36 drug samples fail to qualify CDSCO test
New Delhi: In its latest drug safety alert, the apex drug regulatory body, the Central Drugs Standard Control Organization (CDSCO), has flagged 36 medicine batches for failing to qualify for a random drug sample test for the month of October.
These drug samples which are declared as 'Not of Standard Quality' include two Government manufacturers namely Karnataka Antibiotics and Pharmaceuticals Limited (A Govt. of India Enterprise) and Hindustan Antibiotics Ltd., (A Govt. Of India Enterprise). Besides, Theon Pharmaceutical's Pregabalin Capsules, Akums Drug's Diclofenac, Virgin Linseed oil, Methyl Salicylate and Menthol gel, Karnataka Antibiotics & Pharmaceuticals' Paracetamol tablets, and Unicure India's Norfloxacin tablets were also mentioned in the drug list for the month of October.
In addition, drug major Cipla's Aciclovir Dispersible Tablets IP 800 mg Acivir-800 DT is also on the list. Acyclovir is a nucleotide analogue antiviral used to treat herpes simplex, Varicella zoster, herpes zoster, herpes labialis, and acute herpetic keratitis.
Bethadoxin 12M Syrup, composed of Multivitamins, Minerals, and L-Lysine Hydrochloride Syrup, manufactured by Biological E.Limited, batch no. D1105520, is also declared not of Standard Quality.
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Apart from this, absorbent cotton wool manufactured by Altus Surgical Private Limited and Sterile Hypodermic Syringe (2 mL) manufactured by Gurumangalam International are also on the list of Not of Standard Quality (NSQ).
This came after analysis and testing were conducted by the CDSCO, Drugs Control Department, on 1061 drug samples. Out of these, 1025 samples were found to be of standard quality, while 36 of them were declared as Not of Standard Quality (NSQ).
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A few of the reasons why the drug samples tested failed were the failure of the assay, failure of the dissolution test, failure of the Bacterial Endotoxins Test and Sterility Test, etc.
The samples collected were tested in four laboratories, namely CDL Kolkata, CDTL Mumbai, RDTL Chandigarh, and RDTL Guwahati.
List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, for the Month of October– 2021
Total number of samples tested | 1061 |
Total number of samples declared as of Standard Quality | 1025 |
Total number of samples declared as Not of Standard Quality | 36 |
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. | Absorbent Cotton Wool I.P. | B. No.: 172 Mfg dt: 01/2021 Exp dt: 3 Yrs from Mfg date Mfd by: M/s. Doctor Surgical Works, Plot No. 61, Sector 27-28, HISAR, Haryana. | Surface Active Substances, Fluorescence, Sulphated Ash, Water Soluble substances and Neps | CDSCO, Bangalore | CDL Kolkata |
2. | Rabeprazole Injection IP 20 mg | B. No.: PE3AA11 Mfg dt: 10/2019 Exp dt: 09/2021 Mfd by: M/s. Pure and Cure Healthcare Pvt. Ltd., Plot No. 26A, 27- 30, Sector – 8A, I.I.E., SIDCUL, Haridwar – 249 403, Uttarakhand. | Clarity of Solution & Particulate Matter | Drug Control Department Odisha | CDL Kolkata |
3. | Ranitidine HCl Injection IP 50 mg/2 ml-2ml | B. No.: SI-727 Mfg dt: 03/2020 Exp dt: 02/2022 Mfd by: M/s. Shivam Enterprises (Pharma Division), Suketi Road, Kala Amb – 173030, Himachal Pradesh. | Related Substances | CDSCO South Zone | CDL Kolkata |
