Legal provisions involved: Section 25 of Drugs and Cosmetics Act, 1940 and Rule 45 of the Drugs and Cosmetics Rules, 1945.

Judgement by: Bombay High Court

Judge/Bench: Justice M.M. Nerlikar

Facts

A Drugs Inspector filed a case against a pharma company claiming one of its drugs was not of standard quality. The sample was collected on 12 July 2022 and sent for testing on 14 July 2022. The government lab report came on 18 January 2023, far beyond the 60-day limit fixed by law. The lab later asked for extra time, but this request was made after the deadline and there was no proof that the government approved it.

Key legal provision

Section 25 of Drugs and Cosmetics Act, 1940 

Rule 45 of the Drugs and Cosmetics Rules, 1945

Issues raised

Whether delay beyond 60 days makes the prosecution invalid, and whether departmental negligence can affect the accused’s legal rights?

Arguments of the case

The company argued that the delay was illegal and denied them their right to re-test. The State relied on the lab report to continue the case.

Judgement

The Court quashed the proceedings, called the timeline mandatory, ordered action against erring officials, and suggested more labs and online monitoring to prevent future delays.

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