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  • 36 drug samples fail...

36 drug samples fail to qualify CDSCO test

Farhat NasimWritten by Farhat Nasim Published On 2021-11-14T17:25:00+05:30  |  Updated On 7 Dec 2022 4:59 PM IST
36 drug samples fail to qualify CDSCO test
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New Delhi: In its latest drug safety alert, the apex drug regulatory body, the Central Drugs Standard Control Organization (CDSCO), has flagged 36 medicine batches for failing to qualify for a random drug sample test for the month of October.

These drug samples which are declared as 'Not of Standard Quality' include two Government manufacturers namely Karnataka Antibiotics and Pharmaceuticals Limited (A Govt. of India Enterprise) and Hindustan Antibiotics Ltd., (A Govt. Of India Enterprise). Besides, Theon Pharmaceutical's Pregabalin Capsules, Akums Drug's Diclofenac, Virgin Linseed oil, Methyl Salicylate and Menthol gel, Karnataka Antibiotics & Pharmaceuticals' Paracetamol tablets, and Unicure India's Norfloxacin tablets were also mentioned in the drug list for the month of October.

In addition, drug major Cipla's Aciclovir Dispersible Tablets IP 800 mg Acivir-800 DT is also on the list. Acyclovir is a nucleotide analogue antiviral used to treat herpes simplex, Varicella zoster, herpes zoster, herpes labialis, and acute herpetic keratitis.

Bethadoxin 12M Syrup, composed of Multivitamins, Minerals, and L-Lysine Hydrochloride Syrup, manufactured by Biological E.Limited, batch no. D1105520, is also declared not of Standard Quality.

Also Read: Google Health advisor Dr Robert Califf appointed as USFDA Chief

Apart from this, absorbent cotton wool manufactured by Altus Surgical Private Limited and Sterile Hypodermic Syringe (2 mL) manufactured by Gurumangalam International are also on the list of Not of Standard Quality (NSQ).

This came after analysis and testing were conducted by the CDSCO, Drugs Control Department, on 1061 drug samples. Out of these, 1025 samples were found to be of standard quality, while 36 of them were declared as Not of Standard Quality (NSQ).

Also Read: EU lists transverse myelitis as side-effect of Johnson and Johnson Covid-19 shot

A few of the reasons why the drug samples tested failed were the failure of the assay, failure of the dissolution test, failure of the Bacterial Endotoxins Test and Sterility Test, etc.

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

List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, for the Month of October– 2021

Total number of samples tested

1061

Total number of samples declared as of Standard Quality

1025

Total number of samples declared as Not of Standard Quality

36

Total number of samples declared as Spurious

0

Total number of samples declared as Misbranded

0

S.No.

Name of Drugs/medical device/cosmetics

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

Reason for failure

Drawn By

From

1.

Absorbent Cotton Wool I.P.

B. No.: 172

Mfg dt: 01/2021

Exp dt: 3 Yrs from Mfg date

Mfd by: M/s. Doctor Surgical Works, Plot No. 61, Sector 27-28,

HISAR, Haryana.

Surface Active Substances, Fluorescence, Sulphated Ash, Water Soluble substances and Neps

CDSCO,

Bangalore

CDL

Kolkata

2.

Rabeprazole Injection IP 20 mg

B. No.: PE3AA11 Mfg dt: 10/2019 Exp dt: 09/2021

Mfd by: M/s. Pure and Cure Healthcare Pvt. Ltd., Plot No. 26A, 27- 30, Sector – 8A, I.I.E.,

SIDCUL, Haridwar – 249 403, Uttarakhand.

Clarity of Solution & Particulate Matter

Drug Control Department Odisha

CDL

Kolkata

3.

Ranitidine HCl Injection IP 50 mg/2 ml-2ml

B. No.: SI-727 Mfg dt: 03/2020 Exp dt: 02/2022

Mfd by: M/s. Shivam Enterprises (Pharma Division), Suketi Road, Kala Amb – 173030, Himachal Pradesh.

