Rajasthan government orders three-layer drug testing after tragedy

New Delhi: In the wake of the recent spate of maternity deaths at Kota in Rajasthan, the state is overhauling its drug procurement protocols to prevent a recurrence even as remit of the probe into the tragedy has now extended to the manufacturer of a key injectable that prevents blood loss.

In a span of 12 days - between May 5 and May 17 - five women died after childbirth at the Government Medical College and JK Lon Hospital.

A committee formed to investigate the deaths found that "medications were of standard quality except Tocin, which is oxytocin, in which the content of active pharmaceutical ingredient (API) was found to be nil," a copy of the report seen by ET showed.


The deaths have widened into a probe into a Punjab-based company, Jackson Laboratories, which manufactured the "spurious" oxytocin injections. These injections are used to stop excessive bleeding after childbirth.

Jackson Laboratories did not respond to questions sent by ET.

To prevent a recurrence, Rajasthan has now come up with a three-tier quality check for the purchase of drugs, with unit heads across departments such as the ICU and surgery made responsible for continuously verifying the quality of drugs, medicines and surgical materials in use.

Gayatri Rathore, Principal Secretary, Medical and Health and Family Welfare and Panchayati Raj (Medical and Health) Department, Rajasthan, told ET that oxytocin being ineffective "might have aggravated the condition, but the doctors treating them should have taken proper care and attention to save the patient."

She added that there were lapses on the part of the treating doctors, "and that's why we took strong action against them."

Rathore said the state has given a report to the Punjab FDA to take further action against Punjab-based Jackson. "You are purchasing oxytocin with the intent that it will play its role. But if it is not working, then there's no point. This is totally cheating or mistrust or big fraud on part of the manufacturer to provide such spurious, low-quality medicines, so that's where action has to be taken. You cannot sleep over it if you find that some medicine is not up to the standard, and still, if you don't take any action, that is not warranted," she said.

Rathore said in the present case, oxytocin was purchased at the local-hospital level, since the quantity required was small. While hospitals are supposed to follow all protocols in purchasing and ensuring the quality of medicines, the state government has constituted a committee under the Divisional Commissioner of Kota to determine whether procurement steps to ensure quality measures were followed.

"We are about to receive that report. But the thing is that when the purchases are made at the local level, they are kind of a stopgap arrangement with the regular supply. There is some shortfall, so for the regular supply, when the procurement is done centrally, detailed SOPs are followed. But now, after learning from this incident, we have tried to implement it across - even if it is for five days, for five weeks - the same protocol has to be followed by the government," she said.