CDSCO Drug Alert: 48 drug samples flagged 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 48 medicine batches for failing to qualify random drug sample test for the month of March– 2023.
These drugs samples include Telmisartan Tablets manufactured by Ridley Life Sciences, Domperidone Tablets manufactured by Karnataka Antibiotics & Pharmaceuticals, Pioglitazone Hydrochloride Tablets manufactured by Skymap Pharmaceutical, Domperidone Tablets manufactured by Rivpra Formulation, Gabapentin Tablets manufactured by Synokem Pharmaceuticals and Mascot Health Series, Rolled Bandage (Non Sterilized, Size 15cm x 4 mts manufactured by Disha Surgicals, Dactinomycin for Injection USP 0.5 mg by Celon Laboratories, Iron and Folic Acid Tablets I.P. manufactured by Nestor Pharmaceuticals and others.
In addition to this, the names of the Meswak (Toothpaste for complete Tooth and Gum Care) manufactured by Dabur India Limited, ALGLIMET M1 (Glimepiride 1 mg & Metformin 500 mg Tablets SR) manufactured by Alves Healthcare, Pheniramine Maleate Tablets manufactured by Dabur India Limited, MEROXIA Nano Injection 1 gm (Meropenem Injection I.P.) manufactured by Oscar Remedies, Diphenhydramine HCl, Ammonium- Chloride and Sodium Citrate Cough Expectorant manufactured by Hindustan Laboratories are also on the list.
Furthermore, drug major Glenmark's Telma-AM Tablet (Telmisartan 40 mg and Amlodipine 5 mg Tablets IP) is also on the list of drugs failed to qualify random drug sample test.
Speaking to Medical Dialogues, Glenmark spokesperson said, "We have investigated the matter and found that the TELMA AM Tablets (Telmisartan 40 mg and Amlodipine 5 mg Tablets IP) batch number 18220076 from the NSQ list of “March 2023 Month Drugs Alert” are counterfeit medicines and have not been manufactured by Glenmark. We have requested the CDSCO to take action on this and also made an appeal for removal of the product from the drug alert list."
"As a responsible manufacturer, we have provided proactive information and leads to all concerned regulatory officials from time to time. Additionally, we have taken the necessary measures, which include engaging an external agency to investigate the presence of counterfeit drugs across the country," the company's spokesperson added.
The list came after analysis and tests were conducted by the CDSCO, Drug Control Departments on 1497 samples. Out of this, 1449 samples were found of standard quality were 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 assays, failure of the dissolution test, failure of the disintegration test, failure of pH and identification test, failure of clarity test, failure of specific assay of drug test and others.
The samples collected were tested in CDTL Kolkata, RDTL Chandigarh, CDTL Chennai, CDTL Mumbai, RDTL Guwahati.
List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded for the Month of March –2023.
Total number of samples tested | 1497 |
