Drug Alert: CDSCO Flags 25 Drugs As Not Of Standard Quality
This came after analysis and test conducted by the CDSCO, Drugs Control Departments, on 477 drug samples. Out of this, 452 samples were found of Standard quality while 25 of them were declared as Not of Standard Quality (NSQ).
New Delhi: In its latest drug safety alert, the apex drug regulatory body, Central Drugs Standard Control Organization (CDSCO) recently flagged 25 medicine batches for failing to qualify a random drug sample test for the month of May. These drug samples including Doxepin Hydrochloride Capsules by Intas Pharma, Nifedipine Capsules by Torrent Pharma, and others are declared as 'Not of Standard Quality'.
This came after analysis and test conducted by the CDSCO, Drugs Control Departments, on 477 drug samples. Out of this, 452 samples were found of Standard quality while 25 of them were declared as Not of Standard Quality (NSQ).
A few of the causes why the drug samples tested failed was due to the presence of Assay, Description, pH, Assay of Vitamin B12, Dissolution, Assay of Beclomethasone Dipropionate, Description, Sterility, Free Dexamethasone and the Assay of Dexamethasone Sodium Phosphate, Assay of Folic acid and pH, and others.
The samples collected were tested in three laboratories namely RDTL Chandigarh, CDL Kolkata, RDTL Guwahati.
List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, for the Month of May 2020 reads;
Total number of samples tested |
477 |
Total number of samples declared as of Standard Quality | 452 |
Total number of samples declared as Not of Standard Quality | 25 |
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. | Clonazepam Tablets I.P. (Clozep 0.5 mg) | B. No.: T-19281 Mfg dt: 04/2019, Exp dt: 03/2022, Mfd by: M/s. Jackson Laboratories Pvt. Ltd., 22-24, Majitha Road, Bye Pass, Amristar - 143001. | Dissolution | CDSCO, East Zone, Kolkata | CDL, Kolkata |
2. | Alprazolam Tablets IP | B. No.: TAZP-003, Mfg dt: 12/2018, Exp dt: 11/2020, Mfd by: M/s. Medipol Pharmaceutical India Pvt. Ltd., 1199/3, Bhud, Baddi, Distt. Solan, H.P. India. | Dissolution | CDSCO, East Zone, Kolkata | CDL, Kolkata |
3. | DOXIN - 75 (Doxepin Hydrochloride Capsules I.P. 75 mg) | B. No.: NW2013, Mfg dt: 12/2017, Exp dt: 11/2020, Mfd by: M/s. Intas Pharmaceuticals Ltd., Samardung Road, Kabrey Block, Namthang Elaka, South Sikkim - 737132, India. | Description and Assay | CDSCO, East Zone, Kolkata | CDL, Kolkata |
4. | Iofer -12 (Iron, Folic Acid & Vitamin B 12 Capsules) | B. No.: RW19002, Mfg dt: 04/2019, Exp dt: 09/2020, Mfd by: M/s. Ortin Laboratories Ltd., 275 & 278 (part), I.D.A. Pashamylaram -502307, Medak Dist., Andhra Pradesh. | Assay of Vitamin B12 | CDSCO, East Zone, Kolkata | CDL, Kolkata |
5. | Iofer -12 (Iron, Folic Acid & Vitamin B 12 Capsules) | B. No.: RW19002, Mfg dt: 04/2019, Exp dt: 09/2020, Mfd by: M/s. Ortin Laboratories Ltd., 275 & 278 (part), I.D.A. Pashamylaram -502307, Medak Dist., Andhra Pradesh. | Assay of Vitamin B12 | CDSCO, East Zone, Kolkata | CDL, Kolkata |
