Central Drug Regulatory Authority Reports Spurious Samples of Shelcal 500 and Pan D in September Alert

The Central Drug Regulatory Authority has identified four drugs, including the popular calcium supplement Shelcal 500 and Pan D, as counterfeit. Additionally, 49 other drugs have been deemed not of standard quality. This assessment was part of the authority's monthly drug alert report for September.

Among the drugs found lacking in quality are paracetamol, Pan D, calcium and vitamin D3 supplements, Oxytocin, Metronidazole, and fluconazole. These findings highlight concerns about the efficacy of certain batches produced by companies such as Alkem Health Science, Aristo Pharmaceuticals, Camila Pharmaceuticals, Innova Captain, Hindustan Antibiotics, and Ipca Laboratories.

Drug Quality Monitoring

Rajeev Singh Raghuvanshi, the Drug Controller General of India (DCGI), stated that regular inspections aim to reduce the prevalence of less effective drugs. The Central Drugs Standard Control Organisation (CDSCO) plays a crucial role in this process by actively monitoring and taking action against substandard medications.

In September, nearly 3,000 drug samples were tested. Of these, 49 were recalled due to their inefficacy. Raghuvanshi noted that only about 1.5 per cent of the total samples were found to be less effective. This indicates a relatively low percentage of drugs failing to meet quality standards.

Understanding Drug Quality Issues

An official source clarified that when a specific batch fails to meet quality standards, it does not imply that all drugs under that name are substandard. The issue is isolated to that particular batch only. This distinction is important for understanding the scope of quality concerns.

In August, the Central Drug Regulatory Authority had similarly identified over 50 drug samples as not meeting quality standards. This list included commonly used medications such as paracetamol, Pan D, calcium and vitamin D3 supplements, and anti-diabetes pills.

The ongoing efforts by regulatory authorities aim to ensure that medications available in the market are safe and effective for consumers. By identifying and recalling substandard batches, they work towards maintaining high standards in drug manufacturing and distribution.