Interview: Why India urgently needs a new regulatory framework for medical devices

When the Covid-19 pandemic struck India in March 2020, it exposed several weak spots in the country’s health care system. There were shortages of oxygen and key drugs. Also in short supply was medical equipment such as oxygen ventilators, which are essential for critical patients.

One reason for the shortage of equipment is the lack of transparency in the procurement procedure, said KL Sharma, the former joint secretary in the Ministry of Health and Family Welfare, and author of a new book titled Healing the Pharmacy of the World – An Inside Story of Medical Products Manufacturing and Regulation in India.

“It has been alleged that in many cases, the manufacturers of ventilators were asked to bring the ventilators for testing in Nirman Bhawan [the Delhi offices of the Ministry for Health and Family Welfare], a building which is ill-equipped for such testing,” he said in an interview with Scroll.in.

He also described the state of regulation of medical devices in India, the need to strengthen existing laws, and made suggestions for how the government could work to ensure that future pandemics do not create drug shortages and black marketing.

Excerpts from the interview.

Covid-19 has put the spotlight on the issue of demand, supply and most importantly the cost of medicines, especially experimental ones. This will certainly not be the last pandemic. What do you suggest the government should do to ensure that black marketing is curbed, that access to information about medicines is credible?

The Covid-19 pandemic brought out the best and the worst in the human beings. In India, the pandemic took the entire healthcare sector and the governments, both Central and state, by surprise. The second wave of the pandemic in April-May 2021 has impacted almost every family, with a large number of mortalities especially in the metropolitan cities including Delhi.

The pandemic also created major shortages of critical components such as medicines, oxygen, intensive care facilities, ventilators and personal protection equipment for caregivers both at home and in healthcare facilities. The crisis that India faced during the pandemic especially in terms of the non-availability of ventilators can, to a large extent, be traced to non-transparent procedures adopted for their procurement.

It has been alleged that in many cases, the manufacturers of ventilators were asked to bring the ventilators for testing in Nirman Bhawan, a building which is ill-equipped for such testing. Good quality ventilators manufactured by Indian start-ups were in the process rejected.

Handling a crisis of such ferocity and magnitude will continue to be a challenge even in future. Several steps could be taken for mitigating the disastrous consequences.

One, enforce laying down standards for different kinds of medical devices/equipment without any further delay and take steps for immediate regulation of all devices. Two, build smaller and dispersed healthcare facilities and also make effective arrangements for isolation/quarantine of those who are suffering from infection.

Three, scale up the domestic capacity to manufacture good quality medical devices/equipment. Four, refine procurement processes, make them transparent and make all equipment meeting the requirements eligible for procurement. Five, develop indigenous facilities for process and product certification for removing the excessive reliance on the US Food and Drug Administration or CE certification [signifying that products sold in the European Economic Area have been assessed to meet high safety, health, and environmental protection requirements] which entails avoidable expenditure for domestic manufacturers.

Six, prohibit certification by bodies that are not certified/accredited by authorities concerned either in India or any other country that has rigorous certifications bodies. Lastly, in case of medicines, augment the manufacturing capacity and ensure conformance with quality.

A wide range of medical devices are still not in the notified list of devices. Why did it take India so long to regularise medical devices?

In the absence of a separate legislative framework, either a separate law or distinct provisions within the same law for regulating medical devices, these continue to be regulated as drugs in India under the Drugs and Cosmetics Act, 1940. The Drugs and Cosmetics Act had been enacted in accordance with the provisions of the Government of India Act, 1935.

The usage of the medical devices and their complexity at that point of time were nowhere closer to what it is today. Therefore, the act does not appropriately reflect the current constitutional provisions and, secondly, it ignores the major scientific breakthroughs that have taken place with the intersection of physiology, engineering, chemistry, artificial intelligence and machine learning.

Over, last eight decades, no serious effort has been made to amend the law to make it contemporary. Today, medical devices that include equipment are an integral and essential component of the treatment regimens and even the simplest healthcare procedure calls for use of one or more medical devices.

Medical devices and drugs are essentially distinct, with the former belonging largely to an engineering field. Their regulation calls for separate and specific provisions. Efforts to bring the medical devices under regulation have been made by amending the Drugs and Cosmetics Rules from time to time. It was only in January 2017, that the Medical Devices Rules, 2017, were framed for the first time. Since rules have to be in conformity with the principal legislation, it has only partially improved the position. Further, the international norms have been revised thereafter and in some cases, Bureau of Indian Standards norms are not in conformity with Indian Standards Organisation/International Electrotechnical Commission requirements.

