39 drug samples including Glenmark Telma H fail to clear CDSCO test, 1 declared misbranded
New Delhi: In its latest drug safety alert, the apex drug regulatory body, the Central Drugs Standard Control Organization (CDSCO), has flagged 39 medicine batches for failing to qualify for a random drug sample test for the month of February, while 1 drug sample has been declared misbranded.
These drugs samples which are declared not of standard quality include Ortin Laboratory's Lapril-5 (Enalapril Maleate Tablets IP 5 mg), Vitcal - AC (Calcium Acetate Tablets U.S.P.), Zyst-P (Pantoprazole Sodium Tablets IP), Theon Pharmaceutical's Trypsin, Bromelain & Rutoside Trihydrate Tablets, Hindustan Antibiotics' Cetirizine Syrup I.P. 5 mg / 5 ml – 60ml etc.
In addition, other popular drug samples that are declared not of standard quality include Misoprostol Tablets I.P. 200 mcg manufactured by Cotec Healthcare, Omeprazole Capsules I.P. 20 mg manufactured by Kausikh Therapeutics, Atorvastatin Tablets IP (OZOVAS-10 TABLETS) manufactured by Ozone Pharmaceuticals.
Apart from that, Glenmark's Telma H Tablet, a combination of two medicines, Telmisartan 40 mg and Hydrochlorothiazide 12.5 mg, is also on the list, which is used to manage high blood pressure.
This came after analysis and tests conducted by the CDSCO Drugs Control Department on 1221 samples. Out of these, 1181 samples were found to be of standard quality while 39 of them were declared as Not of Standard Quality (NSQ) and 1 drug was declared misbranded.
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, failure of the sterility test, failure of Vitamin D3 assay, failure of assay etc.
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 February – 2022.
Total number of samples tested | 1221 |
Total number of samples declared as of Standard Quality | 1181 |
Total number of samples declared as Not of Standard Quality | 39 |
Total number of samples declared as Spurious | 0 |
Total number of samples declared as Misbranded | 1 |
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. | Lapril-5 (Enalapril Maleate Tablets IP 5 mg) | B. No.: GA21011 Mfg dt: 06/2021 Exp dt: 05/2023 Mfd by: M/s. Ortin Laboratories Ltd., 275 & 278, (part), I.D.A., Pashamylaram- 502307, Sanga Reddy, Dist. Telangana. | Assay and Dissolution | CDSCO West Zone Mumbai | CDTL Mumbai |
2. | Erythromycin EP | B. No.: EB0121086A Mfg dt: 12/2021 Exp dt: 11/2024 Mfd by: M/s. Unimax Chemicals Pvt. Ltd., E-116, MIDC, Tarapur, Boisar, Dist. Palghar- 401506, Maharashtra. | Assay | CDSCO West Zone Mumbai | CDTL Mumbai |
3. | Vitcal - AC (Calcium Acetate Tablets U.S.P.) | B. No.: KQ20003 Mfg dt: 07/2020 Exp dt: 06/2022 Mfd by: M/s. Ortin Laboratories Limited, 275 & 278 (Part) I.D.A., Pashamylaram - 502307, Sangareddy District, Telangana State, India. | Dissolution | CDSCO West Zone Mumbai | CDL Kolkata |
