Drug Alert: CDSCO declares 28 samples including Soframycin, Ranitidine as sub-standard in quality; Details
New Delhi: Apex drug regulatory body, the Central Drugs Standard Control Organization (CDSCO) has declared batches of 28 drugs made by certain manufacturers as sub-standard in quality, counterfeited and misbranded/ adulterated. These include Norfloxacin Tablets, Soframycin Skin Cream, Ciprofloxacin Tablets, Ranitidine Injection IP.
The move came following analysis and test conducted by the CDSCO on 951 drug samples as a part of the random sampling. The test found that 28 out of the total drug samples did not meet quality and therefore they were affirmed as not of standard quality (NSQ), spurious and misbranded.
The set of these 28 drugs in various dosage forms failed the quality test over the presence of description, Assay of Nortriptyline, particulate matter, Water Content and Assay, extractable volume, sterility, disintegration, dissolution and other parameters. The drug samples were drawn by the drug control department and CDSCO counterparts pan India.
Among the manufacturers, prominent drug maker, Sanofi India's Framycetin Skin Cream (Soframycin Skin Cream) failed the quality test due to assay while a batch of Paracetamol Tablets manufactured by Zee Labs could not meet quality standards over dissolution. Notably, batch of Levocetirizine tablets manufactured by government-run Karnataka Antibiotics & Pharmaceuticals Limited was also found to be spurious.
The drug samples were tested at four laboratories namely CDL Kolkata, CDTL Mumbai, RDTL Guwahati and RDTL Chandigarh.
The medications included in the list are indicative in the treatment of bacterial infection, bacterial infections of the prostate or urinary tract, anxiety and panic disorder, diarrhoea, UTI, RTI, ulcer, constipation, unstable angina and others.
List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, for the month of August 2019 reads;
| S. N. | Name of Drugs/medical device/cosmetics | Batch No./Date of Manufacture/Date of Expiry/Manufactured By | Reason for failure | Drawn By | From |
| 1. | Cefixime Oral Suspension I.P. | B. No.: MCS-17039, Mfg dt: 09/2017, Exp dt: 08/2019, Mfd by: M/s. Maxmed Lifesciences Pvt. Ltd. Plot No. 54, Sector IIDC SIDCUL Rudrapur, Uttarakhand. | Assay | Drug Control Department, Arunachal Pradesh | RDTL, Guwahati |
| 2. | Norfloxacin Tablets I.P. 400 mg | B. No.: NT606, Mfg dt: 02/2019, Exp dt: 01/2021, Mfd by: M/s. Unicure India Ltd. C-21, 22 & 23, Sector-3, Noida, Gautam Budh Nagar, Uttar Pradesh-201301. | Dissolution | Drug Control Department, Assam | RDTL, Guwahati |
| 3. | Norfloxacin Tablets I.P. 400 mg (NORTEC-400) | B. No.: NTK-18004, Mfg dt: 03/2019, Exp dt: 02/2022, Mfd by: M/s. Neutec Healthcare Pvt. Ltd. E- 698, DSIIDC Narela, Industrial Area Delhi- 110040. | Dissolution | Drug Control Department, Meghalaya | RDTL, Guwahati |
| 4. | PGAB-MB 75 (Pregabalin and Mecobalamin Capsules 75 mg) | B. No.: WGC1828, Mfg dt: 06/2018, Exp dt: 05/2021, Mfd by: M/s. West Coast Pharmaceuticals Works Limited, FP-17 & 16/5 Meldi Mata Temple Near Gota railway Station Crossing, Gota, Ahmedabad – 382481, Gujarat. | Dissolution for Pregabalin | CDSCO, Ahmedabad | CDTL, Mumbai |
