Medical device industry has made a strong pitch for seeking clarity on regulatory issues that should be aligned with the Make in India campaign.

Industry leaders participating in a session on the ‘Make in India’ initiative at the FICCI Heal 2015 conference held here have called upon the government to take strong measures to drive the consumption of medical devices in the country, bring clarity to regulatory policy, correct the inverted import duty structure and provide fiscal incentives to give the domestic manufacture of medical devices a strong impetus for growth and turn India into a global innovation hub for medical technology.

Convening the ‘Make in India’ and its relevance to healthcare session, Varun Khanna, managing director - BD India, said, “The ‘Make in India’ campaign must be aligned with key government initiatives to create a strong impact on public health and provide safe medical care accessible to all. Therefore, it is important for the stakeholders in the medical devices and larger healthcare ecosystem to constructively engage in a dialogue to facilitate ‘Make in India’ for the country. The government should strengthen entrepreneurship and innovation to fulfil the clinical unmet needs leading to better patient outcomes.”

The delegates were unanimous that the medical devices industry is poised to grow significantly in the coming years due to the huge unmet need, and it is no longer sustainable to continue with the current 80:20 import-export ratio. They called upon the government to focus on the key initiatives to turn India into a powerhouse of medical devices manufacturing. The recommendations included, market expansion – the current market of medical technology in India is an insignificant fraction of the global market. The government needs to facilitate access and drive consumption by increasing spending in healthcare from current 1 per cent of GDP to at least 3 per cent.

The recommendations also included regulatory clarity – the Act separating medical devices from drugs needs to quickly come into force. It should enforce risk-based classification and allow ease of clinical trials. Also, a nodal ministry has to be made responsible for end-to-end facilitation of the medical technology industry.

It also comprised fiscal incentives – to create a global supply chain and manufacturing in India, the government needs to provide fiscal advantages to investors on the lines of countries like Ireland and China.

Sunil Khurana, chairman FICCI Medical Electronics Forum & CEO, BPL Medical Technologies, also pointed out that the ‘Make in India’ campaign coupled with 100 per cent FDI in this sector will provide a huge impetus in growing the medical devices sector in India.

Import duty was another concern of the medical device industry that is posing difficulties for the manufacturers.

Probir Das, managing director, Terumo India Pvt. Ltd added, “It is very important for the government to address the issue of inverted import duties and formation of manufacturing clusters. The import of components is often more expensive in India than the import of finished goods. Zero duty or very low levels of duty on component imports will facilitate local assembly / production of medical devices.”

Ajay Pitre, co-chair of FICCI Medical Devices Forum & MD, Pitre Business Ventures Pvt. Ltd was amongst the speakers.

FICCI Heal 2015, with back to back sessions over two days from August 31 to September 1 on several key aspects of the healthcare industry, concluded with a valedictory session on ‘Disruptive Innovation and New Age Entrepreneurship in Healthcare.’ It focused on the need for creating an enabling ecosystem to address cultural, infrastructural, financial and legal issues so that constant streams of indigenous innovations are available for market application. There was a strong emphasis on establishing a supportive regulatory system which is expected to play a vital role in encouraging start-ups in the manufacture of medical devices in the country.