After Deaths At Civic-Run Hospitals Due To Adverse Drug Reaction, Bombay HC Sets Up Committee Headed By FDA Joint Director [Read Order]

The Bombay High Court recently set up a committee to examine the drug procurement system of the Municipal Corporation of Greater Mumbai and suggest ways to make it foolproof. The committee will also devise a mechanism in order to keep the medical staff apprised of the patient’s medical history so that any further adverse drug reaction (ADR) can be avoided.

The bench of Justice BR Gavai and Justice Bharati Dangre were hearing a PIL filed by Ketan Tirodkar wherein a 4-year-old news item was brought to the notice of the court talking about the administration of sub-standard antibiotics to women and children at Bhabha Hospital, Kurla in Mumbai.

The news story stated that on April 18, 2014, out of 45 female patients who were administered Ceftriaxone and Cefotaxime injections intravenously, 28 suffered severe reaction. While one patient, Sara Shaikh succumbed to adverse drug reaction (ADR).

It was also reported in the story that a fortnight before the said incident, 18 children at another civic­-run hospital in Bhiwandi had suffered ADR. In 2014, 10 female patients, who were being treated at BMC's Rajawadi Hospital in Ghatkopar also suffered from ADR.

Thus, the petition prayed for officials of the Food and Drug Administration department to be prosecuted for offences punishable under Section 304-A (causing death by accident) of the Indian Penal Code.

Affidavits were filed on behalf of the Municipal Corporation of Greater Mumbai (MCGM) and the State of Maharashtra. In conclusion, both affidavits indicated that the nursing staff was inadequate and with no doctor available in the ward, they administered the antibiotics rapidly. The standard protocol regarding flushing patient’s prior medical history and the speed at which these drugs are to be administered was not followed.

The court noted-

“What is noted is the manner in which the injections were administered and in the affidavit itself, it is stated that it was done rapidly and this was required to be done since there was no adequate nursing staff and no available doctor in the ward. Though from the record, it is seen that the quality of the drug is not the issue, it is accepted that the manner in which the drug was administered without taking into consideration the sensitivity of the patients to the said drug and without adequate inquiry appears to be the moot cause for the Adverse Drug Reaction. This has occurred because of the inadequate staffing pattern in the said hospital.”

In order to ensure that such incidents of ADR do not occur in the future, the court gave directions to set up a committee under the chairmanship of Joint Director, Food and Drug Administration to look into the drug procurement system of MCGM and suggest ways to make it foolproof. The committee will also determine total number of staff required at all civic-run hospitals and ensure strict adherence of the standard operating procedure in cases of ADR.

The court has directed the committee to submit its report before the State of Maharashtra in four months.