Drug Alert: CDSCO flags 27 formulations 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 27 medicine batches for failing to qualify for a random drug sample test for the month of January.
These drug samples including Bochem Healthcare's Ferrous Sulphate & Folic Acid Tablets IP, Zee Laboratories' NITZO -2.6 (Controlled Release Tablets of Nitrogylcerin), Skymap Pharmaceuticals' WARZYME Digestive Enzymes (Pepsin & Fungal Diastase Syrup), Ortin Laboratories' Enalapril Maleate Tablets IP 5 mg, Om Biomedic's Pantoprazole Gastro- Resistant Tablets I.P., Terrace Pharmaceutical's Atenolol Tablets IP 50 mg and others are declared as 'Not of Standard Quality'.
In addition, Paracetamol Tablets IP 650 mg manufactured by Zim Laboratories, popular covid drug Favipiravir Tablets 400 mg manufactured by Maxrelief Healthcare are on the list.
This came after analysis and tests conducted by the CDSCO Drugs Control Department on 1227 samples. Out of these, 1200 samples were found to be of standard quality while 27 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 Sterility test, failure of the dissolution test, failure of disintegration, failure of the Assay of Methylcobalamin & Vitamin D3 assay etc.
The samples collected were tested in six laboratories, namely CDL Kolkata, CDTL Chennai, CDTL Hyderabad, RDTL Chandigarh, RDTL Guwahati, CDTL Mumbai.
List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, for the Month of January – 2022
Total number of samples tested | 1227 |
Total number of samples declared as of Standard Quality | 1200 |
Total number of samples declared as Not of Standard Quality | 27 |
Total number of samples declared as Spurious | - |
Total number of samples declared as Misbranded | - |
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. | Ferrous Sulphate & Folic Acid Tablets IP | B. No.: B210049 Mfg dt: 06/2021 Exp dt: 05/2023 Mfd by: M/s. Bochem Healthcare Pvt. Ltd., 83- 84, Industrial Area, Dewas Road, Nagziri, Ujjain 456010, Madhya Pradesh, India. | Uniformity of Content of Folic Acid | CDSCO East Zone Kolkata | CDL Kolkata |
2. | NITZO -2.6 (Controlled Release Tablets of Nitrogylcerin) | B. No.: 420-1291 Mfg dt: 10/2020 Exp dt: 09/2022 Mfd by: M/s. Zee Laboratories 47, Industrial Area, Paonta Sahib -173 025, Himachal Pradesh. | Assay | CDSCO East Zone Kolkata | CDL Kolkata |
3. | Levetripac-500 Tablets (Levetiracetam Tablets IP 500 mg) | B. No.: APT/04306 Mfg dt: 04/2021 Exp dt: 03/2023 Mfd by: M/s. AmkonPharmaceuticals, Plot No. 242, Phase 9, Industrial Area, Mohali- 160062, Punjab. | Dissolution & Assay | CDSCO East Zone Kolkata | CDL Kolkata |
4. | Clopidogrel & Aspirin Tablets I.P. | B. No.: TACB-017 Mfg dt: 05/2020 Exp dt: 04/2022 Mfd by: M/s. Medipol Pharmaceutical India Pvt. Ltd., 1199/3, Budh, Baddi, Dist. Solan, | Related Substances | CDSCO West Zone Mumbai | CDL Kolkata |
Himachal Pradesh, India. | |||||
5. | Pantoprazole for Injection B.P. 40 mg | B. No.: AA011068 Mfg dt: 04/2021 Exp dt: 03/2023 Mfd by: M/s. ANG Lifesciences India Ltd., Village- Kishanpura, Nalagarh Road, Tehsil- Baddi, Distt. Solan, Himachal Pradesh -174101. | Sterility | Drug Control Department Madhya Pradesh | CDL Kolkata |
