42 drug samples fail to qualify 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 42 medicine batches for failing to qualify for a random drug sample test for the month of September, while 1 drug sample has been declared misbranded.These drug samples that have been declared as 'Not of Standard Quality', include SYNOKEM...
New Delhi: In its latest drug safety alert, the apex drug regulatory body, the Central Drugs Standard Control Organization (CDSCO) has flagged 42 medicine batches for failing to qualify for a random drug sample test for the month of September, while 1 drug sample has been declared misbranded.
These drug samples that have been declared as 'Not of Standard Quality', include SYNOKEM Pharmaceutical's Olmesartan Medoxomil Tablets, which are used in the treatment of hypertension (high blood pressure), heart failure, and prevention of heart attack and stroke, and Cadila Pharmaceutical's PENTALOC-D, which is a combination of two medicines: Domperidone and Pantoprazole. This combination is used to treat acidity, heartburn or Gastroesophageal Reflux Disease (GERD).
The list includes Rathi Laboratorie's Dexamethasone Sodium Phosphate Injection I.P, Zim Laboratories' Paracetamol Tablets IP 650 mg, Pure & Cure Healthcare's Rabeprazole Injection IP 20 mg, Himalaya Meditek's Gentamicin Injection IP – 2ml, Stadmed's Zolam 0.25 (Alprazolam Tablets I.P. 0.25 mg), and others.
Apart from this, the popular Covid-19 drug Favipiravir Tablets 400 mg. (FAVIMAX-400) manufactured by Maxrelief Healthcare is on the list of Not of Standard Quality.
This came after analysis and tests conducted by the CDSCO Drugs Control Department on 1227 samples. Out of these, 1184 samples were found to be of standard quality while 42 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 etc.
The samples collected were tested in five laboratories, namely CDL Kolkata, CDTL Mumbai, RDTL Chandigarh, RDTL Guwahati, and CDTL Hyderabad.
List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, for the Month of September – 2021.
| Total number of samples tested | 1227 |
| Total number of samples declared as of Standard Quality | 1184 |
| Total number of samples declared as Not of Standard Quality | 42 |
| Total number of samples declared as Spurious | 0 |
| Total number of samples declared as Misbranded | 01 |
| 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. | Olmesartan Medoxomil Tablets IP Olmesartan Medoxomil I.P. 40mg | B. No.: 20S1GTA060 Mfg dt: 06/2020 Exp dt: 05/2022 Mfd by: M/s. SYNOKEM Pharmaceuticals Ltd. Plot No: 35-36, Sector- 6A, I.I.E. Sidcul, Ranipur (BHEL) Haridwar- 249403. | Dissolution | CDSCO Sub-Zone Guwahati | RDTL Guwahati |
| 2. | Dexamethasone Sodium Phosphate Injection I.P. | B. No.: DT-72 Mfg dt: 11/2019 Exp dt: 10/2021 Mfd by: M/s. Rathi Laboratories (Hindustan) Pvt. Ltd., Industrial Area, Patna - 800013, Bihar. | Assay | Drug Control Department Jharkhand | RDTL Guwahati |
| 3. | Paracetamol Tablets IP 650 mg. | B. No.: FDR3F004 Mfg dt: 06/2020 Exp dt: 05/2022 Mfd by: M/s. ZIM LABORATORIES LIMITED, B-21/22, MIDC Area, Kalmeshwar-441501 Nagpur, Maharashtra. | Dissolution | CDSCO Sub-Zone Guwahati | RDTL Guwahati |
