Reports

CDSCO Identifies 18 Drugs as Substandard, Including Four from Kerala’s State-Run Pharma Firm

• By Newsdesk
• New Delhi
• Oct 25, 2024

Reports

In its September report, the Central Drugs Standard Control Organisation (CDSCO) has flagged multiple pharmaceutical products, identifying four widely prescribed drugs as spurious. The list includes prominent medications such as Shelcal 500, a calcium supplement; Pan D, an antacid; Urimax D, used in managing Benign Prostatic Hyperplasia (BPH); and Deca-Durabolin 25 Injection, intended for osteoporosis treatment in postmenopausal women.

Spotlight on Kerala Medical Services Corporation

The CDSCO report further identified 18 medications classified as Not of Standard Quality (NSQ). Among these, four drugs were produced by the Kerala Medical Services Corporation, a state-owned entity. This has intensified scrutiny of the pharmaceutical industry in Kerala as CDSCO works to address concerns over drug quality across the country.

Spurious Drugs and Counterfeit Producers

The flagged drugs have been linked to counterfeit manufacturers, underscoring an ongoing issue within India’s pharmaceutical landscape. The CDSCO’s monthly reports serve as a proactive measure to mitigate the presence of spurious drugs, which present significant risks to public health and consumer safety.

Broad Crackdown on Drug Quality

As part of its wider quality assurance efforts, CDSCO declared a total of 49 drugs from 40 companies as NSQ. These medications did not meet required standards and were subject to batch-wise recall as part of a large-scale assessment of over 3,000 drug batches. This includes popular products like Clavam 625, Pan 40 tablets, and the antibiotics Monocef and Ciprodac 500, produced by Alkem Health Science, Aristo Pharmaceuticals, and Cadila Pharmaceuticals, respectively.

Alkem Laboratories Defends Its Products

Alkem Laboratories responded to the CDSCO report, emphasizing that some flagged drugs were identified as spurious and were not manufactured by the company. In a statement to the media, an Alkem representative expressed ongoing cooperation with regulators, affirming a commitment to address counterfeit drug challenges impacting the pharmaceutical industry.