HYDERABAD:The Drugs Controller General of India (DCGI) plans to set up a dedicated cell for supporting and regulating innovation and start-ups in the pharma sector.There is a need to bridge the gap between regulators and innovators, the newly appointed DCGI, Dr S Eswara Reddy, said at the BioAsia conference here on Friday.
This is required because often, innovators who are mostly scientists and researchers do not have knowledge of regulations and, as a result, face a lot of problems, he added. “Many start-ups are also coming up in pharma and allied segments and are clueless about regulation, which is affecting their performance. Unless innovators and regulators work in close coordination, industry cannot come up with innovative products, which are the need of the hour,” he noted.
According to the new DCGI, innovators need to know about the regulatory framework they have to comply with for market authorisation or commercialisation of their products. “Big players or start-ups working on innovative products or solutions can approach the cell at any stage for any purpose,” said Reddy.
The DCGI added that the new body, tentatively named Innovation Support and Regulatory Cell, will have a dedicated and trained staff to address the problems of innovators and start-ups. The proposed cell will be set up at the office of the Central Drugs Standard Control Organsiation at New Delhi within next two to three weeks.