The Bombay High Court has quashed a criminal prosecution under the Drugs and Cosmetics Act, 1940, observing that a Court of Session cannot take direct cognizance of offences as a court of original jurisdiction unless the case is committed to it by a Magistrate. Justice N.J. Jamadar clarified that while the Drugs Act stipulates trials by a Sessions Court, it contains no provision expressly authorizing direct cognizance, thereby making the committal procedure under Section 193 of the CrPC mandatory.
Case Background
Petitioner No. 1, a partnership firm manufacturing pharmaceuticals in Baddi, Himachal Pradesh, and its partners (Petitioner Nos. 2 to 5), were prosecuted following an inspection on November 29, 2016. A Drugs Inspector drew a sample of ‘FEXINOL-12’ (Fexofenadine Hydrochloride Tablets IP) from the Central Medical Store of Vinoba Bhave Civil Hospital in Silvassa.
The sample was sent to the Government Analyst at the Central Drugs Testing Laboratory (CDTL), Mumbai, on November 30, 2016. However, the analysis report, which declared the sample “not of standard quality,” was received only on July 6, 2017—more than seven months later. Following an investigation and sanction obtained in November 2019, the Respondent filed a complaint before the Special Judge at Silvassa on September 28, 2021, and process was issued the same day.
Arguments of the Parties
The Petitioners, represented by Mr. Nitin Bhasin, argued that the inordinate delay in testing violated Rule 45 of the Drugs Rules, 1945. They further contended that the Respondent failed to comply with Section 23(4)(iii) of the Act by not sending a portion of the sample to the manufacturer, thereby depriving them of their right to challenge the findings under Section 25. Additionally, they challenged the direct cognizance taken by the Special Judge, citing Section 193 of the CrPC.
The Respondent (Union of India), represented by Mr. D.P. Singh, justified the delay by stating that the “reference standard and the impurity standard required to test the sample were not readily available.” They further argued that the Petitioners had lost their right to re-test because they failed to notify their intention to adduce evidence within 28 days of receiving a notice under Section 18A.
Court’s Analysis and Observations
The Court scrutinized the impact of the seven-month delay in testing, noting that Rule 45 mandates a report within 60 days. Justice Jamadar observed:
“The provisions contained in Rule 45 of the Rules, 1945, are peremptory in nature… Delayed analysis of the sample thus erodes the sanctity of the analysis. It is for this reason, a time frame has been stipulated for the testing.”
Regarding the procedural issue of direct cognizance, the Court held that while Section 32(2) of the Drugs Act requires a trial by a Court of Session, there is no provision that expressly authorizes a Sessions Court to take cognizance without a committal order from a Magistrate. The Court observed:
“Evidently… there is no provision in the Drugs Act 1940 which expressly provides for the Court of Session taking the cognizance of the offence punishable under the said Act directly… The necessary corollary flowing from Section 4 of the Code, is that the rest of the provisions in the Code in regard to taking of the cognizance of the offence, inclusive of the interdict contained in Section 193 of the Code against the Court of Session taking cognizance of the offence directly, are clearly attracted.”
Further, regarding the loss of the right to re-test under Section 25, the Court found that the drug’s shelf life had expired in August 2018. Since the complaint was lodged only in September 2021—three years after the expiry—the Petitioners could not have exercised their right to have the sample analyzed by the Central Drugs Laboratory even if they had applied to the Court.
Citing the Supreme Court’s decision in Laborate Pharmaceuticals India Ltd. and Ors. V/s. State of Tamil Nadu, Justice Jamadar stated:
“As the valuable right of the accused for reanalysis vested under the Act appears to have been violated and having regard to the possible shelf life of the drug we are of the view that as on date the prosecution, if allowed to continue, would be a lame prosecution.”
The Decision
The High Court concluded that the cumulative failures—including the unauthorized direct cognizance by the Sessions Court, the delayed testing, and filing the case long after the drug’s expiry—deprived the Petitioners of their legal remedies. Continuing the case would amount to an abuse of the judicial process.
The Court ordered:
- The Writ Petition is allowed.
- The order dated September 28, 2021, issuing process against the Petitioners under Section 27(d) of the Drugs Act, 1940, is quashed.
- The proceedings in Special Case No. 32 of 2021 are quashed and set aside.
Case Details:
- Case Title: M/s. C.B.Healthcare and Ors. v. Union of India
- Case Number: Writ Petition No. 2777 of 2024
- Bench: Justice N.J. Jamadar
- Date: March 24, 2026
