Will Desi Slogan Put Patients At Risk?

Last week the union health ministry issued an advisory to state governments and public healthcare institutions to include medical devices approved by India’s drugs control authority — Central Drug Standards Control Organization (CDSCO) — into consideration for procurement and desist from insisting on US Food and Drug Administration (FDA) approvals. Although the intention behind itwas to promote the domestic industry, some fear it may lead to infiltration of inferior products into the country’s healthcare system.

The fact of the matter is that the local industry is still at a nascent stage. This means many critical products with made-in-India tags are only assembled here with imported hardware components from countries like China. With India’s regulatory mechanism as weak as it is, the latest government advisory could end up being the pass to small-time players to push their subpar products into government hospitals under a competitive price tag.

The reason why hospitals and other healthcare institutions in the public sector insist on USFDA certification, one of the highest quality standards globally, is because the market here is predominantly import-dependent. And it is so because the Indian medical devices industry — with only a very few organised players — mostly makes low-end products.

The government advisory, however, was met with great enthusiasm from the local industry, which has been asking for a level-playing field against imported medical devices. They say it is needed to usher in price parity and also to encourage domestic manufacturing of medical devices.

India, which is one of the largest and the fastest growing medical devices market in Asia, currently imports at least 70 per cent of its requirements. This makes healthcare very expensive.

The government’s move to boost local manufacturing can help in cutting down the high costs by also leveraging emerging technology innovations within the country.

In India, medical devices are currently approved by using the same standards applied to drugs and pharmaceuticals as laid out in the Drugs and Cosmetics Act. But a government recommendation to delink the sector from drug regulatory standards in 2015, is again a matter of concern in the context of patient safety at this juncture.

The health ministry has stated in its advisory that the technical specifications designed by the National Health Systems Resource Centre will be used as far as possible for all procurements in future to ensure uniformity. However, the competence and reliability of this new set of standards are yet to be established.

Though the government’s move will reduce the huge import dependency and bring down the overall healthcare costs for common citizens, it may put the patients at high risk unless the overall quality and the standard of materials used in locally-made medical devices are strictly monitored and assured.