Special address: Dr Chandrashekar Ranga, Guest of Honour, Deputy Drugs Controller, India, Central Drugs Standard Control Organisation (CDSCO)

Beginning the summit with a special address, Dr Chandrashekar Ranga, Guest of Honour, Deputy Drugs Controller, India, Central Drugs Standard Control Organisation (CDSCO), informed about the measures for handholding and fast tracking for approval of COVID-19 drugs/vaccines/devices. He notified that a total of 150 expert committee meetings were held in a year from the time COVID19 was declared a pandemic. Apart from it, pharma manufacturers were encouraged to share the safety, immunogenicity and efficacy data with the regulators as and when it was generated instead of waiting for the completion of the clinical trial, so as to enable continuous assessment/rolling review for reducing the processing time, he said.

In addition to it, he also mentioned that proposals of expansion of the existing manufacturing facilities or addition of new manufacturing sites formanufacturing of COVID-19 vaccines to ramp up the production of COVID-19 vaccines were inspected/reviewed andallowed on top priority by CDSCO.

He also put emphasis on the number of drugs and vaccines approved for treating and preventing COVID-19. These include vaccines by the Serum Institute of India, Bharat Biotech, Dr Reddy’s Cadila Pharma, Moderna, Biological E and Gennova Pharma. The drugs approved for treating the disease comprised Favipiravir, Remdesivir, Tocilizumab, Itolizumab, Baricitinib, Casirivimab, Imdevimab and Molnupiravir. Furthermore, over 254 IVD testing kits were also approved.

Besides this, he appreciated the efforts made by pharma manufacturers for dealing with the challenges posed by the pandemic. “Due to the combined efforts of manufacturers and government, Indian pharma was able to meet the challenges of the pandemic successfully,” he concluded.