Drug alert: CDSCO flags 48 drugs as not of standard quality

Published On 2022-04-28 13:24 GMT   |   Update On 2023-10-07 11:20 GMT
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New Delhi: In its latest drug safety alert, the apex drug regulatory body, Central Drugs Standard Control Organization (CDSCO) flagged 48 medicine batches for failing to qualify a random drug sample test for the month of March.

These drugs samples which are declared not of standard quality include Skymap Pharmaceuticals' Trimetazidine Modified Release Tablets, Hindustan Antibiotics' Doxycycline Capsules, Calcium and Vitamin D3 Tablets IP, Theon Pharmaceutical's Trypsin, Bromelain & Rutoside Trihydrate Tablets.

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In addition to this, the list also includes TINVISTA 300 (Tinidazole Tablets IP 300 mg) manufactured by Cadila Pharmaceutical and MAYCOXIA-90 (Etoricoxib Tablets IP) manufactured by Akums Drugs & Pharmaceuticals.

This came after analysis and test were conducted by the CDSCO, Drugs Control Departments on 1454 samples. Out of this, 1406 samples were found of standard quality while 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 the assay, failure of the Disintegration test, failure of the dissolution test, failure of the sterility test.

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

List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, for the Month of March – 2022.


Total number of samples tested

1454

Total number of samples declared as of Standard Quality

1406

Total number of samples declared as Not of Standard Quality

48

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.

Doxycycline Hydrochloride Capsules I.P. 100 mg

B. No.: 2002

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

Formulations Pvt. Ltd., 16-B & 15-F, Industrial Area, Maxi Road, Ujjain -456 010

Madhya Pradesh.

Assay

CDSCO

Visakhapatnam

CDL

Kolkata

2.

Cetirizine Tablets I.P.

B. No.: 104021

Mfg dt: 06/2021 Exp dt: 05/2023

Mfd by: M/s. Ciron Drugs & Pharmaceuticals Pvt. Ltd., Plot No. 35 to 37,

43 to 45, CFC-B,

Dewan Udyog Nagar, Aliyali Palghar, Distt.

Palghar- 401 404 Maharashtra.

Related Substances

CDSCO

Guwahati

CDL

Kolkata

3.

Rolled Bandage

B. No.: A116 Mfg dt: 11/2020 Exp dt: 10/2023

Mfd by: M/s. Anamika Udyog, 127, Multan Nagar, Meerut (India) Uttar Pradesh.

Threads per dm, Weight in (gm/m2), Foreign Matter, Fluorescence

CDSCO

Sub Zone Guwahati

CDL

Kolkata

4.

Doxycycline Capsules I.P. 100 mg

B. No.: C-2106006

Mfg dt: 06/2021 Exp dt: 05/2023

Mfd by: M/s. Rivpra

Assay

CDSCO

Ahmedabad

CDL

Kolkata


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

Haridwar - 249403 Uttarakhand.

5.

Gatoline-100 (Doxycycline Capsules I.P.)

B. No.: CC-200140

Mfg dt: 12/2020 Exp dt: 11/2022

Assay

CDSCO

South Zone Chennai

CDL

Kolkata

Mfd by: M/s. CMG

Biotech Pvt. Ltd., 58,

Industrial Area, Phase

III, Sansarpur Terrace,

Himachal Pradesh –

176501.

6.

Byzyme (Pepsin & Fungal Diastase Syrup), 200ml

B. No.: ZA20781

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

Assay

CDSCO

South Zone Chennai

CDL

Kolkata

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

7.

Vitamin A, Vitamin D3, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Calcium Pantothanate, Niacinamide, Vitamin C & Folic Acid Tablets

B. No.: GMB 21 Mfg dt: 03/2021 Exp dt: 08/2022

Mfd by: M/s. Medline Pharmaceuticals Pvt. Ltd., Plot No. 2 & 3, 1st Main Road, EVP Prabhu Avenue, Chinnakulathuvancherr

yChennai 600 122.

Description & Assay of 'Vitamin D3', 'Riboflavin', & 'Calcium Pantothanate'.

CDSCO

South Zone Chennai

CDL

Kolkata

8.

