Illegal pathology labs, inaccurate diagnostic reports: Bombay HC seeks clarity on govt action framework

Nagpur: Concerned that inaccurate diagnostic reports could seriously jeopardise patient health, the Nagpur bench of the Bombay High Court recently asked the Maharashtra Government to clarify the regulatory framework and enforcement mechanisms to address illegal pathology laboratories.

The HC Division bench comprising Justices Anil Kilor and Rajnish Vyas has asked the State Government to explain the rules and procedure to identify laboratories operating in violation of prescribed norms, along with the action that can be taken against them, in a detailed affidavit within a week, TOI has reported.

These directions were issued by the High Court while considering a criminal PIL filed by a social worker based in Yavatmal against the illegal pathology laboratories operating across the State of Maharashtra.

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As per the latest media report by TOI, the petitioner submitted in the plea that the pathology laboratories are required to function under the supervision of qualified medical professionals, including MBBS doctors or those holding an MD degree in pathology, microbiology or biochemistry. Instead, thousands of laboratories across the State are being operated by technicians holding DMLT or CMLT qualifications, alleged the petitioner.

He further contended that inaccurate or unreliable diagnostic reports could directly influence treatment decisions and potentially endanger the lives of patients.

During the hearing of the matter recently, the State Government could not provide satisfactory details regarding the existing regulatory mechanism and enforcement against such laboratories. Expressing displeasure over this, the bench issued directions to the Government to obtain necessary information from the concerned authorities and place a comprehensive affidavit on record.

Meanwhile, the Government informed the Court that a new regulatory framework was being prepared to facilitate action against laboratories that were found operating illegally.

The petitioner, on the other hand, reiterated that the laboratories could be legally operated only in accordance with the prescribed qualifications and regulatory requirements.

Stressing wider implications for patients, the HC bench noted that inaccurate diagnostic findings and delays in the availability of essential medicines in adequate quantities could cause serious hardship.

Accordingly, the bench advised the Public Health Department to ensure that adequate safeguards for patients are contained in the proposed regulatory framework and accountability within the diagnostic sector is strengthened.

The matter will be heard next by the Court after an affidavit is filed by the State Government.

Medical Dialogues had earlier reported that the Maharashtra Association of Practising Pathologists and Microbiologists (MAPPM) raised serious concerns over 'ghost signature' and illegal laboratory practices and alleged that several blood investigation reports showed the names of pathologists who passed away last year.

Writing to the Maharashtra Medical Council (MMC) and the Pune district collector in February, the Maharashtra Association of Practising Pathologists and Microbiologists (MAPPM) urged the authorities to take immediate action against the laboratories involved. The association informed the Council that blood investigation reports bearing the signature of the deceased doctor were being circulated by multiple laboratories and a private hospital in Maharashtra.

Also Read: Maharashtra medical council to take action on 'ghost signature' on lab reports