The Central Drugs Standard Control Organisation (CDSCO) will soon set up a cell to facilitate flow of information pertaining to regulatory requirements to drug innovators.
The Innovation Support Regulatory Cell, as it is expected to be called, will seek to bridge the gap between the innovator in the life sciences, healthcare and medical devices sectors and the regulator.
Announcing the decision on the cell, exclusively for the purpose, Drugs Controller General (India) S. Eswara Reddy said the facility was expected to become operational within a couple of weeks. He made it public at the CEO Conclave organised as part of the BioAsia 2018 here on Friday, in which IT Minister K.T.Rama Rao and industry leaders, including Dr. Reddy’s Laboratories Chairman Satish Reddy, Biocon CMD Kiran Mazumdar Shaw and Sanofi’s Chief Scientific Officer Philip Larsen participated.
Later, responding to queries from media, Mr. Eswara Reddy said a facility like the cell was required to help the innovators understand what the regulatory requirements are to get marketing approval for a product. The CDSCO is under the Union Ministry of Health and Family Welfare.
Noting that innovators were primarily scientists and thus lack information about the regulatory requirements, he said the Cell would provide clarification to any innovator or start-up company on the entire spectrum of products, including medical devices.
“We will have dedicated manpower under this cell to design standard operating procedures and also put up a FAQ on our website,” he said, while adding that the current level of interaction was minimal.
On the other initiatives of his office, he said the focus was on promoting ease of doing business.
