Nagpur: The Nagpur bench of Bombay high court on Tuesday sought clarity from Maharashtra govt on the regulatory framework and enforcement mechanism for dealing with illegal pathology laboratories, observing that inaccurate diagnostic reports could seriously jeopardise patients’ health.
Pathology laboratories are required to function under the supervision of qualified medical professionals, including MBBS doctors or those holding an MD in pathology, microbiology or biochemistry, according to the petition. 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 court was hearing a criminal PIL filed by Yavatmal-based social worker Digambar Pajgade against allegedly illegal pathology laboratories operating across Maharashtra. Pajgade has alleged that thousands of laboratories across the state are instead being operated by technicians holding DMLT or CMLT qualifications. The petitioner contended that inaccurate or unreliable diagnostic reports could directly influence treatment decisions and potentially endanger patients’ lives. During the hearing, govt failed to provide satisfactory details about the existing regulatory mechanism and enforcement action against such laboratories, prompting the court to express displeasure. The bench directed govt to obtain the necessary information from the concerned authorities and place a comprehensive affidavit on record. Govt informed the court that a new regulatory framework was being prepared to facilitate action against laboratories found operating illegally. Pajgade, who appeared in person, reiterated that laboratories could be legally operated only in accordance with the prescribed qualifications and regulatory requirements. The court also stressed the wider implications for patients, noting that inaccurate diagnostic findings and delays in the availability of essential medicines in adequate quantities could cause serious hardship. The bench advised Public Health Department to ensure that the proposed regulatory framework contains adequate safeguards for patients and strengthens accountability within the diagnostic sector.
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