| 5. | Levocetirizine tablets I.P. 5mg | B. No.: 9704418, Mfg dt: 12/2018, Exp dt: 11/2021, Mfd by: M/s. Karnataka Antibiotics & Pharmaceuticals Limited )A Govt. of India Enterprise), Plot No. 14, II Phase, Peenya, Bengaluru – 560058. | Dissolution | CDSCO, West Zone, Mumbai | CDTL, Mumbai |
| 6. | Alprazolam tablets I.P. | B. No.: TAZP-001, Mfg dt: 11/2018, Exp dt: 10/2020, Mfd by: M/s. Medipol Pharmaceuticals India Pvt. Limited, 1199/3, Bhud, Baddi, distt. Solan. Himachal Pradesh. | Dissolution | CDSCO, West Zone, Mumbai | CDTL, Mumbai |
| 7. | Eryfast-250 (Erythromycin Stearate Tablets B.P. 250 mg) | B. No.: MD926, Mfg dt: 04/2019, Exp dt: 02/2022, Mfd by: M/s. Mihika Pharmaceuticals, 506, Parmeshwari Centre, 18, Dalmia estate, Mulund (W), Mumbai – 400 080. | Assay | CDSCO, West Zone, Mumbai | CDTL, Mumbai |
| 8. | Thyrocure-100 (Thyroxine Tablets I.P. 100 mcg) | B. No.: THDT611, Mfg dt: 12/2018, Exp dt: 05/2020, Mfd by: M/s. Unicure India Ltd., C-21, 22 & 23, Sector-3, Noida – 201 301, Distt. Gautam Budh Nagar (Uttar Pradesh). | Assay | CDSCO, East Zone, Kolkata | CDL, Kolkata |
| 9. | Eufox-O (Ofloxacin and Ornidazole Tablets) | B. No.: CJM711031, Mfg dt: 11/2017, Exp dt: 10/2020, Mfd by: M/s. Celebrity Biopharma Ltd., Vill: Panga Hill Top Estate, Via-Jharmajri, Barotiwala, Distt. Solan, Himachal Pradesh. | Disintegration | CDSCO, East Zone, Kolkata | CDL, Kolkata |
| 10 | Ornizole (Ornidazole Tablets I.P. 500 mg) | B. No.: T-1710151, Mfg dt: 10/2017, Exp dt: 09/2019, Mfd by: M/s. Aagya Biotech Pvt. Ltd., 1.5 KM, Manglour- Saharanpur Road, Manglour-247656, Roorkee, Distt. Haridwar, (Uttarakhand). | Description | CDSCO, East Zone, Kolkata | CDL, Kolkata |
| 11 | ZEPARA –XT 650 mg (Paracetamol Tablets 650mg) | B. No.: 418-955, Mfg dt: 10/2018, Exp dt: 09/2020, Mfd by: M/s. Zee Laboratories, Industrial Area, Paonta Sahib- 173025. (Himachal Pradesh) | Dissolution | CDSCO, East Zone Kolkata | CDL, Kolkata |
| 12 | Ticomox CV (Amoxycillin & Potassium Clavulanate Tablets I.P.) | B. No.: EBT-18L1588, Mfg dt: 12/2018, Exp dt: 02/2020, Mfd by: M/s. Edwin Biotech, Plot No. 184, Indl. Area, Phase IX, SAS, 160059 (Punjab). | Assay & Dissolution | CDSCO, Baddi | CDL, Kolkata |
| 13 | MOXCON-CV 625 (Amoxycillin & Potassium Clavulanate Tablets I.P.) | B. No.: SRDTB-1233, Mfg dt: 06/2019, Exp dt: 11/2020, Mfd by: M/s. Spas Remedise, Vill. Bersan, P.O. - Lodhi Majra, Teh. Baddi, Distt. Solan – 173 205 (Himachal Pradesh). | Dissolution, Water & Assay of Potassium Clavulanate | CDSCO, Baddi | CDL, Kolkata |
| 14 | Framycetin Skin Cream (Soframycin Skin Cream) | B. No.: N8080, Mfg dt: 04/2018, Exp dt: 09/2020, Mfd by: M/s. Sanofi India Limited, Plot No. C-1, Madkaim Ind. Estate, Ponda, Goa – 403 404. | Assay | CDSCO, Baddi | CDL, Kolkata |
| 15 | Monozin 50 (Cefpodoxime Proxetil Oral Suspension I.P.) | B. No.: SRDS-1031 , Mfg dt: 03/2019, Exp dt: 02/2021, Mfd by: M/s. Spas Remedies, Vill. Bersan, P.O. Lodhi Majra, Teh. Baddi, Distt. Solan – 173 205. (Himachal Pradesh). | Assay & "Stability of Cefpodoxime" | CDSCO, Baddi | CDL, Kolkata |
| 16 | Clopidogrel & Aspirin Tablets | B. No.: T8202, Mfg dt: 07/2018, Exp dt: 06/2020, Mfd by: M/s. Bharat Parenterals Ltd., Vill. Haripura, Ta. Savli, Dist. Vadodara -391 520,Gujrat. | Free Salicylic Acid Test | CDSCO, Ahmedabad | CDL, Kolkata |
