Experts ascertain that every innovation that comes in will be closely watched and scrutinised at all levels since there is enough room for more innovations to flow in these difficult times. Being frugal indeed exhibits India’s true engineering talent but this contingency needs critical thinking
By Raelene Kambli
Ever since the COVID-19 pandemic has hit India, my mailbox is flooded with at least 30-40 mails of companies per day that say they have solutions to tackle the current health crisis in our country. These solutions include sanitisation solutions, face masks, portable equipment for ICU needs, rapid testing kits for COVID-19, PPEs for healthcare providers and so on and so forth.
I worry whether all of these companies are genuine or are these just PR gimmicks?
I often ask them bluntly whether or not they have received approvals from the Indian Council of Medical Research (ICMR) and the Drugs Controller General of India (DCGI). Some companies have received approvals from ICMR but many haven’t. Many get back saying that their approvals are pending or the authorities have not got back to them.
Now, the good part of the situation is that most companies have certainly approached the authorities for the required permissions to market their products. Knowing that, currently, the authorities themselves must be flooded with thousands or even lakhs of such approvals, making it exceedingly difficult for most of the companies to get approvals.
On a brighter side though, India’s young and innovative start-up community’s response to this health crisis has been commendable. They have indeed risen to the cause, just like India’s established healthcare companies and Indian conglomerates-Mahindras, Tatas and Marico, who have extended their support to develop the much-needed infrastructure and equipment to combat COVID-19.
Moreover, most of these companies are currently focussing on low-cost equipment and testing kits which can be easily available and affordable. This is the time where most companies, as they say, have resorted to frugal or low-cost innovation to develop need-based equipment and healthcare supplies; but, to what extent?
Now, this is a question that constantly haunts me.
How much can India rely on frugal innovation to tackle this health crisis? And, what kind of innovation does India truly need at this critical point?
In recent times, we have seen various low-cost innovations coming up from different sources in India. We have seen the exceptional work is done by the Western Naval Command team of the Navy on the low-cost non-invasive portable respiratory system and IIT-Roorkee in collaboration with AIIMS, Rishikesh, who developed a low-cost portable ventilator – ‘Prana-Vayu that can be useful to ensure the survival of COVID-19 patients.
Prana-Vayu is based on the controlled operation of the prime mover to deliver the required amount of air to the patient. The automated process controls the pressure and flow rates in the inhalation and exhalation lines. Besides, the ventilator has feedback that can control tidal volume and breathe per minute. The ventilator will be useful for a wide degree of congestions in the respiratory tract and is applicable for all age group patients, especially the elderly. The prototype has been tested successfully for normal and patient-specific breathing conditions. Additionally, it does not require compressed air for functioning and can be especially useful in cases when hospital wards or open areas are converted into ICUs.
Similarly, Professor B S Murty, Director, IIT Hyderabad and Prof V Eswaran, Department of Mechanical and Aerospace Engineering, IIT Hyderabad have appealed to the government to consider the use of bag valve mask as an alternative to ventilators for tackling the shortage of this life-saving equipment in the country. Prof Murty says that this could be a good option to mitigate the shortage. Explaining how the bag valve mask works and how it can be an alternative to ventilators, he elaborates, “Most of the ventilators that we see in hospitals are computerised microprocessor controlled to supply air/oxygen at controlled conditions into a patient who has a respiratory problem. While they are sophisticated, they are also quite expensive and not easily portable. The bag valve masks are simple to use, less expensive and can be used at any location. In most of the cases, they are operated manually by compressing the airbag. However, these can be used with simple pneumatic or battery operated actuators to supply air/oxygen with better control.”
He further warns for certain caveats associated with these devices. “As most of these bag valve masks are operated manually, their effectiveness depends on the experience of the person handling them”, he mentioned.