Bunase 0.5 Respules (Budesonide Nebuliser Suspension BP)

B. No.: RS1195 Mfg dt: 11/2021 Exp dt: 10/2023 Mfd by: M/s.

Aishwarya Healthcare,

Village Thana, Baddi, Himachal Pradesh – 173 205.

Related Substances

CDSCO

South Zone Chennai

CDL

Kolkata

9.

Compound Benzoin Tincture I.P.

B. No.: W-02 Mfg dt: 05/2021 Exp dt: 04/2023

Mfd by: M/s. Walllis Pharmaceuticals, K- 25, Thakur Complex, SDA Compound,

Weight per ml, Ethanol Content, Total Solids and Assay

CDSCO

South Zone Chennai

CDL

Kolkata


Lasudia Mori, Indore Madhya Pradesh.

10.

BENUGOLD

(Methylcobalamin, Alpha Lipoic Acid, Pyridoxine, Benfotiamine, Biotin & Chromium Polynicotinate Capsule)

B. No.: MHD-1611 Mfg dt: 01/2021 Exp dt: 12/2022

Mfd by: M/s. Medinok Healthcare Pvt. Ltd.,

R.S. No. 2/1, Plot No. 87, 88, 89 Vazhudhavur Main Road, Kurumbapet, Puducherry -605009.

Assay of Alpha Lipoic Acid

CDSCO

South Zone Chennai

CDL

Kolkata

11.

Cloxacillin Capsules

I.P. 250 mg

B. No.: CNC2001

Mfg dt: 03/2020 Exp dt: 02/2022

Dissolution &

Assay

CDSCO

South Zone Chennai

CDL

Kolkata

Mfd by: M/s. Modern Laboratories, 45-47, Sector D-2, Sanwer Road, Indore, Madhya Pradesh - 452015, India.

12

Trimetazidine Modified Release Tablets

B. No.: GM20134

Mfg dt: 11/2020 Exp dt: 10/2022

Description

CDSCO

South Zone Chennai

CDL

Kolkata

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

13.

Amikacin Injection IP 100 mg / 2 ml- 2 ml

B. No.: P1317

Mfg dt: 05/2021 Exp dt: 04/2023

Description & Particulate

Matter

CDSCO

South Zone Chennai

CDL

Kolkata

Mfd by: M/s. Bharat Parenterals Ltd., Survey No. 144 & 146 Jarod-Samlaya Road, Tal. Savli, City: Haripura, Dist.

Vadodara – 391 520, Gujarat, India.

14.

Dicyclomine Hydrochloride Injection I.P. 2 ml

B. No.: HLI471D Mfg dt: 04/2021

Exp dt: 03/2023

Description & Particulate

Matter

CDSCO

East Zone Kolkata

CDL

Kolkata

Mfd by: M/s. Himalaya Meditek Private Limited, Plot No. 35 & 36, Pharmacity,


Selaqui Industrial Area, Dehradun 248197 Uttarakhand.

15.

Finasteride Tablets

I.P. 5 mg

B. No.: FNST901

Mfg dt: 06/2021 Exp dt: 05/2023

Dissolution

CDSCO

East Zone Kolkata

CDL

Kolkata

Mfd by: M/s. Unicure India Ltd., C-21, 22 & 23, Sector – 3, Noida -

201 301, Dist. Gautam Budh Nagar, Uttarpradesh.

16.

Doxycycline Capsules I.P. 100 mg

B. No.: DXCY-02

Mfg dt: 05/2021 Exp dt: 04/2023

Assay

CDSCO

East Zone Kolkata

CDL

Kolkata

Mfd by: M/s. Hindustan Antibiotics Ltd., At 11, W.R.A., Faridabad – 121 001, Haryana.

17.

Methylcobalamin Tablets 500 mcg

B. No.: MBT 904

Mfg dt: 05/2021 Exp dt: 04/2023

Assay

CDSCO

East Zone Kolkata

CDL

Kolkata

Mfd by: M/s. Unicure India Ltd., C-21, 22 & 23, Sector – 3, Noida -

201 301, Dist. Gautam Budh Nagar, Uttar Pradesh.

18.

