India is putting the finishing touches on a new policy to regulate the medical devices industry, while the players belonging to the country’s up and coming sector are pinning their hopes on the initiative.

The long-awaited policy will effectively draw a line between medical devices and pharmaceuticals, both of which are being governed by the same set of rules in India. As of now, devices are considered pharmaceutical products for regulatory purposes, often resulting in much confusion.

Largely dependent on imports, India’s medical devices industry relies on overseas markets for more than two-thirds of equipment required for domestic use. The new policy, which highlights strengthening desi production as its stated objective, is expected to give impetus to local manufacturing and cut back imports.

The draft of National Medical Devices Policy-2015, released in June for industry review, proposes an independent authority to integrate the various activities pertaining to the production standards, safety and promotion of medical devices.

The National Medical Devices Authority (NMDA), providing a single window mechanism to the industry, will create benchmarks per international best practices. The proposed central agency will be responsible for facilitating growth of the sector by removing unjustified technical barriers to trade imposed by new regulations. NMDA is also intended to support and prepare indigenous businesses to face competition, access foreign markets and find new business partners abroad.

Dealing with Deficits
Made public by the department of pharmaceuticals under the ministry of Chemicals & Fertilizers, the policy draft lays emphasis on building the required skill sets for the technology intensive medical devices sector, which is driven by innovation.

To identify skill gaps a new Skill Development Committee will be set up under NMDA, which will also devise curriculum and impart training for personnel.

Presently, India’s $4 billion medical device industry is comprised of 800 manufacturers belonging to small to medium cap firms, producing mostly disposables/medical supplies. The high-end equipment business is controlled by multinationals such as Johnson & Johnson, Becton Dickinson, Philips, General Electric and Seimens. Among these, J&J and BD have their own manufacturing plants in India.

Studies predict that the Indian medical devices market could witness more than ten-fold growth over the next ten years due to the increasing requirement for better healthcare facilities across the country.

Tighter regulations would help gain acceptance for made-in-India medical equipment in the global marketplace, which is worth over $220 billion, as per figures given in the policy document.

Reports said the western Indian state of Gujarat will soon have a lab facility to check biocompatibility of medical devices. This is in line with the policy proposal to establish testing centers in public-private partnership for evaluation of devices. Whereas, designated Centers of Excellence will support their validation and certification. For post-marketing surveillance of medical devices, the health ministry launched the Materiovigilance Program of India in July.

Clarity Needed?
Besides forming new regulatory legislation, the government is considering various tax incentives to bolster India’s medical technology sector, senior officials from the chemicals ministry revealed. Giving preference for equipment manufactured locally and by Indian companies.

India is also putting forth efforts to make the industry an attractive destination for global investors, allowing 100% foreign direct investment to the medical device sector in January.

The creation of a strong manufacturing base could lure international players looking to cut production costs. Meanwhile, industry bodies called for more clarity in regulations, especially in the clause delineating medical devices from drugs. They urged the government to focus on initiatives to make India a hub for medical devices. The industry recommended easing of trial laws so that clinical studies on devices can be conducted unhindered.

A similar rationalization of current structure of levies imposed on imported devices would also go a long way in facilitating local assembly and production of devices. The import of device components to India is often more expensive than the import of finished goods, they argue.

Even though the industry generally welcomes the policy, some sections are cautious about the proposal in the document to have a separate price control mechanism for identified medical devices to ensure their affordability. They fear such regulations could create IP conflicts.