Drug alert: CDSCO flags 41 medicine batches as not of standard quality
New Delhi: In its latest drug safety alert, the apex drug regulatory body, Central Drugs Standard Control Organization (CDSCO) has flagged 41 medicine batches for failing to qualify for a random drug sample test for the month of May.
These drugs samples which are declared not of standard quality include Dr. Reddys Laboratories' Omeprazole (Delayed- Release) and Domperidone (SustainedRelease) Capsules, Cadila Pharmaceuticals' CALNIF RETARD (Nifedipine Prolonged Release Tablets I.P. 20 mg), Troikaa Pharmaceuticals' DYNAPAR AQ (Diclofenac Sodium Injection I.P. 75 mg/ml) and others.
The list further includes Synokem pharmaceuticals' Rosuvastatin Calcium Tablets IP 10mg, Symbiosis Pharmaceuticals' Methylcobalamin, Alpha Lipoic Acid, Pyridoxine HCI and Folic Acid Capsules (VEMIFOL PLUS CAPSULES).
This came after analysis and test were conducted by the CDSCO, Drugs Control Departments on 1233 samples. Out of this, 1192 samples were found of standard quality while 41 of them were declared as Not of Standard Quality (NSQ).
A few of the reasons why the drug samples tested failed were the failure of the assay, failure of the dissolution test, failure of disintegration test, failure of moisture content test failure of the sterility test.
The samples collected were tested in five laboratories, namely CDL Kolkata, CDTL Mumbai, RDTL Chandigarh, CDTL Chennai, RDTL Guwahati .
List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded for the Month of May – 2022.
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. | Zinc Sulphate Dispersible Tablets I.P. | B. No.: ZST21050 Mfg dt: 10/2021 Exp dt: 09/2023 Mfd by: M/s. La- Chemico Pvt. Ltd., Taki Road, Kadambagachi, Barasat, North 24 Parganas , Kolkata - 700125, West Bengal. | Uniformity of Dispersion & Disintegration | CDSCO East Zone Kolkata | CDL Kolkata |
2. | Zinc Sulphate Dispersible Tablets I.P. | B. No.: ZST21048 Mfg dt: 10/2021 Exp dt: 09/2023 Mfd by: M/s. La- Chemico Pvt. Ltd., Taki Road, Kadambagachi, Barasat, North 24 Parganas , Kolkata - 700125, West Bengal. | Uniformity of Dispersion & Disintegration | CDSCO East Zone Kolkata | CDL Kolkata |
3. | Metfovan -500 SR Tablets (Metformin Hydrochloride (SR) Tablets) | B. No.: APT/04215 Mfg dt: 03/2021 Exp dt: 02/2023 Mfd by: M/s. Amkon Pharmaceuticals, Plot No. 242, Ind. Area, Phase-IX, S.A.S. Nagar, Mohali – 160 062, Punjab. | Dissolution & Assay | CDSCO East Zone Kolkata | CDL Kolkata |
4. | Acebrophylline Capsules 100 mg | B. No.: PF8AA04 Mfg dt: 11/2020 Exp dt: 10/2022 Mfd by: M/s. Pure & Cure Healthcare Pvt. Ltd., Plot No. 26A, 27- 30, Sector-8A, I.I.E, SIDCUL, Ranipur, Haridwar-249403, Uttarakhand. | Water Content | CDSCO East Zone Kolkata | CDL Kolkata |
