Delhi Medicine

CDSCO Declares 16 Drug Samples Including Clopidogrel, Aspirin Tablets As Not Of Quality Standard

• byDoctor News Daily Team
• 18 February, 2025
• 0 Comments
• 0 Mins

New Delhi: The apex drug regulatory body, Central Drugs Standard Control Organization (CDSCO) has flagged 16 drug samples including Clopidogrel and Aspirin Tablets as 'Not of Standard Quality' after they failed to qualify a random drug sample test for the month of January.
These drug samples included popular formulations and brands such as Diclofenac Gastro Resistant Tablets I.P. 50 mg (Regunac -50); Omecot Capsules (Omperazole Capsules IP); Clopidogrel and Aspirin Tablets; Amitriptyline Tablets I.P., Nitzo - 2.6 (Controlled-Release Tablets of Nitroglycerin) and others.
This came after the analysis and test conducted by the CDSCO, Drugs Control Departments, on 1001 drug samples. Out of this 985 samples were found of Standard quality while 16 of them were declared as 'Not of Standard Quality'.
A few of the causes why the drug samples failed to clear the test include Dissolution test failure, Microbial contamination, Particulate Matter & Clarity of Solution test failure, Assay of Ethyl Alcohol failure, and others.
The collected samples were tested in three laboratories namely CDL Kolkata, RDTL Chandigarh, CDTL Mumbai.
Total number of samples tested
1001
Total number of samples declared as of Standard Quality
985
Total number of samples declared as Not of Standard Quality
16
Total number of samples declared as Spurious
0
Total number of samples declared as Misbranded
0
List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, for the Month of January 2021
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.
Omnikacin – 250 (Amikacin Injection I.P.)
B. No.: C2VAR02 Mfg dt: 01/2020 Exp dt: 12/2021
Mfd by: M/s. Akums Drugs & Pharmaceuticals Ltd., 2, 3, 4 & 5, Sector 6-B, I.I.E., SIDCUL, Ranipur, Haridwar- 249403 Uttarakhand.
Assay
CDSCO,
South Zone
CDL,
Kolkata
2.
Ontic Syrup (Ondansetron Oral Solution I.P- 30 ml)
B. No.: CL19136
Mfg dt: 10/2019 Exp dt: 09/2021
Mfd by: M/s. Corona Remedies Pvt. Ltd., Vill. Jatoli, P.O. Oachghat,
Tehsil: Solan, Dist. Solan Himachal Pradesh - 173223.
Description
CDSCO,
Hyderabad
CDL,
Kolkata
3.
Tolvat 30 (Tolvaptan
Tablets 30 mg)
B. No.: BRA02174D Mfg dt: 02/2020 Exp dt: 01/2023 Mfd by: M/s. MSN Laboratories Private
Limited, Plot No. 42, Anrich Industrial Estate, Bollaram, Sangareddy District-502325, Telangana.
Dissolution
CDSCO,
Hyderabad
CDL,
Kolkata
4.
Disilox MPS (Aluminium, Magnesium & Simethicone Oral Suspension I.P.)
B. No.: C20C92 Mfg dt: 06/2019 Exp dt: 05/2022
Mfd by: M/s. Stadmed Private Limited, 15, Jawpore Road, Kolkata-700074.
Microbial Contamination (Total Aerobic Viable Count)
CDSCO,
East Zone, Kolkata
CDL,
Kolkata
5.
Nitzo - 2.6 (Controlled Release Tablets of Nitroglycerin)
B. No.: 419-1544
Mfg dt: 11/2019 Exp dt: 10/2021 Mfd by: M/s. Zee
Laboratories, 47, Industrial Area, Paonta Sahib – 173025, Himachal Pradesh.
Assay of Glyceryl Trinitrate
CDSCO,
