Government Action on Substandard Drugs

The health ministry is proposing strict measures against drugmakers whose products are deemed as not meeting quality standards, termed as Not of Standard Quality (NSQ). This initiative aims to ensure quality drug production and protect public health.

Proposed Measures

• The ministry plans to issue a notification for the immediate suspension of product licenses of companies producing NSQ drugs, as determined by government laboratories.
• The Central Drugs Standard Control Organisation (CDSCO) is discussing these measures with pharmaceutical lobby groups to address their concerns.

Technical Advisory Board's Recommendations

• The board emphasized the importance of suspending licenses of NSQ drugs immediately, unless manufacturers provide a satisfactory Corrective Action and Preventive Action (CAPA).
• Detailed deliberations led to recommendations for amending the Drug Rules, with license suspensions being revoked only after root cause analysis and CAPA implementation.

Concerns from Pharmaceutical Groups

• Pharma lobby groups, including the Federation of Pharma Entrepreneurs (FOPE), have raised concerns about the proposal, citing global technical issues with NSQ drugs.
• They highlighted challenges faced by government testing labs and inconsistencies in NSQ results between government labs and the appellate laboratory, CDL Kolkata.
• Emphasis was placed on strengthening the drug recall mechanism rather than focusing solely on license suspension.

Potential Impact

• Federation of Pharma Entrepreneurs (FOPE) warned that without proper investigation, the suspension of product permissions could lead to malpractices and adversely affect genuine manufacturers with significant investments and goodwill.
• They stressed the need for an impact analysis to avoid harming the pharmaceutical industry.