THYROZED 25 (THYROXINE SODIUM TABLETS

I.P. 25 mcg)

B. No.: 2021035

Mfg dt: 09/2021 Exp dt: 08/2023 Mfd by: M/s. BVK's

Bioscience Pvt. Ltd.,

Plot No. 789, Rakanpur Ind Area, Rakanpur, Ta-Kalol,

Dist. Gandhinagar – 382721, Gujarat, India.

Assay

CDSCO

East Zone Kolkata

CDL

Kolkata

19.

Calcium and Vitamin D3 Tablets IP (500 mg + 250 IU)

(Calcium 500 mg & Vitamin D3 250 IU)

B. No.: CWTY-103 Mfg dt: 02/2021 Exp dt: 01/2023

Mfd by: M/s. Hindustan

Antibiotics Ltd., 11,

Dissolution &

Assay of Vitamin D3

CDSCO

East Zone Kolkata

CDL

Kolkata

W.E.A. Faridabad –

121 001, Haryana.

20.

Queencath (Female Catheter, Size 12 fr)

B. No.: UCCGL01

Mfg dt: 12/2020 Exp dt: 11/2023

Sterility

CDSCO

South Zone Chennai

CDL

Kolkata


Mfd by: M/s. Morrisons Lifecare Pvt. Ltd. No. 3, Anna Street, Padikuppam, Chennai

– 600 107.

21.

Trypsin, Bromelain & Rutoside Trihydrate Tablets

B. No.: GT201572

Mfg dt: 11/2020 Exp dt: 10/2022 Mfd by: M/s. Theon

Pharmaceutical Ltd., Vill. Saini Majra, Tehsil Nalagarh, Dist. Solan, Himachal Pradesh –

174 101.

Description Length Thickness and Width

CDSCO

West Zone Mumbai

CDTL

Mumbai

22.

Telione - 40 (Telmisartan Tablets IP)

B. No.: THG210385

Mfg dt: 07/2021 Exp dt: 06/2023

Uniformity of weight

CDSCO

West Zone Mumbai

CDTL

Mumbai

Mfd by: M/s. Theon

Pharmaceutical Ltd.,

Vill. Saini Majra, Tehsil

Nalagarh, Dist. Solan,

Himachal Pradesh -

174 101.

23.

MelaXone Plus (Meloxicam

& Paracetamol Injection)

B. No.: PLUS 21-004 Mfg dt: 07/2021

Exp dt: 06/2023 Mfd by: M/s.

Venkateshwara

Particulate Contamination

CDSCO

West Zone Mumbai

CDTL

Mumbai

Hatcheries Pvt. Ltd.,

(Ventri Biologicals

Vaccine Division), Plot

No. 20, International

Biotech Park, Phase II,

Hinjewadi, Pune-

411 057, Maharashtra.

24.

TINVISTA 300

(Tinidazole Tablets IP 300 mg)

B. No.: JKGJ20001 Mfg dt: 03/2020

Exp dt: 02/2024

Disintegration

CDSCO

West Zone Mumbai

CDTL

Mumbai

Mfd by: M/s. Cadila

Pharmaceutical Ltd.,

Industrial Growth

Center, SIDCO,

Samba- 184 121, State

of Jammu & Kashmir.


25.

MAYCOXIA-90

(Etoricoxib Tablets IP)

B. No.: OBZB02 Mfg dt: 07/2021 Exp dt: 06/2023 Mfd by: M/s. Akums Drugs &

Pharmaceuticals Ltd., 19, 20, 21, Sector 6A, I.I.E, SIDCUL,

Ranipur, Haridwar-

249403, Uttarakhand.

Dissolution

CDSCO

West Zone Mumbai

CDTL

Mumbai

26.

Aspirin Gastro- resistant Tablets I.P.

150 mg

B. No.: APET901 Mfg dt: 05/2021 Exp dt: 04/2023

Mfd by: M/s. Unicure India Ltd., C-21, 22 & 23, Sector-3, Noida-

201301, Distt. Gautam

Budh Nagar Uttar Pradesh.

Salicylic Acid

CDSCO

West Zone Mumbai

CDTL

Mumbai

27.

Telmisartan 40 mg and Hydrochlorothiazide

12.5 mg Tablets IP (TELMA H TABLETS)

B. No.: 20DDT-035

Mfg dt: 12/2020 Exp dt: 11/2023 Mfd by: M/s. Dallas Drugs Pvt.Ltd. 156,

D.I.C., Ind.Area Baddi, Distt. Solan, Himachal

Pradesh -173205.