Total number of samples declared as of Standard Quality | 1449 |
48 | |
Total number of samples declared as Spurious | - |
Total number of samples declared as Misbranded | - |
S.No | Name of Drugs/medical device/cosmetic s | Batch No./Date of Manufacture/Date of Expiry/Manufactured By | Reason for failure | Drawn By | From |
1. | Telmirid-40 (Telmisartan Tablets I.P. 40 mg) | B. No.: RT220651 Mfg dt: 08/2022 Exp dt: 07/2024 Mfd by: M/s. Ridley Life Sciences Pvt. Ltd., D- 1651, DSIDC, Indl. Complex, Narela, Delhi 110 040. | Dissolution | CDSCO, East Zone Kolkata | CDTL Kolkata |
2. | Domperidone Tablets I.P. 10 mg | B. No.: 3100422 Mfg dt: 07/2022 Exp dt: 06/2025 Mfd by: M/s. Karnataka Antibiotics & Pharmaceuticals Limited, Plot No. 14 II Phase, Peenya, Bengaluru – 560 058. | Related Substances | CDSCO East Zone Kolkata | CDTL Kolkata |
3. | Pioglitazone Hydrochloride Tablets IP 30 mg | B. No.: GM21077 Mfg dt: 08/2021 Exp dt: 07/2023 Mfd by: M/s. Skymap Pharmaceuticals Pvt. Ltd., B-3, Dev Bhoomi Industrial Estate, Puhana Iqbalpur Road, Roorkee -247667 Uttarakhand.. | Dissolution | CDSCO East Zone Kolkata | CDTL Kolkata |
4. | Domperidone Tablets I.P. 10 mg | B. No.: T-2203140 Mfg dt: 03/2022 Exp dt: 02/2024 Mfd by: M/s. Rivpra Formulation Pvt. Ltd., Plot No. 8, Sector -6A, I.I.E. Sidcul, Haridwar – | Related Substances | CDSCO East Zone Kolkata | CDTL Kolkata |
249 403 Uttarakhand. | |||||
5. | Domperidone Tablets I.P. 10 mg | B. No.: T-2203139 Mfg dt: 03/2022 Exp dt: 02/2024 Mfd by: M/s. Rivpra Formulation Pvt. Ltd., Plot No. 8, Sector -6A, I.I.E. Sidcul, Haridwar – 249 403 Uttarakhand. | Related Substances | CDSCO East Zone Kolkata | CDTL Kolkata |
6. | Gabapentin Tablets I.P. | B. No.: 22S1GTB467 Mfg dt: 11/2022 Exp dt: 10/2024 Mfd by: M/s. Synokem Pharmaceuticals Ltd., Plot No. 35-36, Sector- 6A, I.I.E (SIDCUL), Ranipur (BHEL), Haridwar – 249 403, Uttarakhand. | Related Substances | CDSCO East Zone Kolkata | CDTL Kolkata |
7. | Gabon-300 Tablets (Gabapentin Tablets I.P.) | B. No.: MT225040 Mfg dt: 11/2022 Exp dt: 10/2024 Mfd by: M/s. Mascot Health Series Pvt. Ltd., Plot No. 79, 80, Sec - 6A, I.I.E., (SIDCUL), Haridwar – 249 403, Uttarakhand, India. | Related Substances | CDSCO East Zone Kolkata | CDTL Kolkata |
8. | Rolled Bandage (Non Sterilized, Size 15cm x 4 mts.) | B. No.: 637 Mfg dt: 03/2022 Exp dt: 02/2024 Mfd by: M/s. Disha Surgicals Pvt. Ltd., 145, Sai Puram, Delhi Road, Meerut - 250002 Uttar Pradesh. | Threads per dm (Warp & Weft), Weight in gm per m2 & Fluorescence | CDSCO West Zone Mumbai | CDTL Kolkata |
9. | Absorbent Cotton Wool I.P. | B. No.: 636 Mfg dt: 10/2022 Exp dt: 2 years from Mfd by: M/s. Jajoo Surgicals Pvt. Ltd., Unit 1: 61A/62, Industrial Area No. 3, A.B. Road, Dewas -455001 (MP), | Surface Active Substances, Sinking Time & Sulphated ash | CDSCO West Zone Mumbai | CDTL Kolkata |
India, Unit 2: 82-B-83C, Industrial Area No. 1, A.B. Road, Dewas – 455 001 (MP), India. | |||||