5. | Geragen – 2 ml (Gentamicin Injection IP) | B. No.: V2111674 Mfg dt: 08/2021 Exp dt: 07/2023 Mfd by: M/s. B.M. Pharmaceuticals, 47- 48, Ind. Area, Phase II, Chandigarh - 160002. | Description & Particulate Matter | CDSCO East Zone Kolkata | CDL Kolkata |
6. | DYNAPAR AQ (Diclofenac Sodium Injection I.P. 75 mg/ml) | B. No.: D23S363 Mfg dt: 11/2021 Exp dt: 10/2023 Mfd by: M/s. Troikaa Pharmaceuticals Ltd., At: Survey No: 46/1-4, Kadaiya Village, Nani Daman-396210. | Sterility | CDSCO East Zone Kolkata | CDL Kolkata |
7. | (Afedol- SP) Aceclofenac, Paracetamol & Serratiopeptidase Tablets | B. No.: PBT-238 Mfg dt: 06/2021 Exp dt: 05/2023 Mfd by: M/s. Bonn Schtering Bio Sciences, Plot No. 64 & 65, 1st Floor, Electronic Park, Thirubuvanai, Mannadipet Commune, Puducherry 605 107. | Identification & Assay of Serratiopeptidase | CDSCO, South Zone Chennai | CDL Kolkata |
8. | Agrophylline - 2ml (Etophylline & Theophyline for Injection) | B. No.: AGP-20 Mfg dt: 11/2021 Exp dt: 10/2023 Mfd by: M/s. Agron Remedies Pvt. Ltd. Sarverkhera , | Description & Particulate Matter | CDSCO South Zone Chennai | CDL Kolkata |
Moradabad Road, Kashipur -244713, Uttarakhand. | |||||
9. | SPYCLAV 625 LB (Amoxycillin and Potassium Clavulanate with Lactic Acid Bacillus Tablets) | B. No.: TACLB1011A Mfg dt: 03/2021 Exp dt: 08/2022 Mfd by: M/s. Associated Biotech, Kishanpura, Guru Majra Road, Baddi, Teh. Nalagarh, Distt. Solan, Himachal Pradesh - 174101. | Assay | CDSCO South Zone Chennai | CDL Kolkata |
10. | Metsodoz - 8 Tablets (Methylprednisolone Tablets IP 8 mg) | B. No.: GFM622101 Mfg dt: 07/2021 Exp dt: 06/2023 Mfd by: M/s. Progressive Lifesciences Pvt. Ltd., Latherdevahoon, P.O. Jhabrera, Roorkee, Distt. Haridwar -247 665, Uttarakhand. | Identification & Assay | CDSCO South Zone Chennai | CDL Kolkata |
11. | CALNIF RETARD | B. No.: JKEG21006 | Dissolution | CDSCO | CDL |
(Nifedipine | Mfg dt: 07/2021 | Ahmedabad | Kolkata | ||
Prolonged Release | Exp dt: 06/2024 | ||||
Tablets I.P. 20 mg) | Mfd by: M/s. Cadila | ||||
Pharmaceuticals | |||||
Limited, Industrial | |||||
Growth Centre, | |||||
SIDCO, Samba-184 | |||||
121, Jammu & | |||||
Kashmir. | |||||
12 | Saccharomyces | B. No.: SBC/C/002 | Moisture Content | CDSCO | CDL |
boulardii Capsules | Mfg dt: 09/2021 | Hyderabad | Kolkata | ||
(250 mg) | Exp dt: 08/2023 | ||||
Mfd by: M/s. Unique | |||||
Biotech Limited, Plot | |||||
No.-2, Phase- II, MN | |||||
Park, Kolthur Village, | |||||
Shameerpet Mandal, | |||||
Medchal Malkajgiri | |||||
District, Hyderabad - | |||||
560 078, Telangana, |
India. | |||||
