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October 26, 2024
The Central Drug Standards Control Organisation (CDSCO) has flagged four widely used medications, including Shelcal 500 (a common calcium supplement) and Pan D (an antacid), as “spurious” in its September quality control review. The list, released on Friday, also includes Urimax D, used for managing Benign Prostate Hyperplasia (BPH), and Deca-Durabolin 25 Injection, prescribed for osteoporosis treatment in postmenopausal women.
According to CDSCO, the flagged drugs were identified as being manufactured by unlicensed entities. In addition to these spurious drugs, CDSCO’s review also identified 49 drugs and formulations produced by 40 companies as not meeting standard quality (NSQ). This regulatory update comes as part of CDSCO’s ongoing efforts to combat the prevalence of counterfeit medications and ensure patient safety across the country.
Spotlight on Common Drugs in India’s Pharmaceutical Market
Shelcal 500, Pan D, and other drugs featured in this report are often prescribed for conditions ranging from calcium deficiency to acid reflux, highlighting the extensive reach of these medications within India’s healthcare system. The rise of spurious versions of such common drugs poses a serious public health risk, as they fail to meet quality and efficacy standards and can lead to unintended health complications.
As part of its comprehensive analysis, CDSCO examined over 3,000 batches of various drugs in September. Of these, 49 were declared NSQ, failing to meet the established benchmarks for quality. Among the drugs that did not meet the standards were Clavam 625 and Pan 40 tablets, both manufactured by Alkem Health Science, as well as the antibiotics Monocef and Ciprodac 500, produced by Aristo Pharmaceuticals and Cadila Pharmaceuticals, respectively.
In response to the allegations, Alkem Laboratories defended its products, asserting that CDSCO had tested counterfeit samples. “We are committed to providing quality drugs to patients,” said an Alkem spokesperson, adding that the company had notified the regulator of its findings and would continue cooperating to curb the spread of counterfeit drugs in India.
Regional Analysis of NSQ Drugs
The CDSCO report also highlighted NSQ drugs sourced from various states, detailing quality issues specific to drugs from Kerala and Uttarakhand. The Kerala Medical Services Corporation was cited for producing four NSQ drugs, with additional infractions reported from manufacturing units in Kerala and Uttarakhand.
Addressing India’s Growing Problem with Counterfeit Drugs
India’s pharmaceutical industry has recently faced scrutiny over rising cases of counterfeit and substandard drugs, underscoring the need for tighter regulations and consumer awareness. The country has one of the largest pharmaceutical markets in the world, making it vulnerable to counterfeiting activities that can significantly impact public health.
The CDSCO’s latest findings reflect the organization’s commitment to tackling this issue through strict oversight and collaboration with pharmaceutical companies.
