Shelcal 500, PAN-40, Paracetamol, 46 other drugs fail quality test. Do you consume? Check list here

The Central Drug Regulatory Authority (CDRA) has raised significant concerns regarding the quality of pharmaceutical products available in the market. Among the troubling findings, the widely-used calcium supplement Shelcal 500, combination drug Pan D, Vitamin D3 tablets manufactured by Life Max Cancer Laboratories failed the drug test.

Furthermore, a total of 49 drug samples have been deemed "Not of Standard Quality" (NSQ), which includes familiar medications such as paracetamol, Oxytocin, and fluconazole.

The CDRA's inspection covered approximately 3,000 samples, revealing that only about 1.5% were found to be substandard.

The specific drugs listed as spurious are:

Additionally, the report detailed 49 drugs that failed to meet quality standards. This list includes various products from reputable companies, such as Alkem Health Science, Aristo Pharmaceuticals, and Hindustan Antibiotics. Some notable mentions among the NSQ drugs are:

• Neurotem-NT
• Cefuroxime Axetil Tablets IP 500 mg (JKMSCL Supply)
• Loperamide Hydrochloride Tablets IP (JKMSCL Hospital Supply)
• Floxages-OZ (Ofloxacin and Ornidazole Tablets IP)
• Wintel 40 Tablets

Rajeev Singh Raghuvanshi, Drug Controller General reassured the public that the failure of a drug sample from any specific batch does not imply that all products sold under that name are of poor quality, as only that particular batch is considered substandard.

The spurious and NSQ drugs have been recalled on a batch-wise basis as part of the CDRA's ongoing commitment to public safety.

Among the flagged products were Metronidazole tablets from Hindustan Antibiotics and Domperidone tablets by Rainbow Life Sciences.

The investigation has also highlighted quality issues with Paracetamol tablets produced by Karnataka Antibiotics & Pharmaceuticals Ltd.

Drugmakers’ Denial of Responsibility

In response to the allegations of producing spurious drugs, manufacturers have categorically denied responsibility.

Alkem Laboratoris later issued a statement saying, "We have checked the samples collected by the CDSCO and compared with the actual batches of both products manufactured by Alkem. It has been found that the samples picked by the CDSCO were spurious and not manufactured by Alkem. We have informed the regulator of the same and will continue to work with the authorities to help curb the spurious drug menace in the country.

Risks of Consuming Substandard Medicines

The World Health Organisation (WHO) has warned that the use of ineffective and harmful drugs can lead to serious health issues, including:

Therapeutic Failure

Exacerbation of Disease

Resistance to Medicines

Death

Poor-quality drugs can also cause drug resistance

Substandard medicines compromise the treatment of chronic and infectious diseases, causing disease progression and death.

CDRA Regulatory Actions

As part of its vigilance efforts, the CDRA continues to address the presence of non-standard quality drugs in the market, reinforcing the importance of stringent regulatory measures in protecting public health.

In a related move, the CDRA in August 2024 banned over 156 fixed-dose drug combinations that were deemed likely to pose risks to human health. This includes popular fever medications, painkillers, and allergy tablets, indicating a proactive stance in safeguarding public health.