CDSCO drug alert flags 46 drugs as Not of Standard Quality
New Delhi: In its latest drug safety alert, the apex drug regulatory body, Central Drugs Standard Control Organization (CDSCO) recently flagged 46 medicine batches for failing to qualify a random drug sample test for the month of March. These drug samples including Asthalin - 4 (Salbutamol Sulphate Tablet I.P. 4 mg) manufactured by Cipla, Ciprofloxacin & Tinidazole Tablets (CIPROTEC-TZ) by M/s. Neutec Healthcare Pvt. Ltd, and are declared as 'Not of Standard Quality' while 0 out of the 46 drug samples have been declared as 'Spurious'.
This came after analysis and test conducted by the CDSCO, Drugs Control Departments, on 1673 drug samples. Out of this, 1627 samples were found of Standard quality while 46 of them were declared as Not of Standard Quality (NSQ).
Some of the reasons why the drug samples tested failed was due to the presence of Assay, Description, Particulate Matter & pH, Uniformity of Content & Dissolution, Dissolution, Related Substances, Description, pH, water content & Assay, Assay of Neomycin Sulphate, Polymixin-B Sulphate and others.
The samples collected were tested in four laboratories namely CDTL Mumbai, RDTL Chandigarh, CDL Kolkata, RDTL Guwahati., CDL Chennai.
List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, for the Month of March 2020 reads;
Total number of samples tested |
1673 |
Total number of samples declared as of Standard Quality | 1627 |
Total number of samples declared as Not of Standard Quality | 46 |
Total number of samples declared as Spurious | 0 |
Total number of samples declared as Misbranded | 0 |
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. | Salbetol -2 (Salbutamol Tablets IP 2 mg) | B. No.: 469D005 Mfg date: 04/2019, Exp date: 03/2021, Mfd by: M/s. FDC Limited, Plot No L -40, Verna Industrial Estate, Verna, Salcete, Goa. | Related Substances | CDSCO, Hyderabad | CDL, Kolkata |
2. | Amikacin Sulphate Injection I.P. 500mg / 2ml | B. No.: ANI3905 Mfg dt: 06/2019, Exp dt: 05/2021, Mfd by: M/s. Modern Laboratories, 45 -47, Sector D - 2, Sanwer Road, Indore (M.P.) 452015, India. | Description and Particulate Matter | CDSCO, East Zone, Kolkata | CDL, Kolkata |
3. | Asthalin - 4 (Salbutamol Sulphate Tablet I.P. 4 mg) | B. No.: SA81637, Mfg dt: 04/2018, Exp dt: 03/2021, Mfd by: M/s. Cipla Ltd., Kumrek, Rangpo, Sikkim - 737132, India | Related Substances | CDSCO, East Zone, Kolkata | CDL, Kolkata |
4. | H-E-T – 2 ml (Etofylline & Theophylline Injection) | B. No.: 051904, Mfg dt: 05/2019, Exp dt: 04/2021, Mfd by: M/s. Bhavani Pharmaceuticals (P) Ltd., D- 4-G, Panki Ind. Area-1, Kanpur – 22. | Description and Particulate Matter | CDSCO, Bangalore | CDL, Kolkata |
5. | Amoxycillin Trihydrate Dispersible Tablets I.P. 125 mg | B. No.: EAK103, Mfg dt: 08/2018, Exp dt: 07/2020, Mfd by: M/s. Elegant Drugs Pvt. Ltd., R.S.No. 59/3A, Chalmatti – 581 196, Dist. Dharwad, State Karnakata. | Description and Uniformity of Dispersion | CDSCO, Bangalore | CDL, Kolkata |
