Over 50 Medications Failing Quality Standards: A CDSCO Report

In a recently alarming report, the Central Drug Standards Control Organisation (CDSCO) has flagged over 50 medications commonly prescribed for conditions such as high blood pressure, acid reflux, and erectile dysfunction as failing to meet established quality standards.

This revelation underscores the ongoing challenges in maintaining drug safety and efficacy within India's pharmaceutical sector.

‘Ensuring the safety of #medications is not just a regulatory duty�it's a critical #public_health necessity. #medindia’

Medications Under Scrutiny

The CDSCO's survey identified specific batches of several well-known medications produced by various leading pharmaceutical companies, that do not comply with quality regulations. Notable products highlighted include:

• Pulmosil, a sildenafil injection from a pharmaceutical company, categorized as spurious
• Pantocid, often used for acid reflux and manufactured by the same company, was categorized as spurious
• Telma H, a combination medication for blood pressure management, produced by another pharmaceutical, identified as non-standard
• Clavam 625, an antibiotic formulation from a health science pharmaceutical company which failed to meet quality criteria

Both Pharmaceutical companies have publicly denied producing the questioned batches, raising concerns about the potential presence of counterfeit drugs in the market.

Importance of Drug Regulatory Supervision

A senior official from CDSCO reassured the public, stating, "The identification of a specific batch failing to meet standards does not imply that all drugs under the same name are substandard."

This remark highlights the ongoing commitment to quality monitoring and public health safety. Regular random sampling and rigorous testing protocols are employed to uncover any violations of Good Manufacturing Practices (GMP), ensuring that the majority of products remain safe for consumer use.

While CDSCO officials have noted that the overall number of substandard samples has not shown a significant increase, they continue to stress the importance of vigilance in the manufacturing process ().

The government remains committed to enhancing production standards across the pharmaceutical industry to prevent quality violations that could jeopardize public health.

The findings from CDSCO serve as a vital reminder of the necessity for stringent quality control within the pharmaceutical industry, especially for medications that are crucial for managing prevalent health issues.

As public health remains a top priority, maintaining high safety standards is essential to ensure that consumers have access to effective and reliable medications.

Reference:

1. Spurious Drugs: A Challenge before the Pharmaceutical Industry- (https:www.lexology.com/library/detail.aspx?g=33441186-4fed-4a6a-89f7-827098590078)

Source: Medindia