Drugs & Cosmetics Rules | 60-Day Sample Testing Mandatory; Web-Host Reports: Bombay HC Orders Strict Action Against Erring Officers

The Bombay High Court (Nagpur Bench) last week expressed serious 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 observed that failure to analyse drug samples within the stipulated period not only vitiates prosecutions but also jeopardises public health by allowing sub-standard drugs to remain in circulation. A bench of Justice MM Nerlikar was hearing a criminal writ petition filed by the Directors of M/s Oscar Remedies Pvt. Ltd. (Mr. Ashwani Lamba and others) seeking to quash the criminal prosecution pending before the Chief Judicial Magistrate, Gadchiroli, for allegedly manufacturing a sub-standard drug. The Drug Inspector had drawn samples on 12 July 2022 and forwarded them to the Government Analyst on 14 July 2022. However, the Analyst sought extension only on 1 November 2022, after expiry of the mandatory 60-day period.Also, the report declaring the drug "not of standard quality" was issued as late as 18 January 2023. Despite this, the prosecution was launched in August 2023.The petitioners contended that the delay in analysis violated Rule 45 and rendered the proceedings vitiated. Relying on the judgment in Swapnil s/o Liladhar Mane vs. State of Maharashtra, they argued that the delayed analysis deprived them of their statutory right to get the sample rechecked.The Court examined Rule 45 and reiterated that the Government Analyst is duty-bound to furnish the test report within 60 days of receipt of samples, and any extension must be sought within that period by recording specific reasons.The Court held that, in the absence of a grant of extension and where the extension is sought beyond the stipulated time period, the proceedings could not continue.The Court also expressed surprise at the 'leniency' of the authorities, noting that even after receiving the report on 18 January 2023, the notice was delivered to the manufacturer nearly four months later, on 19 April 2023.While quashing the prosecution, the Court made strong observations regarding the laxity of the Drugs Department. It noted with concern that such lapses ultimately benefit manufacturers of sub-standard drugs and defeat the very objectives of the Drugs and Cosmetics Act, 1940, which is aimed at protecting public health. The Court emphasised that officers entrusted with enforcing drug safety laws cannot afford to be indifferent to statutory timelines and procedural safeguards."… there are 'n' number of cases wherein the lapses on the part of the department of the Drugs and their officers have come on record… the lapses on the part of the Drug department would be beneficial to the manufacturers who are manufacturing the sub-standard drugs… these drugs are adversely affecting the human beings on large scale", the Court observed.Accordingly, while quashing the criminal prosecution against the petitioners, the Court issued detailed directions to the Commissioner of Food and Drugs Administration, Maharashtra to be complied with within three months:Ensure strict compliance with Rule 45 timelines.Take strict action against officers failing to comply with the Act and Rules.Request the Government to create more laboratories if workload causes delays.Government Analysts must seek extension immediately with written reasons if the 60-day limit cannot be met.Create an efficient online system where drug samples and reports are available on a real-time basis.Web-host the entire process so all concerned are aware of the testing outcome.The matter has been listed for noting compliance on 4 May 2026.Case Title: Ashwani & Ors. v. State of Maharashtra [CRIMINAL WRIT PETITION NO. 967 OF 2024]Click Here To Read/Download Order

Drugs & Cosmetics Rules | 60-Day Sample Testing Mandatory; Web-Host Reports: Bombay HC Orders Strict Action Against Erring Officers

Saksham Vaishya

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