- 174315 (H.P.)

Dissolution and Assay of Montelukast

Inspector of Drugs, Assam

RDTL,

Guwahati

56

Serratiopeptidase Tablets IP 10 mg (Serrarid-10)

RT220358

Apr-2022

Mar-2024

RIDLEY LIFE SCIENCE PVT. LTD, D-1651, DSIDC, Indl.

Complex, Narela, Delhi-110040

Disintegration & Description

Inspector of Drugs, Meghalaya

RDTL,

Guwahati

S.No

Name of Drugs/medical device/cosmetics

Batch No.

Date of Manuf

acture

Date of Expiry

Manufacture d By

Reason for failure

Drawn By (From state/CDS

CO Zone)

From (Name of Laboratory)

Remarks

57

Telmisartan Tablets 40 mg and Amlodipine 5 mg Tablets IP (Telma AM)

05230355

03/202

3

02/2026

Glenmark Pharmaceutica ls Ltd., Village Kishanpura, Baddi- Nalagarh Road, Tehsil Baddi, Distt. Solan (H.P.)

Assay & Dissolution of Telmisartan & Amlodipine

CDSCO,

North Zone

Central Drugs Laboratory, Kolkata

The actual manufacturer (as per label claim) has informed that the impugned batch of the product has not been manufactured by them and that it is a spurious drug. Thus, the product is purported to be spurious, however, the same is

subject to outcome of further investigation.

58

Telmisartan Tablets I.P. 40 mg (Telma 40)

I8220890

12/202

2

11/2025

Glenmark Pharmaceutica ls Ltd., Samlik Marchak, Industrial Growth Centre, East Sikkim, Sikkim – 737135

Dissolution

CDSCO,

North Zone

Central Drugs Laboratory, Kolkata

The actual manufacturer (as per label claim) has informed that the impugned batch of the product has not been manufactured by them and that it is a spurious drug. Thus, the product is purported to be spurious, however, the same is subject to outcome of

further investigation.

Also Read: AstraZeneca India bags dual CDSCO nod for Trastuzumab deruxtecan

To view the official notice, click the link below:

https://medicaldialogues.in/pdf_upload/feb2024-alert-235330.pdf

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Orthopedic Surgeon directed to pay compensation to patient for medical negligence

The Urbal II Additional District Consumer Disputes Redressal Commission, Bengaluru recently directed an Orthopaedic Surgeon to pay around Rs 4 lakh compensation to a patient for medical negligence while conducting Total Knee Replacement Surgery.

After the surgery, the patient had to suffer unbearable pain and had to seek treatment at another hospital. The Consumer Court held the doctor liable after noting that the Karnataka Medical Council (KMC) opined that “good quality of implant was not used” resulting in infection in the wound. KMC had also observed that the patient was not managed by proper follow-up and medication and for this, the Council held the treating surgeon responsible.

For more information, click on the link below:

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Security deposit for super speciality counselling refunded to candidates, informs MCC

Through a recent notice, the Medical Counseling Committee (MCC) has informed that the security deposit for super speciality counselling has been refunded to the concerned candidates.

As per the notice, “It is for the information of all the candidates participated in SS Counselling 2023 that as per the eligibility conditions mentioned in the SS Information Bulletin for Security deposit refund, the refund of security deposit has been done on 29.03.2024”.

For more information, click on the link below:
MCC Issues Notice On Security Deposit Refund To NEET SS 2023 Candidates, Details

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European Commission approves Merck Keytruda plus Chemotherapy for lung cancer

Rahway: Merck, known as MSD outside of the United States and Canada, has announced that the European Commission (EC) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with platinum-containing chemotherapy as neoadjuvant treatment, then continued as monotherapy as adjuvant treatment, for resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in adults.

