CDSCO Drug Alert: 48 drug samples flagged Not Of Standard Quality

Published On 2023-04-25 12:30 GMT   |   Update On 2023-10-19 11:14 GMT
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New Delhi: In its latest drug safety alert, the apex drug regulatory body, Central Drugs Standard Control Organization (CDSCO) has flagged 48 medicine batches for failing to qualify random drug sample test for the month of March– 2023.

These drugs samples include Telmisartan Tablets manufactured by Ridley Life Sciences, Domperidone Tablets manufactured by Karnataka Antibiotics & Pharmaceuticals, Pioglitazone Hydrochloride Tablets manufactured by Skymap Pharmaceutical, Domperidone Tablets manufactured by Rivpra Formulation, Gabapentin Tablets manufactured by Synokem Pharmaceuticals and Mascot Health Series, Rolled Bandage (Non Sterilized, Size 15cm x 4 mts manufactured by Disha Surgicals, Dactinomycin for Injection USP 0.5 mg by Celon Laboratories, Iron and Folic Acid Tablets I.P. manufactured by Nestor Pharmaceuticals and others.

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In addition to this, the names of the Meswak (Toothpaste for complete Tooth and Gum Care) manufactured by Dabur India Limited, ALGLIMET M1 (Glimepiride 1 mg & Metformin 500 mg Tablets SR) manufactured by Alves Healthcare, Pheniramine Maleate Tablets manufactured by Dabur India Limited, MEROXIA Nano Injection 1 gm (Meropenem Injection I.P.) manufactured by Oscar Remedies, Diphenhydramine HCl, Ammonium- Chloride and Sodium Citrate Cough Expectorant manufactured by Hindustan Laboratories are also on the list.

Furthermore, drug major Glenmark's Telma-AM Tablet (Telmisartan 40 mg and Amlodipine 5 mg Tablets IP) is also on the list of drugs failed to qualify random drug sample test.

Speaking to Medical Dialogues, Glenmark spokesperson said, "We have investigated the matter and found that the TELMA AM Tablets (Telmisartan 40 mg and Amlodipine 5 mg Tablets IP) batch number 18220076 from the NSQ list of “March 2023 Month Drugs Alert” are counterfeit medicines and have not been manufactured by Glenmark. We have requested the CDSCO to take action on this and also made an appeal for removal of the product from the drug alert list."

"As a responsible manufacturer, we have provided proactive information and leads to all concerned regulatory officials from time to time. Additionally, we have taken the necessary measures, which include engaging an external agency to investigate the presence of counterfeit drugs across the country," the company's spokesperson added.

The list came after analysis and tests were conducted by the CDSCO, Drug Control Departments on 1497 samples. Out of this, 1449 samples were found of standard quality were 48 of them were declared as Not of Standard Quality (NSQ).

A few of the reasons why the drug samples tested failed were the failure of assays, failure of the dissolution test, failure of the disintegration test, failure of pH and identification test, failure of clarity test, failure of specific assay of drug test and others.

The samples collected were tested in CDTL Kolkata, RDTL Chandigarh, CDTL Chennai, CDTL Mumbai, RDTL Guwahati.

List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded for the Month of March –2023.

Total number of samples tested

1497

Total number of samples declared as of Standard Quality

1449

48

Total number of samples declared as Spurious

-

Total number of samples declared as Misbranded

-

S.No

Name of Drugs/medical device/cosmetic s

Batch No./Date of Manufacture/Date of Expiry/Manufactured By

Reason for failure

Drawn By

From

1.

Telmirid-40 (Telmisartan Tablets I.P. 40 mg)

B. No.: RT220651

Mfg dt: 08/2022 Exp dt: 07/2024

Mfd by: M/s. Ridley Life Sciences Pvt. Ltd., D- 1651, DSIDC, Indl.

Complex, Narela, Delhi 110 040.

Dissolution

CDSCO,

East Zone Kolkata

CDTL

Kolkata

2.

Domperidone Tablets I.P. 10 mg

B. No.: 3100422

Mfg dt: 07/2022 Exp dt: 06/2025

Mfd by: M/s. Karnataka Antibiotics & Pharmaceuticals Limited, Plot No. 14 II Phase, Peenya,

Bengaluru – 560 058.

