The Quality Council of India (QCI) may get more powers as it aims to register all pathological laboratories in the country by this year. The move will make it compulsory for labs to register with QCI through memorandums with states.
QCI, a nodal agency for national accreditation structure for conformity assessment, was set up as an autonomous body by the ministry of commerce and industry.
As health is a state subject, QCI is signing up memorandums of understanding with state governments to issue orders, making it mandatory for laboratories to register with the nodal body.
Diagnostics is the second major contributor to the total bio-pharma revenues and accounts for about 19% of the total bio-pharma sector.
T Venkatesh, advisor to the QCI, said: “Registration will stop the mushrooming of laboratories because if they are not registered with QCI they cannot function.”
“Out of 100,000 laboratories in the country, less than 1000 are accredited. They will have to invest 10% of their turnover for accreditation,” Venkatesh said during a workshop organised by Bio-Rad Laboratories here Monday.
Path labs in most of the states are registered under the Shop and Establishments Act, and under the Clinical Establishment Act in some others. QCI has already come out with the essential standards for registration of medical testing laboratories in India.
“The standards include quality control, manpower, equipment and machinery,” he said.
Meanwhile, QCI has signed an MoU with Madhya Pradesh and will sign one with West Bengal in a few days. “States will take a decision to make registration with QCI mandatory in their own interest. All states are willing to do that,” Venkatesh said.
States are likely to give one to two years’ time to path labs for registering with QCI.