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The Central Drugs Regulatory Authority (CDRA) has raised significant concerns regarding the quality of pharmaceutical products available in the market. In troubling findings, widely used calcium supplement Shelcal 500, the combination drug Pan D, and vitamin D3 tablets manufactured by Life Max Cancer Laboratories failed drug tests.
Additionally, a total of 49 drug samples have been deemed “not of standard quality” (NSQ), which include familiar drugs such as paracetamol, oxytocin and fluconazole.
CDRA’s inspection of nearly 3,000 samples revealed that only 1.5% were found substandard.
Specific medications listed as counterfeit are:
- Tamsulosin and dutasteride tablets (UrimaxD)
- Calcium and Vitamin D3 Tablets IP (Shelkal 500)
- Pantoprazole gastro-resistant and domperidone prolongedrelease capsules IP (Pan-D)
- Nandrolone Decanoate Injection IP 25mg/ml (Decadurabolin 25 Inj.)
Additionally, the report details 49 drugs that failed to meet quality standards. The list includes various products from reputed companies like Alkem Health Sciences, Aristo Pharmaceuticals and Hindustan Antibiotics. Some notable mentions in NSQ drugs are:
Drug Controller General Rajiv Singh Raghuvanshi assured the public that the failure of a drug sample from a specific batch does not mean that all products sold under that name are of poor quality, as only that particular batch is considered substandard. Is.
The counterfeit and NSQ medicines have been recalled on a batch-wise basis as part of CDRA’s ongoing commitment to public safety.
The marked products included Hindustan Antibiotics’ Metronidazole tablets and Rainbow Life Sciences’ Domperidone tablets.
The investigation has also highlighted quality issues with paracetamol tablets produced by Karnataka Antibiotics and Pharmaceuticals Limited.
Drug manufacturers deny responsibility
In response to allegations of producing counterfeit drugs, the manufacturers have categorically denied responsibility.
Claiming that the batches in question were not manufactured by them, he said, “The original manufacturer (as per label claim) has informed that the disputed batch of the product is not manufactured by them and is a counterfeit medicine. The product is claimed to be counterfeit; However, this is dependent on the outcome of the investigation.” Times Now Informed.
Risks of consuming substandard medicines
The World Health Organization (WHO) warns that the use of ineffective and harmful medicines can lead to serious health problems, including:
Poor quality medicines can also cause drug resistance
Substandard medicines compromise the treatment of chronic and infectious diseases, leading to disease progression and death.
CDRA Regulatory Actions
As part of its vigilance efforts, CDRA continues to address the presence of non-standard quality medicines in the market, reinforcing the importance of stringent regulatory measures in protecting public health.
In a related move, CDRA banned over 156 fixed-dose drug combinations in August 2024 that were deemed likely to pose a risk to human health. This includes popular fever medicines, pain relievers and allergy pills, indicating a proactive stance in protecting public health.
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