JUDGMENT

HARJIT SINGH BEDI,J.

1. Leave granted.

2. This appeal arises out of the following facts.

The accused appellant No.1 is a manufacturer of Enalapril Maleate tablets, a drug which is being manufactured under licence in its factory premises. The drug was released for sale only after it quality had been certified by an independent laboratory. One such batch bearing No. NT 6000 was sold on 29th September 1999 with its shelf life upto August 2002 and in addition to other organizations some of the drug from the batch was supplied to the Government Medical Stores Depot, Kolkata.

3. The Drugs Inspector, Central Drugs Standard Control Organisation, Kolkata visited the Government Medical Stores Depot at Belvedere, Kolkata on 14th June 2000 and collected samples of the drug and after dividing the sample into four equal parts, sent one portion to the Central Drugs Laboratory, Kolkata under Clause (i) sub- section(4) of Section 23 of the Drugs and Cosmetics Act, 1940 (hereinafter referred to as the 'Act') for test/analysis. The sample portion of the drug was received in the laboratory at Kolkata on 23rd June 2000. The Drugs Inspector received the test report from the Drugs Laboratory on 6th