Association of Practicing Pathologists of India (APPI), the premier association of pathologists in the country, has again strongly urged the state and the Central Governments to expedite the formation of a regulatory body along with introduction of a mandatory guideline for registration of pathological laboratories.

Though APPI and similar organizations have been making this plea to the States and the Centre for sometime now, no action has been initiated by the authorities so far. Currently, since there is no special qualification criteria laid out for an individual to set up and run a pathological lab in the country, the APPI wanted the government to weed out the quakes and unqualified from the field.

In order to achieve an improvised and reliable pathological laboratory services in the country, the association has asked the government to ascertain adequate qualification required for a person to operate pathology labs, guidelines indicating the basic infrastructure and human resources in a lab and above all, an authority to issue license, monitor and control the activities of the lab, said Dr. Sushil Shah, president, APPI.

Although universities in the country offer a Diploma in Medical Laboratory Technology, a one-year course after BSc Microbiology, government has not made it a mandatory qualification to run a pathology lab.

"Today one can start a pathology lab with a shop establishment license issued by the municipality. Since there are no regulatory guidelines, there is no pressure from any inspection committee to see whether you are adequately meeting all the requisites to run a pathology lab," exclaimed Vidur Kaushik, CEO, SRL Ranbaxy Ltd.

In their proposals to the governments, the private associations have requested for an MD in Pathology or a Diploma in clinical pathology after MBBS to be the ideal qualification required for starting a pathology lab.

According to Shah, the Delhi Government for some years was considering over framing guidelines for private pathology labs. However nothing concrete has emerged so far, he said. The same has been the issue with Maharashtra Government.

APPI sources said, a major reason why the government has not acted on the matter is the fact that it could affect the non-qualified players. "Only about 5-10 per cent of the total number of private pathology labs in the country are run by individuals with ideal qualification. In Maharashtra itself, out of 5,000 private path labs, only 500 would be run by post-graduates in pathology. If a qualification is made mandatory, the rest of the path labs will have to shut their shops," said Dr. Shah.

"The government would also be apprehensive of the fact that an adequately qualified lab owner will hesitate to set up labs in rural areas," said Dr. Ajit Pendharkar, secretary, APPI.
APPI is worried about the quality of the tests done by non-qualified lab owners, the processes adopted and the reagents used in these labs. "Quite often the tests done inside these labs are by improper methods. There is no guarantee that the tests conducted in such labs will give right results," said sources.

There are about 40, 000 pathology labs estimated in the country, of these only about 7,000 labs are estimated to have run by those having a postgraduate degree or diploma in pathology. The rest of the labs is said to be run without proper qualification.