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 of National Accreditation Board for Testing and Calibration Laboratories. This is the first step towards total certification of all diagnostic and clinical research labs in the country.

The initiative is in response to a call by the Global Medical Laboratories Association seeking compulsory accreditation of Central Government Health Services (CGHS) labs.

Currently, there are one lakh pathology labs in the country and only 100 located in the metros are accredited. Over 60 laboratories have applied for NABL accreditation. There are 5,000 labs in Karnataka out of which 1,000 are in Bangalore and only ten are accredited. These are: Anand Labs, RV Diagnostics, Manipal Hospital, Samratha, SRL, Clinigene, Narayana Hrudayalaya and Elbit. St. Johns and Wockhardt Hospital labs are awaiting accreditation.

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.

"Although the labs are not accredited, it does not mean there they are not quality labs. The main reasons for not having accreditation are lack of proper directive from the government and awareness. When India is growing to become a medical tourism hub, accreditation is mandatory and labs across the country are gearing up for this,'' Prof. Thuppil Venkatesh, Lead Assessor of NABL, told Pharmabiz. He is also the empanelled assessor NABH, NABCB of QCI and faculty member of NABL ISO 15189 assessors training.

"In terms of qualified and skilled pathologists, India is on par with international standards. It is only with accreditation of labs we would be able to prove quality and competence in the pathology field", said Prof. Venkatesh.

The diagnostics labs are registered as a business centre with municipal corporation certificate. There is no certification for laboratories from any regulatory agency in India. Over 80 percent are small laboratories, which carry out routine diagnostic testing using age-old manual methods. The remaining medium and large labs use modern technology and are manned by qualified personnel.

Laboratories voluntarily opt for accreditation by NABL for several reasons such as gaining clients' confidence, to participate in clinical trials, for undertaking bioavailability studies of certain drugs, to have quality management system in place, Prof. Venkatesh said.

According to Prof. Venkatesh, who is also the professor and head, Department of Biochemistry & Biophysics, St. John's Medical College, Bangalore, around 90 trained empanelled NABL assessors undertake the assessment of the laboratories in India.
Laboratories with 100 patients a day are classified as small labs. The medium labs have up to 400 patients a day. Large labs handle more than 400 patients. The annual accreditation fee for NABL is Rs 10,000 (small), Rs 20,000(medium) and Rs 50,000 (large).