The big players in the diagnostics sector are eagerly waiting for the enactment of Clinical Establishments (Registration and Regulation) Bill 2007, which is likely to be introduced in Parliament during the current monsoon session, as it will put an end to the unhealthy competition in the marker from the small players.

Lack of regulation in the diagnostics service sector is badly affecting the reputation of the industry and the lives of patients resulting in serious issues with the healthcare scenario in the country. While the major players are pursuing efforts to accredit their labs with the international quality standards, a large number of individual labs in the unorganised sector do not have even a single qualified lab technician to test the samples, informed sources said.

Poor quality norms and undercutting of charges by small pathology labs make the sector a no-fair play field for the laboratory services companies, comments Girish Mehta, president and chief executive officer (CEO) of Piramal Diagnostics.

The local shops can offer the services in almost half of the costs since they haven't invested for standard quality equipments and qualified persons for delivering services. "We are in hope that the clinical establishment's bill will bring in a change in this scene and there will be a level playing field for all the companies," he averred. The Mumbai-based Piramal Diagnostics currently has 104 centres across the country.

According to a report from McKinsey & Company in 2002-03, the Indian medical diagnostics industry is estimated at Rs 10,000 crore. The industry is expected to maintain an annual growth of 10 to12 per cent in next five years, informed Mehta.

The issue is not merely of competition, but also the quality of healthcare service in the country, says Dr Arvind Lal, chairman and managing director, Dr Lal Pathlabs. At least 50 per cent of the nearly 50,000 labs working in the country do not have a qualified person to conduct tests. Since healthcare is a matter coming under the state governments, there is lack of uniformity in regulations over these labs, points out Dr Lal.

"The clinical establishment regulation would wean out the laboratories run by non-qualified persons. Further, it should force the labs to comply quality standards like NABL accreditation. Quality will definitely come with cost, but it will save the lives of patients," said Dr Lal.

He said that the emphasis should be on the quality of instrumentation in each laboratory and the standard operation procedure, which will in effect bring control over calibration and other services. The Haryana-based Dr Lal's Pathlab, at present, runs 40 labs and 750 collection centres across the country.

Agreeing with the comment, Ameera Patel, executive director, Metropolis Health Services (India) Pvt Ltd, said that the industry is in hope of getting some common standards for operation to be established through the regulation.

At present only 300 to 400 laboratories are accredited with the NABL for complying standard quality in operations. However, more laboratories are in efforts to comply with the quality standards and the regulation will make sure that a majority of the labs get accredited with standards set by authorities like NABL, opines Patel. The Mumbai-based Metropolis has set 55 laboratories and also established its presence in overseas nations including Middle East, South Africa and Sri Lanka.