4. | Trypsin, Bromelain & Rutoside Trihydrate Tablets | B. No.: GT200466 Mfg dt: 03/2020 Exp dt: 02/2022 Mfd by: M/s. Theon Pharmaceuticals Ltd., | Description & Disintegration | CDSCO West Zone Mumbai | CDL Kolkata |
Vill. Saini Majra , Teh. Nalagarh, Distt. Solan, Himachal Pradesh- 174101. | |||||
5. | Compound Sodium Lactate Injection IP (Ringer Lactate Injection Solution for Injection) | B. No.: 107008 Mfg dt: 07/2021 Exp dt: 06/2023 Mfd by: M/s. Ives Drugs (India), Pvt. Ltd., Works Ghatabillod, Dist.- Dhar, H.O. 504, Chetak Centre, R.N.T. Marg, Indore, Madhya Pradesh – 452 001. | Sterility | Drug Control Department Odisha | CDL Kolkata |
6. | Secremet -1 (Metformin Hydrochloride Prolonged-Release & Glimepiride Tablets I.P.) | B. No.: 210110 Mfg dt: 02/2021 Exp dt: 01/2023 Mfd by: M/s. Bal Pharma Limited, Plot No. 1, 2, 3, & 69, Sector - 4, IIE, SIDCUL, Pantnagar, Rudrapur, Distt. Udham Singh Nagar, Uttarakhand. | Assay of Glimepiride | CDSCO Hyderabad | CDL Kolkata |
7. | Lactospey | B. No.: LSC010 Mfg dt: 04/2020 Exp dt: 03/2022 | Assay of Bifidobacteriu m species | CDSCO Hyderabad | CDL Kolkata |
Mfd by: M/s. Unique Biotech Ltd. | |||||
8. | Lapril-5 (Enalapril Maleate Tablets I.P. 5 mg) | B. No.: GA20005 Mfg dt: 03/2020 Exp dt: 02/2022 | Dissolution & Assay | CDSCO South Zone Chennai | CDL Kolkata |
Mfd by: M/s. Ortin Laboratories Ltd., 275 & 278 (Part), I.D.A. Pashamylaram - 502307, Sanga Reddy Dist.Telangana, India. | |||||
9. | Omeprazole Capsules I.P. 20 mg | B. No.: K0220016 Mfg dt: 02/2020 Exp dt: 01/2022 | Assay & Dissolution | CDSCO South Zone Chennai | CDL Kolkata |
Mfd by: M/s. Kausikh Therapeutics (P) Ltd., Plot No. 6 & 7, Door No. 728, Kakkanji Cross Street, Paraniputhur Road, Gerugambakkam, |
Chennai - 600 128. | |||||
10. | Omeprazole Capsules I.P. 20 mg | B. No.: K0220017 Mfg dt: 02/2020 Exp dt: 01/2022 | Assay & Dissolution | CDSCO South Zone Chennai | CDL Kolkata |
Mfd by: M/s. Kausikh Therapeutics (P) Ltd., Plot No. 6 & 7, Door No. 728, Kakkanji Cross Street, Paraniputhur Road, Gerugambakkam, Chennai - 600 128. | |||||
11. | Misoprostol Tablets I.P. 200 mcg | B. No.: CHT-1086 Mfg dt: 04/2021 Exp dt: 03/2023 | Assay | CDSCO South Zone Chennai | CDL Kolkata |
Mfd by: M/s. Cotec Healthcare Pvt. Ltd., KH. No. 593/1, Roorkee Dehradun Highway, Kishanpur, Roorkee - 247667, Haridwar, Uttarakhand, India. | |||||
12. | Cetirizine Syrup I.P. 5 mg / 5 ml – 60ml | B. No.: L2106027 Mfg dt: 06/2021 Exp dt: 05/2023 | Description & pH | CDSCO South Zone Chennai | CDL Kolkata |
Mfd by: M/s. Hindustan Antibiotics Ltd., C-2 & C-3,Sara Industrial Estate, Rampur, Selaqui, Dehradun, Uttarakhand. | |||||
13. | Zyst-P (Pantoprazole Sodium Tablets IP) | B. No.: FK21001 Mfg dt: 03/2021 | Dissolution | CDSCO East Zone Kolkata | CDL Kolkata |
Exp dt: 02/2023 | |||||
