Plans to regulate medical devices in India get underway

According an article by Reuters, plans have been made to set up a regulator in India that will oversee the country’s $4 billion medical device industry.

A draft policy was published by the central Department of Pharmaceuticals recently stating this is the country’s first effort to regulate an industry that covers everything from thermometers to prostheses.

The policy document outlines the plans to boost local manufacturing reducing the reliance on imports and was welcomed by many in the industry despite concerns over a lack of detail.

Although India is one of the world’s largest pharmaceutical market, its share of the medical devices market is way behind as more than 70 percent of medical equipment sold in the country gets imported, predominantly from the Unites States.

The draft policy issued proposes price controls for some medical devices including surgical instruments, implants and diagnostic equipment.

The overall policy was welcomed by many industry groups, though local makers pressed the government to do more to discourage imports.

Representing most local firms, Rajiv Nath of the Association of Indian Medical Device Industry (AIMED) said: “It's like we are importing Audis and Mercedes for our big hospitals, when the consumer needs Maruti Suzukis and Tata Nanos as well.”

Most medical device makers in India are small and medium-cap firms, making basic, often disposable, equipment and it fall to multinationals like Johnson & Johnson, Philips and Becton Dickinson & Co to provide high-end devices.

Johnson & Johnson and Becton Dickinson already have manufacturing plants in the country, while Philips, General Electric and Siemens AG are ramping-up their India operations.

According to the article by Reuters, the country is still years away from making any meaningful reduction in the percentage of its medical device imports, because newer technologies continue to be launched overseas.

Analysts believe the Indian medical devices market could touch $50 billion by 2025, driven by a burgeoning middle class in need of more and better hospitals and clinics, which would require more medical devices.

The government has taken some steps this year to realise that potential and in January, it allowed 100 percent foreign direct investment into the sector and the government also plans to set up medical device industrial parks in the states of Gujarat and Tamil Nadu.