6. | Fungdid- B Cream (Clotrimazole with Beclomethasone Dipropionate Cream)15 g | B. No.: 19285, Mfg dt: 10/2019, Exp dt: 09/2021, Mfd by: M/s. Rednex Pharmaceuticals, LS No-142, Nr. HBS, Chacharvadi Vasna, Ta Sanand, Di. Ahmedabad. | Assay of Beclomethas one Dipropionate | CDSCO, Ahmedabad zone | CDL, Kolkata |
7. | Fungdid- B Cream (Clotrimazole with Beclomethasone Dipropionate Cream)15 g | B. No.: 19170, Mfg dt: 08/2019, Exp dt: 07/2021, Mfd by: M/s. Rednex Pharmaceuticals, LS No-142, Nr. HBS, Chacharvadi Vasna, Ta Sanand, Di. Ahmedabad. | Assay of Beclomethas one Dipropionate | CDSCO, Ahmedabad zone | CDL, Kolkata |
8. | Nucerin -50 Capsules (Diacerein Capsules I.P. 50 mg) | B. No.: MC19145, Mfg dt: 06/2019, Exp dt: 05/2021, Mfd by: M/s. Mascot Health Services Pvt. Ltd., Plot No. 79, 80, Sec-6A, IIE, Sidcul, Haridwar – 249403. | Dissolution | CDSCO, Ahmedabad zone | CDL, Kolkata |
9. | ReGermina (Prebiotic & Probiotics Capsules) | B. No.: P90087, Mfg dt: 02/2019, Exp dt: 06/2020, Mfd by: M/s. Morepen Laboratories Limited, Plot. No 12-B, Sector-2, Parwanoo, Dist. Solan (H.P.) -173220. | Content of Streptococcu s faecalis and Clostridium butyricum | CDSCO, Hyderabad zone | CDL, Kolkata |
10. | Cipjohn 500 (Ciprofloxacin Tablets I.P. 500 mg) | B. No.: HTN813D, Mfg dt: 04/2018, Exp dt: 03/2021, Mfd by: M/s. Himalaya Meditek Pvt. Ltd., Plot No. 35 & 36, Pharmacity, Selaqui Industrial Area, Dehradun - 248197. | Dissolution | CDSCO, Sub zone Goa | CDL, Kolkata |
11. | Onstal - 4 (Ondansetron Tablets IP 4 mg) | B. No.: T2227 Mfg dt: 08/2018, Exp dt: 07/2020, Mfd by: M/s. Stallion Laboratories, Pvt. Ltd., C-1B, 305/2, 3, 4 & 5, G.I.D.C, Kerala (Bavla), Distt. Ahmedabad – 382220, Gujarat, India. | Description | CDSCO, Sub zone Goa | CDL, Kolkata |
12. | Calcigard -10 (Nifedipine Capsules IP) | B. No.: S175E004 Mfg dt: 06/2018, Exp dt: 05/2020, Mfd by: M/s. Torrent Pharmaceuticals Ltd., At: Plot No. 708/6, Behind Somnath Road, Dabhel Village, Nani Daman -396215. | Dissolution | CDSCO, sub zone Bangalore | CDL, Kolkata |
13. | Gauze Swabs B.P. :88: Type 17 | B. No.: 1907225 Mfg dt: 07/2019, Exp dt: 06/2022, Mfd by: M/s. Premier Enterprises, Chatrapatti -626 102 | Threads per stated Length and Wt. per Unit Area | CDSCO, South Zone Chennai | CDL, Kolkata |
14. | Atorfirst-10 (Atorvastatin Tablets IP 10 mg) | Batch No.: BT-0364 Mfg. dt: 07/2019 Exp. dt: 06/2021 Mfd. By: M/s. Bayberry Pharmaceuticals Pvt. Ltd., At. Plot No.45, HIMUDA, Ind., Area, Bhatolikalan, Dist. Solan, H.P. | Dissolution | CDSCO West Zone Mumbai | CDTL, Mumbai |
15. | Ofloxacin Tablets IP (Floxa-200 Tablets) | Batch No: GPT76 Mfg. dt: 02/2020 Exp. dt: 01/2022 Mfd. By: Anecxa Pharma Sector-8A, Bhel Township, Salarapu Mahdood (U.K.)-249403. | Identification | Drugs Control Department Baddi, Distt. Solan, HP. | RDTL, Chandigarh |
