Delays in Drug Sample Testing and Procedural Violations Lead to Dismissal of Charges under the Drugs and Cosmetics Act
In a significant ruling, the Bombay High Court has quashed the prosecution against M/s. C.B. Healthcare and its partners, citing procedural non-compliance under the Drugs and Cosmetics Act, 1940. The court, presided over by Justice N.J. Jamadar, delivered the judgment on March 24, 2026, highlighting critical lapses by the authorities in handling drug sample testing and the prosecution process.
The case involved a sample of Fexinol-12 tablets, taken from Vinoba Bhave Civil Hospital's Central Medical Store in Silvasa on November 29, 2016. The government analyst's report, which declared the sample "not of standard quality," was issued seven months later, far exceeding the mandatory 60-day testing period stipulated under Rule 45 of the Drugs Rules, 1945. The delay, according to the court, undermined the integrity of the analysis and infringed on the manufacturer’s right to retest the sample.
Further procedural breaches included the failure to send a portion of the drug sample to C.B. Healthcare, the manufacturer, as mandated by Section 23(4)(iii) of the Drugs Act. This omission denied the manufacturer the opportunity to contest the findings of the government analyst, constituting a significant procedural violation.
The court also addressed the improper cognizance taken by the Special Judge at Dadra and Nagar Haveli, which violated Section 193 of the Criminal Procedure Code. The judgment emphasized that the Court of Session cannot directly take cognizance of such offences unless expressly provided by the Act, which was not the case here.
Moreover, the prosecution failed to specify the roles and responsibilities of the firm’s directors, negating the grounds for vicarious liability under Section 34 of the Drugs Act. The court noted that mere designation as directors was insufficient to establish liability without detailed allegations.
In light of these findings, the Bombay High Court ruled that continuing the prosecution would be an abuse of the court's process, leading to the dismissal of the case against C.B. Healthcare and its partners.
Bottom Line:
Drugs and Cosmetics Act, 1940 - Procedural non-compliance, delayed testing of drug samples, and infringement of valuable rights of the accused lead to quashing of prosecution.
Statutory provision(s):
Drugs and Cosmetics Act, 1940 Sections 27(d), 23, 32, 34; Drugs Rules, 1945 Rule 45; Criminal Procedure Code, 1973 Section 193
M/s. C.B. Healthcare v. Union of India, (Bombay) : Law Finder Doc id # 2871230
