In Brief
A pharmaceutical company supplied clotrimazole cream to a hospital, specifying a two-year shelf life. Complaints emerged after the second consignment. Samples were tested months late and found substandard (61.96% vs required 95-105%). The company was blacklisted for two years. However, a parallel test by the Central Drugs Laboratory months after expiry showed 92.01% purity. The Supreme Court held the blacklisting order invalid because: (1) samples were tested improperly delayed, approaching or exceeding shelf life; (2) the appellate lab showed a huge variance (30%), proving the initial report unreliable; (3) the decision-makers ignored the appellate report entirely; and (4) unexplained State-caused delays violated the company's statutory right to appellate testing. The Court allowed the appeal and set aside the blacklisting order."
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