10. | DACILON 0.5 (Dactinomycin for Injection USP 0.5 mg) | B. No.: DMI2243AC Mfg dt: 12/2022 Exp dt: 11/2025 Mfd by: M/s. Celon Laboratories Pvt. Ltd., Plot No.2, ALEAP Industrial Estate, Gajularamaram, Medchal Dist. 500090, Telangana State, India. | Appearance & Assay | CDSCO Hyderabad | CDTL Kolkata |
11. | Rivastigmine Tartarate | B. No.: 20201201 Mfg dt: Nil Exp dt: Nil Mfd by: M/s. Nil | Identification Assay & Water | CDSCO Hyderabad | CDTL Kolkata |
12. | Ritonavir | B. No.: Nil Mfg dt: Nil, Exp dt: Nil, Mfd by: M/s. Nil | Specific Optical Rotation, Water Content, Related Substances, Identification, Assay | CDSCO Hyderabad | CDTL Kolkata |
13. | Iron and Folic Acid Tablets I.P. | B. No.: IQTZ-371 Mfg dt: 12/2022 Exp dt: 11/2024 Mfd by: M/s. Nestor Pharmaceuticals Limited, 11, Western Extension Area, Faridabad – 121 001, India. | Description, Assay and Uniformity of Content of Folic Acid | CDSCO Zonal Office Ahmedabad | CDTL Kolkata |
14. | (DUCOLAX) Bisacodyl Tablet I.P. 5 mg | B. No.: 220259 Mfg dt: 02/2022 Exp dt: 01/2025 Mfd by: M/s. Modi Antibiotics, Plot No. 28, G.I.D.C., Odhav, Ahmedabad 382415, Gujarat. | Assay and Dissolution | CDSCO West Zone Mumbai | CDTL Kolkata |
15. | ALGLIMET M1 (Glimepiride 1 mg & Metformin 500 mg Tablets SR) | B. No.: AT22068 Mfg dt: 03/2022 Exp dt: 02/2024 Mfd by: M/s. Alves Healthcare Pvt. Ltd., | Assay and Dissolution of Glimepiride | CDSCO West Zone Mumbai | CDTL Kolkata |
Nangal Uperia, Swarghat Road, Nalagarh, Distt. Solan – 174 101, Himachal Pradesh, India | |||||
16. | Meswak (Toothpaste for complete Tooth and Gum Care) | B. No.: BM0637 Mfg dt: 07/2022 Exp dt: 07/2024 Mfd by: M/s. Dabur India Limited, Village Monakpur, Tehsil Baddi, Dist.: Solan , Himachal Pradesh –174 101 | Total Bacterial Count and Test for Pathogens | CDSCO West Zone Mumbai | CDTL Kolkata |
17. | MEROXIA Nano Injection 1 gm (Meropenem Injection I.P.) | B. No.: D220162 Mfg dt: 01/2022 Exp dt: 12/2023 Mfd by: M/s. Oscar Remedies Pvt. Ltd., Oskar House, Badi Majra, Yamunanagar - 135 001,Haryana. | Assay of Meropenem & Content of Sodium | CDSCO South Zone Chennai | CDL Kolkata |
18. | Vitamin B Complex Tablets | B. No.: RT-220598 Mfg dt: 05/2022 Exp dt: 10/2023 Mfd by: M/s. Relief Biotech Pvt. Ltd., Khasra No. 72, Makhyali Dundi, Peerpura Road, Roorkee Bypass, Delhi Road, Manglour, Roorkee - 247656, Haridwar, Uttarakhand. | Description and Assay of Thiamine Hydrochloride | CDSCO North Zone Ghaziabad | CDL Kolkata |
19. | APVIL (Pheniramine Maleate Tablets I.P.) | B. No.: RT220155 Mfg dt: 02/2022 Exp dt: 01/2025 Mfd by: M/s. Ridley Life Science Pvt. Ltd., D- 1651, DSIDC, Indl. Complex, Narela, Delhi 110040. | Assay of Pheniramine Maleate | CDSCO East Zone Kolkata | CDL Kolkata |
20. | VASOCON 1 ml (Adrenaline Bitartrate Injection I.P.) | B. No.: KP85229 Mfg dt: 07/06/2022 Exp dt: 06/06/2023 Mfd by: M/s. Neon | Description and Particulate Matter | Drug Control Department Jammu | CDL Kolkata |
