The Bombay High Court, Nagpur Bench, expressed grave concern over repeated and systemic lapses by officers of the Drugs Department in adhering to the mandatory timelines prescribed under Rule 45 of the Drugs and Cosmetics Rules, 1945. The Court emphasised that the failure to analyse drug samples within the statutory sixty-day period not only vitiated prosecutions but also posed a direct threat to public health by permitting sub-standard drugs to remain in circulation. A bench presided over by Justice M.M. Nerlikar was hearing a criminal writ petition filed by the directors of a pharmaceutical company challenging the criminal prosecution pending before the Chief Judicial Magistrate in Gadchiroli for allegedly manufacturing a sub-standard drug. The petitioners contended that the prosecution was fundamentally flawed because the drug inspector drew samples on a specified date and forwarded them to the government analyst within a matter of days, but the analyst sought an extension of time only after the expiry of the mandatory sixty-day period required for analysis. In consequence, the report declaring the drug “not of standard quality” was issued long after the statutory timeline had expired, and the prosecution was launched many months thereafter.
The petitioners relied on established legal precedent to argue that the delayed analysis deprived them of the statutory right to have the sample rechecked by a second analyst within the prescribed period. They maintained that the delayed issuance of the analyst’s report and the subsequent initiation of prosecution proceedings fundamentally violated the statutory safeguards intended to protect fair trial rights and due process. The Court expressed astonishment at the apparent leniency of the authorities, particularly noting that even after the analyst’s report was eventually received, the notice of prosecution was served on the manufacturer only several months later. Observing that such administrative inertia directly undermined the objectives of the Drugs and Cosmetics Act, 1940, the Court underscored that adherence to statutory timelines for sample analysis is integral to ensuring that prosecutions are legally valid and scientifically sound.
While quashing the prosecution in the present case, the Court made strong observations regarding the lax approach of the Drugs Department. It observed that officers entrusted with enforcing drug safety laws could not afford to be indifferent to the statutory timelines and procedural safeguards enshrined in the Rules. Stressing that repeated and systemic lapses could benefit manufacturers of sub-standard drugs at the expense of public health, the Court urged strict compliance with the provisions governing sample testing. The Bombay High Court noted that the purpose of Rule 45 was to ensure timely analysis and reporting so that quality defects in pharmaceutical products could be addressed expeditiously, preserving both consumer safety and the integrity of prosecution proceedings.
The bench stressed that the failure to analyse drug samples within the statutory period not only raised questions about the procedural regularity of the prosecution, but also jeopardised the very legislative intent behind regulating drug quality. It emphasised that public health considerations are of paramount importance and that procedural lapses of this nature could enable sub-standard drugs to remain on the market, thereby endangering consumers. The Court observed that statutory timelines were not mere technicalities but essential safeguards designed to balance the rights of manufacturers with the necessity of protecting public health and ensuring the credibility of enforcement mechanisms.
In its judgment, the Bombay High Court reiterated that officers responsible for enforcing the Drugs and Cosmetics Rules must strictly adhere to the timelines for sample analysis. It underscored that failure to do so jeopardised not only individual prosecutions, but also the broader goal of maintaining high standards of drug quality and safety in the pharmaceutical market. While quashing the impugned prosecution as being vitiated by procedural irregularities, the Court’s observations strongly signalled the need for systemic reform and accountability within the Drugs Department. The Court admonished the department for its lack of diligence and highlighted the serious risks inherent in allowing procedural lapses to persist unchecked.
By setting aside the prosecution on the basis of delayed laboratory analysis, the High Court underscored the principle that statutory safeguards must be honoured in letter and spirit. It made clear that adherence to statutory timelines in relation to sample testing under the Drugs and Cosmetics Rules is not optional but mandatory, intended to protect not only the rights of those prosecuted, but also the larger public interest in ensuring the safety, efficacy, and quality of pharmaceutical products in the market. In doing so, the Court’s order emphasised that strict action and accountability are necessary to reinforce compliance and prevent similar lapses from recurring, thereby safeguarding public health and maintaining the integrity of the legal and regulatory framework governing drugs.
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