Shelcal 500 and Pan D: Central Drug Regulatory Authority Flags Popular Drugs as Spurious

Four drugs labeled spurious, and 49 identified as “Not of Standard Quality” in the latest report, highlighting public health concerns.

The Central Drug Regulatory Authority (CDRA) has flagged four drugs as spurious, including the widely-used calcium supplement Shelcal 500 and the digestive aid Pan D. Additionally, 49 drug samples have been deemed “Not of Standard Quality” in the CDRA’s recent report, which includes commonly used medications such as paracetamol, Oxytocin and fluconazole.

Some of the flagged batches belong to well-known pharmaceutical companies, including Alkem Health Science, Aristo Pharmaceuticals, Camila Pharmaceuticals, Innova Captain, Hindustan Antibiotics, and Ipca Laboratories. Rajeev Singh Raghuvanshi, the Drug Controller General, reassured the public that routine inspections are in place to reduce the circulation of substandard drugs. He noted that out of 3,000 drug samples tested, only 1.5% failed to meet quality standards. It’s important to note that when a specific drug batch fails, it does not imply that all drugs of that name are compromised—only the particular batch in question.

The August report from the CDRA included over 50 drug samples marked as “Not of Standard Quality,” encompassing widely used medicines like paracetamol, calcium and vitamin D3 supplements, and anti-diabetes pills. Notable flagged items included Metronidazole tablets from Hindustan Antibiotics and Domperidone tablets from Rainbow Life Sciences. 

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. Cloxacillin Sodium Capsules 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 

18. Cough Syrup 

Quality concerns were also raised over paracetamol tablets produced by Karnataka Antibiotics & Pharmaceuticals Ltd.

The World Health Organisation (WHO) has emphasized the dangers of substandard medicines, which can lead to therapeutic failure, worsening of diseases, medicine resistance and even death. Poor-quality drugs pose significant risks, especially in the treatment of chronic and infectious diseases, leading to disease progression and fatalities.

The CDRA continues to address these concerns through vigilant monitoring and stringent regulatory actions to protect public health. In a related move earlier this year, the agency banned over 156 fixed-dose drug combinations, including popular fever and pain medications, due to potential health risks, highlighting its proactive efforts to ensure drug safety.