CDSCO flags 34 drugs for failing quality test; Details
New Delhi: The apex drug regulator, Central Drugs Standard Control Organization (CDSCO) has flagged 34 batches of medicines for failing quality tests in January, including Sun Pharmaceutical Ltd's Valaciclovir Hydrochloride, Hydrated Ph. Eur; Zydus Healthcare Ltd's Depotex 16 mg (Methylprednisolone Tablets IP) and others.
The CDSCO recently issued an alert, stating that the regulator tested 1177 drug samples in January. Out of this, 1143 samples were declared as of Standard Quality while 34 drug samples failed to clear the test. The drug samples failed the quality test due to lack of assay content, dissolution, uniformity of volume and presence of particulate matter in the injection.
The samples were tested in various laboratories in Kolkata, Chandigarh, Guwahati and Mumbai. The samples were drawn by CDSCO in Mumbai, Kerala, Assam, Indore, Arunanchal Pradesh, Ghaziabad, Ahmedabad, Bangalore, Mizoram and Jammu.
The formulations mentioned in the list include drugs indicated for treating obesity, mental illness, bacterial infection, arthritis and others. The details read;
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. | Absorbent Cotton Wool I.P., | B. No.: A/1812, Mfg dt: 12/2018, Exp dt: 11/2021, Mfd by: M/s. Altus Surgical Pvt. Ltd., 21/D, Mahagujarat Ind. Estate, Sarkhej-Bavla Road, Moraiya, Ahmedabad. | Water Soluble Substances and Sulphated Ash Content | CDSCO, Ahmedabad | CDL, Kolkata |
2. | Ranitidine Injection I.P. | B. No.: RI-138, Mfg dt: 12/2018, Exp dt: 11/2020, Mfd by: M/s. Rathi Laboratories (Hindustan) Pvt. Ltd. Industrial Area, Patna- 800013. | Particulate matter | CDSCO, North Zone, Ghaziabad | CDL, Kolkata |
3. | REGUNAC – 50 (Diclofenac Gastro- Resistant Tablets I.P. 50 mg) | B. No.: FZ57F801, Mfg dt: 06/2018, Exp dt: 05/2021, Mfd by: M/s. Zim Laboratories Limited, B- 21/22, MIDC Area, Kalmeshwar -441 501, Dist. Nagpur, Maharashtra. | Description | CDSCO, East Zone, Kolkata | CDL, Kolkata |
4. | Diclofenac Sodium Tablets I.P. | B. No.: DF-R008, Mfg dt: 02/2019, Exp dt: 01/2021, Mfd by: M/s. Bengal Chemicals & Pharmaceuticals Ltd., 115-C, Industrial Estate, Pologround, Indore – 452 015. | Disintegration | CDSCO, East Zone, Kolkata | CDL, Kolkata |
5. | Fluconazole Tablets | B. No.: TOH-02, Mfg dt: 04/2019, Exp dt: 03/2021, Mfd by: M/s. Om Biomedic Pvt. Ltd., Plot No. 68,69, 82 & 83, Sector -6A, Sidcul, Haridwar – 249403 (Uttarakhand). | Uniformity of Dispersion | CDSCO, East Zone, Kolkata | CDL, Kolkata |
6. | THEOIMMUNE (Pro-Biotic Capsules) | B. No.: GC190060, Mfg dt: 02/2019, Exp dt: 01/2021, Mfd by: M/s. Theon Pharmaceuticals Ltd., Vill: Saini Majra, Tehsil Nalagarh, Dist. Solan, Himachal Pradesh -174 101. | Assay of Streptococus faecalis, Clostridium butyricum, Bacillus mesentericus, and Lactic Acid bacillus | CDSCO, East Zone, Kolkata | CDL, Kolkata |
7. | Pantoprazole Gastro- resistant Tablets I.P. | B. No.: T-6988, Mfg dt: 08/2018, Exp dt: 07/2020, Mfd by: M/s. Kwality Pharmaceuticals Ltd., Nagkalan, Majitha Road, Amritsar Punjab. | Description | CDSCO, Sub-Zone, Guwahati | CDL, Kolkata |
8. | 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.) | Water, Dissolution and Assay | CDSCO, Bangalore | CDL, Kolkata |
9. | Gabapentin Tablets IP 300 Mg | B. No.: STN-181861, Mfg dt: 03/2019, Exp dt: 02/2021, Mfd by: M/s. Terrace Pharmaceuticals (P) | Description and Related substances | Drug Control Office District- Bilaspur | RDTL, Chandigarh |
|
| Ltd. 3-B (a), Phase-III, Industrial Area Sansarpur Terrace, Distt. Kangra ( H.P)-176501 |