Mfd by: M/s. Ortin | |||||
Laboratories Limited, | |||||
275 & 278 (Part) | |||||
I.D.A., Pashamylaram | |||||
- 502307, Sangareddy | |||||
District, Telangana | |||||
State, India. | |||||
14. | Losartan Tablets I.P. 25 mg | B. No.: 3800221 Mfg dt: 02/2021 | Dissolution | CDSCO East Zone Kolkata | CDL Kolkata |
Exp dt: 01/2024 | |||||
Mfd by: M/s. Karnataka Antibiotics & Phamacetucials |
Limited, Plot No. 14, II Phase, Peenya, Bengaluru 560058. | |||||
15. | Domperidone Tablets I.P. 10 mg | B. No.: 2105031 Mfg dt: 05/2021 Exp dt: 04/2023 Mfd by: M/s. Adroit Pharmaceuticals Pvt. Ltd., At: 46, Garoba Maidan, Nagpur, 440008- Maharashtra. | Related Substances | CDSCO East Zone Kolkata | CDL Kolkata |
16. | Domperidone Tablets I.P. 10 mg | B. No.: T141001 Mfg dt: 07/2021 Exp dt: 06/2023 Mfd by: M/s. ANG Lifesciences India Ltd., Village Malkumajra, Nalagarh Road, Baddi, Distt. Solan 173205, Himachal Pradesh. | Assay | CDSCO East Zone Kolkata | CDL Kolkata |
17. | Balgesic Plus (Aceclofenac & Paracetamol Tablets) | B. No.: 200291 Mfg dt: 08/2021 Exp dt: 07/2023 | Assay of Aceclofenac | CDSCO East Zone Kolkata | CDL Kolkata |
Mfd by: M/s. Bal Pharma Limited, Plot No. 1, 2, 3 & 69, Sector - 4, IIE Sidcul, Pantnagar, Rudrapur, Distt. Udham Singh Nagar, Uttarakhand, India. | |||||
18. | Meropenem Injection IP 500 mg (MEROMAX INJECTION) | B. No.: 4731Z002 Mfg dt: 02/2021 Exp dt: 01/2023 Mfd by: M/s. Scott-Edil Advance Research Laboratories & Education Ltd. Hill Top Ind. Area Bhatoli Kalan, Baddi – 173205, Himachal Pradesh. | Related Substances | CDSCO Sub- Zone Baddi | RDTL Chandigarh |
19. | Calcium with Vitamin D3 Tablets IP (SHELCAL-500 TABLETS) | B. No.: GAVB0034 Mfg dt: 01/2021 Exp dt: 12/2022 Mfd by: M/s. Pure & Cure Healthcare Pvt. | Assay of Vitamin D3 and uniformity of weight | Drug Control Department Delhi | RDTL Chandigarh |
Ltd. Plot No.26A-30, | |||||
Sector 8A, IIE, |
SIDCUL, Ranipur, Haridwar-249403 - Uttarakhand. | |||||
20. | PHENYTOIN SODIUM INJECTION USP | B. No.: PTS-155A Mfg dt: 10/2021 Exp dt: 09/2023 Mfd by: M/s. PUSHKAR PHARMA Bhandariwala, Kheri, Kala-Amb-173030 – Himachal Pradesh. | pH | CDSCO Sub- Zone Jammu | RDTL Chandigarh |
21. | Sucralfate and Oxetacaine Oral Suspension (1g, 20mg/10 ml) (SUCRAMAL- O SUSPENSION ) | B. No.: P2AWU001 Mfg dt: 06/2021 Exp dt: 05/2023 Mfd by: M/s. Pharma Force Lab (Unit-II) Plot No. 85 & 86, | Assay of Oxetacaine | Drug Control Department Pora, Kulgam, Jammu & Kashmir | RDTL Chandigarh |
Industrial Area, | |||||
Gondpur, Tehsil | |||||
Paonta Sahib, District | |||||
Sirmour, Himachal | |||||
Pradesh-173205, | |||||
INDIA. | |||||
22. | Calcium Citrate, Vitamin D3, Magnesium Hydroxide and Zinc Tablets (PROCAL TABLETS) | B. No.: T-2107091 Mfg dt: 06/2021 Exp dt: 12/2022 Mfd by: M/s. Rivpra Formulation Pvt. Ltd. Plot No. 8, Sector-6A, | Assay of Vitamin D3 | Drug Control Department Delhi | RDTL Chandigarh |