The non-existence of a suitable framework to regulate medical devices is admittedly the failure of the existing governance structures to respond effectively to the changed environment in which medical devices/med tech plays a crucial role in every aspect of healthcare. It is a sad commentary on the state of affairs that despite the problems arising due to non-regulation of medical devices being in the knowledge of all authorities concerned, nothing concrete had been done to stop the rot.

The main reason for this is the lack of accountability of the structures and their capacity to usher in the required changes. This also reflects the absence of the will and commitment to reforms both at the level of the political executive and the higher echelons of bureaucracy.

It also reflects that the governmental structures are not equipped in terms of appropriately qualified human resources to steer the sector.

What is your view on the new regulation on medical devices?

No medical product, either medical devices or medicines, should enter the market without proper certification or product approval. India needs to urgently take steps to regulate all medical devices and the sooner it is done, the better it would be. The dangers of using unapproved medical devices manufactured in unregulated premises could have devastating consequences for users.

Pending enactment of the parliamentary legislation, the regulation under Medical Devices Rules, 2017, and the voluntary certification in accordance with Indian Certification for Medical Devices and Indian Certification for Medical Devices Plus should be taken up without any further delay. This will provide the industry the opportunity to expand their business and move beyond Indian territory.

You wrote in your book that the return on investment is important for the pharmaceutical and medical device industry. But the pandemic highlighted an important issue– of how industries can over-price if price capping is not introduced. Take for instance masks, PPE kits etc. How can a correct balance be struck to maintain industry profits and affordability for patients?

Sufficient circumstantial evidence exists to corroborate that prices of some of the medical products are often unfair. In 2015-2016, when the issue of exorbitant prices of imported stents was being examined, the Original Equipment Manufacturers [which make systems or components that are used in another company’s end product] and their partners/franchises/offices in India had been representing that they would be forced to withdraw high-end stents from the Indian market as it would be cost-prohibitive to continue to market such products here.

However, when the government included stents in the National List of Essential Medicines and followed it by fixing the Maximum Retail Price for stents, the withdrawal of the products from the Indian market did not take place to the best of my knowledge.

I am convinced that the prices of many medical products exceed affordability and the value for money. There is also no doubt that in a lot of cases, the manufacturers and, in many others, the distribution channels use the loopholes to maximise profits. This is particularly so when the demand outstrips the supply.

In a Covid-like situation, even artificial shortages were created to exploit vulnerable consumers. The desperate battle to save Covid-19 patients who could not be accommodated in hospitals during the second Covid wave in 2021 in India was disheartening as many essential products such as ventilators, oximeters, oxygen cylinders, Remdesivir and Tocilizumab, etc. were in short supply and being sold at many times their prices in the black market.

Emergency situations require solutions that are different from the solutions that will work in the normal circumstance. The question of black-marketing in such situations has to be dealt with by the local state administration. In times of crisis, the governments have to prevent unfair pricing and barriers to access and other distortions.

Business is also not about losing money and it certainly cannot be all philanthropy. Businesses have to earn reasonable profit not only to sustain their current level of operations, but also to expand the business and more than that to also invest in research and development. However, the moot point remains that the ways and means of building and sustaining spare capacity that could be scaled up and operationalised quickly to deal with emergency situations need to be evolved.

If businesses start doing that on their own, the prices of products will either go up at least in the short run or they will incur incessant losses forcing them to eject mid-course. Government support becomes essential to deal with such emergent situations. The excessive dependence on imports to meet the domestic demand is fraught with the danger that we might not be able to get the product when we need it the most.

It could be tempting to blame industry for all price distortions; however, the issues involved are much more complex. Excessive controls on price front are also counter-productive. It could have consequences that are lethal in terms of compromises on the quality of Active Pharmaceutical Ingredients [the part of any drug that produces the intended effects] or short cuts such as non-adherence with meeting the stability and bioequivalence requirements.

As a cost-cutting measure, in most cases, in India, the manufacturers have stopped enclosing pamphlets that disseminated product-related information and made the print on the label of the medicines too fine to read.

If necessary reforms take place and manufacturers who follow all prescribed processes in letter and spirit and adhere to the Quality Management Systems/Good Manufacturing Practices/Good Laboratory Practices are not forced to compete with those who follow no norms, the market forces will ensure both fair price to the consumers and reasonable profits for the industry. It would be a win-win situation.

However, we are far from that ideal situation and, therefore, for the time being, it would be desirable if the National Pharmaceutical Pricing Authority could come up with a more realistic methodology for fixing the prices of the medical products that does not force the manufacturers to compromise on quality of the product or cut down on dissemination of information.