13. | Enoxaparin Sodium Injection I.P. 60mg/0.6ml | B. No.: SENXB2118 Mfg dt: 12/2021 Exp dt: 11/2023 Mfd by: M/s. Samarth Lifescience Pvt. Ltd., Unit - II, Plot No. 2, Industrial Area, Lodhimajra, Baddi, Himachal Pradesh - 173205. | Sterility | CDSCO Jammu | CDL Kolkata |
14. | Pantoprazole Gastro-Resistant Tablets IP | B. No.: TF1037A Mfg dt: 06/2021 Exp dt: 11/2022 Mfd by: M/s. Navkar Lifesciences, Plot No.76, Lodhi Majra, Industrial Area, Baddi, Distt. Solan , Himachal Pradesh. | Dissolution | CDSCO Sub Zone Bangalore | CDTL Chennai |
15. | Ciprofloxacin Hydrochloride Tablets IP 500 mg | B. No.: 0702620 Mfg dt: 06/2020 Exp dt: 05/2023 Mfd by: M/s. Karnataka Antibiotics & Pharmaceuticals Limited, Plot No.14, II Phase, Peenya, Bangalore -560058. | Dissolution | CDSCO Sub Zone Bangalore | CDTL Chennai |
16. | Telmisartan Tablets IP | B. No.: CT-10408 Mfg dt: 08/2020 Exp dt: 07/2023 Mfd by: M/s Cosmas Pharmacls Ltd., Buranwala Road, Village: Kotta, P.O.: Baratiwala, Solan, Himachal Pradesh – 174103. | Dissolution | Drug Control Department Jharkhand | RDTL Guwahati |
17. | Amoxycillin and Potassium Clavulanate Tablets IP | B. No.: PT-0681A Mfg dt: 01/2021 Exp dt: 12/2022 Mfd by: M/s Saitech | Dissolution of Amoxycillin and Clavulanic Acid | Drug Control Department Jharkhand | RDTL Guwahati |
Medicare Pvt. Ltd., Village Kheri, Trilokpur Road, Kala- Amb, Dist. Sirmour, Himachal Pradesh – 173030. | |||||
18. | Omeprazole (Delayed- Release) and Domperidone (Sustained- Release) Capsules | B. No.: E2100419 Mfg dt: 01/2021 Exp dt: 12/2022 Mfd by: M/s Dr. Reddys Laboratories Ltd. Village Mauja Thana, Baddi- 173205, Dist. Solan, Himachal Pradesh. | Assay of Omeprazole and Domperidone | Drug Control Department Assam | RDTL Guwahati |
19. | Misoprostol Tablets IP 200mcg | B. No.: UHT21298 Mfg dt: 09/2021 Exp dt: 08/2023 Mfd by: M/s Unimarck Healthcare Ltd. WHO- GMP Certified Company Plot No. 24, 25 & 37, Sector 6A, SIDCUL, Haridwar- 249403, Uttarakhand. | Assay | Drug Control Department Assam | RDTL Guwahati |
20. | ATENOLOL Tablets IP 50mg | B. No.: ATTJ21001 Mfg dt: 01/2021 Exp dt: 12/2022 Mfd by: M/s Vivek Pharmachem (India) Ltd., EPIP, Bari Brahmana, Jammu- 181133. | Disintegration and Assay | Drug Control Department Assam | RDTL Guwahati |
21. | Telmisartan Tablets IP 40mg | B. No.: TETY-01 Mfg dt: 04/2021 Exp dt: 03/2023 Mfd by: M/s Nestor Pharmaceuticals Limited, 11, Western Extension Area, Faridabad-121001, Haryana, INDIA. | Dissolution | Drug Control Department Jharkhand | RDTL Guwahati |
22. | Telmisartan Tablets IP 80mg | B. No.: MT212218 Mfg dt: 06/2021 | Dissolution | Drug Control Department | RDTL Guwahati |
Exp dt: 05/2023 Mfd by: M/s Mascot Health Series Pvt. Ltd., Plot No. 79, 80, Sec. -6A, IIE, Sidcul, Haridwar – 249403, Uttarakhand. | Assam | ||||
