Public health alert: 14 substandard drugs found in Telangana this September
Hyderabad: The Drug Control Administration (DCA) of Telangana has identified several substandard drugs circulating within the state, employing a risk-based sampling approach to enhance detection rates. Between January and August 2024, the Drugs Control Laboratory in Hyderabad reported 93 drugs classified as Not of Standard Quality (NSQ). In September alone, 14 additional drugs were flagged as substandard.
The drugs identified in September encompass a range of categories, including antibiotics, anti-ulcer medications, anti-allergics, and haematinics. These drugs failed critical quality tests, including assay, dissolution, and description, potentially rendering them ineffective for treating various medical conditions.
Details of Substandard Drugs Identified in September 2024:
1. Pantlar Tablets (Pantoprazole Gastro-Resistant Tablets I.P.)
Batch No: PTR230601
Manufacturing Date: 02/2024
Expiry Date: 01/2026
Manufacturer: Cartel Laboratories, Telangana
Marketer: Medler Pharma, Telangana
Issue: Dissolution test failed; 18 out of 24 tablets not intact in acid media.
2. Parasyp 250 Suspension (Paracetamol Paediatric Oral Suspension IP 250 mg)
Batch No: PGAC08
Manufacturing Date: 02/2023
Expiry Date: 01/2025
Manufacturer: Akums Drugs and Pharmaceuticals Ltd, Uttarakhand
Marketer: Auspharma Pvt. Ltd., Telangana
Issue: Failed assay for Paracetamol; pink-colored suspension with sedimentation observed.
3. FERRVIS-XT Tablets (Ferrous Ascorbate Folic Acid & Zinc Tablets)
Batch No: RFS-2368
Manufacturing Date: 01/2024
Expiry Date: 12/2025
Manufacturer: Ridge Formulations, Himachal Pradesh
Marketer: Sanvis Life Sciences, Hyderabad
Issue: Dark spots on 9 out of 20 tablets; misbranding due to incorrect labeling.
4. Dixim-O Dry Syrup Suspension (Cefixime & Ofloxacin for Oral Suspension)
Batch No: D240015F
Manufacturing Date: 01/2024
Expiry Date: 12/2025
Manufacturer: Polestar Power Industries, Himachal Pradesh
Marketer: DM Pharma, Chandigarh
Issue: Assay of Ofloxacin does not meet specifications.
5. Pepsain Syrups (Pepsain Digestive Enzyme Syrup)
Batch No: DBB-442
Manufacturing Date: 02/2024
Expiry Date: 07/2025
Manufacturer: Sain Medicaments Pvt. Ltd., Telangana
Issue: Assay of fungal diastase does not comply with IP.
6. Cefixime Dispersible Tablets
Batch No: KLH-1199
Manufacturing Date: 10/2023
Expiry Date: 09/2025
Manufacturer: Park Pharmaceuticals, Himachal Pradesh
Marketer: Knoll Health Care Pvt. Ltd., New Delhi
Issue: Assay of Cefixime does not comply with IP specifications; misbranding due to missing IP on packaging.
7. Cefx-O-200 Tablets (Cefixime Dispersible Tablets IP)
Batch No: DB240047
Manufacturing Date: 02/2024
Expiry Date: 01/2026
Manufacturer: Daxin Pharmaceuticals Pvt. Ltd., Himachal Pradesh
Issue: Assay of Cefixime does not comply with IP specifications.
8. Cefxi-200 Tablets (Cefixime Dispersible Tablets I.P. 200 mg)
Batch No: DB230143
Manufacturing Date: 06/2023
Expiry Date: 05/2025
Manufacturer: Daxin Pharmaceuticals Pvt. Ltd., Himachal Pradesh
Marketer: Medley Pharmaceuticals Ltd., Mumbai
Issue: Assay of Cefixime is not within specified limits.
9. PAZO-40 Tablets (Pantoprazole Gastro-Resistant Tab I.P. 40 mg)
Batch No: GTE0230E
Manufacturing Date: 01/2024
Expiry Date: 12/2025
Manufacturer: Digital Vision, Himachal Pradesh
Marketer: Mabo Pharmaceuticals, Chennai
Issue: Dissolution test failed in buffer stage.
10. Nimpan-40 Tablets (Pantoprazole Tablets IP)
Batch No: NMPN-2401
Manufacturing Date: 01/2024
Expiry Date: 12/2025
Manufacturer: Konis Pharmaceuticals Pvt. Ltd., Himachal Pradesh
Marketer: Nimbel Pharmaceuticals, Hyderabad
Issue: Dissolution test failed in buffer stage.
11. Zinfe-SR Capsules (Sustained Release Haematinic & Zinc Capsules with Vitamins)
Batch No: FZCK-117
Manufacturing Date: 09/2023
Expiry Date: 02/2025
Manufacturer: Ruby Organics Pvt. Ltd., Maharashtra
Marketer: Karnataka Antibiotics & Pharmaceuticals Limited, Bengaluru
Issue: Pellets inside capsules are sticky with lump formation.
12. Rovipod-100 Tablets (Cefpodoxime Dispersible Tablets)
Batch No: TB23-0499B
Manufacturing Date: 10/2023
Expiry Date: 09/2025
Manufacturer: Athens Life Sciences, Himachal Pradesh
Issue: Description does not comply.
13. Vertin 8 mg Tablets (Betahistine tablets IP)
Batch No: RBIA23009
Manufacturing Date: 09/2023
Expiry Date: 08/2026
Manufacturer: Abbott India Limited, Himachal Pradesh
Issue: Description does not comply.
14. TRIZENE Tablets (Levocetirizine Dihydrochloride Tablets IP)
Batch No: T24-007
Manufacturing Date: 01/2024
Expiry Date: 12/2025
Manufacturer: Oaksun Lifesciences, Telangana
Marketer: Innovin Formulations, Telangana
Issue: 20 out of 60 tablets show lamination defects.
The public is encouraged to report any suspected manufacturing activities related to drugs, including narcotic drugs and psychotropic substances, in residential, commercial, or industrial areas. Additionally, complaints regarding illegal activities concerning medicines can be made through the DCA’s Toll-Free Number at 1800-599-6969, operational from 10:30 a.m. to 5:00 p.m. on all working days.
