Drug prosecution and director liability turn on timely notice to contest analysis and specific averments of control over business.

Under Section 25 of the Drugs and Cosmetics Act, the right to seek examination by the Central Drugs Laboratory arises only if the person concerned gives timely notice of intention to controvert the Government Analyst's report; if no such notice is given within the prescribed period, that right lapses, and prosecution is not quashed merely because the complaint was filed after the drugs' shelf life expired. For vicarious liability under Section 34(1), a complaint must specifically allege that the accused director was in charge of and responsible for the company's business at the relevant time; a bare assertion of directorship is insufficient. On these principles, the prosecution against the directors was unsustainable.

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Issues: (i) Whether the manufacturers had lost the statutory right to seek analysis by the Central Drugs Laboratory under Section 25 of the Drugs and Cosmetics Act, 1940 because the complaint was filed after the shelf life of the drugs had expired. (ii) Whether the complaint disclosed the necessary averments to fasten vicarious liability on the directors under Section 34(1) of the Drugs and Cosmetics Act, 1940.

Issue (i): Whether the manufacturers had lost the statutory right to seek analysis by the Central Drugs Laboratory under Section 25 of the Drugs and Cosmetics Act, 1940 because the complaint was filed after the shelf life of the drugs had expired.

Analysis: The statutory scheme under Section 25 shows that the report of the Government Analyst becomes conclusive unless the person concerned, within twenty-eight days of receipt of the report, notifies an intention to adduce evidence in controversion. The right to seek examination by the Central Drugs Laboratory under Section 25(4) arises only after compliance with Section 25(3). On the materials accompanying the complaint, the manufacturers had been served with the Analyst's report and asked to respond, but they did not notify any intention to controvert the report within the prescribed period. Their right under Section 25(3) had therefore already ceased well before the shelf life expired.

Conclusion: The complaint could not be quashed on the ground that the prosecution was launched after expiry of the shelf life; that reasoning was unsustainable.

Issue (ii): Whether the complaint disclosed the necessary averments to fasten vicarious liability on the directors under Section 34(1) of the Drugs and Cosmetics Act, 1940.

Analysis: Vicarious liability under Section 34(1) arises only where the complaint alleges that, at the relevant time, the person was in charge of and responsible to the company for the conduct of its business. A mere assertion that the accused were directors is insufficient. The complaint contained no averment, even prima facie, that the respondents were in charge of the business or responsible for its conduct. On that basis, the complaint did not disclose a case for proceeding against them as directors.

Conclusion: The prosecution against the directors was liable to be quashed for want of the requisite allegations.

Final Conclusion: The appeal failed, and the quashing of the prosecution was sustained on the ground that the complaint did not make out vicarious liability against the directors.

Ratio Decidendi: The right to seek testing by the Central Drugs Laboratory is available only after timely notice of intention to controvert the Government Analyst's report, and a director can be prosecuted under the company-liability provision only if the complaint specifically alleges that he was in charge of and responsible for the conduct of the company's business.

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