CDSCO Declares 35 Drug Samples Including Paracetamol, Hand Sanitizers As Not Of Standard Quality
New Delhi: The apex drug regulatory body, Central Drugs Standard Control Organization (CDSCO) has flagged 35 drug samples and sanitizers as 'Not of Standard Quality' after they failed to qualify a random drug sample test for the month of July.
These drug samples including popular formulations and brands like Paracetamol Tablets IP 500 mg, Pantoprazole Tablets I.P. 40 mg, Isopropyl Alcohol 70% Hand Sanitizer, Amgesic Tablets, and others. The list also includes samples of Calcium and Vitamin D3 Tablets IP, Isopropyl Rubbing Alcohol IP, Nefidinol Retard10 Tablets, and so on.
This came after analysis and test conducted by the CDSCO, Drugs Control Departments, on 808 drug samples. Out of this, 773 samples were found of Standard quality while 35 of them were declared as Not of Standard Quality (NSQ).
To mention, the drug samples that were tested failed due to Assay of Ethyl Alcohol, Assay of Isopropyl Alcohol, Organic Impurities, Limit of non-volatile residue, Non-compliance with a physical description of tablets and unfit for human consumption and others.
The samples collected were tested in three laboratories namely CDL Kolkata, RDTL Chandigarh, RDTL Guwahati.
List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, for the Month of July 2020 ;
Total number of samples tested | 808 |
Total number of samples declared as of Standard Quality | 773 |
Total number of samples declared as Not of Standard Quality | 035 |
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. | PREGINATE (Doxylamine Succinate & Pyridoxine Hydrochloride Tablets) | B. No.: ZD19107, Mfg dt: 02/2019, Exp dt: 01/2021, Mfd by: M/s. Skymap Pharmaceuticals Pvt. Ltd., B – 3, Dev Bhoomi Industrial Estate, Puhana, Iqbalpur Road, Roorkee – 247 667. | Description & Assay of Doxylamine Succinate | CDSCO, East Zone, Kolkata | CDL, Kolkata |
2. | Zonerab (Rabeprazole Sodium Gastro- Resistant Tablets I.P.) | B. No.: ZRB – 12, Mfg dt: 07/2019, Exp dt: 06/2021, Mfd by: M/s. VADSP Pharmaceuticals, Plot No. 124, E.P.I.P., Ind. Area, Phase – 1, Jharmajri, Baddi (H.P.). | Dissolution in Acid Stage & Assay | CDSCO, East Zone, Kolkata | CDL, Kolkata |
3. | Levocetirizine Hydrochloride Tablets I.P. 5 mg | B. No.: SHT8188, Mfg dt: 04/2018, Exp dt: 03/2021, Mfd by: M/s. Syncom Healthcare Limited, D – 42, IIE, Sidcul, Selaqui, Dehradun – 248 197 (Uttarakhand). | Dissolution | CDSCO, North Zone, Ghaziabad | CDL, Kolkata |
4. | Levocetirizine Tablets I.P. 5 mg | B. No.: 9700719, Mfg dt: 05/2019, Exp dt: 04/2021, Mfd by: M/s. Karnataka Antibiotics & Pharmaceuticals Ltd., Plot No. 14, II Phase, Peenya Bangaluru – 560 058. | Dissolution | CDSCO, East Zone, Kolkata | CDL, Kolkata |
5. | Pantoprazole Tablets I.P. 40 mg | B. No.: PNT94087, Mfg dt: 09/2019, Exp dt: 08/2021, Mfd by: M/s. Caplet India Private Limited, 284/1, Bangur Avenue, Block B, Kolkata – 700 135, Works : Rekjuani, Kolkata – 700 135. | Dissolution | CDSCO, East Zone, Kolkata | CDL, Kolkata |