| (H.P.) |
|
10. | (Amoxycillin Dispersible Tablets IP 250 mg ) | B. No.: LBT-1578, Mfg dt: 03/2019, Exp dt: 09/2020, Mfd by: M/s. Legen Healthcare, Plot No.20, Sector -5, Parwanoo, Distt.Solan.(H.P.) 173 220 | Uniformity of Dispersion | Drug Control Office District - Mandi (H.P.) | RDTL, Chandigarh |
11. | Albendazole Tablets IP 400MG | B. No.: 8600219, Mfg dt: 01/2019, Exp dt: 12/2021, Mfd by: M/s. Karnataka Antibiotics & Pharmaceuticals Limited Plot no.14, II Phase, Peenya, Bangalore- 560058. | Dissolution | Drug Control Office Ghaziabad (UP) | RDTL, Chandigarh |
12. | Albendazole Tablets IP 400 MG | B. No.: ABTW-05, Mfg dt: 01/2019, Exp dt: 12/2021, Mfd by: M/s. Nestor Pharmaceuticals Limited 11, Western Extension Area, Faridabad-121001 (Haryana). | Dissolution | Drug Control Office Ghaziabad (UP) | RDTL, Chandigarh |
13. | Albendazole Tablets IP 400 MG | B. No.: 8600119, Mfg dt: 01/2019, Exp dt: 12/2021, Mfd by: M/s. Karnataka Antibiotics & Pharmaceuticals Limited Plot No.14, II Phase, Peenya, Bangalore- 560058. | Dissolution | CDSCO, Sub-Zone, Jammu | RDTL, Chandigarh |
14. | Dom-H (Domperidone Suspension) | B. No.: 1801, Mfg dt: 03/2018, Exp dt: 02/2020, Mfd by: M/s. Harsh Healthcare 100-101, Industrial Area Rau- 453331 Madhya Pradesh. | Assay | Drugs Control Department, Arunachal Pradesh | RDTL, Guwahati |
15. | Albendazole Tablets I.P. | B. No.: 8491015, | Dissolution | Drugs | RDTL, |
| 400mg | Mfg dt: 03/2019, Exp dt: 02/2021, Mfd by: M/s. Bengal Chemicals & Pharmaceuticlas Ltd. 164, Maniktala Main Road, Kolkata-700054. |
| Control Department, Arunachal Pradesh | Guwahati |
16. | Albendazole Tablets I.P. 400mg | B. No.: 9622, Mfg dt: 02/2019, Exp dt: 01/2022, Mfd by: M/s. Orissa Drugs & Chemicals Ltd. 1, Mancheswar Industrial Estate, Bhubaneswar Odisha. | Dissolution | Drugs Control Department, Arunachal Pradesh | RDTL, Guwahati |
17. | Frusemide Tablets I.P. 40 mg. (Rasix) | B. No.: 7127, Mfg dt: 06/2017, Exp dt: 05/2020, Mfd by: M/s.Ramson Remedies 186-187, Insustrial Focal Point, Amritsar, A.O. 2G Floor, Baktawar, Malabar Hill, Mumbai-6. | Dissolution | Drugs Control Department, Arunachal Pradesh | RDTL, Guwahati |
18. | Nimesulide Tablets 100mg | B. No.: NP17016, Mfg dt: 09/2017, Exp dt: 08/2020, Mfd by: M/s. Navketan Pharma Pvt. Ltd., F-106, MIDC, Waluj, Aurangabad-431136 Maharashtra. | Dissolution | Drugs Control Department, Arunachal Pradesh | RDTL, Guwahati |
19. | Telmisartan Tablets I.P. 40mg | B. No.: TMA1001, Mfg dt: 02/2019, Exp dt: 01/2021, Mfd by: M/s. Sai Mirra Innopharm Pvt. Ltd. 288 & 299, SIDCUL Estate, Ambattur, Chennai- 600098 Tamilnadu. | Dissolution | Drugs Control Department, Arunachal Pradesh | RDTL, Guwahati |
20. | Ferrous Sulphate and Folic Acid Tablets I.P. | B. No.: IFTJ18028, 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 |
21. | Preginate (Doxylamine | B. No.: ZD18715, | Adulterated | Drugs | RDTL, |
Succinate and Pyridoxine Hydrochloride Tablets) | Mfg dt: 07/2018, Exp dt: 06/2020, Mfd by: M/s. Skymap Pharmaceuticals Pvt. Ltd. B-3, Dev Bhoomi Industrial Estate Puhana, Iqbalpur Road, Roorkee- 247667Uttarakhand. | Control Department, Nagaland | Guwahati | ||
22. | Radin Syrup (Ranitidine Oral Solution I.P.) | B. No.: S18J025, Mfg dt: 10/2018, Exp dt: 09/2020, Mfd by: M/s. Shri Hari Pharmaceuticals Plot No. 767/1, Vadsar- Motibhoyan Road, Vill- Vadsar- 382721, Taluka, Kalol, Dist- Gandhinagar, Gujarat. | Assay | Drugs Control Department, Mizoram | RDTL, Guwahati |