Laboratories Ltd., At Shantisthal, Plot No. 1- 5, At & post: Shirgaon, Tal Palghar, Dist. Thane - 401 407, Maharashtra. | & Kashmir | ||||
21.. | Hydrocort -100 (Hydrocortisone Sodium Succinate Injection I.P. 100 mg) | B. No.: AQH0039 Mfg dt: 07/2022 Exp dt: 06/2024 Mfd by: M/s. Aqua Vitoe Laboratories Plot No. 4, Village Kunjhal near Jharmajri Baddi, Dist. Solan 173205, Himachal Pradesh, India. | Clarity of Solution | Drug Control Department Jammu & Kashmir | CDL Kolkata |
22. | Lycopene with Vitamins and Minerals Syrup (CARORICH Syrup) | B. No.: NL-22057 Mfg dt: 08/2022 Exp dt: 01/2024 Mfd by: M/s. H.L. Healthcare Pvt. Ltd., Plot No. 25, Ind. Area, Phase-II, Gagret-177 201, Himachal Pradesh. | Assay of Vitamin E Acetate. | Drug Control Department Himachal Pradesh | RDTL Chandigarh |
23. | Aceclofenac, Paracetamol and Thiocolchicoside Tablets (ELFEN- TH4 TABLETS) | B. No.: T-220621 Mfg dt: 06/2022 Exp dt: 05/2024 Mfd by: M/s. Vilin Bio Med Ltd, Unit-II, Khasra No. 85, Madhopur Hazarathpur, Roorkee- 247667, Uttarakhand. | Assay of Aceclofenac and Thiocolchicoside | CDSCO North Zone | RDTL Chandigarh |
24. | Vitamin C Injection IP and Vitamin B12, Folic Acid and Niacinamide Injection (Eldervit-12) | B. No.: JBJM-099 Mfg dt: 11/2022 Exp dt: 10/2024 Mfd by: M/s. JBJM Parenterals Pvt. Ltd,, P- 24, Site-5, UPSIDC Industrial Area, Kasna, Greater Noida-201310, Uttar Pradesh. | Assay of Folic Acid. | CDSCO North Zone | RDTL Chandigarh |
25. | Nirmatrelvir Tablets 150 mg and Ritonavir Tablets IP 100 mg Combipack | B. No.: (A) NR-2204 (B) RT- 2204 Mfg dt: 07/2022 Exp dt: 06/2024 Mfd by: M/s. Neutral | Uniformity of weight, Identification and Assay of Nirmatrelvir. | Drug Control Department Delhi | RDTL Chandigarh |
(Primovir Tablets) | Code: HP/06/176, Marketed by: Astrica HealthCare Pvt Itd. Plot No: 9-18/5, First Floor, Bharathi Nagar, Temple Alwal, Medchal, Telangana-500010. | ||||
26. | Vitamin C, Vitamin B12, Folic Acid and Niacinamide Injection (Eldervit-12) | B. No.: JE-07 Mfg dt: 12/2022 Exp dt: 11/2024 Mfd by: M/s. SVP Lifesciences SARA Industrial Estate, Sector C 10/1, Selaqui, Rampur, Dehradun, U.K. | Identification and Assay of Folic Acid. | CDSCO North Zone | RDTL Chandigarh |
27. | Vitamin C, Vitamin B12, Folic Acid and Nicotinamide Injection (Eldervit -12 Injection) | B. No.: RA2008 Mfg dt: 02/2022 Exp dt: 01/2024 Mfd by: M/s. Ronam Healthcare Pvt. Ltd., Village - Kalujhanda, Tehsil- Baddi, Distt.- Solan (H.P.) 174103. | Assay of Folic Acid | CDSCO Sub-Zone | RDTL Chandigarh |
28. | Vitamin C, Vitamin B12, Folic Acid and Nicotinamide Injection (Eldervit -12 Injection) | B. No.: RA2156 Mfg dt: 12/2022 Exp dt: 11/2024 Mfd by: M/s. Ronam Healthcare Pvt. Ltd., Village - Kalujhanda, Tehsil- Baddi, Distt.- Solan (H.P.) 174103. | Assay of Folic Acid | CDSCO Sub-Zone | RDTL Chandigarh |