6. | Adrenochrome Monosemicarbazone Injection, 2 ml | B. No.: 01ACA295 Mfg dt: 02/2021 Exp dt: 07/2022 | Description & Particulate Matter | CDSCO South Zone Chennai | CDL Kolkata |
Mfd by: M/s. SPM Drugs (P) Ltd., S.F. 52/1 Main Road, K.R. Palayam, Bhavani – 638 301 Tamil Nadu. | |||||
7. | WARZYME Digestive Enzymes (Pepsin & Fungal Diastase Syrup), 200 ml | B. No.: AA21036 Mfg dt: 06/2021 Exp dt: 11/2022 Mfd by: M/s. Skymap Pharmaceuticals Pvt. Ltd., B-3, Dev Bhoomi Industrial Estate, Puhana Iqbalpur Road, Roorkee-247667, Uttarakhand. | Assay of Pepsin & Fungal Diastase | CDSCO South Zone Chennai | CDL Kolkata |
8. | Mymi D (Alpha Lipoic Acid, Pyridoxine Hydrochloride, Methylcobalamin, Folic Acid & Vitamin D3 Tablets) | B. No.: TT21031 Mfg dt: 06/2021 Exp dt: 05/2023 Mfd by: M/s. Kausikh Therapeutics(P) Ltd., Unit II, Plot No. 54, SIDCO Industrial Estate, Thirumudivakkam, Chennai -600044. | Assay of Methylcobala min & Vitamin D3 | CDSCO South Zone Chennai | CDL Kolkata |
9. | Pantoprazole Gastro- Resistant Tablets IP | B. No.: TF1036A Mfg dt: 06/2021 Exp dt: 11/2022 | Dissolution | CDSCO Sub Zone Bangalore | CDTL Chennai |
Mfd by: M/s. Navkar Lifesciences, Plot No.76, Lodhi Majra, Industrial Area, Baddi, Distt. Solan, Himachal Pradesh. |
10. | ENALAPRIL MALEATE TABLETS IP 5 mg | B. No.: GA21002 Mfg dt: 02/2021 Exp dt: 01/2023 Mfd by: M/s. Ortin Laboratories Ltd., 275 & 278 (part), IDA, Pashamylaram-502307, Sanga Reddy, Dist. Telangana. | Dissolution & Assay | CDSCO Zonal Office Hyderabad | CDTL Hyderabad |
11. | Ceftriaxone Injection IP | B. No.: I.269 Mfg dt: 04/2021 Exp dt: 03/2023 Mfd by: M/s. Jackson Laboratories Pvt. Ltd. 22-24, Majitha Road, Bye pass, Amritsar- 143001, Punjab (India). | Clarity of Solution & Particulate matter | Drug Control Department Jharkhand | RDTL Guwahati |
12. | Pantoprazole Sodium Tablets I.P. 40 mg | B. No.: SL20098 Mfg dt: 11/2020 Exp dt: 10/2022 Mfd by: M/s. IBN Herbals (A unit of Curetech Formulations (P) Ltd.), Khasra No. 63, Vill. JuddiKalan, Baddi, Dist. Solan, Himachal Pradesh. | Dissolution | Drug Control Department Jharkhand | RDTL Guwahati |
13. | Alprazolam Tablets IP | B. No.: TP.1901 Mfg dt: 12/2019 Exp dt: 11/2022 Mfd by: M/s. Achemic Pharmaceuticals (INDIA) Pvt. Ltd. 71-A, I.D.A. (Etn) Phase-II, Mangalpur Nacharam, Hyderabad - 500076. | Dissolution | Drug Control Department Bihar | RDTL Guwahati |
14. | Isopropyl Rubbing Alcohol I.P. | B. No.: SP-851 Mfg dt: 05/2020 Exp dt: 04/2023 Mfd by: M/s. Sritech Pharma, F-19, UPSIDC Industrial Area, Gajraula JP Nagar, Uttar Pradesh – 244235. | Assay | Drug Control Department Jharkhand | RDTL Guwahati |
15. | Doxycycline Hydrochloride & | B. No.: DOX-2009 | Description | Drug Control Department | RDTL Guwahati |
Ambroxol HCl Tablets | Mfg dt: 01/2021 Exp dt: 12/2022 Mfd by: M/s. RIDLEY LIFE SCIENCE PVT. LTD., D-1651, DSIDC Indl. Complex, Narela, Delhi-110040 | Assam | |||
16. | Favipiravir Tablets 400 mg | B. No.: TP-0421903 Mfg dt: 04/2021 Exp dt: 03/2023 Mfd by: M/s. Maxrelief Healthcare, Vill.-Anji, Solan, Himachal Pradesh- 173212. | Identification, Dissolution & Assay | Drug Control Department Jharkhand | RDTL Guwahati |
