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by Admin
08 April 2026 11:26 AM
"No offence is made out against the Petitioners... from the documents of the Respondent itself" — In a landmark judgment delivered on 28th August 2025, the Delhi High Court quashed a 2004 criminal complaint filed under the Drugs and Cosmetics Act, 1940, holding that the accused manufacturers could not be subjected to prosecution when a conflicting government laboratory report exonerated them.
Justice Neena Bansal Krishna, while allowing the petition under Section 482 of the CrPC, held that when two government reports present contradictory conclusions on the same drug batch, the Court must adopt the one favouring the accused, especially when the prosecution itself suppressed critical exculpatory evidence
“Two Test Reports – One Favourable to Prosecution, One to Accused – Prosecution Cannot Pick and Choose What to Believe”: High Court
“If two views are possible from material gathered during investigation, the one benefitting the accused must prevail,” rules Delhi HC relying on settled Supreme Court precedents
The judgment was pronounced in the context of a spurious drug charge relating to the widely used pediatric cough formulation “Tixylix Children’s Cough Linctus,” Batch No. B-2024, manufactured in March 2002 and set to expire in February 2005. The complaint was lodged in February 2004, following an adverse report by the Central Indian Pharmacopoeia Laboratory (CIPL), Ghaziabad, which had found the drug "not of standard quality" based on a negative result for Pholcodine, a listed ingredient.
But what the prosecution conveniently chose not to bring on record, and what would ultimately tilt the balance in favour of the accused, was a second test report conducted by another government laboratory in Vadodara, which used the same testing method (TLC) and concluded that the drug did contain Pholcodine and was of standard quality.
The Court sharply observed,
“These documents sought to be placed on record, pertained to Government Departments created during the investigations and significantly not placed on record by the Complainant though they were part of the investigations and are relevant.”
“Prosecution Cannot Withhold Exculpatory Government Evidence – It Undermines Fairness of Trial”
“The Drug Inspector has conveniently chosen not to place these documents on record”: Court censures selective reliance by Drug Department
One of the strongest indictments in the judgment was directed at the Drug Control Department for its failure to place on record the Vadodara report, even though it was created as part of the official correspondence between Drug Inspector, Delhi and Drug Inspector, Gujarat.
The Court called it an “active suppression of vital defence material,” noting,
“These observations are totally contrary to... judgments which provide that if the documents are of unimpeachable quality, they may be considered... The Ld. MM and Ld. ASJ fell in error by refusing to consider the Vadodara Government Analyst’s report.”
The Court held that the accused were entitled to rely on the government laboratory report obtained from their own manufacturing unit, especially since the Delhi Drug Inspector had initiated the Gujarat sampling.
“Violation of Statutory Rights Under Drugs & Cosmetics Act — No Opportunity for Manufacturer to Re-Test”
“The Manufacturer lost the valuable right of re-testing... the Drug Inspector failed to comply with Section 25 of the Act”
The High Court found that the Drug Inspector failed to provide the manufacturer with the sample and test report, as required under Section 25(2) and (3) of the Drugs and Cosmetics Act, 1940, thus denying the manufacturer the opportunity to demand re-testing by a Central Drugs Laboratory.
Although the manufacturer expressed its intention within 28 days to challenge the report, it had to rely on communication forwarded unofficially by the distributor and was never given direct access.
The Court noted: “The Drug Inspector did not make any endeavour to comply with Section 23 of the Act... the Manufacturer lost the valuable right of re-testing as mandated under the Section 25 of D&C Act.”
“Same Testing Method, Contradictory Results — When Procedure Is Doubtful, Accused Cannot Be Prosecuted”
“If the same TLC method was used in both labs, and one test finds the drug conforming to standards, why rely on the other?” asks High Court
The Court meticulously compared both lab reports and found that both used the TLC (Thin Layer Chromatography) method, yet arrived at opposite results—a strong indication of procedural fallibility.
The Ghaziabad lab had even admitted that it could not perform the assay of Promethazine HCl due to unavailability of method—raising further questions on the validity of its conclusion.
“The procedure followed by CIPL, Ghaziabad was not applied correctly. It is evident that a doubt is created regarding the validity of the methodology used... Therefore, prosecution initiated against the Petitioner on the basis of such Report, is also doubtful.”
“Court Must Not Act As a Mouthpiece of Prosecution — It Must Weigh the Material with Judicial Consciousness”
“Judge cannot act merely as a post office... if material exonerates the accused, charges must be dropped,” rules Court quoting Prafulla Kumar Samal
Relying on the classic principle laid down in Union of India v. Prafulla Kumar Samal, the Court reiterated that even at the stage of framing charges, the court has a duty to weigh the evidence to see whether the suspicion is ‘grave’ or merely speculative.
The Vadodara report, being official, unrefuted, and of the same batch, tilted the scale completely.
The judgment concluded: “From the documents of the Respondent itself, no offence is made out against the Petitioners... The Government Analyst Report, Vadodara, establishes that the drug Tixylix being manufactured by the Petitioners, was not spurious but was of Standard Quality.”
Accordingly, the Court quashed Complaint No. 12/2004, discharged all the Petitioners, and disposed of pending applications.
Date of Decision: 28 August 2025
