CDSCO declares 21 drug samples Not of Standard Quality
New Delhi: Apex drug regulatory body, the Central Drugs Standard Control Organization (CDSCO) has declared batches of 21 drugs made by certain manufacturers including Cadila Pharma's Chloramphenicol Capsules, as sub-standard in quality, counterfeited and misbranded, spurious/ adulterated in a random drug sample test.
This came following analysis and test conducted by the CDSCO on 1134 drug samples. Out of this 21 were declared as Not of Standard Quality (NSQ). The drug samples did not meet quality and therefore they were affirmed as not of standard quality (NSQ), spurious, adulterated and misbranded.
The drug samples tested failed due to the presence of Dissolution, Assay, Fineness of Dispersion, Uniformity of Content, Dissolution and Assay, Particulate Matter, Related Substances, Clarity of Solution & Particulate Matter, Identification of Mycophenolate Sodium, Assay of Sucralfate.
The drugs samples collected were manufactured by various drug makers including Cadila Pharma, Unicure India Ltd., Nestor Pharma, Syncom Healthcare Limited, Ultra Life Sciences and others.
The drug samples were tested at four laboratories namely CDL Kolkata, CDTL Mumbai, RDTL Guwahati and CDTL Mumbai.
The drug samples mentioned in the list include Chloramphenicol Capsules manufactured by Cadila Pharma, Ciprofloxacin Tablets, Dispersible Paracetamol Tablets, Primaquine Tablets, Ranitidine Injection, Atorvastatin Tablets, Calcium Carbonate Tablets and so on.
The medications are indicative of treating Bacterial infection, headache, including migraine, toothache, sore throat, dysmenorrhoea, rheumatic pains, malaria, bad cholesterol and so on.
List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, for the month of September 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. | Ciprofloxacin Tablets IP 500 Mg | B. No.: 05028-BTN21, Mfg dt: 02/2018 Exp dt: 01/2020, Mfd by: M/s. Biogenetic Drugs Pvt. Ltd., Vill.- Jharmazri, Baddi-174103, Dist. Solan, Himachal Pradesh. | Dissolution | CDSCO, South Zone, Chennai | CDTL, Chennai |
| 2. | Pantoprazole Sodium Tablets IP 40 mg | B. No.: GSM-18557, Mfg dt: 04/2018, Exp dt: 03/2020, Mfd by: M/s. Chem Pharmaceuticals Pvt. Ltd., plot No. 22, Sector- 3, SIDCUL-IIE, Kudrapur, Dist. US Nagar (Uttarakhand) 263153. | Assay | CDSCO, South Zone, Chennai | CDTL, Chennai |
| 3. | Norfloxacin Tablet I.P. 400 mg. | B. No.: NT603, Mfg dt: 02/2019, Exp dt: 01/2021, Mfd by: M/s. Unicure India Ltd. C-21, 22 & 23 Sector-3, Noida-201301 Dist-Gautam Budh Nagar (UttarPradesh). | Dissolution | Drugs Control Department, Assam | RDTL, Guwahati |
| 4. | Chloramphenicol Capsules I.P. 250 mg. (Starphenicol 250) | B. No.: JK18002, Mfg dt: 03/2019, Exp dt: 02/2020, Mfd by: M/s. Cadila Pharmaceuticals Ltd. Indst. Growth Centre, Samba (Jammu & Kashmir)-184121. | Dissolution | Drugs Control Department, Mizoram | RDTL, Guwahati |
| 5. | Thyrocure-50 (Thyroxine Tablets I.P. 50 mcg) | B. No.: THAT616, Mfg dt: 12/2018, Exp dt: 05/2020, Mfd by: M/s. Unicure India Ltd., C-21, 22 & 23, Sector-3, Noida – 201 301, Distt. Gautam Budh Nagar (Uttar Pradesh). | Assay | CDSCO, East Zone, | CDL, Kolkata |
| 6. | Dispersible Paracetamol Tablets B.P. 250 mg | B. No.: T-17517, Mfg dt: 07/2018, Exp dt: 06/2020, Mfd by: M/s. Jackson Laboratories Pvt. Ltd., 22-24, Majitha Road, Bye Pass, Amristar – 143001 (Punjab). | Fineness of Dispersion | CDSCO, East Zone, | CDL, Kolkata |
| 7. | Primaquine Tablets IP 2.5mg | B. No.: PJVT-01, Mfg dt: 02/2018, Exp dt: 01/2020, Mfd by: M/s. Nestor Pharmaceuticals Limited, 11, Western, Extension Area, Faridabad-121001 (Haryana) | Uniformity of Content, Dissolution and Assay | CDSCO, East Zone, | CDL, Kolkata |
