Introduction to the Crisis

The Central Drugs Standard Control Organisation (CDSCO), India's apex drug regulator, has recently flagged 103 popular drugs, including Azithromycin and Paracetamol, for failing quality tests. This move comes as part of CDSCO's monthly surveillance to ensure drug safety and efficacy in the Indian market. The list includes a variety of medications used to treat conditions like pneumonia, high blood sugar, fever, hypertension, and chronic diseases[1][2].

Drugs Affected

The drugs identified as Not of Standard Quality (NSQ) include:

• Azithromycin Oral Suspension I.P.
• Paracetamol & Serratiopeptidase Tablets
• Polywin Vitamin B Complex Injection
• Sitagliptin Phosphate Tablets I.P
• Albendazole Tablets IP
• Norfloxacin Tablets I.P
• Amoxycillin & Clavulanate Potassium for Oral Suspension I.P
• Telmisartan Tablets IP 40mg
• Aceclofenac

These drugs are used for treating various health conditions, such as chest infections, metabolic disorders, and high blood pressure[1][2].

The Process of Identification

The identification of these drugs as NSQ was based on their failure to meet specified quality parameters. CDSCO and state laboratories conducted these tests as part of routine regulatory surveillance. For the month of February 2025, the Central Drugs Laboratories identified 47 drug samples as NSQ, while State Drugs Testing Laboratories identified 56[1][2].

Spurious Drugs: A Growing Concern

In addition to the NSQ drugs, a spurious batch of Telma H, a hypertension medication, was also detected. Spurious drugs are counterfeit or fake medications that may contain incorrect or contaminated ingredients, posing significant health risks to consumers. The actual manufacturer of Telma H confirmed that the flagged batch was not produced by them, indicating it as a spurious product[1][2].

Understanding Spurious Drugs

Spurious drugs are often designed to mimic legitimate medications but can be ineffective or dangerous. They are typically manufactured without proper authorization and may lack the active ingredients necessary for their intended purpose. This can lead to severe health consequences, including treatment failure and adverse reactions[2].

Impact on Consumers and Healthcare System

The detection of NSQ and spurious drugs highlights the need for enhanced vigilance in drug manufacturing and distribution. It also underscores the importance of purchasing medications from authorized dealers to avoid counterfeit products. Consumers are advised to be cautious when buying drugs, especially those that do not come with proper documentation or from unverified sources.

CDSCO's Regulatory Efforts

CDSCO's monthly alerts serve as a critical tool for identifying and removing unsafe drugs from the market. This process involves continuous collaboration with state regulators to ensure that drugs are thoroughly tested and that any unsafe products are swiftly identified and withdrawn.

The Role of CDSCO in Drug Regulation

As the apex drug regulator in India, CDSCO plays a pivotal role in maintaining drug quality and safety. It conducts regular surveillance, tests drug samples, and publishes lists of NSQ and spurious drugs to keep consumers informed. This proactive approach helps protect public health by minimizing the risk associated with substandard medications.

Conclusion

The recent flagging of over 100 drugs by CDSCO emphasizes the importance of rigorous quality control measures in the pharmaceutical sector. As consumers, being aware of such alerts and choosing medications wisely are crucial for maintaining health and safety.

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