6. | Amloclav 625 (Amoxycillin & Potassium Clavulanate Tablets I.P.) | B. No.: BT136026, Mfg dt: 04/2018, Exp dt: 03/2020, Mfd by: M/s. Shashi Pharma, S.N. 77/P, At. Vill. Dhanot, Chhatral – 382729, Ta. Kalol, Dist. Gandhinagar (Guj.). | Description, Dissolution, Water, and Assay | CDSCO, Bangalore | CDL, Kolkata |
7. | Erythromycin Thiocyanate | B. No.: Q190402020, Mfg dt: 23/04/2019, Exp dt: 22/04/2022, Mfd by: M/s. Ningxia Taiyicin Biotech Co. Ltd., Pacific Road, No. 1, Nuanquan Economic Zone, Helan Country, Yinchuan, Ningxia, China. | Water Content | CDSCO, Ahmedabad | CDL, Kolkata |
8. | Paracetamol, Phenylephrine Hydrochloride and Chlorpheniramine Maleate Syrup (COLDBEST-PC SYRUP) | Batch No: DL5201 D/Mfg. : 09/2019 D/Exp.: 08/2021 Mfd. By- M/s Digital Vision Pvt. Ltd. 176, Mauza Ogli, Nahan Road, Kala Amb, Distt. Sirmour (H.P) | Uniformity of Volume, pH, and Assay of Phenylephrine Hydrochloride Remark-Positive for Diethylene Glycol (Content: 32.30% w/v) | Drugs Control Department Nahan (H.P). | RDTL, Chandigarh |
9. | Norfloxacin & Tinidazole Tablets (EMNORCIN-TL TABLETS) | Batch No.: DVT197270 D/Mfg. : 07/2019 D/Exp.: 06/2021 Mfd. By- M/s Digital Vision Pvt. Ltd. 176, Mauza Ogli, Nahan Road, Kala Amb, Distt. Sirmour (H.P) | Disintegration Test | CDSCO North Zone, Ghaziabad. | RDTL, Chandigarh |
10. | Paracetamol Tablets IP (SYNPAR TABLETS) | Batch No.:19SGJT005 D/Mfg.: 10/2019 D/Exp.: 09/2021 Mfd. By- M/s SYNOKEM Pharmaceuticals Limited Plot No. 36-36, Sector-6A, | Dissolution | CDSCO North Zone, Ghaziabad. | RDTL, Chandigarh |
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| IIE, SIDCUL, Ranipur, Haridwar-249403 (Uttrakhand) |
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11. | Paracetamol Paediatric Oral Suspension IP 125 mg/5 ml (STARMOL SUSPENSION) | Batch No.: RV19007 D/Mfg.: 11/2019 D/Exp.: 10/2021 Mfd. By- M/s Rivpra Formulations Pvt. Ltd., Plot No. 8, Sector-6A, IIE, SIDCUL, Haridwar-249403 (Uttrakhand) | Assay | Drugs Control Department Jammu | RDTL, Chandigarh |
12. | NUPUR HENNA | Batch No.: B731 D/Mfg.: 09/2019 D/Exp.: 08/2022 Mfd. By: M/s Progression Industries Pvt. Ltd., Unit-II, Plot No. 9B, Apparel Park cum Industrial Area, Village Katha, Baddi, Distt. Solan (H.P.)-173205. | Mineral Matter, Acid Insoluble Ash, Extraneous Sand, Total Aerobic Microbial Count, Total yeast and Mould Count | Drugs Control Officer, Srinagar. | RDTL, Chandigarh |
13. | Methylergometrine Maleate Tablets IP | Batch No.:19113201 D/Mfg.: 06/2019 D/Exp.: 05/2021 | Assay | CDSCO North Zone Ghaziabad. | RDTL, Chandigarh |
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| Mfd. By: Mercury Laboratories Limited, Unit: 2, Halol-Baroda Road, Jarod, Tal: Waghodia, Distt. Vadodara-391510 |
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14. | Paracetamol and Mefenamic Acid Suspension ( EVIMOL-DS SUSPENSION ) | Batch No.: L-409 D/Mfg. : 10/2019 D/Exp. :09/2021 Mfd. By: M/s Bioconic Remedies, Plot No. 66-67, Industrial Area, Gondpur, Paonta Sahib, Distt. Sirmour (H.P)-173205. | Assay of Paracetamol and Mefenamic Acid | Drugs Control Department Paonta Sahib, Distt. Sirmour. | RDTL, Chandigarh |
15. | Tinidazole Tablets IP 500 mg | Batch No.: BT-8416 D/Mfg. : 01/2019 D/Exp.: 12/2020 | Assay | CDSCO North Zone, Ghaziabad | RDTL, Chandigarh |
