Drug Alert: CDSCO declares 26 drug 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 Aspirin Gastroresistant tablets IP, Ofloxacin Tablets I.P. 400 mg, Ciprofloxacin Tablets IP (P-CIP 500 TABLETS), Glimepiride Tablets IP 3mg and others.
The move comes following analysis and test conducted by the CDSCO on a total of 843 drug samples as a part of the random sampling. The test found that 26 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 CDSCO, South Zone, Chennai; Drug Control Department at Meghalaya, Mizoram and Assam. CDSCO, Sub Zone/Port Office, Goa; CDSCO, North Zone, Ghaziabad; Office of Drugs Inspector, Sirmour (H.P) and Drugs Control Department Delhi and Jhajjar also named from where the drug samples were drawn.
The set of these 26 drugs in various dosage forms failed the quality test over Particulate Contamination, pH, Test for Salicylic Acid and assay of Aspirin, Test for Dissolution, Identification & Assay, Identification, Uniformity of weight & Assay, Description & Particulate Matter.
The medications included in the list are indicative of preventing blood clots forming following a heart attack or stroke; drug to treat a variety of bacterial infections; medication for the treatment of severe bacterial infections; drug to control high blood sugar in people with type 2 diabetes and others.
List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, for the month of April 2019 read;
| 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. | TELMISARTAN TABLETS IP 40 MG (TELMIRAL 40) | B. No.:78TML18002, Mfg dt: 11/2018, Exp dt: 06/2020, Mfd by: M/s. Crescent Therapeutics Limited Khasra No. 587/588, Beside Jharmajri, Village: Kunjhal, Baddi, Tehsil: Nalagarh, Dist. Solan(H.P) 173205. | Test for Dissolution | CDSCO, South Zone, Chennai. | CDTL, Chennai |
| 2. | Compound Sodium Lactate Injections I.P. | B. No.: R-1/18/145, Mfg dt: 07/2018, Exp dt: 06/2020, Mfd by: M/s. Sanctus Drugs & Pharmaceutical Pvt. Ltd, Plot No. 251, Sector-1, Pithampur, Dist. Dhar (M.P.). | BET | Drug Control Department, Meghalaya | RDTL, Guwahati |
| 3. | Compound Sodium Lactate Injections I.P. | B. No.: R-1/18/140, Mfg dt: 07/2018, Exp dt: 06/2020, Mfd by: M/s. Sanctus Drugs & Pharmaceutical Pvt. Ltd, Plot No. 251, Sector-1, Pithampur, Dist. Dhar, Madhya Pardesh. | BET | Drug Control Department, Meghalaya | RDTL, Guwahati |
| 4. | Amoxycillin And Potassium Clavulanate Tablets I.P. (Clavage-1000) | B. No.: SBPT- 4321, Mfg dt: 02/2018, Exp dt: 07/2019, Mfd by: M/s. Saitech Medicare Pvt. Ltd. Trilokpur Road, Kala Amb (H.P.)- 173030. | Test for Dissolution | Drug Control Department, Mizoram | RDTL, Guwahati |
| 5. | Pantoprazole For Injection (Panzel) | B. No.: 318-7, Mfg dt: 01/2018, Exp dt: 06/2019, Mfd by: M/s. Zee Laboratories, 47, Industrial Areas, Paonta Sahib- 173025. | Particulate Contamination | Drug Control Department, Assam | RDTL, Guwahati |
