‘Quarantine’ likely for drugs until they pass sample tests

Bengaluru: Health authorities in Karnataka plan to introduce a “quarantine” period for procured drugs until sample test reports show they are safe for distribution to government warehouses across the state. 

This is one of the several measures proposed by a sub-committee constituted in December 2024 to look into lapses in the operations of the Karnataka State Medical Supplies Corporation Limited (KSMSCL), following the Ballari maternal deaths issue that broke out in November. 

Harsh Gupta, Principal Secretary, Health and Family Welfare Department, explained that Tamil Nadu follows this “quarantining policy” to ensure drug batches that could be substandard or contain spurious samples do not go out into the market. Karnataka is looking to adopt this model to save time and costs in identifying and recalling affected batches from the market. 

Additionally, the government is also looking to empanel three labs accredited to the National Accreditation Board for Testing and Calibration Laboratories (NABL) to randomly test critical drug samples, such as IV fluids, to ensure that test reports are independently validated across labs. The government currently has just one empanelled NABL-accredited laboratory for drug testing. The department is also looking at conducting random physical inspections of the lab to ensure efficacy is not compromised at any stage of testing. 

Gupta noted that other major measures being implemented include advancing the drug indent and tendering process, clearing vendor payments early, and enhancing manpower by sanctioning additional posts to have more experts and KAS officers in the KSMSCL. 

“We have looked at a complete revision of suggested drugs after the technical committee listed 1,000 drugs for procurement. We have also moved a proposal to simplify tender conditions, awaiting the Finance Department’s approval,” Gupta said. 

This proposal would be modelled along what is followed in Tamil Nadu’s drug procurement process, where the current manufacturing capacity of the bidders are focused on, rather than past performance, to allow more bidders to participate. 

“The Tamil Nadu government goes for standard certification to save time. Officials also call all the bidders for technical evaluation and open the bids before them, which allows them to address any concerns and the bidders to respond accordingly. We want to implement these processes here,” he added. 

Ringer’s lactate issue

The Ringer’s Lactate IV solution manufactured by Paschim Banga pharmaceuticals, which was linked to the deaths of at least 18 women between April 1 and December 31, 2024, was tested multiple times after the five Ballari maternal deaths to ascertain its quality. 

A well-placed source in the health department noted that three NABL-accredited laboratories had cleared the batches, having found no issues with their quality, before an investigation revealed that they were most likely substandard.

“The department will be filing criminal cases on all three of them for their negligence,” the source said.