Out of more than one lakh pathology laboratories in India, only about 80 are accredited by National Accreditation Board for Testing and Calibration of Laboratories. The main reason for this is lack of awareness amongst the entrepreneurs who are running these establishments.

The Quality Council of India (QCI), an independent body under Ministry of Science and Technology, has taken the responsibility of compulsory accreditation of pathology labs in the country as per the norms laid down by NABL. This is the first step towards total certification of all diagnostic and clinical research labs in the country.

Talking with Pharmabiz, Dr Ventkatesh Thuppil lead Assessor, NABL, said, "India's Pathology Labs need more awareness. Laboratory should have policy, that at least annual review, of its process control system. The laboratory should establish the level of the risk that they are willing to accept for reporting an erroneous patients test result. What has not happened in the last 10 years, will happen in next couple of years. More Indian labs will get NABL accreditation, in the coming months."

In most of the private labs there are unpleasant errors in the test reports. This is only because of lack of awareness and one person simultaneously playing many roles. Data management is also major problem in the small private lab.

The main reasons for medical reports to differ from lab to lab are the poor quality of equipments and unqualified staff. Unlike the blood banks, the pathology labs do not come under the purview of the state drugs control department and the Directorate of Health and Family Welfare. A serious problem with the labs is that patients are fleeced and the tests reports have errors in readings, which force them to repeat the tests at another lab.

QCI is providing the required infrastructure for the certification of medical testing laboratories all over the country. NABL is the only body recognized in India to grant accreditation to medical testing laboratories under ISO 15189 system for maintaining the quality and competence in medical testing.

However, the labs are not accredited, it does not mean that they are not quality labs. The main reasons for not having accreditation are lack of proper directive from the government and awareness. In terms of qualified and skilled pathologists, India has such professionals of international standards.