4. | RL (Compound Sodium Lactate Injection I.P. 500 ml) (Ringer Lactate Solution for Injection I.P.) | B. No.: 009068 Mfg dt: 09/2020 Exp dt: 08/2022 Mfd by: M/s.Ives Drugs (India) Pvt. Limited, Ghatabillod, Distt. Dhar, Madhya Pradesh. | Bacterial Endotoxins Test & Sterility | Drug Control Department Madhya Pradesh | CDL Kolkata |
5. | KYCOLD-PLUS Suspension- 60 ml (Paracetamol, Phenylephrine HCl, Chlorpheniramine Maleate, Sodium Citrate & Menthol Suspension) | B. No.: DL5184 Mfg dt: 09/2019 Exp dt: 08/2021 Mfd by: M/s. Digital Vision, 176, Mauza Ogli, Nahan Road, Kala-Amb, Distt. Sirmour, Himachal Pradesh- 173030. | Assay of Phenylephrine Hydrochloride Negative for Diethylene Glycol (DEG) | Drug Control Department Himachal Pradesh | CDL Kolkata |
6. | Amikacin Injection I.P. 2ml | B. No.: GV1A001 Mfg dt: 01/2021 Exp dt: 12/2022 Mfd by: M/s. Scott-Edil Pharmacia Ltd., 56, E.P.I.P. Phase- I, Jharmajri, Baddi, Distt. Solan -173205, Himachal Pradesh. | Description & Particulate Matter | CDSCO East Zone | CDL Kolkata |
7. | Ambrolite D+ (Chlorpheniramine, Phenylephrine and Dextromethorphan Syrup) | B. No.: DJ0I1 Mfg dt: 05/2020 Exp dt: 10/2021 Mfd by: M/s. Healkraft Pharma (India) Pvt. Ltd., (Unit II), Plot No. 135 C, EPIP, Phase -I, Jharmajri, Baddi, Himachal Pradesh. | Assay of Phenylephrine Hydrochloride | CDSCO South Zone | CDL Kolkata |
8. | Ambrolite D+ (Chlorpheniramine, Phenylephrine and Dextromethorphan Syrup) | B. No.: DJ0I2 Mfg dt: 05/2020 Exp dt: 10/2021 Mfd by: M/s. Healkraft Pharma (India) Pvt. Ltd., (Unit II), Plot No. 135 C, EPIP, Phase -I, Jharmajri, Baddi, Himachal Pradesh. | Assay of Phenylephrine Hydrochloride | CDSCO South Zone | CDL Kolkata |
9. | Acivir - 800 DT (Aciclovir Dispersible Tablets IP 800 mg) | B. No.: SN01674 Mfg dt: 10/2020 Exp dt: 09/2023 Mfd by: M/s. Cipla Ltd., (Unit -II), Taza Block, Rorathang, Sikkim 737133. | Uniformity of Dispersion | CDSCO Ahmedabad | CDL Kolkata |
10. | Absorbent Cotton Wool I.P. (ALTUS) | B. No.: A/2105 Mfg dt: 05/2021 Exp dt: 5 Yrs from Mfg | Surface Active Substances, Sulphated Ash, Water Soluble | CDSCO South Zone | CDL Kolkata |
date Mfd by: M/s. Altus Surgical Private Limited, 21/D, Mahagujrat Industrial Estate, Opp. Nova Petrochemical, Sarkhej-Bavala Highway, Villg. Moraiya, Changodar - 382210, Ahmedabad, Gujarat. | substances and Neps | ||||
11. | Ranitidine Tablets IP 150 mg | B. No.: NSTY-05 Mfg dt: 06/2021 Exp dt: 05/2023 Mfd by: M/s. Hindustan Antibiotics Ltd., (A Govt. Of India Enterprise), at 11, W.E.A Faridabad- 121001 Haryana. | Uniformity of weight | CDSCO West Zone | CDTL Mumbai |
12. | Pregabalin Capsules IP | B. No.: GC210322 Mfg dt: 05/2021 Exp dt: 04/2023 Mfd by: M/s. Theon Pharmaceutical Ltd., Vill. Saini Majra, Tehsil Nalagarh, Dist. Solan, Himachal Pradesh - 174 101. | Related Substances | CDSCO West Zone | CDTL Mumbai |
13. | Sterile Hypodermic Syringe (2ml) | B. No.: 19502 Mfg dt: 12/2019 Exp dt: 11/2021 Mfd by: M/s. Gurumangalam International, Rancharda-382115, Ta: Kalol, Dist: Gandhinagar, Gujarat. | Sterility | Drug Control Department Gujarat | RDTL Guwahati |
