Nagpur: The Nagpur bench of Bombay high court on Tuesday directed the Maharashtra govt to furnish a detailed report on action taken against illegal pathology laboratories operating across the state, raising concerns over patient safety and regulatory enforcement.
Hearing a criminal PIL filed by Yavatmal-based social activist Digambar Pajgade, a division bench comprising Justices Anil Kilor and Raj Wakode orally asked the state to disclose steps taken so far and submit a comprehensive account of previous enforcement measures. "What action was taken against such illegal laboratories?" the court asked, seeking clarity on the extent of compliance and oversight.
The petition alleged that thousands of blood testing laboratories are being run unlawfully by technicians holding Diploma in Medical Laboratory Technology (DMLT) or Certificate in Medical Laboratory Technology (CMLT), despite regulations mandating that such facilities be operated only by qualified medical professionals, including MBBS doctors and specialists in pathology, microbiology or biochemistry. The plea argues that this practice poses a direct risk to public health.
In response during earlier hearings, Suvarna Kharat, joint secretary in the state's medical education and drugs department, informed the court that regulation of such establishments falls under the Clinical Establishments (Registration and Regulation) Act, 2010, enacted by the central govt. The state submitted that while hospitals are governed under the Bombay Nursing Homes Registration Act, the oversight of pathology laboratories is aligned with the central legislation.
The court, however, sought a clearer account of enforcement on the ground, directing the state to place on record details of inspections, violations identified and actions taken against unauthorised laboratories. The plea highlighted broader concerns over regulatory fragmentation between state and central frameworks, as well as gaps in implementation that could affect diagnostic accuracy and patient care standards.
Pajgade argued the matter in person, while NS Rao represented the state govt. Deputy Solicitor General Kartik Shukul appeared for the Centre.
Box
Regulatory Gaps
Bench questions state on enforcement and regulatory action taken
Petition alleges labs run illegally by DMLT and CMLT technicians
Rules mandate labs be operated by qualified doctors and specialists
State cites Clinical Establishments Act, 2010, for regulation
Hospitals governed separately under Bombay Nursing Homes Act
Court asks for data on inspections, violations and penalties
Issue raises concerns over patient safety and diagnostic standards