Drug alert: CDSCO flags 48 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) flagged 48 medicine batches for failing to qualify a random drug sample test for the month of March.
These drugs samples which are declared not of standard quality include Skymap Pharmaceuticals' Trimetazidine Modified Release Tablets, Hindustan Antibiotics' Doxycycline Capsules, Calcium and Vitamin D3 Tablets IP, Theon Pharmaceutical's Trypsin, Bromelain & Rutoside Trihydrate Tablets.
In addition to this, the list also includes TINVISTA 300 (Tinidazole Tablets IP 300 mg) manufactured by Cadila Pharmaceutical and MAYCOXIA-90 (Etoricoxib Tablets IP) manufactured by Akums Drugs & Pharmaceuticals.
This came after analysis and test were conducted by the CDSCO, Drugs Control Departments on 1454 samples. Out of this, 1406 samples were found of standard quality while 48 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 Disintegration test, failure of the dissolution test, failure of the sterility test.
The samples collected were tested in four laboratories, namely CDL Kolkata, CDTL Mumbai, RDTL Chandigarh,RDTL Guwahati.
List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, for the Month of March – 2022.
Total number of samples tested | 1454 |
Total number of samples declared as of Standard Quality | 1406 |
Total number of samples declared as Not of Standard Quality | 48 |
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. | Doxycycline Hydrochloride Capsules I.P. 100 mg | B. No.: 2002 Mfg dt: 05/2021 Exp dt: 04/2023 Mfd by: M/s. Super Formulations Pvt. Ltd., 16-B & 15-F, Industrial Area, Maxi Road, Ujjain -456 010 Madhya Pradesh. | Assay | CDSCO Visakhapatnam | CDL Kolkata |
2. | Cetirizine Tablets I.P. | B. No.: 104021 Mfg dt: 06/2021 Exp dt: 05/2023 Mfd by: M/s. Ciron Drugs & Pharmaceuticals Pvt. Ltd., Plot No. 35 to 37, 43 to 45, CFC-B, Dewan Udyog Nagar, Aliyali Palghar, Distt. Palghar- 401 404 Maharashtra. | Related Substances | CDSCO Guwahati | CDL Kolkata |
3. | Rolled Bandage | B. No.: A116 Mfg dt: 11/2020 Exp dt: 10/2023 Mfd by: M/s. Anamika Udyog, 127, Multan Nagar, Meerut (India) Uttar Pradesh. | Threads per dm, Weight in (gm/m2), Foreign Matter, Fluorescence | CDSCO Sub Zone Guwahati | CDL Kolkata |
4. | Doxycycline Capsules I.P. 100 mg | B. No.: C-2106006 Mfg dt: 06/2021 Exp dt: 05/2023 Mfd by: M/s. Rivpra | Assay | CDSCO Ahmedabad | CDL Kolkata |
Formulation Pvt. Ltd., Plot No. 8, Sector-6A, I.I.E., SIDCUL, Haridwar - 249403 Uttarakhand. | |||||
5. | Gatoline-100 (Doxycycline Capsules I.P.) | B. No.: CC-200140 Mfg dt: 12/2020 Exp dt: 11/2022 | Assay | CDSCO South Zone Chennai | CDL Kolkata |
Mfd by: M/s. CMG | |||||
Biotech Pvt. Ltd., 58, | |||||
Industrial Area, Phase | |||||
III, Sansarpur Terrace, | |||||
Himachal Pradesh – | |||||
176501. | |||||
6. | Byzyme (Pepsin & Fungal Diastase Syrup), 200ml | B. No.: ZA20781 Mfg dt: 10/2020 Exp dt: 03/2022 | Assay | CDSCO South Zone Chennai | CDL Kolkata |
Mfd by: M/s. Skymap Pharmaceuticals Pvt. Ltd. B-3, Dev Bhoomi Industrial Estate Puhana Iqbalpur Road, Roorkee -247667 Uttarakhand. | |||||