29. | Diphenhydramine HCl, Ammonium- Chloride and Sodium Citrate Cough Expectorant | B. No.: LDS2005AL Mfg dt: 12/2022 Exp dt: 05/2024 Mfd by: M/s. HINDUSTAN LABORATORIES, LIMITED, Plot No. 5-9, Survey No. 38/2, Aliyali, Palghar (W), Dist – Palghar 401404, Maharashtra. | Assay of Menthol | CDSCO Sub-Zone | RDTL Chandigarh |
30. | Pre and Probiotic | B. No.: HPH 207 | Identification and | CDSCO | RDTL |
Capsules | Mfg dt: 04/2022 Exp dt: 02/2024 Mfd by: M/s. Med Manor Organics Pvt. Ltd., Unit- II, K.No. 143M/7, Village-Raipur, Pargana- Bhagwanpur, Tehsil- Roorkee, Distt. Haridwar, Uttarakhand- 247 661. | Assay of Streptococcus faecalis | North Zone | Chandigarh | |
31. | Vitamin C Injection IP and Vitamin B12, Folic Acid and Nicotinamide Injection (Eldervit-12 Injection) | B. No.: EP-0916 Mfg dt: 10/2022 Exp dt: 09/2024 Mfd by: M/s. E.G Pharmaceuticals, Vill. Mandhala, Teh. Kasauli Distt. Solan, Himachal Pradesh. | Particulate matter | CDSCO North Zone | RDTL Chandigarh |
32. | Telmisartan 40 mg and Amlodipine 5 mg Tablets IP (Telma-AM Tablets) | B. No.: 18220076 Mfg dt: 01/2022 Exp dt: 12/2024 Mfd by: M/s. Glenmark Pharmaceuticals Ltd., Samlik Marchak, Industrial Growth Centre, East Sikkim, Sikkim-737135. | Dissolution of Telmisartan | Drug Control Department Delhi | RDTL Chandigarh |
33. | Metronidazole Tablets IP 400 mg | B. No.: 3000421 Mfg dt: 03/2021 Exp dt: 02/2024 Mfd by: M/s. Karnataka Antibiotics & Pharmaceuticals Ltd., Plot No.14, II Phase, Peenya, Bengaluru-560058. | Dissolution. | CDSCO Subzone Bangalore | CDTL Chennai |
34. | BACLOX-400 (Norfloxacin Tablets IP) | B. No.: AUT-22002 Mfg dt: 08/2022 Exp dt: 07/2025 Mfd by: M/s. Supermax Laboratories, Plot No.40, Pharmacity Selaqui Industrial Area, Dehradun- 248011. | Dissolution | CDSCO West- Zone Mumbai. | CDTL, Mumbai |
35. | ODIMONT-AL (Montelukast, Levocetirizine HCl & Ambroxol HCl (SR) Tablets) | B. No.: GZOA22002 Mfg dt: 11/2022 Exp dt: 10/2024 Mfd by: M/s. GKM New Pharma Spl. Type Plot No. 5, 6, 7 & 8, Pipdic Electronic Park, Thirubuvanai Puducherry- 605 107. | Assay and Dissolution of Montelukast | CDSCO West-Zone | CDTL, Mumbai |
36. | Voglibose Tablets IP 0.2mg | B.No.: 1121-27 Mfg dt: 10/2022 Exp dt: 09/2024 Mfd by: M/s HAB Pharmaceuticals & Research Ltd., 10, Pharmacity, SIDCUL, Selaqui, Dehradun- 248011 | Test for Assay | Sub-zone, Indore | CDTL, Mumbai |
37. | Lactuedge (Lactulose Solution USP) | B. No.: GA22005 Mfg dt: 02/2022 Exp dt: 01/2024 Mfd by: M/s. Skymap Pharmaceuticals Pvt. Ltd., B-3, Dev Bhoomi Industrial Estate, Puhana Iqbalpur Road, Roorkee- 247 667. | Assay and Organic Impurities | CDSCO West-Zone | CDTL, Mumbai |
38. | Albendazole Tablets IP | B. No.: MS4AI2202 Mfg dt: 09/2022 Exp dt: 08/2025 Mfd by: M/s. MAXTAR BIO-GENICS, Khasra No. 705, Vill. Malku Majra, Nalagarh Road , Baddi, Distt. Solan – 173205, Himachal Pradesh, India. | Dissolution | Drug Control Department Meghalaya | RDTL Guwahati |
39. | Amoxycillin, Cloxacillin & Lactic Acid Bacillus Capsules Amoxynol Plus | B. No.: PRB-220203 Mfg dt: 02/2022 Exp dt: 01/2024 Mfd by: M/s. Preet Remedies Ltd. | Assay of Cloxacillin | Drug Control Department Jharkhand | RDTL Guwahati |