Related Substances

CDSCO

South Zone

CDL

Kolkata

4.

RL (Compound Sodium Lactate Injection I.P. 500 ml) (Ringer Lactate Solution for Injection I.P.)

B. No.: 009068

Mfg dt: 09/2020 Exp dt: 08/2022

Mfd by: M/s.Ives Drugs (India) Pvt. Limited,

Ghatabillod, Distt. Dhar, Madhya Pradesh.

Bacterial Endotoxins Test & Sterility

Drug Control Department Madhya Pradesh

CDL

Kolkata

5.

KYCOLD-PLUS

Suspension- 60 ml (Paracetamol, Phenylephrine HCl,

Chlorpheniramine Maleate, Sodium Citrate & Menthol Suspension)

B. No.: DL5184 Mfg dt: 09/2019 Exp dt: 08/2021

Mfd by: M/s. Digital Vision, 176,

Mauza Ogli, Nahan Road, Kala-Amb, Distt. Sirmour, Himachal

Pradesh- 173030.

Assay of Phenylephrine Hydrochloride

Negative for Diethylene Glycol (DEG)

Drug Control Department Himachal Pradesh

CDL

Kolkata

6.

Amikacin Injection

I.P. 2ml

B. No.: GV1A001 Mfg dt: 01/2021 Exp dt: 12/2022

Mfd by: M/s. Scott-Edil Pharmacia Ltd., 56,

E.P.I.P. Phase- I, Jharmajri, Baddi, Distt. Solan -173205, Himachal Pradesh.

Description

& Particulate Matter

CDSCO

East Zone

CDL

Kolkata

7.

Ambrolite D+ (Chlorpheniramine, Phenylephrine and Dextromethorphan Syrup)

B. No.: DJ0I1 Mfg dt: 05/2020 Exp dt: 10/2021

Mfd by: M/s. Healkraft Pharma (India) Pvt. Ltd., (Unit II), Plot No. 135 C, EPIP, Phase -I, Jharmajri, Baddi, Himachal Pradesh.

Assay of Phenylephrine Hydrochloride

CDSCO

South Zone

CDL

Kolkata

8.

Ambrolite D+ (Chlorpheniramine, Phenylephrine and Dextromethorphan Syrup)

B. No.: DJ0I2 Mfg dt: 05/2020 Exp dt: 10/2021

Mfd by: M/s. Healkraft Pharma (India) Pvt. Ltd., (Unit II), Plot No. 135 C, EPIP, Phase -I, Jharmajri, Baddi,

Himachal Pradesh.

Assay of Phenylephrine Hydrochloride

CDSCO

South Zone

CDL

Kolkata

9.

Acivir - 800 DT (Aciclovir Dispersible Tablets IP 800 mg)

B. No.: SN01674

Mfg dt: 10/2020 Exp dt: 09/2023

Mfd by: M/s. Cipla Ltd., (Unit -II), Taza Block, Rorathang, Sikkim 737133.

Uniformity of Dispersion

CDSCO

Ahmedabad

CDL

Kolkata

10.

Absorbent Cotton Wool I.P. (ALTUS)

B. No.: A/2105

Mfg dt: 05/2021

Exp dt: 5 Yrs from Mfg

Surface Active Substances,

Sulphated Ash, Water Soluble

CDSCO

South Zone

CDL

Kolkata

date

Mfd by: M/s. Altus Surgical Private Limited, 21/D, Mahagujrat Industrial Estate, Opp.

Nova Petrochemical, Sarkhej-Bavala Highway, Villg. Moraiya, Changodar - 382210, Ahmedabad, Gujarat.

substances and Neps

11.

Ranitidine Tablets IP 150 mg

B. No.: NSTY-05 Mfg dt: 06/2021 Exp dt: 05/2023 Mfd by: M/s.

Hindustan Antibiotics

Ltd., (A Govt. Of India Enterprise), at 11,

W.E.A Faridabad- 121001 Haryana.

