A day after dna brought to light how lab technicians openly flout norms and sign test reports, the state government has said it is in no position to crack down on them. The state said its hands are tied because the draft guidelines of the Maharashtra Paramedical Act, 2013, have been lying with the President of India's office for a nod since a year.
dna on March 11 reported on the malpractices prevalent in the mushrooming pathology laboratories in the city and state (Missing docs: Lab technicians put lives at risk, sign reports).
Director in-charge of the Directorate of Medical Education and Research (DMER) Dr Pravin Shingare said, "DMER has prepared a draft of the Maharashtra Paramedical Act, 2013, and sent it to the president for his signature, which is pending. Hence, the government can't take any action against these laboratories."
Last year, the medical education department had worked on the draft, which, it claims, has regulations in place that require people, who want to open a pathology lab, to acquire permission from it (the department). However, the state has not made the draft available in the public domain yet.
"If laboratories flout norms under this act, they will face action. In the new draft act, it has been specified that laboratories have to work under qualified pathologist supervision," said Shingare.
There are more than 15,000 such labs across the state, of which 1,600 operate out of Mumbai, Navi Mumbai and Thane.
Activists have expressed their disdain at the state's lackadaisical approach. They have also demanded that draft copies of the Act be made available for deliberation. They said the state has been involved in similar rule-making processes to curtail malpractices for the past 25 years but hasn't made any headway. They have written to chief minister Prithviraj Chavan, seeking expedited enforcement (of the draft act) and regulation of path labs.
"The deliberations to regulate pathology labs are being discussed since 1988. Till date, we don't have regulatory and enforcement control, licensing, penalty or upgraded rules for pathology labs. They are being run akin to grocery shops," said RPY Rao, president, Society for Awareness of Civil Rights.
In 1997, an eight-member expert committee, comprising state officials and doctors from public hospitals, headed by then Food and Drug Administration (FDA) commissioner AK Mago, had submitted a report on regulation of pathology labs across Maharashtra to the state government.
"We, at the FDA, have told the state government that pathology labs need to be regulated," said state FDA commissioner Mahesh Zagade.