| 4. | Atenolol Tablets IP 50 mg | B. No.: ATTJ19006 Mfg dt: 10/2019 Exp dt: 09/2021 Mfd by: M/s. Vivek Pharmachem (India) Ltd. | Disintegration | Drug Control Department Assam | RDTL Guwahati |
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| EPIP, Bari Brahmana, Jammu-181133. |
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| 5. | Atenolol Tablets IP 50 mg | B. No.: ATTJ21001 Mfg dt: 01/2021 Exp dt: 12/2022 Mfd by: M/s. Vivek Pharmachem (India) Ltd. EPIP, Bari Brahmana, Jammu-181133. | Disintegration & Assay | Drug Control Department Assam | RDTL Guwahati |
| 6. | Pantoprazole & Domperidone Tablets (PENTALOC-D) | B. No.: JK19006 Mfg dt: 08/2019 Exp dt: 07/2022 Mfd by: M/s. CADILA PHARMACEUTICALS LIMITED. Industrial Growth Centre, Samba- 184121, State of Jammu & Kashmir. | Dissolution | CDSCO Sub - Zone Guwahati | RDTL Guwahati |
| 7. | Favipiravir Tablets 400 mg. (FAVIMAX-400) | 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 & Assay | Drug Control Department Jharkhand | RDTL Guwahati |
| 8. | AQUA FRESH HAND RUB (Alcohol 75%, Glycerol 2%, Twin Chain Quats 0.2%) | B. No.: Not Mentioned on label of the product Mfg dt: 08/2020 Exp dt: Not Mentioned Mfd by: M/s. Bliss Chemicals Pvt. Ltd, Mumbai. | Misbranded | Drug Control Department Jharkhand | RDTL Guwahati |
| 9. | Diclofenac Sodium Prolonged Release Tablets I.P. | B. No.: IDM20020 Mfg dt: 05/2020 Exp dt: 04/2023 Mfd by: M/s. IBN Herbals (A unit of Curetech Formulations (P) Ltd.), Khasra No. 63, Vill. Juddi Kalan, Baddi, Dist. Solan Himachal Pradesh. | Dissolution | CDSCO Sub-Zone Guwahati | RDTL Guwahati |
| 10. | Sterile Hypodermic Syringe (5ml) | B. No.: 19704 Mfg dt: 12/2019 Exp dt: 11/2021 | Sterility Test | Drugs Control Department | RDTL Guwahati |
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| Mfd by: M/s. Gurumangalam International Rancharda-382115 -Ta: Kalol, Dist: Gandhinagar, Gujarat. |
| Gujarat |
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| 11. | Sterile Hypodermic Syringe (5ml) | B. No.: 19709 Mfg dt: 12/2019 Exp dt: 11/2021 Mfd by: M/s. Gurumangalam International Rancharda-382115 -Ta: Kalol, Dist: Gandhinagar, Gujarat. | Sterility Test | Drugs Control Department Gujarat | RDTL Guwahati |
| 12. | Sterile Hypodermic Syringe (5ml) | B. No.: 19717 Mfg dt: 12/2019 Exp dt: 11/2021 Mfd by: M/s. Gurumangalam International Rancharda-382115 -Ta: Kalol, Dist: Gandhinagar, Gujarat. | Sterility Test | Drugs Control Department Gujarat | RDTL Guwahati |
| 13. | Sterile Hypodermic Syringe (5ml) | B. No.: 19702 Mfg dt: 12/2019 Exp dt: 11/2021 Mfd by: M/s. Gurumangalam International Rancharda-382115 -Ta: Kalol, Dist: Gandhinagar, Gujarat. | Sterility Test | Drugs Control Department Gujarat | RDTL Guwahati |
| 14. | I.V. Cannula with Wings & Injection Port | B. No.: 1081909 Mfg dt: 09/2019 Exp dt: 08/2024 Mfd by: M/s. Bio- Med Healthcare products Pvt. Ltd., Unit-II, Plot No. 62-65, Sector 6A, SIDCUL, Haridwar- 249403 Uttarakhand. | Sterility Test | Drug Control Department Kerala | RDTL Guwahati |
