No criminal intent or gross negligence: HC quashes FIR against doctor, nurse in expired vaccine case

Chhatrapati Sambhajinagar: Observing that no criminal intent or gross medical negligence was involved, the Aurangabad bench of the Bombay High Court has quashed an FIR and all criminal proceedings against a doctor, who is the owner of Pawar Hospital in Majalgaon and a nurse posted there who were accused of giving an expired vaccine to an infant in 2022. 

The case dates back to November 7, 2022, when an infant at Pawar Hospital in Majalgaon was allegedly administered a dose of the rotavirus vaccine that had expired in March that year. However, the child did not suffer any side effects and remained healthy.

Calling the case filing "a mistake, as no element of criminality was involved," the division bench of Justice Vibha Kankanwadi and Justice Sanjay Deshmukh observed that there was no prima facie evidence of gross negligence, nor was there any expert medical board opinion to support the criminal charges against the doctor and the nurse. The bench held that allowing the proceedings to continue would be a misuse of the legal process.

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The First Information Report (FIR) in the case was registered on December 26, 2022, by drug inspector Ashok Dharak, who took action based on a news report. The FIR named the hospital owner, Dr Sharad Madhukar Pawar and nurse Sonali Chandrasen Gore. It included Section 336 (act endangering life or personal safety of others) with Section 34 (acts done by several persons in furtherance of a common intention) of the Indian Penal Code, as well as provisions of the Drugs and Cosmetics Act and Rules.

However, during the hearing, the High Court found several key gaps in the case. The bench noted that the child's maternal grandfather and mother both gave statements affirming that the doctor took immediate remedial measures. According to their statements, Dr Pawar kept the infant under observation at his hospital the entire day to check for any side effects. Hence, the court observed that there was no evidence of criminal intent or gross negligence. 

Further, the vaccine manufacturer, Serum Institute of India, clarified in a letter dated November 21, 2022, that the vaccine ROTASIIL, even if expired, was considered safe if stored properly and that no adverse effects were documented after the product was released to the market.

The court pointed out that the complaint had been filed without taking expert medical advice, which is a requirement in such cases. Referring to a 2005 Supreme Court ruling (Jacob Mathew vs State of Punjab), which underlined that medical professionals should not be prosecuted under criminal law unless there was prima facie evidence of gross negligence, backed by an independent expert medical opinion. 

Further, the bench stated, as reported by TOI, "It is the mistake. No element of criminality is involved. The FIR was registered by the drug inspector without obtaining any opinion from a qualified medical expert, a key procedural requirement under the Jacob Mathew judgment. Even the medical board of Swami Ramanand Teerth Rural Govt Medical College, Ambajogai, could not provide any conclusive opinion on the adverse effects of expired ROTASIIL on a one-and-a-half-month-old child."

In addition, the court noted that offences under the Drugs and Cosmetics Act cannot be reported through a police FIR. Instead, a complaint must be filed in court by the concerned authority. Since this was not done, the FIR itself was found to be invalid.

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