Presence of unauthorised diagnostic labs a serious issue, says HC

Terming the presence of unauthorised pathological labs and clinics in the national capital as a "serious issue", the Delhi High Court on Wednesday asked the AAP government about the steps which can be taken to regulate them till a law is enacted to control such entities.

A bench of Chief Justice Rajendra Menon and Justice V K Rao directed the Delhi government to inspect the labs and clinics and find out who is running them and under which law they were being set up.

The court said that after the inspection, the government should file an affidavit indicating steps that can be taken to regulate these entities till the legislature frames a law for the purpose.

"It is a serious issue. Till the legislature brings a law, what steps can be taken to regulate such activity," it said and listed the matter for further hearing on November 30.

The court gave the government six weeks to indicate the status regarding finalisation of the law which is being formulated to regulate pathological and diagnostic labs as well as clinics.

The direction came after the Delhi government, represented by its additional standing counsel Sanjoy Ghose, said the law was under formulation and views of stakeholders was awaited.

The court was hearing a public interest litigation (PIL) filed by Bejon Kumar Misra, a social activist, which has alleged that the unauthorised labs and diagnostic centres were being managed by unqualified technicians.

It has sought formulation of a policy to regulate the setting up and running of such entities.

The plea has also sought that as an alternative, guidelines be framed for implementation of the Clinical Establishment Act (Registration Regulation Act, 2010) to deal with the entire issue.

Misra has alleged that the unqualified lab technicians were not only conducting various tests, but were also providing inferences based on unscientific and unqualified outcomes, which undermine the health and safety of people.

The plea has said that a small error in the diagnosis would lead to threat of life and irrational treatment to patients.

"Now such illegal labs continue to mushroom in and around Delhi NCT and it can be easily estimated that the total number of such illegal pathological and diagnostic labs can be anywhere between 20,000 to 25,000, and every street in the capital has such illegal pathological labs," the petition has claimed.

It alleged that the Delhi government has no proper mechanism or strategy to stop the mushrooming of such illegal labs.

"The National Accreditation Board for Testing and Calibration Laboratories (NABL) under the Quality Council of India (QCI) is optional and not mandatory before opening of a pathological or diagnostic lab in Delhi," the petition added.