| 17 | Frusemide Injection I.P. 2 ml | B. No.: AI18064, Mfg dt: 07/2018, Exp dt: 06/2020, Mfd by: M/s. Alves Healthcare Pvt. Ltd., Nangal Uperia, Swarghat Road, Nalagarh, Dist. Solan, Himachal Pradesh – 174 101. | Extractable Volume | CDSCO, Ahmedabad | CDL, Kolkata |
| 18 | Dermacur Cream 20g (Clobetasol Propionate Cream) | B. No.: E19009, Mfg dt: 01/2019, Exp dt: 36 months from date of mfg, Mfd by: M/s. Curis Lifesciences Pvt. Ltd., PF-23, Sanand GIDC - II, Sanand, Ahmedabad – 382110. | Assay | CDSCO, Ahmedabad | CDL, Kolkata |
| 19 | FLI Drops Eye Drops 5 ml (Fluorometholone Acetate Ophthalmic Suspension 0.1% w/v) | B. No.: FLD904021, Mfg dt: 04/2019, Exp dt: 03/2021, Mfd by: M/s. Senses Phamaceuticals Ltd., No. 77, 3rd Road, Bommasandra Industrial Area, Bommasandra 4th Phase, Bangalore – 560 099. | Assay | CDSCO, Bangalore | CDL, Kolkata |
| 20 | Dulcoflex (Biscodyl Tablets I.P. 5 mg) | B. No.: DLA18146, Mfg dt: 12/2018, Exp dt: 11/2021, Mfd by: M/s. Recipharm Pharmaservices Pvt. Ltd., Khatha No. 845/713 & 1108/970/1, 34th KM, Tumkur Road, T- Begur, Nelamangala, Bangalore, Rural – 562123. | Disintegration | CDSCO, Bangalore | CDL, Kolkata |
| 21 | Ciprofloxcin Tablets I.P. 500mg | B. No.: RCTW-06, Mfg dt: 01/2019, Exp dt: 12/2021, Mfd by: M/s. Nestor Pharmaceuticals Limited, 11, Westrn Extension Area Faridabad – 121001, India. | Dissolution | CDSCO, North Zone, Ghaziabad | CDL, Kolkata |
| 22 | Climox 1.2g (Amoxycillin & Potassium Clavulanate Injection I.P.) | B. No.: I-17225, Mfg dt: 06/2018, Exp dt: 05/2020, Mfd by: M/s. Jackson Laboratories Pvt. Ltd., 22-24, Majitha Road, Bye Pass, Amritsar 143001 (India) Punjab. | Assay of Potassium Clavulanate | CDSCO, Sub-Zone, Goa | CDL, Kolkata |
| 23 | Abiraterone Acetate | B. No.: 20180303, Mfg dt: 03/2018, Exp dt: 03/2020, Mfd by: M/s. Shijiazhuang Dingmin Pharmaceuticals Sciences Co. Ltd., No. 41 Zhaiyng South Street, Shijiazhuang, Hebei, China | Water Content & Assay | CDSCO, Zone | CDTL, Chennai |
| 24 | Calcium-Vitamins Tonic (CALCINOL SYRUP) | B. No.: T18016, Mfg dt: 07/2018, Exp dt: 12/2019, Mfd by: M/s. Raptakos, Brett & Co. Ltd. 1st Pokhran Road, Thane- 400606. | Assay of Cyanocobalamin | CDSCO, North-Zone Ghaziabad, (UP). | RDTL, Chandigarh |
| 25 | (RANITIDINE INJECTION IP) | B. No.: HLI849K, Mfg dt: 10/2018, Exp dt: 09/2020, Mfd by: M/s. Himalaya Meditek Pvt. Ltd. Plot No. 35 & 36 Pharmacity Selaqui, Industrial Area Dehradun-248197 (Uttarakhand). | Particulate Matter | CDSCO, Ghaziabad (UP). | RDTL, Chandigarh |
| 26 | Allopurinol Tablets IP 300 mg (AURINOL-300 TABLETS) | B. No.: AT/5515, Mfg dt: 11/2018, Exp dt: 10/2020, Mfd by: M/s. Apple Biotech Vill.Deep Nagar, Teh Payal, Ludhiana- 141421 (Punjab) India. | Assay and Dissolution | CDSCO, Sub-Zone- Baddi, H.P. | RDTL, Chandigarh |
| 27 | Lactic Acid Bacillus Capsules (VIZYLAC CAPSULES) | B. No.: G2AD219010, Mfg dt: 02/2019, Exp dt: 07/2020, Mfd by: M/s. Uni Medicolabs Plot No. 25 & 26, Pharma City, Selaqui, Dehradun (Uttrakhand). | Uniformity of filled weight | CDSCO, North-Zone, Ghaziabad, UP. | RDTL, Chandigarh |
| 28 | Gabapentin 400 mg and Nortriptyline 10 mg Tablets (DOLENEURON NT TABLETS ) | B. No.: DNT1099D, Mfg dt: 04/2019, Exp dt: 01/2021, Mfd by: M/s. Pulse Pharmaceuticals Pvt. Ltd. Khasra No:- 400,407 and 409, Karondi, Roorkee, Uttarakhand-247667. | Assay of Nortriptyline | CDSCO, North-Zone, Ghaziabad, UP. | RDTL, Chandigarh |
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