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:
- Tamsulosin and Dutasteride Tablets (UrimaxD)
- Calcium and Vitamin D3 Tablets I.P (SHELCAL 500)
- Pantoprazole Gastro-Resistant and Domperidone ProlongedRelease Capsules I.P. (PAN-D)
- Nandrolone Decanoate Injection IP 25mg/ml (DecaDurabolin 25 Inj.)
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:
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.
They assert that the implicated batches were not produced by them, stating, “The actual manufacturer (as per label claim) has informed that the impugned batch of the product has not been manufactured by them and that it is a spurious drug. The product is purported to be spurious; however, the same is subject to the outcome of the investigation.” Times Now reported.
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:
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.