17. | Trypsin, Bromelain & Rutoside Trihydrate Tablets | B. No.: GT200466 Mfg dt: 03/2020 Exp dt: 02/2022 Mfd by: M/s. Theon Pharmaceuticals Ltd. Vill. Saini Majra, Teh. Nalagarh, Distt. Solan, Himachal Pradesh- 174101. | Description & Disintegration | CDSCO Sub-Zone Guwahati | RDTL Guwahati |
18. | Pantoprazole Sodium Tablets I.P. 40 mg | B. No.: TN-5142 Mfg dt: 11/2020 Exp dt: 10/2022 | Dissolution | Drug Control Department Assam | RDTL Guwahati |
Mfd by: M/s. Naptune Life Sciences Pvt. Ltd. 100-B, EPIP, Phase-II, Thana, Baddi -173205 Himachal Pradesh. | |||||
19. | Pantoprazole Gastro- Resistant Tablets I.P. 40 mg | B. No.: AT201095 Mfg dt: 03/2021 Exp dt: 02/2023 | Dissolution | Drug Control Department Jharkhand | RDTL Guwahati |
Mfd by: M/s. Aarpic Pharmaceuticals Pvt. Ltd., C1/306/5 Kerala G.I.D.C., Kerala, Bavla Road, Dist. Ahmedabad. | |||||
20. | Paracetamol Tablets IP 650 mg | B. No.: FDR3A101 Mfg dt: 01/2021 Exp dt: 12/2022 | Dissolution | CDSCO Sub-Zone Guwahati | RDTL Guwahati |
Mfd by: M/s. ZIM LABORATORIES LIMITED, B-21/22, MIDC Area, Kalmeshwar-441501, Dist. Nagpur, Maharashtra. | |||||
21. | Calcium with Vitamin | B. No.: CV-212 | Dissolution | Drug Control | RDTL |
D3 Tablets | Mfg dt: 11/2020 Exp dt: 05/2022 Mfd by: M/s. VINTOCHEM PHARMACEUTICALS Industrial Area, Maxi Road, Ujjain- 456010 Madhya Pradesh. | Department Jharkhand | Guwahati | ||
22. | Pantoprazole Gastro- Resistant Tablets I.P. | B. No.: TA21-11 Mfg dt: 01/2021 Exp dt: 12/2022 Mfd by: M/s. Om Biomedic Pvt. Ltd. Plot No. 68, 69, 82 & 83, Sector-6A, IIE SIDCUL, Haridwar – 249403 Uttarakhand. | Dissolution | Drug Control Department Meghalaya | RDTL Guwahati |
23. | Calcium with Vitamin D3 Tablets | B. No.: CV-212 Mfg dt: 11/2020 Exp dt: 05/2022 Mfd by: M/s. VINTOCHEM PHARMACEUTICALS Industrial Area, Maxi Road, Ujjain- 456010 Madhya Pradesh. | Dissolution | Drug Control Department Jharkhand | RDTL Guwahati |
24. | Atenolol Tablets IP 50 mg. | B. No.: TPT GOV-21139 Mfg dt: 06/2021 Exp dt: 05/2023 Mfd by: M/s. Terrace Pharmaceutical (P) Ltd., 3-B (a) Phase III, Industrial Area, Sansarpur Terrace, Distt. Kangra, Himachal Pradesh – 176501. | Disintegration | CDSCO West Zone Mumbai | CDTL Mumbai |
25. | Itraconazole Capsules 200 mg | B. No.: MC21250 Mfg dt: 04/2021 Exp dt: 03/2023 Mfd by: M/s. Mascot Health Series Pvt. Ltd. Plot No. 79, 80, Sec.6A, IIE, SIDCUL, Haridwar- 249403 Uttarakhand. | Disintegration | CDSCO North Zone | RDTL Chandigarh |
26. | Ondansetron Orally Disintegrating Tablets IP 4 mg (ONVIN-4MD TABLETS) | B. No.: RV21023 Mfg dt: 07/2021 Exp dt: 06/2023 Mfd by: M/s. Rivpra | Dissolution | CDSCO Sub-Zone Baddi | RDTL Chandigarh |
Formulation Pvt. Ltd. Plot No. 8, Sector-6A, I.I.E. SIDCUL, Haridwar- 249403, Uttarakhand. | |||||
27. | Alcohol/Chlorhexidine Gluconate Hand Rub (MICRO-CV HAND SANITIZER) | B. No.: 8267 Mfg dt: 03/2020 Exp dt: 02/2022 Mfd by: M/s. RAMSON REMEDIES 186-187, Industrial Focal Point, Amritsar A.O: 2, G.Floor Baktawar, Malabar Hill, MUMBAI – 6. | Identification | Drug Control Department Himachal Pradesh | RDTL Chandigarh |
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