Assay of Telmisartan

Drug Control Department Delhi

RDTL

Chandigarh

28.

Esomeprazole with Domperidone Tablets (ESSOF-D TABLETS)

B. No.: APT-10-1524

Mfg dt: 10/2021 Exp dt: 09/2023

Mfd by: M/s. ADWIN PHARMA Vill. Rampur Jattan, Trilokpuri Road, Kala-Amb, Tehsil-Nahan, Distt.

Sirmour, Himachal

Pradesh -173030.

Assay

Drug Control Department Jammu & Kashmir

RDTL

Chandigarh

29.

Zolpidem Tartrate

E.R. Tablets IP

12.5 mg (SOO FRESH-CR-12.5

TABLETS)

. B. No.: TPT-0627

Mfg dt: 06/2021 Exp dt: 05/2023 Mfd by: M/s. Tanpal Pharmaceuticals D- 12-13, Focal Point,

Nabha 147201, Punjab.

Dissolution

Drug Control Department Delhi

RDTL

Chandigarh


30.

Isotretinoin Capsules IP (VISOTIN-10 CAPSULES)

B. No.: VPS-21407D Mfg dt: 11/2021

Exp dt: 10/2024 Mfd by: M/s.

VIDHYASHA

Pharmaceuticals 28, Industrial Area, Johron Trilokpur Road, Kala Amb, Distt. Sirmour Himachal Pradesh -

173030.

Assay

Drug Control Department Himachal Pradesh

RDTL

Chandigarh

31.

Calcitriol and Calcium Capsules (BIO-D3 PLUS CAPSULES)

B. No.: ACB2008A Mfg dt: 09/2020 Exp dt: 08/2023 Mfd by: M/s. MACLEODS

PHARMACEUTICALS

LTD. Village Theda,

P.O. Lodhimajra, Tehsil Baddi, Dist. Solan, Himachal Pradesh, India-

174101.

Assay of Calcitriol

Drug Control Department Delhi

RDTL

Chandigarh

32.

Olmesartan Medoxomil and Amlodipine Tablets (OLMISAVE AM-40 TABLETS)

B. No.: CT11211

Mfg dt: 12/2020 Exp dt: 11/2022

Mfd by: M/s. Cosmas Pharmacls Ltd.

Buranwala Road, Village: Kotla, P.O.: Barotiwala, Solan Himachal Pradesh -

174103.

Assay

Drug Control Department Jammu & Kashmir

RDTL

Chandigarh

33.

VETERINARY INJECTION IP VET. (5 OXYTOCIN

UNITS/ML, 0.5 W/V CHLORBUTOL PHENOL IP

B. No.: 01

Mfg dt: 02/2021 Exp dt: 01/2023

Mfd by: M/s. NEELAM CHEMICAL WORKS

B.O.M.G. Road, Bada

Bazar, Kolkata-7.

Particulate matter, Sterility and the Assay of Oxytocin Activity

Drug Control Department Delhi

RDTL

Chandigarh

34.

OXYTOCIN INJECTION (VET) OXYTOCIN 5 IU/ML,

0.5% W/V PHENOL OR CHLOROBUTOL IP

B. No.: 04

Mfg dt: 01/2022 Exp dt: 12/2024 Mfd by: M/s. Super

Vaishali Laboratories

R.B. Road, Bihar Pin:

Particulate matter, Sterility and the Assay of Oxytocin Activity

Drug Control Department Delhi

RDTL

Chandigarh


823001

35.

OXYTOCIN INJECTION IP (VET) 10 OXYTOCIN UNIT PER ML, 0.5% W/V PHENOL IP

B. No.: Not Mentioned Mfg dt: N.M.

Exp dt: N.M.

Mfd by: M/s. Super Vaishali Address: Not Mentioned

Particulate matter, Sterility and the Assay of Oxytocin Activity

Drug Control Department Delhi

RDTL

Chandigarh

36.

Ibuprofen and Paracetamol Tablets IP (IBUCON TABLETS)

B. No.: PTA/07-27

Mfg dt: 07/2021 Exp dt: 06/2023 Mfd by: M/s.Progressive

Lifesciences Pvt. Ltd. Latherdevahoon, P.O. Jhabrera, Roorkee, Distt. Haridwar-

247665, Uttarakhand.