| 6. | Finzest (Terbinafine Hydrochloride Cream 1% w/w) | B. No.: FZ0417, Mfg dt: 11/2017, Exp dt: 10/2019, Mfd by: M/s. Medizest Pharmaceuticals Pvt. Ltd., Plot No. L-40, Verna Industrial Estate, Verna, Goa-403722. | pH | CDSCO, Sub Zone/Port Office, Goa | CDTL, Mumbai |
| 7. | LEVOCETIRIZINE HYDROCHLORIDE TABLETS IP 5 MG | B. No.: SHT8957, Mfg dt: 09/2018, Exp dt: 08/2021, Mfd by: M/s. SYNCOM Health care Limited,D- 42,IIE SIDCUL, Selaqui, (Dehradun) 248197 Uttarakhand. | Test of Dissolution | CDSCO, North Zone, Ghaziabad | RDTL, Chandigarh |
| 8. | ASPIRIN GASTRO- RESISTANT TABLETS IP | B. No.: HAGT18004, Mfg dt: 09/2018, Exp dt: 08/2020, Mfd by: M/s. RAVIAN LIFE SCIENCE PVT.LTD Plot No 34 Sector -8 A IIE SIDCUL Haridwar-249403, Uttarakhand India. | Test for Salicylic Acid and assay of Aspirin | CDSCO, North Zone, Ghaziabad | RDTL, Chandigarh |
| 9. | Cefixime Tablets IP (MICRA-200 Tablets) | B. No.: R-132, Mfg dt: 02/2018, Exp dt: 01/2020, Mfd by: M/s. Escape Lifesciences Pvt. Ltd. Chudiala Station Road, Village Khelpur Bhagwanpur, Roorkee, UK. | Identification & Assay | Office of Drugs Inspector, Sirmour (H.P) | RDTL, Chandigarh |
| 10. | Ciprofloxacin Tablets IP (P-CIP 500 TABLETS ) | B. No.: R-124, Mfg dt: 02/2018, Exp dt: 01/2020, Mfd by: M/s. Pansun, Pharmaceuticals,Plot No. 183, Sector 6A, IIE,Sidhgual, Haridwar (U.K). | Identification, Uniformity of weight & Assay | Office of Drugs Inspector, Sirmour (H.P) | RDTL, Chandigarh |
| 11. | Amoxycillin and Potassium Clavulanate Tablets IP 625 mg (ANAXIM-CV 625 TABLETS) | B. No.: R-20219, Mfg dt: 12/2018, Exp dt: 11/2020, Mfd by: M/s. AnA Pharmaceuticals Plot No.183, Sector 6A, IIE, Sidhgual Haridwar (U.K). | Identification & Assay | Office of Drugs Inspector, Sirmour (H.P) | RDTL, Chandigarh |
| 12. | Cefixime Tablets IP (GECEFF-200 Tablets) | B. No.: R-129, Mfg dt: 02/2018, Exp dt: 01/2020, Mfd by: M/s. GEFEX PHARMA Pvt. Ltd. IGC, Phase-I, Samba- 184121(J&K). | Identification & Assay | Office of Drugs Inspector, Sirmour (H.P) | RDTL, Chandigarh |
| 13. | Neomycin Sulphate, Polymixin-B Sulphate and Bacitracin Zinc Powder | B. No.: GLEP-181020, Mfg dt: 10/2018, Exp dt: 09/2020, Mfd by: M/s. Grampus Laboratories Vill. Johron, Industrial Area,Kala Amb, Distt. Sirmour (H.P). | Identification | CDSCO, North Zone, Ghaziabad | RDTL, Chandigarh |
| 14. | Neomycin Sulphate, Polymixin-B Sulphate and Bacitracin Zinc Powder | B. No.: GLEP-181006, Mfg dt: 10/2018, Exp dt: 09/2020, Mfd by: M/s. Grampus Laboratories Vill. Johron, Industrial Area,Kala Amb, Distt. Sirmour (H.P). | Identification | CDSCO, North Zone, Ghaziabad | RDTL, Chandigarh |
| 15. | Cefixime and Ofloxacin Tablets (P-XIME-O TABLETS ) | B. No.: R-110, Mfg dt: 02/2018, Exp dt: 01/2020, Mfd by: M/s. Pansun Pharmaceuticals, Plot No. 22&23, Station Road,Bala Industrial Area, Sikkim. | Identification, & Assay | Office of Drugs Inspector, Sirmour (H.P) | RDTL, Chandigarh |
