Drug regulator finds samples of calcium supplement Shelcal 500 and antacid Pan D as spurious
27 Oct 2024
A routine inspection by the Central Drug Regulatory Authority of retail medical shops in select locations of Odisha, West Bengal, Bihar and Uttar Pradesh has found samples of four popular drugs, including the widely used antacid Pan D and calcium supplement Shelcal 500, as spurious.
In all, the drug regulator carried out tests on 3,000 drug samples of which 49, including paracetamol, Oxytocin, Metronidazole and fluconazole, were found to be "Not of Standard Quality" as per its monthly drug alert report for September.
Drug samples found to be spurious include:
- Tamsulosin and Dutasteride Tablets (UrimaxD) – batch no GH30334;
- Calcium and Vitamin D3 Tablets I.P (SHELCAL 500) – Batch no GDXD0581;
- Pantoprazole Gastro-Resistant and Domperidone Prolonged Release Capsules
- I.P. (PAN-D) – Batch no GH30334; and
- Nandrolone Decanoate Injection IP 25mg/ml (DecaDurabolin 25 Inj.) – Batch no G202620.
Some of the batches of drugs which were found to be not of standard quality include formulations by companies such as Alkem Health Science, Aristo Pharmaceuticals, Camila Pharmaceuticals, Innova Captain, Hindustan Antibiotics and Ipca Laboratories.
According to Drug Controller General of India (DCGI) Rajeev Singh Raghuvanshi, periodic inspections and regular monitoring of drugs by the Central Drugs Standard Control Organisation (CDSCO) have helped to drastically bring down the percentage of spurious and substandard drugs.
According to the DCGI, of the total samples tested, only 1.5 per cent failed to meet the required standard.
He also said that the failure of a drug sample of any specific batch to meet the quality standards relate only to that particular batch and not all batches of that drug.