| 15. | Loperamide Hydrochloride Tablets IP 2 mg. (LOMOCARE) | B. No.: LCT-2009 Mfg dt: 09/2020 Exp dt: 04/2022 | Dissolution | Drug Control Department Bihar | RDTL Guwahati |
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| Mfd by: M/s. Suprex Laboratories, II-C, Industrial Area, Maxi Road, Ujjain Madhya Pradesh. |
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| 16. | Pantoprazole Gastro- resistant tablets IP | B. No.: PFT20015MB Mfg dt: 12/2020 Exp dt: 11/2022 Mfd by: M/s. Sri Ram Healthcare Pvt Ltd, 81- C/2, EPIP-I, Jharmajri, Baddi, Distt. Solan, Himachal Pradesh- 173205. | Dissolution | Drug Control Department Jharkhand | RDTL Guwahati |
| 17. | Doxylamine Succinate & Pyridoxine Hydrochloride Tablets | B. No.: PF8BI02 Mfg dt: 03/2020 Exp dt: 02/2022 Mfd by: M/s. Pure & Cure Healthcare Pvt. Ltd., Plot No. 26A, 27- 30, Sector - 8A, I.I.E., SIDCUL, Haridwar - 249403, Uttarakhand. | Disintegration & Assay of Doxylamine Succinate | CDSCO, Ahmedabad | CDL Kolkata |
| 18. | Folic Acid & Ferrous Sulphate Tablets I.P. (IFA Large) | B. No.: 084 Mfg dt: 02/2021 Exp dt: 01/2023 Mfd by: M/s. Deep Pharma, Khedut Sabha Building, Dholka – 382 225, Dist. Ahmedabad. | Description | CDSCO, Ahmedabad | CDL Kolkata |
| 19. | Progesterone Soft Gelatin Capsules 200 mg (ENDOGEST 200) | B. No.: BG0006A Mfg dt: 10/2020 Exp dt: 09/2022 Mfd by: M/s. Steril-Gene Life Sciences (P) Ltd., No. 45 Mangalam Main Road, Mangalam Village, Villianur Commune, Puducherry – 605110. | Disintegration | CDSCO, Ahmedabad | CDL Kolkata |
| 20. | Rabeprazole Injection IP, 20 mg | B. No.: PE3AA14 Mfg dt: 06/2020 Exp dt: 05/2022 Mfd by: M/s. Pure & Cure Healthcare Ltd., Plot No. 26A, 27-30, Sector - 8A, I.I.E., | Description, Clarity of Solution, Particulate Matter, pH, Related Substances & | Drug Control Department Odisha | CDL Kolkata |
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WFI | SIDCUL, Ranipur, Haridwar - 249403, Uttarakhand.
B. No.: T1113A0 Mfg dt: 01/2020 Exp dt: 12/2023 Mfd by: M/s. Pure & Cure Healthcare Ltd., Plot No. 26A, 27-30, Sector - 8A, I.I.E., SIDCUL, Ranipur, Haridwar - 249403, Uttarakhand. | Assay |
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| 21. | Ambilon 50 (Amphotericin B Liposome Injection 50 mg) | B. No.: ALI2163AC Mfg dt: 05/2021 Exp dt: 04/2023 Mfd by: M/s. Celon Laboratories Pvt. Ltd., Plot No. 2, ALEAP Industrial Estate, Gajularamaram, Medchal District-500 090, State Telangana. | Assay | Drug Control Department Andhra Pradesh | CDL Kolkata |
| 22. | Combine Dressing Pad B.P. -1980 | B. No.: CD021 Mfg dt: 12/2020 Exp dt: 3 Years from the Month of Mfg., Mfd by: M/s. Modern Health Care, 782/15, North Street, Chatrapatti-626102, Rajapalayam TamilNadu. | Sterility | CDSCO South Zone Chennai | CDL Kolkata |
| 23. | Alstasan Hand-Rub (Alcohol Based Hand Sanitizer) | B. No.: 87602 Mfg dt: 12/2020 Exp dt: 12/2022 Mfd by: M/s. Chemtex Speciality Ltd., Kolkata- 700046. | Identification of Chlorhexidine Gluconate & Assay of Ethyl Alcohol | CDSCO South Zone Chennai | CDL Kolkata |
