Need for Integration of Various Regulatory Agencies with a Single-Window System: says Pharma Secretary

With a CAGR of close to 15%, the medical devices sector holds the highest growth potential among all the constituents of the healthcare sector ranging from pharma, hospital services etc.

Growing at an accelerated pace in pandemic times and projected to become US$ 65 billion industry by 2024, the medical devices sector offers a big opportunity for domestic players, especially engineering MSMEs to make deep inroads into global markets.

Speaking at the inaugural session of Medical Devices Expo 2021, Ms. S. Aparna, Secretary, Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers emphasized that innovation, adoption and adaptation of new technologies would be key to tap the huge opportunities in both domestic and export markets.

She noted that the medical devices industry which is growing at a CAGR of close to 15% holds the highest growth potential among all the constituents of the healthcare sector ranging from pharma, hospital services etc.

"It is important to remember that this is an interdisciplinary sector with a huge range of products covering reagents, diagnostic kits, high-end imaging equipment and therefore it is a sector that requires a very nuanced approach," said Ms. Aparna.

Other than incentives for domestic production of medical devices, the Secretary also highlighted the critical need for integration of various regulatory agencies with a single-window system and putting in place a transparent, stable, predictable and easy-to- navigate interface between investors, manufactures, exporters and the regulatory eco-system.

As India added sizable production capacity for various critical care items like PPE kits, surgical gloves, sanitizers and N95 masks it has emerged as an important destination for manufacturing healthcare engineering products and services.

"The medical device industry in India consists of large MNCs as well as small and medium enterprises (SMEs) growing at an unprecedented scale. It is poised for significant growth in the next five years," said EEPC India Chairman Mr Mahesh Desai in his inaugural remarks at Medical Devices Expo 2021.

Indian medical device market is the fourth largest in Asia after Japan, China and South Korea. It has, however, potential to overtake some of its peers in size and scale given the government support it has been receiving over the last few years.

The government initiatives to boost the sector include 100% FDI, setting up of Medtech Parks and Production Linked Incentive (PLI) scheme. The recent Medical Devices Amendment Rule 2020 is aimed at making the sector more regularized.

In the light of new opportunities in both domestic and foreign markets, EEPC India's Medical Device Expo on virtual platform seeks to link suppliers and vendors and help build a robust manufacturing eco-system.

As many as 300 foreign buyers from the healthcare sector are expected to participate in the virtual Expo which would showcase Indian products and enable direct interaction between Indian suppliers with buyers and importers from participating countries.

“Covid 19 pandemic has pushed us further on the track of strengthening our medical devices industry and India has appropriately risen up to the cause,” said Mr Arun Kumar Garodia, Vice Chairman of EEPC India.

The Indian healthcare sector has been growing at a brisk pace due to its strengthening coverage, services and increasing expenditure by public as well as private players. It remains very cost-competitive compared to its peers in Asia and Western countries.

[Source: EEPC India/25.03.2021]