HC asks govt to set up panel to check adverse drug reactions

Taking note of the increasing number of adverse drug reaction cases in civic-run hospitals, the Bombay High Court has directed the Maharashtra government to set up a committee to analyse the cause and subsequently come up with a solution.

A division bench of Justices B R Gavai and Bharati Dangre was hearing a public interest litigation filed by activist Ketan Tirodkar in 2014 after 18 children and over 25 women suffered from adverse drug reactions (ADR) at three separate civic-run hospitals in the city.

The bench last week heard brief arguments in the petition and opined that it was necessary to analyse the cause of the ADRs.

"Not only is finding out the cause important, but offering a solution to the same is also equally important," the court said.

A mechanism needs to be worked out so that such incidents of ADR to antibiotic injections, which are normally administered in civic-run hospitals, are not repeated, the court said.

In order to examine the causes and suggest possible solutions, a joint committee comprising senior officers and experts needs to be set up to determine whether the standard protocol of ADR was followed and how hospitals should cope with such cases, it said.

"We direct the state government to constitute a committee under the chairmanship of joint director of the Food and Drug Administration (FDA)," the court said.

The bench directed the committee to submit its first report to the state government within four months.

The committee, which includes joint directors of the medical, education and drug department as well as the public health department of the state government, would have the Brihanmumbai Municipal Corporation's medical superintendent as its member secretary.

The framework of the committee would be to examine the drug procurement system of the civic body, to suggest a mechanism by which drugs can be obtained only from those manufacturers who follow the standards prescribed by the World Health Organisation (WHO), and suggest guidelines to ascertain that all drugs, medicines and equipment obtained by the civic run hospitals are of standard quality.

The committee shall also look into the standard operating procedure in cases of ADRs, to device a mechanism by which the medical history of a patient is made known to the medical staff before administration of any drug.

It shall also determine the adequate strength of staff required to man the civic-run hospitals, said the court.