| 24. | Gentamicin Injection IP – 2ml | B. No.: HLI282B Mfg dt: 02/2020 Exp dt: 01/2022 Mfd by: M/s. Himalaya Meditek Pvt. Ltd., Plot No. 35 & 36 Pharmacity, | Description, Particulate Matter & Assay | CDSCO South Zone Chennai | CDL Kolkata |
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| Selaqui Industrial Area, Dehradun 248197, Uttarakhand. |
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| 25. | Zolam 0.25 (Alprazolam Tablets I.P. 0.25 mg) | B. No.: C21C470 Mfg dt: 06/2020 Exp dt: 05/2023 Mfd by: M/s. Stadmed Private Limited, 15, Jawpore Road, Kolkata – 500 020. | Dissolution | CDSCO East Zone Kolkata | CDL Kolkata |
| 26. | Ciprofloxacin Hydrochloride Tablets IP 500 mg | B. No.: 0702620 Mfg dt: 06/2020 Exp dt: 05/2023 Mfd by: M/s. Karnataka Antibiotics & Pharmaceuticals Limited, Plot No.14, II Phase, Peenya, Bangalore -560058. | Dissolution | CDSCO Sub Zone Bangalore | CDTL Chennai |
| 27. | Prednisolone Sodium Phosphate IP | B. No.: APL/01091/F-21 Mfg dt: 06/2020 Exp dt: 05/2024 Mfd by: M/s. Anuh Pharma Ltd., M/s. Great Pacific Exports Pvt. Ltd., Plot No. D-5/8 & 5/9, TTC, Industrial Area, MIDC Turbhe, Navi Mumbai- 400 703. | Water | CDSCO West Zone | CDTL Mumbai |
| 28. | Pantojack-40 (Pantoprazole Gastro- Resistant Tablets IP 40 mg) | B. No.: T-23680 Mfg dt: 01/2021 Exp dt: 12/2022 Mfd by: M/s. Jackson Laboratories Pvt. Ltd., 22-24, Majitha Road, Bye Pass, Amritsar- 143 001. | Assay | CDSCO West Zone | CDTL Mumbai |
| 29. | Norfloxacin Tablets I.P. 400 mg | B. No.: T0037 Mfg dt: 01/2020 Exp dt: 12/2021 Mfd by: M/s. Zest Pharma, Plot No. 275, Sector F, Sanwer Road, Indore- 452015. | Dissolution | CDSCO West Zone | CDTL Mumbai |
| 30. | CEFIXIME DISPERSIBLE TABLETS IP | B. No.: TPT GOV-2428 Mfg dt: 03/2021 Exp dt: 02/2023 | Disintegration Test | CDSCO North Zone | RDTL Chandigarh |
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| 200 MG | Mfd by: M/s. Terrace Pharmaceuticals (P) Ltd. 3-B (a), Phase-III, Industrial Area, Sansarpur Terrace, Distt. Kangra, Himachal Pradesh - 176501. | and Uniformity of Dispersion |
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| 31. | HAND CLEANSER HAND RUB INSTANT PROTECTION FIGHT GERMS SOFT HANDS pH BALANCED | B. No.: S07 Mfg dt: 04/2021 Exp dt: 03/2024 Mfd by: M/s. Son Research Cosmetic B- 55, Kh no.30/5, Libasthan, Industrial Area, Samaypur, Delhi- 42. | Identification (Negative for Isopropyl Alcohol) The peak of Methanol has been detected and found 61.01% v/v of Methanol | Drug Control Department Delhi | RDTL Chandigarh |
| 32. | LEVOFLOXACIN HEMIHYDRATE IP | B. No.: BILLF210125 Mfg dt: 05/2021 Exp dt: 04/2025 Mfd by: M/s. Infinity Laboratories Pvt. Ltd., Regd. Office-Village Behra, Gulabgarh-Behra Road, P.O. Rampur sainia, Tehsil Derabassi-140507 (Punjab) | Related Substances | Drug Control Department Himachal Pradesh | RDTL Chandigarh |
| 33. | OXYTOCIN INJECTION IP | B. No.: OTC-233A Mfg dt: 02/2021 Exp dt: 07/2022 Mfd by: M/s. PUSHKAR PHARMA Bhandariwala, Kheri, Kala-Amb-173030 Himachal Pradesh. | Assay of Oxytocin Activity | Drug Control Department Srinagar | RDTL Chandigarh |
