India advances towards Medical Devices Self-Reliance, says DoP

He emphasized that the department is committed to supporting the industry in achieving Atmanirbhar Bharat goals.

India has made significant progress towards self-sufficiency in medical devices production, with domestic manufacturing expanding rapidly over the past five years, said Amit Agrawal, Secretary, Department of Pharmaceuticals (DoP), Ministry of Chemicals & Fertilizers.

He emphasized that the department is committed to supporting the industry in achieving Atmanirbhar Bharat goals.

Speaking at a recent healthcare gathering, Agrawal noted, “The country has taken huge steps in the last five years towards self-sufficient in medical devices production with domestic share increasing from under 10% to 30% in the last 5 years. Even for high-end products the share now stands at 20%.”

Reflecting on the growing interest from global stakeholders, Agrawal said, “We organized the 1st edition of MedTech Expo almost 2 years back. During that time, foreign participants showed tremendous interest in Class A & B non-invasive medical device products. This year thousands of foreign delegates from 30 countries participated in the expo and showed interest in Class C – advance invasive products. We are manufacturing Class-C products at 10 to 40 per cent cheaper and have huge potential to increase export of medical devices.”

Sai Ahlladini Panda, Member Secretary, National Pharmaceutical Pricing Authority under DoP, highlighted the importance of improving clinical and other forms of data related to medical devices.

He said, “Life expectancy in India is going up, so we need better and more medical devices. And, to improve the quality, we need data in both quantity and quality, whether clinical or other form of data. This is one area which needs our urgent attention and all stakeholders should work together to address this.”

Gayatri Nair, Economic Advisor, DoP, expressed confidence in government initiatives to build capacity for the sector. “Department is also supporting certain institutes for rolling out capacity-building programmes. Those programmes have just started off, both short-term courses as well as long-term courses. In a year or so, when the technically capable resources come out of those courses, they would add value to the industry and contribute further to strengthening the industry,” she added.

Aseem Sahu, Deputy Drug Controller, CDSCO, explained that the regulatory framework’s evolution reflects the sector’s growth. “Despite the challenges, the regulatory environment has evolved considerably and reflecting in the number of medical devices manufactures has grown from almost 400 to more than 4,000 now over the last 5 years,” he said.

Prof. Salah Derradji, regulator and former President of Universities and Senator, spoke about export opportunities in Algeria. “Algeria produces only 2% of its medical devices requirement and Indian medical devices manufacturers can tap the huge opportunity present in my country. Indian companies need to ramp up their marketing to create visibility, which will ensure a better regulatory harmony,” he said.

Hitendra Sahu, Director, DoP, called on regulators to improve testing standards. “With just 2% of global medical devices demand met by exports from India, we need to rise to the occasion. Regulator should raise the bar on quality, so that we can match global quality standards, thus increasing exports by many fold,” he stated.

The Department of Pharmaceuticals organized the event in association with the Ministry of Commerce and Industry, Export Promotion Council for Medical Devices (EPCMD), and the Central Drugs Standard Control Organisation (CDSCO).

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