7. | Vitamin A, Vitamin D3, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Calcium Pantothanate, Niacinamide, Vitamin C & Folic Acid Tablets | B. No.: GMB 21 Mfg dt: 03/2021 Exp dt: 08/2022 Mfd by: M/s. Medline Pharmaceuticals Pvt. Ltd., Plot No. 2 & 3, 1st Main Road, EVP Prabhu Avenue, Chinnakulathuvancherr yChennai 600 122. | Description & Assay of 'Vitamin D3', 'Riboflavin', & 'Calcium Pantothanate'. | CDSCO South Zone Chennai | CDL Kolkata |
8. | Bunase 0.5 Respules (Budesonide Nebuliser Suspension BP) | B. No.: RS1195 Mfg dt: 11/2021 Exp dt: 10/2023 Mfd by: M/s. Aishwarya Healthcare, Village Thana, Baddi, Himachal Pradesh – 173 205. | Related Substances | CDSCO South Zone Chennai | CDL Kolkata |
9. | Compound Benzoin Tincture I.P. | B. No.: W-02 Mfg dt: 05/2021 Exp dt: 04/2023 Mfd by: M/s. Walllis Pharmaceuticals, K- 25, Thakur Complex, SDA Compound, | Weight per ml, Ethanol Content, Total Solids and Assay | CDSCO South Zone Chennai | CDL Kolkata |
Lasudia Mori, Indore Madhya Pradesh. | |||||
10. | BENUGOLD (Methylcobalamin, Alpha Lipoic Acid, Pyridoxine, Benfotiamine, Biotin & Chromium Polynicotinate Capsule) | B. No.: MHD-1611 Mfg dt: 01/2021 Exp dt: 12/2022 Mfd by: M/s. Medinok Healthcare Pvt. Ltd., R.S. No. 2/1, Plot No. 87, 88, 89 Vazhudhavur Main Road, Kurumbapet, Puducherry -605009. | Assay of Alpha Lipoic Acid | CDSCO South Zone Chennai | CDL Kolkata |
11. | Cloxacillin Capsules I.P. 250 mg | B. No.: CNC2001 Mfg dt: 03/2020 Exp dt: 02/2022 | Dissolution & Assay | CDSCO South Zone Chennai | CDL Kolkata |
Mfd by: M/s. Modern Laboratories, 45-47, Sector D-2, Sanwer Road, Indore, Madhya Pradesh - 452015, India. | |||||
12 | Trimetazidine Modified Release Tablets | B. No.: GM20134 Mfg dt: 11/2020 Exp dt: 10/2022 | Description | CDSCO South Zone Chennai | CDL Kolkata |
Mfd by: M/s. Skymap Pharmaceuticals Pvt. Ltd., B-3, Dev Bhoomi Industrial Estate, Puhana Iqbalpur Road, Roorkee -247667 Uttarakhand. | |||||
13. | Amikacin Injection IP 100 mg / 2 ml- 2 ml | B. No.: P1317 Mfg dt: 05/2021 Exp dt: 04/2023 | Description & Particulate Matter | CDSCO South Zone Chennai | CDL Kolkata |
Mfd by: M/s. Bharat Parenterals Ltd., Survey No. 144 & 146 Jarod-Samlaya Road, Tal. Savli, City: Haripura, Dist. Vadodara – 391 520, Gujarat, India. | |||||
14. | Dicyclomine Hydrochloride Injection I.P. 2 ml | B. No.: HLI471D Mfg dt: 04/2021 Exp dt: 03/2023 | Description & Particulate Matter | CDSCO East Zone Kolkata | CDL Kolkata |
Mfd by: M/s. Himalaya Meditek Private Limited, Plot No. 35 & 36, Pharmacity, |
Selaqui Industrial Area, Dehradun 248197 Uttarakhand. | |||||
15. | Finasteride Tablets I.P. 5 mg | B. No.: FNST901 Mfg dt: 06/2021 Exp dt: 05/2023 | Dissolution | CDSCO East Zone Kolkata | CDL Kolkata |
Mfd by: M/s. Unicure India Ltd., C-21, 22 & 23, Sector – 3, Noida - 201 301, Dist. Gautam Budh Nagar, Uttarpradesh. | |||||
16. | Doxycycline Capsules I.P. 100 mg | B. No.: DXCY-02 Mfg dt: 05/2021 Exp dt: 04/2023 | Assay | CDSCO East Zone Kolkata | CDL Kolkata |
