Medical Dialogues
  • Dermatology
Sign in Signup
This site is intended for healthcare professionals only
Sign in Signup
  • Medical Jobs
  • Medical Matrimony
  • MD Brand Connect
  • MDTV
Medical Dialogues
  • Medical News
      • Anesthesiology
      • Cardiology and CTVS
      • Critical Care
      • Dentistry
      • Dermatology
      • Diabetes and Endocrinology
      • ENT
      • Gastroenterology
      • Medicine
      • Nephrology
      • Neurology
      • Obstretics-Gynaecology
      • Oncology
      • Ophthalmology
      • Orthopaedics
      • Pediatrics-Neonatology
      • Psychiatry
      • Pulmonology
      • Radiology
      • Surgery
      • Urology
      • Laboratory Medicine
      • Diet
      • Nursing
      • Paramedical
      • Physiotherapy
  • Health news
      • Doctor News
      • Government Policies
      • Hospital & Diagnostics
      • International Health News
      • MCI News
      • Medical Organization News
      • Medico Legal News
      • NBE News
      • NMC News
  • Medical Guidelines
      • Anesthesiology
      • Cardiology and CTVS
      • Critical Care
      • Dentistry
      • Dermatology
      • Diabetes and Endocrinology
      • ENT
      • Gastroenterology
      • Medicine
      • Nephrology
      • Neurology
      • Obstretics-Gynaecology
      • Oncology
      • Ophthalmology
      • Orthopaedics
      • Pediatrics-Neonatology
      • Psychiatry
      • Pulmonology
      • Radiology
      • Surgery
      • Urology
      • Laboratory Medicine
      • Diet
      • Nursing
      • Paramedical
      • Physiotherapy
  • AYUSH
    • Ayurveda
    • Homeopathy
    • Siddha
    • Unani
    • Yoga
  • State News
      • Andaman and Nicobar Islands
      • Andhra Pradesh
      • Arunachal Pradesh
      • Assam
      • Bihar
      • Chandigarh
      • Chattisgarh
      • Dadra and Nagar Haveli
      • Daman and Diu
      • Delhi
      • Goa
      • Gujarat
      • Haryana
      • Himachal Pradesh
      • Jammu & Kashmir
      • Jharkhand
      • Karnataka
      • Kerala
      • Ladakh
      • Lakshadweep
      • Madhya Pradesh
      • Maharashtra
      • Manipur
      • Meghalaya
      • Mizoram
      • Nagaland
      • Odisha
      • Puducherry
      • Punjab
      • Rajasthan
      • Sikkim
      • Tamil Nadu
      • Telangana
      • Tripura
      • Uttar Pradesh
      • Uttrakhand
      • West Bengal
  • Medical Education
      • Ayush Education News
      • Dentistry Education News
      • Medical Admission News
      • Medical Colleges News
      • Medical Courses News
      • Medical Universities News
      • Nursing education News
      • Paramedical Education News
      • Study Aborad
  • Industry
    • Health Investment News
    • Health Startup News
    • Medical Devices News
    • Pharma News
  • MDTV
      • Anesthesia
      • CTVS
      • Cardiology
      • Critical Care
      • Dentistry
      • Dermatology
      • Diabetes and Endocrinology
      • Diet and nutrition
      • ENT
      • Gastroenterology
      • Health Dialogues
      • Health News today
      • Health Shorts
      • Health Updates
      • Health video of the day
      • Laboratory Medicine
      • Latest Videos
      • Latest Webinars
      • MD shorts
      • Medical News Today
      • Medical Updates
      • Medical Video of the day
      • Medicine
      • Nephrology
      • Neurology and Neurosurgery
      • Obstetrics and Gynaecology
      • Oncology
      • Ophthalmology
      • Orthopaedics
      • Pediatrics & Neonatology
      • Psychiatry
      • Pulmonology
      • Radiology
      • Surgery
      • Top Videos
      • Urology
This site is intended for healthcare professionals only
Sign InRegister
Medical Dialogues
Sign inRegister
  • Home
  • Medical news
    • Anesthesiology
    • Cardiology and CTVS
    • Critical Care
    • Dentistry
    • Dermatology
    • Diabetes and Endocrinology
    • ENT
    • Gastroenterology
    • Medicine
    • Nephrology
    • Neurology
    • Obstretics-Gynaecology
    • Oncology
    • Ophthalmology
    • Orthopaedics
    • Pediatrics-Neonatology
    • Psychiatry
    • Pulmonology
    • Radiology
    • Surgery
    • Urology
    • Laboratory Medicine
    • Diet
    • Nursing
    • Paramedical
    • Physiotherapy
  • Health news
    • Doctor News
    • Government Policies
    • Hospital & Diagnostics
    • International Health News
    • MCI News
    • Medical Organization News
    • Medico Legal News
    • NBE News
    • NMC News
  • Medical Guidelines
    • Anesthesiology
    • Cardiology and CTVS
    • Critical Care
    • Dentistry
    • Dermatology
    • Diabetes and Endocrinology
    • ENT
    • Gastroenterology
    • Medicine
    • Nephrology
    • Neurology
    • Obstretics-Gynaecology
    • Oncology
    • Ophthalmology
    • Orthopaedics
    • Pediatrics-Neonatology
    • Psychiatry
    • Pulmonology
    • Radiology
    • Surgery
    • Urology
    • Laboratory Medicine
    • Diet
    • Nursing
    • Paramedical
    • Physiotherapy
  • Medical Education
    • Ayush Education News
    • Dentistry Education News
    • Medical Admission News
    • Medical Colleges News
    • Medical Courses News
    • Medical Universities News
    • Nursing education News
    • Paramedical Education News
    • Study Aborad
  • Industry
    • Health Investment News
    • Health Startup News
    • Medical Devices News
    • Pharma News
      • CDSCO (Central Drugs Standard Control Organisation) News
  • Case of the Day
  • Editorial
  • Home
  • News
  • Industry
  • Pharma News
  • CDSCO Declares 14 Drug ...

