The Central Drugs Standard Control Organisation (CDSCO) has flagged 61 drugs, amounting to almost 5.5% of the drug samples it tested in October 2023, as not meeting the required standards, including those from reputed companies like Intas Pharmaceuticals, Emcure Pharmaceuticals, RPG Life Sciences, and Karnataka Antibiotics and Pharmaceuticals Ltd. (KAPL).

According to a CDSCO alert released recently, out of 1,108 samples tested during the month, 61 were identified as not of standard quality (NSQ). Notably, samples from Intas Pharmaceuticals, including bisoprolol fumarate tablets and Emcure Pharmaceuticals' Levocarnitine injection were among those that did not meet the standards.

The list also featured two samples without proper labelling: tigecycline 50 mg from Affy Parenterals and phenolic disinfectant cleaner from Pragati Udyog.

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Non-standard-quality pharmaceuticals are a major source of worry in India, posing considerable risks to public health. The pharmaceutical business, which is an important part of the Indian economy, has seen a rise in the number of substandard pharmaceuticals that do not exceed quality requirements.

Non-standard-quality medications are frequently encountered due to lax regulatory procedures, ineffective enforcement, and a lack of severe quality control mechanisms. These poor drugs endanger not only the health of customers but also the credibility of the Indian pharmaceutical sector on a global scale.

To address this issue a holistic approach is required, including increased regulatory monitoring, improved quality testing processes, and harsh consequences for those found guilty of making or distributing defective pharmaceuticals. To combat this threat and ensure that the drugs available in the market are safe, efficacious, and of high quality the government, pharmaceutical companies, and regulatory agencies need to work together.

According to an official involved in the process, the lack of field personnel is another bottleneck the department is facing in implementing the standards more effectively.

The consequences of non-standard-quality drugs extend beyond national borders, harming the reputation of Indian pharmaceuticals around the world. As a result, immediate and effective steps are required to protect public health and the integrity of India's pharmaceutical business.