Rajasthan C-sec deaths: Centre seeks report after WHO asks for info

Oxytocin is used to induce labour before a delivery and to contract the uterus for preventing blood loss after it. Many of the women who died or developed complications in Rajasthan saw excessive blood loss.

In the latest case, eight women who underwent C-sections at the District Government Hospital in Paota, Jodhpur, on June 20 fell ill after surgery. Two of them who developed complications were moved to AIIMS, Jodhpur, and all are stable now.

Before that, complications were reported after caesarean deliveries at PBM Hospital in Bikaner. Of the six women who developed kidney failure after surgery, two died. The Bikaner cases followed a more severe episode in Kota, where five women died in May after undergoing caesarean deliveries at the New Medical Government Hospital. More than 40 days later, five other women remain admitted and continue to require dialysis after suffering kidney failure.

The Rajasthan authorities have denied a link between the deaths.

On the WHO approaching the Central government, an official said: “It is a routine part of the global pharmacovigilance and regulatory surveillance mechanism. The organisation regularly seeks information… to determine whether such incidents are confined to a particular location or whether there could be any implications for other countries… It should not be construed as a finding against the product or the manufacturer.”

The findings

Centre: In the first week of June, the Central Drugs Standard Control Organisation (CDSCO) held a joint inspection of the manufacturing units in Punjab and Himachal of Jackson Laboratories, the manufacturer of the oxytocin that is under a cloud in Rajasthan, along with the regulators of the two states.

Following the inspection, the licences of the units were cancelled.

Sources said that the inspection found that Jackson Laboratories, which has earlier too faced action over its products, was found to have not complied with a 2023 order by state regulators directing it to stop the production of several tablets, capsules, and injectables, on grounds of its unhygienic conditions.

Sources said a state drug regulator has now ordered Jackson to recall all the medicines it produced after the 2023 order, as well as to recall other drugs it failed in quality control tests. Sources said the company violates several good manufacturing requirements, including separate spaces for various processes.

As per officials, evidence of “record tampering” was also found in the specific batches of oxytocin supplied to Rajasthan. This includes the date of the sample being received by a quality control lab being different on the test report and the lab intake. There is reportedly no record of testing having been done on a key aspect for a drug’s purity, as well as alleged evidence of data files on the testing equipment being modified or deleted.

Sources said the drug inspectors also found that raw data for the tests to check for impurity could not be provided by the company, neither did it reportedly have raw data on testing of the active pharmaceutical ingredient, which is mandated.

The inspecting teams reportedly also found that finished oxytocin was stored at around 27 degrees C instead of the recommended 2 to 8 degrees C.

Rajasthan: On Tuesday, the Rajasthan Drug Control Department cancelled the wholesale drug licence of Kota-based pharma distributor Rajasthan Medical Hall, over the alleged sale of thousands of spurious oxytocin injections and other irregularities.

As per an order issued by Rajasthan Drug Licensing Officer and Assistant Drug Controller Devendra Kumar Garg, officials on May 19 inspected Rajasthan Medical Hall, and discovered irregularities, including that the firm did not maintain a mandatory inspection register and had no qualified pharmacist on site.

Authorities said they also found that, while the firm purchased 9,300 units of Tocin 1 ml injection manufactured by Jackson Laboratories, it sold 10,050 injections from the same batch. The Rajasthan Drug Testing Laboratory later declared the batch spurious, saying tests revealed that the injections contained no trace of oxytocin, its active ingredient.

The Rajasthan Drug Controller order said that, in response to a show-cause notice over the discrepancy in injections procured and sold, Rajasthan Medical Hall produced a letter from Jackson Laboratories claiming that 750 additional injections had been dispatched separately by bus. However, the Drug Control Department found the explanation unsatisfactory.

“Further examination of the matter is underway, and additional action will be taken in accordance with the findings,” the Union Health Ministry source said.