How NITI Aayog will reshape India’s medical‑device manufacturing

What does NITI Aayog plan to do for medical‑device manufacturing?

NITI Aayog is planning regulatory reforms, infrastructure upgrades and financial incentives to strengthen domestic medical and dental device manufacturing and cut reliance on imports. The agency is exploring comprehensive policy interventions that target regulatory challenges, infrastructure gaps and high production costs to boost domestic manufacturing of medical and dental devices. Its consultation is expected to shape recommendations that improve India’s medical and dental device manufacturing capabilities. The discussions also aim to align industrial development with the country’s healthcare priorities. The initiative forms part of broader efforts to strengthen India’s healthcare manufacturing ecosystem and encourage greater domestic production of medical technologies.

The plan therefore combines regulatory change, better facilities and financial support to make Indian device makers more competitive and less dependent on foreign suppliers.

Why is a dedicated medical‑device law needed?

A dedicated medical‑device law is being recommended to replace the current drug‑centric framework because a separate legal framework could improve transparency and streamline approvals for device manufacturers. Only 23 categories of medical devices are presently regulated under the Drugs and Cosmetics Act, leaving most devices without clear rules. NITI Aayog has rejected the health ministry’s proposal to place devices under the Central Drugs Standard Control Organisation, arguing that the CDSCO lacks the required expertise for devices. A senior official confirmed that there is support within the government for the view that CDSCO’s expertise is in pharmacy and chemicals, not in devices. The draft Bill proposes a separate regulator for medical devices modeled on the Food Safety and Standards Authority of India, an autonomous body under the health ministry. This Bill also moves the idea of a dedicated law governing medical devices forward as a major recommendation.

How will regulatory approvals change for device makers?

These steps imply that future approval timelines could be standardized under a single regulatory framework, replacing the fragmented, lengthy process that now extends plant commissioning to four years. By aligning devices with the drug regime, the government expects clearer pathways and potentially shorter review cycles, although the exact new timelines have not been detailed yet.

What cost disadvantages do Indian manufacturers face today?

Domestic manufacturers report a cost disadvantage of roughly 10–15% compared with imported devices. This gap stems from higher capital, energy and logistics expenses, limited access to risk capital, and inadequate testing and research infrastructure, which together raise production costs.

Who is shaping the new medical‑device policy?

The consultation was chaired by NITI Aayog Vice Chairman Ashok Lahiri. It brought together officials from the ministries of Pharmaceuticals, Health, and Science & Technology as well as the Indian Council of Medical Research. Experts from IIT Delhi and IIT Mumbai also took part in the discussions. Industry participants included the Association of Indian Medical Device Industry and companies that make medical and dental devices. NITI Aayog said it held discussions with industry representatives, government officials and experts to pinpoint the sector’s major obstacles. Rajiv Nath, forum coordinator of the Association of Indian Medical Devices Industry, argued that the Ministry of Health must define a separate medical‑device law and regulator, because devices are not drugs.

What financial incentives and infrastructure upgrades are being considered?

Improved infrastructure, easier regulatory approvals and targeted financial support are seen as ways to help domestic manufacturers expand production and compete with imports. Reduced regulatory friction and better infrastructure could lift profit margins and operational efficiency for Indian medical‑equipment makers. The sector currently faces intense competition from global MNCs that already have strong supply chains and distribution networks. Investors are advised to watch future government notifications, changes to approval processes and any fiscal incentives that may be announced in upcoming quarters. The Association of Indian Medical Device Industry has asked for simpler regulatory approvals and financial assistance to enable Indian manufacturers to compete with imported products.

What timeline and next steps should companies watch?

Delays in approvals are discouraging investment and slowing the growth of domestic manufacturing capacity. Shifting regulatory norms create uncertainty, and any new legislation will need time before it shows up in company earnings. Sources said the Aayog has floated a draft Bill to regulate more than 6,000 biomedical devices. India’s medical‑device market is the fourth largest in Asia, valued at over $10 billion and expected to reach $50 billion by 2025.