6. | Zepara – XT Tablets 650 mg (Paracetamol Tablets 650 mg) | B. No.: 419-412, Mfg dt: 03/2019, Exp dt: 02/2021, Mfd by: M/s. Zee Laboratories, 47 Industrial Area, Paonta Sahib – 173 025 Himachal Pradesh. | Dissolution & Assay | CDSCO, East Zone, Kolkata | CDL, Kolkata |
7. | Paracetamol Tablets IP 500 mg | B. No.: MT - 18258, Mfg dt: 10/2018, Exp dt: 09/2020, Mfd by: M/s. Maxchem Pharmaceuticals Pvt. Ltd., Plot No. 22, Sec 03, Sidcul IIE, Rudrapur Distt. U.S. Nagar (Uttarakhand). | Dissolution | CDSCO, North Zone, Ghaziabad | CDL, Kolkata |
8. | Ramigal 5 (Ramipril Tablets I.P. 5 mg) | B. No.: VG8034, Mfg dt: 10/2018, Exp dt: 09/2021, Mfd by: M/s. Visa Drugs & Pharmaceuticals Pvt. Ltd., Village Gullerwala Near Sai Road, Baddi, Distt. Solan – 173 205 (H.P.). | Assay | CDSCO, East Zone, Kolkata | CDL, Kolkata |
9. | Ondansetron Tablets I.P. 4 mg | B. No.: LB19001, Mfg dt: 12/2019, Exp dt: 11/2022, Mfd by: M/s. Mars Therapeutics & Chemicals Ltd., 4-4/1/2, Dommarapochampally Village, Quthubullapur Mandal, Medchel/Malkajigiri Dist., Pin – 500 043, Telangana . | Dissolution and Assay | CDSCO, Hyderabad | CDL, Kolkata |
10. | Sterile Inner Cavity Medical Stents and Introducer System (Esophageal Stent) | B. No.: 20190731-09, Mfg dt: 08/2019, Exp dt: 20/08/2021, Mfd by: M/s. Changzhou New District Garson Medical Stent Apparatus Co. Ltd., Located at No. 06, Huanbao 8 Road, Huanbao Industry Zone, New Zone, New District Changzhou, Jiangsu P.R. China – 213 022. | Sterility | CDSCO, Airport, Mumbai | CDL, Kolkata |
11. | (ULTRA NATURE HANDRUB) | B. No.: 006, Mfg dt: 06/2020, Exp dt: 05/2023, Mfd by: M/s. S.M.Herbal Solutions Libaspur, Delhi. | Identification of Isopropyl Alcohol | Govt of N.C.T. of Delhi, | RDTL, Chandigarh |
12. | (MAYGRISS SANITIZER) | B. No.: VES-140, Mfg dt: 05/2020, Exp dt: 04/2023, Mfd by: M/s. VIVE COSMETICS Plot 773, Sector 82, JLPL, Industrial Area, Mohali, Punjab. | Assay of Ethyl Alcohol | CDSCO, Sub-Zone, Baddi,Himachal Pradesh | RDTL, Chandigarh |
13. | Isopropyl Alcohol 70% Hand Sanitizer (SANEZER HAND SANITIZER) | B. No.: NPE003, Mfg dt: 03/2020, Exp dt: 02/2022, Mfd by: M/s. NOEL PHARMA (INDIA) PVT. LTD. Khasra No. 66/3 & 67/2, Juddi Kalan, Baddi, Distt. Solan (H.P.) 173205. | Assay of Isopropyl Alcohol | CDSCO, Sub- Zone, Baddi, Himachal Pradesh | RDTL, Chandigarh |
14. | Diclofenac Potassium and Paracetamol Tablets (AMGESIC TABLETS) | B. No.: MT-19I04, Mfg dt: 09/2019, Exp dt: 08/2021, Mfd by: M/s. Martin & Brown Bio-Sciences K.No. 918/419, Malkumajra, Nalagarh Road, Baddi, Distt. Solan, (H.P.). | Uniformity of weight | CDSCO (North Zone), Ghaziabad (UP) | RDTL, Chandigarh |
15. | (MOIST HAND SANITIZER GEL) | B. No.: 16401, Mfg dt: 04/2020, Exp dt: 03/2023, Mfd by: M/s. gary Pharmaceuticals P Limited Off NH-95, VPO Heeran- | Assay of Isopropyl Alcohol | CDSCO, Sub- Zone, Baddi, Himachal Pradesh | RDTL, Chandigarh |
141112 (Punjab) | |||||