23. | Dexamethasone Tablets I.P. 0.5mg | B. No.: DXMT-1003 Mfg dt: 05/2020 Exp dt: 04/2023 Mfd by: M/s Wings Biotech, 43 & 44, HPSIDC, Industrial Area, Baddi - 173205, Himachal Pradesh. | Assay | Drug Control Department Jharkhand | RDTL Guwahati |
24. | METRONIDAZOLE TABLETS I.P. | B. No.: MT-21D20 Mfg dt: 04/2021 Exp dt: 03/2023 Mfd by: M/s Martin & Brown Bio-sciences K. No. 918/419, Malkumajra, Nalagarh Road, Baddi, Distt. Solan, Himachal Pradesh. | Dissolution | Drug Control Department Jharkhand | RDTL Guwahati |
25. | Metronidazole Tablets IP | B. No.: DMRT-02 Mfg dt: 04/2021 Exp dt: 03/2024 Mfd by: M/s SGS PHARMACEUTICALS (P) LTD, E-13/1, Sector - 17, Kavi Nagar Indl. Area, Ghaziabad-201002, Uttar Pradesh. | Dissolution | Drug Control Department Jharkhand | RDTL Guwahati |
26. | Enteric Coated Rabeprazole Sodium & Domperidone SR Capsules | B. No.: JC-20726 Mfg dt: 07/2020 Exp dt: 06/2022 Mfd by: M/s Jineka Healthcare Pvt. Ltd., 15, Sector 6-B, IIE, Ranipur, Haridwar- | Assay of Rabeprazole Sodium | Drug Control Department Mizoram | RDTL Guwahati |
249403, Uttarakhand. | |||||
27. | Rosuvastatin Calcium Tablets IP 10mg | B. No.: 21S1GTA035 Mfg dt: 01/2021 Exp dt: 12/2022 Mfd by: M/s SYNOKEM PHARMACEUTICALS LTD. Plot No.: 35-36, Sector-6A, I.I.E.(SIDCUL), Ranipur (BHEL), Haridwar-249403, Uttarakhand. | Dissolution | Drug Control Department Assam | RDTL Guwahati |
28. | Omeprazole Gastro-resistant Capsules I.P. | B. No.: 520-170 Mfg dt: 07/2020 Exp dt: 06/2022 Mfd by: M/s ZEE LABORATORIES, 47, Industrial Area, Paonta Sahib – 173025, Himachal Pradesh. | Dissolution | Drug Control Department Assam | RDTL Guwahati |
29. | Doxofylline Tablets IP 400mg | B. No.: SPTG-20390 Mfg dt: 08/2020 Exp dt: 07/2022 Mfd by: M/s SPECTRUM FORMULATION PVT. LTD, Khasra No. 12, Makhanpur, Bhagwanpur, Roorkee, Haridwar – Uttarakhand. | Dissolution | CDSCO Sub-Zone Guwahati | RDTL Guwahati |
30. | Dexamethasone Tablets I.P. 0.5mg | B. No.: DPO2004 Mfg dt: 08/2020 Exp dt: 07/2022 Mfd by: M/s Danish Health Care (P) Ltd. 76/27-28, Industrial Estate, Maxi Road, Ujjain - 456010, Madhya Pradesh, INDIA. | Assay | Drug Control Department Jharkhand | RDTL Guwahati |
31. | BUPRENORPHINE INJECTION I.P. | B. No.: LM 18870 Mfg dt: 012/2020 Exp dt: 011/2026 Mfd by: M/s Cooper pharma Ltd. C-3, Industrial Area, Selaqui, Dehradun- 248197, Uttarakhand. | Assay | Drug Control Department Bihar | RDTL Guwahati |
32. | BUPRENORPHINE INJECTION I.P. | B. No.: LM 18730 Mfg dt: 08/2018 Exp dt: 07/2024 Mfd by: M/s Cooper pharma Ltd., C-3, Industrial Area, Selaqui, Dehradun- 248197, Uttarakhand. | Assay | Drug Control Department Bihar | RDTL Guwahati |
