CDCSO Declares 31 Formulations As Not of Standard Quality: Details
New Delhi: In its latest drug safety alert, the apex drug regulatory body, the Central Drug Standard Control Organisation (CDSCO), has flagged 31 medicine batches for failing to qualify for a random sample test for June 2024.
The list of drugs declared not of standard quality includes Propylene Glycol manufactured by Manali Petrochemicals, Compound Sodium Lactate Injection I.P., 500 ml (Ringer Lactate Solution for Injection) manufactured by Vision Parenteral, Esomeprazole Gastro-Resistant Tablets manufactured by GlenSmith Labs, Gentamicin Sulphate Injection manufactured by Zee Laboratories, Frusemide Injection manufactured by Nandani Medical; Amoxycillin and Potassium Clavulanate Injection IP 1.2 gm, manufactured by Sai Parenterals Limited, and others.
A few reasons why the drug samples tested failed were the presence of bacterial endotoxins, failure of the dissolution test, failure of the pH, failure of the description and particulate matter, failure of specific assays of the drug test, etc.
NOT OF STANDARD QUALITY ALERT FOR THE MONTH OF JUNE 2024. Here are the 1st 10 drugs
A. CDSCO/Central Laboratories | |||||||
S.No | Product/Drug Name | Batch No. | Manufacturing Date | Expiry Date | Manufactured By | NSQ Result | Reported by CDSCO Laboratory |
1. | Propylene Glycol I.P. | PG- IP/2023- 24/2355 | 11/2023 | 10/2028 | M/s. Manali Petrochemicals Ltd., Manali, Chennai- 600068, India | Relative Density | CDL, Kolkata |
2. | Propylene Glycol USP/IP | BT1205B0 4072023 | 07/2023 | 07/2024 | M/s. Balaji Amines Limited, Plot No. F- 104, Chinchoili M.I.D.C., Tq. Mohol, Distt. Solapur - 413 255, Maharastra | Relative Density | CDL, Kolkata |
3. | Compound Sodium Lactate Injection I.P., 500 ml (Ringer Lactate Solution for Injection) | P2401050 08 | 01/2024 | 12/2025 | M/s. Vision Parenteral Pvt. Ltd., A-2-44, 45, Sector-15, GIDA Industrial Area, Gorakhpur -273209 (U.P.), India | Bacterial endotoxins | CDL, Kolkata |
4. | Esomeprazole Gastro- Resistant Tablets IP 40 mg (Esomedge- 40) | GD23083 | 07/2023 | 06/2025 | M/s. GlenSmith Labs Private Limited, Mfg. by: Skymap Pharmaceuticals Pvt. Ltd., B-3, Dev Bhoomi Industrial Estate, Puhana Iqbalpur Road, Roorkee 247 667. | Dissolution | CDL, Kolkata |
5. | Gentamicin Sulphate Injection I.P. 2 ml | 323-216 | 03/2023 | 02/2025 | M/s. Zee Laboratories Ltd., Behind 47, Indl. Area, Paonta Sahib - 173025 | Description & Particulate matter | CDL, Kolkata |
6. | Frusemide Injection IP 2 ml (FRUSEMIDE) | FRA12347 | 12/2023 | 11/2025 | M/s. Nandani Medical Laboratories Pvt. Ltd., 221/5, Bicholi Hapsi, Kanadia Road, Indore | pH | CDL, Kolkata |
7. | Ceftriaxone for Injection I.P. 1 gm | DC30119 | 10/2023 | 09/2025 | M/s. Captab Biotec Unit-II, Plot No-125, E.P.I.P Road, Mauja Jharmajri, Baddi, Distt.-Solan H.P. | Particulate matter | CDL, Kolkata |
8. | Amoxycillin & Potassium Clavulanate Injection IP 1.2 gm | 23AP04 | 05/2023 | 04/2025 | M/s. Sai Parenterals Limited, D1 & D4, Survey No. 280, Phase- V, IDA, Jeedimetla, Hyderabad-500 055, TS. | Clarity of Solution and Assay of Potassium Clavulanate | CDL, Kolkata |
9. | Cefixime & Ofloxacin Tablets (CEFIKAM OF 200) | DB230057 | 02/2023 | 01/2025 | M/s. Daxin Pharmaceuticals Pvt. Ltd., Plot No-121-122, EPIP, Jharmajri Phase-1, Teh. Baddi, Distt. Solan (H.P.) 174 103. | Assay of Cefixime Trihydrate & Assay Ofloxacin | CDL, Kolkata |
10. | Propylene Glycol USP | 97220141 13 | 11/2023 | 10/2028 | M/s. Shell Eastern Chemicals, The Metropolis Tower, 1, 9 North Buona, Visla
Drive 07 01 Singapore
13858 | Specific Gravity | CDL, Kolkata |
To get the full details of the drugs found of not so standard quality , click the link below:
