HYDERABAD: IT and Industry Minister KT Rama Rao wrote to Union Minister of Health and Family Welfare Dr Harsh Vardhan, drawing attention to the complex system of vaccine regulation in the country and the need for a decentralised approach in the purview of the Covid-19 pandemic.
The Minister stated that the current process of the vaccine regulation in India was one of the most complex in the world.
“India has one of the most complex regulatory systems in the world for vaccine approvals. There are six different ministries at the Central and State level that give approvals for vaccines - Ministry of Health (GOI), Ministry of Animal Husbandry (GOI), Ministry of Science and Technology (GOI), Ministry of Commerce (GOI), Ministry of Environment and Forests (GOI), and Ministry of Health of State governments. It is recommended that India look at setting up a strict but simple and transparent regulatory regime to fast track development of vaccines and also the biotech industry in general,” he wrote.
He requested the Central government to instruct CDSCO to delegate more power and authority, with additional resources, to the CDSCO zonal office in Hyderabad.
In terms of expediting the procedure, the Minister suggested that a framework for parallel approvals for clinical trials be developed at the earliest.
“I request you to kindly constitute a high-level empowered committee to be formed with representation from relevant GOI officials, key State governments and the industry on an expeditious basis to a formulate a strategic plan to expedite the development to of vaccine from India for Covid-19, asserting our position as the global vaccine hub,” he concluded.