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Drug Alert: CDSCO declares 31 samples as sub-standard in quality in random sampling; Details


Drug Alert: CDSCO declares 31 samples as sub-standard in quality in random sampling; Details

New Delhi: Apex drug regulatory body, the Central Drugs Standard Control Organization (CDSCO) has declared more than a dozen drugs as sub-standard in quality, counterfeited and misbranded/ adulterated. These include Paracetamol tablets, Ciprofloxacin tablets, Gentamicin injections and Oxytocin Injections.

The move comes following analysis and test conducted by the CDSCO on 1064 drug samples as a part of the random sampling. The test found that 31 out of the total drug samples did not meet quality and therefore they were affirmed as not of standard quality (NSQ), spurious and misbranded under Form-13, Form-34 and Form- MD-32.

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

The set of these 31 drugs in various dosage forms failed the quality test over the presence of foreign matter, description, particulate matter, extractable volume & assay, sterility, disintegration, dissolution and others parameters. The manufacturers of the drugs are based in states like Rajasthan, Punjab, Chandigarh, Gujarat, Maharashtra, Himachal Pradesh, Uttarakhand and Goa.

The medications included in the list are indicative of treating pain, cold or flu symptoms; antibacterial drug to treat and prevent several infections; induce labour, strengthen labour contractions childbirth, control bleeding after childbirth, or to induce an abortion.

List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, for the month of April 2019 reads;

S.

N.

Name of Drugs/medical

device/cosmetics

Batch No./Date of Manufacture/Date of

Expiry/Manufactured By

Reason for failure Drawn By From
1. IBUPROFEN TABLETS IP 200 MG B. No.: 5922,

Mfg dt: 06/2018, Exp dt: 05/2020, Mfd by: M/s. Vikram

Laboratories (P) Ltd., Behind Tubewell Colony, Meerut Road,

Muzaffarnagar-251002.

Test for Dissolution CDSCO,

South Zone, Chennai

CDTL,

Chennai

2. PANCURE TABLETS (PANTOPRAZOLE TABLETS IP 40 MG) B. No.: SLP-18123,

Mfg dt: 06/2018, Exp dt: 05/2020, Mfd by: M/s. Sterlife

Pharma Pvt Ltd., Plot No. 90 R.S No.3/P1,

Vardhman Industrial Park, Nh-27, Bhojpara-360311, Rajkot, Gujarat.

Test for Dissolution CDSCO,

Zonal Office, Ahmedabad

CDTL,

Chennai

3. Thyrocure – 100 (Thyroxine Tablets

I.P. 100 mcg)

B. No.: THDT605, Mfg dt: 07/2018, Exp dt: 12/2019,

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

Gautam Budh Nagar (U.P.).

Assay CDSCO, East Zone, Kolkata CDL,

Kolkata

4. DIASET 2

(Glimepiride Tablets

I.P. 2 mg)

B. No.: L35C15,

Mfg dt: 06/2018, Exp dt: 05/2021,

Mfd by: M/s. Stadmed Private Limited, C-18, Sarojini Nagar Industrial Estate, Lucknow – 226 008.

Dissolution CDSCO, East Zone, Kolkata CDL,

Kolkata

5. OCONA-CT Scalp Solution (Coal Tar & Ketoconazole Solution) – 50 ml B. No.: COAK89, Mfg dt: 12/2017, Exp dt: 11/2019,

Mfd by: M/s. Akums Drugs & Pharmaceuticals Ltd. 47, 48, Sector – 6A, I.I.E.,

SIDCUL, Haridwar – 249 403, Uttarakhand.

Foreign Matter CDSCO, East Zone, Kolkata CDL,

Kolkata

6. Tranexamic Acid Injection I.P. 500mg

/5 ml

B. No.: TA-024,

Mfg dt: 01/2018, Exp dt: 12/2019, Mfd by: M/s. Redico

Remedies, 123, Mandhala, Barotiwala, Distt. Solan (H.P.) – 174103

Description & Particulate Matter CDSCO,

Hyderabad

CDL,

Kolkata

7. Gentamicin Injection

I.P. 80 mg / 2ml

B. No.: 1794,

Mfg dt: 12/2017, Exp dt: 11/2020, Mfd by: M/s. Sai

Parenterals Pvt. Ltd., D4, Phase V, IDA Jeedimetla, Hyderabad – 500 055.

Description & Particulate Matter CDSCO,

Hyderabad

CDL,

Kolkata

8. Climox 1.2g (Amoxycillin & Potassium Clavulanate Injection I.P.), B. No.: I-16813,

Mfg dt: 04/2018, Exp dt: 03/2020,

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

Pass, Amritsar -143001 (India).

