With growing alarm over the safety of medicines from contaminated cough syrups linked to child fatalities to persistent worries about counterfeit drugs Karnataka has signalled a bold regulatory shift. The state government is exploring the introduction of a third-party drug-testing model under the Quality Council of India (QCI), which would see independent agencies auditing drug-manufacturers and pharmacies. According to the plan, Karnataka could pilot this model on a voluntary basis while awaiting central regulatory amendments.

Officials note that the current regulatory framework, primarily managed by the Karnataka Drugs Control Department, faces capacity constraints. With more than 45,000 pharmacies statewide and limited staff to conduct inspections and sample testing, the state aims to off-load some responsibilities to accredited third-party bodies. “We plan to rope in QCI on a trial basis and proceed from there,” said the Health Minister.

Under this proposed system, once fully operational, manufacturers might be required to undergo periodic certification by QCI-accredited auditors perhaps every one to three years. Until the necessary change to the Drugs Rules is approved by the Centre, the inspections will initially be voluntary. Stakeholders emphasise that a credible third-party model could restore trust in India’s pharmaceutical supply chain and support safe exports.

However, the proposal has stirred debate. Associations of drug-control officers and pharmacy regulators have raised concerns over delegating core statutory functions to external agencies, citing potential repercussions for accountability, transparency and institutional capacity. Despite the criticism, the move represents a significant experiment in regulatory innovation one that may influence national drug-safety strategy if successful.