The Central Drug Regulatory Authority (CDRA) has raised serious concerns about the quality of pharmaceutical products on the market. Notably, the widely-used calcium supplement Shelcal 500, the combination drug Pan D, and Vitamin D3 tablets from Life Max Cancer Laboratories have failed quality tests.
In total, 49 drug samples were classified as “Not of Standard Quality” (NSQ), including common medications such as paracetamol, oxytocin, and fluconazole. The CDRA’s inspection covered around 3,000 samples, revealing that approximately 1.5% were substandard.
The specific drugs identified as spurious include:
- Tamsulosin and Dutasteride Tablets (Urimax D)
- Calcium and Vitamin D3 Tablets I.P. (Shelcal 500)
- Pantoprazole Gastro-Resistant and Domperidone Prolonged Release Capsules I.P. (Pan D)
- Nandrolone Decanoate Injection IP 25mg/ml (Deca Durabolin 25 Inj.)
The report also mentioned 49 drugs that did not meet quality standards, featuring products from reputable companies like Alkem Health Science, Aristo Pharmaceuticals, and Hindustan Antibiotics. Notable NSQ drugs include:
- 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
- Moxica -250 [Amoxicillin Dispersible Tablets IP 250 mg]
- Frusemide Injection IP 20 mg
- Cloxacillin Sodium Capsules IP 250 mg
- Fluorometholone Eye Drops IP
- Panlib 40 Tablets
- B-Cidal 625
- Trypsin, Bromelain & Rutoside Trihydrate Tablets [Flavoshine]
- C Mont LC Kid 60 ml (Montelukast & Leveocetirizine Dihydrochloride syrup)
- Yogaraja Guggulu Tablet
- Telmisartan Tab IP 40 mg
- Pantoprazole Inj. BP 40 mg
- Glimepiride Tab IP
- Cough Syrup
Rajeev Singh Raghuvanshi, the Drug Controller General, assured the public that the failure of a drug sample from a specific batch does not imply that all products under that name are of poor quality, as only that particular batch is deemed substandard. The spurious and NSQ drugs have been recalled on a batch-wise basis as part of the CDRA’s commitment to public safety.
The investigation has also pointed out quality issues with paracetamol tablets produced by Karnataka Antibiotics & Pharmaceuticals Ltd.
Manufacturers’ Denial of Responsibility
In response to the allegations, manufacturers have firmly denied any wrongdoing. Alkem Laboratories stated, “We have checked the samples collected by the CDSCO against the actual batches of both products manufactured by Alkem. It has been determined that the samples picked by the CDSCO were spurious and not produced by us. We have informed the regulator and will continue to collaborate with the authorities to combat the issue of spurious drugs in the country.”
Risks of Consuming Substandard Medicines
The World Health Organization (WHO) has warned that the use of ineffective and harmful drugs can result in severe health consequences, including:
– Therapeutic failure
– Worsening of diseases
– Drug resistance
– Death
Substandard medicines jeopardize the treatment of chronic and infectious diseases, leading to disease progression and fatalities.
CDRA’s Regulatory Actions
In its efforts to combat non-standard quality drugs in the market, the CDRA emphasizes the necessity of stringent regulatory measures to protect public health. In August 2024, the CDRA banned over 156 fixed-dose drug combinations deemed potentially harmful to human health, including common fever medications, painkillers, and allergy tablets, demonstrating a proactive approach to safeguarding public health.