This approval by the EC follows the positive recommendation from the Committee for Medicinal Products for Human Use received in February 2024 and was based on results from the Phase 3 KEYNOTE-671 trial. At a median follow-up of 29.8 months (range, 0.4 to 62.0 months), KEYTRUDA plus chemotherapy in the neoadjuvant setting followed by KEYTRUDA as monotherapy after surgical resection significantly improved overall survival (OS), reducing the risk of death by 28% (HR=0.72 [95% CI, 0.56-0.93]; one-sided p=0.00517) in patients with resectable stage II, IIIA or IIIB NSCLC versus placebo plus chemotherapy in the neoadjuvant setting followed by placebo after surgical resection, regardless of PD-L1 expression. For patients who received the KEYTRUDA-based regimen, median OS was not reached (95% CI, NR-NR) versus 52.4 months (95% CI, 45.7-NR) for patients who received the chemotherapy-placebo regimen. The KEYTRUDA-based regimen also improved event-free survival (EFS), reducing the risk of disease recurrence, progression or death by 41% (HR=0.59 [95% CI, 0.48-0.72]) compared to the chemotherapy-placebo regimen. For patients who received the KEYTRUDA-based regimen, median EFS was improved by nearly two and a half years compared to the chemotherapy-placebo regimen (47.2 months [95% CI, 32.9-NR] versus 18.3 months [95% CI, 14.8-22.1], respectively).

KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD- L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

“Despite the clinical advances for patients with metastatic lung cancer, lung cancer continues to be the leading cause of cancer death in Europe, reinforcing the need to treat these patients in earlier stages of their disease, where we may have the most impact,” said Dr. Solange Peters, chair of the medical oncology and thoracic malignancies department, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland. “The approval of this KEYTRUDA-based regimen is an important milestone for patients diagnosed with resectable non-small cell lung cancer at high risk of recurrence, regardless of PD-L1 expression, providing a new option for these patients that has shown, through the results of the Phase 3 KEYNOTE-671 trial, the potential to help extend their lives.”

This approval allows marketing of this KEYTRUDA regimen for this indication in all 27 EU member states, as well as Iceland, Liechtenstein, Norway and Northern Ireland. KEYTRUDA is now approved for six indications in NSCLC, and for 27 indications overall in the EU. In October 2023, KEYTRUDA was approved in the U.S. for the treatment of patients with resectable (tumors ≥4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.

“The approval of the first anti-PD-1/L1 therapy as part of a treatment regimen in Europe for the neoadjuvant followed by adjuvant treatment of resectable NSCLC based on positive overall survival results demonstrates our continued progress to advance treatments in earlier stages of lung cancer,” said Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. “We are eager to build on this momentum as we plan to seek additional approvals of this regimen around the world, and to work together with the cancer community to help drive earlier diagnoses of lung cancer, an urgent need.”

Lung cancer is the leading cause of cancer death worldwide. In 2022 alone, there were approximately 2.4 million new cases and 1.8 million deaths from lung cancer globally. Non-small cell lung cancer is the most common type of lung cancer, accounting for about 80% of all cases. In recent decades, the overall five-year survival rate for patients diagnosed with lung cancer increased from 11% to 15% on average across EU countries. Improved survival rates are due, in part, to earlier detection and screening, reduction in smoking, advances in diagnostic and surgical procedures, as well as the introduction of new therapies. Early detection and screening remain an important unmet need, as 44% of lung cancer cases are not found until they are advanced.

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Last date for submission of annual declaration details by medical colleges extended: NMC

In a major relief to medical colleges across the country who were asked to submit their Annual Declaration details/data of respective Institutions on National Medical Commission (NMC) portal as required in the NMC Act, 2019 and various other regulations, the NMC has now given them an extension to submit the required detials

Through a public notice, the National Medical Commission (NMC) has announced the extension of the last date for submission of details along with requisite fees including GST on the NMC portal till April 10, 2024.

For more information, click on the link below:
Relief To Medical Colleges: NMC Extends Deadline For Submission Of Annual Declaration Details

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Bengaluru Nephrologist criticizes HDFC for loan spam calls, sparks social media outcry

Bengaluru: A renowned nephrologist Dr Sundar Sankaran has recently taken to social media to address the issue of receiving an overwhelming number of spam calls from HDFC bank’s loan department.  

Terming the callers as a ‘nuisance’, the Bengaluru-based doctor who is a program director at Aster Institute of Renal Transplantation Bangalore in a post on X said, “HDFC loan requirement callers have become a nuisance and if you get angry with them you are pestered with more calls despite blocking. Today after one caller got fired by me another caller claiming to be an HDFC manager and wanted to know why I was rude. Looked like spam calls but HDFC has to act and investigate.”

