The Union Health Ministry has asked the Rajasthan government for a detailed report on women developing complications following caesarean operations across several government hospitals in the state, with some resulting in casualties.
Sources said the ministry sent a note after the World Health Organization (WHO) sought information from the Indian government on the possible link of spurious oxytocin to the cases. The WHO sought information to ascertain whether the issue was localised, or more widespread, with potential risk at other locations, the source said.
Several maternal deaths have been reported from Kota, Bikaner, and Jodhpur over the last couple of months. The women suffered fatal complications, including kidney failure and severe infections, following caesarean sections and routine deliveries. Investigation suggested that the Kota fatalities were linked to the use of fake or substandard oxytocin — a critical drug 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. Tests indicated the drug lacked active pharmaceutical ingredients. However, the deaths in Bikaner are being linked to unsanitary conditions, lack of fumigation in operation theatres, and poor infection control as major contributing factors.
The Centre’s action followed after the Rajasthan government and the top drug regulator in the country cancelled licences of a Kota-based wholesale drug distributor of oxytocin and two factories manufacturing the drug in Punjab and Himachal, respectively. Sources said inspections had discovered widespread irregularities, including the absence of evidence of key tests regarding drug purity and proof of data fudging.
What were the cases about?
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.”
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The WHO, as part of its global surveillance of medical products, usually reaches out to the national drug regulators for information on any spurious or harmful drug whenever there are such reports. It also raises alert when there is a likelihood of these products crossing national borders.
The crackdown on the manufacturer
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 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. The company violated several good manufacturing requirements, including separate spaces for various processes.
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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.
Drug inspectors 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 found that finished oxytocin was stored at around 27 degrees C instead of the recommended 2 to 8 degrees C.
Distributor licence cancelled too
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.
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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 under way, and additional action will be taken in accordance with the findings,” the Union Health Ministry source said.