CDSCO Declares 14 Drug Samples Including BP, dyslipidemia Drug As Not Of Standard Quality

ruchikaBy ruchikaPublished On 2020-12-27T11:30:27+05:30  |  Updated On 2020-12-27T11:30:38+05:30
CDSCO Declares 14 Drug Samples Including BP, dyslipidemia Drug As Not Of Standard Quality

New Delhi: The apex drug regulatory body, Central Drugs Standard Organization (CDSCO) has flagged 14 drug samples as "Not of Standard Quality" after they failed to qualify a random drug sample test for the month of November.These drug samples include popular formulations and brands like Paracetamol Paediatric oral Suspension IP (Parawin –DS Suspension), Paracetamol Tablets I.P. 500 mg,...

New Delhi: The apex drug regulatory body, Central Drugs Standard Organization (CDSCO) has flagged 14 drug samples as "Not of Standard Quality" after they failed to qualify a random drug sample test for the month of November.

These drug samples include popular formulations and brands like Paracetamol Paediatric oral Suspension IP (Parawin –DS Suspension), Paracetamol Tablets I.P. 500 mg, and others. The list also includes samples of Isopropyl Rubbing Alcohol IP Hand Sanitizer (Pure-hand Zenitizer) and Ranitidine Injection IP 25mg/ml (ACILOC Injection).

This came after the analysis and test conducted by the CDSCO on 746 drug samples. Out of this,731 samples were found of Standard quality while 14 of them were declared as Not of Standard Quality (NSQ).

Prominent drugmakers including Cadila Pharma, Synokem Pharma, Goa Antibiotics & Pharmaceuticals Ltd., Goa, (Subsidiary of HLL Lifecare Ltd. A Government of India Enterprise and others are involved in manufacturing the formulations collected by the authorities for random testing.

A few of the causes why the drug samples tested failed were due to Hydrolysis Products & Assay, Related Substances, Particulate Matter, Assay of Rosuvastatin, and others.