Uniformity of weight

CDSCO

West Zone

CDTL

Mumbai

12.

Pregabalin Capsules IP

B. No.: GC210322

Mfg dt: 05/2021 Exp dt: 04/2023 Mfd by: M/s. Theon

Pharmaceutical Ltd.,

Vill. Saini Majra, Tehsil Nalagarh, Dist. Solan, Himachal Pradesh - 174 101.

Related Substances

CDSCO

West Zone

CDTL

Mumbai

13.

Sterile Hypodermic Syringe (2ml)

B. No.: 19502

Mfg dt: 12/2019 Exp dt: 11/2021 Mfd by: M/s.

Gurumangalam

International, Rancharda-382115, Ta:

Kalol, Dist: Gandhinagar, Gujarat.

Sterility

Drug Control Department Gujarat

RDTL

Guwahati

14.

Sterile Hypodermic Syringe (2ml)

B. No.: 19507

Mfg dt: 12/2019 Exp dt: 11/2021 Mfd by: M/s.

Gurumangalam

International Rancharda-382115, Ta: Kalol, Dist:

Gandhinagar, Gujarat.

Sterility

Drug Control Department Gujarat

RDTL

Guwahati

15.

Sterile Hypodermic Syringe (2ml)

B. No.: 19532

Mfg dt: 03/2020

Sterility

Drug Control

RDTL

Guwahati

Exp dt: 02/2022 Mfd by: M/s.

Gurumangalam International Rancharda-382115, Ta: Kalol, Dist:

Gandhinagar, Gujarat.

Department Gujarat

16.

Pantoprazole Gastro Resistant Tablets I.P.

(P-40)

B. No.: PFT21002MB Mfg dt: 02/2021

Exp dt: 01/2023

Mfd by: M/s. Sri Ram Healthcare Pvt Ltd, 81- C/2, EPIP-I, Jharmajri, Baddi, Distt. Solan, Himachal Pradesh - 173205.

Dissolution

Drug Control Department Assam

RDTL

Guwahati

17.

Ofloxacin and Ornidazole Tablets I.P.

B. No.: TI0005A Mfg dt: 09/2020 Exp dt: 08/2022

Mfd by: M/s. NAVKAR LIFESCIENCES, Plot

No.-76, Lodhi Majra, Industrial Area, Baddi,

Distt.- Solan Himachal Pradesh.

Dissolution

Drug Control Department Assam

RDTL

Guwahati

18.

Pregabalin Capsules IP 75 mg

B. No.: T21003

Mfg dt: 01/2021 Exp dt: 12/2022 Mfd by: M/s. Trugen

Pharmaceutical Pvt. Ltd.

Vill. Tejjupur, Near Chodiala Rly. Station, Roorkee, Dist. Haridwar,

Uttarakhandh-247661.

Dissolution

Drug Control Department Assam

RDTL

Guwahati

19.

Rabeprazole Sodium & Itopride (Sustained Release) Capsules

B. No.: I4200001

Mfg dt: 02/2020 Exp dt: 01/2022 Mfd by: M/s. Innova

Captab, 81-B, EPIP,

Phase-I, Jharmajri, Baddi Himachal Pradesh.

Assay

CDSCO

Sub-Zone, Guwahati

RDTL

Guwahati

20.

Infusion Set

B. No.: 060220

Mfg dt: 02/2020 Exp dt: 01/2025 Mfd by: M/s. R. R.

Medicare Products, 3-A,

Sterility

Drug Control Department Jammu & Kashmir

RDTL

Guwahati

Birpur Industrial Estate, Bari Brahmana, Jammu- 181113.

21.

Sterile Hypodermic Syringe 05 ML/CC

B. No.: 19718

Mfg dt: 12/2019 Exp dt: 11/2021 Mfd by: M/s.

Gurumangalam International, Rancharda-382115, Ta: Kalol, Dist:

Gandhinagar, Gujarat.