Assay

Drug Control Department Himachal Pradesh

RDTL

Chandigarh

37.

Lignocaine Hydrochloride Gel IP (LIGNOMARK JELLY)

B. No.: E1C060 Mfg dt: 03/2021

Exp dt: 02/2023

Assay

CDSCO

Sub Zone Jammu

RDTL

Chandigarh

Mfd by: M/s. Smayan

Healthcare Pvt. Ltd.

Plot No. 26-27,

HPSIDC Indl. Area Vill.

Davni, Baddi, Distt.

Solan, Himachal

Pradesh -173205.

38.

FENTANYL INJECTION IP

B. No.: I -1646

Mfg dt: 09/2021 Exp dt: 08/2023

Mfd by: M/s. Jackson Laboratories Pvt. Ltd. 22-24, Majitha Road,

Bye Pass, Amritsar- 143001 (India) Punjab.

Particulate matter Bacterial Endotoxins and Sterility

CDSCO

Sub Zone Jammu

RDTL

Chandigarh

39.

Intravenous Infusion Set

B. No.: 201061

Mfg dt: 05/2020 Exp dt: 04/2025

Mfd by: M/s. Lars Medicare Private Limited, Kila No.: 16- 17, Sultanpur, Opp. Sports Authority of India, Near Bahalgarh

Chowk, Sonepat-

Description, kinking of the tubing & Leakage Test

Drug Control Department Kerala

RDTL

Guwahati


131021, Haryana (India).

40.

Paracetamol Tablets IP

B. No.: LPST-004 Mfg dt: 05/2021 Exp dt: 04/2024

Mfd by: M/s. Laborate Pharmaceuticals India Ltd.(Unit-II), #31,

Rajban Road, Nariwala, Paonta Sahib, Himachal

Pradesh.

Dissolution

Drug Control Department Assam

RDTL

Guwahati

41.

Rabeprazole Tablets IP 20mg

B. No.: PLO7AK04 Mfg dt: 05/2020 Exp dt: 04/2022

Mfd by: M/s. Akums

Dissolution

Drug Control Department Arunachal Pradesh

RDTL

Guwahati

Drugs &

Pharmaceuticals Ltd.,

Plot No.-26A, 27-30,

Sector 8A, I.I.E.,

Sidcul, Haridwar-

249403, Uttarakhand.

42.

Ofloxacin and Ornidazole Tablets I.P.

B. No.: UUF2002 Mfg dt: 02/2020 Exp dt 07/2022

Mfd by: M/s. Coral

Dissolution

Drug Control Department Arunachal Pradesh

RDTL

Guwahati

Laboratories Ltd., Plot

No. 27/28, Pharmacity,

Selaqui, Dehradun-

248197, Uttarakhand,

India.

43.

SNEZEE 500 TAB

Paracetamol IP 500 mg Phenylephrine HCI IP 5 mg

Caffeine IP 30 mg Diphenhydramine HCI IP 25 mg

B. No.: TP-0121843

Mfg dt: 01/2021 Exp dt 12/2022

Mfd by: M/s. Maxrelief Health Care, Vill: Anji, Solan, Himachal

Pradesh- 173212.

Assay

Drug Control Department Jharkhand

RDTL

Guwahati

44.

METRONIDAZOLE TABLETS I.P.

B. No.: MT-20E12 Mfg dt: 05/2020

Exp dt 04/2022

Dissolution

Drug Control Department Jharkhand

RDTL

Guwahati

Mfd by: M/s. MARTIN & BROWN BIO- SCIENCES, K.No.

918/419, Malkumajra, Nalagarh Road, Baddi, Distt. Solan, Himachal


Pradesh.

45.

Amoxicillin and Potassium Clavulanate Tablets IP

B. No.: T-22286

Mfg dt: 05/2020 Exp dt: 04/2022

Mfd by: M/s. Jackson

Assay

Drug Control Department Jharkhand

RDTL

Guwahati

Laboratories Pvt. Ltd.,

22-24, Majitha Road,

Bye Pass, Amritsar-

143001 Punjab (India).


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