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  • Drug Alert: CDSCO...

Drug Alert: CDSCO flags 27 formulations as not of standard quality

Susmita RoyWritten by Susmita Roy Published On 2022-02-14T17:17:50+05:30  |  Updated On 11 Oct 2023 3:31 PM IST
Drug Alert: CDSCO flags 27 formulations as not of standard quality
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New Delhi: In its latest drug safety alert, the apex drug regulatory body, Central Drugs Standard Control Organization (CDSCO) flagged 27 medicine batches for failing to qualify for a random drug sample test for the month of January.

These drug samples including Bochem Healthcare's Ferrous Sulphate & Folic Acid Tablets IP, Zee Laboratories' NITZO -2.6 (Controlled Release Tablets of Nitrogylcerin), Skymap Pharmaceuticals' WARZYME Digestive Enzymes (Pepsin & Fungal Diastase Syrup), Ortin Laboratories' Enalapril Maleate Tablets IP 5 mg, Om Biomedic's Pantoprazole Gastro- Resistant Tablets I.P., Terrace Pharmaceutical's Atenolol Tablets IP 50 mg and others are declared as 'Not of Standard Quality'.

In addition, Paracetamol Tablets IP 650 mg manufactured by Zim Laboratories, popular covid drug Favipiravir Tablets 400 mg manufactured by Maxrelief Healthcare are on the list.

This came after analysis and tests conducted by the CDSCO Drugs Control Department on 1227 samples. Out of these, 1200 samples were found to be of standard quality while 27 of them were declared as Not of Standard Quality (NSQ).

Also Read:33 drug samples fail to clear CDSCO test, 2 declared misbranded

A few of the reasons why the drug samples tested failed were the failure of the assay, failure of the Sterility test, failure of the dissolution test, failure of disintegration, failure of the Assay of Methylcobalamin & Vitamin D3 assay etc.

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

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

Total number of samples tested

1227

Total number of samples declared as of Standard Quality

1200

Total number of samples declared as Not of Standard Quality

27

Total number of samples declared as Spurious

-

Total number of samples declared as Misbranded

-


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.

Ferrous Sulphate &

Folic Acid Tablets IP

B. No.: B210049

Mfg dt: 06/2021

Exp dt: 05/2023

Mfd by: M/s. Bochem Healthcare Pvt. Ltd., 83- 84, Industrial Area, Dewas Road, Nagziri, Ujjain 456010, Madhya Pradesh, India.

Uniformity of Content of Folic Acid

CDSCO

East Zone Kolkata

CDL

Kolkata

2.

NITZO -2.6 (Controlled Release Tablets of Nitrogylcerin)

B. No.: 420-1291

Mfg dt: 10/2020

Exp dt: 09/2022

Mfd by: M/s. Zee Laboratories 47, Industrial Area, Paonta Sahib -173 025, Himachal Pradesh.

Assay

CDSCO

East Zone Kolkata

CDL

Kolkata

3.

Levetripac-500 Tablets (Levetiracetam Tablets IP 500 mg)

B. No.: APT/04306

Mfg dt: 04/2021

Exp dt: 03/2023

Mfd by: M/s. AmkonPharmaceuticals, Plot No. 242, Phase 9, Industrial Area, Mohali- 160062, Punjab.

Dissolution &

Assay

CDSCO

East Zone Kolkata

CDL

Kolkata

4.

Clopidogrel & Aspirin Tablets I.P.

B. No.: TACB-017

Mfg dt: 05/2020

Exp dt: 04/2022

Mfd by: M/s. Medipol Pharmaceutical India Pvt. Ltd., 1199/3, Budh, Baddi, Dist. Solan,

Related Substances

CDSCO

West Zone Mumbai

CDL

Kolkata


Himachal Pradesh, India.

5.

Pantoprazole for Injection B.P. 40 mg

B. No.: AA011068

Mfg dt: 04/2021

Exp dt: 03/2023

Mfd by: M/s. ANG Lifesciences India Ltd., Village- Kishanpura, Nalagarh Road, Tehsil- Baddi, Distt. Solan, Himachal Pradesh -174101.

Sterility

Drug Control Department Madhya Pradesh

CDL

Kolkata

6.

Adrenochrome Monosemicarbazone Injection, 2 ml

B. No.: 01ACA295

Mfg dt: 02/2021

Exp dt: 07/2022

Description & Particulate Matter

CDSCO

South Zone Chennai

CDL

Kolkata

Mfd by: M/s. SPM Drugs (P) Ltd., S.F. 52/1 Main Road, K.R. Palayam, Bhavani – 638 301 Tamil Nadu.

7.