Related Substances

CDSCO

East Zone Kolkata

CDTL

Kolkata

3.

Pioglitazone Hydrochloride Tablets IP 30 mg

B. No.: GM21077

Mfg dt: 08/2021 Exp dt: 07/2023

Mfd by: M/s. Skymap Pharmaceuticals Pvt. Ltd., B-3, Dev Bhoomi Industrial Estate, Puhana Iqbalpur Road, Roorkee -247667

Uttarakhand..

Dissolution

CDSCO

East Zone Kolkata

CDTL

Kolkata

4.

Domperidone Tablets I.P. 10 mg

B. No.: T-2203140

Mfg dt: 03/2022 Exp dt: 02/2024 Mfd by: M/s. Rivpra

Formulation Pvt. Ltd., Plot No. 8, Sector -6A,

I.I.E. Sidcul, Haridwar

Related Substances

CDSCO

East Zone Kolkata

CDTL

Kolkata


249 403 Uttarakhand.

5.

Domperidone Tablets I.P. 10 mg

B. No.: T-2203139

Mfg dt: 03/2022 Exp dt: 02/2024 Mfd by: M/s. Rivpra

Formulation Pvt. Ltd., Plot No. 8, Sector -6A,

I.I.E. Sidcul, Haridwar

249 403 Uttarakhand.

Related Substances

CDSCO

East Zone Kolkata

CDTL

Kolkata

6.

Gabapentin Tablets I.P.

B. No.: 22S1GTB467 Mfg dt: 11/2022

Exp dt: 10/2024

Mfd by: M/s. Synokem Pharmaceuticals Ltd., Plot No. 35-36, Sector- 6A, I.I.E (SIDCUL),

Ranipur (BHEL),

Haridwar – 249 403, Uttarakhand.

Related Substances

CDSCO

East Zone Kolkata

CDTL

Kolkata

7.

Gabon-300 Tablets (Gabapentin Tablets I.P.)

B. No.: MT225040

Mfg dt: 11/2022 Exp dt: 10/2024

Mfd by: M/s. Mascot Health Series Pvt. Ltd., Plot No. 79, 80, Sec - 6A, I.I.E., (SIDCUL),

Haridwar 249 403,

Uttarakhand, India.

Related Substances

CDSCO

East Zone Kolkata

CDTL

Kolkata

8.

Rolled Bandage (Non Sterilized, Size 15cm x 4 mts.)

B. No.: 637

Mfg dt: 03/2022 Exp dt: 02/2024 Mfd by: M/s. Disha

Surgicals Pvt. Ltd., 145, Sai Puram, Delhi Road, Meerut - 250002

Uttar Pradesh.

Threads per dm (Warp & Weft), Weight in gm per m2 & Fluorescence

CDSCO

West Zone Mumbai

CDTL

Kolkata

9.

Absorbent Cotton Wool I.P.

B. No.: 636

Mfg dt: 10/2022

Exp dt: 2 years from Mfd by: M/s. Jajoo Surgicals Pvt. Ltd., Unit 1: 61A/62, Industrial Area No. 3, A.B. Road,

Dewas -455001 (MP),

Surface Active Substances, Sinking Time & Sulphated ash

CDSCO

West Zone Mumbai

CDTL

Kolkata


India, Unit 2: 82-B-83C, Industrial Area No. 1,

A.B. Road, Dewas

455 001 (MP), India.

10.

DACILON 0.5

(Dactinomycin for Injection USP

0.5 mg)

B. No.: DMI2243AC Mfg dt: 12/2022 Exp dt: 11/2025 Mfd by: M/s. Celon

Laboratories Pvt. Ltd., Plot No.2, ALEAP

Industrial Estate, Gajularamaram, Medchal Dist. 500090,

Telangana State, India.

Appearance &

Assay

CDSCO

Hyderabad

CDTL

Kolkata

11.

Rivastigmine Tartarate

B. No.: 20201201

Mfg dt: Nil Exp dt: Nil

Mfd by: M/s. Nil

Identification Assay & Water

CDSCO

Hyderabad

CDTL

Kolkata

12.

