The Central Drug Regulatory Authority (CDRA) has sounded the alarm over the alarming prevalence of substandard pharmaceutical products in India. A recent investigation uncovered a troubling reality: popular medications, including the widely used calcium supplement Shelcal 500, combination drug Pan D, and Vitamin D3 tablets manufactured by Life Max Cancer Laboratories, have failed drug tests. This revelation extends beyond these specific brands, with a staggering 49 drug samples deemed “Not of Standard Quality” (NSQ). This list encompasses familiar medications like paracetamol, Oxytocin, and fluconazole, raising serious concerns about the safety and efficacy of drugs circulating within the Indian market.
The CDRA’s comprehensive inspection, covering approximately 3,000 drug samples, highlighted a concerning trend. While only about 1.5% of the tested samples were found to be substandard, this figure represents a significant number of drugs that could potentially harm patients. The investigation revealed that the substandard drugs include products from reputable pharmaceutical companies, such as Alkem Health Science, Aristo Pharmaceuticals, and Hindustan Antibiotics. These findings underscore the vulnerability of even established manufacturers to quality control lapses.
Rajeev Singh Raghuvanshi, Drug Controller General, has reassured the public that the failure of a single batch from a specific brand does not necessarily imply that all products under that name are of poor quality. However, he emphasized that the CDRA is taking immediate action to ensure public safety. The spurious and NSQ drugs have been recalled on a batch-wise basis, with the CDRA actively monitoring the situation and taking necessary steps to prevent further distribution of substandard medications.
The investigation has also highlighted the risks associated with consuming substandard medicines. The World Health Organisation (WHO) has issued a stark warning, emphasizing that the use of ineffective and harmful drugs can lead to serious health complications, including:
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Therapeutic Failure:
Substandard drugs may not provide the intended therapeutic benefit, leading to ineffective treatment and prolonged illness.*
Exacerbation of Disease:
The use of ineffective drugs can worsen existing health conditions, potentially leading to more severe symptoms and complications.*
Resistance to Medicines:
Substandard drugs can contribute to the development of drug resistance, making future treatments less effective and posing a significant threat to public health.*
Death:
In some cases, the use of substandard drugs can be fatal, particularly when they contain incorrect or insufficient dosages of active ingredients.The CDRA’s vigilance efforts are crucial in addressing this ongoing challenge. In August 2024, the CDRA took a proactive step by banning over 156 fixed-dose drug combinations that were deemed to pose potential risks to human health. This included popular fever medications, painkillers, and allergy tablets, demonstrating a commitment to safeguarding public health.
The discovery of substandard drugs in the Indian market serves as a stark reminder of the critical importance of stringent regulatory measures and robust quality control processes. As consumers, we must remain vigilant, being cautious about the source of our medications and reporting any suspected quality issues to the CDRA. Only through a collective effort can we ensure the safety and efficacy of the medicines we rely on for our well-being.