Punjab drug firm’s licence cancelled in Rajasthan maternal deaths; WHO seeks report

A cluster of unexplained maternal deaths in Rajasthan has triggered a nationwide drug safety probe. At least seven postpartum women died within two months, leading the Union Health Ministry to cancel the manufacturing licence of Jackson Laboratories Private Limited, the Amritsar-based company behind the oxytocin injection 'TOCIN', suspected to be linked with the deaths.

The licence of a distributor in Rajasthan was also scrapped by the state authorities for allegedly providing spurious oxytocin injections to government hospitals.

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The World Health Organisation (WHO) has also intervened, requesting a detailed report from the Indian government.

Testing by the Rajasthan Drug Control Department revealed the injection failed quality standards due to insufficient levels of the active Oxytocin ingredient.

Step against Jackson after joint inspections

Officials said joint inspections were carried out at Jackson Laboratories' facilities by the Central Drugs Standard Control Organisation (CDSCO) and state drug regulators in Punjab and Himachal Pradesh to see if good-manufacturing practice norms were transgressed. Based on inspection findings, the two states’ respective licensing authorities cancelled the company's manufacturing licences. It was also decided to recall its products from across the country.

The Centre, besides scrapping the pharmaceutical company’s licence, has also sought a detailed report from the Rajasthan government to establish the facts on the matter.

International focus on tragedies; WHO steps in

The cases have drawn international attention since Oxytocin is one of the most critical drugs used in maternity care across the globe. It is generally used to induce labour before childbirth and help contract the uterus after the birth in order to avoid excessive loss of blood.

Many of the women who lost their lives in Rajasthan or developed complications reportedly had severe blood loss. Any compromise in the quality of the critical medicine could seriously impact the health of mothers and their newborns.

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The Centre took the step to seek a report from Rajasthan all the more urgently since the WHO sought to know whether similar incidents took place elsewhere in the country. Officials are now looking into supply chains, records of batch distribution of the medicine, and hospital procurement systems to determine whether the issue could pose a greater threat.

According to officials, the ongoing investigation into the matter is expected to find whether the fatal cases in Rajasthan were caused by compromised drugs and whether additional action is needed to improve surveillance of drugs that are widely used in public healthcare.

Centre says WHO's move standard procedure

Sources in the health ministry said the WHO’s communication on the matter is routine under global pharmacovigilance protocols. The organisation regularly seeks information from national regulators to determine whether incidents are localised or carry cross-border implications due to possible distribution. They stressed the world health body’s request should not be seen as a finding against the product or manufacturer, but as standard procedure for assessing potential public health risks.

Of the seven women who died in Rajasthan, five perished after Caesarean section deliveries at two government hospitals in Kota between May 5 and 17, while two passed away at a hospital in Bikaner in June. Also, eight women developed severe health complications, including kidney impairment and septicemia, following C-sections at a district hospital in Jodhpur.

What steps Rajasthan took

The health department of Rajasthan initiated an investigation into the matter, halted surgeries across affected operation theatres, and tested batches of IV fluids and drugs, said a Deccan Herald report.

Preliminary findings pointed to negligence, both institutional and administrative, the report said, adding departmental actions were also initiated against concerned medical staff members at the hospitals where the cases occurred.

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Subsequently, the joint Centre-state enquiries took place.

Soon, suspected Oxytocin vials and several other irregularities were detected at the Rajasthan Medical Hall, the distributor in Kota, after an inspection. It was alleged that the company purchased more than 9,000 units of the suspected injections from Jackson Laboratories, the Deccan Herald reported.

It was found that Rajasthan Medical Hall sold more than 10,000 units from the same batch, it added. The firm was showcaused. Subsequently, joint raids took place at the Amritsar-based firm which has also been blacklisted in some other states, including Karnataka, Odisha, Tamil Nadu and also the Union Territory of Jammu and Kashmir.

Rajasthan’s drug-control authorities also cancelled the licence of Rajasthan Medical Hall this week.

Jackson Laboratories’ Managing Director Jugal Kishore said on May 27 that It has been nearly 40 years that they have been manufacturing the critical medicine, and no serious complaint had ever come forward.

Rajasthan opposition slams ruling BJP

Meanwhile, a political row also erupted over the tragic deaths. The health minister of Rajasthan, Gajendra Singh Khimser, remarked earlier in June that the critically ill pregnant women were admitted at a hospital in Bikaner, and they “did not come dancing and singing”. He told the media this after visiting some of the women in the hospital. The state is ruled by the Bharatiya Janata Party.

Former state chief minister Ashok Gehlot said the health minister should take the matter seriously and that women were afraid to go to government hospitals, which he claimed was not the case when his party was in power.

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The BJP found it difficult to defend Khimser’s remarks, with one of his state colleagues in the state government admitting that words should be chosen responsibly.

Congress state president Govind Singh Dotasara slammed the health minister, saying he was unable to manage his department. He also alleged that the investigation report pertaining to the case was not made public.

Jan Swasthya Abhiyan (People Health Movement), an NGO, urged the state government to carry out an independent and time-bound judicial inquiry into the incidents, besides filing first information reports against those responsible, the Deccan Herald report added. It also asked the government to bring comprehensive reforms.

(With agency inputs)