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| Mfd. By: M/s Omega Biotech Ltd., 7th Mile Stone, Dehradun Road, Roorkee - 247667 (UK) |
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16. | Paracetamol, Phenylephrine Hydrochloride and Chlorpheniramine Maleate Syrup (COLDBEST-PC SYRUP) | Batch No.: DL5201 D/Mfg. : Sep./2019 D/Exp.: Aug./2021 Mfd. By: M/s Digital Vision Pvt. Ltd. 176, Mauza Ogli, Nahan Road, Kala Amb, Distt. Sirmour (H.P)-173030 | pH and Assay of Phenylephrine Hydrochloride Remark-Positive for Diethylene Glycol(Content: 35.87%w/v) | Drugs Control Officer, FDA, Panipat (Hr.) | RDTL, Chandigarh |
17. | Paracetamol, Phenylephrine Hydrochloride and Chlorpheniramine Maleate Syrup (COLDBEST-PC SYRUP) | Batch No.: DL5201 D/Mfg.: Sep./2019 D/Exp.: Aug./2021 Mfd. By: M/s Digital Vision Pvt. Ltd. 176, Mauza Ogli, Nahan Road, Kala Amb, Distt. Sirmour (H.P)-173030 | pH and Assay of Phenylephrine Hydrochloride Remark-Positive for Diethylene Glycol(Content: 34.24%w/v) | Drugs Control Department, Jammu | RDTL, Chandigarh |
18. | Paracetamol, Phenylephrine Hydrochloride and Chlorpheniramine Maleate Syrup (COLDBEST-PC SYRUP) | Batch No: DL5201 D/Mfg. : Sep./2019 D/Exp.: Aug./2021 Mfd. By: M/s Digital Vision Pvt. Ltd. 20 176, Mauza Ogli, Nahan Road, Kala Amb, Distt. Sirmour (H.P)- 173030 | Uniformity of Volume, pH, and Assay of Phenylephrine Hydrochloride Remark-Positive for Diethylene Glycol(Content: 34.97%w/v) | Drugs Control Officer, FDA, Ambala (Hr.) | RDTL, Chandigarh |
19. | Tamsulosin Hydrochloride Modified Release Capsule (GOTAM-0.4 CAPSULES) | Batch No.: CC-190002 D/Mfg.: 01/2019 D/Exp.: 12/2020 Mfd. By: M/s CMG Biotech Pvt. Ltd.58, Industrial Area, Phase III, Sansarpur Terrace, HP-176501 | Dissolution | CDSCO North Zone Ghaziabad | RDTL, Chandigarh |
20. | Metoprolol Succinate Extended-Release Tablets USP Metorol- XL 50 mg | Batch No.: CT9167 D/Mfg.: 03/2019 D/Exp.: 02/2021 Mfd. By: M/s Cian Healthcare Pvt. Ltd. Kh. No.:248, Village. Sisona, Bhagwanpur, Roorkee, Haridwar, Uttarakhand | Dissolution | CDSCO North Zone Ghaziabad | RDTL, Chandigarh |
21. | Sodium Chloride Injection IP | Batch No.:190719 D/Mfg.: 07/2019 D/Exp. :06/2021 Mfd. By: M/s Haseeb Pharmaceuticals Pvt. Ltd., Plot No. F9/14,15,16, MIDC,Nagpur-440016 | Assay | Drugs & Food Control Organisation, Udhampur (J&K) | RDTL, Chandigarh |
22. | Metoprolol Succinate Extended-Release Tablets USP (METOROL-XL 50 TABLETS) | Batch No.: T8030128 D/Mfg. 03/2018 D/Exp. 02/2020 Mfd. By: M/s ION Healthcare Pvt. Ltd. Baddi- Barotiwala road, Baddi, Distt. Solan (H.P)-173205 | Dissolution | CDSCO North Zone Ghazian bad | RDTL, Chandigarh |
23. | Albendazole Tablets I.P. 400 mg | B. No.: BBT19327A, Mfg dt: 08/2019, Exp dt: 07/2021, Mfd by: M/s. Biomax Biotechnics (P) Ltd. 261, HSHDC, Indsutrial Estate Alipur, Barwala, Haryana- 134118. | Dissolution | Drugs Control Department, Arunachal Pradesh. | RDTL, Guwahati |
24. | Albendazole Tablets I.P. 400 mg | B. No.: ABT18036, Mfg dt: 08/2018, Exp dt: 07/2020, | Dissolution | Drugs Control Department, Assam | RDTL, Guwahati |