Mfd by: M/s. Hindustan Antibiotics Ltd., At 11, W.R.A., Faridabad – 121 001, Haryana. | |||||
17. | Methylcobalamin Tablets 500 mcg | B. No.: MBT 904 Mfg dt: 05/2021 Exp dt: 04/2023 | Assay | CDSCO East Zone Kolkata | CDL Kolkata |
Mfd by: M/s. Unicure India Ltd., C-21, 22 & 23, Sector – 3, Noida - 201 301, Dist. Gautam Budh Nagar, Uttar Pradesh. | |||||
18. | THYROZED 25 (THYROXINE SODIUM TABLETS I.P. 25 mcg) | B. No.: 2021035 Mfg dt: 09/2021 Exp dt: 08/2023 Mfd by: M/s. BVK's Bioscience Pvt. Ltd., Plot No. 789, Rakanpur Ind Area, Rakanpur, Ta-Kalol, Dist. Gandhinagar – 382721, Gujarat, India. | Assay | CDSCO East Zone Kolkata | CDL Kolkata |
19. | Calcium and Vitamin D3 Tablets IP (500 mg + 250 IU) (Calcium 500 mg & Vitamin D3 250 IU) | B. No.: CWTY-103 Mfg dt: 02/2021 Exp dt: 01/2023 Mfd by: M/s. Hindustan Antibiotics Ltd., 11, | Dissolution & Assay of Vitamin D3 | CDSCO East Zone Kolkata | CDL Kolkata |
W.E.A. Faridabad – | |||||
121 001, Haryana. | |||||
20. | Queencath (Female Catheter, Size 12 fr) | B. No.: UCCGL01 Mfg dt: 12/2020 Exp dt: 11/2023 | Sterility | CDSCO South Zone Chennai | CDL Kolkata |
Mfd by: M/s. Morrisons Lifecare Pvt. Ltd. No. 3, Anna Street, Padikuppam, Chennai – 600 107. | |||||
21. | Trypsin, Bromelain & Rutoside Trihydrate Tablets | B. No.: GT201572 Mfg dt: 11/2020 Exp dt: 10/2022 Mfd by: M/s. Theon Pharmaceutical Ltd., Vill. Saini Majra, Tehsil Nalagarh, Dist. Solan, Himachal Pradesh – 174 101. | Description Length Thickness and Width | CDSCO West Zone Mumbai | CDTL Mumbai |
22. | Telione - 40 (Telmisartan Tablets IP) | B. No.: THG210385 Mfg dt: 07/2021 Exp dt: 06/2023 | Uniformity of weight | CDSCO West Zone Mumbai | CDTL Mumbai |
Mfd by: M/s. Theon | |||||
Pharmaceutical Ltd., | |||||
Vill. Saini Majra, Tehsil | |||||
Nalagarh, Dist. Solan, | |||||
Himachal Pradesh - | |||||
174 101. | |||||
23. | MelaXone Plus (Meloxicam & Paracetamol Injection) | B. No.: PLUS 21-004 Mfg dt: 07/2021 Exp dt: 06/2023 Mfd by: M/s. Venkateshwara | Particulate Contamination | CDSCO West Zone Mumbai | CDTL Mumbai |
Hatcheries Pvt. Ltd., | |||||
(Ventri Biologicals | |||||
Vaccine Division), Plot | |||||
No. 20, International | |||||
Biotech Park, Phase II, | |||||
Hinjewadi, Pune- | |||||
411 057, Maharashtra. | |||||
24. | TINVISTA 300 (Tinidazole Tablets IP 300 mg) | B. No.: JKGJ20001 Mfg dt: 03/2020 Exp dt: 02/2024 | Disintegration | CDSCO West Zone Mumbai | CDTL Mumbai |
Mfd by: M/s. Cadila | |||||
Pharmaceutical Ltd., | |||||
Industrial Growth | |||||
Center, SIDCO, | |||||
Samba- 184 121, State | |||||
of Jammu & Kashmir. |
25. | MAYCOXIA-90 (Etoricoxib Tablets IP) | B. No.: OBZB02 Mfg dt: 07/2021 Exp dt: 06/2023 Mfd by: M/s. Akums Drugs & Pharmaceuticals Ltd., 19, 20, 21, Sector 6A, I.I.E, SIDCUL, Ranipur, Haridwar- 249403, Uttarakhand. | Dissolution | CDSCO West Zone Mumbai | CDTL Mumbai |
26. | Aspirin Gastro- resistant Tablets I.P. 150 mg | B. No.: APET901 Mfg dt: 05/2021 Exp dt: 04/2023 Mfd by: M/s. Unicure India Ltd., C-21, 22 & 23, Sector-3, Noida- 201301, Distt. Gautam Budh Nagar Uttar Pradesh. | Salicylic Acid | CDSCO West Zone Mumbai | CDTL Mumbai |
