Drug And Cosmetic Act | Sample Testing Must Be Completed Within 60 Days Under Rule 45 – Delay Vitiates Entire Prosecution: Bombay High Court

“Delayed Drug Testing Violates Accused’s Right To Seek Re-Analysis – Time Is Of Essence In Drug Quality Testing”, In a significant ruling impacting the pharmaceutical regulatory regime, the Bombay High Court struck down a criminal prosecution launched against a drug manufacturer and its directors for alleged sale of sub-standard drugs, citing blatant non-compliance with Rule 45 of the Drugs and Cosmetics Rules, 1945. Justice M.M. Nerlikar categorically held that “the delayed analysis of the sample violates the vital right of the accused to get the sample rechecked”, adding that “in matters of drug quality testing, time is not a procedural formality — it is a statutory command.”

“When Law Prescribes A Thing To Be Done In A Particular Manner, It Must Be Done In That Manner Or Not At All”

The Court observed that the Drug Inspector had drawn samples of RTZOL-DSR Capsules from M/s. City Medical Shop on 12.07.2022, and the same were sent to the Government Analyst on 14.07.2022. However, the analyst only sought an extension on 01.11.2022 — well beyond the mandatory 60-day period — and ultimately submitted the report on 18.01.2023, without any evidence of valid extension granted.

Expressing concern over the procedural lapse, the Court said, “Rule 45 mandates that the Government Analyst shall furnish his report within 60 days of receiving the sample. If extension is required, it must be sought within the stipulated time, not after its expiry.” It further noted that there was “no proof on record to show that such extension was granted by the Government”, thus rendering the report unsustainable and the entire prosecution vitiated.

“Accused Cannot Be Deprived Of Their Statutory Right To Re-Test A Perishable Sample”

Highlighting the prejudice caused to the accused due to procedural delay, the Court remarked, “The sample in question has a shelf life — quality of a drug can deteriorate over time. If testing is delayed, the accused loses the statutory opportunity to seek re-testing of a viable sample.” The Court referred to its previous ruling in Swapnil s/o Liladhar Mane v. State of Maharashtra, 2024(4) Mh.L.J. (Cri.) 673, where it was held that “analysis within 60 days is essential to preserve the evidentiary integrity and fairness of prosecution.”

Rejecting the State’s defence that the accused had failed to act under Sections 25(3) and 25(4) of the Drugs and Cosmetics Act, the Court noted with disapproval, “After receiving the CA report on 18.01.2023, the notice was served on the manufacturer only on 19.04.2023 — after a gap of nearly four months. Such bureaucratic lethargy is unacceptable in a matter impacting public health and the rights of the accused.”

“Lapses Of Drug Department Benefit Manufacturers Of Sub-Standard Drugs — This Frustrates The Purpose Of The Act”

Justice Nerlikar did not hesitate in laying bare the systemic failure within the drug regulatory mechanism. “There are numerous cases where departmental lapses allow sub-standard drug manufacturers to escape liability. Such procedural failures directly frustrate the very purpose of the Drugs and Cosmetics Act, 1940.”

Recalling the objectives of the Act, the Court noted, “This law was enacted to ensure the safety, efficacy, and quality of drugs and cosmetics; to prevent sub-standard products from reaching consumers; and to safeguard public health. But such aims stand defeated when statutory timelines are ignored with impunity.”

In an especially sharp observation, the Court held: “The Drug Inspector, who was entrusted with the matter, has not taken any effort to even send a reminder to the Government Analyst. When authorities become silent spectators, they compromise both justice and public health. Such conduct must not go unchecked.”

“Drug Analysis Must Be Tracked In Real Time — Web-Hosted Monitoring System Ordered”

While allowing the writ petition and quashing the prosecution in S.C.C. No. 637/2023, the High Court took an extraordinary step by issuing a detailed set of directions to the Commissioner of Food and Drugs Administration, Maharashtra, aimed at structural reform of the testing mechanism.

“The Commissioner shall ensure that drug reports are submitted within 60 days, as mandated under Rule 45. In case of failure, strict disciplinary action shall follow. The Government Analyst must not casually ignore the statutory timeline, and if extension is needed, it must be sought within time and with specific reasons in writing,” the Court directed.

More importantly, the Court mandated the creation of an online, web-hosted, real-time monitoring system that would allow drug sample testing to be tracked transparently and efficiently.

“The Commissioner of Food and Drugs Administration shall ensure that this entire process is digitized and monitored in real time. The failure to do so risks public exposure to harmful or ineffective substances, which is unacceptable in a regulated system,” the Court ordered.

“Strict Law Must Be Matched By Strict Implementation — Or Else, Public Health Will Suffer Irreparably”

In conclusion, Justice Nerlikar remarked, “If the Drugs and Cosmetics Act, 1940 and the Rules of 1945 are to serve any meaningful purpose, they must be followed in letter and spirit by the authorities entrusted with their implementation. Failure to do so only aids the violators and endangers the public.”

The petition was accordingly allowed, and the matter has been listed for compliance reporting on 4th May 2026. The Court directed the State to submit proof of compliance with the reform directions within three months.

Date of Decision: 17 January 2026