Streamlining regulations for a vibrant medical devices industry

The potential of Indian medical devices industry is immense. With the implementation of enabling measures, such as streamlining regulations, achieving self-reliance in domestic production and global competitiveness is within our reach. Currently, local firms meet only 34.6 percent of USD 12-billion Indian market demand, with imports accounting for the remaining 64.4 percent, amounting to USD 7.6 billion in FY2023.

By 2030, domestic medical devices sector could expand to USD 50 billion with a planned strategy of slashing import dependency to 35 percent, while simultaneously bolstering exports to USD 18 billion. This transition can potentially generate 1.5 million new jobs, further fuelling economic growth and innovation in the sector. But are we really prepared to make the most out of Indian medical devices industry?

By simplifying and rationalizing regulatory processes, the industry can experience enhanced efficiency, reduced bureaucratic hurdles, and users access to accelerated affordable innovation. A transparent and predictable regulatory framework not only attracts domestic investments but also encourages foreign investments, leading to technological advancements and job creation.

A good law needs to be simple, reasonable, and implementable and give direction of intent for a progressive aspiring nation. Medical electronic devices, which are an engineering product like cars, cannot be manufactured or regulated like drugs, and need to be stored, transported, installed, and maintained and regularly calibrated to ensure patient safety for the lifecycle of the product.

We cannot be building world-class expressways and expect public to drive at a speed limit of 60 km/hour, and impose fine for breaking the law or have unrealistic expectations from pharma-background inspectors (seeking biocompatibility data or clean rooms or shelf-life stability studies for every medical device). Instead, if strong appropriate regulatory discipline is inculcated as per the best international practices, we need to aim for safer higher speed limits until we have the confidence to trust our drivers.

A strong post-market surveillance is needed to monitor the medical devices marketplace to ensure the regulatory system is performing well, and when triggered by an adverse event reporting then instead of witch-hunting, systemic, preventive, and corrective actions are sought by regulators to ensure patient safety.

Esteemed members of the Parliamentary Standing Committee of Health & Family Welfare Ministry have rightly recommended a separate legislation for medical devices, instead of a combined legislation for drugs, medical devices, and cosmetics.

Unlike the present structure, the proposed national regulator should license the manufacturing of all classes of medical devices – Class A, B, C, and D – and all state regulators should be part of the national regulatory body.

The Committee also consented to the fact that with industry growing by leaps and bounds, the government should not merge regulation of medical devices with pharma. It is high time the medical devices regulations are dispensed with by qualified and well-trained medical devices officers with appropriate engineering and scientific competencies to give a fillip to the industry in India.

The Health and Family Welfare Ministry, along with compulsory compliance to quality management system as per schedule 5 of the MDR, 2017, should allow cognizance to third-party voluntary assurance schemes like Quality Council of India’s ICMED 13485 so that along with patient safety, focus can be on building global quality competitiveness.