| 8. | Primaquine Tablets I.P., | B. No.: PRD1801, Mfg dt: 03/2018, Exp dt: 02/2020, Mfd by: M/s. La-Chemico Private Limited, Taki Road, Kadambagachi, Barasat, North 24- Parganas, Kolkata- 700125. | Uniformity of Content and Assay | CDSCO, East Zone, Kolkata | CDL, Kolkata |
| 9. | Ranitidine Injection I.P. | B. No.: I-17347, Mfg dt: 07/2018, Exp dt: 06/2020, Mfd by: M/s. Jackson Laboratories Pvt. Ltd., 22-24, Majitha Road, Bye Pass, Amritsar-143 001 (Punjab). | Particulate Matter | CDSCO, Sub Zone Jammu | CDL, Kolkata |
| 10. | Amiject 500 (Amikacin Sulphate Injection I.P.) | B. No.: L079018, Mfg dt: 04/2019, Exp dt: 03/2021, Mfd by: M/s. Abaris Healthcare Pvt. Ltd., Survey No.1407-11, Village-Rajpur, Taluka- Kadi, Distt. Mehsana (Gujarat). | Description & Particulate Matter | CDSCO, Ahmedabad Zone | CDL, Kolkata |
| 11. | PQ-7.5 (Primaquine Phosphate Tablets I.P.) | B. No.: PRM-1001B, Mfg dt: 01/2017, Exp dt: 12/2019, Mfd by: M/s. Ridley Life Sciences Pvt. Ltd., D- 1651, DSIDC Indl. Complex, Nbarela, Delhi- 110 040. | Uniformity of Content, Dissolution & Assay | CDSCO, Subzone Bangalore | CDL, Kolkata |
| 12. | Cetfast (Cetirizine Hydrochloride Tablets I.P.) | B. No.: MT-17533, Mfg dt: 03/2018, Exp dt: 02/2020, Mfd by: M/s. Medimark Drugs &Pharmaceuticals, Plot No. 39, Sector - 6A, IIE, Sidcul Haridwar - 249403 (Uttarakhand). | Assay | CDSCO, North Zone | CDL, Kolkata |
| 13. | Okacet-L (Levocetirizine Tablets I.P. 5 mg) | B. No.: AFB8D36, Mfg dt: 09/2018, Exp dt: 08/2020, Mfd by: M/s. Pure & Cure Healthcare Pvt. Ltd., Plot No. 26A-30, Sector-8A, I.I.E. SIDCUL, Haridwar- 249403 (Uttarakhand). | Related Substances | CDSCO, North Zone | CDL, Kolkata |
| 14. | Zylocef-S 375 (Ceftriaxone & Sulbactam for Injection) | B. No.: 14718/A, 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). | Clarity of Solution & Particulate Matter | CDSCO, Baddi | CDL, Kolkata |
| 15. | Atorvastatin Tablets IP 20mg | B. No.: 968-01, Mfg dt: 01/2019, Exp dt: 12/2020, Mfd by: M/s. Hab Pharmaceuticals & Research Limited., 10, Pharmacity, SIDCUL, Selaqui, Dehradun – 248011 (Uttarakhand). | Assay | CDSCO, West Zone Mumbai | CDTL, Mumbai |
| 16. | Calcium Carbonate Tablets I.P. | B. No.: T190324, Mfg dt: 03/2019, Exp dt: 02/2021, Mfd by: M/s. Micron Pharmaceuticals, 2117, A-2, Phase-III, G.I.D.C., Vapi – 396195 (Gujarat). | Uniformity of Weight | CDSCO, SubZone Indore | CDTL, Mumbai |
| 17. | Cetirizine Hydrochloride Tablets IP 10mg | B. No.: SHT9114, Mfg dt: 01/2019, Exp dt: 12/2021, Mfd by: M/s. Syncom Healthcare Limited., D- 42, IIE SIDCUL., Selaqui, Dehradun – 248197 (Uttarakhand). | Related Substances | CDSCO, SubZone Indore | CDTL, Mumbai |
| 18. | Mycophenolate Sodium Tablets USP 720 mg (Mycophaz-720 Tablets ) | B. No.: AT/7822, Mfg dt: 02/2019, Exp dt: 01/2021, Mfd by: M/s. Apple Biotech Vill.Deep Nagar, Tehsil Payal, Ludhiana (Punjab )-141421. | Identification of Mycophenola te Sodium | CDSCO, Sub-Zone, Baddi, | RDTL, Chandigarh |
| 19. | Ofloxacin Tablets 400 mg (Ofloz-400 Tablets) | B. No.: AHT-1133, Mfg dt: 01/2019, Exp dt: 12/2020, Mfd by: M/s. Algen Healthcare Limited 134/2. Vill. Khara Khari, Sadhaura Road, Kala Amb, Distt. Sirmour (Himachal Pradesh). | Uniformity of weight and Assay | CDSCO, Sub-Zone- Baddi, H.P. | RDTL, Chandigarh |
| 20. | Sucralfate with Oxetacaine Oral Suspension (Sucrazed-O Suspension ) | B. No.: SL-416, Mfg dt: 06/2019, Exp dt: 05/2021, Mfd by: M/s. Sridhara Lifesciences Pvt. Ltd. Khasra No. 28, Sisona, Bhagwanpur, Roorkee, Distt. Haridwar (Uttrakhand). | Assay of Sucralfate | CDSCO, Sub-Zone- Baddi, H.P. | RDTL, Chandigarh |
| 21. | Sucralfate with Oxetacaine Oral Suspension (Sucrazed-O Suspension ) | B. No.: ULL-1855, Mfg dt: 09/2018, Exp dt: 08/2020, Mfd by: M/s. Ultramed Life Sciences Khasra No. 26, Shiv Ganga Indi. Estate, Lakeshwari Bhagwanpur, Roorkee- 247667 (Uttrakhand). | Assay of Sucralfate | Drugs Controller Kupwara (HQ), J&K | RDTL, Chandigarh |
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