Sterility & Bacterial

Endotoxin

Drug Control Department Gujarat

RDTL

Guwahati

22.

Infusion Set

B. No.: 050220

Mfg dt: 02/2020 Exp dt: 01/2025 Mfd by: M/s. R R

Medicare Products, 3A-

Birpur Indl Estate Bari Brahmana, Jammu- 181113.

Sterility & Bacterial

Endotoxin

Drug Control Department Jammu & Kashmir

RDTL

Guwahati

23.

Sterile Hypodermic Syringe 5 ml

B. No.: 19719

Mfg dt: 12/2019 Exp dt: 11/2021 Mfd by: M/s.

Gurumangalam International, Rancharda-382115, (Ta: Kalol) Dist: Gandhinagar, Gujarat.

Sterility

Drug Control Department Gujarat

RDTL

Guwahati

24.

Levetiracetam IP

B. No.: LEV/10/21

Mfg dt: 04/2021 Exp dt: 03/2024

Mfd by: M/s. Pranshav Health Care Plot No. 824/16, Near SaintGobin Glass India Ltd., GIDC, Jhagadia-

393110 Gujarat.

Related Substances

CDSCO

Sub-Zone Baddi

RDTL

Chandigarh

25.

Tramadol Hydrochloride and Acetaminophen Tablets USP (DOLOSAFE D TABLETS)

B. No.: NDSD-02102 Mfg dt: 04/2021

Exp dt: 03/2024 Mfd by: M/s. Tidal

Laboratories Pvt. Ltd. Patch-5, Phase-II, Gowalthai, Distt.

Bilaspur-174201, Himachal Pradesh.

Dissolution

Drug Control Department Himachal Pradesh

RDTL

Chandigarh

26.

Methylcobalamin, Vitamin C, Vitamin E, Beta Carotene, Zinc Sulphate, Sodium Selenite, Chromium Picolinate, Lutein and Lycopene Capsules (OCTOXID CAPSULES)

B. No.: OTXC-02102 Mfg dt: 06/2021

Exp dt: 11/2022 Mfd by: M/s. Tidal

Laboratories Pvt. Ltd. Patch-5, Phase-II, Gowalthai, Distt.

Bilaspur-174201, Himachal Pradesh.

Identification of Methylcobalamin, Vitamin E

Drug Control Department Himachal Pradesh

RDTL

Chandigarh

27.

Pancreatin, Bile Constituents and Activated Dimethicone Tablets (ENZOX PLUS TABLETS)

B. No.: ENZP-02105-02

Mfg dt: 05/2021 Exp dt: 04/2024 Mfd by: M/s. Tidal

Laboratories Pvt. Ltd. Patch-5, Phase-II, Gowalthai, Distt.

Bilaspur-174201, Himachal Pradesh.

Assay of Activated Dimethicone

Drug Control Department Himachal Pradesh

RDTL

Chandigarh

28.

COMPOUND SODIUM LACTATE INJECTION IP

B. No.: FFS2005B0114

Mfg dt: 06/2020 Exp dt: 05/2023

Mfd by: M/s. Pharma Impex Laboratories Pvt. Ltd. South Uttarbhag, Ramnagar, Baruipur,

Distt. South 24PGS West Bengal -743387.

Description, pH, Particulate Contamination, Bacterial Endotoxins and Sterility

CDSCO

North Zone

RDTL

Chandigarh

29.

Multivitamins, Minerals and L-Lysine Hydrochloride Syrup

(BETHADOXIN- 12M SYRUP)

B. No.: D1105520

Mfg dt: 10/2020 Exp dt: 03/2022

Mfd by: M/s. Biological E.Limited, Plot No. 31 & 32, Pharma City,

Selaqui, Dehradun- 248197, Uttarakhand.

Identification of Selenium and Assay of Pyridoxine Hydrochloride

CDSCO

North Zone

RDTL

Chandigarh

30.

