The Nagpur Bench of the Bombay High Court has set aside criminal proceedings in a case concerning the alleged manufacture of a “substandard” batch of medicine, citing delays and procedural lapses that undermined the rights of the accused.
Justice Urmila Joshi-Phalke ruled that the prosecution in connection with a 2016 batch of Rabeprazole and Domperidone (Rabetroy-DSR) capsules amounted to an “abuse of process of court.” The complaint, filed in October 2020, came well after the expiry of the drug in April 2018, depriving the company director of the statutory right under the Drugs and Cosmetics Act to seek re-analysis of the sample.
The Court also highlighted serious lapses in the handling of the case, particularly the Government Analyst’s report, which was issued nearly ten months after receiving the sample far beyond the 60-day limit prescribed under Rule 45 of the Drugs and Cosmetics Rules. This delay, the Court held, was fatal to the prosecution’s case.
Additionally, the Court noted that while a director of the company was named as responsible, the actual company linked to the drug’s manufacture was not arraigned as an accused. Relying on Supreme Court precedents, the Court reiterated that prosecution of a company is a condition precedent before its officers or directors can be held vicariously liable.
Quashing the case, the Court observed that summoning a company director without proper legal basis or compliance with statutory timelines would amount to an abuse of the judicial process.
Appearances:
Shri Akshay Naik, Senior Counsel assisted by Shri Rohan Deo, Advocate for the Applicant.
Mrs. Mugdha Chandurkar, Counsel for the Non-applicant.