| 16. | Ciprofloxacin HCl Tablets IP (PENCIP- 500 TABLETS) | B. No.: R-21719, Mfg dt: 12/2018, Exp dt: 11/2020, Mfd by: M/s. Pansun, Pharmaceuticals,Plot No. 183, Sector 6A, IIE, Sidhgual, Haridwar (U.K). | Identification, & Assay | Office of Drugs Inspector, Sirmour (H.P) | RDTL, Chandigarh |
| 17. | Glimepiride Tablets IP 3mg | B. No.: GPDT18005, Mfg dt: 10/2018, Exp dt: 09/2020, Mfd by: M/s. RAVIAN LIFESCIENCE PVT. LTD., Plot No. 34, Sector- 8A, IIE, SIDCUL, Haridwar-249403, (Uttarakhand). | Test for Dissolution | Drugs Control Department, Delhi | RDTL, Chandigarh |
| 18. | Lignocaine and Adrenaline Injection IP | B. No.: V-7079, Mfg dt: 11/2017, Exp dt: 10/2019, Mfd by: M/s. ALPA LABORATORIES LTD, 33/2, A.B.Road, Pigdamber-453446, Indore (M.P.). | Test for Assay | Drugs Control Officer, Jhajjar | RDTL, Chandigarh |
| 19. | PRE AND PROBIOTIC CAPSULES-DS | B. No.: UPPC-1801 Mfg dt: 08/2018, Exp dt: 01/2020, Mfd by: M/s. Heal (India) Laboratories Pvt. Ltd.,No. 197/1,Periyapalayam Road, Manjankaranai- 601102,Tamilnadu. | Identification & Assay | CDSCO, North Zone, Ghaziabad | RDTL, Chandigarh |
| 20. | METRONIDAZOLE BENZOATE ORAL SUSPENSION | B. No.: MNSG18-255, Mfg dt: 11/2018, Exp dt: 10/2020, Mfd by: M/s. ORNATE LABS PVT. LTD. Bela Industrial Estate, Muzaffarpur-842005, Bihar | Test for Metronidazole | CDSCO, North Zone, Ghaziabad | RDTL, Chandigarh |
| 21. | Drotaverine Hydrochloride Injection | B. No.: DTB-003, Mfg dt: 10/2017, Exp dt: 09/2019, Mfd by: M/s. Radico Remedies, 123, Mandhala, Barotiwala, Distt. Solan (H.P.) 174103. | Description & Particulate Matter | CDSCO, Hyderabad Zone | CDL, Kolkata |
| 22. | Ofloxacin Tablets I.P. 400 mg | B. No.: BT8291, Mfg dt: 10/2018 Exp dt: 09/2020, Mfd by: M/s. Omega Biotech Ltd., 7th Mile Stone, Dehradun Road, Roorkee-247667, Uttarakhand. | Uniformity of weight | CDSCO, North Zone, Ghaziabad | CDL, Kolkata |
| 23. | Alprazolam Tablets I.P. | B. No.: TAZP-002, Mfg dt: 11/2018, Exp dt: 10/2020, Mfd by: M/s. Medipol Pharmaceuticals India Pvt. Ltd., 1199/3, Bhud, Baddi, Distt. Solan, H.P., India. | Test for Dissolution | CDSCO, North Zone, Ghaziabad | CDL, Kolkata |
| 24. | M-BETASONE (Betamethasone Tablets I.P. 0.5 mg) | B. No.: OPT7531, Mfg dt: 01/2018, Exp dt: 06/2020, Mfd by: M/s. Omega Pharma, Khasra No. 482, Village Saliyar, Roorkee, Dist. Haridwar, Uttarakhand | Assay & Related substances | CDSCO, Ahmedabad Zone. | CDL, Kolkata |
| 25. | Domperidone Tablets I.P. 10 mg | B. No.: DMP-18, Mfg dt: 02/2017, Exp dt: 01/2020, Mfd by: M/s. Bewell Labs Pvt. Ltd., Rabindranagar, P.O. Laskarpur, Dist. 24 Parganas (S) West Bengal 700 153. | Assay & Dissolution | CDSCO, East Zone, Kolkata | CDL, Kolkata |
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