CDSCO Flags Nearly 50 Common Medicines as Substandard, Raising Safety Concerns

The Central Drugs Standard Control Organisation (CDSCO) recently identified nearly 50 commonly used medicines as substandard, issuing a "not of standard quality" (NSQ) alert. The report highlighted 50 specific drugs, each linked to unique batch numbers and manufacturing dates. These results stemmed from routine random sampling carried out by state drug officers across multiple laboratories, sparking concerns about the safety and reliability of these medications.

Among the drugs that failed the quality checks were common medications such as paracetamol, calcium, and vitamin D3 supplements, as well as treatments for high blood pressure and diabetes, including Metformin Hydrochloride. The substandard batches were produced by prominent pharmaceutical companies like Alkem Laboratories, Hetero Drugs, Karnataka Antibiotics & Pharmaceuticals Ltd, Hindustan Antibiotics Limited, and Pure & Cure Healthcare.

The release of such a list every month demonstrates that the Drugs Controller General of India (DCGI) maintains ongoing vigilance over drug quality, regularly monitoring and taking action against manufacturers found to be distributing substandard products. This consistent scrutiny highlights the regulatory body's commitment to ensuring public health and safety.

In addition, several prominent pharmaceutical companies, including Sun Pharma, Glenmark Pharmaceuticals, and Macleods Pharmaceuticals, have come under government scrutiny. Following the release of the drug alert list, these companies, along with Alkem, asserted that the flagged batches were counterfeit and not manufactured by them. This response underscores ongoing concerns regarding drug authenticity and the integrity of supply chains in the pharmaceutical industry.

The discovery of widely used drugs failing quality checks (QC) has sparked serious concerns about the risks posed to consumers. These substandard medications can lead to complications and harmful side effects. In a proactive move to mitigate these risks, the drug regulator recently prohibited more than 156 fixed-dose drug combinations (FDCs) that pose potential threats to human health, underscoring the urgent need for tighter regulation within the pharmaceutical industry.

India stands as a pivotal player in the global pharmaceutical manufacturing landscape, earning the title of the "Pharmacy of the World." This sector holds strategic significance for the country, providing affordable, quality-assured medicines to more than 200 nations. However, the recent identification of substandard drugs could profoundly affect the pricing of active pharmaceutical ingredients (APIs) in both domestic and international arenas. The credibility of Indian pharmaceuticals is crucial to its status as a leading manufacturing hub; thus, any perceptions of compromised quality could diminish trust in these products. If foreign markets begin to view Indian pharmaceuticals as unreliable following recent quality alerts, it may lead to a decrease in demand for Indian APIs. This decline in demand could compel manufacturers to reduce their prices in order to remain competitive, potentially impacting profitability and the overall health of the industry.