LB | 183-186, HPSIDC, Industrial Area, Baddi- 173205- Himachal Pradesh. | ||||
40. | Ascorbic Acid Tablets IP 500mg | B. No.: T392012 Mfg dt: 01/2022 Exp dt: 12/2023 Mfd by: M/s. ANG Lifesciences India Ltd. Village Malkumajra, Nalagarh Road, Baddi, Distt. Solan- 173205, Himachal Pradesh. | Description | Drug Control Department Assam | RDTL Guwahati |
41. | CIPROFLOXACI N HYDROCHLORI DE TABLETS I.P. 500 mg | B. No.: 0701122 Mfg dt: 05/2022 Exp dt: 04/2025 Mfd by: M/s. KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LIMITED, Plot No. 14, II Phase, Peenya, Bengaluru – 560 058. | Dissolution | Drug Control Department Jharkhand | RDTL Guwahati |
42. | Calcium & Vitamin D3 Tablets I. P. | B. No.: RT-221004 Mfg dt: 10/2022 Exp dt: 03/2024 Mfd by: M/s. Relief Biotech Pvt. Ltd. Khasra No. 72, Makhyali Dundi, Peerpura Road, Roorkee, Byepass, Deli Road, Manglour, Roorkee-247656, Haridwar, Uttarakhand. | Identification and Assay of Vitamin D3 | Drug Control Department Bihar | RDTL Guwahati |
43. | Calcium & Vitamin D3 Tablets I. P. (Calcidoc-500) | B. No.: T2030158A Mfg dt: 03/2022 Exp dt: 02/2024 Mfd by: M/s. ION Healthcare Pvt. Ltd. Baddi – Barotiwala Road, Baddi, Distt. Solan, Himachal Pradesh - 173205. | Assay of Vitamin D3 | Drug Control Department Jharkhand | RDTL Guwahati |
44. | Calcium & Vitamin D3 Tablets I.P. | B. No.: RT-221008 Mfg dt: 10/2022 Exp dt: 03/2024 | Assay of Vitamin D3 | Drug Control Department | RDTL Guwahati |
Mfd by: M/s. Relief Biotech Pvt. Ltd. Khasra No. 72, Makhyali Dundi, Peerpura Road, Roorkee Bypass, Delhi Road, Manglour, Roorkee-247656, Haridwar, Uttarakhand. | Bihar | ||||
45. | O2 (Ofloxacin & Ornidazole Tablets I.P.) | B. No.: E20034 Mfg dt: 01/2022 Exp dt: 12/2024 Mfd by: M/s. Medley Pharmaceutical Ltd. Lane No. 3, Phase-1, SIDCO Industrial Complex, Bari Brahmama, Jammu- 181133. | Identification and Assay of Ofloxacin & Ornidazole | Drug Control Department Assam | RDTL Guwahati |
46. | CIPROFLOXACI N HYDROCHLORI DE TABLETS I.P. 500 mg | B. No.: KA3202 Mfg dt: 01/2022 Exp dt: 12/2024 Mfd by: M/s. Karnataka Antibiotics & Pharmaceuticals Limited, Plot No. 37, Site No.34/4, NTTF Main Road, II Phase, Peenya, Bengaluru – 560058, India. | Dissolution | Drug Control Department Jharkhand | RDTL Guwahati |
47. | ALCIFLOX 500 (Ciprofloxacin Tablets I.P.) | B. No.: ACT22004SL Mfg dt: 02/2022 Exp dt: 01/2025 Mfd by: M/s. Shiva Biogenetic Laboratories Pvt. Ltd. village Manpura, Baddi, Dist. Solan, Himachal Pradesh- 174101. | Dissolution | Drug Control Department Jharkhand | RDTL Guwahati |
48. | Telmisartan Tablets IP 40 mg | B. No.: T101004 Mfg dt: 09/2021 Exp dt: 08/2023 Mfd by: M/s. ANG Lifesciences India Ltd. Village Malkumajra, Nalagarh Road, Baddi, Distt. Solan- 173205- Himachal Pradesh. | Dissolution & Description | Drug Control Department Bihar | RDTL Guwahati |
