Mandatory Certificate For Indian Pathology Labs

[Guest guest]

Mandatory Certificate For Pathology Labs Coming

Sanjay Sardana

New Delhi, September 29: Clinical testing or pathology laboratories may

never be the same again. The government is considering a proposal to make it

mandatory for clinical reference laboratories to obtain the National

Accreditation Board for Calibration and Laboratory Testing (NABL)

certification before granting them licences to operate.

The mandatory NABL accreditation will result in these laboratories

conforming to, complying with and maintaining at least the most basic and

relevant quality standards. It will also result in improving the standard of

tests and reports generated by these laboratories.

The government has already sent a communication to the state medical

associations and governing bodies for the same, a top industry source told

FE.

The clinical or pathology labs are laboratories conducting day-to-day

routine as well as complicated blood and urine and other tests for patients.

Out of more than 30,000 clinical reference laboratories in India, only a

handful are NABL accredited and conform to international standards.

The government had earlier introduced Good Clinical Practices (GCP) for the

Indian clinical reference laboratories. However, the acceptance and

implementation of GCP guidelines in USA, UK and other economically more

advanced nations has been the norm for several decades now and the move by

the Indian government will go a long way in improving the standards in

India, the source added.

The industry is of the opinion that there is a serious need to ensure that

all clinical testing laboratories in the country should obtain accreditation

from NABL, complying with and maintaining at least the most basic and

relevant quality standards.

“We being one of the few NABL-accredited laboratories obviously favour the

move, but it is also expected to improve the facilities tremendously for the

patients,” SRL Ranbaxy chief executive officer, Vidur Kaushik said.

There is a feeling among the industry that it is extremely important to have

mandatory guidelines to ensure the quality of clinical research, testing,

and clinical trials, to confirm the sanctity and veracity of all the data

generated, the source added.

One of the major clinical reference laboratory testing company in India, SRL

Ranbaxy had recently written to the Union health minister, Shatrughan Sinha

asking the ministry to make the NABL accreditation mandatory for all

clinical testing laboratories.

Accuracy of the test results is important as the doctor’s diagnosis and

patient’s treatment is totally dependent on the clinical laboratory tests.

Thus, it is extremely important for the tests and all associated aspects of

the same, right from specimen collection to result delivery, to conform to

stringent quality standards.

Source: THE FINANCIAL EXPRESS

___________________

Forwarded by: Dr. E. Mohamed Rafique

E-mail: " <mohamedrafique799@...>

________________