Federation of Indian Chambers of Commerce and Industry (FICCI) and Confederation of Indian Industry (CII) are in discussion with the Planning Commission to frame regulation for the diagnostic industry.

The regulation will help the Indian diagnostic industry to forge a path for the private labs to work with the public sector and help improve the standards of diagnostics. Talks are on with the government and there are some sectors of the government that are keen to put some regulation in place, but nothing has really moved forward yet. The government should make accreditation mandatory and not optional. We urgently need to have a body that registers and governs all laboratories, Ameera Shah, MD & CEO of Metropolis Healthcare Ltd & co-chairman for FICCI Healthcare Committee told Pharmabiz.

The Indian diagnostic industry is a fragmented industry with hundreds of thousands of labs and very little consolidation. The government has put no regulation in place that mandates even a minimum standard for laboratories, she added.

As of now, the changes are still on the discussion board. It will take time to actually to implement them. Meanwhile, the Government has passed The Clinical Establishment Act which is unfortunately, an optional act and only five states have opted to accept it. So, we are hoping that all the states will accept at least the mandate of minimum requirement of registering laboratories and putting certain standards, stated Shah.

The business model of international tests being off loaded to India under the umbrella to contract diagnostics is on the upswing. Samples from the Middle East and Sri Lanka are sent to India because many advanced tests are not available in these countries. There is economies-of-scale in terms of cost and time too. But outsourcing of tests from western countries to India is still distant, going by the lack of a formal regulation in the field, she pointed out.

The diagnostic and pharmaceutical industry in India interface in the area of conducting clinical trials which cover from phase I studies through Post Marketing Surveillance projects. Many international clinical research organizations have established offices in India directly or through affiliates to offer cost-effective solutions to their sponsors. The major central labs have invested in high-end technologies and instruments to offer esoteric testing, biomarkers, genomic testing, molecular diagnostics and DNA extraction techniques. The Central Laboratories actively contribute in drug development process by bringing these technologies at their doorstep and thus cutting back time for drug development. This is where Metropolis has expanded operations globally, either through direct presence or through alliance with global central laboratories, she stated.

The pharmaceutical industry in the country has given a boost to clinical studies done in India, as well as internationally. India is a preferred destination for clinical research because of diverse patient pool availability and sponsors would save around 30 per cent cost if they conduct studies in India. “But when it comes to Central Laboratory sponsors cannot expect a 30 percent cost saving. This is because global testing standards, internationally-accepted automated testing instruments do not come at 30 per cent reduced cost. The fixed cost of running and managing instruments are globally same. However, best possible efforts are made to keep pricing at optimum level with no compromise in quality,” pointed out Shah.