In Brief
Hemant Surgicals imported sterile infusion sets and stocked them for sale in India. Drug inspectors alleged the devices were misbranded due to inadequate labeling and initiated prosecution under Rule 96(1)(xii) of the Drugs and Cosmetics Rules. The Supreme Court held that Rule 96(1)(xii)—which mandates import license labeling—applies only to drugs and their preparations, not medical devices like infusion sets. Moreover, at the time of inspection (February 2014), the applicable labeling standard was the Indian Standard requiring only expiry date and manufacturer details—which had been complied with. The Government Analyst confirmed the samples passed all quality tests. Prosecuting under amended labeling rules introduced later was futile and retroactive. The Court quashed the proceedings.
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