Delay Beyond 60 Days in Drug Sample Testing Vitiates Prosecution: Bombay High Court Quashes Case Under Drugs and Cosmetics Act
Directs action against erring officials, calls for additional labs and online monitoring to prevent future delays
Justice M.M. Nerlikar, Bombay High Court, Nagpur Bench
The Bombay High Court, Nagpur Bench, has quashed criminal proceedings against a pharmaceutical company and its directors after finding gross non-compliance with Rule 45 of the Drugs and Cosmetics Rules, 1945, which mandates that drug samples must be tested within 60 days of receipt.
The Court directed initiation of departmental action against erring officials and observed that systemic delays must be addressed through creation of additional laboratories and an online monitoring mechanism to ensure timely testing of drug samples in future.
Justice M.M. Nerlikar categorically observed, “It is necessary to mention at this juncture that the manufacturers, who are manufacturing the sub-standard drugs are required to be dealt sternly for the reason that the effect of such drug on the public at large is huge. However, 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. As could be seen that the lapses on the part of the Drug department would be beneficial to the manufacturers who are manufacturing the sub-standard drugs. As was observed earlier that these drugs are adversely affecting the human beings on large scale, it is necessary to issue directions to the department of drugs so that in future they should maintain the time line provided under the Drugs and Cosmetics Act, 1940 and Rules of 1945”.
“When the Act or Rules provides to do a particular thing in a particular manner and if the Authorities are sitting idle, under such circumstances, it is necessary to hold the concerned officer responsible”, the bench further observed.
Advocate V.R. Borkar appeared for the petitioner and A.R. Chutke, APP for the State appeared for the respondent.
For context, in the matter, a Drugs Inspector initiated prosecution alleging that a drug manufactured by the petitioners was not of standard quality. The sample was drawn on 12-07-2022 and forwarded to the Government Analyst on 14-07-2022. However, the analyst’s report was received only on 18-01-2023, which was well beyond the prescribed 60-day period.
Although an extension was sought by the Government Analyst, the Court noted that it was done after the expiry of the statutory period, and there was no material to show that such extension was ever granted by the Government.
Considering the facts, the Court reiterated that time is of the essence in drug testing, as delayed analysis compromises the accuracy of results and deprives the accused of their right to seek re-testing under the Drugs and Cosmetics Act. Relying on earlier precedent, the Court held that delayed testing without valid extension cannot sustain a criminal prosecution.
The Bench also expressed concern over the casual approach of the Drug Department, observing that inaction and procedural lapses by authorities ultimately frustrate the very objectives of the Drugs and Cosmetics Act, which is to protect public health.
Accordingly, the bench while quashing the prosecution, directed a compliance report to be furnished within three months.
Cause Title: Ashwani v. State of Maharashtra at the instance of Nalanda B. Urkude, working as a Drugs Inspector [Neutral Citation: 2026:BHC-NAG:945]
Appearance:
Petitioner: V.R. Borkar, Advocate
Respondent: A.R. Chutke, APP