33. | ODIMONT-AL (Montelukast, Levocetirizine HCl & Ambroxol HCl (SR) Tablets) | B. No.: GZOA21003 Mfg dt: 11/2021 Exp dt: 10/2023 Mfd by: M/s GKM New Pharma. Plot No.5, 6, 7 & 8, Pipdic Electronic Park, Thirubuvanai, Puducherry- 605 107. | Dissolution | CDSCO Sub-Zone Goa | CDTL Mumbai |
34. | Fluconazole Capsules I.P. 150 mg | B. No.: 4700821 Mfg dt: 11/2021 Exp dt: 10/2023 Mfd by: M/s Karnataka Antibiotics & Pharmaceutical Pvt. Ltd., Plot No.14, II Phase, Peenya, Bengaluru - 560 058. | Uniformity of weight | CDSCO Zonal Office Ahmedabad | CDTL Mumbai |
35. | Methylcobalamin, Alpha Lipoic Acid, Pyridoxine HCI and Folic Acid Capsules (VEMIFOL PLUS CAPSULES) | B. No.: SOC-1911A Mfg dt: 02/2022 Exp dt: 01/2024 Mfd by: M/s Symbiosis Pharmaceuticals Pvt. Ltd. (Plant-3) Plant at: Trilokpur Road, Kala Amb-173030, Himachal Pradesh. | Assay of Alpha Lipoic Acid | CDSCO Sub-Zone Baddi | RDTL Chandigarh |
Marketed by: VIVEX PHARMACEUTICALS PVT. LTD. SCO 131, Sector-110, TDI City, Mohali, SAS Nagar- 140307. | |||||
36. | Iron (III) Hydroxide Polymaltose Complex with Folic Acid Syrup (POLY- FORTE SYRUP) | B. No.: DLK-071C Mfg dt: 11/2021 Exp dt: 04/2023 Mfd by: M/s Digital Vision 176, Mauza Ogli, Nahan Road, Kala-Amb, Distt. Sirmour, Himachal Pradesh -173030. Marketed by: ORISON PHARMACEUTICALS 51, Industrial Estate, Ambala Cantt- 133006. | Assay of Folic Acid | CDSCO Sub-Zone Baddi | RDTL Chandigarh |
37. | Diclofenac Diethylamine, Methyl Salicylate, Linseed Oil and Menthol Gel (ARMNAC GEL) | B. No.: 017 Mfg dt: 02/2022 Exp dt: 01/2024 Mfd by: M/s GMH Laboratories Plot No. 13, Industrial Township, Bhatoli Kalan, Baddi, Distt. Solan, Himachal Pradesh -173205. | Assay of Linseed Oil | CDSCO Sub-Zone Baddi | RDTL Chandigarh |
38. | Doxofylline Tablets IP 400 mg (DOXOSIGN TABLETS) | B. No.: 994-09 Mfg dt: 06/2021 Exp dt: 05/2024 Mfd by: M/s HAB PHARMACEUTICALS & RESEARCH LIMITED 10, Pharmacity, SIDCUL, Selaqui, Dehradun – 248011, Uttrakhand. | Dissolution | CDSCO North-Zone | RDTL Chandigarh |
39. | Ondansetron Injection IP (ONET INJECTION) | B. No.: EA11107 Mfg dt: 11/2021 Exp dt: 10/2023 | Sterility | CDSCO Sub-Zone Baddi | RDTL Chandigarh |
Mfd by: M/s Elder Labs Limited Vill: Kishanpura, Baddi- Nalagarh Road, Baddi, Distt.-Solan, Himachal Pradesh - 174101. | |||||
40. | Cloxacillin Sodium Capsules IP 500 mg (CLOXRID-500 CAPSULES) | B. No.: CLO-2003 Mfg dt: 07/2020 Exp dt: 06/2022 Mfd by: M/s RIDLEY LIFE SCIENCE PVT . LTD. D-1651, DSIDC Indl. Complex, Narela, Delhi-110040. | Identification | CDSCO North-Zone | RDTL Chandigarh |
41. | Amlodipine Tablets IP (AMLOTIS-10 TABLETS) | B. No.: 2113452T001 Mfg dt: 06/2021 Exp dt: 05/2023 Mfd by: M/s Scott-Edil Pharmacia Ltd. Unit- II, Plot No. 21-22, E.P.I.P., Phase-1, Jharmajri, Baddi, Distt. Solan-173205, Himachal Pradesh, INDIA. | Assay | CDSCO Sub-Zone Baddi | RDTL Chandigarh |
