Kota/Jaipur: A Dinoprostone Gel sample seized from Kota’s New Medical College Hospital (NMCH) has failed quality testing, intensifying scrutiny of medicines administered around the time five new mothers died after post-caesarean complications in May.Dinoprostone Gel is used in pregnant women at or near term to ripen the cervix and induce labour. The sample was among 37 medicines and medical devices seized by drug controllers after complications were reported among women before their deaths.A senior health department official said the failed batch, H-084, was supplied by a pharmaceutical company based in Roorkee, Uttarakhand. It was supplied directly to the government-run NMCH and provided free to patients under the state’s free medicine scheme. The sample was collected from the hospital on May 17.According to the Drug Control Department, the gel failed on two quality parameters. Laboratory analysis found the drug content was only about 50% of the prescribed level, while the gel weight was also inconsistent.Officials, however, said the substandard Dinoprostone Gel has not been linked to the maternal deaths under investigation. They said the deficiency in active ingredients was unlikely to have caused the fatalities, and the inquiry into the deaths is continuing separately.Assistant Drug Controller Prahlad Meena said the failure report was received a day earlier. Drug Control Officer Yogesh Kumar took action on Tuesday evening and froze the affected batch across Rajasthan through the department’s online monitoring system.The department recovered and barred the use of 60 gel units from the NMCH store and 1,170 units from the Medical College Drug Warehouse at Nayapura. The batch has also been recalled from hospitals and wards across the state. A notice has been issued to the manufacturing firm, and the batch has been banned for distribution and sale in Rajasthan.The development follows an earlier quality failure involving an oxytocin injection sample. Jackson Laboratories Pvt. Ltd., the Amritsar-based manufacturer of TOCIN, challenged a Rajasthan health department laboratory report that found no active ingredient in a batch of oxytocin injections tested after the deaths at the Kota hospital between May 5 and May 17.The company approached a Kota court seeking retesting. The health department has sent samples to a Kolkata drug-testing laboratory. Officials said prosecution will remain on hold until the fresh report is received, while legal action will follow if the batch fails again.