India is a major exporter of generic drugs, but it lags in research and development. Is there lack of investment or lack of risk-taking?

First of all, it needs to be understood that India has never been in the forefront of drug discovery and development. To be very frank, notwithstanding our claims to the contrary, the ecosystem for research even in basic sciences has not been fostered in India and the translational part that takes basic scientific discoveries from laboratory to patient is still not in existence.

Scientific institutions still continue to work in silos and the wheel continues to be invented many times over. Research and development activities have largely been restricted to public sector. Most of them have not performed well and exhibit excessive bureaucracy. Clinical research and clinical trials involve a rigorous approach on the basis of scientific, statistical, ethical and legal considerations. However, there are question marks on ensuring the availability of quality scientific and technical manpower and the educational institutions, barring a few honourable exceptions, have been more of a drag on the resources.

To top it all, barriers such as the delay in according approvals and excessive restrictions on the use of animals for clinical research force the industry to shift the minuscule research activities that it undertakes at present to foreign universities or establishments.

The absence of the ecosystem for research and development has led the Indian pharmaceutical industry to look for areas that yield quick returns and requires lesser investment. Manufacturing generic medicines fits this prescription very well. However, this is not without its share of problems and there are plenty of complaints about the made in India generic medicines not being efficacious.

In view of the fact that there have been serious concerns about the quality of medicines manufactured in India, even for retaining the leadership in generic medicines, the concerns expressed will need to be addressed at the earliest possible.

There is strong evidence to suggest that the medicines that had undergone proper clinical trials as per the prescribed processes, had been proved to be efficacious on a sample that is representative of the population and have been manufactured, transported, stored and dispensed/administered by following the prescribed protocols, are most likely to be beneficial to patients.

In a nutshell, the absence of the required ecosystem that nurtures research and development and innovation, the lack of necessary human resources with specialisation in different streams, working in silos, scarcity of funding and uncertainty about the outcomes and risk aversion, all contribute to the missing research and development culture in India.

This capacity can only be built up over a period of time with a clear system of incentives and disincentives. In the interregnum, India should concentrate on doing most efficiently what we are best capable of and showcase that India is a country that will not compromise on quality.

What is your opinion about Indian certification standards for medical devices? There is always a concern that our quality standards are not at par with those of western countries.

At the outset, it needs to be appreciated that the measurement of quality without specifying standards is not possible and the standards are meaningless without the authority to enforce them. The defects in medical devices or their non-conformance with the specified standards can expose patients to serious risks including injury, sickness and death. Deviations from expectations and claims could threaten patients’ health and increase their pain, discomfort and suffering.

Medical devices continue to be regulated only partially in India and even after they came under regulation as per Medical Devices Rules, 2017, the quality management system adopted is the one that was prevalent in 2003 and not the latest one. Therefore, even after 2023, it will not be possible for Indian industry to be ready for catering to the global markets.

The Indian Certification for Medical Devices and Indian Certification for Medical Devices Plus are voluntary certification schemes that are designed to support the regulators with functional quality assurance and product certification system...Pending complete regulation of medical devices by the Central Drugs Standard Control Organisation, ICMED 13485 Plus provides a mechanism for the Indian industry to demonstrate compliance with a number of product standards – [such as those set by the ] American Society for Testing and Materials or EN [“European Norm”] or Indian Standards Organisation or the International Electrotechnical Commission.

It also prepares Indian industry to enter the global market. Many regulatory bodies ask for reduced regulatory oversight from those that have voluntary certification. The US, Health Canada, Brazil, Australia, Japan and even the World Health Organisation waive on-site factory audits of manufacturers who are certified voluntarily.

Eventually in India also, we will need to develop the non-governmental structures to fill the regulatory gaps. This is important as currently in case of international certification, the genuineness and authenticity of the certificates cannot be verified easily. An Indian Certification for Medical Devices Plus certification can help them to make an informed choice.

Currently, an Indian manufacturer selling products in India has no mechanism to demonstrate conformance to standards. At the same time, it is necessary that the Indian Certification for Medical Devices scheme becomes inclusive and is fully in conformity with the best international guidelines. Indian authorities should not push the domestic manufacturers to shell out a lot of money for acquiring European or American certification or obtaining fake certificates. A lot of work needs to be done to operationalise Indian Certification for Medical Devices schemes as a large chunk of the Indian industry is still not ready to embrace any regulation.

This reporting was supported by a grant from the Thakur Family Foundation. Thakur Family Foundation has not exercised any editorial control over the contents of this article.