27. | Telmisartan 40 mg and Hydrochlorothiazide 12.5 mg Tablets IP (TELMA H TABLETS) | B. No.: 20DDT-035 Mfg dt: 12/2020 Exp dt: 11/2023 Mfd by: M/s. Dallas Drugs Pvt.Ltd. 156, D.I.C., Ind.Area Baddi, Distt. Solan, Himachal Pradesh -173205. | Assay of Telmisartan | Drug Control Department Delhi | RDTL Chandigarh |
28. | Esomeprazole with Domperidone Tablets (ESSOF-D TABLETS) | B. No.: APT-10-1524 Mfg dt: 10/2021 Exp dt: 09/2023 Mfd by: M/s. ADWIN PHARMA Vill. Rampur Jattan, Trilokpuri Road, Kala-Amb, Tehsil-Nahan, Distt. Sirmour, Himachal Pradesh -173030. | Assay | Drug Control Department Jammu & Kashmir | RDTL Chandigarh |
29. | Zolpidem Tartrate E.R. Tablets IP 12.5 mg (SOO FRESH-CR-12.5 TABLETS) | . B. No.: TPT-0627 Mfg dt: 06/2021 Exp dt: 05/2023 Mfd by: M/s. Tanpal Pharmaceuticals D- 12-13, Focal Point, Nabha 147201, Punjab. | Dissolution | Drug Control Department Delhi | RDTL Chandigarh |
30. | Isotretinoin Capsules IP (VISOTIN-10 CAPSULES) | B. No.: VPS-21407D Mfg dt: 11/2021 Exp dt: 10/2024 Mfd by: M/s. VIDHYASHA Pharmaceuticals 28, Industrial Area, Johron Trilokpur Road, Kala Amb, Distt. Sirmour Himachal Pradesh - 173030. | Assay | Drug Control Department Himachal Pradesh | RDTL Chandigarh |
31. | Calcitriol and Calcium Capsules (BIO-D3 PLUS CAPSULES) | B. No.: ACB2008A Mfg dt: 09/2020 Exp dt: 08/2023 Mfd by: M/s. MACLEODS PHARMACEUTICALS LTD. Village Theda, P.O. Lodhimajra, Tehsil Baddi, Dist. Solan, Himachal Pradesh, India- 174101. | Assay of Calcitriol | Drug Control Department Delhi | RDTL Chandigarh |
32. | Olmesartan Medoxomil and Amlodipine Tablets (OLMISAVE AM-40 TABLETS) | B. No.: CT11211 Mfg dt: 12/2020 Exp dt: 11/2022 Mfd by: M/s. Cosmas Pharmacls Ltd. Buranwala Road, Village: Kotla, P.O.: Barotiwala, Solan Himachal Pradesh - 174103. | Assay | Drug Control Department Jammu & Kashmir | RDTL Chandigarh |
33. | VETERINARY INJECTION IP VET. (5 OXYTOCIN UNITS/ML, 0.5 W/V CHLORBUTOL PHENOL IP | B. No.: 01 Mfg dt: 02/2021 Exp dt: 01/2023 Mfd by: M/s. NEELAM CHEMICAL WORKS B.O.M.G. Road, Bada Bazar, Kolkata-7. | Particulate matter, Sterility and the Assay of Oxytocin Activity | Drug Control Department Delhi | RDTL Chandigarh |
34. | OXYTOCIN INJECTION (VET) OXYTOCIN 5 IU/ML, 0.5% W/V PHENOL OR CHLOROBUTOL IP | B. No.: 04 Mfg dt: 01/2022 Exp dt: 12/2024 Mfd by: M/s. Super Vaishali Laboratories R.B. Road, Bihar Pin: | Particulate matter, Sterility and the Assay of Oxytocin Activity | Drug Control Department Delhi | RDTL Chandigarh |
823001 | |||||
35. | OXYTOCIN INJECTION IP (VET) 10 OXYTOCIN UNIT PER ML, 0.5% W/V PHENOL IP | B. No.: Not Mentioned Mfg dt: N.M. Exp dt: N.M. Mfd by: M/s. Super Vaishali Address: Not Mentioned | Particulate matter, Sterility and the Assay of Oxytocin Activity | Drug Control Department Delhi | RDTL Chandigarh |
