Today, the pandemic of COVID-19 has created havoc across the world. During the times of this unprecedented crisis, tremendous amount of research is ongoing in the world to finda drug and vaccine against this dreaded disease. Across the globe, people are eagerly looking at the biopharmaceutical industry to come up with a drug and a vaccine.

The biopharmaceutical industry also is responding to this pandemic crisis with speed and agility. World over, various existing drugs are undergoing clinical trials for repurposing them to treat COVID-19. Some of the trial results have been published and these are now being approved by the regulators to be used for the patients under certain conditions. Also, new drug molecules are under clinical development to evaluate their safety and efficacy for treating COVID-19.

Vaccine research for COVID-19 is also undergoing at an unprecedented pace. Currently, >100 vaccine candidates are being evaluated in the pipeline and around 13 are already in the clinical development stage – at various phases of clinical trials. It is being hoped that towards the fourth quarter of 2020, pivotal phase 3 results of certain vaccines will be available and if the trials are successful, we expect them to be approved for emergency use authorization in this year itself.

Generally, it takes 10-15 years for development of a vaccine and to be approved by the regulators for its use in the general population. For a vaccine against COVID-19, everyone is working tirelessly to get this done in 12-18 months!

Thus, as can be seen, the bio-pharmaceutical industry and the research institutes are rising to the occasion once again – this time to find treatment options for COVID-19.

India too is in this race for developing indigenous vaccine candidates and the regulators have approved early phase clinical trials for some of them.

One thing that needs to be constantly followed is that while we are working with lightning speed – which indeed is the need of the hour – it is imperative for all the stakeholders to follow all the guidelines and regulations applicable for clinical trials. Each stakeholder needs to significantlyaccelerate their part and at the same time ensure that ethics and quality are always maintained.

As we are aware, the results of these clinical trials drive the policies and treatment protocols for COVID-19 in different countries. Thus, maintaining speed with quality and ethics is essential for all stakeholders. Patient safety has always been and will always remain of paramount importance in all that we do in drug development!

Is India a hub for clinical research? The answer is No!

Currently, we are not doing enough clinical research in our country. The numbers speak for themselves!

If we analyze data from a global clinical trials registry www.clinicaltrials.gov (a global platform where the clinical studies are registered before they are initiated), it is observed that <1.2% of these global studies are registered in India. India, as we all know, is the second most populous nation in the world, and has almost 1/5th of the global disease burden. With <1.2% of the clinical studies being done in India, it is evident that we need to do much more clinical research in India given the huge unmet medical needs of our Indian patients.

Is there a target for India to have a percentage share of the global clinical studies? The simple answer is No! We need to as much research in India that our patients require. Looking at the huge unmet medical needs of our Indian patients, we certainly need to increase our clinical research activities in India.

Can India do more clinical research for patients in India and in the World? Certainly Yes!

In India, and probably world over, clinical trial has almost become a household name. The results of clinical trials of drugs and vaccines to treat COVID-19 get widespread media coverage at times become a front-page news! People have started to understand the importance of clinical trials in the entire drug development process. Perhaps, they now realize that any drug that they or their family members consume today, has undergone these rigors of clinical trials.

India is certainly well-poised to do clinical research for the unmet medical needs of the patients in India and in the world. Few reasons for these are mentioned below:

• India has a well-balanced regulatory landscape –

o The government, policy makers and regulators are well-aligned with the view that India should do more clinical research activities. They strongly encourage drug research and development that will help not only the Indian patients but also the patients across the globe. They are keen to promote innovation in India and are very supportive of having more clinical research activities in India.

o The New Drugs and Clinical Trial rules 2019 are well-balanced regulations governing clinical trials in India. These rules protect the rights, safety and well-being of the trial participants and at the same time has made it convenient for researchers to conduct ethical and quality clinical trials in India.

o The timelines for clinical trial approval process have been significantly shortened and this gives a competitive edge to India when compared to many other countries.

• Has the requisite Infrastructure

o India has the skilled researchers to do these studies.

o We have hospitals across the country and many of them have good research centers of their own.

o Availability of trained skilled professionals across various stakeholder segments.

o Availability of significant number of institutional Ethics Committees that are registered with the regulators.

• Adoption of digital technology

o India has widely adopted digital technology in various fields, and these can be adopted for clinical research too.

o E-Medical records is slowly and steadily gaining acceptance across the hospitals in India. Having said this, this is one field where India must take a quantum leap to increase the adoption of e-Medical records across the hospitals.

In this fight against the unmet medical needs of our patients, India can take the lead to find newer treatment options. For this India has a lot to offer and at the same time, India still has a lot to do to take that quantum leap. India aims to become a globally recognized force in this crusade against dreaded diseases that will alleviate the sufferings of the patients.