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

List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, for the Month of November-2020

Total number of samples tested

746

Total number of samples declared as of Standard Quality

731

Total number of samples declared as Not of Standard Quality

14

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.

Pheniramine Maleate Tablets I.P.

B. No.: TPNM-003 Mfg dt: 12/2018 Exp dt: 11/2020

Mfd by: M/s. Medipol Pharmaceutical India Pvt. Ltd., 1199/3, Bhud, Baddi, Distt, Solan, Himachal Pradesh.

Description

CDSCO,

East Zone Kolkata

CDL,

Kolkata

2.

Folic Acid Tablets I.P.

B. No.: FA-1901

Mfg dt: 08/2019, Exp dt: 01/2021

Mfd by: M/s. HLL Lifecare limited, 11A-1 & 12/C-1, Sector-E, Industrial Area, Sanwer road, Indore- 452015.

Hydrolysis Products & Assay

CDSCO

East Zone Kolkata

CDL,

Kolkata

3.

Levocetrizine Tablets

I.P. 5mg

B. No.: 1911

Mfg dt: 10/2019 Exp dt: 09/2021 Mfd by: M/s. Deepin

Pharmaceuticals Pvt. Ltd.,

Village: Dharawara, Post: Kalaria-453001, Tehsil: Depalpur (Madhya.Pradesh).

Description

CDSCO

Zonal Office Hyderabad

CDL,

Kolkata

4.

Glimas-1,Glimepiride Tablets I.P. 5mg

B. No.: MT191240

Mfg dt: 08/2019 Exp dt: 07/2021

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

Dissolution

CDSCO

Zonal Office Hyderabad

CDL,

Kolkata

5.

Erythromycin Stearate Tablets I.P. 250 mg

B. No.: ENT1911 Mfg dt: 12/2019 Exp dt: 11/2021

Mfd by: M/s. Modern Laboratories 45-47, Sector D- 2, Sanwer Road, Indore (MP) 452015.

Description & Dissolution

CDSCO

South Zone

CDL,

Kolkata

6.

Ethyl Alcohol, Isopropyl Alcohol (Xerorub Hand Santizer)

B. No.: S-34520

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

Mfd by: M/s. Seamac Formulations Pvt. Ltd. Plot No. 35, Phase 3rd, Industrial Area, Sansarpur Terrace, Distt.

Kangra (Himachal Pradesh) – 176501.

Assay of Ethyl Alcohol, Isopropyl Alcohol

Drugs Control Department Himachal Pradesh

RDTL,

Chandigarh

7.

Telmisartan Tablets

I.P. (Telmimac 40 mg Tablets)

B. No.: TC4T-027 Mfg dt: 05/2020 Exp dt: 10/2022

Mfd by: M/s. IOSIS Remedies, Rajpura road, Village- Khera Nihla, Tehsil-Nalagarh, District- Solan Himachal Pradesh- 174101.

Dissolution

Drugs Control Department Himachal Pradesh

RDTL,

Chandigarh

8.

Isopropyl Rubbing Alcohol IP Hand Sanitizer (Pure-hand Zenitizer)

B. No.: SRI-331 Mfg dt: 03/2020 Exp dt: 02/2022

Mfd by: M/s. Shri Ramesth Industry Pvt. Ltd. Baddi Barotiwala Road Vill. Juddi Kalan, P.O. & teh Baddi, Distt. Solan 173205 (Himachal Pradesh).

Specific Gravity, Acidity, Limit of non Volatile residue and Assay of Isopropyl Alcohol

Drugs Control Department

Himachal Pradesh

RDTL,

Chandigarh

9.

Paracetamol Paediatric oral Suspension IP (Parawin –DS Suspension)

B. No.: PWS-1905 Mfg dt: 12/2019 Exp dt: 11/2021 Mfd by: M/s. Apple

Formulations Pvt. Ltd. plot No.

208, Kishanpur, Roorkee-

247667 (U.K.).

Related Substances

CDSCO

Sub-Zone Jammu

RDTL,

Chandigarh

10.