I.I.E. SIDCUL, | |||||
Haridwar-249403 – | |||||
Uttarakhand. | |||||
23. | Telmisartan 40 mg and Hydrochlorothiazide 12.5 mg Tablets IP (TELMA H TABLETS) | B. No.: 18200994 Mfg dt: 10/2020 Exp dt: 09/2023 Mfd by: M/s. Glenmark Pharmaceuticals Ltd. | Assay of Telmisartan | Drug Control Department Delhi | RDTL Chandigarh |
Samlik, Marchak, | |||||
Industrial Growth | |||||
Centre, East Sikkim, | |||||
Sikkim-737135. | |||||
24. | CLEAR DROPS HAND SANITIZER (ETHYL) | B. No.: 104 Mfg dt: 05/2021 Exp dt: 04/2023 Mfd by: M/s. A to Z Laboratories Haryana | Assay of Isopropyl Alcohol (90%) and Ethyl Alcohol | Drug Control Department Himachal Pradesh | RDTL Chandigarh |
Road-144001. | |||||
25. | STREPTOCOCCUS FAECALIS, CLOSTRIDIUM BUTYRICUM, BACILLUS MESENTERICUS AND LACTIC ACID BACILLUS CAPSULES | B. No.: CHC-1055 Mfg dt: 11/2021 Exp dt: 10/2023 Mfd by: M/s. Cotec Healthcare Pvt.Ltd., N.H.No.74, Roorkee- Dehdradun Highway, Kishanpur, Roorkee- 247667, Haridwar Uttarakhand. | Assay of Streptococcu s faecalis | CDSCO North Zone | RDTL Chandigarh |
26. | Sucralfate and Oxetacaine Oral Suspension (1g, 20mg/10ml) (SUCRAMAL-O SUSPENSION) | B. No.: P2AWU002 Mfg dt: 06/2021 Exp dt: 05/2023 Mfd by: M/s. PHARMA FORCE LAB (Unit-II) Plot No. 85 & 86, | Assay of Oxetacaine | Drug Control Department (J&K) | RDTL Chandigarh |
Industrial Area, | |||||
Gondpur, Tehsil | |||||
Paonta Sahib, District | |||||
Sirmour, Himachal | |||||
Pradesh-173205, | |||||
INDIA. | |||||
27. | Atorvastatin Tablets IP (OZOVAS-10 TABLETS) | B. No.: BE9047 Mfg dt: 03/2021 Exp dt: 02/2023 | Dissolution | Drug Control DepartmentHima chal Pradesh | RDTL Chandigarh |
Mfd by: M/s. OZONE | |||||
PHARMACEUTICALS | |||||
LTD. Katha, Baddi- | |||||
173205, Himachal | |||||
Pradesh. | |||||
28. | Esomeprazole Tablets IP (ESSOF- 20 TABLETS) | B. No.: APT-07-0596 Mfg dt: 07/2021 Exp dt: 06/2023 | Dissolution | Drug Control Department (J&K) | RDTL Chandigarh |
Mfd by: M/s. Adwin | |||||
Pharma Vill. Rampur | |||||
Jattan, Trilokpur Road, | |||||
Kala-Amb, Tehsil- | |||||
Nahan, Distt. Sirmour | |||||
Himachal Pradesh - | |||||
173030. | |||||
29. | Doxycycline and Ambroxol Capsules (DOXYLAB CAPSULES) | B. No.: DBQC-004 Mfg dt: 10/2021 Exp dt: 09/2023 Mfd by: M/s. | Assay of Doxycycline | Drug Control DepartmentHima chal Pradesh | RDTL Chandigarh |
LABORATE |
PHARMACEUTICALS INDIA LTD., 51 Indl. Area, Paonta Sahib Himachal Pradesh. | |||||
30. | Sertraline Hydrochloride Tablets IP 50 mg (SERTOMAX-50 TABLETS) | B. No.: TPT-01014 Mfg dt: 03/2021 Exp dt: 02/2023 Mfd by: M/s. Tanpal Pharmaceuticals D-12- | Dissolution | Drug Control Department Delhi | RDTL Chandigarh |
13, Focal Point, Nabha | |||||
147201-Punjab. | |||||
31. | Hypodermic Syringe 2 ml | B. No.: 19556 Mfg dt: 06/2020 Exp dt: 05/2022 | Description & Sterility | CDSCO, Ahmedabad Zone | RDTL Guwahati |
