Online : Times of India : Qality : Pathology labs come under scanner by Rucha Biju Chitrodia | TNN

Those among us who have been handed wrong reports at pathology laboratories have reason for hope. A nine-member working group has been recently set up at the behest of Dr R Chidambaram, principal scientific advisor to the Government of India, to not just recommend scientific and technological measures for countering spurious and sub-standard drugs, but also examine diagnostic centres. Thus, apart from looking for ways to check fake drugs, the committee will analyse pathology labs that do not produce adequate and correct results, and suggest ways to improve upon them.
   While the working group will not look into regulatory aspects for the critical segment, its committee's quality-monitoring agenda is welcome from consumer perspective. As Dr Chandra Gulati, Delhibased editor at the Monthly Index of Medical Specialities and a member of the committee, says a wrong report is more dangerous than a fake drug. After all, the entire line of treatment is based on right or wrong diagnosis of a medical condition.
   Another member of the committee who does not wish to be identified says the group will first study and analyse the measures adopted the world over, especially in Europe and the US. It will then consider whether some or all of them are applicable to India, with or without modification, says Gulati.
   As far as regulation is concerned, currently there is no Central, single-point regulator for the crucial diagnostic segment, considering health is a state subject. "But some states already have their clinical establishment Acts in place,'' says an official in the ministry of health and family welfare.
   Dr S B Chavan, director general of health services, Maharashtra, says individual Acts are framed on the basis of the model registration Act circulated by the Government of India. "Each state frames the rules according to its convenience under the ambit of the Act.''
   In Maharashtra, for instance, only a qualified pathologist can run a pathology lab and his assistant technicians must possess a DMLT or Diploma in Medical Laboratory Technician. But then, there is no authority that monitors this most important detail at present. An effort was made in this direction by bringing laboratories under the purview of the Bombay Nursing Home Act (Amendment) 2006. The amended Act, however, is yet to be passed.
   As Dr Milind Bhide, a Mumbai pathologist, says: "Nobody regulates pathology labs. There is no medical registration required to start one.''
   The sole Central effort towards standardisation and regulation, as mentioned earlier in these columns, was made by the National Accreditation Board for Testing & Calibration Laboratories (NABL), under the government's department of science and technology. "It complies with ISO 15189 2007 specifications, which is a worldwide standard for clinical laboratories,'' says Dr Bhide. The accreditation is an ongoing process and reviewed every year.
   However, so far, it is voluntary. As Bhide says, "Unfortunately, what happens is labs that are accreditated have to compete with others that aren't.''