14. | Sterile Hypodermic Syringe (2ml) | B. No.: 19507 Mfg dt: 12/2019 Exp dt: 11/2021 Mfd by: M/s. Gurumangalam International Rancharda-382115, Ta: Kalol, Dist: Gandhinagar, Gujarat. | Sterility | Drug Control Department Gujarat | RDTL Guwahati |
15. | Sterile Hypodermic Syringe (2ml) | B. No.: 19532 Mfg dt: 03/2020 | Sterility | Drug Control | RDTL Guwahati |
Exp dt: 02/2022 Mfd by: M/s. Gurumangalam International Rancharda-382115, Ta: Kalol, Dist: Gandhinagar, Gujarat. | Department Gujarat | ||||
16. | Pantoprazole Gastro Resistant Tablets I.P. (P-40) | B. No.: PFT21002MB Mfg dt: 02/2021 Exp dt: 01/2023 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 Assam | RDTL Guwahati |
17. | Ofloxacin and Ornidazole Tablets I.P. | B. No.: TI0005A Mfg dt: 09/2020 Exp dt: 08/2022 Mfd by: M/s. NAVKAR LIFESCIENCES, Plot No.-76, Lodhi Majra, Industrial Area, Baddi, Distt.- Solan Himachal Pradesh. | Dissolution | Drug Control Department Assam | RDTL Guwahati |
18. | Pregabalin Capsules IP 75 mg | B. No.: T21003 Mfg dt: 01/2021 Exp dt: 12/2022 Mfd by: M/s. Trugen Pharmaceutical Pvt. Ltd. Vill. Tejjupur, Near Chodiala Rly. Station, Roorkee, Dist. Haridwar, Uttarakhandh-247661. | Dissolution | Drug Control Department Assam | RDTL Guwahati |
19. | Rabeprazole Sodium & Itopride (Sustained Release) Capsules | B. No.: I4200001 Mfg dt: 02/2020 Exp dt: 01/2022 Mfd by: M/s. Innova Captab, 81-B, EPIP, Phase-I, Jharmajri, Baddi Himachal Pradesh. | Assay | CDSCO Sub-Zone, Guwahati | RDTL Guwahati |
20. | Infusion Set | B. No.: 060220 Mfg dt: 02/2020 Exp dt: 01/2025 Mfd by: M/s. R. R. Medicare Products, 3-A, | Sterility | Drug Control Department Jammu & Kashmir | RDTL Guwahati |
Birpur Industrial Estate, Bari Brahmana, Jammu- 181113. | |||||
21. | Sterile Hypodermic Syringe 05 ML/CC | B. No.: 19718 Mfg dt: 12/2019 Exp dt: 11/2021 Mfd by: M/s. Gurumangalam International, Rancharda-382115, Ta: Kalol, Dist: Gandhinagar, Gujarat. | Sterility & Bacterial Endotoxin | Drug Control Department Gujarat | RDTL Guwahati |
22. | Infusion Set | B. No.: 050220 Mfg dt: 02/2020 Exp dt: 01/2025 Mfd by: M/s. R R Medicare Products, 3A- Birpur Indl Estate Bari Brahmana, Jammu- 181113. | Sterility & Bacterial Endotoxin | Drug Control Department Jammu & Kashmir | RDTL Guwahati |
23. | Sterile Hypodermic Syringe 5 ml | B. No.: 19719 Mfg dt: 12/2019 Exp dt: 11/2021 Mfd by: M/s. Gurumangalam International, Rancharda-382115, (Ta: Kalol) Dist: Gandhinagar, Gujarat. | Sterility | Drug Control Department Gujarat | RDTL Guwahati |
24. | Levetiracetam IP | B. No.: LEV/10/21 Mfg dt: 04/2021 Exp dt: 03/2024 Mfd by: M/s. Pranshav Health Care Plot No. 824/16, Near SaintGobin Glass India Ltd., GIDC, Jhagadia- 393110 Gujarat. | Related Substances | CDSCO Sub-Zone Baddi | RDTL Chandigarh |
25. | Tramadol Hydrochloride and Acetaminophen Tablets USP (DOLOSAFE D TABLETS) | B. No.: NDSD-02102 Mfg dt: 04/2021 Exp dt: 03/2024 Mfd by: M/s. Tidal Laboratories Pvt. Ltd. Patch-5, Phase-II, Gowalthai, Distt. Bilaspur-174201, Himachal Pradesh. | Dissolution | Drug Control Department Himachal Pradesh | RDTL Chandigarh |
26. | Methylcobalamin, Vitamin C, Vitamin E, Beta Carotene, Zinc Sulphate, Sodium Selenite, Chromium Picolinate, Lutein and Lycopene Capsules (OCTOXID CAPSULES) | B. No.: OTXC-02102 Mfg dt: 06/2021 Exp dt: 11/2022 Mfd by: M/s. Tidal Laboratories Pvt. Ltd. Patch-5, Phase-II, Gowalthai, Distt. Bilaspur-174201, Himachal Pradesh. | Identification of Methylcobalamin, Vitamin E | Drug Control Department Himachal Pradesh | RDTL Chandigarh |
