Mumbai: The Bombay High Court has directed the Maharashtra government to constitute a committee to examine the Brihanmumbai Municipal Corporation’s drug procurement system. The committee will also suggest how the system can ensure that only drugs obtained from manufacturers prescribed by the World Health Organisation are in circulation.
A division bench of Justices B R Gavai and Bharati Dangre was hearing a criminal public interest litigation filed by Ketan Tirodkar that pointed out a news report about administration of substandard antibiotics to women and children in Bhabha Hospital at Kurla. The article, published on April 18, 2014, said that out of 45 female patients who were administered Ceftriaxone and Cefotaxine injections intravenously, 28 suffered severe reactions and one succumbed to Adverse Drug Reaction (ADR). The article also states that there were incidents of ADR a fortnight earlier in a civic-run hospital at Bhiwandi which affected 18 children and on August 22, 2014, 10 women patients suffered from ADR at BMC’s Rajawadi Hospital.
Mr. Tirodkar has sought a complaint to be registered under Section 304 A (causing death by negligence) of the Indian Penal Code against the officials of the Food and Drug Administration (FDA) Department. His petition also seeks directions to hand over investigations to the State Criminal Investigations Department.
An affidavit filed by the Joint Commissioner of FDA states, “There was no standard operating procedure maintained and adopted by the hospital for highly potent drugs.” The stores do not have airconditioned facilities for storage, required for antibiotics (they need to be below 25 degrees celsius), it says. The affidavit also says that as per the Drugs and Cosmetic Act, Ceftriazone and Cefotaxime are included in Schedule H-1, and the warning on their labels says that it is dangerous to take them except in accordance with medical advice.
The court said, “It is seen that the drug was administered without taking into consideration the sensitivity of patients and without adequate inquiry, which appears to be the cause for ADR. This has occurred because of inadequate staffing in the hospitals.” The court also said that even though the incidents occurred around four years ago, a mechanism needs to be worked out so that ADR to the antibiotic injections, which are normally administered in civic-run hospitals, does not occur again.
