Full list of Indian drugs found spurious, sub-standard by regulator

Four drugs, including popular calcium supplement Shelcal 500, have been identified as spurious by the Central Drug Regulatory Authority.

The Central Drug Regulatory Authority has identified four drugs, including popular calcium supplement Shelcal 500 and Pan D, as spurious. Additionally, 49 drug samples were deemed “Not of Standard Quality” in its latest report. These include widely-used medications like paracetamol, Oxytocin, and fluconazole.

Some of the batches of drugs which have been listed as not of standard quality are by companies like Alkem Health Science, Aristo Pharmaceuticals, Camila Pharmaceuticals, Innova Captain, Hindustan Antibiotics and Ipca Laboratories.

Drug Controller General Rajeev Singh Raghuvanshi assured that periodic inspections aim to minimize less efficacious drugs. Out of 3,000 samples tested, only 1.5% were found substandard.

List of drugs, medicines declared as Spurious

1. Tamsulosin and Dutasteride Tablets (UrimaxD)

2. Calcium and Vitamin D3 Tablets I.P (SHELCAL 500)

3. Pantoprazole Gastro-Resistant and Domperidone ProlongedRelease Capsules I.P. (PAN-D)

4. Nandrolone Decanoate Injection IP 25mg/ml (DecaDurabolin 25 Inj.)

List of drugs, medicines deemed not of ‘standard quality’

1. Neurotem-NT

2. Cefuroxime Axetil Tablets IP 500 mg (JKMSCL Supply)

3. Loperamide Hydrochloride Tablets IP (JKMSCL Hospital Supply)

4. Floxages-OZ (Ofloxacin and Ornidazole Tablets IP)

5. Wintel 40 Tablets

6. Moxica -250 [Amoxicillin Dispersible Tablets IP 250 mg]

7. Frusemide Injection IP 20 mg

8. Cloxacillin Sodium Capsules IP 250 mg

9. Fluorometholone Eye Drops IP

10. Panlib 40 Tablets

11. B – Cidal 625

12. Trypsin, Bromelain & Rutoside Trihydrate Tablets [Flavoshine]

13. C Mont LC Kid 60 ml (Montelukast & Leveocetirizine Dihydrochloride syrup)

14. Yogaraja Guggulu Tablet

15. Telmisartan Tab IP 40 mg

16. Pantoprazole Inj. BP 40 mg

17. Glimepiride Tab IP

18. Cough Syrup

The failure of a drug sample of any specific batch to meet the quality standards does not mean that all drugs being sold by that name are sub-standard. Only that specific batch is considered not of standard quality, an official source said.

The Central Drug Regulatory Authority in its August report had listed samples of over 50 drugs, including widely used paracetamol, Pan D, calcium and vitamin D3 supplements and anti-diabetes pills as “Not of Standard Quality”.

HINDUSTAN TIMES