Central Drugs Lab Report Supersedes Local Finding, HC Quashes Case Against Pharmaceutical Company

The Himachal Pradesh High Court recently issued a judgment with potentially significant implications for the pharmaceutical industry in India. 

The single-judge bench of Justice Rakesh Kainthla quashed the verdict of the trial court which upheld the report of a local lab against a state-based pharmaceutical company.

The case involved a legal dispute between a drug manufacturer, Hetro Labs Limited, and the state authorities regarding the quality of a medication.

The dispute began as the Drug Inspector had drawn a sample of Azilsartan Medoxomil tablets manufactured by Hetro Labs in March 2021. Initial analysis by a Government Analyst found the sample to be non-compliant with quality standards.

Hetro Labs challenged this finding and commissioned an independent analysis at the Central Drugs Laboratory (CDL) in Kolkata. The CDL report conclusively determined that the sample met all the prescribed specifications.

Based on the established legal framework under the Drugs & Cosmetics Act, the High Court acknowledged the primacy of CDL reports. Specifically, Section 25(4) grants conclusive weight to such reports, superseding any conflicting findings from local analysts.

Accepting the CDL report as definitive, the High Court quashed the case against Hetro Labs. This judgment underscores the importance of CDL analysis in resolving drug quality disputes and reaffirms its preeminent position within the regulatory framework.