Drugs Inspector & Anr vs Fizikem Laboratories Pvt. Ltd.& Anr

The Supreme Court ruled that a Drugs Inspector appointed under Section 21 of the Drugs and Cosmetics Act, 1940 lacks jurisdiction to prosecute under Section 32 for offences related to the manufacture and sale of Ayurvedic drugs containing sildenafil citrate, as the respondents did not possess the necessary license for such manufacture. The Court clarified that prosecution for contraventions of Sections 18 and 19(a)(i) requires a specific licensing authority, and thus the prosecution initiated was invalid. The appeal was allowed, overturning the High Court's decision.