Health sector seeks clarity on medical device rules

Health sector seeks clarity on medical device rules
While the healthcare sector claims to be ‘satisfied’ with the move to formulate new rules regarding medical devices, industry still seeks more clarity. The rules are proposed to be internationally harmonised to attract investments, and thereby, reduce costs of devices. BPL India Chairman Ajit Nambiar said, “We welcome the initiative that will add a boost to the digital infrastructure in rural India, and also initiatives to reduce the cost of medical devices.”

Vikram Hospital CEO J Sudhir Pai said, “The Budget has been satisfactory for the healthcare sector. New rules regarding medical devices to be formulated will aid investments into the sectors, and effectively bring down cost of the devices.” “It is important that the country start designing and manufacturing medical devices that are best-in-class and follow international standards in quality and compliance. This will ensure patient safety and also make the domestic industry globally competitive,” said Suresh Sugavanam, vice president and MD, Underwriters Laboratories (South Asia).

However, noting that the announcement requires further detailing and clarity, Madurai’s Meenakshi Mission Hospital chairman Gurushankar said, “While the government’s move to reduce the cost of medical devices is positive, it is unclear how this will be achieved. I hope customs duties come down as most devices are imported.” Trivitron Healthcare CMD G S K Velu said, “We need to see if the Indian manufacturing segment will be benefited, since we are still a 70% import-dependent industry.”

“Unfortunately, the finance minister has not addressed the industry’s request for a nominal duty protection of at least 10% for all items with export of over Rs 5 crore, and at least 7.5% for rest,” he added. Stating that a ban on import of second-hand medical equipment and electronics, to ensure safety of patients, should be considered while drafting new rules, Velu said, “Just like we do not allow import of second-hand cars fearing loss of investments, the government should be more diligent when it comes to people’s health. The government should look at giving 15% preferential pricing for all Indian-origin medical devices.”

“There is a gaping hole in Budget changes pertaining to medical devices, and there is no explicit change of the current lopsided duty structure that is disincentivising local manufacturing. However, a silver lining is the increase in the overall outlay for the Ministry of Health and Family Welfare from the 2015-16 revised Budget of Rs 7,719 crore, to Rs 11,360 crore for 2017-18,” said Pushpa Vijayaraghavan, director of Sathguru Management Consultants.
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