| 34. | OXYTOCIN INJECTION IP | B. No.: OTC-256A Mfg dt: 04/2021 Exp dt: 09/2022 Mfd by: M/s. PUSHKAR PHARMA Bhandariwala, Kheri, Kala-Amb-173030 Himachal Pradesh. | Assay of Oxytocin Activity | Drug Control Department Srinagar | RDTL Chandigarh |
| 35. | Budesonide Nebuliser Suspension BP (0.5 mg/2 ml) (BUDELIFE | B. No.: RS0059 Mfg dt: 03/2020 Exp dt: 02/2022 Mfd by: M/s. Aishwarya | Assay of Budesonide | Drug Control Department Himachal | RDTL Chandigarh |
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| RESPULES | Healthcare Village Thane, Baddi, Himachal Pradesh-173205. |
| Pradesh |
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| 36. | Budesonide Nebuliser Suspension BP (BUPICORT 0.5 MG/2 ML) | B. No.: RS1071 Mfg dt: 06/2021 Exp dt: 05/2023 Mfd by: M/s. AISHWARYA HEALTHCARE Village Thane, Baddi, Himachal Pradesh-173205. | Assay | Drug Control Department Himachal Pradesh | RDTL Chandigarh |
| 37. | LORAZEPAM INJECTION IP | B. No.: I - 21800 Mfg dt: 03/2020 Exp dt: 02/2022 Mfd by: M/s. Jackson Laboratories Pvt. Ltd. 22-24, Majitha Road,Bye Pass, Amritsar-143001. | Assay | Drug Control Department Himachal Pradesh | RDTL Chandigarh |
| 38. | Fluoxetine Capsules IP 20 mg | B. No.: 1021-01 Mfg dt: 05/2019 Exp dt: 04/2022 Mfd by: M/s. HAB PHARMACEUTICALS & RESEARCH LIMITED 10, Pharmacity, SIDCUL, Selaqui, Dehradun-248011. | Uniformity of filled weight | CDSCO North Zone | RDTL Chandigarh |
| 39. | OXYTOCIN INJECTION IP | B. No.: OTC-256A Mfg dt: 04/2021 Exp dt: 09/2022 Mfd by: M/s. PUSHKAR PHARMA Bhandariwala, Kheri, Kala-Amb-173030 Himachal Pradesh. | Assay of Oxytocin Activity | Drug Control Department Jammu & Kashmir | RDTL Chandigarh |
| 40. | SODIUM CHLORIDE AND DEXTROSE INJECTION IP 0.9% W/V & 5% W/V | B. No.: FFS2003B0154 Mfg dt: 06/2020 Exp dt: 05/2023 Mfd by: M/s. Pharma Impex Laboratories Pvt. Ltd. South Uttarbhag, Ramnagar, Baruipur, Dist. South 24PGS WB- 743387. | Description, Particulate matter | CDSCO North Zone | RDTL Chandigarh |
| 41. | BISACODYL GASTRO - RESISTANT TABLETS IP 5 MG | B. No.: C-0L0933 Mfg dt: 12/2020 Exp dt: 11/2022 Mfd by: M/s. MOREPEN LABORATORIES | Dissolution | CDSCO North Zone | RDTL Chandigarh |
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| LIMITED Unit-V, Plot No. 12-C, Sector-2, Parwanoo, Distt. Solan (H.P.)-173220. |
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| 42. | Paracetamol Tablets IP (CAREMOL TABLETS) | B. No.: CLT-14398 Mfg dt: 12/2019 Exp dt: 11/2022 Mfd by: M/s. Caremax Formulations Plot No. 56 & 61, Industrial Area, Phase-III, Sansarpur Terrace, Distt. Kangra (H.P.)-176501. | Dissolution | CDSCO North Zone | RDTL Chandigarh |
| 43. | DIVIRON-50 TABLETS (DICLOFENAC SODIUM TABLETS IP 50 mg) | B. No.: T-23089 Mfg dt: 10/2020 Exp dt: 09/2022 Mfd by: M/s. Jackson Laboratories Pvt. Ltd., 22-24, Majitha Road, Bye Pass Amritisar- 143001. | Disintegration | Drug Control Department Hyderabad | CDTL Hyderabad |
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