WARZYME Digestive Enzymes (Pepsin & Fungal Diastase Syrup), 200 ml

B. No.: AA21036

Mfg dt: 06/2021

Exp dt: 11/2022

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

Assay of Pepsin & Fungal Diastase

CDSCO

South Zone Chennai

CDL

Kolkata

8.

Mymi D (Alpha Lipoic Acid, Pyridoxine Hydrochloride, Methylcobalamin, Folic Acid & Vitamin D3 Tablets)

B. No.: TT21031

Mfg dt: 06/2021

Exp dt: 05/2023

Mfd by: M/s. Kausikh Therapeutics(P) Ltd., Unit II, Plot No. 54, SIDCO Industrial Estate, Thirumudivakkam, Chennai -600044.

Assay of Methylcobala min & Vitamin D3

CDSCO

South Zone Chennai

CDL

Kolkata

9.

Pantoprazole Gastro- Resistant Tablets IP

B. No.: TF1036A

Mfg dt: 06/2021

Exp dt: 11/2022

Dissolution

CDSCO

Sub Zone Bangalore

CDTL

Chennai

Mfd by: M/s. Navkar Lifesciences, Plot No.76, Lodhi Majra, Industrial Area, Baddi, Distt. Solan, Himachal Pradesh.


10.

ENALAPRIL MALEATE TABLETS

IP 5 mg

B. No.: GA21002

Mfg dt: 02/2021

Exp dt: 01/2023

Mfd by: M/s. Ortin

Laboratories Ltd., 275 & 278 (part), IDA, Pashamylaram-502307, Sanga Reddy, Dist. Telangana.

Dissolution &

Assay

CDSCO

Zonal Office Hyderabad

CDTL

Hyderabad

11.

Ceftriaxone Injection IP

B. No.: I.269

Mfg dt: 04/2021

Exp dt: 03/2023

Mfd by: M/s. Jackson Laboratories Pvt. Ltd. 22-24, Majitha Road, Bye pass, Amritsar- 143001, Punjab (India).

Clarity of Solution & Particulate matter

Drug Control Department Jharkhand

RDTL

Guwahati

12.

Pantoprazole Sodium Tablets I.P. 40 mg

B. No.: SL20098

Mfg dt: 11/2020

Exp dt: 10/2022

Mfd by: M/s. IBN Herbals (A unit of Curetech Formulations (P) Ltd.), Khasra No. 63, Vill. JuddiKalan, Baddi, Dist. Solan, Himachal Pradesh.

Dissolution

Drug Control Department Jharkhand

RDTL

Guwahati

13.

Alprazolam Tablets IP

B. No.: TP.1901

Mfg dt: 12/2019

Exp dt: 11/2022

Mfd by: M/s. Achemic Pharmaceuticals (INDIA) Pvt. Ltd. 71-A, I.D.A. (Etn) Phase-II, Mangalpur Nacharam, Hyderabad - 500076.

Dissolution

Drug Control Department Bihar

RDTL

Guwahati

14.

Isopropyl Rubbing Alcohol I.P.

B. No.: SP-851

Mfg dt: 05/2020

Exp dt: 04/2023

Mfd by: M/s. Sritech Pharma, F-19, UPSIDC Industrial Area, Gajraula JP Nagar, Uttar Pradesh – 244235.

Assay

Drug Control Department Jharkhand

RDTL

Guwahati

15.

Doxycycline Hydrochloride &

B. No.: DOX-2009

Description

Drug Control Department

RDTL

Guwahati


Ambroxol HCl Tablets

Mfg dt: 01/2021

Exp dt: 12/2022

Mfd by: M/s. RIDLEY LIFE SCIENCE PVT. LTD., D-1651, DSIDC Indl. Complex, Narela, Delhi-110040

Assam

16.

Favipiravir Tablets 400 mg

B. No.: TP-0421903

Mfg dt: 04/2021

Exp dt: 03/2023

Mfd by: M/s. Maxrelief Healthcare, Vill.-Anji, Solan, Himachal Pradesh- 173212.

Identification, Dissolution & Assay

Drug Control Department Jharkhand

RDTL

Guwahati

17.

Trypsin, Bromelain & Rutoside Trihydrate Tablets

B. No.: GT200466

Mfg dt: 03/2020

Exp dt: 02/2022

Mfd by: M/s. Theon Pharmaceuticals Ltd. Vill. Saini Majra, Teh. Nalagarh, Distt. Solan, Himachal Pradesh- 174101.

Description & Disintegration

CDSCO

Sub-Zone Guwahati

RDTL

Guwahati

18.