36. | Ibuprofen and Paracetamol Tablets IP (IBUCON TABLETS) | B. No.: PTA/07-27 Mfg dt: 07/2021 Exp dt: 06/2023 Mfd by: M/s.Progressive Lifesciences Pvt. Ltd. Latherdevahoon, P.O. Jhabrera, Roorkee, Distt. Haridwar- 247665, Uttarakhand. | Assay | Drug Control Department Himachal Pradesh | RDTL Chandigarh |
37. | Lignocaine Hydrochloride Gel IP (LIGNOMARK JELLY) | B. No.: E1C060 Mfg dt: 03/2021 Exp dt: 02/2023 | Assay | CDSCO Sub Zone Jammu | RDTL Chandigarh |
Mfd by: M/s. Smayan | |||||
Healthcare Pvt. Ltd. | |||||
Plot No. 26-27, | |||||
HPSIDC Indl. Area Vill. | |||||
Davni, Baddi, Distt. | |||||
Solan, Himachal | |||||
Pradesh -173205. | |||||
38. | FENTANYL INJECTION IP | B. No.: I -1646 Mfg dt: 09/2021 Exp dt: 08/2023 Mfd by: M/s. Jackson Laboratories Pvt. Ltd. 22-24, Majitha Road, Bye Pass, Amritsar- 143001 (India) Punjab. | Particulate matter Bacterial Endotoxins and Sterility | CDSCO Sub Zone Jammu | RDTL Chandigarh |
39. | Intravenous Infusion Set | B. No.: 201061 Mfg dt: 05/2020 Exp dt: 04/2025 Mfd by: M/s. Lars Medicare Private Limited, Kila No.: 16- 17, Sultanpur, Opp. Sports Authority of India, Near Bahalgarh Chowk, Sonepat- | Description, kinking of the tubing & Leakage Test | Drug Control Department Kerala | RDTL Guwahati |
131021, Haryana (India). | |||||
40. | Paracetamol Tablets IP | B. No.: LPST-004 Mfg dt: 05/2021 Exp dt: 04/2024 Mfd by: M/s. Laborate Pharmaceuticals India Ltd.(Unit-II), #31, Rajban Road, Nariwala, Paonta Sahib, Himachal Pradesh. | Dissolution | Drug Control Department Assam | RDTL Guwahati |
41. | Rabeprazole Tablets IP 20mg | B. No.: PLO7AK04 Mfg dt: 05/2020 Exp dt: 04/2022 Mfd by: M/s. Akums | Dissolution | Drug Control Department Arunachal Pradesh | RDTL Guwahati |
Drugs & | |||||
Pharmaceuticals Ltd., | |||||
Plot No.-26A, 27-30, | |||||
Sector 8A, I.I.E., | |||||
Sidcul, Haridwar- | |||||
249403, Uttarakhand. | |||||
42. | Ofloxacin and Ornidazole Tablets I.P. | B. No.: UUF2002 Mfg dt: 02/2020 Exp dt 07/2022 Mfd by: M/s. Coral | Dissolution | Drug Control Department Arunachal Pradesh | RDTL Guwahati |
Laboratories Ltd., Plot | |||||
No. 27/28, Pharmacity, | |||||
Selaqui, Dehradun- | |||||
248197, Uttarakhand, | |||||
India. | |||||
43. | SNEZEE 500 TAB Paracetamol IP 500 mg Phenylephrine HCI IP 5 mg Caffeine IP 30 mg Diphenhydramine HCI IP 25 mg | B. No.: TP-0121843 Mfg dt: 01/2021 Exp dt 12/2022 Mfd by: M/s. Maxrelief Health Care, Vill: Anji, Solan, Himachal Pradesh- 173212. | Assay | Drug Control Department Jharkhand | RDTL Guwahati |
44. | METRONIDAZOLE TABLETS I.P. | B. No.: MT-20E12 Mfg dt: 05/2020 Exp dt 04/2022 | Dissolution | Drug Control Department Jharkhand | RDTL Guwahati |
Mfd by: M/s. MARTIN & BROWN BIO- SCIENCES, K.No. 918/419, Malkumajra, Nalagarh Road, Baddi, Distt. Solan, Himachal |
Pradesh. | |||||
45. | Amoxicillin and Potassium Clavulanate Tablets IP | B. No.: T-22286 Mfg dt: 05/2020 Exp dt: 04/2022 Mfd by: M/s. Jackson | Assay | Drug Control Department Jharkhand | RDTL Guwahati |
Laboratories Pvt. Ltd., | |||||
22-24, Majitha Road, | |||||
Bye Pass, Amritsar- | |||||
143001 Punjab (India). |
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