The Central Drug Regulatory Authority (CDRA) has raised significant concerns regarding the quality of pharmaceutical products available in the market. Among the worrying findings, the widely used calcium supplement Shelcal 500, combination medicine Pan D, vitamin D3 The tablets manufactured by Life Max Cancer Laboratories failed the drug test.
Additionally, a total of 49 drug samples have been deemed “non-standard quality” (NSQ), including well-known drugs such as paracetamol, oxytocin and fluconazole.
The CDRA inspection covered approximately 3,000 samples, and revealed that only about 1.5% were substandard.
Specific medications listed as spurious are:
- Tamsulosin and Dutasteride Tablets (UrimaxD)
- Calcium and Vitamin D3 IP Tablets (SHELCAL 500)
- Gastro-resistant Pantoprazole and Domperidone IP Extended Release Capsules (PAN-D)
- Nandrolone Decanoate Injection IP 25 mg/ml (DecaDurabolin 25 Inj.)
Additionally, the report details 49 medications that did not meet quality standards. This list includes several products from renowned companies such as Alkem Health Science, Aristo Pharmaceuticals, and Hindustan Antibiotics. Some notable mentions among NSQ medications are:
Rajeev Singh Raghuvanshi, Controller General of Drugs, 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.
Spurious and NSQ medications have been removed from the market in batches as part of the CDRA’s ongoing commitment to public safety.
Among the products targeted were metronidazole tablets from Hindustan Antibiotics and Rainbow Life Sciences Domperidone Tablets.
The investigation has also highlighted quality issues with paracetamol tablets produced by Karnataka Antibiotics & Pharmaceuticals Ltd.
Denial of liability by drug manufacturers
In response to accusations of producing spurious drugs, the manufacturers have categorically denied responsibility.
They claim that the batches involved were not produced by them, stating: “The actual manufacturer (as claimed on the label) has advised that the impugned batch of the product has not been manufactured by them and that it is a spurious drug. The product is assumed to be spurious; However, it is subject to the result of the investigation.” times now reported.
Risks of consuming substandard medicines
He World Health Organization (WHO) has warned that the use of ineffective and harmful medications can lead to serious health problems, 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 oversight efforts, the CDRA continues to address the presence of non-standard quality medicines on the market, reinforcing the importance of strict regulatory measures to protect public health.
In a related move, in August 2024 the CDRA banned more than 156 fixed-dose drug combinations that were considered likely to pose risks to human health. This includes popular fever medications, painkillers and allergy pills, indicating a proactive stance in safeguarding public health.
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