Further, he included the phone numbers from which he received the constant spam calls in the post shared on March 30.

Also read- Pune Doctor Duped By Fraudsters In Drug Parcel Scam, Loses Rs 1 Crore

In response to the doctor’s post, the HDFC service manager said, “Hi Sundar, sorry to hear about your experience. Please DM us the caller details and your contact number on which the call was received for better assistance.” 

Slamming HDFC bank for not taking action, Dr Sankaran said, “No need for DM. I have given the numbers just act. I have DM’d earlier with so many numbers so many times but no action was taken because HDFC doesn’t care!” 

“HDFC Bank doesn’t care about its customers. It’s the largest private bank in India and still soliciting business by outsourcing to telemarketing companies and claiming ignorance. The chairman and CEO should have some shame and act responsibly,” he added.

Speaking to Moneycontrol, Dr Sankaran said, “This is very troublesome when we are checking patients who are sick. People may say ignore the unknown callers but many times it’s a desperate patients trying to reach me for help and I can’t afford to keep my phone in silence.”

Meanwhile, several X users including doctors have shared their similar experiences with HDFC Bank and also advised him how to get rid of such pestering calls.

Also read- UP Doctor Duped Of Rs 40 Lakh In Digital Arrest Scam

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TN Doctors see red over fresh service recruitment exam notice, demand hiring of already qualified candidates

Chennai: Doctors, who qualified in last year’s MRB examination held to recruit assistant surgeons for 1,021 posts, are upset with the new recruitment notification issued by the Medical Services Recruitment Board (MRB) inviting applications for 2,553 vacant posts of assistant surgeons temporarily in the Tamil Nadu Medical Service. 

According to a recent report by The Hindu, shocked over the new recruitment notification, they are demanding that candidates who qualified previously should be considered to fill the vacant posts instead of holding a new examination.

As per the new notification dated 15.03.2024 for 2,553 vacant posts, the candidates are required to submit their applications from April 24 to May 15 and the date of examination will be intimated later.

Also Read: Chennai: House Surgeons demand Incentive Marks in Government Service Recruitment against COVID-19 service

The Hindu reports that even though the previous notification for recruitment in 1,021 posts was issued back in October 2022, it got delayed due to multiple reasons and finally the recruitments were completed in February 2024. Meanwhile, a number of candidates approached the Court seeking incentive marks for their work in government hospitals during the COVID-19 pandemic.

Last year, house surgeons serving in COVID wards across various government or government-approved private medical college hospitals sought incentive marks in the upcoming government doctor recruitment drive conducted by the Medical Recruitment Board. Expressing their concerns, the house surgeons sought equitable treatment with doctors recruited on contract and post-graduate professionals assigned responsibilities during the pandemic. They argue that the nature of their duties, especially in COVID-19 wards, warrants recognition in the form of incentive marks during the recruitment process. Eventually, they were granted the incentive marks.

Following this, some of the qualified doctors approached the Madurai Bench of the Madras High Court seeking a direction to the Health Department for increasing the number of vacancies notified. They claimed that the grant of incentive marks affected their prospects of securing a posting.

Passing an order in this regard, the Court on February 14 issued directions to the Health Department to consider the representation of the petitioner doctors and pass appropriate orders within four weeks from the date of order.

Some of the candidates have now pointed out that despite the order by the Court, a new notification was issued on March 15 by the Government inviting fresh applications. They also added that they have made a representation to the Health Department requesting it increase the number of vacancies and fill up the vacancies from the list of qualified candidates.

Commenting on the matter, a candidate who qualified in the previous exam told The Hindu, “In the MRB examination held in 2018, the average cut-off of an aspirant was 55 for BC, 52.5 for MBC and 50 for SC. There was an increase in the number of aspirants for the past five years, and giving incentive marks for those who worked during COVID-19 affected the prospects of many candidates. For instance, a SC candidate, despite getting 63 marks, did not get a posting. In such circumstances, releasing a new notification indicates that those with merit marks are being ignored.”

The doctor argued that a vacancy should not be kept unfilled for such a long time with health being an essential service that affects the poor. “Now, they have brought up 2,553 vacancies. A number of posts were kept vacant for more than five years. This breaches the purpose of MRB as outlined by Government Order 1,” he added.