BUPIVACAINE HYDROCHLORIDE IN DEXTROSE INJECTION USP

B. No.: HIBU2003G Mfg dt: 09/2020 Exp dt: 08/2022 Mfd by: M/s. Health Biotech Ltd, Village:

Sadoli, Nalagarh Road, Baddi, Distt: Solan,Himachal Pradesh -173205.

Bacterial Endotoxins

Drug Control Department Himachal Pradesh

RDTL

Chandigarh

31.

DICLOFENAC, VIRGIN LINSEED

OIL, METHYL SALICYLATE AND

B. No.: JZAA02 Mfg dt: 01/2021

Exp dt: 12/2022 Mfd by: M/s. Akums

Assay of Menthol

CDSCO

North Zone

RDTL

Chandigarh

MENTHOL GEL

Drugs & Pharmaceuticals Ltd. Plot No. : 47,48,

Sector-6A, IIE, SIDCUL,

Ranipur, Haridwar- 249403, Uttarakhand.

32.

Diclofenac Sodium Tablets IP (DECIFEN-50 TABLETS

B. No.: CLT-14750

Mfg dt: 03/2020 Exp dt: 02/2023

Mfd by: M/s. Caremax Formulations Plot No. 56 & 61, Industrial Area, Phase III, Sansarpur Terrace, Distt. Kangra Himachal Pradesh -

176501.

Disintegration Test

CDSCO

North Zone

RDTL

Chandigarh

33.

Meropenem Injection IP 500 mg (MEROMAX 500 MG INJECTION)

B. No.: DP1013 Mfg dt: 05/2021 Exp dt: 04/2023

Mfd by: M/s. Scott-Edil Pharmacia Ltd. 56, E.P.I.P., Phase-1,

Jharmajri, Baddi, Distt. Solan-173205, Himachal Pradesh.

Particulate matter

CDSCO

Sub-Zone Baddi

RDTL

Chandigarh

34.

PARACETAMOL TABLETS IP 500 MG

B. No.: 2518021

Mfg dt: 08/2021 Exp dt: 07/2024 Mfd by: M/s.

KARNATAKA ANTIBIOTICS & PHARMACEUTICALS

LIMITED (A Govt. of India Enterprise) Plot No. 14, II Phase,

Peenya, Bangaluru- 560058.

Dissolution

CDSCO

Sub-Zone Baddi

RDTL

Chandigarh

35.

NORFLOXACIN TABLETS IP 400 MG

B. No.: NT802 Mfg dt: 10/2020 Exp dt: 09/2022

Mfd by: M/s. Unicure India Ltd., C-21,22 & 23, Sector-3, Noida-201301 Distt. Gautam Budh Nagar, Uttar Pradesh.

Dissolution

CDSCO

Sub-Zone Baddi

RDTL

Chandigarh

36.

CEFUROXIME AXETIL TABLETS IP

500 MG

B. No.: XATX-01 Mfg dt: 07/2020 Exp dt: 06/2022 Mfd by: M/s. HINDUSTAN

ANTIBIOTICS LTD. (A

Government of India Enterprise ) at 11,

W.E.A. Faridabad- 121001 Haryana.

Dissolution

CDSCO

Sub-Zone Baddi

RDTL

Chandigarh


To view the official list, click on the link below:

https://medicaldialogues.in/pdf_upload/octdrug-alert-list-163858-163932.pdf
covid19drug testdrug safety alertdrug alertCentral Drugs Standard Control OrganizationCDSCONORFLOXACINPARACETAMOLMENTHOL GELTramadolPantoprazoleRanitidineRinger LactateRabeprazoleHindustan AntibioticsKARNATAKA ANTIBIOTICS & PHARMACEUTICALS LIMITED
Farhat Nasim
Farhat Nasim

    Farhat Nasim joined Medical Dialogue an Editor for the Business Section in 2017. She Covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a graduate of St.Xavier’s College Ranchi. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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