Opinion

Modern Regulatory Framework for Patient Safety

Patient safety may be hugely compromised with exposure to obsolete technology and the absence of calibration.

By Rajiv Nath, Forum Coordinator, AiMeD

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The most important aspect of our National Medical Devices (NMD) Policy 2023 is the patient-centric approach. The policy aims to build an innovative and globally competitive industry in India, supported by world class infrastructure in alignment with PM Gati Shakti, Make in India and Atmanirbhar Bharat programmes. The goal is to become a global leader in the manufacturing and innovation of medical devices by increasing our market share in the global market from the current 1.5 per cent to 10-12 per cent in the next 25 years. This is a huge step forward considering the lack of access to homegrown medical devices noticed at the onset of COVID-19 in 2020, which had led to severe lockdowns and critical healthcare insecurity exposed. Regretfully, the government is now being misled by some administrators and India recently slid back by two steps from achieving these global ambitions.

First, by recently allowing the imports of preowned medical equipment and re-manufacturing or re-furbishing of medical imaging systems and other medical electronic equipment it will increase the risk of importing contaminated products into the country. This will negatively impact the manufacturing and innovation of medical devices in India, slow down investments in the sector, and discourage domestic manufacturers.

We must understand the motives of MNCs who want to dump their obsolete and old equipment in India, as this used equipment have no market in  their own countries. They are replacing them with new products and new technology. We should also understand why these preowned products are not allowed in China, Vietnam, Thailand, Indonesia etc.

This is an attempt to mislead Indian policymakers and derail them from PM Gati Shakti, Make in India and Atmanirbhar Bharat programmes by  allowing these substandard products in India and it confuses investors as they will not be able to compete commercially with these low-priced imports.

Should India be importing preowned equipment in the name of affordable access where clinics don’t necessarily give a discount to patients by way of age of equipment or would patients gain more long term by country seeking investments to Make in India?

Patient safety may be hugely compromised with exposure to obsolete technology and the absence of calibration and validated performance and attempts for maintenance by jugaads. This policy needs a review and rollback as it is better for India and for the consumers for the country to invest in Make in India.

Who is confusing the government?
An Industry Promotion Body called FICCI that’s permitted its medical devices division to be misused for helping
overseas manufacturers dangle carrots of affordable access to patients to befool the policymakers so that their overseas replacement market can thrive and the near obsolete equipment is dumped in India so money is made twice and to the detriment of the upcoming healthy domestic competition by way of recent investments in medical electronics devices manufacturing.

One step forward two steps back

The government is planning to table the New Bill on Drugs, Cosmetics & Devices to Parliament this monsoon  session with the intended aim of ensuring higher Patient Safety. Regretfully an opportunity to provide progressive
modern regulations bench marked to the latest best international regulations is being squandered away as it’s a  flawed Bill by a flawed process – drafted without following due democratic pre-legislative processes. It continues to
seek to regulate devices alongside drugs instead of using the opportunity to bring in a progressive modern separate law for addressing patient safety needs as in Canada, the UK, the EU, Brazil, Japan, Saudi Arabia etc. It’s even revised the definition of a manufacturer that will now allow a marketing company to be labelled and licensed as a manufacturer and proposes to legalise pseudo manufacturing for possible low quality cheaper imports that may affect patient safety. Unfortunately, the Bill discourages investments to manufacture these in  India by treating actual manufacturers as potential criminals while overseas manufacturers are not needing to go through the same rigours to demonstrate conformity.

Patients gain if there’s healthy competition between multiple domestic manufacturers. For this, investment and entrepreneurship in medical device manufacturing need to be encouraged. Those engineers and scientists who step forward to design and develop products need to do so fearlessly following defined simple regulatory pathways.

Manufacturers similarly need to be disciplined and compliant to regulatory conformity requirements and prove conformity by third-party certification or testing to accredited certification bodies and laboratories. The regulators
and QCI’s NABCB (National Accreditation Board of Certification Bodies) need to jointly supervise the performance of these Certification Bodies and laboratories to ensure a competent staff with relevant expertise is auditing manufacturers and seeking continuous improvement in quality management systems and product performance.  India needs to move away from ‘Inspector Raj’ with inspectors empowered for search and seizure for even licensed manufacturers and treat them as criminals with threats of imprisonment for even minor offences.
Laws need to be reasonable and implementable and change for a progressive aspiring nation.

Medical electronic devices which are engineering products like cars can’t 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. Users need to be trained and skilled to use medical devices safely and appropriately and have a shared responsibility. We can’t be building world-class expressways designed for a speed of over 120 km per hour and expect the public to drive at a speed limit of 60 km per hour and fine and harass the majority of them for breaking the law.

Instead, if strong discipline is inculcated, we need to aim for safer higher speed limits until we have the confidence
to trust our drivers like in Germany and possibly not even have an upper speed limit but a minimal speed limit on the expressways. 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.

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