The Drugs Controller General of India (DGCI) is contemplating to set up a dedicated cell for supporting and regulating innovation and start-ups in the pharmaceutical sector in the country.

Speaking at the BioAsia summit in Hyderabad, the newly appointed DCGI Dr S Eswara Reddy stressed upon the need to bridge the gap between regulators and innovators. “As many innovators are scientists and researchers, they do not have much knowledge of drug regulations and procedures to handle it. This gap must be bridged. As part of this we have decided to set up dedicated support cells and regulate their innovations right from the beginning stage so that they do not face any regulatory hurdles in the later stage,” said Dr Reddy.

According to Dr Reddy, there are many start-ups which are coming in the pharma and allied segments and are clueless about regulations. As a result, they face a lot of problems. “Even in pharma sector there are many start-ups which are coming up and are facing regulatory hurdles which are affecting their performance. Unless innovators and regulators work in close coordination, industry cannot come up with innovative products which is the need of the hour,” Reddy pointed out.

Adding further, the DCGI felt that innovators need to know about the regulatory framework they have to comply with for market authorization or commercialisation of their products. “Bit players or start-ups working on innovative products or solutions can approach the cell at any stage for any purpose. By doing so they will get full support from the DCGI innovator regulatory cell and all hurdles relating to regulations will be cleared,” observed Dr Reddy.

Informing further on the timeline of formation of the new dedicated cell, the DCGI said that the tentative time period for setting up of the new innovation support and regulatory cell, will be 2-3 weeks period and it is expected to come up at the office of the Central Drugs Standard Control Organization in New Delhi.