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 |
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