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SAFETY STANDARDS: MAKING INDIA'S HEALTHCARE SECTOR SAFER AND FUTURE READY!

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Safety Standards: Making India’s Healthcare Sector Safer and Future Ready!

Jibu Mathew is Business Head of UL’s Life and Health Business Unit for South Asia and emerging markets. He has varied experience in IT consulting, regulatory advisory and market access strategy in Medical Electronics, Healthcare and High-tech industry for more than a decade. He is also an Industry representative in Bureau of Indian Standards [BIS] Committee on Medical and Hospital Standards.

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Safety is omnipresent and intrinsic to the entire healthcare delivery spectrum and the entire medical fraternity must move towards industry equilibrium. Medical devices are crucially linked to the growing demands of the healthcare chain which need a strong regulatory framework. This also means sourcing the right kind of equipment and devices from the right vendors and checking them for regulatory approval stamps from established certifying bodies.

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Introduction: India’s Beleaguered Healthcare Infrastructure

Historically, healthcare set-ups were always admired for their commitment and expertise to provide their patient with a new lease of life! From a simple fever to complex surgeries and medical miracles, people from different parts of the world have traveled to India to benefit from the quality services and a comparative cost advantage. India may be a global tourism hub, with a growth rate expected to touch an astounding $8 billion by 2020[1]. However, access to safe and quality healthcare eludes a vast majority of the population[2]. Adding further woe is the dismal expenditure for the sector.

Consider this:

• India has one bed for every 1,050 patients as compared to the US, which has one bed for every 350 patients.

• India’s ratio of 0.7 doctors and 1.5 nurses per 1,000 people is much lower than the WHO average of 2.5 doctors and nurses per 1,000 people.

• To combat this poor doctor-patient ratio, India needs to add 1.54 million doctors and 2.4 million nurses to match the global average[3].

Changing Disease Burden In India

Over the past few years, there has been a palpable transition from infectious to non-communicable diseases (NCD) in the country, owing to change in dietary patterns, economic growth and greater life expectancy. While NCDs remove the threat of immediate mortality, they call for an urgent need to ramp up healthcare technology and innovation to prevent adverse outcomes. For instance, WHO’s health profile for India (2014) points out that 53 percent of deaths in the country are on account of non-communicable diseases (NCD), with diabetes and cardiovascular diseases taking the lead[4]. One in four Indians risks dying from an NCD before they reach the age of 70, the report states. Further, diabetes is engulfing the nation at an alarming rate – 65.1 million people are suffering from the disease in the country, compared to 50.8 million in 2010. By 2030, 100 million people are expected to be diabetic[5].

India – The Healthcare Technology Paradox

To combat the paucity of traditional health infrastructure, e-health, m-health and home healthcare services brought about pioneering changes in healthcare delivery for the rural and inaccessible area[6]. With increasing corporatization and FDI inflows in private healthcare, state of the art treatment is becoming increasingly available to metros, tier 1 and tier 2 cities[7].

This brings to the front an important aspect of healthcare delivery – the use of medical devices, ranging from humble objects like gloves and syringes to complex tools like implants, ventilators and scanning technologies. The medical device sector reveals a deep-seated, but interesting paradox in India’s healthcare system – while the country boasts of being the manufacturing capital of the world for pharmaceuticals, 75% of the medical devices are imported from countries like China, with nearly 30% coming from the United States alone[8]. Most of these devices rampantly used are either substandard, un-calibrated and continue to compromise patient safety!

These revelations imply that it takes just one faulty/substandard medical device to play havoc in our lives. When we approach our healthcare provider, we blatantly overlook what goes on behind the scene – have we ever noticed what kind of medical equipment or invasive devices are being used to cure our ailment? Is it safe and hygienic and absolutely necessary for use? Does it have a regulatory stamp of approval? Is it calibrated correctly? The steep costs of importing these devices are ultimately passed on to the consumer, making access to safe and quality healthcare unaffordable.

Medical Devices Market – Current Scenario

Despite its significant growth, the medical devices industry in India is still at a very nascent stage. In terms of market size, the total medical device consumption in the country at present is to the tune of $ 5.8 billion. When corresponded with the 1.2 billion plus population, the penetration of medical devices into healthcare sector is very minimal, especially in comparison to similar economies, such as China, Korea or Japan.