Ritonavir

B. No.: Nil Mfg dt: Nil, Exp dt: Nil,

Mfd by: M/s. Nil

Specific Optical Rotation, Water Content, Related Substances,

Identification, Assay

CDSCO

Hyderabad

CDTL

Kolkata

13.

Iron and Folic Acid Tablets I.P.

B. No.: IQTZ-371 Mfg dt: 12/2022 Exp dt: 11/2024 Mfd by: M/s. Nestor Pharmaceuticals

Limited, 11, Western Extension Area, Faridabad 121 001,

India.

Description, Assay and Uniformity of Content of Folic Acid

CDSCO

Zonal Office Ahmedabad

CDTL

Kolkata

14.

(DUCOLAX)

Bisacodyl Tablet

I.P. 5 mg

B. No.: 220259

Mfg dt: 02/2022 Exp dt: 01/2025 Mfd by: M/s. Modi

Antibiotics, Plot No. 28, G.I.D.C., Odhav,

Ahmedabad 382415,

Gujarat.

Assay and Dissolution

CDSCO

West Zone Mumbai

CDTL

Kolkata

15.

ALGLIMET M1

(Glimepiride 1 mg

& Metformin 500 mg Tablets SR)

B. No.: AT22068

Mfg dt: 03/2022 Exp dt: 02/2024 Mfd by: M/s. Alves

Healthcare Pvt. Ltd.,

Assay and Dissolution of Glimepiride

CDSCO

West Zone Mumbai

CDTL

Kolkata


Nangal Uperia, Swarghat Road, Nalagarh, Distt. Solan – 174 101, Himachal

Pradesh, India

16.

Meswak (Toothpaste for complete Tooth and Gum Care)

B. No.: BM0637 Mfg dt: 07/2022 Exp dt: 07/2024

Mfd by: M/s. Dabur India Limited, Village Monakpur, Tehsil Baddi, Dist.: Solan , Himachal

Pradesh –174 101

Total Bacterial Count and Test for Pathogens

CDSCO

West Zone Mumbai

CDTL

Kolkata

17.

MEROXIA Nano

Injection 1 gm (Meropenem Injection I.P.)

B. No.: D220162

Mfg dt: 01/2022 Exp dt: 12/2023 Mfd by: M/s. Oscar Remedies Pvt. Ltd., Oskar House, Badi

Majra, Yamunanagar -

135 001,Haryana.

Assay of Meropenem &

Content of Sodium

CDSCO

South Zone Chennai

CDL

Kolkata

18.

Vitamin B Complex Tablets

B. No.: RT-220598

Mfg dt: 05/2022 Exp dt: 10/2023 Mfd by: M/s. Relief Biotech Pvt. Ltd.,

Khasra No. 72, Makhyali Dundi, Peerpura Road, Roorkee Bypass, Delhi Road, Manglour, Roorkee - 247656,

Haridwar, Uttarakhand.

Description and Assay of Thiamine Hydrochloride

CDSCO

North Zone Ghaziabad

CDL

Kolkata

19.

APVIL

(Pheniramine Maleate Tablets I.P.)

B. No.: RT220155

Mfg dt: 02/2022 Exp dt: 01/2025

Mfd by: M/s. Ridley Life Science Pvt. Ltd., D- 1651, DSIDC, Indl.

Complex, Narela, Delhi 110040.

Assay of Pheniramine Maleate

CDSCO

East Zone Kolkata

CDL

Kolkata

20.

VASOCON 1 ml

(Adrenaline Bitartrate Injection I.P.)

B. No.: KP85229

Mfg dt: 07/06/2022 Exp dt: 06/06/2023 Mfd by: M/s. Neon

Description and Particulate Matter

Drug Control Department

Jammu

CDL

Kolkata


Laboratories Ltd., At Shantisthal, Plot No. 1- 5, At & post: Shirgaon, Tal Palghar, Dist. Thane

- 401 407, Maharashtra.

& Kashmir

21..

Hydrocort -100 (Hydrocortisone Sodium Succinate Injection I.P.

100 mg)

B. No.: AQH0039 Mfg dt: 07/2022 Exp dt: 06/2024

Mfd by: M/s. Aqua Vitoe Laboratories Plot No. 4, Village Kunjhal near Jharmajri Baddi, Dist.

