The Drugs Controller General of India (DGCI) is considering setting 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 recently appointed DCGI Dr. S Eswar Reddy stressed upon the need to need to bridge the gap between regulators and innovators.
“Many innovators and regulators are researchers and scientists; they don’t have much information of drug regulations and techniques to handle it. This gap must be crossed over. As part of this we have decided to set up dedicated support cells and regulate their innovations ideal from the beginning stage so that they don’t face any regulatory hurdles in the later stage,” said Dr. Reddy.
As indicated by Dr. Reddy, there are many new start-ups which are coming in the pharmaceutical and allied segments and are clueless regarding regulations.
Accordingly, they face a lot of problems. “And also in the pharmaceutical sector, there are many start-ups which are coming up and are facing regulatory hurdles which are influencing their performance. Unless innovators and regulators work in close coordination, the industry can’t come up with innovative products which are the need of the hour,” Reddy brought up.
Including further, the DCGI felt that innovators need to know about the regulatory structure they need to agree to for market authorization or commercialization of their products.
“Start-ups or bit players working on solutions or new products can approach the cell at any stage for any reason. By doing as such they will get full support from the DCGI innovator regulatory cell and all obstacles relating to regulations will be clear,” observed Dr. Reddy.
Informing further on the timeline of the formation of the new dedicated cell, the DCGI said that the provisional time period for setting up of the new innovation support and regulatory cell, will be 2-3 weeks period and it is relied upon to come up at the office of the Central Drugs Standard Control Organization in New Delhi.