While most of these innovations come as hope in these testing times, some create confusion. Can any portable system replace high-end life-saving devices in critical patients? Does low-cost mean low quality? But what if we don’t have enough devices to save the lives of millions, do we have a choice but to resort to what is available? How do the government bodies react to the available innovations in the country?
Dr Renu Swarup, Secretary, Department of Biotechnology (DBT), informs, “We need basic innovations which can address to the COVID-19 infection, that include disinfectant, sanitisers, PPE, and respiratory support systems like oxygen masks and ventilators, along with innovations in diagnostics which are quick and can be sensitive and specific, therapeutics which includes drugs, monoclonal antibody-based therapy, repurposed drugs and prophylaxis for frontline healthcare cadres. The global research community and we in India are also working on vaccine research to address the challenge. DBT and its Public Sector Unit (PSU) Biotechnology Industry Research Assistance Council (BIRAC), are working very closely with scientific research groups and the innovation ecosystem in India to support innovations in the above-mentioned areas. However, innovation needs to be validated following proper protocols and will have to go through proper regulatory approval. There are set procedures and systems in place by regulatory agencies for approval which need to be followed. If the innovations are validated using established regulatory guidelines and necessary approval, there should not be any repercussions.”
Likewise, Prof B Ravi from Biomedical Engineering and Technology (incuation) Centre (BETiC) says, “There are too many promises floating on the internet. It is to be noted that medical devices need to go through multiple levels of testing, first at the lab (biocompatibility, mechanical and electrical safety), then in hospitals, all with various regulatory approvals. After that, mass production (which requires people, equipment and materials), and transport to hospitals. So, many different entities need to work together closely for a new device to make a large-scale difference. The best option seems to be the tie-ups between existing manufacturers (whose devices like ventilators, masks, PPE etc., have already been approved and in production) with other large manufacturers (like Mahindra and Maruti), but even this has difficulties since automobile manufacturers do not have the quality management system for medical devices (ISO 13485) that is essential.”
Further, as informed by Dr Swarup, DBT has put together a major COVID-19 Consortium to support the development of medical equipment, diagnostics, therapeutics, drugs and vaccines to meet the healthcare challenges.
“The first indigenous kit is being developed by a start-up in Pune and manufacturing has been scaled up to produce nearly one lakh kits per week. With a manufacturing facility for indigenous development of ventilators, testing kits, imaging equipment and ultrasound and high-end radiology equipment set up in Vishakapatnam, the manufacturing will start in the first week of April as per the following targets. DBT, along with DCGI, has developed a Rapid Response Regulatory Framework to provide expedited regulatory approvals for all diagnostics drugs and vaccines. This has been notified. Vaccine development is being supported by three Indian industries and the proposal for having a manufacturing capacity ready for vaccine production for the Indian population is under development in discussion with the industry. Research on therapeutic and drug development has started in the DBT autonomous research laboratories”, she disclosed.
While these experts ascertain that every innovation that comes in will be closely watched and scrutinised at all levels, there is enough room for more innovations to flow in these difficult times. Being frugal indeed exhibits India’s true engineering talent but this contingency needs critical thinking.
Sharing a provider point of view, Dr Vijay D’silva, Director – Medical Affairs and Critical Care, Asian Heart Institute, Mumbai, opines that India requires innovation on multiple fronts, the most important being innovative strategies to tackle the spread. “One way to do it is by extensive screening. We also need to build more separate COVID-19 hospitals so that we can protect other patients from being infected and contain the spread. We need to build many quarantine units to accommodate the increasing number of patients. We also need more and more people to manufacture PPE for healthcare workers as there is a huge shortage and they are at a higher risk. Moreover, we need a disaster/epidemic resilient information system that can guide healthcare providers, government and patients in this health crisis.”
Dr D’silva rightly points out that India at this point needs innovation at multiple levels. The concept of frugality, therefore, becomes critical in the Indian context and in this present crisis, as it offers an opportunity to develop and deploy with minimal resources to meet the nation’s pre-eminent goals.
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