Solan 173205, Himachal

Pradesh, India.

Clarity of Solution

Drug Control Department Jammu

& Kashmir

CDL

Kolkata

22.

Lycopene with Vitamins and Minerals Syrup (CARORICH

Syrup)

B. No.: NL-22057

Mfg dt: 08/2022 Exp dt: 01/2024 Mfd by: M/s. H.L.

Healthcare Pvt. Ltd., Plot No. 25, Ind. Area, Phase-II, Gagret-177

201, Himachal Pradesh.

Assay of Vitamin E Acetate.

Drug Control Department Himachal Pradesh

RDTL

Chandigarh

23.

Aceclofenac, Paracetamol and Thiocolchicoside Tablets (ELFEN- TH4 TABLETS)

B. No.: T-220621

Mfg dt: 06/2022 Exp dt: 05/2024

Mfd by: M/s. Vilin Bio Med Ltd, Unit-II, Khasra No. 85, Madhopur Hazarathpur, Roorkee- 247667, Uttarakhand.

Assay of Aceclofenac and Thiocolchicoside

CDSCO

North Zone

RDTL

Chandigarh

24.

Vitamin C Injection IP and Vitamin B12, Folic Acid and Niacinamide Injection (Eldervit-12)

B. No.: JBJM-099 Mfg dt: 11/2022 Exp dt: 10/2024 Mfd by: M/s. JBJM

Parenterals Pvt. Ltd,, P-

24, Site-5, UPSIDC

Industrial Area, Kasna, Greater Noida-201310, Uttar Pradesh.

Assay of Folic Acid.

CDSCO

North Zone

RDTL

Chandigarh

25.

Nirmatrelvir Tablets 150 mg and Ritonavir Tablets IP 100

mg Combipack

B. No.: (A) NR-2204

(B) RT- 2204 Mfg dt: 07/2022 Exp dt: 06/2024 Mfd by: M/s. Neutral

Uniformity of weight, Identification and Assay of Nirmatrelvir.

Drug Control Department Delhi

RDTL

Chandigarh


(Primovir Tablets)

Code: HP/06/176, Marketed by: Astrica HealthCare Pvt Itd. Plot No: 9-18/5, First Floor, Bharathi Nagar, Temple Alwal, Medchal,

Telangana-500010.

26.

Vitamin C, Vitamin B12, Folic Acid and Niacinamide Injection (Eldervit-12)

B. No.: JE-07 Mfg dt: 12/2022 Exp dt: 11/2024 Mfd by: M/s. SVP

Lifesciences SARA Industrial Estate, Sector C 10/1, Selaqui, Rampur, Dehradun,

U.K.

Identification and Assay of Folic Acid.

CDSCO

North Zone

RDTL

Chandigarh

27.

Vitamin C, Vitamin B12, Folic Acid and Nicotinamide Injection (Eldervit

-12 Injection)

B. No.: RA2008 Mfg dt: 02/2022 Exp dt: 01/2024

Mfd by: M/s. Ronam Healthcare Pvt. Ltd., Village - Kalujhanda, Tehsil- Baddi, Distt.-

Solan (H.P.) 174103.

Assay of Folic Acid

CDSCO

Sub-Zone

RDTL

Chandigarh

28.

Vitamin C, Vitamin B12, Folic Acid and Nicotinamide Injection (Eldervit

-12 Injection)

B. No.: RA2156 Mfg dt: 12/2022 Exp dt: 11/2024

Mfd by: M/s. Ronam Healthcare Pvt. Ltd., Village - Kalujhanda, Tehsil- Baddi, Distt.-

Solan (H.P.) 174103.

Assay of Folic Acid

CDSCO

Sub-Zone

RDTL

Chandigarh

29.

Diphenhydramine HCl, Ammonium- Chloride and Sodium Citrate Cough Expectorant

B. No.: LDS2005AL Mfg dt: 12/2022 Exp dt: 05/2024 Mfd by: M/s. HINDUSTAN LABORATORIES,

LIMITED, Plot No. 5-9,

Survey No. 38/2, Aliyali, Palghar (W), Dist Palghar 401404, Maharashtra.

Assay of Menthol

CDSCO

Sub-Zone

RDTL

Chandigarh

30.