However, the medical devices sector in India is specifically focused on two aspects – penetration and affordability. Keeping this in view, there is a lot of innovation, in pockets, that is contributing to the growth of this sector. This is specifically in non-communicable diseases space, where screening devices for point of care testing are being created for e.g: cardiovascular diseases, diabetes etc. The medical device industry in India is currently dominated by MNCs that manufacture and import products. There are also small and medium businesses, mainly dealing with disposables and implants and medical electronics. The third segment is that of the startup community.

Challenges In The Med Tech Industry: Inadequate And Antiquated Regulations

Despite the promising emergence of multiple startups in the med tech industry that are targeting the domestic segment, India’s regulations for medical devices are largely inadequate and antiquated. What’s more, the entire sector is loosely governed with lack of strong regulations controlling the production, import or distribution of medical equipments and devices, encouraging the inflow of substandard devices entering the Indian market and harming the consumers. While the government’s support through ‘Make in India’ campaign to help India reach the $ 50 billion devices market by 2025 has laid the platform for the growth of the med-tech sector in India, it also puts a thrust on ensuring that they follow global best practices in manufacturing them. From performance testing and usability to non-clinical testing, the devices need to pass standards tests for evaluation before medical professionals can actually use them, which call for the role of third-party testing labs to test devices and products for a minimum quality level.

Currently, the medical devices industry is faced with an ambiguous regulatory framework, wherein medical devices are treated as drugs under the Drugs and Cosmetics Act. As a result, the distinctive identity for medical devices has been absent for long. Earlier this year, a newborn and a three-month-old were severely burned after a short circuit sparked a blaze in a hospital nursery in Meerut[9]. Over the last few years, the country has been marred by such incidents, raising serious concerns about overall safety in hospitals and the safety and quality standards of medical equipments in particular in India. Sample this… Of the 700 device makers in India and more than 2000 devices sold locally, ranging from a pair of humble reading glasses and gloves to critical MRI machines and implants, only a dismal 22 of them are presently under any direct regulatory supervision by the Drug Controller General of India’s office. India has become a dumping ground for many used and refurbished medical devices which are not calibrated to work in Indian conditions[10].

Safety Compliance, Standardisation & Third Party Certification Is The Key!

India is slowly witnessing gradual change over the last 12-18 months, with a regulatory framework currently developed by the Ministry of Health & Family Welfare and CDSCO (Central Drugs Standard Control Organization). While this landmark move is definitely a welcome step to overhaul the regulatory system in the country, experts still feel that there are significant concerns to be addressed in the draft Medical Devices Rules 2016[11].

Experts believe that following the highest safety standards is the only way to achieve accurate and consistent medical care outcomes. Standards fuel innovation rather than acting as a barrier (as commonly thought), by ensuring a framework / boundaries under which devices can operate. “Can you imagine the impact if there were no standards on the performance requirement of a pacemaker”? Even though India is at the cusp of a quality revolution of sorts, we still have some catching up to do in terms of the conformity assessment framework. In a growingly complex, competitive economic landscape, the need to align people, processes and technology is stronger than ever. In order to compete globally, India needs to develop a culture of product safety and standards.

Safety is omnipresent and intrinsic to the entire healthcare delivery spectrum and the entire medical fraternity must move towards industry equilibrium. Medical devices are crucially linked to the growing demands of the healthcare chain which need a strong regulatory framework. This also means sourcing the right kind of equipment and devices from the right vendors and checking them for regulatory approval stamps from established certifying bodies. From safety, performance testing and usability to non- clinical testing, any medical device requires to be compliant to standards tests for evaluation before medical professionals can actually use them, which call for the role of third party conformity assessment bodies, testing labs to test devices and products to ensure safety and quality is maintained. What India needs is a set of gold standards in the medical devices industry while strengthening the basic device testing infrastructure.

Conclusion – Standards Not A Market Barrier, But A Quality Enhancer

For the country to be in the highest pinnacle of world standards, quality cannot be compromised. Whether it is creating a safe environment for us to live, or dream big with Smart Cities and Make in India Campaigns, our country is marching towards ambitious plans of becoming a hub for global arbitration, reviving the manufacturing sector and strengthening services sector, to name a few. For any of these to become a success, the key is the need to adopt national and international standards while creating a framework for regulations and compliance. However, India has historically struggled to develop a holistic system of standards and regulatory framework. With plenty of legislations in place to drive quality, the challenge has always been enforcement and until such time non-compliant devices continues to creep into the Healthcare delivery system, keeping end users guessing when the next patient safety disaster will happen.

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