HC Seeks Clarity on Action Against Illegal Pathology Labs
A division bench comprising Justices Anil Kilor and Rajnish Vyas directed state govt to file a detailed affidavit within a week explaining the rules and procedure for identifying laboratories operating in violation of prescribed norms and the action that can be taken against them.
The Nagpur bench of the Bombay High Court sought clarification from the Maharashtra government regarding the regulatory framework and enforcement mechanisms for addressing illegal pathology laboratories. These laboratories, which operate without adhering to the prescribed standards, pose a significant threat to patients' health due to inaccurate diagnostic reports.
A division bench of Justices Anil Kilor and Rajnish Vyas instructed the state government to file a comprehensive affidavit within a week, outlining the rules, procedures for identifying laboratories violating norms, and the actions that can be taken against them. The court was hearing a criminal petition filed by Yavatmal-based social worker Digambar Pajgade against illegal pathology laboratories operating across Maharashtra.
Pajgade alleged that thousands of pathology laboratories are operated by technicians holding DMLT or CMLT qualifications instead of MBBS doctors or those with an MD in pathology, microbiology, or biochemistry. He contended that inaccurate diagnostic reports could directly influence treatment decisions, potentially endangering patients' lives.
The government's response to the court hearing was insufficient in providing details about the existing regulatory mechanism and enforcement actions against such laboratories, leading the court to express dissatisfaction. The bench directed the government to gather necessary information from concerned authorities and present a comprehensive affidavit.
The government informed the court that a new regulatory framework was being prepared to address illegal laboratories. Pajgade reiterated that laboratories could only legally operate in accordance with prescribed qualifications and regulatory requirements. The court highlighted the broader implications, noting that inaccurate diagnostic findings and delays in essential medicines could cause serious hardship for patients.
The bench advised the Public Health Department to ensure that the proposed regulatory framework includes adequate safeguards for patients and strengthens accountability within the diagnostic sector. The matter will be further considered after the government files its affidavit.
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