Should Patient Safety Pay The Price For ‘Atmanirbhar Bharat’?

Even as the Covid-19 pandemic upended the world’s healthcare systems, India took it in its stride to fight the outbreak by taking strong measures to contain and mitigate the virus, ramping up production of Covid-19 protective gears, and expanding the health infrastructure for its citizens.

This was followed by a self-reliant promise to ensure that we are not hit by the global supply chain disruptions, for example, about 70 per cent of active pharmaceutical ingredients come from China, and many products are imported. While the move is promising at this time of uncertainty, we must not forget that the pandemic is a global crisis that will need global solutions to battle the crisis.

India not only manufactured thousands of ventilators and personal protective equipment (PPE) kits by improving its production capacity domestically but also supplied essential raw material and finished products to other countries for medicines to meet the burgeoning healthcare needs.

At the same time, India also received help in the form of PPEs and ventilators from other countries such as the US and China. We are living in times when global ties matter, now more than ever. For a country like India that made progress in its ease of doing business jumping from 140 spots in 2014 to 63rd rank in the World Bank Doing Business (DB) 2020 rankings. But the new Public Procurement Order (PPO) is a “self-contradictory” policy that may act as an obstacle in the country’s pathway to reach the top 50 in World Bank’s next DB and affect patient safety. Let us understand how.

As per the new PPO, nodal ministries and departments have the power to demand a higher proportion of local content in the products supplied by companies for their tenders. The requirement earlier was 50 per cent or more local content for Class-1 suppliers and 20 per cent to 50 per cent local content for Class-2 suppliers. Any manufacturer who is not eligible under these parameters will be debarred from participating in government tender below Rs 2,000 million. While the move will certainly promote our mission of “Make In India” and promote “Atmanirbhar Bharat” as we will be giving more preference to domestic suppliers. What the government may have overlooked is whether the country has enough local capacity to meet the healthcare needs of 1.4 billion people.

Understanding India’s import dependency

 Let us take medical devices as an example. India imports more than 85 per cent of the medical devices from other countries. In the medical devices market, exports were valued at Rs 16,300 crore ($2.1 billion) and imports three times that at Rs 43,365.9 crore ($6.2 billion) in the FY 2018-19. It is imperative to note that in 2018-19, exports of medical devices grew at the rate of 25.2 per cent and imports almost at the same rate (23.8 per cent) compared to 2017-18. India’s share in the global medical device market is a meagre 1.6 per cent. These statistics highlight how securing the lives of 1.4 billion people with state-of-art medical devices is at a nascent stage and how embracing globalisation is critical for India.

Now, until the domestic medical device market matures and can meet the potential healthcare demands, opting for the revised PPO, could deny patients access to new generation life-saving medical devices. Hence, there is a dire need for the medical technology sector to work in tandem with policymakers to come up with robust strategies and build a stable environment for global medical device companies till local production can catch up.

 With the revised PPO, why is patient safety at stake?

India has been facing hurdles in weeding out substandard medical products that have flooded the markets more so during Covid-19. When riding on “Atmanirbhar” wings, quality healthcare and patient safety have been at stake as low-quality ventilators and personal protective equipment (PPE) kits found their way into the Indian healthcare industry. Many reports emerged in the last few months that stated many ventilators and PPE kits were underperforming posing a threat to patient safety. Ventilators produced by a Rajkot-based company is an example where we witnessed how the company manipulated its software running the ventilator to display a higher level of oxygen being pumped into the lungs of the patient than it was. For PPEs, as per media reports, the Indian Medical Association (IMA) Maharashtra State President, Dr Avinash Bhondwe raised the concern regarding the sale of spurious PPE kits to the doctors. The Association of Surgeons of India blamed unauthorized PPE manufacturers in the country for selling low quality and fake PPEs at the one-third price of the kits that met the quality standards.

 At a time when we witnessed quality healthcare taking a hit to meet patient demands during the healthcare crisis, the new public procurement norm may do more harm than good. In the absence of quality medical devices in hospitals, patients will bear the brunt which also highlights the challenge of access to quality healthcare faced by Indians. Moreover, India’s dependency on other countries for medical devices indicates that there is a dire need to build local capacity and address the infrastructural gaps to ensure quality care for all.

India reported a 23.9 per cent of GDP fall in its first-quarter that indicates all output and incomes of several sectors, such as public and private institutions in India are falling. Considering this, the government must implement policies that are driven by the healthcare needs of the public rather than emotional rhetoric such as making India “Atmanirbhar” overnight. Moreover, what can make innovative medical devices inaccessible in government hospitals and government-supported schemes is a clause in the PPO that states, the local content with no examination and review required on the production and financial capacity of the domestic manufacturer. Therefore, there is a dire need for policymakers to introspect and revisit the amendments in PPO from a patient’s perspective. All the stakeholders need to join hands and work towards building a healthcare system where quality healthcare is accessible to all patients.

(The author is a chairperson, Indian Academy of Public Health, Indian Alliance of Patients Group & Member, Governing Board, National Institute of Health & Family Welfare, Ministry of Health & Family Welfare.) (Views expressed are personal.)