Quality of diagnostic kits to be regulated

Health ministry is planning to regulate the quality and effectiveness of test kits and tools used by diagnostic labs in the country.

The move is meant to introduce a system of quality certification and registration for such tools. Currently, very few diagnostic tools, including HIV kits, Hepatitis B and C tests, Malaria and blood group reagents, have government approvals.

Reportedly, H1N1 and Dengue are prominent among a number of other tests that use diagnostic tools which have not officially been endorsed. There are also an array of new tests that are being promoted by private diagnostic laboratories.

“There is indiscriminate use of diagnostic tools for testing the presence of communicable diseases in the private sector. The sector requires urgent attention,” said a senior health ministry official.

Officials said the health ministry has formed a 17-member expert task force to re-examine the regulation, evaluation and standardisation of diagnostic tools available in India, as a majority of the treatment decisions are based on test results.

In addition to the Department of Health, experts from Department of Biotechnology and Indian Council of Medical Research are also part of this exercise, they added.

According to industry estimates, there are over 40,000 pathology laboratories in the country serving a total of approximately 1-1.25 million patients per day. These include specialised laboratories, work facilities in hospitals and nursing homes, and small testing centres with basic facilities that forms part of a Rs 6,000 crore domestic diagnostic industry.

Diagnostics service chains like SRL, Metropolis and Dr Lal Path Labs have a market share of just below 10 per cent in India today.

Management consultancy ICRA estimates that 60-70 per cent of treatment decisions are based on test results. Increasing disease prevalence, rising consumer awareness and preference for a healthy lifestyle with preventive care are the key triggers that drive the industry growth.