India’s response to COVID-19: initiatives, strategies and clinical trends

Suman Ray

 email: suman@nistads.res.in

Summary:

WHO has defined Coronavirus disease 2019 (COVID-19) as a pneumonia of unknown cause detected in Wuhan, China. It was declared was declared a Public Health Emergency of International Concern on 30th January 2020 by WHO. There is no FDA-approved products to prevent or treat COVID-19 and the only therapeutic option left is supportive care, on the public health front, interventions like travel restrictions, quarantine, and case/contact isolation are other preventive measures. Lack of cure has put the healthcare system overloaded across the world. Outbreaks and emergencies have been declared by Government of India (GOI) from time to time: (a) Novel coronavirus 2019-24th February, 2020 (b) Nipah vurus, 7th August, 2018 and (c) Zika virus infection-26th May, 2017. “India ramps up efforts to contain the spread of the novel coronavirus” WHO reports.

 

The Central Drugs Standard Control Organization (CDSCO) of India has taken a series of actions designed to accelerate development of drugs, vaccines and diagnostics for use in the management of the COVID-19 pandemic. According to India’s CDSCO, it would be difficult to adhere to all the protocol and regulations while conducting clinical trials of COVID-19 drugs in the country, researchers would be forced to make some modifications. Although scientists and policymakers are actively involved in clinical research on COVID-19 however, only 1.2% of such trials currently take place in the country due to stringent regulations in place for human clinical trials. Both the Serum Institute of India and Cadila Healthcare are involved in developing a COVID-19 vaccine, although it is in the pre-clinical stage and human trials are yet to be conducted.

“India is now in a decisive phase of the response. Surveillance is playing a central role. Our entire field presence, including the National Public Health Surveillance Project, has been fully re-purposed to support the government to overcome this challenge,” says Dr Henk Bekedam, WHO Representative to India (WHO). According to CTRI database, total 13 Clinical trial (Interventional) of COVID-19 are undergoing in India and are currently registered in CTRI database. One trial is in phase 2 stage (Convalescent Plasma therapy) and is expected to be promising. Various hospitals in India are conducting clinical trials for COVID-19. The Serum Institute of India and Cadila Healthcare in India are involved in developing a COVID-19 vaccine, although it is in the pre-clinical stage.

COVID-19 pandemic threatens a global surge in substandard and falsified medical products either directly or indirectly related to COVID-19. Even if the cure is found, there are many barriers before global immunisation is feasible. Though Government of India (GOI) takes various initiatives, strategies and clinical trials to fight COVID-19, however, it needs to focus on COVID-19 epidemic in various dimensions.

Note: Manuscript to be communicated.

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