Pre and Probiotic

B. No.: HPH 207

Identification and

CDSCO

RDTL

Capsules

Mfg dt: 04/2022 Exp dt: 02/2024

Mfd by: M/s. Med Manor Organics Pvt. Ltd., Unit- II, K.No. 143M/7,

Village-Raipur, Pargana- Bhagwanpur, Tehsil- Roorkee, Distt. Haridwar, Uttarakhand- 247 661.

Assay of Streptococcus faecalis

North Zone

Chandigarh

31.

Vitamin C Injection IP and Vitamin B12, Folic Acid and Nicotinamide Injection (Eldervit-12

Injection)

B. No.: EP-0916

Mfg dt: 10/2022 Exp dt: 09/2024 Mfd by: M/s. E.G

Pharmaceuticals, Vill. Mandhala, Teh. Kasauli Distt. Solan, Himachal

Pradesh.

Particulate matter

CDSCO

North Zone

RDTL

Chandigarh

32.

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

B. No.: 18220076

Mfg dt: 01/2022 Exp dt: 12/2024

Mfd by: M/s. Glenmark Pharmaceuticals Ltd., Samlik Marchak, Industrial Growth Centre, East Sikkim,

Sikkim-737135.

Dissolution of Telmisartan

Drug Control Department Delhi

RDTL

Chandigarh

33.

Metronidazole Tablets IP 400 mg

B. No.: 3000421

Mfg dt: 03/2021 Exp dt: 02/2024

Mfd by: M/s. Karnataka Antibiotics & Pharmaceuticals Ltd., Plot No.14,

II Phase, Peenya,

Bengaluru-560058.

Dissolution.

CDSCO

Subzone Bangalore

CDTL

Chennai

34.

BACLOX-400

(Norfloxacin Tablets IP)

B. No.: AUT-22002

Mfg dt: 08/2022 Exp dt: 07/2025

Mfd by: M/s. Supermax Laboratories, Plot No.40, Pharmacity Selaqui Industrial Area,

Dehradun- 248011.

Dissolution

CDSCO

West- Zone Mumbai.

CDTL,

Mumbai


35.

ODIMONT-AL

(Montelukast, Levocetirizine HCl & Ambroxol HCl (SR)

Tablets)

B. No.: GZOA22002 Mfg dt: 11/2022

Exp dt: 10/2024

Mfd by: M/s. GKM New Pharma Spl. Type Plot No. 5, 6, 7 & 8, Pipdic Electronic Park, Thirubuvanai Puducherry- 605 107.

Assay and Dissolution of Montelukast

CDSCO

West-Zone

CDTL,

Mumbai

36.

Voglibose Tablets IP 0.2mg

B.No.: 1121-27

Mfg dt: 10/2022 Exp dt: 09/2024 Mfd by: M/s HAB Pharmaceuticals & Research Ltd., 10,

Pharmacity, SIDCUL, Selaqui, Dehradun-

248011

Test for Assay

Sub-zone, Indore

CDTL,

Mumbai

37.

Lactuedge (Lactulose Solution USP)

B. No.: GA22005

Mfg dt: 02/2022 Exp dt: 01/2024

Mfd by: M/s. Skymap Pharmaceuticals Pvt. Ltd., B-3, Dev Bhoomi Industrial Estate, Puhana Iqbalpur Road,

Roorkee- 247 667.

Assay and Organic Impurities

CDSCO

West-Zone

CDTL,

Mumbai

38.

Albendazole Tablets IP

B. No.: MS4AI2202 Mfg dt: 09/2022 Exp dt: 08/2025

Mfd by: M/s. MAXTAR BIO-GENICS,

Khasra No. 705, Vill. Malku Majra, Nalagarh Road , Baddi, Distt.

Solan – 173205, Himachal Pradesh,

India.

Dissolution

Drug Control Department Meghalaya

RDTL

Guwahati

39.

Amoxycillin, Cloxacillin & Lactic Acid Bacillus Capsules Amoxynol Plus

B. No.: PRB-220203

Mfg dt: 02/2022 Exp dt: 01/2024

Mfd by: M/s. Preet Remedies Ltd.

