RE-INVIGORATING INDIAN MEDICAL DEVICES INDUSTRY

Looking at your vast and rich experience and understanding about the Indian Medical Device Sector as well as in the Government policy formulation and implementation, can you please highlight important action points to facilitate healthy growth of the Medical Device Sector in India.

In brief, the basic elements that will need to be addressed for this are:

(i) revisiting the legal and administrative architecture including enactment of suitable legislations and framing of rules that are globally harmonized and strengthening regulatory structures/institutions;

(ii) reducing the regulatory burden by establishing mechanisms outside the regulatory structures to ease compliance and take off the burden of the regulator without compromising the quality;

(iii) strengthening the internal quality control and quality assurance mechanisms in manufacturing units including rewarding them for pointing out non-conformances;

(iv) restructuring the current Production Linked Incentive Scheme and Medical Devices Parks Scheme in consultation with stakeholders not only from within the country but also with the largest global players and incentivizing the make in India by offering attractive packages to relocate to India;

(v) addressing problems with the development of human resources by substantial augmentation of educational and training facilities;

(vi) augmenting collaboration with the best R&D organizations in the developed countries;

(vii) ensuring best use of the facilities in the public sector and making them available to Industry including for handholding in specific areas;

(viii) revamping procurement process by enhancing the transparency in the processes;

(ix) enhancing domestic demand for medical devices including by subsidizing such devices that help improve the quality of life and

(x) leveraging artificial intelligence and machine learning tools for improving the decision making matrices.

Sh. K.L. Sharma is a career civil servant with four decades of experience. Having been part of the Cabinet Secretariat for around 11 years, he has a ringside view of the governance in India. He also trained the middle and senior-level government officials on writing proposals for the Cabinet and Cabinet Committee at the Lal Bahadur Shastri National Academy of Administration, Mussoorie and the Institute of Secretariat Training & Management, New Delhi. He has authored the bestselling book “Healing the Pharmacy of the World” which has a detailed chapter on medical devices. He brought about a string of reforms in the regulation of medical products during his stint as Joint Secretary in MoHFW from 2014 to 2017.