16. | 70% Alcohol Hand Cleanser (SEVEN SEAS) | B. No.: 140, Mfg dt: 04/2020, Exp dt: 04/2022, Mfd by: M/s. Seven Seas Beauty Products G.T. Karnal Road Indl. Area, Delhi-33. | Assay of Isopropyl Alcohol | Govt. of N.C.T of Delhi | RDTL, Chandigarh |
17. | Calcium Carbonate, Methylcobalamin, L-Methyl Folate, Pyridoxal 5 Phosphate and Vitamin D3 Tablets (VERECAL PLUS TABLETS) | B. No.: SPT-2070, Mfg dt: 07/2019, Exp dt: 12/2020, Mfd by: M/s. SPECTRUM FORMULATION PVT. LTD. Khasra No.12, Makhanpur, Bhagwanpur, Roorkee, Haridwar- (U.K.). | Assay of Pyridoxal-5 Phosphate, L- Methylfolate Calcium | CDSCO Sub- Zone, Baddi, Himachal Pradesh | RDTL, Chandigarh |
18. | (FLUCONAZOLE INJECTION USP 0.2% W/V) | B. No.: A9123, Mfg dt: 04/2019, Exp dt: 03/2021, Mfd by: M/s. AISHWARYA HEALTHCARE Vill.Thana, Baddi, Himachal Pradesh- 173205. | Organic Impurities | CDSCO, Sub- Zone, Jammu | RDTL, Chandigarh |
19. | (ESCITALOPRAM TABLETS I.P. 10 MG) | B. No.: ATT-110, Mfg dt: 05/2019, Exp dt: 04/2021, Mfd by: M/s. Alliaance Biotech 440/3, Vill. Katha, Baddi, Solan (H.P.)-173205. | Assay & Dissolution | CDSCO (North- Zone), Ghaziabad (UP) | RDTL, Chandigarh |
20. | (CARVEDILOL TABLETS IP 6.25 MG) | B. No.: CADG904001, Mfg dt: 04/2019, Exp dt: 03/2021, Mfd by: M/s. Celebrity Biopharma Ltd. Vill. Panga, Jharmajri, Hilltop Estate, Barotiwala, Distt.-Solan H.P. 174103. | Assay | Drug and Food Control Organization, Srinagar, Bemina (J & K) | RDTL, Chandigarh |
21. | (CIPROFLOXACIN TABLETS I.P. 500 mg) | B. No.: DT-042, Mfg dt: 05/2019, Exp dt: 10/2020, Mfd by: M/s. Daffodills Pharmaceuticals Ltd. Jawahar Nagar, Rohta Road, Meerut- 250001, | Assay & Dissolution | CDSCO, Sub- Zone, Jammu | RDTL, Chandigarh |
Uttar Pradesh. | |||||
22. | (ALBENDAZOLE TABLETS IP 400 MG) | B. No.: 03285, Mfg dt: 12/2019, Exp dt: 11/2021, Mfd by: M/s. Healthy Life Pharma Pvt. Ltd., N-31/1, MIDC, Tarapur, Dist Palghar, Boisar-401506, Maharashtra. | Dissolution | CDSCO Sub- Zone, Baddi, Himachal Pradesh | RDTL, Chandigarh |
23. | (CALCIUM AND VITAMIN D3 TABLETS IP) | B. No.: CVDT-1371, Mfg dt: 04/2019, Exp dt: 03/2021, Mfd by: M/s. WINGS BIOTECH 43 & 44 HPSIDC, Industrial Area, Baddi- 173205 (HP). | Dissolution of Calcium Carbonate | CDSCO Sub- Zone, Baddi, Himachal Pradesh | RDTL, Chandigarh |
24. | Isopropyl Rubbing Alcohol IP (ADDIISURE INSTANT HAND SANITIZER) | B. No.: 393, Mfg dt: 03/2020, Exp dt: 02/2022, Mfd by: M/s. ADDII BIOTECH PVT. LTD Vill. Kaundi, P.O. Thana, Teh. Baddi, Distt. Solan-173205 (H.P.). | Limit of non volatile residue | CDSCO Sub- Zone, Baddi, Himachal Pradesh | RDTL, Chandigarh |
25. | 70% Alcohol (KAZIMA COSMETICS TEA TREE HAND CLEANSING GEL) | B. No.: BK001, Mfg dt: 05/2020, Exp dt: 04/2022, Mfd by: M/s. KAZIMA COSMETICS 309, First Floor, Patparganj, Indl. Area, New Delhi-110092. | Identification of Isopropyl Alcohol | Govt. of N.C.T. of Delhi | RDTL, Chandigarh |