Ranitidine Injection IP 25mg/ml (ACILOC Injection)

B. No.: RP20139

Mfg dt: 06/2020 Exp dt: 05/2023 Mfd by: M/s. Cadila

Pharmaceuticals Ltd. 1389,

Particulate Matter

Office of the Dy. Controller Jammu

RDTL,

Chandigarh

Dholka-382225, Distt.: Ahmedabad.

11.

Pregabalin and Methylcobalamin Capsules I.P. (Mobil-P Capsules)

B. No.: C9090149C

Mfg dt: 09/2019 Exp dt: 02/2021

Mfd by: M/s. ION Healthcare Pvt. Ltd. Baddi-Barotiwala Road, Baddi, Distt. Solan (H.P.). 173205.

Description

Drugs Control Department Himachal

Pradesh

RDTL,

Chandigarh

12.

Hebose-50 (Acarbose Tablets IP 50 mg)

B. No.: MT190814

Mfg dt: 06/2019 Exp dt: 05/2021

Mfd by: M/s. Mascot health Series Pvt. LTD., Plot No. 79, 80, Sec-6A, IIE, Sidcul, Haridwar-249403 Uttarakhand.

Dissolution & Assay

CDSCO

West Zone Mumbai

CDTL,

Mumbai

13.

Paracetamol Tablets

I.P. 500 mg

B. No.: 251907

Mfg dt: 06/2019 Exp dt: 05/2022

Mfd by: M/s. Goa Antibiotics & Pharmaceuticals Ltd., Goa, (Subsidiary of HLL Lifecare Ltd. A Government of India Enterprise), Near Tuem Industrial Estate, Tuem, Pernem- Goa- 403512.

Dissolution

CDSCO

West Zone Mumbai

CDTL,

Mumbai

14.

Rosloy ASP 10/75 (Rosuvastatin & Aspirin Capsules)

B. No.: 19ISGC040 Mfg dt: 09/2019 Exp dt: 02/2021

Mfd by: M/s. Synokem Pharmaceuticals Ltd, Plot No. 56-57, Sector 6 A. I.I.E. (SIDCUL), Ranipur (BHEL),

Haridwar- 249403 Uttarakhand.

Assay of Rosuvastatin

CDSCO

West Zone Mumbai

CDTL,

Mumbai


To access the official document, click on the link below-

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=Njc2NQ==
cdsco drug test drug samples cadila pharma Paracetamol Ranitidine Rosuvastatin Aspirin bp drug dyslipidemia 
ruchika
ruchika

    Ruchika joined Medical Dialogue an Desk Editor for the Business Section in 2019. 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 from Delhi University. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

    Show Full Article
    Next Story
    Similar Posts
    NO DATA FOUND

    Editorial

    Air pollution and allergic rhinitis: Understanding the invisible, yet the inevitable  connection

    Air pollution and allergic rhinitis: Understanding the invisible, yet the inevitable connection

    Treatment challenges in managing Gastroparesis related to PPI Use: Analyzing scope of Probiotics

    Treatment challenges in managing Gastroparesis related to PPI Use: Analyzing scope of Probiotics

    Review: Efficacy of Antiviral Agents Against  Omicron Subvariant BA.2

    Review: Efficacy of Antiviral Agents Against Omicron Subvariant BA.2

    Choice of Antibiotics in Common Infections: Doxycycline or Azithromycin?

    Choice of Antibiotics in Common Infections: Doxycycline or Azithromycin?

    Role of acyclovir in Management of chickenpox: Analyzing the importance of starting early

    Role of acyclovir in Management of chickenpox: Analyzing the importance of starting early

    View All

    Journal Club Today

    Women who embraced their partner to have lower stress-induced cortisol response

    Women who embraced their partner to have lower stress-induced cortisol response

    View All

    Health News Today

    Health Bulletin 20/May/2022

    Health Bulletin 20/May/2022

    View All
    © 2019 All Rights Reserved.
    Powered By: Hocalwire
    We use cookies for analytics, advertising and to improve our site. You agree to our use of cookies by continuing to use our site. To know more, see our Cookie Policy and Cookie Settings.Ok
    X
    X