Pantoprazole Sodium Tablets I.P. 40 mg

B. No.: TN-5142

Mfg dt: 11/2020

Exp dt: 10/2022

Dissolution

Drug Control Department Assam

RDTL

Guwahati

Mfd by: M/s. Naptune Life Sciences Pvt. Ltd. 100-B, EPIP, Phase-II, Thana, Baddi -173205 Himachal Pradesh.

19.

Pantoprazole Gastro- Resistant Tablets I.P.

40 mg

B. No.: AT201095

Mfg dt: 03/2021

Exp dt: 02/2023

Dissolution

Drug Control Department Jharkhand

RDTL

Guwahati

Mfd by: M/s. Aarpic Pharmaceuticals Pvt. Ltd., C1/306/5 Kerala G.I.D.C., Kerala, Bavla Road, Dist. Ahmedabad.

20.

Paracetamol Tablets IP 650 mg

B. No.: FDR3A101

Mfg dt: 01/2021

Exp dt: 12/2022

Dissolution

CDSCO

Sub-Zone Guwahati

RDTL

Guwahati

Mfd by: M/s. ZIM LABORATORIES LIMITED, B-21/22, MIDC Area, Kalmeshwar-441501, Dist. Nagpur, Maharashtra.

21.

Calcium with Vitamin

B. No.: CV-212

Dissolution

Drug Control

RDTL


D3 Tablets

Mfg dt: 11/2020

Exp dt: 05/2022 Mfd by: M/s. VINTOCHEM PHARMACEUTICALS Industrial Area, Maxi Road, Ujjain- 456010 Madhya Pradesh.

Department Jharkhand

Guwahati

22.

Pantoprazole Gastro- Resistant Tablets I.P.

B. No.: TA21-11

Mfg dt: 01/2021

Exp dt: 12/2022 Mfd by: M/s. Om Biomedic Pvt. Ltd. Plot No. 68, 69, 82 & 83, Sector-6A, IIE SIDCUL, Haridwar – 249403 Uttarakhand.

Dissolution

Drug Control Department Meghalaya

RDTL

Guwahati

23.

Calcium with Vitamin D3 Tablets

B. No.: CV-212

Mfg dt: 11/2020

Exp dt: 05/2022

Mfd by: M/s. VINTOCHEM PHARMACEUTICALS Industrial Area, Maxi Road, Ujjain- 456010 Madhya Pradesh.

Dissolution

Drug Control Department Jharkhand

RDTL

Guwahati

24.

Atenolol Tablets IP 50 mg.

B. No.: TPT GOV-21139

Mfg dt: 06/2021

Exp dt: 05/2023

Mfd by: M/s. Terrace Pharmaceutical (P) Ltd., 3-B (a) Phase III, Industrial Area, Sansarpur Terrace, Distt. Kangra, Himachal Pradesh – 176501.

Disintegration

CDSCO

West Zone Mumbai

CDTL

Mumbai

25.

Itraconazole Capsules 200 mg

B. No.: MC21250

Mfg dt: 04/2021

Exp dt: 03/2023

Mfd by: M/s. Mascot Health Series Pvt. Ltd. Plot No. 79, 80, Sec.6A, IIE, SIDCUL, Haridwar- 249403 Uttarakhand.

Disintegration

CDSCO

North Zone

RDTL

Chandigarh

26.

Ondansetron Orally Disintegrating Tablets IP 4 mg (ONVIN-4MD TABLETS)

B. No.: RV21023

Mfg dt: 07/2021

Exp dt: 06/2023

Mfd by: M/s. Rivpra

Dissolution

CDSCO

Sub-Zone Baddi

RDTL

Chandigarh


Formulation Pvt. Ltd. Plot No. 8, Sector-6A, I.I.E. SIDCUL, Haridwar- 249403, Uttarakhand.

27.

Alcohol/Chlorhexidine Gluconate Hand Rub (MICRO-CV HAND SANITIZER)

B. No.: 8267

Mfg dt: 03/2020

Exp dt: 02/2022

Mfd by: M/s. RAMSON REMEDIES 186-187, Industrial Focal Point, Amritsar A.O: 2, G.Floor Baktawar, Malabar Hill, MUMBAI – 6.

Identification

Drug Control Department Himachal Pradesh

RDTL

Chandigarh

To view the official notice, click the link below:

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=ODEyMw==


cdscodrug alertparacetamolnot of standard qualitydrug testfavipravircentral drugs standard control organization
Susmita Roy
Susmita Roy

    Mpharm (Pharmacology)

    Susmita Roy, B pharm, M pharm Pharmacology, graduated from Gurunanak Institute of Pharmaceutical Science and Technology with a bachelor's degree in Pharmacy. She is currently working as an assistant professor at Haldia Institute of Pharmacy in West Bengal. She has been part of Medical Dialogues since March 2021.

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