Particulate Matter & Clarity of Solution CDSCO, Sub

Zone Goa

CDL,

Kolkata

9. Oxytocin Injection I.P. B. No.: I-16999,

Mfg dt: 05/2018, Exp dt: 04/2020,

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

Description, Particulate Matter, Extractable Volume & Assay CDSCO, Sub

Zone, Baddi

CDL,

Kolkata

10. Hemosponge (Absorbable Gelatin Sponge U.S.P.) B. No.: 20180601,

Mfg dt: 06/2018, Exp dt: 05/2022,

Mfd by: M/s. Goodwill Lifesciences, 157-158, RJD Integrated Textile Park, Paal-Hazira Road, Ichhapore, Surat – 394510

Sterility CDSCO,

Ahmedabad

CDL,

Kolkata

11. Vomiros-4MD (Ondansetron Orally Disintegrating Tablets IP) B. No.: ST-457,

Mfg dt: 11/2018, Exp dt: 10/2020,

Mfd by: M/s. Sridhara Life Science Pvt. Ltd., Khasra No.285, 290, Village- Sisona, Bhagwanpur, Roorkee, Haridwar (Uttarakhand) 247661.

Disintegration CDSCO,

West Zone, Mumbai

CDTL,

Mumbai

12. Carbamazepine Tablets I.P. 200 mg B. No.: CRB801, Mfg dt: 02/2018, Exp dt: 01/2021, Mfd by: M/s. Medico

Remedies Limited, (A WHO GMP & ISO 9001-

2015 Certified Company)

50, Juhu Supreme Shopping Center, Gulmohar Cross Road No.9, Juhu, Mumbai-400

049. Factory at 8 & 9 Dewan & Sons Udyog

Nagar, Palghar 401 404 Maharashtra.

Disintegration CDSCO,

West Zone, Mumbai

CDTL,

Mumbai

13. Fusigen Ointment (Sodium Fusidate Ointment BP) B. No.: GF568003,

Mfg dt: 11/2018, Exp dt: 04/2021, Mfd by: M/s. Geno

Pharmaceuticals Private Limited., situated at Thivim Industrial Estate, Karaswada, Mapusa, Goa- 403526.

Assay CDSCO, Sub

Zone/ Port Office, Goa

CDTL,

Mumbai

14. Ciprofloxacin Tablets I.P. 500mg B. No.: CT70140,

Mfg dt: 06/2017, Exp dt: 05/2019, Mfd by: M/s. Omega

Dissolution Drugs Control Department Assam RDTL,

Guwahati

Biotech Ltd. 7th Mile Stone,
Dehradun Road, Roorkee,
Uttarakhand- 247667.
15. Cefpodoxime Proxetil Dispersible Tablets (Eziprod 200) B. No.: MHV-100, Mfg dt: 12/2017, Exp dt: 11/2019, Mfd by: M/s. Vee

Laboratories Village Kaller,

Assay &

Disintegration

Drugs Control Department Mizoram RDTL,

Guwahati

Subathu Road, Saproon
(Post) Solan- 173211
(H.P.).
16. Paracetamol Tablets I.P 650 mg (Pelmol-650) B. No.: MST-17528,

Mfg dt: 07/2017, Exp dt: 06/2019, Mfd by: M/s. M Sea

Pharmaceuticals Pvt. Ltd. Surajpur, Paonta Sahib, Dist- Sirmour (H.P.)-

173025.

Dissolution Drugs Control Department Assam RDTL,

Guwahati

17. Paracetamol Tablets I.P 500 mg B. No.: CT70153,

Mfg dt: 06/2017, Exp dt: 05/2019, Mfd by: M/s. Omega Biotech Ltd., 7th Mile

Stone, Dehradun Road, Roorkee, Uttarakhand- 247667.

Dissolution Drugs Control Department Assam RDTL,

Guwahati

18. Paracetamol Tablets I.P 500 mg B. No.: BT70106,

Mfg dt: 05/2017, Exp dt: 04/2019, Mfd by: M/s. Omega Biotech Ltd., 7th Mile

Stone, Dehradun Road, Roorkee, Uttarakhand-

247667.

Dissolution Drugs Control Department Assam RDTL,

Guwahati

19. Paracetamol Tablets I.P 500 mg B. No. : CT70154,

Mfg dt: 06/2017, Exp dt: 05/2019, Mfd by: M/s. Omega Biotech Ltd., 7th Mile

Stone, Dehradun Road, Roorkee, Uttarakhand-

247667.

Dissolution Drugs Control Department Assam RDTL,

Guwahati

20. Ciprofloxacin HCL Tablets I.P 500mg B. No.: CT70140,

Mfg dt: 06/2017, Exp dt: 05/2019, Mfd by: M/s. Omega Biotech Ltd., 7th Mile

Stone, Dehradun Road, Roorkee, Uttarakhand-

247667.