27. | Pancreatin, Bile Constituents and Activated Dimethicone Tablets (ENZOX PLUS TABLETS) | B. No.: ENZP-02105-02 Mfg dt: 05/2021 Exp dt: 04/2024 Mfd by: M/s. Tidal Laboratories Pvt. Ltd. Patch-5, Phase-II, Gowalthai, Distt. Bilaspur-174201, Himachal Pradesh. | Assay of Activated Dimethicone | Drug Control Department Himachal Pradesh | RDTL Chandigarh |
28. | COMPOUND SODIUM LACTATE INJECTION IP | B. No.: FFS2005B0114 Mfg dt: 06/2020 Exp dt: 05/2023 Mfd by: M/s. Pharma Impex Laboratories Pvt. Ltd. South Uttarbhag, Ramnagar, Baruipur, Distt. South 24PGS West Bengal -743387. | Description, pH, Particulate Contamination, Bacterial Endotoxins and Sterility | CDSCO North Zone | RDTL Chandigarh |
29. | Multivitamins, Minerals and L-Lysine Hydrochloride Syrup (BETHADOXIN- 12M SYRUP) | B. No.: D1105520 Mfg dt: 10/2020 Exp dt: 03/2022 Mfd by: M/s. Biological E.Limited, Plot No. 31 & 32, Pharma City, Selaqui, Dehradun- 248197, Uttarakhand. | Identification of Selenium and Assay of Pyridoxine Hydrochloride | CDSCO North Zone | RDTL Chandigarh |
30. | BUPIVACAINE HYDROCHLORIDE IN DEXTROSE INJECTION USP | B. No.: HIBU2003G Mfg dt: 09/2020 Exp dt: 08/2022 Mfd by: M/s. Health Biotech Ltd, Village: Sadoli, Nalagarh Road, Baddi, Distt: Solan,Himachal Pradesh -173205. | Bacterial Endotoxins | Drug Control Department Himachal Pradesh | RDTL Chandigarh |
31. | DICLOFENAC, VIRGIN LINSEED OIL, METHYL SALICYLATE AND | B. No.: JZAA02 Mfg dt: 01/2021 Exp dt: 12/2022 Mfd by: M/s. Akums | Assay of Menthol | CDSCO North Zone | RDTL Chandigarh |
MENTHOL GEL | Drugs & Pharmaceuticals Ltd. Plot No. : 47,48, Sector-6A, IIE, SIDCUL, Ranipur, Haridwar- 249403, Uttarakhand. | ||||
32. | Diclofenac Sodium Tablets IP (DECIFEN-50 TABLETS | B. No.: CLT-14750 Mfg dt: 03/2020 Exp dt: 02/2023 Mfd by: M/s. Caremax Formulations Plot No. 56 & 61, Industrial Area, Phase III, Sansarpur Terrace, Distt. Kangra Himachal Pradesh - 176501. | Disintegration Test | CDSCO North Zone | RDTL Chandigarh |
33. | Meropenem Injection IP 500 mg (MEROMAX 500 MG INJECTION) | B. No.: DP1013 Mfg dt: 05/2021 Exp dt: 04/2023 Mfd by: M/s. Scott-Edil Pharmacia Ltd. 56, E.P.I.P., Phase-1, Jharmajri, Baddi, Distt. Solan-173205, Himachal Pradesh. | Particulate matter | CDSCO Sub-Zone Baddi | RDTL Chandigarh |
34. | PARACETAMOL TABLETS IP 500 MG | B. No.: 2518021 Mfg dt: 08/2021 Exp dt: 07/2024 Mfd by: M/s. KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LIMITED (A Govt. of India Enterprise) Plot No. 14, II Phase, Peenya, Bangaluru- 560058. | Dissolution | CDSCO Sub-Zone Baddi | RDTL Chandigarh |
35. | NORFLOXACIN TABLETS IP 400 MG | B. No.: NT802 Mfg dt: 10/2020 Exp dt: 09/2022 Mfd by: M/s. Unicure India Ltd., C-21,22 & 23, Sector-3, Noida-201301 Distt. Gautam Budh Nagar, Uttar Pradesh. | Dissolution | CDSCO Sub-Zone Baddi | RDTL Chandigarh |
36. | CEFUROXIME AXETIL TABLETS IP 500 MG | B. No.: XATX-01 Mfg dt: 07/2020 Exp dt: 06/2022 Mfd by: M/s. HINDUSTAN ANTIBIOTICS LTD. (A Government of India Enterprise ) at 11, W.E.A. Faridabad- 121001 Haryana. | Dissolution | CDSCO Sub-Zone Baddi | RDTL Chandigarh |
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