During an investigation into the deaths of pregnant women at New Medical College Hospital in Kota, serious information was revealed: the Dinoprostone gel used during childbirth was found to be substandard after testing.
Suspension of Drug Supplies
Following the receipt of a report on quality non-compliance, supplies of the corresponding batch of the drug were suspended across the entire state of Rajasthan. A similar situation previously occurred with the Oxytocin injection, which was also deemed substandard.
Non-Compliance with Standards
According to sources in the Department of Drugs, Dinoprostone Gel failed inspection on two main parameters. It was established that the active substance content in the gel was only about fifty percent of the established norm. Furthermore, the gel lacked the necessary homogeneity in weight. The Department considers these two deficiencies a serious violation of regulations.
Inspection and Batch Blocking
After receiving the report, Yogesh Kumar conducted an inspection of the New Medical College warehouse under the guidance of Assistant Drug Controller Prahlad Mina. Subsequently, the entire batch was immediately frozen. This drug was delivered to government hospitals through the Rajasthan Medical Services Corporation Limited.
Expansion of Investigation Scope
Given the seriousness of the situation, the Department of Drugs team proceeded to the medical college's drug warehouse. This batch was blocked across Rajasthan via the online supply system to prevent further use. The department is now determining which specific hospitals received this drug. When the AIIMS team arrived to investigate the deaths at the hospital, they were advised to take samples of four drugs, one of which was Dinoprostone Gel. Given the discovery of the substandard condition of this drug, the scope of the investigation expanded. The non-compliance of first the injection, and then the gel, increases the severity of the case.