26. | (OLIBLISS HAND CLEANSER GEL) | B. No.: BSAS001, Mfg dt: 06/2020, Exp dt: 05/2023, Mfd by: M/s. OLICARE COSMOCEUTICALS 2nd Floor, Property No. 152, Pocket-L, Sector-3, DSIIDC, Bawana Industrial Area, Delhi-110039. | Identification of Isopropyl Alcohol | Govt. of N.C.T. of Delhi | RDTL, Chandigarh |
27. | Methylcobalamin, Folic Acid, Alpha Lipoic Acid, Pyrodoxine HCI, Chromium Picolinate and Selenium Tablets (M-NEURON PLUS TABLETS) | B. No.: HMP 113, Mfg dt: 08/2019, Exp dt: 01/2021, Mfd by: M/s. Med Manor Organics Pvt. Ltd. Unit-II, KH-No. 143M/7, Village- Raipur Pargana Bhagwanpur, Tehsil- Roorkee, Distt. Haridwar, Uttarakhand-247661. | Identification of Selenium and Assay of Chromium Picolinate, Selenious Acid calculated as Elemental Selenium | CDSCO (North- Zone), Ghaziabad (UP) | RDTL, Chandigarh |
28. | (PANCHVATI HAND CLEANSER GEL) | B. No.: HCG.106, Mfg dt: 05/2020, Exp dt: 04/2022, Mfd by: M/s. Baldev Industries 103- DSIDC, Okhla Ph-1, N.Delhi-20. | Identification of Isopropyl Alcohol | Govt. of N.C.T. of Delhi | RDTL, Chandigarh |
29. | Ethanol and Isopropyl Alcohol (MEDI-PLUS INSTANT HAND SANITIZER) | B. No.: F512, Mfg dt: 05/2020, Exp dt: 04/2022, Mfd by: M/s. Swisskem Healthcare Khasra No. 77/3, Bathri, Tehsil Haroli, Distt. Una ( H.P.). | Assay of Isopropyl Alcohol | CDSCO Sub- Zone, Baddi, Himachal Pradesh | RDTL, Chandigarh |
30. | Isopropyl Alcohol Emollients and Moisturizer Hand Rub IP (PURE- HANDRUB PLUS) | B. No.: EHX-281, Mfg dt: 04/2020, Exp dt: 03/2022, Mfd by: M/s. Dr.Edwin Lab Plot No. 517, Indl. Area, Phase IX, SAS Nagar- 160059 (Pb.). | Identification and Assay of Isopropyl Alcohol | CDSCO Sub- Zone, Baddi, Himachal Pradesh | RDTL, Chandigarh |
31. | (BEARD HOOD HAND CLEANER) | B. No.: J031, Mfg dt: 03/2020, Exp dt: 02/2022, Mfd by: M/s. Ambrosia Herbals 317, FIE Patparganj, Industrial Area, Delhi-110092. | Assay of Isopropyl Alcohol | Govt. of .N.C.T.of Delhi | RDTL, Chandigarh |
32. | (SEEJAL +INSTANT HAND SANITIZER) | B. No.: JDL-1719, Mfg dt: 04/2020, Exp dt: 03/2022, Mfd by: M/s. JPEE DRUGS Plot No.-53, Sector 6-A, SIDCUL, Haridwar (Uttarakhand). | Assay of Isopropyl Alcohol | CDSCO (North- Zone), Ghaziabad (UP) | RDTL, Chandigarh |
33. | Glimepiride Tablets I.P. 2mg. | B. No.: MT182240, Mfg dt: 02/2019, Exp dt: 01/2021, Mfd by: M/s. Mascot Health Series Pvt. Ltd. Plot no. 79, 80, Sector-6A, IIE, SIDCUL, Haridwar-249403(U.K). | Dissolution | Drugs Control Department, Bihar | RDTL, Guwahati |
34. | Nefidinol Retard- 10 Tablets | B. No.: T8120289, Mfg dt: 12/2018, Exp dt: 11/2020, Mfd by: M/s. Rhydburg pharmaceuticals Ltd. C2&3, S.I.E.L, Selaqui, Dehradun (U.K). | Non-compliance with physical description of tablets and unfit for human consumption | Drugs Control Department, Nagaland | RDTL, Guwahati |
35. | Domperidone & Omeprazole Capsules (ROCID D CAPSULES) | B. No.: RC-010, Mfg dt: 07/2019, Exp dt: 05/2022, Mfd by: M/s. Ronak Life Care Pvt. Ltd. R.S. No.: 41(Part) At & Post Fajpur, Dist.-Patan-384265, Gujarat. | Dissolution | Drugs Control Department, Mizoram | RDTL, Guwahati |
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