The Daily further adds that responding to a Right to Information (RTI) application, the Directorate of Public Health and Preventive Medicine informed in November 2023 that there were 1,752 vacancies for the post of assistant surgeons.

Referring to this, another doctor added, “When there are 1,752 vacant posts, why not fill accordingly instead of only 1,021 posts. In fact, not all 1,021 posts have been filled. Only around 777 doctors have joined. So there are a good number of posts to which already qualified candidates from the MRB list can be recruited, instead of the fresh notification.”

Meanwhile, another qualified candidate noted that the State Government did not hold the MRB examination for nearly five years and due to this several candidates were left waiting. He opined, “This new notification should be withdrawn.”

Commenting on the matter, an official informed the Daily that all the aspects can only be looked into after the elections.

Medical Dialogues had earlier reported that expressing dissatisfaction with the Health Department’s handling of vacant positions and the allocation of merit marks, the doctors were planning to challenge the department’s decision to issue a fresh notification for 2,553 assistant surgeon posts, despite 1,251 vacancies remaining unfilled from the April 2023 MRB exam, in the Court.

Dr Parthiban Shivan, representing the aspirants, had earlier informed about the plans to challenge this move in the Madras High Court, arguing that according to regulations, new notifications cannot be issued until all previously announced posts are filled.

The last MRB exam was held in 2023 after five years for 1,021 assistant surgeon posts and as a result, a large number of candidates appeared, aspirants informed. The department called nearly 1,600 candidates for the 1,021 posts, of which, 777 were posted.

Also Read: Tamil Nadu doctors to move High Court against recruitment for 2553 posts of Assistant Surgeons

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Health Bulletin 01/ April/ 2024

Here are the top health news for the day:

NMC extends deadline for submission of annual declaration details
In a major relief to medical colleges across the country who were asked to submit their Annual Declaration details/data of respective Institutions on National Medical Commission (NMC) portal as required in the NMC Act, 2019 and various other regulations, the NMC has now given them an extension to submit the required detials

Through a public notice, the National Medical Commission (NMC) has announced the extension of the last date for submission of details along with requisite fees including GST on the NMC portal till April 10, 2024.

For more information, click on the link below:
Relief To Medical Colleges: NMC Extends Deadline For Submission Of Annual Declaration Details

NEET SS 2023: Security deposit refunded for super speciality counselling

Through a recent notice, the Medical Counseling Committee (MCC) has informed that the security deposit for super speciality counselling has been refunded to the concerned candidates.

As per the notice, “It is for the information of all the candidates participated in SS Counselling 2023 that as per the eligibility conditions mentioned in the SS Information Bulletin for Security deposit refund, the refund of security deposit has been done on 29.03.2024”.

For more information, click on the link below:
MCC Issues Notice On Security Deposit Refund To NEET SS 2023 Candidates, Details


Surgeon penalized for substandard knee implant in replacement surgery

The Urbal II Additional District Consumer Disputes Redressal Commission, Bengaluru recently directed an Orthopaedic Surgeon to pay around Rs 4 lakh compensation to a patient for medical negligence while conducting Total Knee Replacement Surgery.

After the surgery, the patient had to suffer unbearable pain and had to seek treatment at another hospital. The Consumer Court held the doctor liable after noting that the Karnataka Medical Council (KMC) opined that “good quality of implant was not used” resulting in infection in the wound. KMC had also observed that the patient was not managed by proper follow-up and medication and for this, the Council held the treating surgeon responsible.

For more information, click on the link below:

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Study finds association between TB infection and increased risk of various cancers

A population-wide observational study to be presented at this year’s European Congress of Clinical Microbiology and Infectious Diseases (ECCMID 2024) in Barcelona, Spain (27-30 April) shows an association between tuberculosis (TB) and cancer, with those with current or previous TB more likely to have a diagnosis of a variety of cancers, including lung, blood, gynecological and colorectal cancers.

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Study suggests high blood pressure could begin in childhood

Children and teenagers living with overweight or obesity are more likely to have high blood pressure as adults (aged 50–64 years), suggesting the processes behind the condition could begin as early as childhood, suggests new research being presented at this year’s European Congress on Obesity (ECO) in Venice, Italy (12-15 May).

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