Assay of Cloxacillin

Drug Control Department Jharkhand

RDTL

Guwahati


LB

183-186, HPSIDC,

Industrial Area, Baddi- 173205- Himachal Pradesh.

40.

Ascorbic Acid Tablets IP 500mg

B. No.: T392012

Mfg dt: 01/2022 Exp dt: 12/2023 Mfd by: M/s. ANG

Lifesciences India Ltd.

Village Malkumajra, Nalagarh Road, Baddi, Distt. Solan-

173205, Himachal Pradesh.

Description

Drug Control Department Assam

RDTL

Guwahati

41.

CIPROFLOXACI N HYDROCHLORI DE TABLETS I.P.

500 mg

B. No.: 0701122

Mfg dt: 05/2022 Exp dt: 04/2025 Mfd by: M/s.

KARNATAKA

ANTIBIOTICS & PHARMACEUTICALS LIMITED, Plot No. 14, II

Phase, Peenya, Bengaluru 560 058.

Dissolution

Drug Control Department Jharkhand

RDTL

Guwahati

42.

Calcium & Vitamin D3 Tablets I. P.

B. No.: RT-221004

Mfg dt: 10/2022 Exp dt: 03/2024 Mfd by: M/s. Relief Biotech Pvt. Ltd.

Khasra No. 72, Makhyali

Dundi, Peerpura Road, Roorkee, Byepass, Deli Road, Manglour, Roorkee-247656,

Haridwar, Uttarakhand.

Identification and Assay of Vitamin D3

Drug Control Department Bihar

RDTL

Guwahati

43.

Calcium & Vitamin D3 Tablets I. P. (Calcidoc-500)

B. No.: T2030158A

Mfg dt: 03/2022 Exp dt: 02/2024 Mfd by: M/s. ION Healthcare Pvt. Ltd. Baddi – Barotiwala Road, Baddi,

Distt. Solan, Himachal

Pradesh - 173205.

Assay of Vitamin D3

Drug Control Department Jharkhand

RDTL

Guwahati

44.

Calcium & Vitamin D3 Tablets I.P.

B. No.: RT-221008

Mfg dt: 10/2022 Exp dt: 03/2024

Assay of Vitamin D3

Drug Control Department

RDTL

Guwahati


Mfd by: M/s. Relief Biotech Pvt. Ltd.

Khasra No. 72, Makhyali Dundi, Peerpura Road, Roorkee Bypass, Delhi Road, Manglour, Roorkee-247656,

Haridwar, Uttarakhand.

Bihar

45.

O2 (Ofloxacin & Ornidazole Tablets I.P.)

B. No.: E20034

Mfg dt: 01/2022 Exp dt: 12/2024

Mfd by: M/s. Medley Pharmaceutical Ltd. Lane No. 3, Phase-1, SIDCO Industrial Complex, Bari Brahmama, Jammu-

181133.

Identification and Assay of Ofloxacin & Ornidazole

Drug Control Department Assam

RDTL

Guwahati

46.

CIPROFLOXACI N HYDROCHLORI DE TABLETS I.P.

500 mg

B. No.: KA3202 Mfg dt: 01/2022 Exp dt: 12/2024

Mfd by: M/s. Karnataka Antibiotics & Pharmaceuticals Limited, Plot No. 37, Site No.34/4, NTTF Main Road, II Phase, Peenya, Bengaluru

560058, India.

Dissolution

Drug Control Department Jharkhand

RDTL

Guwahati

47.

ALCIFLOX 500

(Ciprofloxacin Tablets I.P.)

B. No.: ACT22004SL Mfg dt: 02/2022

Exp dt: 01/2025 Mfd by: M/s. Shiva

Biogenetic Laboratories

Pvt. Ltd. village Manpura, Baddi, Dist. Solan, Himachal Pradesh- 174101.

Dissolution

Drug Control Department Jharkhand

RDTL

Guwahati

48.

Telmisartan Tablets IP 40 mg

B. No.: T101004

Mfg dt: 09/2021 Exp dt: 08/2023 Mfd by: M/s. ANG Lifesciences India Ltd. Village Malkumajra, Nalagarh Road, Baddi, Distt. Solan- 173205- Himachal Pradesh.

Dissolution & Description

Drug Control Department Bihar

RDTL

Guwahati


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