Nagpur: A regulatory gap affecting numerous pathology labs in Maharashtra was highlighted on Thursday when the state govt informed the Nagpur bench of Bombay high court that it does not have the legal authority to take action against illegal diagnostic centres in the state.
The statement was made during the hearing of a criminal public interest litigation filed by social activist Digambar Pajgade, who claimed that many pathology labs are operated by unqualified technicians, posing a significant threat to public health. The case was heard by a division bench comprising Justices Anil Kilor and Raj Wakode, which postponed the hearing to March 10.
Pajgade, appearing in person, argued that current regulations allow only qualified medical professionals, such as MBBS doctors with specialisations in pathology, microbiology, or biochemistry, to run pathology labs legally. He alleged that thousands of labs across Maharashtra are operated by technicians with only technical qualifications such as a diploma in medical laboratory technology (DMLT) or certificate in medical laboratory technology (CMLT).
In response, the state submitted an affidavit through medical education and drugs department joint secretary Dr Suvarna Kharat stating that regulating pathology labs is not within the dept jurisdiction. The affidavit noted that hospitals in Maharashtra are regulated under the Bombay Nursing Homes Registration Act, while pathology labs and other medical facilities are governed by the Clinical Establishments (Registration and Regulation) Act, 2010, a law enacted by the central govt. Since the regulation of diagnostic labs falls under central legislation, the state suggested that it does not have direct authority to enforce action against such establishments.
Acknowledging the issue, the bench requested deputy solicitor general Kartik Shukul, representing the central govt, to clarify the Centre position and explain the regulatory framework for pathology labs. NS Rao represented the state govt during the hearing.>