Dissolution Drugs Control Department Assam RDTL,

Guwahati

21. PANTOPRAZOLE GASTRO- RESISTANT TABLETS IP 40 MG B. No.: TJPE802, Mfg dt: 03/2018, Exp dt: 02/2020,

Mfd by: M/s. Unicure (India) Ltd. (Unit – II) 46(B)/49/B, Village Raipur, Bhagwanpur, Roorkee – 247661 (U.K.).

Dissolution CDSCO,

S.Z., Jammu.

RDTL,

Chandigarh

22. B-COMPLEX TABLETS NFI B. No.: T-17313,

Mfg dt: 07/2018, Exp dt: 06/2020,

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

Identification B and the Assay of Calcium Pantothenate H.Q. State Jammu RDTL,

Chandigarh

23. B-COMPLEX TABLETS NFI B. No.: T-17377,

Mfg dt: 07./2018, Exp dt: 06./2020, Mfd by: M/s. Jackson

Laboratories Pvt. Ltd. 22- 24, Majitha Road, Bye Pass, Amritsar- 143001(India).

Identification B and the Assay of Calcium Pantothenate. H.Q. State Jammu RDTL,

Chandigarh

24. Amoxycillin, Potassium Clavulanate and Lactic Acid Bacillus Tablets ( AMOXRAG-625 TABLETS ) B. No.: SLB-759, Mfg dt: 08/2018, Exp dt: 01/2020,

Mfd by: M/s. SKOHIND LABS 20, Ext                           HPSIDC,

Ind. Area, Baddi (H.P.) 173205.

Identification B and the Assay of Potassium Clavulanate Diluted calculated as Clavulanic Acid, Lactic Acid

Bacillus.

H.P State RDTL,

Chandigarh

25. Hydroxy Propyl Methyl Cellulose Ophthalmic Solution ( HYPROMELLOSE OPHTHALMIC SOLUTION USP ) B. No.: 8B05170,

Mfg dt: 12/2018, Exp dt: 11/2020,

Mfd by: M/s. Ciron Drugs & Pharmaceuticals Pvt Ltd.

N-118, 119, 113, 119/1, 119/2, & 118/1, M.I.D.C.,

Tarapur, Boisar, Dist.Palghar – 401506.

Sterility FDA,

Haryana

RDTL,

Chandigarh

26. Hydroxypropyl Methyl Cellulose Ophthalmic Solution USP along with sterile Pricon Angular Cannula 23G. ( APPAVISC PFS SOLUTION ) B. No.: PFB-701, OPCP-195,

Mfg dt: 02/2018, Exp dt: 01/2020,

Mfd by: M/s. Appasamy Ocular Devices (P) Ltd., Plot No. 74-D, Katha Baddi, Distt.Solan (H.P.)- 173205 Mfd. By: Iscon Surgicals Limited 22/4 Heavy Industrial Area

Jodhpur-342003, Rajasthan, India.

Sterility B. Drug Controller officer, Haryana Karnal RDTL,

Chandigarh

27. (DEXAMETHASON E SODIUM PHOSPHATE INJECTION IP) B. No.: 317-936,

Mfg dt: 09/2017, Exp dt: 08/2019, Mfd by: M/s. Zee

Laboratories Ltd Behind 47, Industrial Area, Paonta Sahib -173025. INDIA.

Assay of Dexamethasone Sodium Phosphate Calculated as Dexamethasone Phosphate Drugs Controller officer, Jhajjar RDTL,

Chandigarh

28. Amoxycillin Trihydrate, Clavulanate Potassium Tablets (AMOXCV-625 TABLETS) B. No.: VRBT-1863, Mfg dt: 09/2018, Exp dt: 02/2020,

Mfd by: M/s. Vaishnav Remedies Khasra No. 524, Village – Sailyar Shalapur, Madhopur Road, Roorkee, Distt- Haridwar Uttrakhand

– 247667.

Identification and the Assay of Amoxycillin Trihydrate calculated as Amoxycillin, Clavulanate Potassium calculated as

Clavulanic Acid.

Drugs Controller officer, Haryana Karnal RDTL,

Chandigarh

29. Heparin Injection IP 25000 units (AZZIRIN INJECTION ) B. No.: MCP19388,

Mfg dt: 08/2018, Exp dt: 07/2020, Mfd by: M/s. Health Biotech Ltd. Unit-II, Sandholl-173205.

Assay of Heparin Sodium Drugs Controller officer, Panchkula RDTL,

Chandigarh

Also Read: Red Flag: CDSCO warns against Medtronic pacemaker for battery-related malfunction


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