Are there any incentives?

The primary aim of recent policy frameworks has been to promote R&D in the country.

• Department of Pharmaceutical’s recently launched Draft R&D and Innovation Policy (2021) promotes interdisciplinary collaborations to develop translational skills and startup ecosystem. The draft policy also focuses on strengthening regulatory framework, incentivizing investments, and creating a facilitatory ecosystem for innovation. • The approach paper to draft National Medical Devices Policy 2022 focuses on strong collaborations for developing accessible, affordable, and sustainable innovations in the medical devices sector. • Also, under the New drugs and Clinical trials rules 2019, fast-track regulatory approvals are granted. This significantly brings down the cost of clinical trials in India as compared to developed countries.

Apart from the above policy frameworks, the Government of India has initiated multiple reforms to further streamline investment opportunities in India, thus, increasing the ease of doing business.

• National Single Window System: It is a digital platform that facilitates the application of ~500 regulatory approvals and services across 32 central government ministries and departments, including 14 states and union territories of India. • Bonded Warehouse and Manufacturing Facilities: It allows for greater competitiveness in the export market by allowing for zero-rated import of inputs when the final goods are earmarked for export. • Reducing compliance burdens: In the recent years, more than 22,000 compliance have been reduced with ~13,000 compliances simplified.

Are there any incentives?

The Government of India provides several incentives for the promotion of manufacturing in India. Similarly, various specific or customised incentives are also rolled out by state governments. The manufacturers of pharmaceutical goods registered in India can avail benefits of the following schemes:

1. Production-linked incentive (PLI) scheme

• PLI includes US$ 1 billion incentive linked to sales to augment the manufacturing of key starting materials (KSMs), drug intermediates (DIs), and active pharmaceutical ingredients (APIs). • It also includes US$ 2 billion incentives for the manufacturing of biopharmaceuticals, complex generics, orphan drugs, cell and gene therapies, and phytopharmaceuticals. These incentives have been implemented to further increase manufacturing capabilities of India.