Mfd by: M/s. | |||||
Gurumangalam | |||||
International, | |||||
Rancharda-382115, | |||||
(Ta: Kalol), Gujarat. | |||||
32. | Hypodermic Syringe 2 ml | B. No.: 19554 Mfg dt: 03/2020 Exp dt: 02/2022 | Description & Sterility | CDSCO, Ahmedabad Zone | RDTL Guwahati |
Mfd by: M/s. | |||||
Gurumangalam | |||||
International, | |||||
Rancharda-382115, | |||||
(Ta: Kalol), Gujarat. | |||||
33. | Omeprazole Capsules IP 20 mg | B. No.: CAG-21010 Mfg dt: 01/2021 Exp dt: 12/2022 | Dissolution | CDSCO Sub – Zone Guwahati | RDTL Guwahati |
Mfd by: M/s. Pro Laboratories Pvt. Ltd. 140-141, Makkanpur, | |||||
Bhagwanpur, Roorkee, | |||||
Dist. Haridwar- | |||||
Uttarakhand- 247661. | |||||
34. | Paracetamol Tablets I.P. 500 mg | B. No.: 19T20003 Mfg dt: 07/2019 Exp dt: 06/2022 | Dissolution | Drug Control DepartmentJhark hand | RDTL Guwahati |
Mfd by: M/s. KRAS | |||||
PHARMACEUTICALS | |||||
PVT. LTD. | |||||
(An ISO 9001:2015 | |||||
company) C-15, | |||||
Industrial Area, Phase |
II, Fatwah – 803201, Bihar. | |||||
35. | Pantoprazole Gastro- resistant tablets IP Pantoprazole 40 mg | B. No.: PFT21006MB Mfg dt: 05/2021 Exp dt: 04/2023 | Dissolution | Drug Control DepartmentBihar | RDTL Guwahati |
Mfd by: M/s. Sri Ram Health Care Pvt Ltd 81-C/2 EPIP-I, | |||||
Jharmajri, Baddi, Distt- | |||||
Solan ,Himachal | |||||
Pradesh- 173205. | |||||
36. | Calcium With Cholecalciferol Tablets I.P. | B. No.: T5026 Mfg dt: 10/2020 Exp dt: 03/2022 | Dissolution | Drug Control DepartmentAssa m | RDTL Guwahati |
Mfd by: M/s. Tuttsan Pharma Pvt, Ltd. Plot No. 10, Block No | |||||
58, At & Post Khatraj, | |||||
Taluka Kalol, Dist. | |||||
Gandhinagar, Gujarat. | |||||
37. | Flupentixol & Melitracen Hydrochloride Tablets | B. No.: 21JP/T-1669D Mfg dt: 09/2021 Exp dt: 08/2023 | Misbranded | Drug Control DepartmentAssa m | RDTL Guwahati |
Mfd by: M/s. Jips Pharmaceuticals Pvt. Ltd., Address: Not readable/ not visible/ not appeared in a conspicuous manner on the label. | |||||
38. | Telmisartan Tablets IP 40 mg | B. No.: TETY-01 Mfg dt: 04/2021 Exp dt: 03/2023 | Dissolution | Drug Control DepartmentJhark hand | RDTL Guwahati |
Mfd by: M/s. Nestor Pharmaceuticals Limited, 11, Western Extension Area, Faridabad - 121001, Haryana, India. | |||||
39. | Ranitidine Tablets IP 150 mg. | B. No.: NSTX-11 Mfg dt: 11/2020 Exp dt: 10/2022 | Description | CDSCO Guwahati Sub- Zone | RDTL Guwahati |
Mfd by: M/s. | |||||
HINDUSTAN | |||||
ANTIBIOTICS LTD. | |||||
at 11. W.E.A. | |||||
Faridabad-121001 | |||||
Haryana. |
40. | Intravenous Infusion Set | B. No.: 201047 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-131021, Haryana (India). | Kinking of the tubing | Drug Control Department Kerala | RDTL Guwahati |
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