East Zone, Kolkata
CDL,
Kolkata
6.
Diclofenac Gastro Resistant Tablets I.P. 50 mg (Regunac -50)
B. No.: FZ57K801 Mfg dt: 10/2018 Exp dt: 09/2021 Mfd by: M/s. Zim
Laboratories Ltd., B-21/22, MIDC Area, Kalmeshwar, Nagpur, Maharashtra.
Description
CDSCO,
East Zone, Kolkata
CDL,
Kolkata
7.
Amlor -2.5(Amlodipine Besylate Tablets I.P. 2.5 mg)
B. No.: KN20001
Mfg dt: 05/2020 Exp dt: 04/2022 Mfd by: M/s. Ortin
Laboratories Ltd., 275 & 278 (Part), I.D.A. Pashamylaram
-502307, Sangareddy Dist. T.S., Telangana.
Dissolution, Related Substances and Assay
CDSCO,
East Zone, Kolkata
CDL,
Kolkata
8.
Amitriptyline Tablets I.P.
B. No.: TAMF-026 Mfg dt: 03/2020 Exp dt: 02/2022
Mfd by: M/s. Medipol Pharmaceutical India Pvt. Ltd., 1199/3, Bhud, Baddi, Dist. Solan, Himachal
Pradesh.
Description
CDSCO,
East Zone, Kolkata
CDL,
Kolkata
9.
Ancef 1 gm (Ceftriaxone Injection
I.P.)
Sterile Water For Injection I.P. 10 ml
B. No.: 13018A
Mfg dt: 03/2019 Exp dt: 02/2021 Mfd by: M/s. Osper
Formulations Pvt. Ltd., Plot No. 134-B, Export Promotion Industrial Park, Phase- 1, Jharmajri Baddi, Dist. Solan, Himachal Pradesh.
B. No.: 1902022
Mfg dt: 02/2019 Exp dt: 01/2022 Mfd by: M/s.
legency Remedies Pvt. Ltd.,
P.O. Baddi, Dist. Solan Himachal Pradesh.
Particulate Matter & Clarity of Solution
CDSCO,
Sub Zone, Baddi
CDL,
Kolkata
10.
VEDARK INSTANT HAND SANITIZER
B. No.: A-142
Mfg dt: 05/2020 Exp dt: 04/2022
Mfd by: M/s. Gladios Products Pvt. Ltd., 31, Virat industrial Estate, Dhanot
Gandhinagar-382721 Gujarat.
Identification of Chlorhexidine Gluconate
CDSCO
North Zone
RDTL,
Chandigarh
11.
DAYS 2X HAND SANITIZER
B. No.: BYHS29 Mfg dt: 09/2020 Exp dt: 08/2023
Mfd by: M/s. Yadav's Health & Beauty Herbal Products Plot No.25, EPIP, Phase-2, Thana, Baddi, Distt. Solan, Himachal Pradesh -173205.
Assay of Ethyl Alcohol
Drug Control Departmen t Himachal Pradesh
RDTL,
Chandigarh
12.
Doxycycline and Lactic Acid Bacillus Capsules (Mesodox LB Capsules)
B. No.: HBC-4052 Mfg dt: 02/2020 Exp dt: 07/2021
Mfd by: M/s. Haustus Biotech Pvt. Ltd. 44-45, Indl.Area, Tahliwal, Distt.Una Himachal Pradesh.
Uniformity of filled weight
CDSCO
North Zone
RDTL,
Chandigarh
13.
Hand Sanitizer
B. No.: V20EL011 Mfg dt: 04/2020 Exp dt: 08/2022
Mfd by: M/s. Vowcare Products Plot No.77, Zone 4th, I.G.C., SIDCO
Lassipora, Dist. Pulwama Jammu & Kashmir 192305.
Assay of Isopropyl Alcohol Hydrogen Peroxide Glycerol
Drug Control Departmen t Srinagar
RDTL,
Chandigarh
14.
(Omeprazole Capsules I.P.) 20 mg
B. No.: 5703320
Mfg dt: 06/2020 Exp dt: 05/2022
Mfd by: M/s. Karnataka Antibiotics & Pharmaceuticals Ltd., (A Govt. of India Enterprise), Plot No.14, II Phase, Peenya, Bengaluru -
560 058 Karnataka.
Dissolution (Acid Stage)
CDSCO,
West Zone Mumbai
CDTL,
Mumbai
15.
Omecot Capsules (Omperazole Capsules IP)
B. No.: MC 19235
Mfg dt: 08/2019 Exp dt: 07/2021
Mfd by: M/s. Mascot Health Series Pvt Ltd., Plot No. 79, 80, Sector 6 A, IIE, Sidcul,
Haridwar 249 403, Uttarakhand.
Assay & Dissolution
CDSCO,
West Zone Mumbai
CDTL,
Mumbai
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