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| Mfd by: M/s. Vivek Pharmachem (India) Ltd. NH-8, Chimanpura, Amer, Jaipur-303102 |
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25. | Albendazole Tablets I.P. 400 mg | B. No.: ABT18036, Mfg dt: 08/2018, Exp dt: 07/2020, | Dissolution | Drugs Control Department, Assam | RDTL, Guwahati |
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| Mfd by: M/s. Vivek Pharmachem (India) Ltd. NH-8, Chimanpura, Amer, Jaipur-303102 |
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26. | Pheniramine Maleate Tablets I.P. (MOREVIL-25 Tablets) | B. No.: NT-190221 Mfg dt: 02/2019, Exp dt: 01/2021, Mfd by: M/s.Gracure Pharmaceuticals Ltd. Brahman Bell Road, Vill. Belldyod, Nalagarh, Dist. Solan (H.P) | Physical Parameter | Drugs Control Department, Nagaland. | RDTL, Guwahati |
27. | Albendazole Tablets I.P. (REBEN) | B. No.: T9030099, Mfg dt: 03/2019, Exp dt: 02/2021, | Dissolution | Drugs Control Department, Nagaland. | RDTL, Guwahati |
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| Mfd by: M/s. Rhydburg Pharmaceuticals Ltd, C2 & 3, S.I.E.L, Selaqui, Dehradun, UK |
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28. | Ferrous Sulphate and Folic Acid Tablets I.P | B. No.: IFTJ18025, Mfg dt: 09/2018, Exp dt: 08/2020, Mfd by: M/s. Vivek Pharmachem (India) Ltd. EPIP, Bari Brahmana, Jammu-181133 | Disintegration | Drugs Control Department, Assam. | RDTL, Guwahati |
29. | Pantoprazole Gastro- Resistant Tablets I.P. (ALPANT-40) | B. No.: MST-18403, Mfg dt:07/2018, Exp dt: 06/2020, Mfd by: M/s. M Sea Pharmaceuticals (P) Ltd, Surajpur, Paonta Sahib, Sirmour, H.P.-173025 | Assay and Dissolution | Drugs Control Department, Assam. | RDTL, Guwahati |
30. | Glimepiride Tablets I.P. 1mg | B. No.: TPT-0316, Mfg dt: 03/2019, Exp dt: 02/2021, Mfd by: M/s. Tanpal Pharmaceuticals D-12-13, Focal Point, Nabha-147201 | Dissolution | Drugs Control Department Mizoram | RDTL, Guwahati |
31. | Glimepiride Tablets I.P. 1mg | B. No.: TPT-0316, Mfg dt: 03/2019, Exp dt: 02/2021, Mfd by: M/s. Tanpal Pharmaceuticals D-12-13, Focal Point, Nabha-147201 | Dissolution | Drugs Control Department Mizoram | RDTL, Guwahati |
32. | Glimepiride Tablets I.P. 2 mg | B. No.: TPT-0317, Mfg dt: 03/2019, Exp dt: 02/2021, Mfd by: M/s. Tanpal Pharmaceuticals D-12-13, Focal Point, Nabha-147201 | Assay and Dissolution | Drugs Control Department Mizoram | RDTL, Guwahati |
33. | Paracetamol, Propyphenazone and Caffeine Tablets (Dart Analgesic Tablets) | B. No.: 1802012, Mfg dt: 02/2018, Exp dt: 01/2021, Mfd by: M/s. Juggat Pharma 47/1, 20th K.M., Mysuru Road, Bengaluru- 560074. | Disintegration | Drugs Control Department Mizoram | RDTL, Guwahati |
34. | Albendazole Tablets I.P. 400mg | B. No.: 8491015, Mfg dt: 03/2019, Exp dt: 02/2021, Mfd by: M/s. Bengal Chemicals & Pharmaceuticals Ltd. 164, Maniktala Main Road, Kolkata-700054 | Dissolution | Drugs Control Department Arunachal Pradesh. | RDTL, Guwahati |
35. | Ciprofloxacin & Tinidazole Tablets (CIPROTEC-TZ) | B. No.: CTZ-19001, Mfg dt: 08/2019, Exp dt: 07/2022, Mfd by: M/s. Neutec Healthcare Pvt. Ltd. E-698, DSIIDC, Industrial Area, Narela, Delhi-110040 | Disintegration | Drugs Control Department Arunachal Pradesh | RDTL, Guwahati |
