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No clear law yet to act against illegal pathology labs: Health minister
He informed the House that the government is preparing a new law to regulate pathology laboratories in the state. The proposed framework will involve consultations with people’s representatives, medical experts and other stakeholders before finalising the legislation.
Pune: After legislators voiced concern in the Maharashtra Legislative Council on Wednesday that a proposed law to regulate diagnostic laboratories in the state has remained only in discussion for several years despite repeated reminders about illegal and bogus pathology laboratories operating across Maharashtra, health minister Prakash Abitkar told the House that action against such diagnostic laboratories cannot currently be taken under the existing Act due to a lack of clarity in its provisions.
Raising the issue in the House, MLC Manisha Kayande questioned whether technicians running pathology laboratories without qualified pathologists could be booked under the Maharashtra Medical Practitioners Act, 1961, given the absence of a specific regulatory law for diagnostic labs.
Kayande pointed out that discussions about amending the law or introducing new legislation have been ongoing for the past four to five years, but no concrete action has been taken. She alleged that “vested interests” could be delaying the process while illegal laboratories continue to function.
She also highlighted instances where pathologists from Telangana were found signing patients’ reports or even lab reports signed by deceased pathologists. “Several laboratories are allegedly issuing diagnostic reports with fake signatures or without authorisation, which could lead to serious consequences for patients. Such cases should be treated as offences under the MMP Act. Strict action should be taken against bogus doctors and laboratories issuing reports without qualified specialists,” she said.
Responding to the query, Maharashtra health minister Prakash Abitkar said that action against such laboratories cannot currently be taken under the existing Act due to a lack of clarity in its provisions regarding diagnostic laboratories.
He informed the House that the government is preparing a new law to regulate pathology laboratories in the state. The proposed framework will involve consultations with people’s representatives, medical experts and other stakeholders before finalising the legislation.
At present, the provisions of the 1961 Act are implemented through the Directorate of Medical Education and Research and the public health department, but the Act does not clearly define the regulation and monitoring of pathology laboratories, the minister said.
According to the government, the proposed regulatory framework is likely to mandate that only MD-qualified pathologists can sign diagnostic reports to ensure the final diagnosis is verified by a qualified specialist. However, officials acknowledged that technicians with BSc or DMLT qualifications may be allowed to conduct preliminary laboratory tests.
The minister also noted that the shortage of MD pathologists in the state poses a challenge in implementing stricter regulations. Abitkar told the House that a meeting with stakeholders will be held next week to discuss the regulatory framework and that the government intends to introduce a bill during the ongoing Assembly session.
However, MLC Vikram Kale criticised the government for repeating similar assurances over the past six years without bringing a concrete law. He said that the pathology tests are also available at the village level, but there are no rules for unregulated laboratories. Kale urged the government to hold an urgent meeting and create a law to bring clarity and strengthen oversight of pathology laboratories across the state.
