Gujarat HC quashes proceedings against pharma companies due to delay by drug inspectors
The medicines were found substandard and spurious, but the pharma companies had to be let off because of lassitude on part of government’s drug inspectors who delayed the procedure for so long that the shelf life of the medicines got over and the re-testing of the drugs was not possible.
The Gujarat high court on Wednesday quashed proceedings against two drug manufacturers for production and sale of spurious drugs. The HC did so because the delay caused in action on part of drug inspectors left no time for the accused manufacturers for re-test of the medicines at the Central Drugs Laboratory in Kolkata. The HC said that this left the manufacturers without their “valuable right” to have a second opinion on quality of drugs as contemplated in section 25(4) of the Drugs and Cosmetics Act.
One of the cases involved an injection named ‘gynotocin 1ml’ manufactured by one Patel Pharma. The samples were seized in Porbandar in January 2004. A month later, the drug inspector sent the samples to government analyst in Vadodara, who sent his opinion in July 2004 that the drug was substandard.