23. | Paracetamol Tablets I.P. 650 (Cule 650) | B. No.: TPT-190266, Mfg dt: 02/2019, Exp dt: 01/2021, Mfd by: M/s. Talwar Pharma Jhabrera Road, Kurdi, Manglour- 247656, Roorkee, Dist- Haridwar Uttarakhand. | Dissolution | Drugs Control Department, Assam | RDTL, Guwahati |
24. | Dressipad (1 Surgical Dressing 10cm. X 10cm.) | B. No.: KSCD-29, Mfg dt: 01/2019, Exp dt: 12/2021, Mfd by: M/s.K.S. Surgical Pvt. Ltd. Vill- Begmabad, Budhana, Unchi Sadak, Modi Nagar, U.P. | Sterility test | Drugs Control Department, Kerala | RDTL, Guwahati |
25. | Dressipad (1 Surgical Dressing 10cm. X 10cm.) | B. No.: KSCD-12, Mfg dt: 11/2017, Exp dt: 10/2020, Mfd by: M/s. K.S. Surgical Pvt. Ltd. Vill- Begmabad, Budhana, Unchi Sadak, Modi Nagar, U.P. | Sterility test | Drugs Control Department, Kerala | RDTL, Guwahati |
26. | Vitamin B-complex Tablet (Prophylactic) NFI (III) | B. No.: T8605, Mfg dt: 12/2018, Exp dt: 05/2020, Mfd by: M/s. Zest Pharma, Plot No.275, Sector F, Sanwer Road, | Assay of Vitamin B1 | Drugs Inspector, CDSCO, Sub Zone, Indore | CDTL, Mumbai |
|
| Indore (M.P.) 452015. |
|
|
|
27. | Depotex 16 mg (Methylprednisolone Tablets IP) | B. No.: AFV1010, Mfg dt: 03/2019, Exp dt: 02/2021, Mfd by: M/s. Zydus Healthcare Ltd., Manufatured at : Vill. Saini Majra, Nalagarh- Ropar Road, Nalagarh, Distt.: Solan-HP. | Dissolution | CDSCO, West Zone, Mumbai | CDTL, Mumbai |
28. | Olmemark-40 (Olmesartan Medoxomil Tablet IP 40 mg) | B. No.: TPT8689, Mfg dt: 06/2018, Exp dt: 05/2020, Mfd by: M/s. Trugen Pharmaceuticals Pvt. Ltd., Village-Tejjupur, Near Chodiala Rly. Station Roorkey, Dist- Haridwar (UK)- 247661. | Dissolution | CDSCO, Sub Zone, Indore. | CDTL, Mumbai |
29. | Decodil Expectorant | B. No.: LF19008, Mfg dt: 02/2019, Exp dt: 01/2021, Mfd by: M/s. Ortin Laboratories Ltd., 275 & 278 (part) I.D.A. Pashamilaram 502307, Sanga Reddy Dist. Telangana. | pH | CDSCO, West Zone, Mumbai | CDTL, Mumbai |
30. | Ampicillin Capsules I.P. 250 mg | B. No.: CB181217, Mfg dt: 12/2018, Exp dt: 11/2020, Mfd by: M/s. Micron Pharmaceuticals, 2117, A-2, Phase III, G.I.D.C, Vapi-396195, Gujarat. | Assay | CDSCO, West Zone, Mumbai | CDTL, Mumbai |
31. | Valaciclovir Hydrochloride, Hydrated Ph. Eur. | B. No.: AA41927, Mfg dt: 05/2019, Exp dt: 04/2022, Mfd by: M/s. Sun Pharmaceutical Industries Limited, Industrial Area No.3, Dewas 455001 Madhya Pradesh. | Related Substances | CDSCO, Sub Zone, Indore. | CDTL, Mumbai |
32. | Valaciclovir Hydrochloride, Hydrated Ph. Eur. | B. No.: AA41926, Mfg dt: 04/2019, Exp dt: 03/2022, Mfd by: M/s. Sun Pharmaceutical | Related Substances | CDSCO, Sub Zone, Indore. | CDTL, Mumbai |
|
| Industries Limited, Industrial Area No.3, Dewas 455001 M.P. |
|
|
|
33. | Oral Rehydration Salts IP | B. No.: GP19127, Mfg dt: 02/2019, Exp dt: 01/2022, Mfd by: M/s. Globela Pharma Pvt. Ltd., 357, 358 GIDC, Sachin, Surat-394230, Gujarat. | Assay for Potassium | CDSCO, West Zone, Mumbai | CDTL, Mumbai |
34. | Oral Rehydration Salts IP | B. No.: GP19128, Mfg dt: 02/2019, Exp dt: 01/2022, Mfd by: M/s. Globela Pharma Pvt. Ltd., 357, 358 GIDC, Sachin, Surat-394230, Gujarat. | Assay for Potassium | CDSCO, West Zone, Mumbai | CDTL, Mumbai |
Also Read: Drug Alert: CDSCO Declares 49 Drug Samples As Not Of Standard Quality; Details
For more details click on the below:
Disclaimer: This site is primarily intended for healthcare professionals. Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement or prescription. Use of this site is subject to our terms of use, privacy policy, advertisement policy. © 2020 Minerva Medical Treatment Pvt Ltd