Synthetic oxytocin, a hormone, is used in hospitals to augment labour and to control postpartum haemorrhage.
Authorities have also cancelled the manufacturing licence of Jackson Laboratories’ manufacturing facility in Himachal Pradesh, according to officials, even as investigations at the unit are ongoing.
Meanwhile, the World Health Organization (WHO) has sought details from the Indian government on the matter, particularly to ascertain whether the same Jackson Laboratories drug was exported, highlighting concerns over the potential for a wider public health crisis.
The documents show that a joint inspection by officials of the Central Drugs Standard Control Organisation (CDSCO) and the Punjab drug regulator, conducted under the risk-based inspection framework, identified 58 critical observations and 451 major observations at Jackson Laboratories’ facility in Punjab.
The investigation declared the product as “not of standard quality” and reported serious non-compliance of provisions of Schedule M, Schedule U, Rule 74 & 78 of the Drugs Rules 1945.
The team found that the firm had not performed any testing for the impugned product/finished product. “The team opined that the certificate of analysis submitted by the firm is not reliable,” said an official.The team also found that the drugmaker failed to provide analytical method verification/validation, process validation, and stability study data for oxytocin injection IP 5IU/ml in line with the requirements of the Drugs Rules.
Investigators also reported that instead of using water from a reverse osmosis (RO) plant, tap water was directly processed at the manufacturing site.
“The firm is not following principles of GMP (good manufacturing practices) at any stage,” the report said, adding that the products were found stored under unhygienic conditions.
According to the report, the manufacturing area was found to be dirty, and the tablet section of the unit opened directly to the outside.
“Critical area of parental department is not having controlled area. It was found that multiple tablet punching machine is kept in a common area,” the report said.
Investigators found batches being manufactured with no identification, no batch records and no documentation, according to the report. Reject bottles, loose labels and printed blister rolls lay scattered across production areas, it said.
The Centre has also sought a detailed report from the Rajasthan government to establish the facts surrounding the incident, a government official said. “Further examination is underway and additional action will be taken in accordance with the findings of the investigation and applicable regulatory provisions.”
The health ministry said it is awaiting the Rajasthan government’s detailed report as the investigation continues.