BENGALURU: To improve drug safety and quality control across the state’s public healthcare system, the health department issued two separate orders directing strict enforcement of protocols in complaint handling and inspection of drug and medical device suppliers.
According to an order dated May 5, the Karnataka State Medical Supplies Corporation Ltd (KSMSCL) has been instructed to issue a standard operating procedure (SOP) for all health facilities under the health department.
The SOP aims to standardise the process for addressing complaints related to the quality of medicines and consumables, even if these are cleared in ‘pre-distribution’ lab tests.
As per the SOP, the drug therapeutics committee in each health facility will be responsible for monitoring the quality of drugs and consumables. In case of adverse drug reactions or suspicion of substandard quality, the committee is authorised to initiate an alert on the e-medicine platform. If required, the hospital may locally withhold usage of the suspected batch until further verification.
Additionally, KSMSCL will ensure that no further supply of the medicine concerned or consumable takes place until the issue is resolved — either confirmed or rejected after proper examination.
In a follow-up measure, the second order issued on May 6 outlines the formation of dedicated inspection teams to assess drug manufacturing units, medical equipment producers and National Accreditation Board for Testing and Calibration Laboratories (NABL)-accredited laboratories.
The inspection teams will include subject experts such as pharmacologists, biomedical engineers, drug inspectors and senior pharmacy officers who will be tasked with checking manufacturing practices, assessing quality assurance protocols, batch-testing processes and verifying all necessary documentation.
For medical device manufacturers, the inspections will focus on the safety, functionality and accuracy of the equipment being supplied.