36. | Rabeprazole 20mg & Domeperidone 30 mg. SR Capsule | B. No.: CRD-7015, Mfg dt: 06/2018, Exp dt: 05/2020, Mfd by: M/s. Cotec Healthcare (P) Ltd. NH. No.- 74, Roorkee-Dehradun Highway, Kishanpur, Roorkee (U.K) -244667 | Assay of Rabeprazole | Drugs Control Department Tripura | RDTL, Guwahati |
37. | Levocetirizine HCL Tablets I.P. 5mg | B. No.: SHT9389, Mfg dt: 03/2019, Exp dt: 02/2021, Mfd by: M/s. Synokem Healthcare Ltd. D-42, IIE, SIDCUL, Selaqui, Dehradun-248197 (U.K) | Dissolution | Drug Control Department, Assam | RDTL, Guwahati |
38. | Norfloxacin Tablets I.P. (NORPIC -400) | B. No.: NR1801, Mfg dt: 02/2018, Exp dt: 01/2021, Mfd by: M/s. Danish Healthcare (P) Ltd. 76/27, Industrial Estate, Maxi Road, Ujjain-456010 | Physical Parameter | Drugs Control Department, Mizoram | RDTL, Guwahati |
39. | Metronidazole Tablets I.P. 400mg | B. No.: MZT19009, Mfg dt: 05/2019, Exp dt: 04/2021, Mfd by: M/s. Vivek Pharmachem (India) Ltd. NH-8, Chimanpura, Amer, Jaipur-303102 | Dissolution | CDSCO, Sub-Zone, RDTL, Assam | RDTL, Guwahati |
40. | Cefixime Dispersible Tablets I.P. 200mg (CEFONIX 200) | B. No.: EL-G/015/A, Mfg dt: 09/2019, Exp dt: 08/2021, Mfd by: M/s. Elvia Care Pvt. Ltd. Vill. Berson, Tehsil, Nalagarh, Dist-Solan (H.P) | Disintegration | Drugs Control Department, Mizoram | RDTL, Guwahati |
41. | Alprazolam Tablets I.P. 0.25 mg | B. No.: TAZ-7005 Mfg dt: 01/2018, Exp dt: 12/2020, Mfd by: M/s. Cotec Healthcare (P) Ltd. NH. No.- 74, Roorkee-Dehradun Highway, Kishanpur, Roorkee (U.K) -244667 | Dissolution | Drugs Control Department, Arunachal Pradesh | RDTL, Guwahati |
42. | Frusemide Tablets I.P. 40mg (RASIX Tablets) | B. No.: 7127 Mfg dt: 06/2017, Exp dt: 05/2020, Mfd by: M/s. Ramson Remedies 186-187, Industrial Focal Point, Amritsar, A.O.: 2, G. Floor, Baktawar, Malabar Hill, Mumbai-6. | Dissolution | Drugs Control Department, Arunachal Pradesh | RDTL, Guwahati |
43. | Compound Sodium Lactate Injection I.P. (RL) | B. No.: 190039 Mfg dt: 04/2019, Exp dt: 03/2021, Mfd by: M/s. D.J.Laboratories Pvt. Ltd. 255, Sector-1, Industrial Area, Pithampur-454775. | Sterility Test and Particulate Contamination | Drugs Control Department, Meghalaya | RDTL, Guwahati |
44. | Telmijack- 40 (Telmisartan Tablets IP 40 MG) | B. No.: T-19301 Mfg dt: 04/2019, Exp dt: 03/2021, Mfd by: M/s. Jackson Laboratories Pvt. Ltd. 22-24, Majitha Road, Bye Pass, Amritsar-143001 | Dissolution | CDSCO, West Zone, Mumbai | CDTL, Mumbai |
45. | Ibuprofen Tablets IP 400mg | B. No.: LL484103 Mfg dt: 09/2019, Exp dt: 08/2022, Mfd by: M/s. Lesanto Laboratories, Plot No. 9, 10, 11 and 20, Survey No. 53, Palghar, Maharashtra. | Dissolution | CDSCO, West Zone, Mumbai | CDTL, Mumbai |
46. | JFIX-LB (Cefixime Trihydrate with Lactic Acid Tablets IP) | B. No.: HS.114 Mfg dt: 09/2019, Exp dt: 08/2021, Mfd by: M/s. Rivpra Formulations Pvt. LIMITED., Plot No. 8, Sector -6A, I.I.E., Sidcul, Haridwar-249403 (U.K) | Identification of Cefixime | CDSCO, Sub Zone, Indore | CDTL, Mumbai |
