Drugs & Cosmetics Rules | 60-Day Drug Sample Testing Mandatory; Bombay High Court Directs Web-Based Monitoring, Strict Action Against Erring Officers For Rule 45 Non-Compliance
Safiya Malik
The High Court of Bombay at Nagpur, Single Bench of Justice M.M. Nerlikar, in an order dated January 17, 2026, set aside the pending criminal prosecution against the manufacturer and its directors after finding non-compliance with the mandatory 60-day timeline for analysis of drug samples under Rule 45 of the Drugs and Cosmetics Rules, 1945. The Court recorded serious concern over recurring, systemic lapses by Drugs Department officers in adhering to these timelines, noting that delayed analysis can invalidate prosecutions and can also leave allegedly sub-standard medicines in the market, affecting public health. Along with quashing the case, it directed the State Drugs Administration and Government Analysts to ensure timely testing, prompt extension requests where necessary, creation of an online monitoring system, and departmental action for non-compliance within a fixed timeframe.
The petitioners, comprising directors and the manufacturing company, approached the High Court seeking quashing of a criminal prosecution initiated under the Drugs and Cosmetics Act, 1940. The prosecution arose from an inspection conducted by a Drugs Inspector at a medical shop, during which samples of a drug were drawn and forwarded to the Government Analyst for testing. The samples were dispatched within two days of collection. Under Rule 45 of the Drugs and Cosmetics Rules, 1945, the Government Analyst is required to furnish the test or analysis report within sixty days of receipt of the sample, with a proviso permitting extension upon seeking prior approval with reasons.
In the present case, although the samples were sent promptly, the Government Analyst furnished the report several months later. The request for extension of time was made after the expiry of the sixty-day period, and the record did not disclose whether such extension was granted by the Government. The petitioners contended that this delay violated the mandatory requirements of Rule 45 and vitiated the prosecution. The State opposed the petition, contending that the drug was reported to be not of standard quality and that the petitioners had not exercised their statutory right to seek re-analysis.
The Court recorded that it was undisputed that the samples were forwarded to the Government Analyst on 14.07.2022 and that the report was received only on 18.01.2023. It noted that “admittedly, the extension was sought beyond 60 days.” The Court observed that Rule 45 “mandates that it is the duty of the Government Analyst to analyse or test the samples of the Drug within a period of 60 days from the receipt of the samples.”
Relying on precedent, Swapnil s/o Liladhar Mane vs. State of Maharashtra, the Court observed that “the analysis of the sample within a period of sixty days is necessary to ensure the standard of quality for the purpose of the analysis and an accurate report.” It further recorded that delayed analysis “violates the vital right of the accused to get the sample rechecked.”
The Court stated that although the proviso to Rule 45 permits extension, “the extension being sought beyond the stipulated time period” and the absence of clarity regarding its grant rendered the continuation of proceedings unsustainable. It also recorded that the Drug Inspector “has not taken any efforts at least to send the reminder to the Government Analyst.”
The Court expressed concern over the delay in issuing notice to the manufacturer after receipt of the analyst’s report and observed that “the leniency shown by the authorities while dealing with the strict time limit provided under the Rule, 1945” was surprising. While noting that manufacturers of sub-standard drugs must be dealt with sternly, the Court observed that repeated lapses by departmental authorities had come on record and that “the objectives with which the Act was enacted is getting frustrated.”
The Court directed that “the Commissioner, Food and Drugs Administration, Drug Department, State of Maharashtra, Mumbai shall ensure the report of samples shall be received by the concerned officer within time as provided under Rule 45 of the Drugs and Cosmetics Rules, 1945.
“In case of failure by any of the concerned Officer to comply with the provisions of the Drugs and Cosmetics Act, 1940, so also Rules, 1945, strict action should be taken against them. In case, the samples are not tested due to heavy work load at the Government Laboratory, then the Commissioner shall request the Government to create more laboratories in order to tackle the situation.”
The Government Analysts shall ensure “they should send the report timely as provided under Rule 45 of the Rules, 1945 and in case, it is not possible to comply the prescribed time limit, benefit should be taken of proviso provided to Rule 45 and seek extension immediately by giving reasons in writing to the Government. The Government should act promptly on the communication of the Government Analyst seeking extension and shall ensure timely communication and co-ordination between Government and Government Analysts.”
“The Commissioner of Food and Drugs Administration, Drug Department is also directed to ensure that an efficient online system be created, whereby the drug samples which are sent for test/analysis are expeditiously tested and analyzed by the Government Analyst within 60 days, and the reports sent by them are available online on a real-time basis. This creation of an effective mechanism is to ensure that the entire process is monitored, and unnecessary delay is not caused in the conduct of the test/analysis of the drugs sample sent for test to the Government Analysts.”
“The Commissioner of Food and Drugs Administration, Drug Department, State of Maharashtra shall preferably ensure that this entire process be web-hosted so that all the concerned are aware of the process of testing and its outcome.”
“The above directions shall be complied within three months from the date of receipt of the order by the Commissioner of Food and Drugs Administration, Drug Department, State of Maharashtra. The compliance to be reported to this Court within three months from the date of receipt of the order.”
Advocates Representing the Parties
For the Petitioners: Shri V.R. Borkar, Advocate
For the Respondents: Shri A.R. Chutke, Additional Public Prosecutor
Case Title: Ashwani & Ors. v. State of Maharashtra
Neutral Citation: 2026: BHC-NAG:945
Case Number: Criminal Writ Petition No. 967 of 2024
Bench: Justice M.M. Nerlikar