16. | Metoclopramide Hydrochloride Injection IP 5 mg/ml | Batch No: MEI1902 Mfg. dt: 05/2019 Exp. dt: 04/2021 Mfd. By: M/s. Modern Laboratories 45-47, Sector D-2, Sanwer Road, Indore (M.P.) 452015, India. | pH | CDSCO, Sub-Zone, Jammu | RDTL, Chandigarh |
17. | Dexamethasone Injection IP (Uni- Dexa Injection) | Batch No: ULI-180019 Mfg. dt: 07/2018 Exp. dt: 06/2020 Mfd. By: M/s. Unital Formulations 144- B EPIP, Phase-1, Jharmajri Baddi, Solan (H.P.) | Sterility, Free Dexamethas one and the Assay of Dexamethas one Sodium Phosphate | CDSCO Sub-Zone, Baddi, | RDTL, Chandigarh |
18. | Levetiracetam Injection (Nuatam Injection) | Batch No: L2001/17 Mfg. dt: 01/2020 Exp. dt: 12/2021 Mfd. By: M/s. SBS Biotech Mouza Rampur Jattan, Nahan Road, Kala Amb, Dist. Sirmour (H.P.) | Particulate matter | CDSCO, Sub-Zone, Baddi | RDTL, Chandigarh |
19. | P-QUIN-2.5 (Primaquine Tablets I.P. 2.5 mg) | Batch No: T1903 Mfg. dt : 09/2018 Exp. dt: 08/2020 Mfd. By: M/s. Quest Laboratories Pvt. Ltd., Plot No. 45, Sector-III, Pithampur, Dist. Dhar- 454775, (M.P) | Assay and Dissolution | Drugs Control Department, Manipur | RDTL, Guwahati |
20. | Cefpodoxime Tablets I.P. 200 mg | Batch No.: GSM2T9I002 Mfg. dt:09/2019 Exp. dt:02/2022 Mfd. By: M/s. Nootan Pharmaceuticals, Vill: Tripta, Barotiwala, Dist-Solan (H.P) 174103 | Dissolution | Drugs Control Department, Tripura | RDTL, Guwahati |
21. | Ferrous Sulphate and Folic Acid Syrup I.P. | Batch No.: 19579 Mfg. dt: 07/2019 Exp. dt: 12/2020 Mfd. By: M/s. HLL Lifecare Limited Kangala-591225, Dist-Belgaum, Karnataka, Works at: 72/5, Muradpura (Orangpura), Dhar Road, Near Kalaria, Indore 453001 (M.P) | Assay of Folic acid and pH | Drugs Control Department, Arunachal Pradesh | RDTL, Guwahati |
22. | Ferrous Sulphate and Folic Acid Syrup I.P. | Batch No.: 19583 Mfg. dt: 07/2019 Exp. dt: 12/2020 Mfd. By: HLL Lifecare Limited Kangala-591225, Dist-Belgaum, Karnataka, Works at: 72/5, Muradpura (Orangpura), Dhar Road, Near Kalaria, Indore 453001 (M.P) | pH | Drugs Control Department, Arunachal Pradesh | RDTL, Guwahati |
23. | Ferrous Sulphate & Folic Acid Tablets I.P. (Large) | Batch No.: 19574 Mfg. dt: 07/2019 Exp. dt: 12/2020 Mfd. By: HLL Lifecare Limited Kangala-591225, Dist-Belgaum, Karnataka, Works at: 72/5, Muradpura (Orangpura), Dhar Road, Near Kalaria, Indore 453001 (M.P) | pH | Drugs Control Department, Arunachal Pradesh | RDTL, Guwahati |
24. | Ferrous Sulphate and Folic Acid Syrup I.P. | Batch No.: 19581 Mfg. dt: 07/2019 Exp. dt: 12/2020 Mfd. By: HLL Lifecare Limited Kangala-591225, Dist-Belgaum, Karnataka, Works at: 72/5, Muradpura (Orangpura), Dhar Road, Near Kalaria, Indore 453001 (M.P) | pH | Drugs Control Department, Arunachal Pradesh. | RDTL, Guwahati |
25. | Ferrous Sulphate and Folic Acid Syrup I.P. | Batch No.: 19580 Mfg. dt: 07/2019 Exp. dt: 12/2020 Mfd. By: HLL Lifecare Limited Kangala-591225, Dist-Belgaum, Karnataka, Works at: 72/5, Muradpura (Orangpura), Dhar Road, Near Kalaria, Indore 453001 (M.P) | pH | Drugs Control Department, Arunachal Pradesh | RDTL, Guwahati |
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